chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Immediate post-injection reaction, Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on about 22-FEB-2007 was vaccinated with a dose of Gardasil. On 22-FEB-2007, immediately following vaccination, the patient experienced nausea and headache. Shortly thereafter, the patient experienced vomiting and developed a fever which lasted for 1.5 days. Unspecified medical attention was sought. The symptoms resolved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female teenager who on 18-JUL-2007 was vaccinated with a dose of Gardasil. On 18-JUL-2007, the patient experienced syncope. The patient outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Pain
Clinical narrative: Information has been received from a health professional concerning a 12 year old female with no pertinent medical history who on 14-MAY-2007 was vaccinated IM in the deltoid ("which arm unknown") with the first 0.5 ml dose of Gardasil. There was no concomitant medication. On 14-MAY-2007, the patient developed pain. Unspecified medical attention was sought. Subsequently, after a "couple of days" the patient recovered from pain. On 17-JUL-2007, the patient was vaccinated IM in the buttocks with the second 0.5 ml dose of Gardasil (lot #657872/0515U). This is one of two reports received from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia universalis, Antiphospholipid antibodies, Laboratory test, Vaccine positive rechallenge
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a physician and a 21 year old female consumer who in the end of 20-JAN-2007, was vaccinated with the first dose of GARDASIL. There was no concomitant medication. Subsequently, the patient developed alopecia universalis. On 10-FEB-2007, "one week after receiving the first dose," 25 percent of the patient's hair fell out in clumps. It was reported that the hair she lost after the first dose had begun to grow back. In March 2007, the patient was vaccinated with the second dose of Gardasil. One week after receiving the second dose, "all her remaining hair fell out so that she was completely bald." Unspecific medical attention was sought. Laboratory tests performed included a "lupus test" (results not reported). It was reported that she will not be receiving the third dose. It was reported that the hair she lost after the second dose had not begun to grow back. At the time of the report, the patient was recovering. Additional information has been requested.  9/25/07 Reviewed rheumatologist medical records of 4/10-8/28/2007 which reveal patient experienced alopecia starting approx 2/10/07 after tanning session.  Whe then developed other problems: abnormal thyroid, iron deficiency, nose ulcers, rash on face, neck & hands, worsening pain of wrists & hands, intermittent left knee swelling & pain, pleuritic chest pain, back pain, migraines w/nausea & photophobia since 10/06, dry eyes, diffuse myalgias, paresthesias, 9# weight loss, night sweats, palpitations.  Saw dermatologist & had injections which resulted in some hair loss in other areas. Hair loss continued on subsequent visits becoming more global.  Referred for endocrine evaluation secondary to birth control pills.  6/11/07 developed raw urticarial skin lesions. By 7/19 began to have return patchy hair growth. FINAL DX: alopecia areata universalis.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypersomnia
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow up information has been received from a physician's office concerning a 16 year old female patient who feels like fainting, nausea with most vaccines and fear of needles who on 26-JUN-2007 at 10:30 AM who was vaccinated in to right arm with a first dose of GARDASIL. Concomitant therapy includes MMR. The patient went home and felt like she was going to faint but she never fainted after receiving her first dose of GARDASIL. The office also reported that the patient slept for a "really long time". The patient sought unspecified medical attention. The patient recovered. Additional information has been requested. In follow up it was indicated that patient had nausea and she fainted in the office. On 29-JUN-2007 the patient recovered. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Injection site irritation, Myalgia
Clinical narrative: Information has been received from a certified medical assistant concerning multiple patients who were vaccinated on unspecified dates with Gardasil (lot #'s unknown). The certified medical assistant reports that 80 percent of the patients in her office who have received Gardasil have experienced injection-site irritation and muscle soreness. No other information was available. Additional information is being requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with her first dose of Gardasil. Subsequently the patient experienced fainting episode. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Antiphospholipid antibodies negative, Antithrombin III, Blood homocysteine normal, Blood test normal, Cardiolipin antibody negative
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with LOVENOX and is currently being treated with COUMADIN. Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.   7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian  from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX:  Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on COUMADIN.  ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on COUMADIN.  This is in follow-up to report (s) previously submitted on 8/14/2007. On 18-APR-2007, a doppler ultrasound was performed reporting a positive DVT in the left I.J. and proximal subclavian vein. A CT venogram was also performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Deep vein thrombosis was considered to be life threatening. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Coagulation factor V level normal, Coagulation factor decreased, Deep vein thrombosis, Immunology test normal, Protein C
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with LOVENOX and is currently being treated with COUMADIN. Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.   7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian  from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX:  Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on COUMADIN.  ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on COUMADIN.  This is in follow-up to report (s) previously submitted on 8/14/2007. On 18-APR-2007, a doppler ultrasound was performed reporting a positive DVT in the left I.J. and proximal subclavian vein. A CT venogram was also performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Deep vein thrombosis was considered to be life threatening. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Protein total normal, Prothrombin level normal, Skin discolouration, Subclavian vein thrombosis, Ultrasound Doppler
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with LOVENOX and is currently being treated with COUMADIN. Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.   7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian  from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX:  Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on COUMADIN.  ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on COUMADIN.  This is in follow-up to report (s) previously submitted on 8/14/2007. On 18-APR-2007, a doppler ultrasound was performed reporting a positive DVT in the left I.J. and proximal subclavian vein. A CT venogram was also performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Deep vein thrombosis was considered to be life threatening. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Venogram
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient with no medical history or allergies who on 05-OCT-2006, was vaccinated IM into her left arm with a first 0.5ml dose of Gardasil (Lot# 653937/0637F). On 21-DEC-2006, the patient was vaccinated IM into her right arm with a second 0.5 ml dose of Gardasil (Lot# 654885/1424F) and on 10-APR-2007 she was vaccinated IM into her left arm with a third 0.5ml dose of the vaccine (Lot # 655322/0091U). There was no concomitant medication. On 18-APR-2007, the patient developed a deep vein thrombosis in her left arm after her third dose of the vaccine. It was reported that the patient was initially treated with LOVENOX and is currently being treated with COUMADIN. Laboratory diagnostic studies performed included Prothrombin, protein C, factor V Leiden, anticardiolipin antibodies, Homocysteine, Antithrombin III and Lupus Anticoagulant. All were reported to be within normal limits. A doppler ultrasound and a CT venogram were also performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.   7/7/08 ER visit dated 7/02/07 and labs from 4/18/07-2/11/08. Pt seen in ER for c/o L arm tingling, color changes and swelling following a DX of DVT of L subclavian  from 4/18/2007. PE (+) for hyperemia of the L arm, venous engorgement of the L arm, L jugular, and the L lingual area, resolving colatereralization of the L chest wall venous systems. DX:  Hyperemia of Left Arm, Deep Vein Thrombosis by hx, Hypocoagulation 2' to Warfarin. 7/15/2008 MR received for OVs 4/23/2007-10/26/2007 . Seen in f/u for ER visit with DX: Thrombus Left carotid jugular. Pt started on COUMADIN.  ER f/u again 7/13/07 with Assessment: DVT with L arm paresthesias. Doing well by 5/10/07 on COUMADIN.  This is in follow-up to report (s) previously submitted on 8/14/2007. On 18-APR-2007, a doppler ultrasound was performed reporting a positive DVT in the left I.J. and proximal subclavian vein. A CT venogram was also performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Deep vein thrombosis was considered to be life threatening. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician assistant concerning a 24 year old female patient with no medical history or allergies who on 08-JAN-2007, was vaccinated IM with a first dose of Gardasil (Lot # 655165/1425F). On 15-MAR-2007, the patient was vaccinated with a second dose of Gardasil (Lot# 655324/0088U). Concomitant therapy included hormonal contraceptives (unspecified). Subsequently, after both vaccinations the patient experienced shooting pains in the arm and neck on the side of the injection. The pain lasted for about a month each time. The physician assistant did not know which arm was used for the injections. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. No product quality complaint was involved. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Rash generalised
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female with a history of tonsillectomy and wisdom teeth removal and no drug reactions or allergies who on 17-JUL-2007 was vaccinated with a first dose of Gardasil (lot # 0469U) one pre-filled syringe IM. Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ). On 17-JUL-2007 3 hours after the patient was vaccinated with Gardasil the patient developed a rash. The rash was approximately 200 lesions that "looked like acne" at the injection site of the right deltoid and spread to the patient's back, chest and right breast. There were no lesions on the left arm. Medical attention was sought. The patient took diphenhydramine hydrochloride (BENADRYL) for a complaint of slight itching to the lesions. After the patient's second dose of diphenhydramine hydrochloride (BENADRYL) the patient stated that the rash "got a little better". At  the time of reporting the patient was still recovering. No additional information was available. Additional information has been requested.
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a medical assistant concerning a female who was vaccinated with Gardasil. Concomitant therapy included DTaP. Subsequently the patient "went to the hospital". Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Information has been received from a pharmacy student concerning a 20 year old white female who in May 2007, was vaccinated with a first dose of Gardasil (lot # unknown). There was no concomitant medication. The patient developed a widespread rash and itching 24 hours after administration of her first dose of Gardasil. Medical attention was sought. The patient was evaluated at a local emergency room and was treated with a steroid injection as well as a course of oral steroids. At the time of reporting on an unknown date the patient recovered from the widespread rash and itching. No further information was available. Follow-up information was received. The patient  had no illness at the time of the vaccination and a drug allergy to penicillin. The patient was vaccinated on 12-JUN-2007 (previously reported as May 2007) with a first dose of GARDISIL at 10:45AM. On 13-Jun-2007, the patient had hives around stomach, legs, arms and face at 2:00PM. The physician gave a BENADRYL shot. On 21-JUN-2007 the patient recovered. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Rash macular, Rash pruritic
Clinical narrative: Information has been received from a mother concerning her 22 year old daughter with no pertinent medical history or drug reactions/allergies who on 06-JUN-2007 was vaccinated with a first dose of Gardasil (lot # unknown) and Recombivax (manufacturer unknown) was administered. On 13-JUL-2007 the female was vaccinated with a second dose of Gardasil. Concomitant therapy included Recombivax (manufacturer unknown) (lot # unknown) for prophylaxis (duration and dose not reported). In July 2007 at an unspecified time after the second dose, her daughter started "breaking out" with red, itchy spots on her arm or arms. She is not sure which are or arms have developed the spots. Medical attention was sought, a dose of At the time of reporting the female patient had not recovered. No further information is available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who on approximately 05-JUL-2007 was vaccinated with a dose of Gardasil. On approximately 05-JUL-2007, the "patient fainted while still in the office". Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of Gardasil. Subsequently the "patient fainted after receiving Gardasil". Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure normal, Hypoaesthesia, Nausea, Pallor, Paraesthesia
Clinical narrative: Information has been received from a medical assistant concerning a "9 to 14" year old female who was vaccinated with a dose of Gardasil. Subsequently, the patient experienced tingling and numbness in her arm, nausea and it was reported that the patient's "face turned white." Her blood pressure was satisfactory. The "patient was in the office for an hour to an hour and a half and then was sent home." The patient outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 18-JUL-2007 was vaccinated with a dose of Gardasil. Concomitant therapy included Menactra. On 18-JUL-2007 the patient fainted after vaccination with Gardasil while still in the office. Unspecified medical attention was sought. On 18-JUL-2007 the patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a females who was vaccinated in 2007 with a first dose of Gardasil. Subsequently, both patient fainted. Unspecified medical attention was sought. The patient recovered from fainting before leaving the office. No laboratory or diagnostic tests were performed. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who on 17-JUL-2007 was vaccinated with a dose of Gardasil. On 17-JUL-2007 the "patient received a dose of Gardasil and fainted. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a female who was vaccinated IM with a dose of Gardasil. It was reported that the patient may have received more than one other unspecified vaccination. Subsequently, the patient fainted. The patient did not seek medical attention. The patient outcome was unknown. This is one of three reports from the same source. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated IM with a dose of Gardasil. Subsequently the patient experienced dizziness and nausea for approximately 15 minutes after the vaccination. (The patient did not have anything to eat or drink prior to the office visit). Medical attention was sought. The patient recovered from dizziness and nausea. No product quality omplaint was involved.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of Gardasil concomitantly with "other vaccines". The patient reported that the Gardasil injection was painful. The patient outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Syncope
Clinical narrative: Information has received from a licensed practical nurse concerning a female who was vaccinated IM with a dose of Gardasil. It was reported that the patient may have received more than one other unspecified vaccination. Subsequently, the patient fainted. The did not seek medical attention. The patient outcome was unknown. This is one of three reports from the same source. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenectomy, Lymphadenopathy
Clinical narrative: Information has been received from a pharmacist concerning a female who was vaccinated with a dose of Gardasil. Subsequently the patient developed lymphadenopathy. The pharmacist thought that the patient went to the emergency room, but was unsure whether the patient was admitted to the hospital. The pharmacist also believed that the lymph node was removed, but was not aware which procedure was utilized for the removal. The patient visited the emergency room, however it is unknown if the patient was hospitalized. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a registered nurse concerning her 18 year old daughter with a penicillin allergy who on 12-JUN-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy administered on 12-JUL-2007 was Havrix. Subsequently the patient's menstrual cycle was interrupted. The patient's menstrual period was due on 28-JUN-2007, and at the time of the report the patient had not received her menstrual period. The patient's menstrual cycle was usually 30-35 days. The mother confirmed that the patient is not pregnant. There were no laboratory or diagnostic tests performed. At the time of the report the patient's outcome was unknown. No further information is available.
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Hyperhidrosis, Nausea, Syncope
Clinical narrative: Information has been received from a physician concerning a female (age not reported) with no drug reactions/allergies who on 19-JUL-2007 was vaccinated with a first dose of Gardasil (lot# unknown) 0.5 mL injection. Concomitant therapy also given on 19-JUL-2007 included MENACTRA and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 19-JUL-2007 the patient experienced nausea, sweating and fainted. Medical attention was sought. The patient recovered within half an hour. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Syncope
Clinical narrative: Information has been received from a nurse concerning a female (age not reported) who just had back surgery with a history of depression and anxiety who on an unspecified date was vaccinated with a first dose of Gardasil (lot # unknown). On an unspecified date the patient was vaccinated with a second dose of Gardasil 0.5mL injection. Concomitant therapy included therapy unspecified "a ton of medications" and just had back surgery. Two days post-vaccination the patient fainted. Medical attention was sought. Unspecified diagnostic tests were performed. At the time of reporting it was unknown if the patient had recovered but with therapy (unspecified) the adverse event improved. No additional information is available. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female with asthma and no drug reactions/allergies who on 17-MAY-2007 was vaccinated with Gardasil (lot # 657736/0389U) 0.5 mL IM in the left arm. Concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (ADVAIR). On 17-MAY-2007 the patient developed injection site swelling immediately after vaccination with Gardasil. For the following two weeks she had a bruise at the site. Medical attention was sought. At the time of reporting the patient had recovered. No further information is available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning a female (age unknown) who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, the patient experienced syncope immediately after being vaccinated. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a physician concerning a female (age unknown) who, on an unspecified date, was vaccinated with a dose of GARDASIL. Subsequently, the patient experienced syncope immediately after being vaccinated. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Follow-up information indicated that the office felt that "no specific patient had a reaction directly related to GARDASIL". Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, the patient experienced syncope when she was leaving the office. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. Follow-up information indicated that the office felt that "no specific patient has a reaction directly related to Gardasil.  Additional information has been requested
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Registered Nurse concerning 3 females who were vaccinated with Gardasil and fainted. The patients recovered completely after a few minutes. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site nodule
Clinical narrative: Information has been received from a physician concerning a 15 year old female who in approximately May 2007, was vaccinated with 0.5 mL of the first dose of Gardasil. Subsequently the patient developed a subcutaneous pea size nodule at the injection site that can not be seen but can be felt. As of 20-JUL-2007, the patient had not recovered. Medical attention was sought. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pain, Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 19 year old female with a penicillin and cefaclor (Ceclor) allergy who on 19-JUN-2007 was vaccinated with a third dose of Gardasil. On 19-JUN-2007 the patient developed a fever, slight clear nose drainage, and localized pain and redness over the deltoid area. It was reported that on 20-JUN-2007 the patient vomited twice. There was no rash, tongue swelling, or cough. Unspecified medical attention was sought. On 20-JUN-2007 the patient recovered from vomiting and fever. In June 2007, after "several days" the patient recovered from localized redness and pain. In approximately June 2007, the patient recovered from drainage from the nose. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blister
Clinical narrative: Information has been received concerning a 17 year old female with no medical history or allergies who on 09-APR-2007, was vaccinated with a first 0.5ml dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On approximately 09-MAY-2007, a month after receiving the vaccine, the patient developed small clear blisters on top of her hands. No medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested. Initial and follow up information has been received from a mother concerning a 18 year old white female student with no medical history or allergies who on 09-APR-2007, was vaccinated in left deltoid with a first dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). On 11-APR-2007, the patient developed small clear blisters on top of her hands/small blister-like pimples on top of her hand. No medical attention was sought. No laboratory diagnostic studies were performed. On 16-APR-2007 the patient recovered. No product quality complaint was involved. This is one of two reports from the same source. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Dysmenorrhoea, Erythema, Swelling
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow-up information has been received from a licensed practical nurse concerning an 18 year old female with a history of dysmenorrhea who on 25-JUN-2007 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL. Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI-CYCLEN) (manufacturer unknown). On 25-JUN-2007 the patient experienced swelling, redness, and burning in both hands. The patient was advised to take diphenhydramine hydrochloride (BENADRYL) for the swelling, redness, and burning of the hands. There were no laboratory or diagnostic testing performed. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Carbohydrate antigen 125 increased, Condition aggravated
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2007. Information has been received from a father concerning his 23 year old daughter with a history of cancer who in early 2007 was vaccinated with the first dose of 0.5 ml of Gardasil. The patient completed the three vaccination series of Gardasil (dates not reported). Concomitant therapy included tetanus toxoid and "other medications she has been on for a long time" (therapies were unspecified). Subsequently the patient's CA 125 levels increased from 14 to 24 over the four month period of treatment with Gardasil and the patient experienced anxiety. The patient sought unspecified medical treatment. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who on an unspecified date, was vaccinated with a first dose of Gardasil. Subsequently, the patient fainted after vaccine was administered. The patient was either sitting or standing when the vaccine was administered. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. This is 2 of three reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who on an unspecified date, was vaccinated with a first dose of Gardasil. Subsequently, the patient fainted after vaccine was administered. The patient was either sitting or standing when the vaccine was administered. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. This is one of three reports from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Chest discomfort
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with no drug allergies and no medical history, who on 19-JUL-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot# 658100/0525U). Concomitant vaccination included MENACTRA. Concomitant therapy included CLARITIN. Within 24 hours the patient experienced "chest tightness" over her sternum. The patient sought unspecified medical attention. No laboratory diagnostics were performed. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MMR, MNQ
Symptoms: Blood pressure normal, Dizziness, Hypoaesthesia, Immediate post-injection reaction, Injection site pain
Clinical narrative: Information has been received from a certified medical assistant concerning a 15 year old female patient with no medical history or allergies who on 19-JUL-2007, was vaccinated IM into the left deltoid with a dose of Gardasil (Lot# 657621/0387U). Suspect concomitant therapy included VAQTA administered into the left arm, at a separate site MENACTRA and MMR II, both administered into the right arm. On 19-JUL-2007 immediately after the vaccination, the patient experience3d pain at the injection site of the Gardasil vaccine. Then the patient experienced numbness of the left arm and dizziness at home about one hour after the vaccination. It was reported that the patient returned to the office and was observed for 30 to 45 minutes. Laboratory diagnostic studies performed included a blood pressure measurement which was normal. After observation in the office, the patient's symptoms resolved and have not returned as of 23-JUL-2007. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received a nurse concerning a female patient who was vaccinated IM with a first dose of Gardasil. Almost immediately after receiving the vaccine, the patient fainted. Medical attention was not sought because the patient was in the office at the time of the occurrence. It was reported that the patient recovered shortly after and left the office feeling fine. No product quality complaint was involved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Initial and follow up information has been received from a nurse at the physician's office concerning a 21 year old female patient who on 18-MAY-2007 was vaccinated with a first dose of Gardasil and on 17-JUL-2007 was vaccinated with a second dose of Gardasil. She had no pertinent medical history and there were no concomitant medications. In follow up it was indicated that her symptoms started on 18-JUL-2007 in the early morning the next day of second vaccination. She had a fever, dizziness, nausea, vomiting, body aches, and headaches. She was rushed to the emergency room (ER)/acute care, and she was not admitted to the hospital. Acute care felt that the patient's symptoms were a probable side effect from her Gardasil vaccination. The patient recovered at this time and was doing fine. The nurse reported that the patient did not have a similar event after her first injection. The reporter felt that the nausea and vomiting were considered serious as another medical event. Additional information has been requested. In follow-up information the reporter indicated that the patient went to emergency room for fever, dizziness, nausea, vomiting x6, severe headache, body aches since early AM. Nausea and vomiting started during night. The patient took TYLENOL for muscle aches. She vomited twice and had low grade temperature in AM (99.2 0F). In the medical record it was indicated that se was treated with IM 12.5 mg of promethazine hydrochloride. she was given prescription for 25 mg promethazine hydrochloride tablet ass needed and acetaminophen for headache by mouth. The urine analysis showed trace of ketones. The serum pregnancy test was negative. On 20-JUL-2007 the patient recovered. The reporter felt the nausea, vomiting and headache was probably related to therapy with GARDASIL. The reporter felt that the patient requiring visit to the emergency room was to prevent patient from being serious and considered as a serious other medical event. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Urine analysis abnormal, Vaccination complication, Vomiting
Clinical narrative: Initial and follow up information has been received from a nurse at the physician's office concerning a 21 year old female patient who on 18-MAY-2007 was vaccinated with a first dose of Gardasil and on 17-JUL-2007 was vaccinated with a second dose of Gardasil. She had no pertinent medical history and there were no concomitant medications. In follow up it was indicated that her symptoms started on 18-JUL-2007 in the early morning the next day of second vaccination. She had a fever, dizziness, nausea, vomiting, body aches, and headaches. She was rushed to the emergency room (ER)/acute care, and she was not admitted to the hospital. Acute care felt that the patient's symptoms were a probable side effect from her Gardasil vaccination. The patient recovered at this time and was doing fine. The nurse reported that the patient did not have a similar event after her first injection. The reporter felt that the nausea and vomiting were considered serious as another medical event. Additional information has been requested. In follow-up information the reporter indicated that the patient went to emergency room for fever, dizziness, nausea, vomiting x6, severe headache, body aches since early AM. Nausea and vomiting started during night. The patient took TYLENOL for muscle aches. She vomited twice and had low grade temperature in AM (99.2 0F). In the medical record it was indicated that se was treated with IM 12.5 mg of promethazine hydrochloride. she was given prescription for 25 mg promethazine hydrochloride tablet ass needed and acetaminophen for headache by mouth. The urine analysis showed trace of ketones. The serum pregnancy test was negative. On 20-JUL-2007 the patient recovered. The reporter felt the nausea, vomiting and headache was probably related to therapy with GARDASIL. The reporter felt that the patient requiring visit to the emergency room was to prevent patient from being serious and considered as a serious other medical event. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Lethargy
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 12-JUN-2007 was vaccinated with Gardasil (lot# 657736/0389U) 0.5mL injection. The physician reported that the patient experienced lethargy for 3 days after being vaccinated with Gardasil. Medical attention was sought. At the time of reporting the patient recovered on 12-JUN-2007. No further information was reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 23 year old female who on 09-MAR-2007 at 1:00 PM was vaccinated with a first dose of Gardasil (Lot # 656049/0187U). There was no concomitant medication. On 10-MAR-2007 at 7:00 PM the patient developed body aches, fever, chills, nausea and vomiting. It was reported the patient could not work. There was no rash or diarrhea. Unspecified medical attention was sought. There were no laboratory or diagnostic testing performed. On 13-MAR-2007, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue
Clinical narrative: Information has been received from a physician concerning  a female patient who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently the patient developed severe fatigue. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pain, Syncope
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who on 20-JUL-2007 was vaccinated with GARDASIL (lot # unknown). Concomitant therapy included MENACTRA. On 20-JUL-2007 the patient fainted after receiving Gardasil for 3 to 5 minutes and came too and fainted again. Medical attention was sought. No additional information was provided. At the time of reporting the patient recovered. This is one of two reports from the same source. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 8/14/2007. On 16-AUG-2007 follow-up information was received from a nurse. The nurse reported that the patient did not have breakfast and had a medical history of reactive airway disease. The patient had experienced anxiety about the vaccinations that morning resulting in her need to use albuterol (2 puffs). The nurse felt that the patient's syncope reaction was caused by the pain from receiving 2 vaccinations. The patient was monitored for an hour and a half following the reaction and has recovered. The mother of the patient was contacted the following day and it was confirmed that the patient was recovered. This is one of two reports from the same source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness postural, Syncope
Clinical narrative: Information has been received from a physician concerning a 25 year old female who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, the patient stood up, felt dizzy and then she fainted and was fine after a couple minutes. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Diarrhoea, Headache, Lumbar puncture, Malaise, Pyrexia
Clinical narrative: Information has been received from a physician concerning a patient (age and gender unknown), who on 19-JUL-2007 was vaccinated with a dose of Gardasil. On 20-JUL-2007 the patient experienced fever and diarrhea. The diarrhea has resolved. The patient continued to experience persistent fever, malaise, and a headache. The patient has taken MOTRIN every 4 to 6 hours "around the clock." The patient was sent to the emergency room for a spinal tap. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Staphylococcal infection
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a 0.5mL dose of GARDASIL. Subsequently, four weeks after being vaccinated the patient developed "mrsa around the mouth." The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Headache, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female with seasonal allergy who on 23-MAY-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot #653735/0688F). There was no concomitant medication. On 23-MAY-2007 the patient experienced temperature of 102 F, headache and"arm blew up". Unspecified medical attention was sought. She was treated with TYLENOL and ice. Subsequently, the patient recovered. On 24-JUL-2007 the patient was vaccinated IM with a 0.5 ml second dose of Gardasil and no adverse symptoms were noted. This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a female with papilloma viral infection who was vaccinated with a 0.5 ml dose of Gardasil (lot # unknown). Subsequently the patient "came back" and seemed to have a worst condition then before of the papilloma virus. Unspecified medical attention was sought. At the time of the report, the outcome was unknown. This is one of several reports from the same source. Additional information has been requested.