chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Activated partial thromboplastin time, Injection site nodule, Injection site pain, Platelet count, Prothrombin time
Clinical narrative: Information has been received from a health professional concerning a 26 year old female with a history of asthma, hypothyroidism and anxiety, who on 17-MAY-2007 was vaccinated IM with the third dose of Gardasil vaccine (Lot # 657736/0389U). There was no concomitant medication. On 18-JUN-2007, the patient experience nodule and tenderness at injection site, tender 3 in. down arm. Subsequently, the patient recovered from the nodule and tenderness at the injection site, tender 3 in. down arm. No product quality complaint was involved. No further information is available.
Age: 12.0
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Lymphadenopathy, Musculoskeletal pain, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 08-AUG-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast). Concomitant therapy included MENACTRA vaccine (dip toxoid) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 10-Oct-2007 the patient was vaccinated IM with the second dose of GARDASIL vaccine (yeast) (lot# 658219/0680U). Three to four days post vaccination of second dose, the patient had experienced supraclavicular adenopathy or severe pain above the shoulder blade. The patient had no problem with her first dose. Unspecified medical attention was sought. Subsequently the patient recovered. No additional quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Pruritus, Rash, Rash erythematous
Clinical narrative: Information has been received from a physician concerning a 16 year old female with an allergy to penicillin who on 05-OCT-2007 was vaccinated with her first and only dose of GARDASIL vaccine (yeast) ( lot and batch # not specified). There was no concomitant medication. On 05-OCT-2007 the patient developed a rash within a few hours of the vaccination on her arm and hand. Eventually the rash also appeared on the other arm and her legs as well. It all appeared on the same day as the vaccination. Unspecified medical attention was received. She still has some rash, but not as extensive and was reported as recovering. Additional information has been requested.  01/07/08 This is in follow-up to report(s) previously submitted on 11/14/2007. On 02-NOV-2007 follow-up information was received that the patient received first GARDASIL on 05-OCT-2007-several hours later complained of red rash on hands, gradually moving up arms to neck and down legs, some pruritis helped minimally by BENADRYL. Rash still present on 16-OCT-2007 although less noticeable. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient who on 09-AUG-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 658282/0929U). On 10-OCT-2007 the patient received the second dose (lot # 1265U). Five days after both doses the patient experienced nausea and vomiting. Unknown medical attention was sought. Subsequently the patient recovered a day after. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a physician concerning a 13 year old white female patient with an allergy to peanuts, who on 09-AUG-2007 was vaccinated with the first dose og GARDASIL (lot # 658282/0929U). On 10-OCT-2007 the patient received the second dose (lot # 659435/1265U). Vomiting began five days after both doses in association with stomach pain. "Self limited" occured after both doses. No fever and no rash. Missed 2-3 days of school. Unknown medical attention was sought. Subsequently the patient recovered. No product quality complaint was involved.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Hypertension
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old who was vaccinated with a first 0.5 ml dose of GARDASIL vaccine (yeast). Subsequently the patient experienced a high blood pressure of 200/100. Unspecified medical attention was sought. It was reported that the blood pressure eventually started to decrease after a week. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning a 25 year old female who on an unspecified date was vaccinated with GARDASIL vaccine (yeast) (lot # unknown) injection. The physician reported that the patient experienced severe pain after receiving the third dose of GARDASIL vaccine (yeast). No additional information was provided. This is one of two reports from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Eye swelling
Clinical narrative: Information has been received from a health professional concerning a 20 year old female patient who on 27-JUL-2007 was vaccinated IM in the left deltoid with the first dose of Gardasil vaccine. Three to four hours post vaccination, the patient developed a swollen left eye. Unknown medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a company representative concerning a patient who was vaccinated with GARDASIL vaccine (yeast). Subsequently the patient experienced "an adverse event which was called in after hours". No further details were provided. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure, Eye irritation
Clinical narrative: Information has been received from a 32 year old female medical assistant concerning herself and another female employee, who on 11-OCT-2007 was preparing a pre-filled syringe to vaccinate a patient with Gardasil(lot #653650/0640F). On 11-OCT-2007, the pre-filled syringe leaked onto the medical assistant's hand. She washed her hands with soap and water but experienced slight burning on her hand with no redness (reported in WAES #0710USA02796). It was also noted that the other employee helping at this time of vaccine administration was splashed in the left eye with the solution. The employee had a burning sensation in her eye. The employee rinsed her eye out. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a female consumer who was vaccinated with GARDASIL vaccine (yeast). Subsequently the patient reported she experienced a reaction (not specified). No further details were provided. Additional  information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Electrocardiogram, Nausea, Syncope
Clinical narrative: Information has been received from a nurse concerning a 22 year old female who on 11-SEP-2007 was vaccinated with Gardasil vaccine (lot #658488/0930U). On 11-SEP-2007, the patient fainted after she received the vaccine. She remained in the office for another 45  minutes due to nausea and lightheadedness. It was reported that the patient had not had anything to eat that day prior to the vaccination. There was no record of the patient hitting her head or losing consciousness. A brief neurologic exam was performed in the office with no neurologic deficit found. The patient had no pertinent medical history and no known allergies. Later in the day on 11-SEP-2007, the patient went to the emergency room and was given an electrocardiogram (results not provided) and IV fluids. The patient was not admitted to the hospital. The patient was not "100 percent" when contacted on 12-SEP-2007 and went to see her primary care physician on 13-SEP-2007. On 25-SEP-2007, the patient was contacted by the office and she was recovered at this time. No other information was provided. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Rash pruritic
Clinical narrative: Information has been received from a medical assistant concerning an 18 year old female with no medical history, who on 08-OCT-2007 was vaccinated with Gardasil vaccine (lot #658558/1061U). Concomitant therapy included Provera, which was started the same day as the HPV vaccine. On 15-OCT-2007, the patient experienced a red itchy rash to her chest, back and arms. The patient was seen in the office but no treatment was specified. The patient's red itchy rash persisted. No further details were provided. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a certified medical assistant, concerning a 20 year old female patient with no pertinent medical history and no known allergies, who on 11-OCT-2007 was vaccinated IM in the left deltoid, with the first dose, 0.5 mL of Gardasil (lot #659435/1265U). Concomitant Therapy included Ovcon-35. About 2 minutes after the vaccination, the patient passed out. She was lifted up and laid in a room, and a cold cloth was placed on her head. The patient recovered on the same day. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Epstein-Barr virus test negative, Mononucleosis heterophile test negative, Rash
Clinical narrative: Information has been received from a licensed practical nurse (LPN), concerning a 15 year old female patient, who on 20-JUL-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot #656051/0244U). Concomitant therapy included lorazepam. On 18-SEP-2007 the patient developed a rash of unknown origin. All lab tests, including testing for mononucleosis and Lyme disease, were negative. The LPN indicated that "many different treatment options" were tried, with no success. On 08-Oct-2007, the patient was vaccinated with the second dose of GARDASIL vaccine (yeast). At the time of this report, the patient had not recovered. Additional information has been requested. On 08-OCT-2007, the patient returned to the office with a rash over the same areas as previouls y described. Treatment included ATARAX. All lab tests, including testing for mononucleosis and Lyme disease, were negative. On 18-OCT-2007, an injection of BENADRYL was administered and a DECADRON/DEXpak was prescribed; the patient reported her mother had given her TAGAMET. On 30-OCT-2007, the patient was given XYZAL, continued on KENALOG and DECODRON were administered IN. The LPN indicated that "many different treatment options" were tried with no success. At the tiem of this report, the outcome of the events was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Information has been received from a certified medical assistant concerning a 24 year old female with a history of abnormal Papanicolaou smear and papilloma viral infection, who on 25-JAN-2007 was vaccinated intramuscularly with the first dose of GARDASIL vaccine (0.5mL) (lot # 654702/0011U), on 02-APR-2007 with the second dose of GARDASIL vaccine (lot # 656051/0244U) and on 10-SEP-2007 with the third dose of GARDASIL vaccine (lot # 658556/1060U) in the left arm IM. Concomitant therapy included SEASONIQUE. In approximately October 2007, following the third vaccination, the patient developed an injection site reaction. The patient called her physician and reported having a sore hard knot/lump at the injection site in the left arm the exact same spot where the patient recevied the vaccination (5 weeks prior). Medical attention was sought. At the time of this report, the patient had not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. The physician advised the patient to alternate area with heat and ice. The patient did well and there were no problems since.  on an unspecified date the patient recovered. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Skin laceration, Syncope
Clinical narrative: Information has been received from a nurse concerning a 12 year old female with no history of drug reactions/allergies, who on an unspecified date was vaccinated with a first dose of Gardasil vaccine. On 20-JUN-2007, the patient was vaccinated with a second dose of Gardasil vaccine. On 20-JUN-2007, 15 minutes after receiving the second dose, the patient fainted. The patient hit her head when she fell and needed stitches which was done by the physician in the office. At the time of reporting, the outcome was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a 12 year old female who on approximately 11-OCT-2007 was vaccinated with GARDASIL vaccine(yeast) and fainted after receiving the vaccine. Medical attention was provided, the event occurred in the office. The outcome was not reported. Additional information has been requested. This is in follow-up to report(s) previously sumitted on 11/14/2007. Information has been received from a  nurse concerning a 12 year old Hispanic female with no known allergies. At the time of being vaccinated, the patient had back pain, axilla pain, and her hands were red, hard, swollen when cold outside. On 11-OCT-2007, the patient was vaccinated with a first dose of GARDASIL (lot # 697006/0188U) IM in the right deltoid between 8:30 and 9:30 AM. On 12-OCT-2007, the patient was also given a first dose of HAVRIX (lot # AHAVB2078A) IM in the left deltoid between 8:30 and 9:30 AM and a first dose of MENACTRA IM in the left deltoid between 8:30 and 9:30 AM. On 12-OCT-2007, after leaving the room, the patient felt nauseated, dizzy, spit up phlegm, and fainted in the office. The patient was diagnosed with vasovagal response. Medical attention was provided. The outcome was not reported. No additional information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 21 year old female  patient who on 03-AUG-2007 was vaccinated in the left arm with a first dose of Gardasil vaccine. Concomitant therapy included hormonal contraceptives (unspecified). The patient experienced tingling, numbness and pain in her arm within minutes of receiving the dose. The patient sought medical attention. On 04-AUG-2007, the patient recovered. The Nurse Practitioner requested information on whether she should administer the 2nd dose, but was not involved in the administration of the first dose which was received at a health clinic. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blister, Body temperature increased, Pain, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter who on 11-JUL-2007 was vaccinated with her first dose of GARDASIL vaccine (yeast). On 01-AUG-2007, 20 days after receiving the first dose, the patient "came down with what was labeled a summer virus by her doctor". Her symptoms included fever of 103 which lasted a full 6 days accompanied by extreme achiness throughout her body and blisters which lined her throat. On 20-SEP-2007 the patient received her second dose of GARDASIL vaccine (yeast). On 02-OCT-2007, 12 days after receiving the second dose, the patient came down with the exact same symptoms she had in August. At the time of the report she was into the third day of symptoms with no relief. The reporter indicated that "the vaccination is the only common denominator in both instances. I spoke with my daughter's doctor regarding the possibility of my daughter's condition being a result of a reaction to the GARDASIL vaccine (yeast). She explained that because the drug is so new, there are not enough documented cases yet by which to make a conclusion and suggested, rather, that it is purely coincidence. They advised that if my daughter came down with the same symptoms after her third shot this coming January, it would most likely be attributed to the (vaccine) and would have to be reported. I am not certain I want to wait and experiment in such a way with my child's health. This virus or whatever it is she has really knocks her off her feet. Her throat is so sore that I have to coax her to eat mashed bananas.. She really suffers with it and, therefore, I am considering not going through with the third shot. I understand that all three shots are needed in order for the vaccination to be effective, but at this point, I am more concerned about the suffering my child has had to endure as a possible result of the vaccination. Additional information has been requested. Follow-up received 04/16/2008 indicated that the consumer received the third dose of the vaccine on 26-JAN-2008. The consumer's sister also had a similar reaction to GARDASIL (WAES#0710USA03615). Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge, Viral infection
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter who on 11-JUL-2007 was vaccinated with her first dose of GARDASIL vaccine (yeast). On 01-AUG-2007, 20 days after receiving the first dose, the patient "came down with what was labeled a summer virus by her doctor". Her symptoms included fever of 103 which lasted a full 6 days accompanied by extreme achiness throughout her body and blisters which lined her throat. On 20-SEP-2007 the patient received her second dose of GARDASIL vaccine (yeast). On 02-OCT-2007, 12 days after receiving the second dose, the patient came down with the exact same symptoms she had in August. At the time of the report she was into the third day of symptoms with no relief. The reporter indicated that "the vaccination is the only common denominator in both instances. I spoke with my daughter's doctor regarding the possibility of my daughter's condition being a result of a reaction to the GARDASIL vaccine (yeast). She explained that because the drug is so new, there are not enough documented cases yet by which to make a conclusion and suggested, rather, that it is purely coincidence. They advised that if my daughter came down with the same symptoms after her third shot this coming January, it would most likely be attributed to the (vaccine) and would have to be reported. I am not certain I want to wait and experiment in such a way with my child's health. This virus or whatever it is she has really knocks her off her feet. Her throat is so sore that I have to coax her to eat mashed bananas.. She really suffers with it and, therefore, I am considering not going through with the third shot. I understand that all three shots are needed in order for the vaccination to be effective, but at this point, I am more concerned about the suffering my child has had to endure as a possible result of the vaccination. Additional information has been requested. Follow-up received 04/16/2008 indicated that the consumer received the third dose of the vaccine on 26-JAN-2008. The consumer's sister also had a similar reaction to GARDASIL (WAES#0710USA03615). Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration
Clinical narrative: Information has been received from a physician concerning a 23 year old female who was vaccinated with a third 0.5 mL dose of Gardasil vaccine. Concomitant therapy included Advair. Subsequently, the patient developed a hard lump in her arm where she was vaccinated. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. The patient's hard lump in the arm persisted. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Eczema, Feeling hot, Rash, Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 19 year old female student who on an unspecified date was vaccinated with the first dose of Gardasil vaccine. On 05-OCT-2007(also reported as 08-OCT2007),  the patient was vaccinated with the second dose of Gardasil vaccine (lot # not reported). On 06-OCT-2007, the patient sought medical attention because she developed a warm raised eczema like rash on her face after receiving the second dose of vaccine. On 06-OCT-2007, she developed a pruritic rash on her cheeks. It was a vesicular rash with linear streaks on her cheeks and forehead. On 09-OCT-2007,  her cheeks felt warm to the the touch. She was treated with Benadryl, Keflex and Hydrocortisone 1% creme. On 12-OCT-2007, the patient was recovering. The patient was not planning on receiving her third dose. On an unspecified date the patient recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypotension, Immediate post-injection reaction
Clinical narrative: Information has been received from a health professional concerning an 18 year old female , who on 21-MAY-2007 was vaccinated with a second 0.5 dose of Gardasil vaccine (lot# 653938/0954F). Immediately after injection, the patient experienced lightheadedness and had a blood pressure of 104/60. The patient was placed in Trendelenburg position with her legs up and she felt better after 5 minutes. She was also given a snack and water. The patient recovered that same day. Subsequently, the patient recovered from lightheadedness. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Dizziness, Heart rate increased, Respiratory rate increased
Clinical narrative: Information has been received from a health professional concerning a 19 year old white female student who on 04-OCT-2007 was vaccinated IM with a first dose of GARDASIL vaccine (yeast) lot #658560/1062U. The reporter reported that approximately 5 minutes after the injection patient complained of lightheadedness. Her blood pressure measurement (BP) 88/58, Heart Rate (HR) 72 and Respiration Rate (RR) was 20 at that time. She was put in trendelenburg position and given snack and water. Her blood pressure measurement (BP) 100/58, Heart Rate (HR) 80 and Respiration Rate (RR) was 16. Within 10 minutes her lightheaded subsided. The patient recovered fully. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning 2 female patients (ages not reported) who on unspecified dates were vaccinated with a dose of Gardasil vaccine, injection (form), 0.5 mL. Concomitant medication was not reported. Subsequently, on unspecified dates after the patients received the Gardasil vaccine, they experienced lightheadedness and dizziness. Unspecified medical attention was sought. The outcome of the events was not reported. No product quality complaint was involved.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Arthralgia, Blood electrolytes normal, Cold sweat, Computerised tomogram normal, Dizziness
Clinical narrative: Information has been received from a physician concerning a 11 year old female with cold symptoms at the time of vaccination and no known drug reaction/allergies or concomitant medication use, was vaccinated (route and site not reported) at the end of September 2007 with Gardasil (dose and lot# not reported). On the same day, the patient was concomitantly vaccinated with Varivax (dose not specified), MENACTRA and BOOSTRIX. Ten minutes post vaccination the patient experienced lightheadedness, nausea and a headache. The patient became dehydrated and was hospitalized and stayed overnight. The patient was given IV fluids and IV pain medication for the headache. A CT scan and diagnostic lab test (electrolytes) were performed and results were normal. The patient had recovered 2 days post vaccination. The physician felt that the patient's lightheadedness, nausea, headache and dehydration were considered disabling and other important medical events. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Full blood count normal, Headache, Myalgia, Nausea, Pallor
Clinical narrative: Information has been received from a physician concerning a 11 year old female with cold symptoms at the time of vaccination and no known drug reaction/allergies or concomitant medication use, was vaccinated (route and site not reported) at the end of September 2007 with Gardasil (dose and lot# not reported). On the same day, the patient was concomitantly vaccinated with Varivax (dose not specified), MENACTRA and BOOSTRIX. Ten minutes post vaccination the patient experienced lightheadedness, nausea and a headache. The patient became dehydrated and was hospitalized and stayed overnight. The patient was given IV fluids and IV pain medication for the headache. A CT scan and diagnostic lab test (electrolytes) were performed and results were normal. The patient had recovered 2 days post vaccination. The physician felt that the patient's lightheadedness, nausea, headache and dehydration were considered disabling and other important medical events. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 11 year old female with cold symptoms at the time of vaccination and no known drug reaction/allergies or concomitant medication use, was vaccinated (route and site not reported) at the end of September 2007 with Gardasil (dose and lot# not reported). On the same day, the patient was concomitantly vaccinated with Varivax (dose not specified), MENACTRA and BOOSTRIX. Ten minutes post vaccination the patient experienced lightheadedness, nausea and a headache. The patient became dehydrated and was hospitalized and stayed overnight. The patient was given IV fluids and IV pain medication for the headache. A CT scan and diagnostic lab test (electrolytes) were performed and results were normal. The patient had recovered 2 days post vaccination. The physician felt that the patient's lightheadedness, nausea, headache and dehydration were considered disabling and other important medical events. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Blood electrolytes normal, Computerised tomogram normal, Dehydration, Dizziness, Headache
Clinical narrative: Information has been received from a physician concerning a 11 year old female with cold symptoms at the time of vaccination and no known drug reaction/allergies or concomitant medication use, was vaccinated (route and site not reported) at the end of September 2007 with Gardasil (dose and lot# not reported). On the same day, the patient was concomitantly vaccinated with Varivax (dose not specified), MENACTRA and BOOSTRIX. Ten minutes post vaccination the patient experienced lightheadedness, nausea and a headache. The patient became dehydrated and was hospitalized and stayed overnight. The patient was given IV fluids and IV pain medication for the headache. A CT scan and diagnostic lab test (electrolytes) were performed and results were normal. The patient had recovered 2 days post vaccination. The physician felt that the patient's lightheadedness, nausea, headache and dehydration were considered disabling and other important medical events. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Nausea
Clinical narrative: Information has been received from a physician concerning a 11 year old female with cold symptoms at the time of vaccination and no known drug reaction/allergies or concomitant medication use, was vaccinated (route and site not reported) at the end of September 2007 with Gardasil (dose and lot# not reported). On the same day, the patient was concomitantly vaccinated with Varivax (dose not specified), MENACTRA and BOOSTRIX. Ten minutes post vaccination the patient experienced lightheadedness, nausea and a headache. The patient became dehydrated and was hospitalized and stayed overnight. The patient was given IV fluids and IV pain medication for the headache. A CT scan and diagnostic lab test (electrolytes) were performed and results were normal. The patient had recovered 2 days post vaccination. The physician felt that the patient's lightheadedness, nausea, headache and dehydration were considered disabling and other important medical events. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Condition aggravated, Convulsion
Clinical narrative: Post HPV vaccine #2 -> patient complained of numbness right side extremity, difficulty speaking - hx AVM seizure disorder - vital signs 132/93 HR/132 PO 100 70 - transferred HUP ER - CT head negative
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Hypoaesthesia, Laboratory test, Speech disorder
Clinical narrative: Post HPV vaccine #2 -> patient complained of numbness right side extremity, difficulty speaking - hx AVM seizure disorder - vital signs 132/93 HR/132 PO 100 70 - transferred HUP ER - CT head negative
Age: 70.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Erythema, Influenza like illness, Swelling
Clinical narrative: Swelling and redness of entire bicep region of right arm from shoulder to elbow. Flu-like symptoms for one day and then cellulitis type infection as described above.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Dysphonia, Sleep disorder, Wheezing
Clinical narrative: Patient has developed wheezing and hoarseness throughout the night, waking multiple times (4 times - normally she sleeps through the night).  This morning, 16 Nov 2007 at 0530, she is still displaying these symptoms  At her checkup yesterday, she was healthy with no concerns.  I will call the doctor's office this morning to see what can be done to keep her comfortable.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pain, Pruritus, Rash, Swelling
Clinical narrative: SWELLING, REDNESS, PAIN, RASH, AND ITCHING
Age: 0.92
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives 24 hours after flu shot
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Cold compress therapy, Erythema, Oedema peripheral, Tenderness
Clinical narrative: Mother states left arm red, swollen, tender to touch.  Recommended cool compresses or ice to site with Tylenol or Ibuprophen for symptomatic relief.  Mother to call physician on 11/18/2007 of no improvement.
Age: 38.0
Sex: F
Vaccine: FLUN3
Symptoms: Aphonia, Cough, Headache, Influenza, Nausea
Clinical narrative: Flu symptoms appeared 36 hours later - fever, headache. naseua, loss of voice, coughing
Age: 38.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: Flu symptoms appeared 36 hours later - fever, headache. naseua, loss of voice, coughing
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Eye swelling, Urticaria
Clinical narrative: Day following vaccine administration (11/01/07), mother contacted our office stating patient woke up with hives on his face and torso. Patient was referred to either report to the ER or call their physician to be scheduled for an appointment. Mother called physician on 11/01/07 they suggested he take Benadryl and call them if child worsened or no better. Mother stated child was doing ok and on Friday morning (11/09/07) the child's eyes were swollen. Mother stated she called the physician and they saw the child. Child was placed on medication. The physician indicated that the child's hives could have been a result of the administered Meningococcal vaccine. Mother also kept an appointment with the physician for the child to be seen on 11/14/07.  11/16/07 Spoke with mother. Mother stated that the child is doing better. Advised mother to keep in touch with the physician for follow up care. Informed mother that event would be reported to the VAERS today.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Hyperhidrosis, Pain in extremity, Vomiting
Clinical narrative: Pneumonia Vaccine approx. 9:30am. Arm extremely painful several hours later. At approx. 6:00pm began to have chills, sweats, then experienced "waves of dizziness" and "threw up". Gradually felt better.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: dizziness last couple of days
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fatigue, Neck pain, Pain in extremity
Clinical narrative: Left arm and left neck hurt after shots. S/P Menactra and Boostrix on left arm, and HPV on right arm on 11/13, + feeling left neck pain on 11/14/07, worsed on 11/15/07, but arm pain getting better on 11/15/07, + feeling tirdness, fatigue, no vomiting, no HA.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Hyperhidrosis, Pain in extremity
Clinical narrative: Pneumonia vaccine approx. 9:30AM. Arm became painful 5-6  hours later. 9 or 10 hours later was suddenly soaked in sweat and experienced "waves of dizziness". (Wife experienced similar symptoms one hour earlier)Gradually felt better.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Dermatitis allergic, Erythema multiforme, Rash pruritic
Clinical narrative: puritic rash onset approx. 7am on 11/11/07, seen at Bloomington Hospital ED at 1:20pm 11/11/07, Decadron injection, Medrol Dose pack and Vistaril po.  Dx:  erythema multifomre and allergic dermatitis
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Swollen tongue
Clinical narrative: Patient received the flu shot (FluLaval, Lot # AFLLA053AA) at our health fair.  He developed swelling of the tongue with in six hours of taking the shot.  He had no previously known allergies to the vaccine components or contraindications to receiving the shot.  He called the employee health nurse(this writer) the next morning and reported the swollen tongue.  He was advised to see the doctor.  The doctor told him he had an allergic reaction to the flu vaccine.  She gave hime a steroid shot and advised him to get OTC Allegra as an antihistamine.  This morning (the 16th and two days after receiving the shot) he is back at work and reporting the the swelling has greatly decreased.  This writer does not know if the treating physician made a report of this episode.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne
Clinical narrative: The client has a pusy pimple on the middle finger of her left hand.  She stated that it was not painful.  She noticed the pimple on November 15, after recieving the vaccine on November 14.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chills, Dysphonia, Full blood count normal, Headache, Influenza serology negative
Clinical narrative: Severe headaches, fever, chills, pale, hoarse voice.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Mononucleosis heterophile test negative, Pallor, Pyrexia, Streptococcal identification test negative
Clinical narrative: Severe headaches, fever, chills, pale, hoarse voice.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: NOne
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Ecchymosis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Developed pain, swelling and redness at site of injection the following day.  This progressed to the point that child required an ER visit due to pain.  Patient has history of hemophilia so there was some concern that this was a muscle bleed, but his hematologist did not think that it was.  On 5 days after the injection, when I saw the patient, his entire upper arm had an erythematous almost ecchymotic appearance with several blister-like lesions.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Skin lesion
Clinical narrative: Developed pain, swelling and redness at site of injection the following day.  This progressed to the point that child required an ER visit due to pain.  Patient has history of hemophilia so there was some concern that this was a muscle bleed, but his hematologist did not think that it was.  On 5 days after the injection, when I saw the patient, his entire upper arm had an erythematous almost ecchymotic appearance with several blister-like lesions.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Crying, Mood altered, Movement disorder, Muscle rigidity, Musculoskeletal stiffness
Clinical narrative: Mom brought patient back to office about 20-30 minutes after discharge home.  Child had complained shortly after shot that her hands were tingling and she couldn't move them.  The patient was crying and upset when I saw her.  Both of her upper extremities were quite stiff distally especially the fingers which were extended and quite rigid.  With lots of coaxing she could bend them but was unable to squeeze my fingers.  She was treated with oral diphenhydramine to which she responded and she was discharged home within 45 minutes.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Paraesthesia
Clinical narrative: Mom brought patient back to office about 20-30 minutes after discharge home.  Child had complained shortly after shot that her hands were tingling and she couldn't move them.  The patient was crying and upset when I saw her.  Both of her upper extremities were quite stiff distally especially the fingers which were extended and quite rigid.  With lots of coaxing she could bend them but was unable to squeeze my fingers.  She was treated with oral diphenhydramine to which she responded and she was discharged home within 45 minutes.
Age: 1.42
Sex: F
Vaccine: MMRV
Symptoms: Pruritus, Rash
Clinical narrative: CHILD PRESENTED IN OFFICE WITH RASH ON CHEST, ARMS, AND BACK FOR ONE WEEK. GIVEN ATARAX FOR ITCHING.
Age: 66.0
Sex: M
Vaccine: FLU3, HEPA, PPV, TYP, VARZOS
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Patient developed redness/swelling in left arm within 24 hours of administration, swelling has extended to left wrist.  No systemic symptoms.  Patient provided NSAID and topical steroid therapy.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Ultrasound Doppler
Clinical narrative: Per nursing notes (8/28 at 1830): Patient c/o pain to R upper arm at site where pna shot was given on 8/28 site red, swollen red area approx 10x4 inches.  site marked.  MD paged.  Vanco ordered and apply hot packs. Patient has remained afebrile.  Received vanco 1g x 1 on 9/29 at 2300.  11/20/2007 MR receved for DOS 8/28-30/2007 with Discharge DX: Right neck nodule.  Local allergic reactions to Pneumovax RUE. Pt initially admitted for abdominal pain received Pneumovax prior to D/C.  Subsequently developed an area of erythema at injection site. Afebrile.  D/C delayed x 1 day for tx with abx.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling of body temperature change, Hyperhidrosis, Nausea, Pain
Clinical narrative: Pt. had Pneumovax and influenza shot both in the right deltoid.  Same day redness, pain, and swelling.  Pt. put ice on it and took ibuprofen, no better.  2 days after the shots, pt. felt hot and cold, had generalized aches, appeared pale, had nausea, and sweating.  In the office, pt. appeared pale, BP 96/68. pulse 112, temp 101.6 F.  No stridor/wheeze.  Area of erythema on right deltoid was 10cm circular, warm, raised.  Pt. was given liquid Benadryl, and liquid Motrin.  After 15 minutes, pt. feeling better, less nausea, BP improved to 108/68, pt. tolerating sips of water.  Total observation for 45 minutes.  Pt. ambulated out of office feeling somewhat better.  VS stable.  Instructed to continue liquid Benadryl and Motrin at home every 6 hours for generalized hives reaction.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pallor, Pyrexia, Skin warm, Swelling
Clinical narrative: Pt. had Pneumovax and influenza shot both in the right deltoid.  Same day redness, pain, and swelling.  Pt. put ice on it and took ibuprofen, no better.  2 days after the shots, pt. felt hot and cold, had generalized aches, appeared pale, had nausea, and sweating.  In the office, pt. appeared pale, BP 96/68. pulse 112, temp 101.6 F.  No stridor/wheeze.  Area of erythema on right deltoid was 10cm circular, warm, raised.  Pt. was given liquid Benadryl, and liquid Motrin.  After 15 minutes, pt. feeling better, less nausea, BP improved to 108/68, pt. tolerating sips of water.  Total observation for 45 minutes.  Pt. ambulated out of office feeling somewhat better.  VS stable.  Instructed to continue liquid Benadryl and Motrin at home every 6 hours for generalized hives reaction.
Age: 42.0
Sex: M
Vaccine: PNC
Symptoms: Encephalitis, Mental status changes, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Patient admitted 10/22/07 to 11/4/07 for mental status changes diagnosed with encephalitis.  MRI showed right temporal lobe signal c/w with HSV encephalitis. HSV testing was negative. Patient was treated with acyclovir and improved. 1/28/08-records received-presented to ED with C/O fall from his bicycle, witnesses indicated he just fell from bike. Acting strage with repetitive questioning and left sided weakness. Demonstrated left cerebellar functioning with corresponding ataxic gate. DX encephalitis.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Patient complained of a 'poison ivy like rash"at the injection site, she spoke with her primary care physician, who told her it was a common occurance for a flu shot and should not be anything to worry about
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Headache, Influenza serology negative, Pain, Pyrexia
Clinical narrative: Fever 104 F within 24 hours of vaccination.  Also has vomiting, dry cough, headache and body aches.  Treated with 7 day course of Tamiflu
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Fever 104 F within 24 hours of vaccination.  Also has vomiting, dry cough, headache and body aches.  Treated with 7 day course of Tamiflu
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Anencephaly, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy
Clinical narrative: Information has been received for the Pregnancy Registry for Gardasil from a physician concerning an 18 year old female patient with no pertinent medical history or drug reactions/allergies who on 27-AUG-2007 was vaccinated with a dose of Gardasil. There was no concomitant medications. The physician reported that the patient received Gardasil and became pregnant on an unspecified date. Her last menstrual period (LMP) was on 10-AUG-2007. The estimated delivery date would be 16-MAY-2008. Routine pregnancy panels laboratory tests were done. No result available. The physician reported that the fetus had acrenia and a therapeutic abortion was planned. No further information available. The outcome was unknown. In follow up telephone information it was reported by the medical assistant that patient was scheduled to be seen with a physician for the "abortion" on 13-NOV-2007. No further information was available at this time. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia haemolytic autoimmune, Antibody test positive, Antinuclear antibody positive, Cold agglutinins positive, Epstein-Barr virus antibody positive
Clinical narrative: Information has been received from a physician concerning a 15 year old female with no known medical history, drug reactions/allergies or concomitant medication use who at the end of August 2007 (exact date unknown), was vaccinated (site and route not reported) with the 1st dose of Gardasil (dose and lot# not reported). In the beginning of October 2007, the patient became very tired and later jaundiced with a low hemoglobin at 5. Laboratory evaluations revealed IgM positive to Epstein Barr virus, positive cold agglutinins, positive antibodies to mycoplasma and positive antinuclear antibodies (ANA). The patient was admitted to the hospital with Autoimmune Hemolytic Anemia for 2.5 weeks with blood transfusions given. The patient was discharged from the hospital (exact date not reported). The patient had been receiving steroids for approximately one week and was undergoing a steroid taper. The physician felt that the patient's tiredness, jaundice and Hemolytic Anemia were considered disabling and life threatening and other important medical events. No ongoing hemolysis at the time. At the time of this report the patient was recovering. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Haemoglobin decreased, Jaundice, Mycoplasma serology positive, Transfusion
Clinical narrative: Information has been received from a physician concerning a 15 year old female with no known medical history, drug reactions/allergies or concomitant medication use who at the end of August 2007 (exact date unknown), was vaccinated (site and route not reported) with the 1st dose of Gardasil (dose and lot# not reported). In the beginning of October 2007, the patient became very tired and later jaundiced with a low hemoglobin at 5. Laboratory evaluations revealed IgM positive to Epstein Barr virus, positive cold agglutinins, positive antibodies to mycoplasma and positive antinuclear antibodies (ANA). The patient was admitted to the hospital with Autoimmune Hemolytic Anemia for 2.5 weeks with blood transfusions given. The patient was discharged from the hospital (exact date not reported). The patient had been receiving steroids for approximately one week and was undergoing a steroid taper. The physician felt that the patient's tiredness, jaundice and Hemolytic Anemia were considered disabling and life threatening and other important medical events. No ongoing hemolysis at the time. At the time of this report the patient was recovering. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hemiparesis
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 16 year old female with a history of smoking and use of oral contraception who was vaccinated IM with a second dose of Gardasil. Concomitant therapy included hormonal oral contraceptives (unspecified). The nurse reported that after 2 months getting her second vaccination the patient had a stroke and she was hospitalized. The patient continued to have weakness on one side of her body. The patient was recovering. The reporter considered the event stroke as disabling and life threatening. Additional information has been requested. 7/4/08-records received for DOS 3/12-3/21/07-DC DX: Left-sided middle cerebral artery stroke with subfalcine herniation status post left-sided craniectomy for decompression. Presented with left-sided MCA stroke. Witnessed collapse to the ground had been exerting herself physically lately. PE: reflexes increased on right side, awakens to voice but does not follow commands, semipurposeful movement in left upper extremity. Consensus cause of stroke was postulated to be a combination of smoking and birth control pill use. Discharged to rehab. 7/9/08-ER report for DOS 3/11/07-non-responsive- 7/9/08-records received for DOS 4/6-4/9/08-DC DX: Encephalomalacia. During rehab hospitalization developed worsening headache and swelling in area of craniectomy flap, new baseline right-sided weakness secondary to stroke. Questionable LSD use.  Readmitted to rehab.
Sex: M
Vaccine: PNC
Symptoms: Gastric cancer
Clinical narrative: Subject in pneumococcal vaccine trial (not blinded) was diagnosed with gastric cancer. This is an SAE in our trial because it is 'New Cancer'. Relationship to study treatment is 'None'. The only further information we might obtain about this event would be the biopsy results.  Vaccination took place on 10/5/07 and diagnosis was made on 11/2/07.  We would be happy to forward the Study's SAE form upon request.  11/27/07 Reviewed study SAE form which reveals patient diagnosed w/gastric cancer on 11/2/07. FINAL DX: gastric cancer.