chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: IPV, UNK, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness around injection site on left upper arm began with 24 hours of vaccine administration.
Age: 50.0
Sex: U
Vaccine: ANTH, FLU3, HEP, SMALL
Symptoms: Arthralgia, Bone pain
Clinical narrative: Ache bones, ache joints
Age: 10.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: MMR given LA, SQ, immediate reaction at injection site, redness, swelling, itching observed patient for 20 minutes, patient start c/o itchiness on neck and upper body but denies SOB. SRO2 100% room air. Patient was given Benadryl 0.75 ml IM per doctor patient had local reaction. No O2 ordered.
Sex: U
Vaccine: ANTH
Symptoms: Anorexia, Back pain, Blister, Blood pressure increased, Diabetes mellitus
Clinical narrative: Head blisters, sleeping disorders, appetite loss, high blood pressure, low back pain, diabetes.
Sex: U
Vaccine: ANTH
Symptoms: Sleep disorder
Clinical narrative: Head blisters, sleeping disorders, appetite loss, high blood pressure, low back pain, diabetes.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: 4/2/07 Child received shot around 3pm. By 730pm mom states child fever around 101 (although she did not know exact temp). States left thigh red and swollen and child crying and unconsolable for past 1 hr. Sent ED at hospital. Told give Tylenol x 24 hrs and observe. In ER temp 99.
Age: 0.52
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Crying, Pallor, Respiratory arrest, Skin discolouration, Syncope vasovagal
Clinical narrative: After receiving 5 pediatric vaccines at 11:00, client stopped breathing, color bright red, then at. Went pale, and had weak cry. Client did not regain normal color or cry, 911 called, at hospital. Upon vasovagal s/s, nurse placed on back to promote circulation abd stimulated client by rubbing soles, undressing and changing positions keeping supine.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Swelling 4" diameter around injection site, painful, indurated, erythematous.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Pruritus, Rash macular
Clinical narrative: Slightly red around left deltoid where DTaP was administered. Itchy and blotchy.
Sex: U
Vaccine: MMRV
Symptoms: Varicella post vaccine, Viral test negative
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated IM with a second dose of measles virus vaccine live (Endera-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process). Subsequently the patient developed varicella. The lesions were tested and they were negative for the vaccine strain. The physician felt that the varicella infection was unrelated to vaccination. There was no product quality complaint involved. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a registered pharmacist concerning a pediatric patient who was vaccinated with a dose of measles virus vaccine live (Edners-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process). Subsequently, the patient experienced a rash. unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a female over 60 years old who on 21, Dec 2006 was vaccinated subcutaenously with a 0.5 ml dose of measles virus vaccine (+) mumps virus vaccine (+) rubella virus vaccine live (RA 27/3) (+) varicella virus vaccine live (Oak/Merck upgrade process) instead of varicella-Zoster virus vaccine live (Oka/Merck) (MSD). It was reported that reported that there was no product confusion, but rather that both vaccinations were stored next to each other in the freezer and nurse " grabbed the wrong one". The patient did not experience any known symptoms. Unspecified medical attention was sought. No additional information to report. There was not a product quality complaint involved. Follow-up information was received from a nurse who reiterated that there was no product confusion but human error. The bottles were stored near each other and the administering nurse accidentally pulled out the wrong vaccine.
Age: 65.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a male over 60 years old who on 21, Dec 2006 was vaccinated subcutaneously with a 0.5 ml dose of Proquad instead of varicella-zoster virus vaccine live (Oka/Merck) (MSD). It was reported that there was no product confusion, but rather that both vaccinations were stored next to each other in the same freezer and a nurse "grabbed the wrong one" The patient did not experience any known symptoms. Unspecified medical attention was sought. No additional information to report. There was not a product quality complaint involved. Follow-up information was received form a nurse who reiterated that there was no product confusion but human error. The bottles were stored near each other and the administering nurse accidentally pulled out the wrong one.
Age: 1.03
Sex: F
Vaccine: MMRV, PNC
Symptoms: Irritability, Skin discolouration
Clinical narrative: Information has been received from a physician concerning a 15 month old female with no pre-existing allergies, birth defects, or medical conditions who on 21-DEC-2006 was vaccinated SC in the left thigh with her first 0.5 ml dose of measles virus vaccine (+) mumps virus vaccine (+) rubella virus vaccine (RA 27/3) (+) varicella virus vaccine (Oka/Merck upgrade process) (lot# 655842/1330F). There was no illness at th etime of vaccination. Concomitant therapy that day included a fourth dose of PREVNAR (Batch # B08545A) administered IM in the right thigh. Subsequently, the patient experienced pink and "ray" spots on lower thigh and was irritable for 72 hours after injection, form which she was recovering at the time of this report. Unspecified medical attention was sought. No additional information to report. There was no product quality complaint involved. Additional information has been requested.  Follow up information receivved from a registered nurse indicated that on 22-DEC-2006 the patient developed a fever of 102 degrees that lasted 72 hours. She also developed a rash on her lower libs, torso, and face. Some rash was raised and some was flat. The child was also irritable and not sleeping. The patient recovered 4 days after immunization. There were no relevant diagnostic test or laboratory data.  No additional information is expected.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema multiforme, Rash
Clinical narrative: Information has been received from a physician concerning a 12 month old male who on 4, Nov 2006 was vaccinated subcutaenously in the left arm with a first dose of measles virus vaccine (+) mumps virus vaccine (+) rubella virus vaccine (RA 27/3) (+) varicella virus vaccine (Oka/Merck upgrade process) (lot# 655141/0833F). Eleven days following the vaccination, on 15, Nov 2006, the patient developed a rash. The rash developed into erythema multiforme and required a visit to the ER and an extra office visit. It was reported that the patient was also on an antibiotic for an ear infection. Subsequently. the patient recovered from erythema multiforme on an unspecified date. Additional information is not expected.
Age: 1.1
Sex: M
Vaccine: DPP, FLUX, MMRV, PNC, RV5
Symptoms: Blister, Gait disturbance, Varicella
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a 1 year old male foster child and a history of being premature by 3 months and no allergies, who on 20, Dec 2006 was vaccinated subcutaenously with a 0.5 ml 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 (Oka/Merck upgrade process)  (lot# 655314/0978F). Concomitant vaccinations given on the same day included: pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR), rotavirus G1 G2 G4 P1 reassortant vaccine live (human-bovine) (MSD), influenza virus vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. Eleven days post vaccination. On 01, Jan 2007 the patient developed an outbreak of chickenpox. The child had approximately 15 blisters noted on his forehead and feet/ankles. Unspecified medical attention was sought and no laboratory or diagnostic tests were performed. It was reported that the child had difficulty walking due to the blisters on the feet. No outcome was reported. No product quality complaint was involved. Additional information has been requested
Age: 1.5
Sex: M
Vaccine: MMRV
Symptoms: Body temperature, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Information has been received from a physician concerning an 15 month old Hispanic male (also reported as female) who on 26, Dec 2006 at 2:50 pm was vaccinated subcutaenously with his first 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 (Oka/Merck upgrade process) (lot# 655142/0974F). concomitant therapy included tuberculin purified protein derivative (manufacturer not specified). On 04, Jan 2007, the patient experienced and itchy rash all over his face and other body parts. Treatment with diphenbydramine (BENADRYL) was prescribed. A follow -up visit was scheduled for the next week. No further information to report. there was no product quality complaint involved. follow up information was received from a  doctor indicating that on 04, Jan 2007, the patient woke up with a arythematous, itchy, papular rash which was generalized and also affected the face. There was no difficulty breathing; the patient was afebrile and playful. No laboratory or diagnostic studies were performed. The outcome was reported as recovered. No additional information is expected.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner (N.P) concerning a 4 year old white male child with no pre-existing allergies, birth defects or medical conditions. who on 18, Sep 2006 was vaccinated subcutaneously in the right arm with a first 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 (Oka/Merck upgrade process) (lot# 653666/0517F) There was no illness at the time of vaccination. subsequently, the patient developed a varicella-like rash on 10, Oct 2006 at 09:00 am. It was reported that the patient's mother noticed a rash around his neck, legs, belly and chest. It was reported that medical attention was sought and unknown treatment was provided. No diagnostic of laboratory tests were performed. The patient recovered. No further information is expected.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Skin lesion
Clinical narrative: Information has been received from a physician concerning a 5 year old male who was vaccinated with a second, 0.5 ml, 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 (Oka/Merck upgrade process). Subsequently, the patient experienced 10 to 15 lesions. Unspecified medical attention was sought. The outcome was reported as recovered. No additional information to report. There was no product quality complaint involved. Additional information has been requested.
Age: 1.35
Sex: F
Vaccine: MMRV
Symptoms: Crying
Clinical narrative: Information has been received from a licensed practical nurse concerning an 18 month old female with no pertinent medical history and no drug reactions/allergies who on 18, Jan 2007 was vaccinated SC in the left arm with a first dose of PROQUAD (Merck) (lot# 655842/1330F). There was no concomitant mediation. It was noted that the child has been crying since she was vaccinated. The child was given TYLENOL and was scheduled to be evaluated by the physician on 19, Jan 2007. There were no lab diagnostic studies performed. Unspecified medical attention was sought. The outcome was not recovered. There was no product quality complaint. Additional information has been requested. There were no adverse events following prior vaccinations of the patient.  Follow up infromation indicated that on 19-JAN-2007, the patient was thought to be having pain at the injection site, she was fussy and irritable. This resolved with TYLENOL and MOTRIN over "2 days". On approximately 05-FEB-2007, two weeks later, the patient had a couple of episodes of staring with tight fists. The reporter was not sure if it was normal behaviour. There was no follow up from the parents. No additional information is expected.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 5 year old male who in approximately 2003 (at 13 months of age) was vaccinated with varicella virus vaccine live. In September 2006, the patient was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process). On 11, Jan 2007 the patient experienced a very mild outbreak of chicken pox. The patient sought unspecified medical attention. Additional information has been requested.
Age: 1.28
Sex: M
Vaccine: MMRV
Symptoms: Pruritus generalised, Rash vesicular, Varicella post vaccine
Clinical narrative: Information has been received form a physician's assistant concerning a 15 month old male who in the "end of November 2006", was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process). At the "end of December 2006", four weeks after receiving the vaccine, the patient developed chickenpox; over 100 lesions. The patient had a doctor's visit on 26, Dec 2006. The lesions cleared up within ten days. The patient was considered recovered at the time of the report. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/4/2007. Information has been received from a physician's assistant concerning a 15 month old male, with no pre-existing allergies, birth defects, medical conditions or illness at the time of vaccination. On 20-NOV-2006, the patient was vaccinated subcutaneously into the thigh, with his first dose, 0.5ml, of PROQUAD (Oka/Merck upgrade process) (Lot # 655000/0829F). On 26-DEC-2006, four weeks after receiving the vaccine, the patient developed an generalized itchy, vesicular rash, with greater than 200 lesions over his entire body, determined to be chickenpox. The patient had a doctor's visit on 26-DEC-2006. The lesions cleared up within ten days. The patient recovered on 05-JAN-2007. Unspecified medical attention was sought. There was no product quality complaint. There were no lab diagnostic studies performed. No specimen collected. No further information is expected.
Age: 1.5
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Information has been received from a physician concerning a 15 month old female who on 15, Jan 2007 was vaccinated with 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 (Oka/Merck upgrade process) (lot # 656170/1400F). On 24, Jan 2007, the patient experienced a fever. On 25, Jan 2007, the patient experienced a rash form head to toe. The patient's fever and rash from head to toe persisted. Unspecified medical attention was sought. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: MMRV
Symptoms: Accidental exposure, Burning sensation
Clinical narrative: Information has been received concerning a 25 year old female medical assistant, who on 26, Jan 2007, during the patient administration 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 (Oka/Merck upgrade process) (lot # 656551/1532F) was inadvertently sprayed on her are with the vaccine. The medical assistant experienced burning on her arm. The arm was flushed with saline. The symptoms resolved on 26, Jan 2007 At the time of the report the medical assistant was considered to be recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: MMRV
Symptoms: Accidental exposure, Burning sensation, Eye burns
Clinical narrative: Information has been received from a health care worker concerning a 29 year old female medical assistant with drug hypersensitivity to cefuroxime axetil (CEFTIN), morphine, and cyclobenzaprine hydrochloride (MSD), (WAES # 0703USA03178), who on 26, Jan 2007, during the patient administration 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 (Oka/Merck upgrade process) (lot# 656551/1532F) was inadvertently sprayed with the vaccine into both eyes. The medical assistant immediately experienced burning of the eyes. The eyes were flushed with saline. The burning continued in her eyes and on the skin around the eyes. At the time of the report the burning in her eyes and skin around the eyes continued, and she was reported to be not recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Irritability, Rash papular, Rhinorrhoea
Clinical narrative: Information has been received from a health professional concerning a 15 month old white female with no pre-existing allergies, birth defects, or medical conditions who on 15, Jan 2007 at 1:30 pm was vaccinated in the left thigh with a first 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 (Oka/Merck upgrade process) (lot# 656170/1400F). There was no illness at the time of vaccination. Concomitant therapy that day at 1:30 pm included a forth dose of diphtheria toxoid (+) pertussis acellular 5-component vaccine(+) tetanus toxoid (DAPTACEL) (lot # U1774BA). On 25, Jan 2007 in the AM, the patient experienced a raised papular rash primarily over her trunk and extremities. Clear rhinorrhea was noted from the nose. No conjunctivitis was noted. The mom also reported the baby was fussier than normal. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/4/2007.  Information has been received from a health professional concerning a 15-month-old female with no pre-existing allergies, birth defects, or medical conditions who on 15-JAN-2007 at 1:30PM was vaccinated IM in the left thigh with a first dose of PROQUAD (Merck) (Lot # 656170/1400F).  There was no illness at the time of vaccination.  Concomitant therapy that day at 1:30PM included a forth dose of DAPTACEL (Lot # U1774BA).  On 25-JAN-2007 in the AM, the patient experienced a raised papular rash primarily over her trunk and extremities.  Clear rhinorrhea was noted from the nose.  No conjunctivitis was noted.  The mom also reported that the baby was fussier than normal.  The outcome was reported as recovered within a couple of days.  There were no relevant diagnostic tests or laboratory data.  There were no adverse events following prior vaccinations.  No additional information is expected.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Varicella
Clinical narrative: Information has been received form a health professional concerning a female who on 12, Feb 2007 was vaccinated with a 0.5 ml 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 (Oka/Merck upgrade process) (lot # "Y1050-2"). Concomitant therapy included prednisolone Na phosphate (ORAPRED). On "08, Jan 2004" the patient had a documented case of chickenpox. Unspecified medial attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: M
Vaccine: MMRV
Symptoms: Blood test, Laboratory test, Lymphadenopathy
Clinical narrative: Information has been received form a physician concerning a male who was vaccinated subcutaneously, high on the thigh, with 0.5 ml measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process). Two to three days later, the patient's mother noticed that lymph node in the upper thigh swelled. Unspecified medical attention was sought. Unspecified "blood tests" were performed, with no results provided. At the time of the report, the patient's status was not recovered. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site rash, Rash morbilliform, Rash vesicular
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 12 month old male who on 05, Feb 2007 was vaccinated SC with a first 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 (Oka/Merck upgrade process) (lot# 656447/11547F). On 13, Feb 2007 the patient experienced varicella / measles like rash at injection site after receiving the measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) vaccination. The rash, which was less than 50 lesions, was localized at the injection site. The  patient sought unspecified medical attention and was given diphenhydramine hydrochloride (BENADRYL) when the reaction presented. As of 15, Feb 2007 the patient was recovering. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: HEPA, MMRV, PNC
Symptoms: Inappropriate schedule of drug administration, Injection site rash, Pyrexia, Rash erythematous, Rash maculo-papular
Clinical narrative: Information has been received from a licensed practical nurse concerning a 10 month old male with no pertinent medical history, drug reaction or allergies, who on 05, Feb 2007 at 14:30, was vaccinated subcutaneously, into the right leg, with his first dose of PROQUAD (lot # 656163/1354F). Concomitant therapy included Havrix and Prevnar. On 13, Feb 2007, the patient was seen at the doctor's office with an erythematous maculpapular rash primarily at the injection site on his leg, and fever of 102 F (via ear). Initial onset of symptoms was 12, February 2007. Treatment was Motrin and Tylenol. The patient is scheduled to return to the doctor's office on 19, February 2007, at which time it will be determined if Varicella Zoster Virus (VZV) is appropriate. The patient was considered to be recovered from the reported events at the time of this report. No lab diagnostic studies were performed. There was no product quality complaint. No further information is expected.
Age: 1.04
Sex: M
Vaccine: MMRV
Symptoms: Vaccination complication, Varicella
Clinical narrative: Information has been received from a physician concerning a 16 month old male with no pre-existing allergies, birth defects, or medical conditions who on 18, Oct 2006 at 3:30 pm was vaccinated SC in the left arm with a first 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 (Oka/Merck upgrade process) (lot # 655141/0833F). On 23, Feb 2007 at 11:00 am the patient experienced an adverse event. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/4/2007. Follow up information received from a nurse manager indicated that the adverse event was chickenpox. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMRV
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 15 month old male who on 27, Feb 2007 was vaccinated SC with a 0.5 ml 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 (Oka/Merck upgrade process) (lot# 656166/1397F) 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) (MSD). It was reported that the patient received a dose of varicella virus vaccine live (Oka/Merck (MSD) (lot # 654695/1055F) on 10, Nov 2006. Unspecified medical attention was sought. No problems were reported. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 1.6
Sex: M
Vaccine: MMRV
Symptoms: Body temperature increased, Culture urine negative, Decreased appetite, Fatigue, Irritability
Clinical narrative: Information has been received from a health professional concerning a 12 and half month old Caucasian male with no  medical history or allergies who on o5, Feb 2007 at 9:00 am was vaccinated subcutaneously in the right arm with a first dose of Proquad (lot# 656444/1529F). Concomitant therapy included vitamins (unspecified). On 13, Feb 2007 the patient experienced fever of 99 F to 104 F for two days, decreased appetite, fatigue for three days and irritability. On 15, Feb 2007 the patient experienced fever of 99 F to 101 F while in the office for an acute visit. There were no illness at time of vaccination. The patient recovered on 16, Feb 2007. Additional information has been requested.
Age: 1.6
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: Information has been received from a health professional concerning a 12 and half month old Caucasian male with no  medical history or allergies who on o5, Feb 2007 at 9:00 am was vaccinated subcutaneously in the right arm with a first dose of Proquad (lot# 656444/1529F). Concomitant therapy included vitamins (unspecified). On 13, Feb 2007 the patient experienced fever of 99 F to 104 F for two days, decreased appetite, fatigue for three days and irritability. On 15, Feb 2007 the patient experienced fever of 99 F to 101 F while in the office for an acute visit. There were no illness at time of vaccination. The patient recovered on 16, Feb 2007. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a 4 year old male (chart # 1473) who on an unknown date was vaccinated with 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 (Oka/Merck upgrade process) (lot # 655747/1117F). Concomitant therapy was not reported. On an unknown date, the patient experienced skin raised 3" x 3" around the injection site. The patient received measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) in the right thigh. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: HPV4
Symptoms: Agitation, Inappropriate schedule of drug administration, Underdose
Clinical narrative: Initial and follow up information has been received from a health professional concerning a 39 year old whit female patient with NKDA and with HPV and with a family history of breast cancer (mother) who on 07, Nov 2006 was vaccinated with a second IM dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 654540/0800F) into the left deltoid. It was reported that the patient jerked her arm away and the needle came out of the patient's arm and did not received a full dose of the vaccine. It was reported that it was "hard to tell how much of the injection was lost." "A 1/3 of the injection came out of the patient's arm and what is left in the vial." It was recommended that the patient get re-vaccinated with dose number 2. The patient was "upset for the inconvenience" and the patient decided to discontinue the injection because she had a "bad experience", she already had HPV and she had trouble getting to the office. No symptoms were noted. A first dose of HPB rL1 6 11 16 18 VLP vaccine (yeast) (lot # 653650/0696F) was given IM into the deltoid on 05, Sep 2006. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Nausea, Otitis media, Ultrasound scan normal
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female who on 13, Sep 2006 and 08, Nov 2006 was vaccinated intramuscularly with a first and second 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 653650/0640F). There was no concomitant medication. In approximately November 2006, the patient became pregnant about 3 weeks before she was vaccinated with her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient's last menstrual period was 15, Oct 2006 and her estimated due data is 22, Jul 2007. No symptoms were noted. The patient sought unspecified medical attention. Other medications used during pregnancy included amoxicillin (+) clavolanate potassium (AUGMENTIX) started on 28, Nov 2006 875mg, twice a day for otitis media, ampicillin started on 04, Dec 2006 500 mg once a day administered for nausea due to amoxicillin (+) clevulanate potassium (AUGMENTIN), and prenatal vitamins started on 28, Nov 2006. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 4/6/2007. Information has been received from a registered nurse concerning a 24 year old female with a history one previous pregnancy and one live birth, who on 13-SEP-2006 and 08-NOV-2006 was vaccinated intramuscularly with a first and second 0.5 ml dose of GARDASIL (Lot# 653650/0640F). There was no concomitant medication. In approximately November 2006, the patient became pregnant about 3 weeks before she was vaccinated with her second dose of GARDASIL. The patient's last menstrual period was 15-OCT-2006 and her estimated due date is 22-JUL-2007. On approximately 28-NOV-2006 the patient experienced otitis media. On approximately 04-DEC-2006 the patient was nauseated. On 09-FEB-2007, the patient had an ultrasound which was within normal limits. The patient sought unspecified medical attention. Other medications used during pregnancy included AUGMENTIN, started on 28-NOV-2006, 875 mg, twice a day for otitis media, ampicillin started on 04-DEC-2006, 500 mg once a day administered for nausea due to AUGMENTIN, and prenatal vitamins started on 28-NOV-2006. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This is in follow-up to report(s) previously submitted on 4/6/2007. Information has been received from a physician concerning a 22 year old female working in public relations (weight 146#, height 64.5") with pertinent medical history and penicillin allergy who on 18-DEC-2006 (before Christmas) was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #654540/1151F), injection, 0.5 mL, in the right deltoid. Concomitant medication was not reported. Subsequently, on 26-DEC-2006, the patient called the physician's office and complained of redness, swelling, soreness and itching at injection site from the last week. The physician instructed the patient to ice the site locally and take BENADRYL OTC and CHLOR-TRIMETON for the itch. The patient sought unspecified medical attention. On 28-DEC-2006, the patient recovered from the events. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Medical device complication
Clinical narrative: Information has been received from a health professional who reported that a prefilled syringe (Lot # 654540/1162F) malfunctioned and the vaccine sprayed across the room. The patient did not miss being vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Additional information has been requested.  This is in follow-up to report (s) previously submitted on 4/6/2007.  In follow-up it was reported by the nurse, that the patient did not receive any of the vaccine from the malfunctioning syringe.  The patient received the GARDASIL from a completely new syringe.  Follow-up information confirmed no known patient was identified or involved with the event.  Therefore WAES #0701USA01666 is being deleted from our files.  This report was previously sent in a quarterly submission to PLA V501 on 06-APR-2007.  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Drug exposure during pregnancy, Foetal heart rate, Nausea, Pregnancy
Clinical narrative: Information has been received as part of a pregnancy registry from a nurse practitioner concerning a 15 year old caucasion female with food allergies to coconut and mushrooms and a of history migraines, streptococcal infection and pharyngitis who on 20, Nov 2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast), 0.5 mL by intramuscular injection, first dose (lot# 6539381/0954F). Concomitant medication included (CLARITIN) and (NASONEX). On 20, Nov 2006, the patient indicated that her last period was one week ago (13, Nov 2006). On 05, Dec 2006, the patient was seen in an clinic with complaints of nausea and dizziness and had a positive urine pregnancy test at that time. On 11, Dec 2006, the patient underwent and ultrasound which revealed that she was 7 1/2 weeks pregnant. CRL 10.4 mm, positive fetal heartbeat. Additional information is not expected.  This is in follow-up to report(s) previously submitted on 4/6/2007. On 08-JAN-2007, the patient was placed on therapy with PHENERGAN, 25mg, one every 4 to 6 hours for the treatment of nausea and vomiting. Follow-up information was received from a certified medical assistant. On 30-JUL-2007, the patient delivered a liveform female infant (8 pounds, 2 ounces). The infant was normal and there were no congenital anomalies. No further information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test urine positive, Ultrasound scan
Clinical narrative: Information has been received as part of a pregnancy registry from a nurse practitioner concerning a 15 year old caucasion female with food allergies to coconut and mushrooms and a of history migraines, streptococcal infection and pharyngitis who on 20, Nov 2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast), 0.5 mL by intramuscular injection, first dose (lot# 6539381/0954F). Concomitant medication included (CLARITIN) and (NASONEX). On 20, Nov 2006, the patient indicated that her last period was one week ago (13, Nov 2006). On 05, Dec 2006, the patient was seen in an clinic with complaints of nausea and dizziness and had a positive urine pregnancy test at that time. On 11, Dec 2006, the patient underwent and ultrasound which revealed that she was 7 1/2 weeks pregnant. CRL 10.4 mm, positive fetal heartbeat. Additional information is not expected.  This is in follow-up to report(s) previously submitted on 4/6/2007. On 08-JAN-2007, the patient was placed on therapy with PHENERGAN, 25mg, one every 4 to 6 hours for the treatment of nausea and vomiting. Follow-up information was received from a certified medical assistant. On 30-JUL-2007, the patient delivered a liveform female infant (8 pounds, 2 ounces). The infant was normal and there were no congenital anomalies. No further information is expected.
Age: 38.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Ocular hyperaemia
Clinical narrative: Information has been received from a nurse practitioner concerning a 38 year old female with colitis ulcerative and no allergies who on 22, Jan 2007 was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 22, Jan 2007 the patient had eye redness of the white of the eye, tiredness, fatigue and lightheadedness. As of 05, Feb 2007, the patient's symptoms continued. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female with no pre-existing conditions who on 29, Nov 2006, was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 28, Dec 2006, the patient was vaccinated with second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 654389/0961F) IM right arm 30 days after the 1st dose. At the time of the vaccination, the patient had no  illness. The patient did not experience adverse effects. No additional information is expected.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, No adverse effect
Clinical narrative: Information has been received from a nurse that on 16, Feb 2007, they administered a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) in a patient's hip. No adverse event was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician via a company representative concerning a female patient who was vaccinated with the first dose. 0.5 ml, IM, of HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient "developed hives all over her body." At the time of this report, the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning a 40 year old female who on 27, Feb 2007 was vaccinated with the first dose, 0.5 ml, of HPV rL1 6 11 16 18 VLP vaccine (yeast). concomitant therapy included estrogens (unspecified. On 27, Feb 2007, "starting a short time after her first dose, "the NP reported that the patient experienced pain at the injection site. At the time of this report, the patient was recovering from the event. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Dizziness, Laboratory test
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with GARDASIL vaccine first dose. Concomitant therapy included DEPO-PROVERA. On approximately 15, Feb 2007, the patient experienced continuing dizziness when administered GARDASIL vaccine. A blood test was performed and the patient was found to be anemic. The nurse practitioner was unsure whether to continue further series with GARDASIL vaccine. Unspecified medical attention was sought. As of 01, Mar 2007, the patient's continuing dizziness and anemic persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/6/2007. In follow up, the nurse practitioner did not recall the patient and had no further information to provide.
Sex: U
Vaccine: HPV4
Symptoms: Facial palsy
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). One day post vaccination with HPV rL1 6 11 16 18 VLP vaccine (yeast, the patient developed facial palsy (not further specified). The patient outcome was not reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Facial palsy
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with Gardasil. Concomitant therapy included influenza virus vaccine (unspecified). One day post Gardasil, the patient developed facial palsy (not further specified). The patient outcome was not provided. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: This is in follow-up to report(s) previously submitted on 4/6/2007. Initial and follow-up information has been received from a registered nurse concerning a 25 year old female teacher with asthma and hives when takes cefprozil who on 01-MAR-2007 was vaccinated intramuscularly in to left deltoid with a first dose of GARDASIL, (LOT# 656049/0187U). Concomitant therapy included montelukast sodium. Subsequently the patient experiences an 8 inch rash on hip area. The nurse reported that the patient developed hives from the therapy. The patient sought medical attention. The patient's outcome was unknown. In follow-up it was indicated that patient reported 8" string of hives around left hip morning after she got the injection. Hives resolved with 25 mg BENADRYL. Hives had reoccurred several times since. The allergist felt above incident was coincidental with vaccine and unrelated. Patient will continue with series of GARDASIL. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure fluctuation, Blood pressure orthostatic, Decreased appetite, Dehydration, Dizziness
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter who on 12-FEB-2007 was vaccinated with Gardasil (lot # not reported)  0.5 ml IM. There was no concomitant medication. On 12-FEB-2007 the patient experienced her arm hurting really bad after getting the injection and she developed a headache. Three days after the injection, on 15-FEB-2007, the patient experienced fainting, dizziness, headaches, "dehydrating", not eating, everything kind of hurts, and she only wanted to sleep. Her blood pressure was not steady and was all over the place. Medical attention was sought. Orthostatic test was performed. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pain, Pain in extremity, Somnolence, Syncope
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter who on 12-FEB-2007 was vaccinated with Gardasil (lot # not reported)  0.5 ml IM. There was no concomitant medication. On 12-FEB-2007 the patient experienced her arm hurting really bad after getting the injection and she developed a headache. Three days after the injection, on 15-FEB-2007, the patient experienced fainting, dizziness, headaches, "dehydrating", not eating, everything kind of hurts, and she only wanted to sleep. Her blood pressure was not steady and was all over the place. Medical attention was sought. Orthostatic test was performed. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female, with no pertinent medical history, who on 26-FEB-2007 was vaccinated with Gardasil (LOT# 654702/0011U). There was no concomitant therapy. On 26-FEB-2007, within 24 hours of Gardasil administration, the patient experienced a rash on her abdomen. The patient had phoned the office to report the rash. The rash was not seen by the nurse practitioner or physician. No prescription medication therapy was provided to the patient. Subsequently, the patient recovered in 1 day. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/6/2007.  Initial and follow-up information has been received from a nurse practitioner (N.P.) concerning a 24 year old female, with no pertinent medical history, who on 26-FEB-2007 was vaccinated IM with a dose of GARDASIL (LOT# 654702/0011U).  There was no concomitant therapy.  On 26-FEB-2007, within 24 hours of GARDASIL administration, the patient experienced a rash on her abdomen.  The patient had phoned the office to report the rash.  The rash was not viewed by the nurse practitioner or physician.  No prescription medication therapy was provided to the patient.  Subsequently, the patient recovered in 1 day.  Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Bone pain, Chills, Dyspnoea, Inappropriate schedule of drug administration, Lethargy
Clinical narrative: Information has been received from a physician concerning a 27 year old female with no known drug allergies and a history of a left thrombosis (2001), loop electrosurgical excision procedure for mild dysplasia (06-DEC-2006) and a pregnancy (2001) who was vaccinated intramuscularly on 27-NOV-2006 with the first dose of Gardasil (Lot # not provided). On 27-FEB-2007 the patient was vaccinated intramuscularly in the right deltoid with the second dose of Gardasil (Lot # 654702/0011U). Five to eight hours post vaccination the patient developed a rash on right shoulder that spread up to her neck, myalgia, lethargy, chills, bone aching and mild shortness of breath. It was reported that 48 hours later, the patient returned to her physicians office who recommended treatment with Benadryl. The physician reported that the patient did not take the Benadryl. It was reported that the rash as resolving and the patient. The physician reported that the patient was seen again in his office on 01-MAR-2007 and was still experiencing lethargy and bone pain. The physician also reported that the patient did not have any adverse effects after that the first of Gardasil. He states that he was unsure if the third dose of Gardasil will be administered. Additional information has been rechecked.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Rash
Clinical narrative: Information has been received from a physician concerning a 27 year old female with no known drug allergies and a history of a left thrombosis (2001), loop electrosurgical excision procedure for mild dysplasia (06-DEC-2006) and a pregnancy (2001) who was vaccinated intramuscularly on 27-NOV-2006 with the first dose of Gardasil (Lot # not provided). On 27-FEB-2007 the patient was vaccinated intramuscularly in the right deltoid with the second dose of Gardasil (Lot # 654702/0011U). Five to eight hours post vaccination the patient developed a rash on right shoulder that spread up to her neck, myalgia, lethargy, chills, bone aching and mild shortness of breath. It was reported that 48 hours later, the patient returned to her physicians office who recommended treatment with Benadryl. The physician reported that the patient did not take the Benadryl. It was reported that the rash as resolving and the patient. The physician reported that the patient was seen again in his office on 01-MAR-2007 and was still experiencing lethargy and bone pain. The physician also reported that the patient did not have any adverse effects after that the first of Gardasil. He states that he was unsure if the third dose of Gardasil will be administered. Additional information has been rechecked.