chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site induration, Injection site warmth, Pain, Pallor
Clinical narrative: Information has been received from a 59 year old female with no allergies or medical history who on 03-Nov-2006 was vaccinated in the left arm with a first dose of varicella-zoster virus vaccine live. Concomitant therapy included levothyroxine Na (SYNTHYROID), calcium (unspecified), and atorvastatin calcium (LIPITOR). On 03-Nov-2006, immediately after vaccination, the patient's arm swelled "like a baseball" and became burning hot and hard at injection site. She reported that 10 hours later, her arm was "blood red and sore" and was like this for one week. She was reported that on 08-Nov-2006, her left forearm got a rash and since then, "almost everyday" she has a rash and lesions show up 'all over her body". Her body was swollen and itches and the lesions are "huge lumps". They are "not drying up. Unspecified medical attention was sought. She was taking preabalin (LYRICA) for pain and was on steroids. A CBC was performed on approximately 03-Nov-2006 (results not provided). At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information was received from the patient's physician who reported that the patient had an itchy, stinging, painful rash on the right neck, right shoulder, and right back. There was erythema, no crusting or pustules, and the area blanches when touched. She was being treated with preabalin (LYRICA) and prednisone on a decreasing scale and hydroxysine hydrochloride (ATARAX). The physician will check with the patient "in the next day or two". 6/17/10 Additional information indicated that the patient developed arm swelling at the injection stie, a rash on her extremities and back which turned to blisters. Pain and itching were noted. The physician reported that this lasted 10 weeks and the patient recovered. It was also reported that the patient's husband (WAES #0703USA03408) contracted a rash from his wife. No additional information is expected.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin lesion, Skin ulcer, Swelling
Clinical narrative: Information has been received from a 59 year old female with no allergies or medical history who on 03-Nov-2006 was vaccinated in the left arm with a first dose of varicella-zoster virus vaccine live. Concomitant therapy included levothyroxine Na (SYNTHYROID), calcium (unspecified), and atorvastatin calcium (LIPITOR). On 03-Nov-2006, immediately after vaccination, the patient's arm swelled "like a baseball" and became burning hot and hard at injection site. She reported that 10 hours later, her arm was "blood red and sore" and was like this for one week. She was reported that on 08-Nov-2006, her left forearm got a rash and since then, "almost everyday" she has a rash and lesions show up 'all over her body". Her body was swollen and itches and the lesions are "huge lumps". They are "not drying up. Unspecified medical attention was sought. She was taking preabalin (LYRICA) for pain and was on steroids. A CBC was performed on approximately 03-Nov-2006 (results not provided). At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information was received from the patient's physician who reported that the patient had an itchy, stinging, painful rash on the right neck, right shoulder, and right back. There was erythema, no crusting or pustules, and the area blanches when touched. She was being treated with preabalin (LYRICA) and prednisone on a decreasing scale and hydroxysine hydrochloride (ATARAX). The physician will check with the patient "in the next day or two". 6/17/10 Additional information indicated that the patient developed arm swelling at the injection stie, a rash on her extremities and back which turned to blisters. Pain and itching were noted. The physician reported that this lasted 10 weeks and the patient recovered. It was also reported that the patient's husband (WAES #0703USA03408) contracted a rash from his wife. No additional information is expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male married patient who was vaccinated with a dose of varicella-zoster virus vaccine live (Merck). Subsequently the patient developed shingles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2006. Additional information has been received from a physician who reported that the patient's shingles was diagnosed by a dermatologist. Additional information has been requested.
Age: 1.33
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 16 month old infant who on 14-Nov-2006 was accidently vaccinated with a dose of varicella-zoster virus vaccine live. The pharmacist reported that the patient received half of a dose and the other half spilled out onto the nurse's hand and sheet. She explained that the pharmacy had stored both varicella-zoster virus vaccine live and varicella virus vaccine live next to each other and inadvertently picked up the wrong box of vaccine when dispensing it. She reported that this was not confusion. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. Additional information from the pharmacist explained that the problem was that ZOSTAVAX (Merck) is a frozen vaccine and was stored next to VARIVAX (Merck) in the freezer. The technician inadvertely grabbed the wrong vaccine and handed it to a nurse, who handed it to another nurse and who in turn, handed it to a third nurse. Nof of them double checked the vaccine. The reporter inteded on more clearly lableling the vaccines in the freezer. No further information is expected.
Age: 35.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Varicella virus test negative, Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a 35 year old female who on 10-Nov-2006 was inadvertently vaccinated with a dose of varicella-zoster virus vaccine live (Merck). Concomitant therapy included prenatal vitamins. It was reported that the patient was wanting to become pregnant but her titers (from an unspecified date) were negative for varicella. The patient was told to receive varicella virus vaccine live prior to getting pregnant. The patient received her first dose of varicella virus vaccine live on 13-Oct-2006. The patient then went to an urgent care clinic on 10-Nov-2006 to get her second dose of varicella virus vaccine live and was inadvertently vaccinated with varicella-zoster virus vaccine live (Merck). The patient had developed a localized injection site reaction. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2006. Additional information from the healthcare professional at the clinic indicated that they did not have any additional information regarding the cause of the medication error, the clinic has since changed the storage location for VARIVAX (Merck). Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with a dose of varicella-zoster virus vaccine live (Merck) on an unspecified date. Subsequently two weeks post-vaccination the patient developed a rash that looked like an "outbreak of shingles". Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2005. Additional information from the physician indicated that the patient recovered on 16-NOV-2006. No other information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a health professional concerning a female with severe post herpetic neuralgia and a history of shingles who in October 2006 was vaccinated with a dose of varicella-zoster virus vaccine live. Subsequently, the patient's "immunization system actually unimproved". Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Rash erythematous, Rash pruritic, Scab, Skin lesion
Clinical narrative: Information has been received from a 77 year old female with allergies to cefaclor (CECLOR) and relafan, and a history of shoulder replacement in 1997, who on 10-Nov-2006 was vaccinated in her arm with a first dose of varicella-zoster virus vaccine live. Concomitant vaccination included a dose of influenza virus vaccine (unspecified) (manufacturer unknown) and a dose of pneumococcal 23v polysaccharide (manufacturer unknown). Concomitant therapy included metoprolol succiante (TOPROL XL TABLETS), simvastatin, escitalopram oxalate (LEXAPRO), aspirin, esomeprazole magnesium (NEXIUM) and minerals (unspecified) (+) vitamins (unspecified) (CENTRUM). On 15-Nov-2006 the patient developed little red itchy bumps all over her body. The patient "thinks it's chicken pox". It was reported that the bumps "kept building up and gradually got worse" starting on 18-Nov-2006. She reported that some of th bumps were turning into scabs. She was putting triancinoioneacetonide ointment on them. Medical attention was not sought though the patient stated that she was going to call her physician and make an appointment. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information was available. Additional information has been requested. 6/17/10 Additional informatin from the nurse practioner indicated that on 20-NOV-2006 she examined the patient in the office and the patient had about 6 lesions, 4 mm in size. No other information was available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site rash, Injection site vesicles, Pruritus, Skin discolouration
Clinical narrative: Information has been received from a physician assistant concerning a 70 year old female who on an unspecified date was vaccinated in the left arm with a dose of varicella-zoster virus vaccine live. One day after vaccination, the patient developed small blisters at the injection site (left arm) and under the left breast and nipple. At the time of the report, it was 21 days later and the patient still had a slight rash at the injection site and left breast with an itchy burning general rash on the trunk. The rash on the left breast had a bluish discoloration 21 days after the rash started. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information was received from the reporter who noted that almost "immediately" after vaccination the patient experienced five to ten pustules at the site of injection and then went home. At day 21 post-injection, the patient returned with the same small blisters now on her left breast and nipple and a generalized itchy, burning rash on her trunk (area not specified). The patient was started on valacyclovir hydrochloride (VALTREX) and cultures were obtained. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female who on 15-Nov-2006 was vaccinated SC with a 0.5 ml first dose of varicella-zoster virus vaccine live (lot#652946/1012F) instead of a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (upgrade process). It was noted that there was no product confusion. No medical attention was sought. Additional information was received from the administering nurse reported that there was no confusion with the packaging. They kept measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (upgrade process), varicella virus vaccine live, and varicella-zoster virus vaccine live in the freezer together with an intranasal flu vaccine. Occasionally, the flu vaccine would fall onto the other small vaccine boxes. They took the top lid off the boxes so they could easily get to the vials of vaccine. At some point, the boxes got tipped over and someone put the vaccine into the wrong box. The reporter looked for measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live in the purple box and grabbed the vial, not realizing that the lid was the wrong color. Essentially, someone put the vaccine in the wrong box and he did not catch it. He realized a week later that the wrong vaccine was given. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex serology, Herpes zoster, Scab
Clinical narrative: Information has been received from a physician concerning a female married patient who was vaccinated with a dose of varicella-zoster virus vaccine live (Merck). Subsequently the patient developed shingles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 12/14/2006. Additional information has been received from a physician who reported that he diagnosed the patient with shingles. Her rash developed 72 hours post-vaccination. A scab was unearthed and a sample was sent to a lab; however, there was a mistake, and it was only tested for herpes simplex virus. There were no other samples to test. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Urticaria
Clinical narrative: Information has been received from a 66 year old female with Graves disease and no allergies who on 10 Nov 2006 was vaccinated with a dose of varicella zoster virus vaccine live. Concomitant therapy included SYNTHROID. Concomitant vaccination on approximately 27 Oct 2006 included a dose of influenza virus vaccine (unspecified). On 12 Nov 2006, two days after vaccination, the patient developed blisters on the same arm where the injections was given. The blisters were approximately six inches below the injection site and on her left arm. On 13 Nov 2006, the third day after vaccination, she also developed welts on her left arm. The blisters and welts caused itching. Presently, the blisters and the welts were fading, but she could still see them. No medical attention was sought and no diagnostic laboratory test were performed. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a male physician who on approximately 18-Oct-2006 was vaccinated with a dose varicella-zoster virus vaccine live. On 22-Nov-2006 the physician reported that he has thoracic zoster on his left side which hurts. He rated his pain a 5 on a scale of 0 thorugh 10 being the most. No speciment was collected for PCR analysis or DFA as he was traveling in another country. At the time of the report, he still had pain. No further information was provided. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female who on 15 Nov 2006 was vaccinated SC with a 0.5mL first dose of varicella-zoster virus vaccine live (lot # 652946/1012F) instead of a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (MSD). It was noted that there was no product confusion. No medical attention was sought. Additional information was received from the administering nurse who reported that there was no confusion with the packaging. They kept measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (MSD), varicella virus vaccine live (MSD), and varicella-zoster virus vaccine live in the freezer together with an intranasal flu vaccine. Occasionally, the flu vaccine would fall onto the other small vaccine boxes. They took the top lid off of the boxes so they could easily get to the vials of vaccine. At some point, the boxes got tipped over and someone put the vaccine into the wrong box. The reporter looked for measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (MSD) in the purple box and grabbed the vial, not realizing that the lid was the wrong color. Essentially, someone put the vaccine in the wrong box and he did not catch it. He realized a week later that the wrong vaccine was given. Additional information has been requested. 6/17/10 Additional informationi has been received from the administering nurse who reported that according to the parent, on 16-NOV-2006 the nite of the vaccination was swollen and reddened. On 22-NOV-2006, the patient had a low grade fever and complained of a headache. On 24-NOV-2006, the patient broke out in chickenpox on the back, underarms, and back of the knees. On 04-DEC-2006, the chickenpox had cleared up and were healing. The patient subsequently recovered. Additional informatin is not expected.
Age: 61.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Dyspnoea, Erythema, Heart rate increased, Injection site mass, Pruritus
Clinical narrative: Information has been received from a health professional concerning a 61 year old white female with hypertension, "hyperlipids", allergies to bee stings and penicillin who on 09 Nov 2006 at 10:00 was vaccinated in the left deltoid with a first dose of Zostavax (lot # 652965/0622F). Concomitant therapy included influenza virus vaccine (unspecified). There was no illness at the time of vaccination. On 10 Nov 2006 at 12:00 am, the patient developed a lump in her muscle the size of a tennis ball which was red, raised and hot to touch. The patient had shortness of breath and rapid pulse rate. The patient is allergic to bee stings and she described her reaction as such. Unspecified medical attention was sought. No epinephrine was given. One week post vaccination, the lum was gone and some redness and itching were noted. The patient recovered on 18 Nov 2006. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Skin warm
Clinical narrative: Information has been received from a health professional concerning a 61 year old white female with hypertension, "hyperlipids", allergies to bee stings and penicillin who on 09 Nov 2006 at 10:00 was vaccinated in the left deltoid with a first dose of Zostavax (lot # 652965/0622F). Concomitant therapy included influenza virus vaccine (unspecified). There was no illness at the time of vaccination. On 10 Nov 2006 at 12:00 am, the patient developed a lump in her muscle the size of a tennis ball which was red, raised and hot to touch. The patient had shortness of breath and rapid pulse rate. The patient is allergic to bee stings and she described her reaction as such. Unspecified medical attention was sought. No epinephrine was given. One week post vaccination, the lum was gone and some redness and itching were noted. The patient recovered on 18 Nov 2006. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Joint swelling, Myalgia, Oedema peripheral, Pain
Clinical narrative: Information has been received from a 65 year old male consumer with no known allergies and a history of  heart attack in August 2006, who on 02 Nov 2006 was vaccinated with a dose of Zostavax. Concomitant therapy included unspecified "heart medication." On 04  Nov 2006 the patient went to the emergency room because he was having severe pain in his hands and shoulder. The patient was given acetaminophen (+) Vicodin, unspecified blood work was done, and x-rays of his shoulder and hand were done (results not reported). The patient was sent home from the emergency room after 4 hours. On the following Monday or Tuesday the patient saw his physician  who told him to take Advil or Tylenol. At the time of the report the patient continued to have pain in his hand and shoulders, and swelling in his hands and wrist. The patient was also complaining of pain at the injection site when  it is pressed, however he did not have any redness or swelling at the site. The patient was reported to be recovering on therapy. There was no product quality complaint involved. No furter information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of Zostavax. Subsequently the patient experienced localized swelling, redness and pain at the injection site. Unspecified medical attention was sought. The patient was given an antibiotic and it helped with the pain and swelling. There was no product quality complaint involved. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Skin lesion
Clinical narrative: Information has been received from a physician concerning his approximately 60 year old wife with no history of shingles who on an unspecified date was vaccinated with a dose of Zostavax. Two weeks after vaccination, the patient has an outbreak of itchy lesions. The patient did not have any pain. The lesions were unilateral and were still present but had improved. Bacitracin was applied to the lesions. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. It was also reported that the patient's daughter developed chickenpox two weeks after the patient was vaccinated with Zostavax (WAES# 0612USA00243). 06/17/10 Additional information indicated that the injection site within 1 week was red and inflammed 8-10 cm. On 11-NOV-2006 the patient noted 3 lesions typical of varicella or herpes zoter; one on the right foreamr and 2 on the right upper arm area post axillary fold. Each lesion was 1.5 cm diameter and lasted 3 weeks with residual herpes zoster scar. The patient recovered other than some post herpectic scars. The patient recovered on 01-DEC-2006.
Age: 1.5
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Drug ineffective, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning an 18 month old female who was accidentally vaccinated with a dose of Zostavax instead of a dose of Varivax. The patient was not experiencing any known symptoms. The reporter did not know why this happened. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Injection site vesicles, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning his wife who on 27 Nov 2006 was vaccinated with a dose of Zostavax. Concomitant vaccination on the same day included a dose of influenza virus vaccine (unspecified) and a dose of Pneumovax (MSD). On 29 Nov 2006, 48 hours later, the patient developed a low grade fever (100.5) and pain at the Zostavax injection site with the appearance of local vesicles at injection site which have persisted for 24 hours. She was taking nonsteroidal anti-inflammatory drugs for the pain and fever without complete relief. As of 04 Dec 2006, she was doing better. The vesicular lesions were healing and the injection site pain in "both arms" was less severe. No further information is available.
Age: 25.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection transmission via personal contact, Viral infection
Clinical narrative: Information has been received from a physician concerning his approximately 20 year old daughter whose mother was vaccinated on an unspecified date with a dose of varicella zoster virus vaccine live. Two weeks after her mother was vaccinated, the patient had an outbreak of chickenpox. The daughter has no lesions presently. Additional information has been requested. It was also reported that the patient's mother had an outbreak of itchy unilateral lesions after vaccination with varicella zoster virus vaccine live (WAES0611USA07521). This is in follow-up to report(s) previously submitted on 12/14/2006. Information has been received from a physician concerning his 25 year old daughter whose mother was vaccinated on 19-OCT-2006 at 10:00 AM with a SC second dose of ZOSTAVAX (Merck). Two weeks after her mother was vaccinated, on approximately 01-NOV-2006, the patient had an outbreak chickenpox. It was also described as a wide spread puritic rash of chickenpox. It was noted that the daughter lives with the mother. The daughter has no lesions presently. Additional information has been requested. It was also reported that the patient's mother had an outbreak of itchy unilateral lesions after vaccination with ZOSTAVAX (Merck) (WAES # 0611USA07521).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Infection transmission via personal contact
Clinical narrative: Information has been received from a female registered nurse who on an unspecified date gave a patient Zostavax. Subsequently, one week later, she developed a rash on her left thigh which was painful. She believed that the rash was shingles. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Vomiting
Clinical narrative: Initial and follow up information has been received from a Registered Nurse concerning a white female patient who on the afternoon of 10 Oct 206 was vaccinated IM with her first dose of Gardasil (yeast), lot #653650/0720F, and experienced flu-like symptoms and vomiting. No medical attention was sought. Within a day or two, the patient recovered. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 12/14/2006.  Initial and follow up information has been received from a Registered Nurse concerning a white female patient who on the afternoon of 10-OCT-2006 was vaccinated IM with her first dose of GARDASIL, lot #653650/0702F, and experienced flu-like symptoms and vomiting.  No medical attention was sought.  Within a day or two, the patient recovered.  Follow up information indicated that the patient received her second dose of GARDASIL and had no adverse experience.  Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Initial and follow up information has been received from a Nurse Practitioner concerning an approximately 22 year old female patient who in October 2006, was vaccinated IM with a dose of Gardasil (yeast). Subsequently, she experienced nausea, lightheadedness/lightheaded feeling/dizziness, weakness, pallor, and sweating but did not lose consciousness. No medical attention was sought. The nurse practitioner indicated the patient was "doing fine", and had recovered after 20 minutes. No product quality complaint was involved. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: HPV4
Symptoms: Haemorrhage, Injection site induration
Clinical narrative: Information has been received from a health professional concerning an approximately 48 year old female patient with condyloma with mild to moderate dysplasia who on 31 Oct 2006 was vaccinated IM into the deltoid with a second 0.5mL dose of Gardasil (yeast) (lot # 653978/0955F). Concomitant therapy included aspirin. It was reported that after the nurse gave the injection blood immediately ran out of the site and it was hard and lumpy. It was reported that the nurse used proper placement technique and a standard 1 inch needle (not the prefilled device). The patient had no problems with the first dose. The patient did not report any discomfort from the hard and lumpy area. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with a 0.5 mL dose of Gardasil (yeast). Subsequently, the patient fainted. Unspecified medical attention was sought. A short time after vaccination, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Pruritus
Clinical narrative: Information has been received from a medical assistant concerning a 24 year old female with no other relevant history reported. On 19 Oct 2006, the patient was vaccinated with the first dose of Gardasil (yeast). There were no other concomitant medications reported. On 19 Oct 2006, the patient developed some initial itching at the injection site that resolved (date unknown). On 02 Nov 2006, the patient reported that she awoke with a large red bump at the injection that was itchy "this developed about 13 days post dose". The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vulvovaginal pruritus
Clinical narrative: Information has been received from a nurse concerning a 12 year old female who on 30 Seo 2006 was vaccinated with the first 0.5 mL dose of Gardasil reported as "oral". On 01 Oct 2006, the patient developed intense vaginal itching. The patient sought unspecified medical attention. On 03 Oct 2006, the patient recovered from the event. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 12/14/2006.  Information has been received from a medical assistant (previously reported as a nurse) concerning a 15 year old female student (previously reported as a 12 year old) with asthma.  On 04-OCT-2006, at 4:30 PM, (previously reported as 30-SEP-2006), the patient was vaccinated in the left deltoid with the first 0.5 mL dose of GARDASIL (Lot # 654540/0800F).  There were no illnesses noted at the time of vaccination.  On 04-OCT-2006 (previously reported as 01-OCT-2006), at 6:30 PM, the patient developed intense vaginal itching which continued to the day after.  It was reported then it stopped abruptly on Day# 3.  On 06-OCT-2006, the patient had recovered from the event.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Injection site anaesthesia, Paraesthesia
Clinical narrative: Information has been received from a female physician assistant (age not reported) who on an unspecified date was vaccinated with 1 dose of 0.5 ML of Gardasil (yeast) (Lot#653978/0955F). The physician assistant reported that after she was injected with Gardasil (yeast) she felt numbness from the injection site progress all the way to her fingers. Unspecified medical attention was sought. At the time of this report, the physician assistant had recovered from the event (date unknown). Additional information has been requested.  This is in follow-up to report (s) previously submitted on 12/14/2006.  Initial and follow-up information has been received from a white, 26 year old female, physician assistant whose reported weight was 130 pounds and whose reported height was 67 inches, with no pre-existing allergies or illness who on 01-NOV-2006 was vaccinated intramuscularly (IM) into the left deltoid muscle with the first dose of 0.5 mL dose of GADASIL (Lot # 653978/0955F).  The physician assistant reported she felt numbness and tingling down through her left arm and into her hand as GARDASIL vaccine was administered.  It was reported that there were no long term effects, all signs and symptoms resolved in a few minutes.  Unspecified medical attention was sought.  At the time of this report, the physician assistant had recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Information has been received from a health professional concerning a her 19 to 21 year old daughter who on approximately 21 Sep 2006 "about 6 weeks ago" was vaccinated IM with a first dose of Gardasil (yeast). Within 5 to 6 hours of vaccination, the patient developed hives and swelling of her hands and feet. The patient was given (Benadryl) and the symptoms began to heal. Subsequently, the patient recovering. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning the experience of another physician's patient. On an unspecified date, a 12 year old female was vaccinated with a dose of Gardasil (yeast). Subsequently the patient developed a rash on her arm. Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Rash
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date received the first dose of Gardasil (yeast) (Lot # not provided). On 02 Nov 2006 the patient was vaccinated with the second dose of Gardasil (yeast) (Lot # not provided). On 03 Nov 2006 the patient experienced joint pain and developed a rash. Unspecified medical attention was sought. At the time of this report the patient was recovering from the event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Joint swelling, Pain, Pruritus, Urticaria
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 01-Nov-2006 was vaccinated with 0.5 ml of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#653650/0640F). At the same time, the patient received medroxyprogesterone acetate (DEPO-PROVERA) " in glut". On 01-Nov-2006 (conflicting information also reported as 02-Nov-2006), the patient developed body aches. On 03-Nov-2006 the patient developed hives all over body and also experienced ankle swelling. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 12/14/2006.  Initial and follow up information has been received from a physician and a registered nurse concerning a 14 year old female student with an unspecified allery reported as "unknown antibiotic".  On 01-NOV-2006, at 4:00 PM, the patient was vaccinated intramuscularly in the left arm with the first 0.5 mL dose of GARDASIL (Lot #653650/0640F).  At that same time, the patient received DEPO-PROVERA "in glut".  On 02-NOV-2006, the patient developed body aches, swollen ankles and itchy hives on stomach and arms (previously reported as hives all over body).  The patient followed up with the physician.  At the time of this report, the outcome of the events were unknown.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a health professional concerning a female patient who was vaccinated with a first 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The next morning, the patient felt sick to her stomach. It was noted that once she went to school she felt better. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 19 year old female patient who is the daughter of one of the office employees, who on 02-Nov-2006 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#653650/0696F). Concomitant therapy included hormonal contraceptives (unspecified). On 02-Nov-2006 the patient developed nausea, low grade fever, achiness and a headache post vaccination. It was reported that these events continued into the evening on 02-Nov-2006. On 03-Nov-2006, the next morning the patient had recovered from all of the events. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 12/14/2006.  Information has been received from a nurse concerning a 19 year old female patient who is the daughter of one of the office employees, who on 02-NOV-2006 was vaccinated with the first dose of GARDASIL (Lot # 653650/0696F).  Concomitant therapy included hormonal contraceptives (unspecified).  On 02-NOV-2006 the patient developed nausea, dizziness, low grade fever, achiness and a headache post vaccination.  It was reported that these events continued into the evening on 02-NOV-2006.  On 03-NOV-2006, the next morning the patient had recovered from all of the events.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a Nurse Practitioner concerning a female patient who on 27-Oct-2006 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient fainted in the office, hit her head on the floor and required stitches. Medical attention was sought. At the time of the report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced numbness and pain in her arm. The patient sought unspecified medical attention. Subsequently, the patient recovered from pain in injection arm and is recovering from the numbness. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a female (NOS) who was vaccinated on an unknown date intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently the patient fainted. Subsequently, the patient recovered from the syncope. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal
Clinical narrative: Information has been received from a health professional concerning a 20 year old female who on 26-Oct-2006 was vaccinated "in the right hip" with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot#654540/0800F). Within 15 minutes, the patient experienced a "funny feeling" in upper right thigh. The patient said "the feeling was gone later that day". No medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a female who "between the beginning of the September and now" (date not specified) was vaccinated IM with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently on an unspecified date, the patient experienced a "definite tingling" at the injection site. Unspecified medical attention was sought. At the time of this report, the patients outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthropod bite, Menorrhagia, Migraine, Rash, Urticaria
Clinical narrative: Information has been received from an office manager concerning a 14 year old female who on 02-Nov-2006 was vaccinated intramuscularly in the arm with a 0.5 ml dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 03-Nov-2006 the patient started her menses and experienced a migraine. On 06-Nov-2006 the patient experienced a rash on her vaccinated arm which also spread to her face. Unspecified medical attention was sought. The patient was treated with diphenhydramine (BENADRYL) and the rash had subsided. AT the time of report, the patient was recovering from the migraine. No product quality complaint was involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 12/14/2006.  Information has been received from an office manager concerning a 14 year old female with no pertinent medical history who on 02-NOV-2006, at 15:00, was vaccinated intramuscularly in the left arm with a 0.5 ml first dose of GARDASIL.  On 03-NOV-2006 the patient started her menses and experienced a migraine.  On 06-NOV-2006 the patient developed hives on her vaccinated arm which also spread to her face.  Unspecified medical attention was sought.  The patient was treated with BENADRYL and the rash had subsided.  At the time of report, the patient was recovering from the migraine.  Follow-up reported that the patient had a new puppy with fleas.  The pediatrician diagnosed that the rash was due to flea bites and not due to an allergy.  The patient was expected to received the second dose in January 2007.  No product quality complaint was involved.  Additional information is not available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Face oedema, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 13 year old female who was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced swelling in her face, stomach was extended with fluids and her lower extremities were swollen. Unspecified medical attention was sought. The patient was put on "hydrosteroids". She is scheduled for a follow-up visit the week of November 13th. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, the patient's pap smear came out positive. Medical attention was sought. Her outcome was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on an unspecified date was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5 ml). Subsequently, two weeks following vaccination, the patient experienced pain at the injection area. The patient also complained of pain in the same area when lifting her arm. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Information has been received from a physician concerning an approximately 18 year old female who on approximately 02-Nov-2006 was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On week after vaccination, on approximately 09-Nov-2006, the patient experienced pain at the injection site, and had redness, soreness and swelling. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female patient (demographics not provided) who on an unspecified date was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently the patient developed a rash on her face and stomach. The patient sought unspecified medical advice. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female with low level depression and anxiety and penicillin allergy and sulfonamide allergy who on 30-Oct-2006 was vaccinated intramuscularly in the right deltoid with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot#653978/0955F). Concomitant therapy included escitalopram oxalate (LEXAPRO), loratadine (CLARITIN) acetaminophen (TYLENOL). On 30-Oct-2006, following vaccination, the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered and no other symptoms were noted. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning an 15 year old female with a history of polycystic ovary syndrome, who on 12-Sep-2006 was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#654540/0800F). Subsequently, shortly after receiving the vaccination the patient fainted. Subsequently, the patient recovered from the syncope. Unspecified medical attention was sought. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a physician's assistant concerning a 11 year old female who on unspecified date was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently the patient developed swollen lymph nodes in groin her area. Unspecified medical attention was sought. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Hyperhidrosis, Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning his daughter, a 19 year old female who at 15:00 on 08-Nov-2006 "was feeling great anxiety" before receiving an intramuscular injection with the vaccination HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#654540/0800F). On 08-Nov-2006 after receiving the vaccination the patient experienced throbbing pain, a tingling sensation down length of her arm, elbow, wrist, jaw line and down her neck, fever, swelling and redness at the injection site, was "terribly itchy", had veins protruding, swollen glands, nausea and "felt hot and sweaty" (the patient was reported to be afebrile). Unspecified medical attention was sought. At the time of the report it was unknown if the patient had recovered. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain, Paraesthesia, Pruritus, Pyrexia
Clinical narrative: Information has been received from a physician concerning his daughter, a 19 year old female who at 15:00 on 08-Nov-2006 "was feeling great anxiety" before receiving an intramuscular injection with the vaccination HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#654540/0800F). On 08-Nov-2006 after receiving the vaccination the patient experienced throbbing pain, a tingling sensation down length of her arm, elbow, wrist, jaw line and down her neck, fever, swelling and redness at the injection site, was "terribly itchy", had veins protruding, swollen glands, nausea and "felt hot and sweaty" (the patient was reported to be afebrile). Unspecified medical attention was sought. At the time of the report it was unknown if the patient had recovered. Additional information is not expected.