chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Feverish, very achy, arm where immunization given was very swollen and bright red, felt like I had been beaten all over, unable to do my work went to bed had sweats, woke up wringing wet. Applied ice pack to arm took Tylenol for pain and rested.
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, HPV4, IPV, MNQ, TDAP
Symptoms: Asthenia, Dizziness, Immediate post-injection reaction
Clinical narrative: Patient felt mild dizziness and weakness immediately after vaccines were given.  No loss of consciousness.  No breathing problems.  She was observed for about 30 min and fully recovered.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Pain and muscle ache runs down to my elbow.  Wasn't concerned until 3 days later and it still aches like a toothache and the aching runs down to my hand.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness, pain, itching to right upper arm, chills/sweating.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Immediate post-injection reaction, Injection site induration
Clinical narrative: Immediately after patient was injected with FLUVIRIN (flu vaccine) the patient developed an anaphylactic reaction requiring an EPI PEN injection on site and care at the local hospital. After the injection was given the patient complained of dizziness, tingling fingers, tachycardia, warm and hard injection site, and difficulty breathing. One EPIPEN was administered and an ambulance arrived 5 minutes after they were called.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site warmth, Paraesthesia, Tachycardia
Clinical narrative: Immediately after patient was injected with FLUVIRIN (flu vaccine) the patient developed an anaphylactic reaction requiring an EPI PEN injection on site and care at the local hospital. After the injection was given the patient complained of dizziness, tingling fingers, tachycardia, warm and hard injection site, and difficulty breathing. One EPIPEN was administered and an ambulance arrived 5 minutes after they were called.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Immediately after patient was injected with FLUVIRIN (flu vaccine) the patient developed an anaphylactic reaction requiring an EPI PEN injection on site and care at the local hospital. After the injection was given the patient complained of dizziness, tingling fingers, tachycardia, warm and hard injection site, and difficulty breathing. One EPIPEN was administered and an ambulance arrived 5 minutes after they were called.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pruritus, Rash, Skin warm, Swelling
Clinical narrative: Vaccine was administered 8/17/2010. On 8/19/10 patient reported rash, redness & swelling (about size of an apple) rash was warm to touch. Recommended ice & BENADRYL/hydrocortisone cream for itching, swelling. MD has appt w/her MD 8/21/10. Rash was much better on 8/22/10 per pt.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Cerebral ventricle dilatation, Congenital cerebellar agenesis, Drug exposure during pregnancy, Ultrasound scan abnormal
Clinical narrative: Initial report received on 23 August 2010: The patient was enrolled in a randomized, open label, single center, dose- and regimen-ranging study to evaluate immunogenicity, safety and tolerability of different formulations of S-OIV FLUVIRIN in healthy children and adults ages 3 to 64 years. Study vaccine was commenced on 29 Aug 2010 (7.5cmg with MF59). On 23 Aug 2010, the patient (see mother case PHHO2010CR12865) underwent prenatal control and an abdominal ultrasound revealed a presumptive cerebral congenital malformation due to agenesis of the corpus callosum and dilatation of the third ventricle. Another abdominal ultrasound was scheduled to define the diagnosis. At the time of reporting, the event was persisting. The investigator did suspect a possible relationship between the event and the study vaccine. Follow-up received on 24 Aug 2010 (prior to initial circulation): Study vaccine was commenced on 29 Aug 2009 (not 23 August 2010). On 13 Sep 2009, the mother received the second dose of study vaccine. Follow up received on 30 Aug 2010: The neonate's mother did not have any previous children born with congenital abnormalities or any previous spontaneous abortions. The neonates' mother's last menstrual period was on 08 Apr 2010. The pregnancy was confirmed on 20 May 2010. The estimated date of delivery was reported as 15 Jan 2011.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a female who in May 2008, was vaccinated with her first and only dose of GARDASIL. Subsequently the patient had local injection site reaction. The red and swollen area was approximately 20cm x 10cm. It was unknown if the patient sought medical attention. At the time of the report, the patient had recovered. Follow up information has been received from a registered nurse concerning a 12 year old female with obesity, anxiety, depression and attention deficit/hyperactivity disorder, who on 01-MAY-2008 was vaccinated with the first dose of GARDASIL (lot # 659653/1448U) IM in the right arm. Concomitant therapy included the first dose of BOOSTRIX (GSK) (lot # AC52B019AA) IM in the left arm on 01-MAY-2009 and the second dose of VARIVAX (MSD, lot # 659699/1768U) SC in the left arm on 01-MAY-2009. On 02-MAY-2008 the patient experienced redness and swelling at injection site, approximately 20cm x 10cm and painful. The patient was treated with KEFLEX with diagnosis of allergic reaction versus cellulitis. The patient did not seek medical attention. At the time of the report, the patient recovered on an unknown date. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Nephrotic syndrome
Clinical narrative: Information has been received from a practice administrator concerning a 19 year old female patient with a history of nephrotic syndrome and allergies to sulfa, cephalosporins and PEDIAZOLE who on 19-JAN-2007 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (Lot # 654702/0011U). On 16-MAR-2007 the patient was vaccinated intramuscularly with the second 0.5 mL dose of GARDASIL (Lot # 656049/0187U) and on 21-AUG-2007 the patient was vaccinated with the third dose of GARDASIL (Lot number was not recorded by the office). There was no concomitant medication. It was reported that the patient relapsed with her nephrotic syndrome in October 2007. The patient had been in remission with her nephrotic syndrome for 10 years prior to her relapse. The patient sought medical attention, her mother called the office. The reporter stated that the patient's adverse reaction was possibly related to therapy with GARDASIL. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Hypersensitivity, Skin test, Swelling, Urticaria
Clinical narrative: Information has been received from a medical assistant concerning an approximately 22 year old female patient with no pertinent medical history and no drug reactions or allergies who in May 2009 ("1 year ago"), was vaccinated with the first dose of GARDASIL.  The date of administration was unknown.  There was no concomitant medication.  Subsequently the patient experienced blurred vision and swelling.  She was evaluated at a local emergency room and was diagnosed with an anaphylactic reaction.  The patient was treated with BENADRYL and recovered on an unspecified date.  The patient was now referred to the reporting practice for allergy evaluation due to the history of anaphylactic reaction to her first dose of GARDASIL.  Because the event happened a year prior, and the patient lived and was treated in another state, no therapy or event details were available.  The physician's record did not contain the names of any of the patient's other physicians.  The health care professional contacted during telephone follow up could not supply the following information: date of vaccination, lot number, date of event, hospital name, and primary healthcare provider name and contact information.  Follow up information was received from the allergy and asthma physician who reported that the 22 year old female patient received her first dose of GARDASIL about one year ago.  In May 2009 ("several hours later"), the patient developed urticaria but no respiratory or circulatory compromise.  Therefore, while she appeared to have had a hypersensitivity reaction, it was not anaphylaxis.  Over the past year, the patient had several similar episodes of urticaria and anxiety, cause unknown.  The patient was recently seen by the physician who performed skin testing followed by administration of a dose of GARDASIL without incident.  There was no evidence of an IgE mediated reaction.  A vial of vaccine was being requested to replace the one used to make dilutions for allergy testing.  The patient wished to complete the vaccine series, and the physician felt that her urticaria was unlikely to be related to GARDASIL vaccine.  Additional information is not expected.  This is an amended report.  The adverse event "anaphylactic reaction" has been changed to "hypersensitivity reaction".
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred
Clinical narrative: Information has been received from a medical assistant concerning an approximately 22 year old female patient with no pertinent medical history and no drug reactions or allergies who in May 2009 ("1 year ago"), was vaccinated with the first dose of GARDASIL.  The date of administration was unknown.  There was no concomitant medication.  Subsequently the patient experienced blurred vision and swelling.  She was evaluated at a local emergency room and was diagnosed with an anaphylactic reaction.  The patient was treated with BENADRYL and recovered on an unspecified date.  The patient was now referred to the reporting practice for allergy evaluation due to the history of anaphylactic reaction to her first dose of GARDASIL.  Because the event happened a year prior, and the patient lived and was treated in another state, no therapy or event details were available.  The physician's record did not contain the names of any of the patient's other physicians.  The health care professional contacted during telephone follow up could not supply the following information: date of vaccination, lot number, date of event, hospital name, and primary healthcare provider name and contact information.  Follow up information was received from the allergy and asthma physician who reported that the 22 year old female patient received her first dose of GARDASIL about one year ago.  In May 2009 ("several hours later"), the patient developed urticaria but no respiratory or circulatory compromise.  Therefore, while she appeared to have had a hypersensitivity reaction, it was not anaphylaxis.  Over the past year, the patient had several similar episodes of urticaria and anxiety, cause unknown.  The patient was recently seen by the physician who performed skin testing followed by administration of a dose of GARDASIL without incident.  There was no evidence of an IgE mediated reaction.  A vial of vaccine was being requested to replace the one used to make dilutions for allergy testing.  The patient wished to complete the vaccine series, and the physician felt that her urticaria was unlikely to be related to GARDASIL vaccine.  Additional information is not expected.  This is an amended report.  The adverse event "anaphylactic reaction" has been changed to "hypersensitivity reaction".
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a consumer regarding a case in litigation concerning her niece who on an unspecified date was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). The patient had "devastating consequences" after she was given the vaccine. The reporter stated "if my sister had known all of the side effects she would not have given her daughter the vaccine. We are causing our most important commodity (our children) to suffer needlessly". No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Bronchospasm, Chest X-ray abnormal, Chest pain, Cough, Dizziness
Clinical narrative: Information has been received from a 26 year old female with no pertinent medical history and no drug allergies, who in February 2009, was vaccinated with the first dose of GARDASIL.  There was no concomitant medication.  She remained in the office for 15 minutes after her injection.  Upon driving home she became dizzy and tired.  She went home and laid down.  She then developed nausea and vomiting, a "very high fever and became really dizzy.  She was seen at the hospital and received phenergan and medication to lower her fever.  She was then discharged home.  She continued with flu-like symptoms and a week later developed "really bad chest pains."  She was seen by doctor.  A chest x-ray diagnosed her with pneumonia.  She was given an injection of ROCEPHIN in the office and sent home with a "z-pack" for 10 days.  She needed a second round of antibiotics that lasted for an additional 14 days.  The patient recovered within 2.5 weeks.  Follow up information received from a licensed practical nurse stated that the patient was seen in the office on 29-FEB-2009 stating she had been coughing up blood for 3 days and was treated as noted above.  In March 2009 a second chest x-ray for follow-up showed right lower lobe improved but pleural infusion noted since last study.  On 01-APR-2009 another chest x-ray was normal.  She was complaining of coughing, sent to pulmonologist, for post infection bronchospasm and was started on steroid.  She was last seen in the office on 01-APR-2009.  No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Haemoptysis, Influenza like illness, Nausea, Pleural effusion
Clinical narrative: Information has been received from a 26 year old female with no pertinent medical history and no drug allergies, who in February 2009, was vaccinated with the first dose of GARDASIL.  There was no concomitant medication.  She remained in the office for 15 minutes after her injection.  Upon driving home she became dizzy and tired.  She went home and laid down.  She then developed nausea and vomiting, a "very high fever and became really dizzy.  She was seen at the hospital and received phenergan and medication to lower her fever.  She was then discharged home.  She continued with flu-like symptoms and a week later developed "really bad chest pains."  She was seen by doctor.  A chest x-ray diagnosed her with pneumonia.  She was given an injection of ROCEPHIN in the office and sent home with a "z-pack" for 10 days.  She needed a second round of antibiotics that lasted for an additional 14 days.  The patient recovered within 2.5 weeks.  Follow up information received from a licensed practical nurse stated that the patient was seen in the office on 29-FEB-2009 stating she had been coughing up blood for 3 days and was treated as noted above.  In March 2009 a second chest x-ray for follow-up showed right lower lobe improved but pleural infusion noted since last study.  On 01-APR-2009 another chest x-ray was normal.  She was complaining of coughing, sent to pulmonologist, for post infection bronchospasm and was started on steroid.  She was last seen in the office on 01-APR-2009.  No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Pneumonia, Pyrexia, Vomiting
Clinical narrative: Information has been received from a 26 year old female with no pertinent medical history and no drug allergies, who in February 2009, was vaccinated with the first dose of GARDASIL.  There was no concomitant medication.  She remained in the office for 15 minutes after her injection.  Upon driving home she became dizzy and tired.  She went home and laid down.  She then developed nausea and vomiting, a "very high fever and became really dizzy.  She was seen at the hospital and received phenergan and medication to lower her fever.  She was then discharged home.  She continued with flu-like symptoms and a week later developed "really bad chest pains."  She was seen by doctor.  A chest x-ray diagnosed her with pneumonia.  She was given an injection of ROCEPHIN in the office and sent home with a "z-pack" for 10 days.  She needed a second round of antibiotics that lasted for an additional 14 days.  The patient recovered within 2.5 weeks.  Follow up information received from a licensed practical nurse stated that the patient was seen in the office on 29-FEB-2009 stating she had been coughing up blood for 3 days and was treated as noted above.  In March 2009 a second chest x-ray for follow-up showed right lower lobe improved but pleural infusion noted since last study.  On 01-APR-2009 another chest x-ray was normal.  She was complaining of coughing, sent to pulmonologist, for post infection bronchospasm and was started on steroid.  She was last seen in the office on 01-APR-2009.  No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Hypoaesthesia, Loss of consciousness, Oropharyngeal pain
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female student with a history of anxiety and with no known allergies at the time of injection who on 12-MAY-2009 was vaccinated IM at the left deltoid with the first dose of GARDASIL (Lot# 662300/0100Y) at approximately noon. Concomitant therapy included YAZ. On 12-MAY-2009 15-20 seconds after injection the patient experienced dizziness, diaphoretic, and loss of consciousness (LOC) for 15-20 seconds while upright in chair. The patient regained consciousness in 20 seconds. The patient reported throat soreness, feeling of swelling, syncope, ringing in ears and numbness at left "FA". The patient was given XYZAL 5mg orally. After 10 minutes the patient felt "normal" and symptoms resolved. The patient had no visible or palpable swelling in neck of pharynx. There was no SOB, stridor or on room air and respiratory rate and heart rate remained WNL. There was no rash. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling, Syncope, Tinnitus
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female student with a history of anxiety and with no known allergies at the time of injection who on 12-MAY-2009 was vaccinated IM at the left deltoid with the first dose of GARDASIL (Lot# 662300/0100Y) at approximately noon. Concomitant therapy included YAZ. On 12-MAY-2009 15-20 seconds after injection the patient experienced dizziness, diaphoretic, and loss of consciousness (LOC) for 15-20 seconds while upright in chair. The patient regained consciousness in 20 seconds. The patient reported throat soreness, feeling of swelling, syncope, ringing in ears and numbness at left "FA". The patient was given XYZAL 5mg orally. After 10 minutes the patient felt "normal" and symptoms resolved. The patient had no visible or palpable swelling in neck of pharynx. There was no SOB, stridor or on room air and respiratory rate and heart rate remained WNL. There was no rash. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Body temperature increased, Headache, Malaise, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with the second dose of GARDASIL (lot number not available). Subsequently, "the patient developed a fever of 104 degrees after receiving her second dose of GARDASIL". Unspecified medical attention had been sought. At the time of the report, the patient had recovered. Follow-up information has been received from a registered nurse concerning a 17 year old female with no illness at time of vaccination who at 3:15 PM on 13-JUL-2009 was vaccinated with the second dose of GARDASIL (lot#661766/0652X) IM into the left arm. About 90 minutes after receiving the vaccine, at 5:00 PM the patient experienced headache. She took ibuprofen but did not receive any relief until the second dose of ibuprofen was given 4 hours after the first dose. Symptoms progressed with fever 102 degrees F, stomach ache and general malaise. Fever continued over 4-5 days reaching maximum of 104 degrees F. Alternate doses of ibuprofen and acetaminophen were given to control fever. The patient called the doctor but was not seen by the doctor. There were no relevant diagnostic tests performed. 4-5 days post vaccination, the patient recovered. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Dizziness, Muscular weakness, Weight bearing difficulty
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient with asthma and rhinitis allergic who on 06-MAY-2009 was vaccinated with a first standard dose of GARDASIL (lot#661952/1129X) via intramuscular route. Concomitant therapy included VAQTA (MSD) (lot#659832/0932X) and VARIVAX (MSD) (lot#663322/0050Y). On 06-MAY-2009, after receiving the first dose of GARDASIL, the patient felt dizzy and leg weakness. The symptoms resolved the next day but reoccurred 6 days after vaccinations. The symptoms again resolved the next day. It was also reported that the patient received the first dose of GARDASIL from her pediatrician. Within 24 hours of receiving GARDASIL, the patient experienced generalized muscle weakness of her body. The patient had sought unspecified medical attention. No laboratory diagnostics study was performed. Follow-up information received from the physician indicated that on 06-MAY-2009, the patient received the first dose of GARDASIL (lot#661952/1129X) via intramuscular route, VAQTA (MSD) (lot#659832/0932X) via intramuscular route and VARIVAX (MSD) (lot# 663322/0050Y) via subcutaneous route. There was no illness at time of vaccination. On 15-JUL-2009, the primary medical doctor e-mailed the physician concerning the patient who had "extreme dizziness and leg weakness a few hours after the first dose of GARDASIL which recurred the next day and again 6 days later. The leg weakness was significant enough that the patient could not bear weight on the leg. It was reported that the patient did not require emergency room/doctor visit. At the time of report, the patient recovered. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning a 26 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 04-MAY-2009 was vaccinated with the first 0.5 mL dose of GARDASIL (Lot # 661846/1312X) intramuscularly. On 08-JUL-2009 the patient received the second 0.5 mL dose of GARDASIL (Lot # 662300/0100Y) intramuscularly. Concomitant therapy included NUVARING. It was reported that on 13-JUL-2009, five days after receiving her second dose of GARDASIL, the patient developed a 3-4 cm nodule on her left arm at the injection site. It was reported that the nodule was warm to the touch. There were no laboratory diagnostic tests performed. The patient sought medical attention with an office visit. It was reported that the patient had not recovered at the time of the report. Follow-up information has been received from a physician concerning to this patient with no known drug allergies or medical history. The physician reported that the patient on 12-JUL-2009 experienced left arm swelling, tenderness and induration. The patient performed a serial physical exam with no known results. At the time of this report, on unspecified date the patient recovered from left arm swelling, tenderness and induration.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Lip injury, Loss of consciousness
Clinical narrative: Information has been received from a nurse concerning a 22 year old female who on 16-JUL-2009 was vaccinated with the first dose of GARDASIL (lot# 660616/0570X) (dose, route not specified). On 16-JUL-2009 the patient passed out after receiving the first dose of GARDASIL. The patient recovered on 16-JUL-2009. The patient sought unspecified medical attention. Follow-up information has been received from a physician via medical records. It was reported that the patient was a female with no known drug allergies who on 16-JUL-2009, received the first dose (on right side, exact site not specified) of GARDASIL (lot # 660391/0063X, also reported as lot# 660616/0570X) at 10:00 am. There was no illness at time of vaccination. It was reported that the patient had an appointment with the physician for a physical exam. The patient received the vaccination and appeared fine and left the exam room and walked out to the front desk to check out. She was speaking at the check out desk and without any warning fell to the floor at 10:15. She was immediately assisted. The patient was unconscious briefly, bit her lip and hit her head on the floor pretty hard. It was reported that the patient had no deep laceration in her lip. She was left lying on the floor with ice on her lip and given smelling salts. She was moved to an exam room and monitored for about 2 hours and recovered. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Cold sweat, Dizziness, Nausea, Pallor
Clinical narrative: Information has been received from a physician concerning a 11 year old female with asthma and with no drug reactions/allergies who on 22-JUL-2009 or 23-JUL-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL. Concomitant therapies included FLOVENT and PROAIR. Within 5 minutes of the injection the patient developed chest pain, nausea, dizziness, feeling clammy and pale coloring. The patient was in the office at the time of the reaction. The patient was discharged home and then sent to the physician for follow up and to determine if the patient should continue with the GARDASIL series. The physician will not recommend continuing the GARDASIL series until additional information is obtained (not specified). At the time of report the patient's status was recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female with no pertinent medical history and no known allergies who on 29-JUL-2009 was vaccinated IM in the right arm with the first 0.5ml dose of GARDASIL (lot# 662229/1497X). There was no concomitant medication. The nurse reported that the patient had developed an injection site reaction on the back of the arm involving an area of 2 inches in wide and 4 inches in length on 30-JUL-2009. It was more of an oval-shaped area. She was itching, warmth and redness in that area. The nurse thought the GARDASIL might have been given in the back of the arm subcutaneously but she was not positive  The patient sought medical attention through an office visit. No lab diagnostics study was performed. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Swollen tongue, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female with asthma and penicillin allergy and some unspecified allergies, who on 31-JUL-2009 was vaccinated with her 2nd dose of GARDASIL (lot#662229/1497X). The date of the 1st dose was unknown. On the same day the patient experienced swollen tongue and hives on the right side of her face after the 2nd dose of the vaccination on 31-JUL-2009. There were no labs and diagnostic tests performed. The patient sought unspecified medical attention. At the time of the report. The patient's status was recovered. The nurse practitioner stated that the patient did not experience and adverse events after the first dose of GARDASIL. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning her daughter, a 16 year old female patient who on 24-JUL-2009, at 2:30 p.m. was vaccinated with a second dose of GARDASIL (lot#661953/1130X) intramuscularly in the right deltoid. On 27-JUL-2009, at 1:00 p.m., the patient's right arm was red, swollen and real sore, she also could not pick up her right arm very high. The nurse reported that the patient's right arm was hot to touch and from elbow to hands were turning a purplish blue. The patient was sent to emergency room. At time of report, the patient's outcome was unknown. Follow-up information has been received from the registered nurse concerning her daughter with penicillin allergy whose arm was red, swollen and very painful on 26-JUL-2009. On 27-JUL-2009, the registered nurse called back to report that the patient was instructed to elevate arm and to take BENADRYL, TYLENOL or MOTRIN for pain. At the time of the report, the patient recovered. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with no known drug reactions/allergies or pertinent medical history who on 04-AUG-2009 was vaccinated with the first dose of GARDASIL (LOT#661846/1312X). There was no concomitant medication. The physician reported that the patient fainted after administration of GARDASIL. No lab tests were performed. It was noted that the patient recovered while she was still in the office. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Arthralgia, Contusion, Dizziness, Electrocardiogram normal, Erythema
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female with no pertinent history and no drug reactions/allergies who on 07-OCT-2008 was vaccinated IM with the first 0.5ml dose of GARDASIL (Lot# 659184/0843X) and on 10-AUG-2009 was vaccinated IM with the second 0.5ml dose of GARDASIL (Lot# 662300/0100Y). The patient also received the second dose of VARIVAX (Merck) (first dose given on 02-DEC-1996) on 10-AUG-2009. Concomitant therapy included amoxicillin (manufacturer unknown). On 10-AUG-2009 the patient fainted after receiving the GARDASIL. The patient hit her head when she fainted and the left ear was bleeding around the earring. There was bleeding on the left side of the face and head. The patient also had left knee pain. The patient was alert and oriented during the time she was resting on a pillow. There was a red new bruise on the left cheek. The patient left after 20 minutes. The patient went to an unspecified emergency room on 11-AUG-2009 because she was feeling faint and was diagnosed with vasovagal syncope. Lab diagnostics studies performed: vitals checked at the office on 10-AUG-2009, EKG and blood work were normal at the emergency room on 11-AUG-2009. At the time of report the patient's status was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Haematology test normal, Haemorrhage, Head injury, Syncope
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female with no pertinent history and no drug reactions/allergies who on 07-OCT-2008 was vaccinated IM with the first 0.5ml dose of GARDASIL (Lot# 659184/0843X) and on 10-AUG-2009 was vaccinated IM with the second 0.5ml dose of GARDASIL (Lot# 662300/0100Y). The patient also received the second dose of VARIVAX (Merck) (first dose given on 02-DEC-1996) on 10-AUG-2009. Concomitant therapy included amoxicillin (manufacturer unknown). On 10-AUG-2009 the patient fainted after receiving the GARDASIL. The patient hit her head when she fainted and the left ear was bleeding around the earring. There was bleeding on the left side of the face and head. The patient also had left knee pain. The patient was alert and oriented during the time she was resting on a pillow. There was a red new bruise on the left cheek. The patient left after 20 minutes. The patient went to an unspecified emergency room on 11-AUG-2009 because she was feeling faint and was diagnosed with vasovagal syncope. Lab diagnostics studies performed: vitals checked at the office on 10-AUG-2009, EKG and blood work were normal at the emergency room on 11-AUG-2009. At the time of report the patient's status was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning an 11 year old female who was vaccinated intramuscularly with her second 0.5 ml dose of GARDASIL and fainted on 17-AUG-2009. Concomitant therapy included BOOSTRIX. It was not known if she had a similar experience after the first dose. The patient sought medical attention at the physician's office. The patient recovered the same day. Follow up information was received from a registered nurse (R.N.) concerning the 11 year old female student with no medical history or concurrent condition who on 17-AUG-2009 at 11:00 AM was vaccinated intramuscularly in the right deltoid with her first (also reported as the second dose) dose of GARDASIL (lot # 662300/0100Y). Concomitant therapy included the first dose of BOOSTRIX vaccinated intramuscularly in the left deltoid (lot#AC52B029AA) on 17-AUG-2009 at 11:00. There was no illness at the time of vaccination. On 17-AUG-2009 at 11:00 AM the patient experienced vasovagal syncope within 2 minutes of GARDASIL and BOOSTRIX administration. At the time of report the patient had recovered. No relevant diagnostic tests or laboratory data was collected. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Injection site nodule, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient with no medical history who on 18-AUG-2008 was vaccinated with the first dose of GARDASIL (0.5ml, lot # 660393/0067X). There was no concomitant medication. The patient developed nodule underneath the injection site which was sensitive and dark in color 4 months after the first vaccination, in December 2008. The patient was given corticosteroids (unspecified) injection and was referred to Dermatologist. The patient would not be getting any further doses. At the reporting time the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Laboratory test
Clinical narrative: Information has been received from a physician concerning his daughter with unspecified medical history, drug reactions or allergies, who on an unspecified date was vaccinated with the second dose of GARDASIL (route and lot # unknown). Concomitant medication was unspecified. The physician reported that after receiving the second dose of GARDASIL the patient experienced headaches. Lab diagnostic studies performed were unspecified. It was unspecified if the patient sought medical attention. At the time of the report the patient's outcome was unknown. Follow up information has been received. It was reported that the patient had not returned to the office. They did not receive any records of the patient and had not seen or heard anything regarding the patient. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure abnormal, Cold sweat, Dizziness, Hyperhidrosis, Mydriasis
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no pertinent medical history and no drug reactions/allergies who in June 2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL (Lot#662300/0100Y) in the left deltoid. On Monday, 24-AUG-2009, the patient was vaccinated IM with her second 0.5 ml dose of GARDASIL. Concomitant therapy included LO/OVRAL. Post vaccination the patient felt faint, had a weak pulse and blood pressure, was sweaty, clammy and her eyes were dilated. Doctor monitored the patient for about 20 minutes and administered oxygen. The EMT/ambulance was called but the patient was not transported to the hospital. Upon ambulance arrival the patient was feeling better. The patient had fully recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pulse pressure decreased
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no pertinent medical history and no drug reactions/allergies who in June 2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL (Lot#662300/0100Y) in the left deltoid. On Monday, 24-AUG-2009, the patient was vaccinated IM with her second 0.5 ml dose of GARDASIL. Concomitant therapy included LO/OVRAL. Post vaccination the patient felt faint, had a weak pulse and blood pressure, was sweaty, clammy and her eyes were dilated. Doctor monitored the patient for about 20 minutes and administered oxygen. The EMT/ambulance was called but the patient was not transported to the hospital. Upon ambulance arrival the patient was feeling better. The patient had fully recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure before pregnancy, Headache, Loss of consciousness, Palpitations, Tilt table test
Clinical narrative: Information has been received from a physician and an office worker, for the Pregnancy Registry for GARDASIL, concerning a 17 year old female who on 18-JUN-2007 was vaccinated with the first dose of GARDASIL (Lot # 657622/0388U). On 20-AUG-2007 the patient was vaccinated with the second dose of GARDASIL (LOT # 658282/0929U, expiration date 25-MAR-2010) and on 17-DEC-2007 she received the third dose of GARDASIL (LOT # 654540/1209U, expiration dated on 21-DEC-2009). There was no concomitant medication. Between the first and third dose of GARDASIL the patient developed headaches, blackouts and heart palpitations. The patient experienced these symptoms daily for two years and had blackouts 2-3 times daily. The results of tilt test were unspecified. The patient was prescribed TIPURIC (manufacturer unspecified) for epilepsy, but the physician believed this was a misdiagnosis and the patient was taken off the medication. In February 2009 the patient found out she was pregnant and the symptoms went away. After the baby was delivered on 28-JUL-2009 the headaches, blackouts and heart palpitations returned. The patient saw a neurologist who told the patient that her symptoms were from GARDASIL. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Blood test, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Information has been received from a consumer who is the patient's father and a medical assistant concerning an 18 year old female with penicillin allergy and a history of unspecified back problems who on 03-OCT-2007 was vaccinated with the first dose of GARDASIL (lot#658558/1061U). On 14-DEC-2007 and 25-APR-2008 the patient was vaccinated with the second dose (lot# 659055/1522U) and the third dose of GARDASIL. There was no concomitant medication. In fall of 2008, the patient started experiencing pain in her feet, ankles and knees. In June 2009, the patient complained about joint pain and "she cannot get out of her bed in the morning". The patient was seen by the physician last week and was diagnosed of rheumatoid arthritis. The blood test was performed with unspecified result. The patient referred to a rheumatologist for the treatment of rheumatoid arthritis. The medical assistant could not comment whether or not the condition was disabling or life threatening. At the time of the report, the patient had not recovered. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pyrexia
Clinical narrative: Information has been received from a physician's assistant concerning a 17 year old female with no pertinent medical history reported and no known drug allergies who on 16-JUL-2009 was vaccinated intramuscularly with the first 0.5mL dose of GARDASIL (lot number 660389/1968U), into the right arm. It was noted that the patient received a dose of DTAP (manufacturer unknown) and the first dose of MENACTRA, lot number U2621AA, intramuscularly into the left arm, on 09-JUL-2009. Six days after receiving the dose of GARDASIL, the patient developed a headache. She also had a temperature of 100 degrees F. No lab tests were performed. At the time of reporting, the patient had not recovered from headache and temperature of 100 degrees F. The patient sought medical attention by making an office visit. Follow-up information was received from the physician's assistant who reported that the patient on 09-JUL-2009 was also vaccinated with the first dose of DAPTACEL (previously reported as manufacturer unknown), lot number C3098AA, intramuscularly into the right arm in the morning. It was reported that on 22-JUL-2009 (also reported as 23-JUL-2009) the patient had severe headache with fever 100 degrees F. On 24-JUL-2009 the patient recovered. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Myalgia, Tenderness
Clinical narrative: Information has been received from a registered nurse (R.N.)concerning an 11 year old female who on 12-AUG-2009 was vaccinated with the first dose of GARDASIL (lot # 662300/0100Y) in her left arm. On 25-AUG-2009, "yesterday", the patient had decreased left shoulder mobility and was unable to move her left arm. The nurse stated the patient had myalgia in the arm. At the time of this report, the patient's symptoms persisted. The patient contacted the physician's office and sought unspecified medical attention. Follow-up information has been received from the registered nurse concerning the 11 year old female student with rhinitis allergic, no known drug allergies, and no illness at time of vaccination who 12-AUG-2009 at 9:30 was vaccinated IM with the first dose of GARDASIL in her left deltoid. There was no concomitant medication. On 25-AUG-2009 a.m. the patient experienced decreased movement of left arm, point tenderness left shoulder, reduced shoulder flexion and external rotation, no masses; full shoulder rotation, no deformity, swelling or tenderness of left arm. The patient had normal neurologic sensation. It was diagnosed with myalgia 729.1. The patient was instructed to rest, slowly resume activity, range of motion exercises, massage the affected area. The patient was treated with ibuprofen and heat prn. There were no laboratory studies performed. There were no adverse events following prior vaccination. The patient's mother called on 01-SEP-2009 and reported the patient had no symptoms and was doing well. The responsible physician consulted with Infectious Disease and will observe the patient for signs and symptoms of brachial plexitis. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Head injury, Laceration, Neurological examination normal, Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who on 31-AUG-2009 was vaccinated with dose of GARDASIL (lot number 663454/0672Y). Concomitant therapy includes "2 other vaccines" (dose and indication unknown). The physician reported that on 31-AUG-2009 the patient fainted in the hallway 15 minutes after receiving the GARDASIL. The physician reported that the patient had 1/4 inch laceration in her head and was taken to the ER. At the time of the report the patient's outcome was recovered. Follow up information has been received from a registered nurse concerning a 12 year old female student who on 31-AUG-2009 was vaccinated into left arm with a first dose of GARDASIL (lot number 663454/0672Y). Concomitant vaccination on the same day included a second dose of FLUZONE (Sanofi, lot# V3190AA) and a second dose of HAVRIX (GSK, lot# AHAVB357CA) in the patient's right arm. Subsequently, the patient fainted in hallway exiting room and hit her head with laceration. Neurological examination was normal. The patient was sent to ER for suture. At the time of the report, the patient had recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Electromyogram normal, Fibromyalgia, Laboratory test normal, Musculoskeletal pain, Myalgia
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 08-SEP-2009 was vaccinated with a first dose of GARDASIL (lot# 663453/0249Y). Concomitant vaccination on the same day included a dose of MENACTRA. After receiving the first dose of GARDASIL the patient experienced soreness in her shoulder, the specific shoulder was unspecified, and muscles. The physician reported that the patient was sent to see a neurologist and any test done came back negative. So the patient was then sent to see a rheumatologist and was diagnosed with fibro myalgia. At the time of the report, the patient had not recovered. Follow up information from the physician indicated that on 08-SEP-2009 the patient received the first dose of GARDASIL and concomitantly received a dose of MENACTRA (lot# U3021AA). After the patient received the first dose of GARDASIL she experienced soreness in her shoulder and muscles. The patient had a normal electromyography (EMG) test and other tests (not specified) that were performed, which were normal. The patient was diagnosed with Fibromyalgia. The physician considered the patient's condition to be disabling and not life-threatening. The patient was not hospitalized. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Borrelia test negative, Dizziness, Headache, Hypoaesthesia, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with no pertinent medical history and no drug allergies, who on 11-MAR-2009 was vaccinated with her first dose of GARDASIL (0.5ml, IM, lot # 662404/0312Y) in the left arm. There was no concomitant medications. Two hours after the second vaccination, the patient developed dizziness, vomiting, numbness/tingling to the left arm and both legs. On 16-SEP-2009 the patient experienced numbness in her feet. There were no labs and diagnostic tests performed. No reports of adverse effects after the first vaccination. The patient made a phone call for medical attention. At the time of the report, the patient was not recovered. Follow up information has been received from a registered nurse concerning a 15 year old female with no known drug allergies, who on 11-MAR-2009 at 9:30 am was vaccinated with the second dose of GARDASIL (lot # 662404/0312Y) IM in the left arm deltoid. The patient's mom called after the patient received injection and stated that her daughter was experienced dizziness, vomiting, headache and tingling of the left arm and both feet on 15-SEP-2009. The patient went to neurologist on 17-SEP-2009 for further evaluation, and her examination was negative. The Lyme's test was negative. The neurologist did consider Guillain-Barre syndrome because of symptoms. The outcome was not reported. Follow up information has been received on 10-MAR-2010 via a phone call from the medical assistant stated that after the patient had received the second dose of GARDASIL, she complained of headache, nausea and left upper extremity tingling. The medical assistant reported that the patient's "numbness improved". The patient was referred to a Neurologist for a Neurology evaluation. It was reported that the patient's father reportedly had a past history of Guillain-Barre syndrome, (GBS) "several years before". The neurologist documented that the patient's symptoms and neurology exam findings were not suggestive of GBS or Transverse Myelitis. Additional information has been requested.