chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Blood pressure decreased, Dizziness, Dysphagia, Headache
Clinical narrative: Soon after the vaccine (approx. 5 minutes), he was pale, weak and complained headache and dizziness, was breathing okay and conscious. HR - 40 gave oxygen right away and his pallor and HR improved 53 ---> 59 ---> 68 --->. Pulse ox 98-100% with oxygen, BP 46/64. Called ambulance. He then started complaining throat irritation and difficulty of swallowing, transferred to ER. 05/23/07-records received-DX Mild Dehydration. Vasovagal episode. Syncope after vaccine, with few minutes of loss of consciousness. No SOB, no rash. C/O tenderness left clavicle line.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Heart rate decreased, Oxygen saturation, Oxygen supplementation, Pallor, Throat irritation
Clinical narrative: Soon after the vaccine (approx. 5 minutes), he was pale, weak and complained headache and dizziness, was breathing okay and conscious. HR - 40 gave oxygen right away and his pallor and HR improved 53 ---> 59 ---> 68 --->. Pulse ox 98-100% with oxygen, BP 46/64. Called ambulance. He then started complaining throat irritation and difficulty of swallowing, transferred to ER. 05/23/07-records received-DX Mild Dehydration. Vasovagal episode. Syncope after vaccine, with few minutes of loss of consciousness. No SOB, no rash. C/O tenderness left clavicle line.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Swelling face, Urticaria
Clinical narrative: Pt was given Dtap - and Hib at 10 AM - at 6pm dev facial swelling and generalized hives - sent to ER - later transferred 06/07/07-records received from facility for DOS 5/14-5/16/07-DC DX: Allergic reaction. Day of immunizations, breastfeeding after mother ate shrimp the day before and was handled by his father after father handled chili peppers, devloped eye swelling hives and itchiness surrounding both eyes. No dyspnea, throat swelling or wheezing. Prior allergic reaction one month ago. PE: swelling of eyelids, bilaterally rigtht greater than left, urticaria on upper limbs, trunk and scalp.
Age: 1.14
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC
Symptoms: Anorexia, Diarrhoea, Pyrexia, Rash generalised
Clinical narrative: (1) High fever 103.6 x 10 days (on 2 off) (2) Loss of appetite (3) Diarrhea (4) Rashes all over the body
Age: 13.0
Sex: F
Vaccine: HEP, TDAP, TTOX
Symptoms: Contusion, Full blood count, Petechiae, Platelet count normal, Thrombocytopenia
Clinical narrative: 2 weeks after immunization patient developed thrombocytopenia (low platelet count), Bruising, Petechiae. Patient was referred to PCH ER / Heme Onc.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: nausea and vomiting (n & v), Diarrhea
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Crying
Clinical narrative: Unconsolable crying x 3 hours.
Age: 1.2
Sex: M
Vaccine: MMRV, PNC
Symptoms: Eye pruritus, Pruritus, Rash macular
Clinical narrative: Child had itching of ears and itching of eyes mild macular rash. Within one hour of receiving vaccine. Foster mother called NP Benadryl given. Child recovered without complications.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Feeling abnormal
Clinical narrative: Received shots approx 2PM. Started crying 1 1/2-2 hrs later. Went on for 4-5 hrs. Uncontrollable crying no fever, No redness or swelling on legs at shot site. Mom stated Pt was miserable. Spoke with MD that evening. Mom put her in bathtub to soothe.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Back pain, Full blood count, Metabolic function test, Muscular weakness
Clinical narrative: Started with pain in her back along her spine along - back, neck pain, hip pain. With weakness of muscle. Office note-Seen by doctor on 4/12/07, seen by rheumatologist on 5/10/07. still with pain in spine, still no pain. Office visit note for 4/18/07-C/O severe lower back pain started on same day she received vaccine. Mild right shoulder pain. PE: moderate tenderness on pressure of spinaly bony ridge from lower thoracic to sacral area. No warmth redness or swelling of back. Gait guarded and back flexion limited due to back pain. Assessment: severe back pain due to underlying genetic/immunologic problem of chronicity family history and inflammatory bowel disease. ANA positive suggests autoimmune phenomenon HLS B27 genotype would be strong consideration. Rheumatology consult
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Neck pain, Urine analysis, X-ray
Clinical narrative: Started with pain in her back along her spine along - back, neck pain, hip pain. With weakness of muscle. Office note-Seen by doctor on 4/12/07, seen by rheumatologist on 5/10/07. still with pain in spine, still no pain. Office visit note for 4/18/07-C/O severe lower back pain started on same day she received vaccine. Mild right shoulder pain. PE: moderate tenderness on pressure of spinaly bony ridge from lower thoracic to sacral area. No warmth redness or swelling of back. Gait guarded and back flexion limited due to back pain. Assessment: severe back pain due to underlying genetic/immunologic problem of chronicity family history and inflammatory bowel disease. ANA positive suggests autoimmune phenomenon HLS B27 genotype would be strong consideration. Rheumatology consult
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Antinuclear antibody negative, Dyskinesia, Electroencephalogram normal, Full blood count, Liver function test normal
Clinical narrative: 1. Uncontrollable, rapid jerking of left arm at elbow lasted 3 hours was stopped with IV Ativan in ER. 2.Same symptoms 2 days later - went to Neurology Department. 3. Tics - shoulder shrugging and winking - all on left side dx - Tic disorder is on Clonidine .1mg 2x day.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Streptococcal identification test negative, Thyroid function test normal, Tic
Clinical narrative: 1. Uncontrollable, rapid jerking of left arm at elbow lasted 3 hours was stopped with IV Ativan in ER. 2.Same symptoms 2 days later - went to Neurology Department. 3. Tics - shoulder shrugging and winking - all on left side dx - Tic disorder is on Clonidine .1mg 2x day.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Cold compress therapy, Injection site erythema, Injection site swelling
Clinical narrative: Patient came into clinic to have PPD read. Mom states both (R) and (L) upper arms red and swollen. Advised to apply ice to sites and RTC if symptom worsen.
Age: 13.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Medication error, Wrong drug administered
Clinical narrative: Child didn't need Dtap already had Tdap 2/14/07
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Hypersensitivity, Pain, Swelling
Clinical narrative: Patient was described to have allergic reaction (swelling and pain) visit on 4/2/07 with F.N.P. dx: cellulitis, Rx: Keflex 250mg/ 5ml 1 tsp QID x 5 days.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: L upper arm swelling, redness, itching, and tenderness upon palpation
Age: 5.0
Sex: M
Vaccine: UNK, VARCEL
Symptoms: Dyskinesia, Eye rolling, Musculoskeletal stiffness, Pallor, Syncope
Clinical narrative: Patient shortly after receiving his Varivax vaccine and PPD fainted. He was by mom before regional rolling of the eyeball and stiff. When I came in the room he was jerking has arms, pale and was breathing. He was non responsive for about 5 minutes and by the time ambulance came he was awake.
Age: 5.0
Sex: M
Vaccine: UNK, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient shortly after receiving his Varivax vaccine and PPD fainted. He was by mom before regional rolling of the eyeball and stiff. When I came in the room he was jerking has arms, pale and was breathing. He was non responsive for about 5 minutes and by the time ambulance came he was awake.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Crying, Cyanosis, Foaming at mouth, Full blood count, Metabolic function test
Clinical narrative: One to 2 hrs after the vaccine was given the baby made a loud cry, the mother ran to the room and found her with her arms in the air and not breathing; her face turned blue. Mom picked her up immediately and screamed. The nanny and dad ran to the room. She was blue in the face, then she cried and turned completely pale. Her eyes and mouth were red/pink around. She was suctioned and found to have foamy mucus. No milk in her mouth 1 hr after the episode. I examined her and she was back to normal cooing, smiling.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Neurological examination, Ocular hyperaemia, Pallor, Respiratory arrest, Stomatitis
Clinical narrative: One to 2 hrs after the vaccine was given the baby made a loud cry, the mother ran to the room and found her with her arms in the air and not breathing; her face turned blue. Mom picked her up immediately and screamed. The nanny and dad ran to the room. She was blue in the face, then she cried and turned completely pale. Her eyes and mouth were red/pink around. She was suctioned and found to have foamy mucus. No milk in her mouth 1 hr after the episode. I examined her and she was back to normal cooing, smiling.
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Chest pain, Cough, Dysphonia, Headache, Pharyngolaryngeal pain
Clinical narrative: Headaches, sore throat, hoarse, nasal drainage, sinus drainage, coughing, lots of coughing, chest aches, wheezing
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Rhinorrhoea, Sinus operation, Wheezing
Clinical narrative: Headaches, sore throat, hoarse, nasal drainage, sinus drainage, coughing, lots of coughing, chest aches, wheezing
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Left deltoid red, swollen, itching started at 1:00p after injection given on 5/16/07.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Erythema, Feeling cold, Immediate post-injection reaction, Induration
Clinical narrative: Patient was given Td toxoid 0.5cc SQ instead of PPD as ordered. Immediate pain at site and coolness of right arm. 24 hours later developed 2cm of erythema/ induration with increase pain and inability to F/E wrist. Continued monitoring at future visit until resolved.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain
Clinical narrative: Patient was given Td toxoid 0.5cc SQ instead of PPD as ordered. Immediate pain at site and coolness of right arm. 24 hours later developed 2cm of erythema/ induration with increase pain and inability to F/E wrist. Continued monitoring at future visit until resolved.
Age: 21.0
Sex: M
Vaccine: JEV
Symptoms: Fatigue, Lip swelling, Pain
Clinical narrative: Swollen left upper lip; took Claritin in on 10th with some relief. Saw provider at  health center on 5/10 in am. "Achy, fatigued" by 11 am; patient states this would be r/t sleep deprivation.
Age: 11.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Many scattered red, macules to papular primarily on neck and torso.
Age: 46.0
Sex: M
Vaccine: RAB
Symptoms: Nausea, Vomiting projectile
Clinical narrative: Donor states "violently" vomiting and nausea x 3 days. Did not seek medical attention or take any medications.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pruritus
Clinical narrative: Donor states 2-3 days post immunization had moderate itching intermittently at injection site, lasting approx. 2 days.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dehydration, Dizziness, Incorrect dose administered
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female who on an unspecified date was vaccinated with Gardasil (lot # not reported) 0.7 ml IM injection. The physician reported that when she went to administer the vaccine to the patient, the vaccine delivered 0.7ml as opposed to 0.5 ml. Subsequently the patient experienced dizzy spells; work-up was negative. The physician reported that the dizzy spells were not related to Gardasil but to dehydration. No further information was available at the time of reporting. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site mass, Injection site pain, Injection site scar
Clinical narrative: Information has been received from a registered nurse concerning her 25 year old daughter who in September 2006, was vaccinated with her first dose of Gardasil, intramuscular injection in "gluteal region". There was no concomitant medication. In November 2006, the patient received her second dose of Gardasil, intramuscular injection in deltoid. On 08-MAR-2007, the patient received her third dose of Gardasil, intramuscular injection in deltoid. On 09-MAR-2007, the patient experienced tenderness at injection site, erythema at injection site, a raised lump size of quarter at injection site and scar at injection site which was described as the skin being discolored and having a different texture with underlying hardness. As of 02-APR-2007, the patient had not recovered. The product quality complaint unit was not involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Skin discolouration
Clinical narrative: Information has been received from a registered nurse concerning her 25 year old daughter who in September 2006, was vaccinated with her first dose of Gardasil, intramuscular injection in "gluteal region". There was no concomitant medication. In November 2006, the patient received her second dose of Gardasil, intramuscular injection in deltoid. On 08-MAR-2007, the patient received her third dose of Gardasil, intramuscular injection in deltoid. On 09-MAR-2007, the patient experienced tenderness at injection site, erythema at injection site, a raised lump size of quarter at injection site and scar at injection site which was described as the skin being discolored and having a different texture with underlying hardness. As of 02-APR-2007, the patient had not recovered. The product quality complaint unit was not involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Nausea
Clinical narrative: Information has been received from a medical assistant concerning a 23 year old female with no pertinent medical history who on approximately 02-FEB-2007 was vaccinated with a first dose of Gardasil. On 02-APR-2007, the patient was vaccinated, intramuscularly, with a second dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On 02-APR-2007, within a few hours of the vaccination, the patient experienced shortness of breath and nausea. She called the physician's office and the physician prescribed Benadryl. There were no laboratory or diagnostic tests performed. The patient's outcome was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: This is in follow-up to report (s) previously submitted on 5/14/2007 Information has been received from a company representative, reporting in a literature article (article name and author not specified) concerning a 22 year old female who was vaccinated with a dose or doses of GARDASIL (date unspecified). According to the article, the woman "became infected with the 4 strains of HPV, "although she was "involved in the studies" for GARDASIL and had shown a "strong conversion" during the studies. Additional information has been requested. Follow up information confirmed that only one patient was identified or involved with the events (WAES #0610USA04009). Therefore, WAES # 0704USA00327 is being deleted from our files. No further information is expected. This report was previously sent in a monthly submission to PLA V501 on 14-MAR-2007.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 22 year old female patient, who on 14-MAR-2007 was vaccinated with the first dose, 0.5ml, IM, of Gardasil. On 17-MAR-2007 the patient experienced "pain in lower right leg (down from the knee), aching" and reported a problem with sleeping. At the time of this report, the leg pain, aching and problem with sleeping had not resolved. The patient sought unspecified medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal, Smear cervix normal
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient with a negative pap smear on March 2006. In October 2006, the patient was vaccinated with the first dose 0.5 mL, of Gardasil, on December 2006 with the second dose 0.5 mL of Gardasil. On 10-MAR-2007 the patient presented with positive HPV with atypical squamous cells of undetermined significance (ASCUS) pap smear after receiving second vaccination. The patient did not have the third vaccination as of this report date and the outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Genital rash, Vulvovaginal pruritus
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who on 24-MAR-2007 was vaccinated with a second dose of Gardasil. On 26-MAR-2007 the patient developed a rash around the genital area and vaginal itch. It was unknown whether the physician plan to administer the third dose. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Arthritis, Dizziness, Nausea, Vomiting
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 15 year old female patient who on 20-FEB-2007 was vaccinated with her first 0.5 mL dose of Gardasil in the left arm. On 26-FEB-2007, the patient called the office complaining of nausea, vomiting, dizziness and arthritic like symptoms. Laboratory evaluation revealde normal CBC, ANA, and RA. She was seen in the office on 28-MAR-2007 and was limping. Follow-up on 27-APR-2007 indicated that the patient was doing better, but still had hip discomfort. It was noted that the injection was not administered in the hip. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a consumer concerning her daughter, an 18 year old female, who on 01-APR-2007 was vaccinated with a dose, 0.5ml, of Gardasil. There was no concomitant medication. The consumer reported that on 01-APR-2007 after receiving the vaccination, her daughter "broke out in hives." At the time of this report, the consumer's daughter had not recovered from the hives. The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Cellulitis, Eschar, Injection site abscess, Injection site erythema, Localised infection
Clinical narrative: Information has been received from a physician concerning a 15 year old female who in January 2007, was vaccinated with the first dose of Gardasil. Concomitant medication was not reported. In January 2007 within days of the vaccination, the patient developed redish patches on her distal arm near injection site after her first vaccination with Gardasil. Near the injection site was a small abscess with tiny eschar over it. The event was inferior and anterior to the injection site. The physician stated that it could be an infected follicle or low grade cellulitis. The patient also had a sore throat. The patient sought unspecified medical attention and was treated with Keflex. The patient's redish patches on distal arm near injection site, small abscess with tiny eschar over it and sore throat persisted. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pharyngolaryngeal pain
Clinical narrative: Information has been received from a physician concerning a 15 year old female who in January 2007, was vaccinated with the first dose of Gardasil. Concomitant medication was not reported. In January 2007 within days of the vaccination, the patient developed redish patches on her distal arm near injection site after her first vaccination with Gardasil. Near the injection site was a small abscess with tiny eschar over it. The event was inferior and anterior to the injection site. The physician stated that it could be an infected follicle or low grade cellulitis. The patient also had a sore throat. The patient sought unspecified medical attention and was treated with Keflex. The patient's redish patches on distal arm near injection site, small abscess with tiny eschar over it and sore throat persisted. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Hot flush, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a teenage female (age not reported) who on unspecified dates was vaccinated with the first and second doses of Gardasil. Concomitant medication was not reported. Subsequently on an unspecified dates, the patient developed hot flashes after her first and second doses of Gardasil. The onset of the hot flashes began within 24 hours post vaccination and the hot flashes lasted for a couple of days. The patient sought unspecified medical attention. The outcome and action taken with regards to therapy with Gardasil was not reported. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 5/17/2007. Information has been received from a nurse practitioner concerning a 20 year old female with no illness at the time of being vaccinated who on 14-JAN-2007 was vaccinated with the first dose of GARDASIL (lot # 654389/0961F) injection in the left deltoid at 4:30 PM. On 06-MAR-2007, the patient was vaccinated with the second dose of GARDASIL (lot # 654741/0013U) injection in the left deltoid at 11:30 AM. The patient was not on concomitant medication. On 15-JAN-2007 and 07-MAR-2007, the patient developed hot flashes after her first and second dose of GARDASIL respectively. The onset of the hot flashes began within 24 hours post vaccination and the hot flashes lasted for a couple of days. The patient sought unspecified medical attention. On unspecified dates, the patient recovered from the hot flashes. No additional information is expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Chills, Cough, Dizziness, Pain
Clinical narrative: This is in follow-up to report (s) previously submitted on 5/14/2007. Information has been received from a certified medical assistant concerning a 25 year old female with no pertinent medical history and with penicillin allergy (nausea, vomiting and hives at age 5) who on 28-MAR-2007, was vaccinated with first dose of Gardasil (Lot#655618/0186U). There was no concomitant medication. On 30-MAR-2007, the patient developed widespread body aches, chills and dizziness two days after receiving the vaccine. When she took a deep breath she experienced coughing that lasted a few seconds and some tightness. On 31-MAR-2007, within 24 hours, (at 12:00 noon), the patient recovered from widespread body aches, chills, coughing, tightness and dizziness without treatment. The patient sought unspecified medical attention. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose increased
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 24 year old, female, receptionist, whose reported weight was 130 pounds and whose reported height was 62.5 inches with juvenile onset diabetes, insulin dependent diabetic with penicillin allergy and atropine allergy, who at 10:00 a.m. on 14-MAR-2007 was vaccinated into the right deltoid muscle with the first dose of Gardasil, (lot # 656049/0187U). Concomitant therapy included insulin human (Humulin), Synthroid, Lipitor, and calcium (unspecified), "zelnoim", vitamins (unspecified), "yazmin". It was reported that the patient had 4-5 days of increased blood sugars in the range of 500-600. This began 1 1/2 days, approximately on 16-MAR-2007, after receiving Gardasil. The patient's blood sugars. "The patient did constant, intermittent blood sugars using a bolus of insulin to counteract". It was reported that it took several days to stablize the patient's blood sugars. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: Information has been received from a health professional concerning a 12 year old white female patient who on 24-JAN-2007 was vaccinated IM with a first dose 0.5 mL of Gardasil lot #655619/1427F. Concomitant therapy included hepatitis A virus vaccine (unspecified) also administered IM on 24-JAN-2007. In approximately 27-JAN-2007, the patient developed joint pain and stiffness after receiving the vaccination. Subsequently, the patient recovered from joint pain and stiffness after few weeks. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a company representative, reporting on a literature article (article name and author not specified) concerning female patients who were vaccinated with a dose of doses of Gardasil. According to the article, there have been "injuries" when the vaccine is given concomitantly with "vaccines other than Recombivax HB. The article indicated that "1/3 of the "adverse events" occurred in girls who were 16 years old or younger who were given Gardasil concomitantly" with other vaccines. According to the representative, the article also stated that Gardasil can "enhance cancer when given to a woman who is already infected with one of the strains of the virus included in the vaccine," although in this instance, the representative did not indicate a specific patient was involved. Follow up information confirmed that only one patient was identified or involved with the events (WAES #0610USA04009).  Therefore (WAES #0610USA04009) is being deleted from our file.  No further information is expected.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a company representative, reporting on a literature article (article name and author not specified) concerning patients who were vaccinated with a dose or doses of GARDASIL (date unspecified). According to the article, there were 4 cases of fainting after receiving GARDASIL. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 5/14/2007.  Follow up information confirmed that only one patient was identified with the events (WAES #0610USA04009).  Therefore, WAES # 0704USA000572 is being deleted from our files.  No further information is expected.  This report was previously sent in a monthly submission to PLA V501 on 14-MAR-2007.
Sex: F
Vaccine: HPV4
Symptoms: Petechiae
Clinical narrative: Information has been received from a health professional concerning a female consumer who in March 2007, was vaccinated with Gardasil. In March 2007, the patient experienced petechiae rash all over her body within 24 hours after receiving the first dose of Gardasil. No medical attention was required. This is one of two reports received from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 05/14/2007. Information has been received from a licensed practical nurse concerning a female patient who in March 2007, "past few weeks," was vaccinated with GARDASIL. Within 24 hours the patient developed a petechiae rash all over her body. No treatment was required. This is one of two reports received from the same source. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Blood pressure decreased, Dizziness, Hypotension, Nausea
Clinical narrative: Information has been received from a nurse concerning a 20 year old female student with sulfonamide allergy, house dust allergy and mycotic allergy and a history of mitral value prolapse, mitral value regurgitation, "other episodes" of syncope, cardiac disorder and migraines who on 29-MAR-2007 was vaccinated with Gardasil IM in the left deltoid. Concomitant therapy included Ortho-Tri-Cyclen. On 29-MAR-2007, immediately following vaccination, the patient felt faint and nauseous. The patient's blood pressure was 117/86. The patient was treated with smelling salts, cool compress, food and cranberry juice. The patient went home after feeling better. On 30-Mar-2007 the patient visited the physician in the student health center at school where the patient complained of nauseousness and dizziness. The physician's diagnosis was hypotension and GI upset. On 03-Apr-2007 the nurse contacted the patient who was fully recovered from the events. The patient will continue the series of vaccinations. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a 0.5 ml dose of Gardasil. Subsequently the patient became extremely tired. Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 02-APR-2007 was vaccinated with a first dose of Gardasil. On 02-APR-2007 the patient experienced soreness at the injection site. 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: Burning sensation, Headache, Injection site irritation
Clinical narrative: This is in follow-up to report (s) previously submitted on 5/14/2007. Information has been received from a receptionist in a physician's office concerning her daughter who was "not too long ago" vaccinated with a first dose of Gardasil. The patient stated to her mother that the injection site burned like fire. The patient also developed a headache after leaving the office. The patient's physician was not contacted by the reporter or the patient regarding the patient's experience. It was reported that the patient's injection site irritation and headache did improve. Follow-up information was received from the physician's office indicating that they do not know which patient this event pertains to. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Cold compress therapy, Dizziness
Clinical narrative: Information has been received from a registered nurse concerning a multiple female patients who on unspecified dates (since October 2006) were vaccinated with the first dose of Gardasil. Concomitant medication was not reported. Subsequently on unspecified dates, the patient felt faint after receiving Gardasil, 0.5 ml, IM. The patient's were treated with smelling salts, cool compress, food and cranberry juice. The nurse reported that the patient's usually had not eaten prior to the vaccination. The outcome and causality of the event was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Swelling
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on approximately 20-MAR-2007, "a couple weeks ago", was vaccinated with a first dose of Gardasil. Subsequently the patient developed swelling. The patient sought unspecified medical attention. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a nurse practitioner concerning a female (age not reported) who on approximately 20-FEB-2007 (approximately 6 weeks ago) was vaccinated with the first dose of Gardasil, injection. Concomitant medication was not reported. On 20-FEB-2007 (approximately 6 weeks ago), the patient developed erythema in the arm in which she was vaccinated as well as a pruritic rash. The symptoms developed the same day she was vaccinated. The patient sought unspecified medical attention. Subsequently, the patient recovered from erythema arm and pruritic rash approximately 36 hours later. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a nurse practitioner, via a company representative, concerning a 15 year old female patient, who on 01-FEB-2007 was vaccinated with the first dose of Gardasil (Lot # 655503/0012U). There was no concomitant medication. On 02-FEB-2007, within 24 hours after the vaccination, the patient developed a rash on the arm and trunk. On approximately 04-FEB-2007 ("48 hours later") the patient's rash spread to the legs. The nurse practitioner stated that the rash "lasted 2 weeks with no fever or itching," and confirmed that the patient had recovered from the rash. The patient sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Injection site reaction, Lymphadenopathy
Clinical narrative: Initial and follow-up information has been received from a physician concerning an 18 year old female patient who on approximately 26-MAR-2007 was vaccinated in her left upper arm with a first dose of GARDASIL. About 4 days after the vaccination she developed 4 swollen lymph nodes in the injection site area, but the physician said the injection site did not drain to these lymph nodes. The physician recommended no treatment and was following up with the patient in 2 weeks. A blood count was done which was normal. At the time of this report, the outcome of the patient was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site swelling, Metrorrhagia
Clinical narrative: Information has been received from a nurse concerning a 22 year old female patient who in April 2007, was vaccinated with a first dose of Gardasil. The patient developed a knot and swelling at the injection site, after the vaccination. The next day the patient developed spotty vaginal bleeding. Unspecified medical attention was sought. The patient's outcome was unknown. Follow-up from the patient's physician stated that the patient did not feel that the vaginal bleeding was related to vaccination with Gardasil. No further details are available.
Age: 20.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Anorexia, Chills, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a Physician Assistant (P.A.) concerning a 20 year old female with a history of depression who on 23-JAN-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included possible meningococcal vaccine, and hormonal contraceptives (unspecified). On 23-JAN-2007 immediately post vaccination the patient "blacked out and then threw up." The patient arrived home and she felt like she "passed out or fell right to sleep", when awoke she developed chills, low grade fever, sweating, nausea, no appetite, and felt like she "could not move." This happened two or three times all night between sleeping, and waking cycles with symptoms. However, at 4:00AM all symptoms stopped. Unspecified medical attention was sought. On 24-JAN-2007 patient recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Movement disorder, Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a Physician Assistant (P.A.) concerning a 20 year old female with a history of depression who on 23-JAN-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy included possible meningococcal vaccine, and hormonal contraceptives (unspecified). On 23-JAN-2007 immediately post vaccination the patient "blacked out and then threw up." The patient arrived home and she felt like she "passed out or fell right to sleep", when awoke she developed chills, low grade fever, sweating, nausea, no appetite, and felt like she "could not move." This happened two or three times all night between sleeping, and waking cycles with symptoms. However, at 4:00AM all symptoms stopped. Unspecified medical attention was sought. On 24-JAN-2007 patient recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a physician (allergist) concerning a female between 18 to 20 years old who on 11-JAN-2007 was vaccinated with first dose of Gardasil. Concomitant therapy included dicloxacillin from 04-JAN-2007 to 14-JAN-2007. On 28-JAN-2007, the patient developed a hives rash over her arms and legs when administered the vaccine. The patient sought unspecified medical attention.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Initial and follow up information has been received from a physician and a nurse concerning a 24 year old  female patient, who on 26-JAN-2007 (reported by the nurse as 25-JAN-2007) was vaccinated with the first dose, 0.5ml, of Gardasil, and on approximately 26-MAR-2007 ("two months later") with the second dose of Gardasil. There was no concomitant medication. On 27-JAN-2007 the patient developed diarrhea, nausea and vomiting. The patient recovered from the events (date unspecified); following the second vaccination, the physician reported that there were "no ill effects." The patient sought unspecified medical attention. No further information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a physician's assistant concerning a 17 year old female who on 21-MAR-2007 was vaccinated with the first dose of Gardasil. On 04-APR-2007 the patient was diagnosed with genital warts. unspecified medical attention was sought. At the time of this report, the patient's genital warts persisted. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site pain, Nausea, Pyrexia
Clinical narrative: Information has been received from a nurse concerning her 15 year old daughter who on 17-MAR-2007 was vaccinated with a dose of Gardasil, IM. Concomitant medication was not reported. On 17-MAR-2007, the patient experienced pain at the injection site immediately after vaccination with Gardasil. The pain resolved by the end of the day. On 20-MAR-2007 (three days later), the pain came back and it was associated with nausea and fever. The patient sought unspecified medical attention. It was also mentioned that no other vaccinations were administered that day. The symptoms resolved after an unspecified time. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a health professional (Nurse) concerning an 18 year old female patient who in approximately April 2007, was vaccinated with a first dose 0.5 mL of Gardasil. The patient experienced pain in the injection site right after receiving the injection. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 26 year old female with no medical history or known drug allergies who on approximately 30-MAR-2007 ("last week") was vaccinated with a 0.5 mL first dose of Gardasil. There was no concomitant medications. On same day after she received the vaccination, the patient experienced arm pain. The next day, the patient started to experience flu like symptoms and developed a fever of 103 degrees. That same day, the patient had started to take MERIDIA. No laboratory diagnostic studies were performed. At the time of this report, the patient was recovering. No product quality complaint was involved. The reporter did not believe that the flu like symptoms and fever of 103 degrees were related to therapy with Gardasil. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chills, Condition aggravated, Hyperhidrosis, Pyrexia, Rash
Clinical narrative: This is in follow-up to report (s) previously submitted on 5/14/2007. Information has been received from a Registered Nurse (R.N.) concerning a 12 year old female patient who on 08-MAR-2007 was vaccinated with a second dose of Gardasil. Patient had a rash before getting the vaccination. On 08-MAR-2007 the patient's rash (on her chest and neck) became worse and she was shaking, had fever and sweating. Unspecified medical attention was sought. The patient recovered. Additional information has been requested. Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a 20 year old (previously mentioned as 12 year old) female student with asthma and rash, hives to amoxicillin(+) clavulante potassium who on 08-MAR-2007 was vaccinated IM in left deltoid with a second dose of GARDASIL. Concomitant therapy included TRINESSA., montelukast sodium (MSD) and ZYRTEC. Patient had a rash before getting the vaccination. On 08-MAR-2077 the patient's rash ( on her chest and neck) became worse and she was shaking, had fever and sweating. Unspecified medical attention was sought. In follow up it was reported that on 09-MAR-2007 patient woke up at 01:00AM shaking shivering for 1 1/4 hour. At 4:30AM she broke out sweating with fever. On 11-MAR-2007 patient's mother reported that she recovered. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tremor, Urticaria
Clinical narrative: This is in follow-up to report (s) previously submitted on 5/14/2007. Information has been received from a Registered Nurse (R.N.) concerning a 12 year old female patient who on 08-MAR-2007 was vaccinated with a second dose of Gardasil. Patient had a rash before getting the vaccination. On 08-MAR-2007 the patient's rash (on her chest and neck) became worse and she was shaking, had fever and sweating. Unspecified medical attention was sought. The patient recovered. Additional information has been requested. Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a 20 year old (previously mentioned as 12 year old) female student with asthma and rash, hives to amoxicillin(+) clavulante potassium who on 08-MAR-2007 was vaccinated IM in left deltoid with a second dose of GARDASIL. Concomitant therapy included TRINESSA., montelukast sodium (MSD) and ZYRTEC. Patient had a rash before getting the vaccination. On 08-MAR-2077 the patient's rash ( on her chest and neck) became worse and she was shaking, had fever and sweating. Unspecified medical attention was sought. In follow up it was reported that on 09-MAR-2007 patient woke up at 01:00AM shaking shivering for 1 1/4 hour. At 4:30AM she broke out sweating with fever. On 11-MAR-2007 patient's mother reported that she recovered. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chills, Hyperhidrosis, Pyrexia, Tremor
Clinical narrative: This is in follow-up to report (s) previously submitted on 5/14/2007. Information has been received from a Registered Nurse (R.N.) concerning a 12 year old female patient who on 08-MAR-2007 was vaccinated with a second dose of Gardasil. Patient had a rash before getting the vaccination. On 08-MAR-2007 the patient's rash (on her chest and neck) became worse and she was shaking, had fever and sweating. Unspecified medical attention was sought. The patient recovered. Additional information has been requested. Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a 20 year old (previously mentioned as 12 year old) female student with asthma and rash, hives to amoxicillin(+) clavulante potassium who on 08-MAR-2007 was vaccinated IM in left deltoid with a second dose of GARDASIL. Concomitant therapy included TRINESSA., montelukast sodium (MSD) and ZYRTEC. Patient had a rash before getting the vaccination. On 08-MAR-2077 the patient's rash ( on her chest and neck) became worse and she was shaking, had fever and sweating. Unspecified medical attention was sought. In follow up it was reported that on 09-MAR-2007 patient woke up at 01:00AM shaking shivering for 1 1/4 hour. At 4:30AM she broke out sweating with fever. On 11-MAR-2007 patient's mother reported that she recovered. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Pain
Clinical narrative: Information has been received from a certified medical assistant (CMA), via a company representative, concerning a 14 year old female patient, who on 29-MAR-2007 was vaccinated with the first dose of Gardasil (Lot # 656372/0243U). The CMA reported that on 29-MAR-2007 the patient "experienced headache, nausea and general achy symptoms." At the time of this report, the patient had recovered from the events. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007. Follow-information was received from the CMA, which stated that the patient was administered her first doseof GARDASIL (656050/0245U) IM in the left arm on 04-Apr-2007 at 3:30 pm. 10:00 am on 05-Apr-2007, onset of the patient's experiences began and lasted 48 hours. She was treated with MOTRIN, and received on 07-Apr-2007. Medical attention was not sought. No further information was provided.
Sex: F
Vaccine: SMALL
Symptoms: Blister, Fatigue, Injection site vesicles
Clinical narrative: Few scattered vesicular lesions on forearm and face. No systemic symptoms except fatigue. Major reaction at site of vaccina vaccination, left arm.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site pain
Clinical narrative: Information has been received from a physician's assistant and a nurse, concerning the nurse's 14 year old daughter, who on 02-FEB-2007, was vaccinated in the right hip, with the first dose, 0.5ml, of Gardasil, and on 04-APR-2007 was vaccinated in the back of her right arm, with the second dose, 0.5ml, of Gardasil. The nurse reported that on 04-APR-2007, the vaccination was administered near her daughter's elbow "in the area of subcutaneous fat," and added that her daughter experienced "injection site soreness" in her right arm. The nurse reported that the arm soreness resolved on the same day, 04-APR-2007. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Rash generalised
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 21 year old female patient, who on 05-FEB-2007 was vaccinated IM, with the first dose of Gardasil, and on 02-APR-2007 with the second dose of Gardasil (Lot #654535/0136U). Concomitant therapy included an antibiotic containing sulfa (unspecified). On 05-APR-2007, three days later after the second dose was administered, the patient developed a red rash from her chin to her toes. The physician indicated he believed "the antibiotic containing sulfa" was "the cause of the rash." At the time of the report, it unknown if the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.