chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia, Menstruation irregular, Vaginal odour
Clinical narrative: Information has been received from a consumer concerning her daughter, an 11 year old female patient who in approximately December 2006 ("about two months ago"), was vaccinated with the first dose of HPV (yeast). There was no concomitant medication. On approximately 20-JAN-2007 ("next menses"), the mother reported her daughter's "menses was longer than usual," and lasted for six days. The mother reported her daughter's menses usually "last three days." She also reported the menses was "very heavy and had a foul odor." The patient did not seek medical attention. It was unknown if the patient recovered. Additional information has been requested. Follow-up received 04/03/2010. The nurse was unable to contact the patient since the vaccination was administered, had no knowledge of the patient's menstrual cycle changes, and did not know if the patient had recovered. No further information is expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Muscle disorder
Clinical narrative: Information has been received from a Health care Professional concerning a 26 year old female police officer with muscle sensitivity who on 02-NOV-2006 was vaccinated in left deltoid with a 2nd dose of HPV, lot # 653736/0868F. On 23-NOV-2006 the patient was sore at muscle site on an off for 3 days, and she still noticed sensitivity three weeks post injection. No medical attention was sought. The patient reported as recovered. No further information is available. Follow-up received 04/03/2009. On her visit on 16-JAN-2007 the patient reported the event. The patient reported as recovered. No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician assistant (PA) concerning a female patient who in "early" December 2006, was vaccinated with the first dose of HPV (yeast). The PA reported that the patient "did not have any symptoms except" what the PA stated was "normal pain at the moment of injection." The patient sought unspecified medical attention.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria, Vomiting
Clinical narrative: Information has been received from a Physician Assistant (P.A.) concerning a 20 year old female with a history of hives once a year who on 21-FEB-2007 was vaccinated IM with a dose of HPV, lot # 655618/0786U. On 22-FEB-2007 the patient developed hives over her entire body and vomiting. The reporter also noted that in addition to her history of hives, members of her family had a stomach virus with vomiting so it was unclear if her symptoms were from the vaccine. BENADRYL was ordered for the hives. The patient's outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 17 year old female with a cardiac murmur who on 28-NOV-2006 was vaccinated IM with her first dose of HPV, lot #654540/0800F. On 29-FEB-06 the patient experienced minor soreness around the injection site. The patient did not return for her 2nd dose until 27-FEB-2007. The patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Crying, Pain, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner and a licensed practical nurse concerning a teenage female (age not reported) who on an unspecified date was vaccinated with 0.5 mL of Gardasil. Subsequently, the patient ended up crying and reported she had pain, when the vaccine was being administered, either left or right arm and had some pain afterwards. Unspecified medical attention was sought. At the time of this report, the patient had recovered from the events (date unknown). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Crying, Pain
Clinical narrative: Information has been received from a nurse practitioner and a licensed practical nurse concerning a teenage female (age not reported) who on an unspecified date was vaccinated with 0.5 mL of Gardasil. Subsequently, the patient ended up crying and reported she had pain, when the vaccine was being administered, either the left or right arm and had some pain afterwards. Unspecified medical attention was sought. At the time of this report the patient had recovered from the events (date unknown). Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Fungal infection
Clinical narrative: This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a consumer concerning her 11 year old daughter with asthma and sulfonamide allergy and a history of yeast infections who in approximately November 2006, was vaccinated with a first dose of Gardasil. Concomitant therapy included ALLEGRA, SINGULAIR, ADVAIR, NASONEX, PROZAC. Subsequently, it was reported that the patient's "yeast infection has become more severe." Unspecified medical attention was sought. At the time of the report, the patient had not recovered. Additional information was received from a physician who reported that her office did not administer the vaccine to the patient nor had the patient addressed the event with her. The patient's mother was notified to provide the name of the ordering physician. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Complex regional pain syndrome
Clinical narrative: Initial and follow-up information has been received from a physician concerning a female who was vaccinated with a 0.5 ml dose of Gardasil (lot #655617/1447F). Subsequently, 2 days after vaccination, the patient experienced "RSD reaction" that started in her upper extremities and then moved to her lower extremities. The patient is undergoing a neurology work-up. At the time of the follow-up report, the patient had not recovered. Additional information has been requested. 05/15/07-records received for DOS-1/15/07-seen for repeat chlamydia testing after treatment. C/O episodes of chest tightness without SOB and is worried about pulmonary embolus after reading about this risk on the internet. NuvaRing prescribed. Letter from parent included in notes-per parent. patient had thrid in a series of 3 shots of B12 on 4/16. Developed paresthesia in arm and fingers curled into her palm. Contacted neurologist who referred her to ER, treated with bendaryl and morphine and her arm straightened. Also previously seeing a physical therapist.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female with asthma who on 26-OCT-2006 was vaccinated with the first 0.5 ml dose of GARDASIL vaccine (yeast), (Lot # 653735/0688P). On 12-28-06, the patient was vaccinated with the second 0.5 ml dose of GARDASIL vaccine (yeast) (Lot # 654389/0916F). The nurse reported that the patient had adverse experiences after vaccination. The patient experienced neck pain. Also, the patient's arm "had hurt all the way down, off and on". At the time of the report the patient's symptoms began after the first and second dose of GARDASIL vaccine (yeast). At the time of the report, the symptoms had not resolved. The nurse also mentioned that the patient participated in gymnastics. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007. Since her initial injection, on 26-OCT-2006 (AE onste date also reported on 17-FEB-2007).
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning an approximately 13 year old ("about 13 years of age") female patient who was vaccinated with a dose of Gardasil. Subsequently the nurse reported that the patient's period (menstrual cycle) is "a little over a week late." At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Dizziness, Dizziness, Full blood count, Haematocrit decreased
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning a 14 year old female patient with an allergy to wool, who on 27-DEC-2006 was vaccinated with a dose of Gardasil (Lot # 653735/0688F). Concomitant therapy included DEPO-PROVERA, also administered on 27-DEC-2006. In approximately December 2006 ("since vaccination"), the patient "experienced anemia, dizziness, and heavy menstrual cycles." The NP also stated that the patient reported she "felt like she was going to pass out, but did not report passing out." The NP added that the "patient is receiving iron to treat the anemia." Diagnostic labs were performed (date not specified) including a complete blood count (CBC) (result not provided), hemoglobin 10.8 (unit not provided), and hematocrit 31.7 (unit not provided). At the time of this report, the patient had not recovered. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Initial and follow up information has been received from a registered nurse practitioner (NP) concerning a 14 year old female with an allergy to wool, who on 27-DEC-2006 (previously reported as 21-NOV-2006) was vaccinated in the right deltoid, with the first dose of GARDASIL (Lot # 653735/0688F). Concomitant therapy included DEPO-PROVERA, also adminsitered at the same visit. There was no illness at the time of vaccination. On 27-FEB-2007 (previously reported as December 2006, 01-FEB-2007 or "since vaccination"), the patient "experienced anemia, dizziness, and heavy menstrual cycles". The NP also stated that the patient reported she "felt like she was going to pass out, but did not report passing out". The NP added that the "patient is receiving iron to treat the anemia". Diagnostic labs were performed on 23-FEB-2007 including a complete blood count (result not provided), hemoglobin 10.8 (unit not provided), and hematocrit 31.7 (unit not provided). Follow up information received from the nurse practitioner indicated that the patient had also been experiencing lightheadedness. On 14-MAR-2007, additional labs were drawn; hemoglobin 11.3 and hematocrit 34.3 (units not specified). The NP confirmed that the patient had recovered from the events, with the exception of the anemia, which is improving. The patient continues to be treated, and the nurse practitioner added that the patient and her mother feel the anemia was "due to GARDASIL". No further information is expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Haemoglobin normal, Menorrhagia, Syncope
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning a 14 year old female patient with an allergy to wool, who on 27-DEC-2006 was vaccinated with a dose of Gardasil (Lot # 653735/0688F). Concomitant therapy included DEPO-PROVERA, also administered on 27-DEC-2006. In approximately December 2006 ("since vaccination"), the patient "experienced anemia, dizziness, and heavy menstrual cycles." The NP also stated that the patient reported she "felt like she was going to pass out, but did not report passing out." The NP added that the "patient is receiving iron to treat the anemia." Diagnostic labs were performed (date not specified) including a complete blood count (CBC) (result not provided), hemoglobin 10.8 (unit not provided), and hematocrit 31.7 (unit not provided). At the time of this report, the patient had not recovered. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Initial and follow up information has been received from a registered nurse practitioner (NP) concerning a 14 year old female with an allergy to wool, who on 27-DEC-2006 (previously reported as 21-NOV-2006) was vaccinated in the right deltoid, with the first dose of GARDASIL (Lot # 653735/0688F). Concomitant therapy included DEPO-PROVERA, also adminsitered at the same visit. There was no illness at the time of vaccination. On 27-FEB-2007 (previously reported as December 2006, 01-FEB-2007 or "since vaccination"), the patient "experienced anemia, dizziness, and heavy menstrual cycles". The NP also stated that the patient reported she "felt like she was going to pass out, but did not report passing out". The NP added that the "patient is receiving iron to treat the anemia". Diagnostic labs were performed on 23-FEB-2007 including a complete blood count (result not provided), hemoglobin 10.8 (unit not provided), and hematocrit 31.7 (unit not provided). Follow up information received from the nurse practitioner indicated that the patient had also been experiencing lightheadedness. On 14-MAR-2007, additional labs were drawn; hemoglobin 11.3 and hematocrit 34.3 (units not specified). The NP confirmed that the patient had recovered from the events, with the exception of the anemia, which is improving. The patient continues to be treated, and the nurse practitioner added that the patient and her mother feel the anemia was "due to GARDASIL". No further information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Oedema peripheral, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician, via a company representative concerning a female patient who on approximately 21 Feb 2007 ("last week") was vaccinated with the first dose of Gardasil. The physician reported that the "patient came back a few days after first dose of (Gardasil) and complained arm pain, swelling, fever and nausea" (approximately 23 Feb 2007). The physician confirmed that the patient had recovered "after a few days" (approximately 26 Feb 2007). The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report (s) previously submitted on 03/14/2007.  Initial and follow up information has been received from a physician, concerning a 20 year old female student with allergies to ZITHROMAX and CLARITIN who on 22-FEB-2007 (previously reported as approximately 21-FEB-2007) was vaccinated with the first dose, 0.5ml. IM, of GARDASIL (Lot # 654702/0011U).  The physician reported 10 hours after injection the patient developed a swollen left arm then fever, nausea and vomiting.  The physician clarified that the "patient did not seek medical care for these problems," but that she reported them to him at the next visit (28-FEB-2007) (previously reported as the "patient came back a few days afte first dose").  The physician confirmed that the patient had recovered from the swollen arm, fever, neausea and vomiting on 28-FEB-2007 (originally reported as recovered "after a few day," approximately 26-FEB-2007).  No further informaton is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 16 year old female patient with depression who on 28-DEC-2006 was vaccinated IM with her first dose of Gardasil, lot #654389/0961F. Concomitant therapy included CONCERTA and DEPO-PROVERA. The patient developed a generalized "hive like rash" after her first dose of Gardasil. The nurse reported that the rash "comes and goes". Unspecified medical attention was sought. The patient had not recovered as of the report date. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Erythema nodosum, Haemoglobin normal, Lymphocyte count decreased, Neutrophil count increased
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) concerning an 18 year old female patient who on 26-FEB-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included ORTHO-CYCLEN. On 28-FEB-2007 the patient developed red, painful lesions on her feet. The physician characterized the above lesions as similar to erythema nodosum. The physician ordered erythrocyte sedimentation rate (ESR) measurement, the result of which had not yet been obtained. The patient's outcome was unknown. Additional information has been requested. This is in follow-up to reports previously submitted on 3/14/2007. Initial and follow up information has been received from a license practial nurse (L.P.N.) concerning a 18 year old female stundent who on 26-FEB-2007 was vaccinated IM in left upper quardant gluteus with her first dose of GARDASIL lot #654389/0961F. Concomitant therapy included ORTHO-CYCLEN On 28-FEB-2007 the patient developed red, painful lesions on her feet. The physician characterized the above lesions as similar to erythema nodosum. The physician ordered erythrocyte sedimentation rate (ESR) measurement, the result of which had not yet been obtained. The patient's outcome was unknown. In follow up it was reported that the lesion started 2 days after the injection. The patient's feet were painful night before. On 12-MAR-2007 complete blood count was done and the laboratory result of red blood cell count was 3.65. Hemoglobin 11.7. Neutrophils 64.4 and lymphocytes was 22.0. the patient was recovered. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Red blood cell count decreased, Red blood cell sedimentation rate, Skin lesion
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) concerning an 18 year old female patient who on 26-FEB-2007 was vaccinated with the first dose of Gardasil. Concomitant therapy included ORTHO-CYCLEN. On 28-FEB-2007 the patient developed red, painful lesions on her feet. The physician characterized the above lesions as similar to erythema nodosum. The physician ordered erythrocyte sedimentation rate (ESR) measurement, the result of which had not yet been obtained. The patient's outcome was unknown. Additional information has been requested. This is in follow-up to reports previously submitted on 3/14/2007. Initial and follow up information has been received from a license practial nurse (L.P.N.) concerning a 18 year old female stundent who on 26-FEB-2007 was vaccinated IM in left upper quardant gluteus with her first dose of GARDASIL lot #654389/0961F. Concomitant therapy included ORTHO-CYCLEN On 28-FEB-2007 the patient developed red, painful lesions on her feet. The physician characterized the above lesions as similar to erythema nodosum. The physician ordered erythrocyte sedimentation rate (ESR) measurement, the result of which had not yet been obtained. The patient's outcome was unknown. In follow up it was reported that the lesion started 2 days after the injection. The patient's feet were painful night before. On 12-MAR-2007 complete blood count was done and the laboratory result of red blood cell count was 3.65. Hemoglobin 11.7. Neutrophils 64.4 and lymphocytes was 22.0. the patient was recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Agitation, Dizziness, Nausea
Clinical narrative: Information has been received from a health professional concerning a 17 year old female patient with history of acne and dyspepsia who on 28-FEB-2007 was vaccinated IM with her first dose of Gardasil lot #655503/0012U. Concomitant therapy included PREVACID, RETIN-A and CLEOCIN. The patient reported that she felt dizzy, nauseated and agitated starting 30 minutes after receiving the infection. The physician advised the patient to rest, monitor symptoms and call the office if no improvement. The patient's outcome was unknown. Additional information has been requested. Intial and follow-up information has been recieved from a health professional concerning a 17 year old female patient with history of acne and dyspeaio who was vaccinated on 28-Feb-2007 at 12:10am in to left deltoid IM with her first dose 0.5mL of GRADASIL, lot #655503/00120. COncomitant therapy included lansoprazole, trtinoin and clindamycin. On 28-FEB-2007 at 12:40AM the patient reported that she felt dizzy, bnauseated and agitated starting 30 minutes after recieving the injection. Yhe patient was lightheaded for approximately 6 hours. The physician advised the patient to rest, monitor symptoms and call the office if no improvement. The patoent's outcome was unknown. in follow-up it was reported that patient recoveredon 28-FEB-2007. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Blister, Herpes zoster, Pain, Rash
Clinical narrative: Information has been received from the mother of a female consumer who in January 2007, was vaccinated with a dose of Gardasil. The patient experienced pain, a rash and then full blown blisters. She went to her physician and was diagnosed as shingles. The patient's outcome was unknown. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a registered nurse concerning a female with high grade cervical dysplasia who on 23-FEB-2007 was vaccinated intramuscularly, into the left deltoid, with a first 0.5 ml dose of Gardasil (lot #653736/0014U). There was no concomitant medication. A few days after the vaccination, the patient developed a red, itchy, bumpy rash at the injection site. Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. At the time of the report, the patient's outcome was unknown. Additional information has been requested. Follow-up received 04/03/2009. Subsequently the patient recovered.  Penicillin allergy. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Back pain, Chills, Dizziness, Injection site pain
Clinical narrative: This is in follow-up to report (s) previously submitted on 3/14/2007. Information has been received from a nurse practitioner concerning a 26 year old female with no pertinent medical history who on 18-DEC-2006 was vaccinated intramuscularly, into the left deltoid with a first 0.5 ml dose of Gardasil (lot # "0604F"). Concomitant therapy included vitamins (unspecified). On 18-DEC-2006 the patient experienced soreness at the injection site, sacral back pain, mild low abdominal cramping, nausea, generalized itchiness, mild dizziness and "felt feverish with chills." Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. The patient recovered in 1 week without treatment. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pruritus, Pyrexia
Clinical narrative: This is in follow-up to report (s) previously submitted on 3/14/2007. Information has been received from a nurse practitioner concerning a 26 year old female with no pertinent medical history who on 18-DEC-2006 was vaccinated intramuscularly, into the left deltoid with a first 0.5 ml dose of Gardasil (lot # "0604F"). Concomitant therapy included vitamins (unspecified). On 18-DEC-2006 the patient experienced soreness at the injection site, sacral back pain, mild low abdominal cramping, nausea, generalized itchiness, mild dizziness and "felt feverish with chills." Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. The patient recovered in 1 week without treatment. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a health professional concerning her 16 year old daughter who on 21-FEB-2007 was vaccinated with a first dose of Gardasil. On 21-FEB-2007 the patient experienced a bad headache. She was given two ADVIL and her headache went away the following day. On 21-FEB-2007, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received a licensed practical nurse (LPN) concerning an approximately 13 year old ('about 13 years of age") female patient who was vaccinated with a dose of Gardasil. Subsequently the nurse reported that the patient's period (menstrual cycle) is "a little over a week late." At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Information has been received from a physician via a company representative concerning a female in her early 20's who, on an unspecified date, was vaccinated with a dose of Gardasil. It was reported that the patient experienced neck pain and stiffness after the injection. The pain was reported to have lasted much longer than expected. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician's assistant concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil (lot # not reported). Concomitant therapy was unspecified. The  patient sought unspecified medical attention. Subsequently, the patient experienced a rash. The specifics of the rash were not reported. The outcome of the rash was not reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injected limb mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a physician concerning an 18 year old female student (weight 131#, height 66.5") who on 14-DEC-2006 at 2 pm was vaccinated with the first dose of Gardasil (lot #654540/1162F), IM in the right arm. Concomitant therapy included Menactra (lot #41974ab), IM in the left arm. On approximately 14-DEC-2006, the patient developed fever T > 100 within 24 hours of vaccination, her arm was very sore and she "could not use for 48 hours". Subsequently on 16-DEC-2006, the patient recovered from fever T > 100, arm was very sore and could not use arm for 48 hours. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Head injury, Headache, Syncope
Clinical narrative: Information has been received from a physician concerning a female who on approximately 12-FEB-2007 was vaccinated intramuscularly with a dose of Gardasil. On approximately 12-FEB-2007 the patient fainted after the administration of Gardasil. It was reported that this patient may have fainted while on the way to the car and hit her head at an unspecified area. Medical attention was sought and the patient's mother was requesting a computed axial tomography because the patient was experiencing bad headaches. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Headache, Syncope
Clinical narrative: Information has been received from a physician concerning a female who on approximately 12-FEB-2007 was vaccinated intramuscularly with a dose of HPV. On approximately 12-FEB-2007 the patient fainted after the administration of HPV. It was reported that this patient may have fainted while on the way to the car and hit her head at an unspecified area. Medical attention was sought and the patient's mother was requesting a computed axial tomography because the patient was experiencing bad headaches. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: This is in follow-up to report (s) previously submitted on 3/14/2007. Information has been received from a family nurse practitioner (FNP) concerning numerous patients who on an unspecified dates were vaccinated with HPV (lot # not reported). Subsequently, the patients experienced stinging and sore arm after the vaccination. The outcome of the stinging and sore arm was not reported. No other information was available at the time of reporting. Additional information has been requested. Information has been received from a certified family nurse practitioner (CPNP) concerning a 25 year old female clinic employee who in August 2006 was vaccinated with the first dose of GARDASIL (lot # not reported). In October 2006, the patient was vaccinated with second dose of GARDASIL (lot # not reported). In February 2007, the patient was vaccinated with third dose of GARDASIL (lot # not reported). In October 2006, the patient experienced stinging and sore arm after the second vaccination. The patient recovered after three days. In February 2007, the patient again experienced stinging and sore arm after the third vaccination. The patient recovered after three days. Additional information was received from the CPNP via telephone. The sore lasted about 3 days. There was no reaction with the first dose which came from a pre-loaded syringe. The second and third doses of vaccine were from a vial. No additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with IM with a 0.5 ml dose of Gardasil (lot 654885/1424F # or lot # 655619/1427F). Subsequently within a few minutes the patient experienced dizziness and felt as if she was going to faint. The patient did not faint and was not sent to the hospital. The patient laid down for a few minutes and had something to drink. The patient recovered on an unspecified date. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with IM with a 0.5 ml dose of HPV (lot 654885/1424F # or lot # 655619/1427F). Subsequently within a few minutes the patient experienced dizziness and felt as if she was going to faint. The patient did not faint and was not sent to the hospital. The patient laid down for a few minutes and had something to drink. The patient recovered on an unspecified date. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: HPV4
Symptoms: Blood alkaline phosphatase, Blood creatinine, Body temperature increased, Chills, Drug administered at inappropriate site
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner concerning a 60 year old white female cigarette smoker (40 cigarettes per day) with hypothyroidism who on 30-OCT-2006 was vaccinated, into the right "glute" with a first dose of HPV (lot # 653978/0955F). Concomitant therapy included levothyroxine Na (SYNTHROID). On 04-NOV-2006 the patient experienced stiff neck, myalgia, mild chills, sweats and temperature of 101. On 06-NOV-2006 the patient experienced enlarged cervical lymph nodes. Subsequently, the patient recovered. It was reported that the patient thought that she had the flu. On 12-JAN-2007 the patient was vaccinated, into the right "glute" with a second dose of HPV (lot # 654389/0961F). On 17-JAN-2007 the patient experienced stiff neck, myalgia, mild chills, sweats and temperature of 101. On 19-JAN-2007 the patient experienced enlarged cervical lymph nodes. The nurse practitioner felt that the patient had an "exaggerated immune response." At the time of the report, the patient's stiff neck and myalgia and mild chills and sweats and temperature of 101 and enlarged cervical lymph nodes persisted. The patient refused her third vaccination. No further information is available.
Age: 60.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Influenza, Lymphadenopathy, Musculoskeletal stiffness, Myalgia
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner concerning a 60 year old white female cigarette smoker (40 cigarettes per day) with hypothyroidism who on 30-OCT-2006 was vaccinated, into the right "glute" with a first dose of HPV (lot # 653978/0955F). Concomitant therapy included levothyroxine Na (SYNTHROID). On 04-NOV-2006 the patient experienced stiff neck, myalgia, mild chills, sweats and temperature of 101. On 06-NOV-2006 the patient experienced enlarged cervical lymph nodes. Subsequently, the patient recovered. It was reported that the patient thought that she had the flu. On 12-JAN-2007 the patient was vaccinated, into the right "glute" with a second dose of HPV (lot # 654389/0961F). On 17-JAN-2007 the patient experienced stiff neck, myalgia, mild chills, sweats and temperature of 101. On 19-JAN-2007 the patient experienced enlarged cervical lymph nodes. The nurse practitioner felt that the patient had an "exaggerated immune response." At the time of the report, the patient's stiff neck and myalgia and mild chills and sweats and temperature of 101 and enlarged cervical lymph nodes persisted. The patient refused her third vaccination. No further information is available.
Age: 25.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Myalgia, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 25  year old female who on 01-FEB-2007 was vaccinated IM with a 0.5 ml dose of varicella-zoster (lot # 652966/0722f), the patient was supposed to receive HPV. The vaccine was incorrectly selected by a pharmacy technician due to the products being released at similar times and that it was not a labeling issue and then nursing did not check the product before administering. The pharmacist confirmed that this was a result of human error. Unspecified medical attention was sought. At the time of the report the patient had not had any adverse experiences and was "fine." The pharmacy technician was re educated about the vaccines. There was no product quality complaint involved. No further information was provided. Additional information has been requested. Additional information received from the pharmacist on 27-MAR-2007 indicated that the patient developed arm/muscle soreness from two days, it resolved without treatment. On 13-FEB-2007 at 12:00 P.M. the patient was vaccinated IM in the left arm with a dose of
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Antimicrobial susceptibility test, Injection site erythema, Rash pustular, Skin lesion, Varicella
Clinical narrative: Information has been received from a health professional concerning a 66 year old male with gout, cholelithiasis and elevated cholesterol levels and no known allergies who on 06-DEC-2006 was vaccinated SC with a 0.5 ml dose of varicella-zoster (lot # 652965/0622F). Concomitant therapy included probenecid (BENEMID), diazepam (VALIUM), vitamins (unspecified) and "triclor". Approximately one week later (also reported as 22-DEC-2006) the patient presented to the physician with a 2 inch red area at the injection site and 12-15 lesions were noted on the leg and shoulder. The patient was diagnosed with chickenpox pustules by the physician. It was reported that a lyme titer was done (results not provided). There was no product quality complaint involved. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Lethargy, Pyrexia
Clinical narrative: Information has been received from a 64 year old female consumer with no known medical history or allergies who on 03-FEB-2007 was vaccinated with a dose of varicella-zoster. Concomitant therapy included levothyroxine Na (SYNTHROID) and duloxetine hydrochloride (CYMBALTA). Subsequently since vaccination, the patient has had mild constant headaches, a low grade fever and feels lethargic. She reported that she was vaccinated in a pharmacy. The patient did not seek medical attention. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner concerning an 82 year old female with hypercholesterolaemia, hypothyroidism, hypertension and allergy to codeine who on 08-DEC-2006 was vaccinated SC with a dose of Zostavax (lot # 652966/1211F). Concomitant therapy included aspirin, "climara", CORGARD, PREVACID and SYNTHYROID. On 04-FEB-2007 the patient developed a red vesicular rash on her right cheek. She had an appointment on 05-FEB-2007 and was diagnosed with shingles. She has treated with VALTREX 1 gram TID. No laboratory tests were performed. It was reported that the patient had a history of shingles; in December 2004. February 2006 and possibly 30 years ago. At the time of the report, the patient was recovering. Additional information indicated that the patient recovered on 20-FEB-2007. No additional information is expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 72 year old female with an allergy to "Ketek" who on 30-JAN-2007 was vaccinated SC with a dose of Zostavax 9lot # 652936/0981F). Concomitant therapy included calcium (unspecified).On 31-JAN-2007 the patient developed redness, slight swelling, soreness and hotness around the injection site. The area was about the size of two half dollars. The patient was scheduled to have an appointment on 06-FEB-2007. The patient reported that the area has not improved other than a decrease in soreness. No laboratory tests were performed. There was no product quality complaint involved. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: HPV4, VARZOS
Symptoms: Incorrect dose administered, Incorrect drug dosage form administered
Clinical narrative: Information has been received from a health professional concerning a 77 year old male with no known allergies who on 06-FEB-2007 was vaccinated IM in the right arm with a 1 ml dose of Zostavax (lot # 656412/1476F). The Zostavax was reconstituted with Gardasil (lot # 654741/1208F) and the combined product was administered to the patient. It was reported that the patient was on an unspecified concomitant medication. No symptoms have been reported. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 62 year old female pharmacy worker with no known allergies, and a history of lymphoma, which has been in remission for years with no current treatment, who on 18-JAN-2007 or 25-JAN-2007 (a Thursday) was vaccinated with a 0.5 ml dose of Zostavax. "On the following Saturday", on 20-JAN-2007 or 27-JAN-2007 (three days later), the patient had a bruised, swollen, hot, red area around the injection site that was approximately 4-6 inches in diameter. Medical attention was not sought. On an unspecified date the patient recovered. There was no product quality involved. No further information was provided. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 76 year old male who on 01-FEB-2007 was vaccinated with a dose of Zostavax. On 05-FEB-2007 the patient experienced a zoster outbreak on his face. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pustule, Injection site rash, Injection site vesicles
Clinical narrative: Information has been received from a physician concerning an "at least 60 year old" patient who on an unspecified date was vaccinated SC with a single first dose of Zostavax. Subsequently the patient developed a rash at the injection site that looked like "little pox with pustules." Unspecified medical attention was sought. The patient recovered on 05-FEB-2007. There was no product quality complaint involved. No further information was provided. Additional information has been requested. 06/22/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Initial and follow-up information has been received from a physician concerning an 82 year old female with allergies to sulfa, KEFLEX, MEPERGAN, MACRODANTIN and horse serum, who on 22-DEC-2006 was vaccinated SC in the left arm with a single first dose of ZOSTAVAX (Oka/Merck) (lot # 652947/1212F). The patient had bronchiectasis and post herpetic neuralgia at the time of vaccination. On the same day the patient developed a vesicular eruption rash at the injection site which was 2.5 cm in diameter and looked like "little pox with pustules." The pustules had some weeping. Unspecified medical attention was sought. The patient recovered "over 2 weeks time" on approximately 06-JAN-2007 (previously reported as 05-FEB-2007). There was no product quality complaint involved. No further information was provided. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Swelling face, Urticaria
Clinical narrative: Information has been received from a physician concerning a 63-year -old female patient who on 19-JAN-2007 was vaccinated with a dose of Zostavax (lot# 652947/1411F). Subsequently, on an unspecified date following vaccination, the patient developed a "hive like reaction, no vesicles" on one side of her face. Unspecified medical attention was sought and she was treated with BENADRYL. It was reported that the patient recovered. No product quality complaint was involved. Additional information has been requested. 06/22/2007 This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a physician concerning a 64-year-old female patient with allergies to sulfa, penicillin, DEMEROL  and clindamycin, who on 19-JAN-2007 in the pm was vaccinated subcutaneously in the left arm with a dose of ZOSTAVAX (Oka/Merck) (lot# 652497/1411F). Subsequently, when the patient awoke the day following the vaccination, the patient had developed a "hive like reaction, no vesicles" on one side of her face and swelling over the left side of her face was reported. She also reported localized swelling on her left arm. Unspecified medical attention was sought and she was treated with BENADRYL. It was reported that the patient's face swelling resolved after 3 days and the arm swelling resolved after 7 days. The "hive-like" reaction recovered on an unspecified date. No product quality complaint was involved. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Cough, Erythema, Fibromyalgia, Lymphadenopathy
Clinical narrative: Information has been received from a nurse practitioner concerning a 63 year old female who on 19-JAN-2007 was vaccinated with a dose of Zostavax (lot # 654603/1405F). There was no concomitant medication. On 21-JAN-2007 the patient developed arm soreness and cold like symptoms. Medical attention was sought. The patient was treated with lidocaine cream for her sore arm. There was no product quality complaint involved. No further information was available. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007: 6/22/2007. Information has been received from a 63 year old female consumer with a compromised immune system, fibromyalgia, asthma, allergies to codeine, vicodin, iron, keflex, pamelor, all anti-inflammatory medicines, all anti-depressant medicines, all anti-seizure medicines and levaquin and chilli pepper allergy who on 19-JAN-2007 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # 652966/0722P). Concomitant therapy included SYNTHROID, LIPITOR, Ateolol (manufacturer unknown) and omeprazole (MSD). "Two days later," on 21-JAN-2007 the patient developed swollen lymph nodes in her neck, knots "all up and down" her arm (also reported as 3 knots on her arm above the injection site), a large red rash on the injection arm, pain all over her body, a sore stiff neck, a burning sensation inside her nose, and her chest teele itchy in the respiratory area. The patient reported that she also experienced a cough that she developed 48-72 hours after vaccination. It was reported that the side effects have gotten increasingly worse. Unspecified medical attention was sought. At the time of the report the patient had not recovered. Follow-up information from the patient's primary physician stated that his office did not administer the vaccine and did not have any additional information. Additional information was received from the consumer who reported that the lot number previously provided was incorrect. The correct ZOSTAVAX (Merck) lot number is 654003/1405F. The consumer also reported that she has not had any improvement. The pain in her neck and shoulders was worse and it triggered and episode of fibromyalgia. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Musculoskeletal stiffness, Nasopharyngitis, Neck pain, Pain, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 63 year old female who on 19-JAN-2007 was vaccinated with a dose of Zostavax (lot # 654603/1405F). There was no concomitant medication. On 21-JAN-2007 the patient developed arm soreness and cold like symptoms. Medical attention was sought. The patient was treated with lidocaine cream for her sore arm. There was no product quality complaint involved. No further information was available. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007: 6/22/2007. Information has been received from a 63 year old female consumer with a compromised immune system, fibromyalgia, asthma, allergies to codeine, vicodin, iron, keflex, pamelor, all anti-inflammatory medicines, all anti-depressant medicines, all anti-seizure medicines and levaquin and chilli pepper allergy who on 19-JAN-2007 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # 652966/0722P). Concomitant therapy included SYNTHROID, LIPITOR, Ateolol (manufacturer unknown) and omeprazole (MSD). "Two days later," on 21-JAN-2007 the patient developed swollen lymph nodes in her neck, knots "all up and down" her arm (also reported as 3 knots on her arm above the injection site), a large red rash on the injection arm, pain all over her body, a sore stiff neck, a burning sensation inside her nose, and her chest teele itchy in the respiratory area. The patient reported that she also experienced a cough that she developed 48-72 hours after vaccination. It was reported that the side effects have gotten increasingly worse. Unspecified medical attention was sought. At the time of the report the patient had not recovered. Follow-up information from the patient's primary physician stated that his office did not administer the vaccine and did not have any additional information. Additional information was received from the consumer who reported that the lot number previously provided was incorrect. The correct ZOSTAVAX (Merck) lot number is 654003/1405F. The consumer also reported that she has not had any improvement. The pain in her neck and shoulders was worse and it triggered and episode of fibromyalgia. Additional information has been requested.