chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pyrexia, Rash, Rash macular
Clinical narrative: This report was identified from a line listing on request by the Company from the FDA under the Freedom of Information Act. A 24 year old female patient with ulcers and HSIL/CIN III (29-JUL-2011, PAP) and with no pre-existing illness was vaccinated intramuscularly with a first dose of GARDASIL (Lot # 666163/0664Z) in her right arm on 20-FEB-2012. Concomitant therapy included Bauhinia purpurea, Cirsium oligophyllis, Rauvolfia tetraphylia, bacopa, caffeine, methylhexaneamine (USP LABD OXY ELITE PRO) and "fat burners". On 22-FEB-2012, the patient called to report elevated fever and rash since 20-FEB-2012 evening. Rash was "blotching" on arms, legs and thighs. "No itching, no swelling". "No shortness of breath". Temperature was 100 degrees with 102 degrees as highest. Patients took ibuprofen/BENADRYL as directed. The patient reported via phone call only and did not see physician or return to clinic for visual. The original reporting source was provided by a consumer. The VAERS ID # is 451098. It was reported that the patient's experiences were considered non-serious. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pruritus generalised, Rash, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 26 years old female patient with no medical history and no illness at time of vaccination was vaccinated IM into right arm with dose 3 GARDASIL on 04-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. On 05-JUN-2012 the patient woke up to use bathroom and was itching all over at 2 am. She noticed rash on her legs and buttocks. That morning she went to work and throughout the day the rash progressed and more 'spots" developed. They are raised and had a clear head to some of them. She did not eat anything different or change detergent. Her husband did not have this rash following sleep on 04-JUN-2012. The only change in routine was receiving dose 3 GARDASIL. She as itching all over. The welts were on both legs both on the front and backside of her legs, on both buttocks, around the bikini area and she had these "raised spots/rash" on both arms and back also as of 6 pm on 05-JUN-2012. The patient went to emergency clinic at 6 pm and received 1 shot of corticosteroids (unspecified) (corticosteroids (unspecified)) in the buttock and a prescription for 20 mg prednisone tablet for 4 days. The original reporting source was the patient. The VAERS ID # is 456834-1. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Local reaction
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17year old female with no previous illness and unknown medical history who on 01-JUN-2012 was vaccinated IM into right arm with first dose of GARDASIL (lot # 668554/0306AA). Other suspect therapy include VARIVAX (Merck) (lot # 671163/1208AA), SC into right arm with second dose. Other concomitant therapy included BOOSTRIX (manufacturer: GlaxoSmithKline, lot # AC52B02AA, IM left arm); MENACTRA (manufacturer: Sanofi Pasteur, lot # U3904AA, IM left arm); HAVRIX (manufacturer: GlaxoSmithKline, lot # AHAVB522AA, IM right arm). On 02-JUN-2012 patient presented with VARIVAX (Merck) vaccine (R) arm, local reaction 15 cm x 45 cm red and denies pain. No conditions, no lab data provided. The original reporting source was not provided. The VAERS ID # is 457217.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Nodule, Pruritus, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Multiple nodules or rash over both left and right fingers, red, palpable, occasionally itching, present more on the index fingers. Severe itching/ rash over the left ear cartilage.
Age: 63.0
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Arthralgia, Asthenia, Dizziness, Erythema, Fatigue
Clinical narrative: At around 4PM I noticed a large red area around the injections on my left arm, and it was becoming extremely painful, along with extreme fatigue, dizziness, muscle and joint pains, and a headache. That night the headache increased in severity, I had a fever of 102, and developed diaphoresis. The redness expanded to my elbow and shoulder and the pain from it extended up the left side of may neck. I checked my B/P and it was 107/80 pulse of 110 and I was extremely diaphoretic. My husband took me to the ER. Now it is the 19th and I am still very weak, dizzy, achy, and the redness is nearly all the way around my left arm and about an inch diameter on my right arm.
Age: 63.0
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Headache, Hyperhidrosis, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: At around 4PM I noticed a large red area around the injections on my left arm, and it was becoming extremely painful, along with extreme fatigue, dizziness, muscle and joint pains, and a headache. That night the headache increased in severity, I had a fever of 102, and developed diaphoresis. The redness expanded to my elbow and shoulder and the pain from it extended up the left side of may neck. I checked my B/P and it was 107/80 pulse of 110 and I was extremely diaphoretic. My husband took me to the ER. Now it is the 19th and I am still very weak, dizzy, achy, and the redness is nearly all the way around my left arm and about an inch diameter on my right arm.
Age: 63.0
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Neck pain, Pain, Pyrexia
Clinical narrative: At around 4PM I noticed a large red area around the injections on my left arm, and it was becoming extremely painful, along with extreme fatigue, dizziness, muscle and joint pains, and a headache. That night the headache increased in severity, I had a fever of 102, and developed diaphoresis. The redness expanded to my elbow and shoulder and the pain from it extended up the left side of may neck. I checked my B/P and it was 107/80 pulse of 110 and I was extremely diaphoretic. My husband took me to the ER. Now it is the 19th and I am still very weak, dizzy, achy, and the redness is nearly all the way around my left arm and about an inch diameter on my right arm.
Age: 53.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Oedema peripheral, Pruritus, Skin warm
Clinical narrative: Left arm swollen & warm to touch, itchy.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Fatigue, fever, joint pain, nausea, vomiting, severe headache, rigors, pain and selling at site very hot red spot on arm that keeps getting larger.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Nausea, Pyrexia
Clinical narrative: Fatigue, fever, joint pain, nausea, vomiting, severe headache, rigors, pain and selling at site very hot red spot on arm that keeps getting larger.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Fatigue, fever, joint pain, nausea, vomiting, severe headache, rigors, pain and selling at site very hot red spot on arm that keeps getting larger.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Migraine, Muscle spasms, Nausea
Clinical narrative: High fever, dizziness, weakness, tunnel vision, cramping, headache (migraine), tingling in fingers, nausea.  On going.  Have not ceased.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Pyrexia, Tunnel vision
Clinical narrative: High fever, dizziness, weakness, tunnel vision, cramping, headache (migraine), tingling in fingers, nausea.  On going.  Have not ceased.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Abasia, Crying, Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: Mother states that the child was crying all evening since she received the shot, and was complaining that her leg hurt and she couldn't walk, the mother noticed that it was still bleeding a little and was swollen.
Age: 1.26
Sex: F
Vaccine: MNQ
Symptoms: Diarrhoea, Frequent bowel movements, Injection site erythema, Injection site induration
Clinical narrative: Injection site hard and red, loose, watery stools 5 or 6 times a day.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Continued itching at site through 8/19/2012.
Age: 28.0
Sex: F
Vaccine: MEN
Symptoms: Anxiety, Back pain, Chest discomfort, Confusional state, Dizziness
Clinical narrative: Slowly started with slight headache and pain in the shoulder of injection sight. Pain and stiffness in the neck and in upper spine worsened over last 3 days. Second day after injection started feeling very fatigued and nauseous. Today neck and chest feels very stiff. Feeling fatigued with muscle weakness also with occasional rapid heart beat, some confusion, feeling tired, sensitive to light, on the verge of vomiting. Tightness in chest is worsening, lightheaded and dizzy. Anxiety attack occurred today followed by shaking muscles and trembling. no fever. Pain in neck and upper back worsened.
Age: 28.0
Sex: F
Vaccine: MEN
Symptoms: Fatigue, Headache, Heart rate increased, Injection site pain, Muscular weakness
Clinical narrative: Slowly started with slight headache and pain in the shoulder of injection sight. Pain and stiffness in the neck and in upper spine worsened over last 3 days. Second day after injection started feeling very fatigued and nauseous. Today neck and chest feels very stiff. Feeling fatigued with muscle weakness also with occasional rapid heart beat, some confusion, feeling tired, sensitive to light, on the verge of vomiting. Tightness in chest is worsening, lightheaded and dizzy. Anxiety attack occurred today followed by shaking muscles and trembling. no fever. Pain in neck and upper back worsened.
Age: 28.0
Sex: F
Vaccine: MEN
Symptoms: Musculoskeletal stiffness, Nausea, Neck pain, Photophobia, Tremor
Clinical narrative: Slowly started with slight headache and pain in the shoulder of injection sight. Pain and stiffness in the neck and in upper spine worsened over last 3 days. Second day after injection started feeling very fatigued and nauseous. Today neck and chest feels very stiff. Feeling fatigued with muscle weakness also with occasional rapid heart beat, some confusion, feeling tired, sensitive to light, on the verge of vomiting. Tightness in chest is worsening, lightheaded and dizzy. Anxiety attack occurred today followed by shaking muscles and trembling. no fever. Pain in neck and upper back worsened.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Injection site reaction, Injection site vesicles, Migraine, Pain
Clinical narrative: Patient states about 4 to 5 hours after immunization he started feeling body aches and and migraine type headache. Over the next 2 days had small blister like bumps around the injection on his left arm. He states it looked like they were filled with fluid or pus. Patient went to his family doctor on Friday 8/17/12 to be checked out. Doctor told him it like he got a live virus shot. Doctor prescribe a Zithromycin Z-pak and rest. I talked to patient on Sunday 8/19/12 to follow up with him from his first discussion with the other pharmacist on Friday 8/17/12. He stated he is starting to fell better.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Purulent discharge
Clinical narrative: Patient states about 4 to 5 hours after immunization he started feeling body aches and and migraine type headache. Over the next 2 days had small blister like bumps around the injection on his left arm. He states it looked like they were filled with fluid or pus. Patient went to his family doctor on Friday 8/17/12 to be checked out. Doctor told him it like he got a live virus shot. Doctor prescribe a Zithromycin Z-pak and rest. I talked to patient on Sunday 8/19/12 to follow up with him from his first discussion with the other pharmacist on Friday 8/17/12. He stated he is starting to fell better.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Burning sensation, Hypoaesthesia, Pain in extremity, Paraesthesia, Sensation of heaviness
Clinical narrative: Pain in arm started about a half hour after shot was given. Then about 2 hours after shot there was a burning sensation and tingling down arm into the fingers. It is now 18 days later and my arm is getting worse. There's still burning, tingling and numbness down my arm into my fingers. My arm feels heavy.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Autopsy, Death
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 72 years old male patient with no known drug allergies who was vaccinated subcutaneously into upper left deltoid with a dose of 0.65 ml ZOSTAVAX (lot # 672563/1649AA, expiration date 21-JAN-2013) on 19-JUL-2012. No other co-suspects were reported. Concomitant medications included lisinopril, COUMADIN, spironolactone and carvedilol. Pharmacist stated she read in the local paper and found out that client was died at her home residence on 24-JUL-2012. Cause of death was unknown. It was unknown if autopsy was performed. Pharmacist stated the patient did have health conditions, unspecified, but she wanted to make sure that no problem existed with this ZOSTAVAX lot number. This event (death) was considered to be life-threatening and disabling. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DT, MMR, VARCEL
Symptoms: Acoustic stimulation tests abnormal, Atrial septal defect, Blood bilirubin increased, Caesarean section, Cardiac murmur
Clinical narrative: Information has been received from a health professional for the pregnancy registry for VARIVAX (Merck) concerning male baby whose mother on 06-APR-2011, was vaccinated with a dose of VARIVAX (Merck) 0.5 ml, subcutaneously (lot number 668455/1310Z, Exp. 07-OCT-2012). Secondary suspect therapy included vaccination with a dose of MMR II, 0.5 ml, subcutaneously (lot number 669017/1250Z, Exp. 28-JUN-2012). Other concomitant therapy included prenatal vitamins (unspecified). The vaccines were administered while the mother was 10 weeks pregnant. It was reported that on 10-MAY-2011, the mother started taking prenatal vitamins. On 20-NOV-2011, 40 weeks from last menstrual period (LMP), the patient gave birth to the baby boy via C-section with a birth weight of 8 pound and 1 ounce. The baby had neonatal jaundice. The total bilirubin was 12.2 mg/dl on 27-NOV-2011 and 7.3 on 06-DEC-2011. On 06-DEC-2011, review of neurological revealed swelling of the scalp. Physical exam revealed 2 cephalohematoma on each parietal region. CARDIOVASCULAR exam found systolic murmur on left sternal border. The assessment of the routine infant health check revealed neonatal jaundice, contusion of scalp and cardiac murmur. On 23-DEC-2011, the baby was seen in audiology for an evaluation at the request of a doctor. The baby failed his initial newborn hearing screening on his right ear. The baby's father did indicate he did seem to respond well to sounds and they had no significant family history of hearing loss. Audiological findings reveal normal distortion product otacoustic emissions at 2000 through 8000 Hz bilaterally. This was a good indicator normal outer hair-cell cochlear function, which was a good indicator of normal peripheral hearing mechanism. A diagnosis of abnormal auditory perception was made. The patient would see the doctor for any medical needs and had now passed his newborn hearing screening bilaterally. On 28-DEC-2011 a congenital transthoracic echocardiogram revealed normal echocardiogram. There was physiologic acceleration of flow in the branch pulmonary arteries with no evidence of narrowing. There was a left to right shunt through a patent foramen ovale. Thymic tissue was prominent. At the time of the report, the outcome of the events was unknown. The mother's experience has been captured in MARRS# 1104USA01360. Follow up information has been received from the health care worker refers to the approximately 35 days old infant. The health worker stated the patient's mother vaccinated with the first dose VARIVAX (Merck) (lot #668455/1310Z) subcutaneous on 06-APR-2011 morning in the patient's right arm. Other suspect was the patient's mother vaccinated with the first dose of MMR II (lot #669017/1250Z) on 06-APR-2011 morning in the patient's left arm and the first dose of DECAVAC (lot#U3815CA, reported as TD) intramuscular in right deltoid. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: DT, MMR, VARCEL
Symptoms: Cephalhaematoma, Contusion, Diagnostic procedure, Echocardiogram, Echocardiogram normal
Clinical narrative: Information has been received from a health professional for the pregnancy registry for VARIVAX (Merck) concerning male baby whose mother on 06-APR-2011, was vaccinated with a dose of VARIVAX (Merck) 0.5 ml, subcutaneously (lot number 668455/1310Z, Exp. 07-OCT-2012). Secondary suspect therapy included vaccination with a dose of MMR II, 0.5 ml, subcutaneously (lot number 669017/1250Z, Exp. 28-JUN-2012). Other concomitant therapy included prenatal vitamins (unspecified). The vaccines were administered while the mother was 10 weeks pregnant. It was reported that on 10-MAY-2011, the mother started taking prenatal vitamins. On 20-NOV-2011, 40 weeks from last menstrual period (LMP), the patient gave birth to the baby boy via C-section with a birth weight of 8 pound and 1 ounce. The baby had neonatal jaundice. The total bilirubin was 12.2 mg/dl on 27-NOV-2011 and 7.3 on 06-DEC-2011. On 06-DEC-2011, review of neurological revealed swelling of the scalp. Physical exam revealed 2 cephalohematoma on each parietal region. CARDIOVASCULAR exam found systolic murmur on left sternal border. The assessment of the routine infant health check revealed neonatal jaundice, contusion of scalp and cardiac murmur. On 23-DEC-2011, the baby was seen in audiology for an evaluation at the request of a doctor. The baby failed his initial newborn hearing screening on his right ear. The baby's father did indicate he did seem to respond well to sounds and they had no significant family history of hearing loss. Audiological findings reveal normal distortion product otacoustic emissions at 2000 through 8000 Hz bilaterally. This was a good indicator normal outer hair-cell cochlear function, which was a good indicator of normal peripheral hearing mechanism. A diagnosis of abnormal auditory perception was made. The patient would see the doctor for any medical needs and had now passed his newborn hearing screening bilaterally. On 28-DEC-2011 a congenital transthoracic echocardiogram revealed normal echocardiogram. There was physiologic acceleration of flow in the branch pulmonary arteries with no evidence of narrowing. There was a left to right shunt through a patent foramen ovale. Thymic tissue was prominent. At the time of the report, the outcome of the events was unknown. The mother's experience has been captured in MARRS# 1104USA01360. Follow up information has been received from the health care worker refers to the approximately 35 days old infant. The health worker stated the patient's mother vaccinated with the first dose VARIVAX (Merck) (lot #668455/1310Z) subcutaneous on 06-APR-2011 morning in the patient's right arm. Other suspect was the patient's mother vaccinated with the first dose of MMR II (lot #669017/1250Z) on 06-APR-2011 morning in the patient's left arm and the first dose of DECAVAC (lot#U3815CA, reported as TD) intramuscular in right deltoid. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: DT, MMR, VARCEL
Symptoms: Eosinophil percentage increased, Foetal exposure during pregnancy, Hearing impaired, Jaundice neonatal, Mean platelet volume increased
Clinical narrative: Information has been received from a health professional for the pregnancy registry for VARIVAX (Merck) concerning male baby whose mother on 06-APR-2011, was vaccinated with a dose of VARIVAX (Merck) 0.5 ml, subcutaneously (lot number 668455/1310Z, Exp. 07-OCT-2012). Secondary suspect therapy included vaccination with a dose of MMR II, 0.5 ml, subcutaneously (lot number 669017/1250Z, Exp. 28-JUN-2012). Other concomitant therapy included prenatal vitamins (unspecified). The vaccines were administered while the mother was 10 weeks pregnant. It was reported that on 10-MAY-2011, the mother started taking prenatal vitamins. On 20-NOV-2011, 40 weeks from last menstrual period (LMP), the patient gave birth to the baby boy via C-section with a birth weight of 8 pound and 1 ounce. The baby had neonatal jaundice. The total bilirubin was 12.2 mg/dl on 27-NOV-2011 and 7.3 on 06-DEC-2011. On 06-DEC-2011, review of neurological revealed swelling of the scalp. Physical exam revealed 2 cephalohematoma on each parietal region. CARDIOVASCULAR exam found systolic murmur on left sternal border. The assessment of the routine infant health check revealed neonatal jaundice, contusion of scalp and cardiac murmur. On 23-DEC-2011, the baby was seen in audiology for an evaluation at the request of a doctor. The baby failed his initial newborn hearing screening on his right ear. The baby's father did indicate he did seem to respond well to sounds and they had no significant family history of hearing loss. Audiological findings reveal normal distortion product otacoustic emissions at 2000 through 8000 Hz bilaterally. This was a good indicator normal outer hair-cell cochlear function, which was a good indicator of normal peripheral hearing mechanism. A diagnosis of abnormal auditory perception was made. The patient would see the doctor for any medical needs and had now passed his newborn hearing screening bilaterally. On 28-DEC-2011 a congenital transthoracic echocardiogram revealed normal echocardiogram. There was physiologic acceleration of flow in the branch pulmonary arteries with no evidence of narrowing. There was a left to right shunt through a patent foramen ovale. Thymic tissue was prominent. At the time of the report, the outcome of the events was unknown. The mother's experience has been captured in MARRS# 1104USA01360. Follow up information has been received from the health care worker refers to the approximately 35 days old infant. The health worker stated the patient's mother vaccinated with the first dose VARIVAX (Merck) (lot #668455/1310Z) subcutaneous on 06-APR-2011 morning in the patient's right arm. Other suspect was the patient's mother vaccinated with the first dose of MMR II (lot #669017/1250Z) on 06-APR-2011 morning in the patient's left arm and the first dose of DECAVAC (lot#U3815CA, reported as TD) intramuscular in right deltoid. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: DT, MMR, VARCEL
Symptoms: Monocyte count increased, Monocyte percentage increased, Neurological examination abnormal, Otoacoustic emissions test, Red cell distribution width increased
Clinical narrative: Information has been received from a health professional for the pregnancy registry for VARIVAX (Merck) concerning male baby whose mother on 06-APR-2011, was vaccinated with a dose of VARIVAX (Merck) 0.5 ml, subcutaneously (lot number 668455/1310Z, Exp. 07-OCT-2012). Secondary suspect therapy included vaccination with a dose of MMR II, 0.5 ml, subcutaneously (lot number 669017/1250Z, Exp. 28-JUN-2012). Other concomitant therapy included prenatal vitamins (unspecified). The vaccines were administered while the mother was 10 weeks pregnant. It was reported that on 10-MAY-2011, the mother started taking prenatal vitamins. On 20-NOV-2011, 40 weeks from last menstrual period (LMP), the patient gave birth to the baby boy via C-section with a birth weight of 8 pound and 1 ounce. The baby had neonatal jaundice. The total bilirubin was 12.2 mg/dl on 27-NOV-2011 and 7.3 on 06-DEC-2011. On 06-DEC-2011, review of neurological revealed swelling of the scalp. Physical exam revealed 2 cephalohematoma on each parietal region. CARDIOVASCULAR exam found systolic murmur on left sternal border. The assessment of the routine infant health check revealed neonatal jaundice, contusion of scalp and cardiac murmur. On 23-DEC-2011, the baby was seen in audiology for an evaluation at the request of a doctor. The baby failed his initial newborn hearing screening on his right ear. The baby's father did indicate he did seem to respond well to sounds and they had no significant family history of hearing loss. Audiological findings reveal normal distortion product otacoustic emissions at 2000 through 8000 Hz bilaterally. This was a good indicator normal outer hair-cell cochlear function, which was a good indicator of normal peripheral hearing mechanism. A diagnosis of abnormal auditory perception was made. The patient would see the doctor for any medical needs and had now passed his newborn hearing screening bilaterally. On 28-DEC-2011 a congenital transthoracic echocardiogram revealed normal echocardiogram. There was physiologic acceleration of flow in the branch pulmonary arteries with no evidence of narrowing. There was a left to right shunt through a patent foramen ovale. Thymic tissue was prominent. At the time of the report, the outcome of the events was unknown. The mother's experience has been captured in MARRS# 1104USA01360. Follow up information has been received from the health care worker refers to the approximately 35 days old infant. The health worker stated the patient's mother vaccinated with the first dose VARIVAX (Merck) (lot #668455/1310Z) subcutaneous on 06-APR-2011 morning in the patient's right arm. Other suspect was the patient's mother vaccinated with the first dose of MMR II (lot #669017/1250Z) on 06-APR-2011 morning in the patient's left arm and the first dose of DECAVAC (lot#U3815CA, reported as TD) intramuscular in right deltoid. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: DT, MMR, VARCEL
Symptoms: Swelling
Clinical narrative: Information has been received from a health professional for the pregnancy registry for VARIVAX (Merck) concerning male baby whose mother on 06-APR-2011, was vaccinated with a dose of VARIVAX (Merck) 0.5 ml, subcutaneously (lot number 668455/1310Z, Exp. 07-OCT-2012). Secondary suspect therapy included vaccination with a dose of MMR II, 0.5 ml, subcutaneously (lot number 669017/1250Z, Exp. 28-JUN-2012). Other concomitant therapy included prenatal vitamins (unspecified). The vaccines were administered while the mother was 10 weeks pregnant. It was reported that on 10-MAY-2011, the mother started taking prenatal vitamins. On 20-NOV-2011, 40 weeks from last menstrual period (LMP), the patient gave birth to the baby boy via C-section with a birth weight of 8 pound and 1 ounce. The baby had neonatal jaundice. The total bilirubin was 12.2 mg/dl on 27-NOV-2011 and 7.3 on 06-DEC-2011. On 06-DEC-2011, review of neurological revealed swelling of the scalp. Physical exam revealed 2 cephalohematoma on each parietal region. CARDIOVASCULAR exam found systolic murmur on left sternal border. The assessment of the routine infant health check revealed neonatal jaundice, contusion of scalp and cardiac murmur. On 23-DEC-2011, the baby was seen in audiology for an evaluation at the request of a doctor. The baby failed his initial newborn hearing screening on his right ear. The baby's father did indicate he did seem to respond well to sounds and they had no significant family history of hearing loss. Audiological findings reveal normal distortion product otacoustic emissions at 2000 through 8000 Hz bilaterally. This was a good indicator normal outer hair-cell cochlear function, which was a good indicator of normal peripheral hearing mechanism. A diagnosis of abnormal auditory perception was made. The patient would see the doctor for any medical needs and had now passed his newborn hearing screening bilaterally. On 28-DEC-2011 a congenital transthoracic echocardiogram revealed normal echocardiogram. There was physiologic acceleration of flow in the branch pulmonary arteries with no evidence of narrowing. There was a left to right shunt through a patent foramen ovale. Thymic tissue was prominent. At the time of the report, the outcome of the events was unknown. The mother's experience has been captured in MARRS# 1104USA01360. Follow up information has been received from the health care worker refers to the approximately 35 days old infant. The health worker stated the patient's mother vaccinated with the first dose VARIVAX (Merck) (lot #668455/1310Z) subcutaneous on 06-APR-2011 morning in the patient's right arm. Other suspect was the patient's mother vaccinated with the first dose of MMR II (lot #669017/1250Z) on 06-APR-2011 morning in the patient's left arm and the first dose of DECAVAC (lot#U3815CA, reported as TD) intramuscular in right deltoid. Additional information is not expected.
Age: 21.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a mother refers to a 21 year old patient. The patient was vaccinated respectively with first and second dose of GARDASIL in August-2011 (reported as "a year ago") and on 08-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patient had sought medical attention. Additional information has been requested. This is one of several reports received from same source.
Age: 1.21
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 3 years old male patient without drug reactions or allergies. The patient has no pertinent medical history. The patient was vaccinated one 0.5ml dose of VARIVAX (lot number 665691/1236Y; expired date 27-AUG-2011) subcutaneously on 26-MAR-2010. No other co-suspects were reported. There were no concomitant medications. On 08-AUG-2012 the patient was seen in the office and diagnosed with a mild case of chickenpox. The patient had less than 50 widespread lesions. The patient was directed to take BENADRYL as treatment for the adverse event. There was no laboratory diagnostics study performed. The patient was recovering at the time of report. The patient had visit the office for medical attention. Additional information is not expected.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a mother refers to a 16 year old patient. The patient was vaccinated respectively with first and second dose of GARDASIL in August-2011 (reported as one year ago) and on 08-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. It was unknown of the patient had sought medical attention. Additional information has been requested. This is one of several reported received from same source.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a 60 years old female consumer with asthma and no drug reactions or allergies refers to herself. The patient was vaccinated with a dose of ZOSTAVAX on 25-JUL-2012. Concomitant medications included: AMBIEN. In approximately 2012 the patient experienced a raised, red welt at the injection site of ther right arm. No treatment was given for the adverse events. No lab diagnostics studies performed. The outcome of the patient was unknown. The patient sought unspecified medical attention. Additional information is not expected. This is one of reports from same source.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 years old female patient with no pertinent medical history and with no drug reactions or allergies. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX (Lot # 671142/1268AA, dose not reported) on 27-JUN-2012. Concomitant medications included nonsteroidal anti-inflammatory drug (unspecified), atorvastatin, VESICARE, estradiol, ALIGN, PRILOSEC and calcium with vitamin D. On 06-AUG-2012 the patient experienced varicella like rash on her body. There was no pain or itching with rash. The patient saw a physician for medical attention. There were no lab diagnostic studies performed. No treatment was given. At the time of this report the patient had not recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Headache, Maternal exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse, for GARDASIL,a Pregnancy Registry product, concerning a 17 years old female patient without drug reaction. The patient's current condition included vitamin D deficiency. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated intramuscularly with the first, second and third dose of 0.5 ml GARDASIL (lot number unknown) on 08-SEP-2011, 08-NOV-2011 and 25-JUL-2012, respectively. No other co-suspects were reported. There were no concomitant medications. The patient became pregnant with an LMP of 26-MAY-2012 and an EDD of 02-MAR-2013. Initial exposure to GARDASIL was at 8 weeks. The patient was exposed to GARDASIL during trimester 1. The reporter stated that the date of the patient's menstrual period that the patient provided was incorrect, and therefore she was not suspected of benign pregnant when coming in to receive her third dose of GARDASIL on 25-JUL-2012. The reporter also noted that on 25-JUL-2012 at her office visit, the patient's primary complaint was of headaches and she was sent to neurology for evaluation. Laboratory diagnostics studies about routine blood work were performed and results were unknown. The patient had contacted physician for medical attention. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a nurse refers to one of three patients of unknown age. On an unspecified date the patients was vaccinated with a dose of PNEUMOVAX23 (Lot#, dose and route not reported, but the three patients got the vaccine from the same lot number). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patients experienced tenderness at the injection site. The patients sought for unspecified medical attention. This is one of several reports received from a same source.  Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report received from an office manager who is also a medical assistant refers to a 75 years old male patient. The patient was inadvertently vaccinated with a dose of GARDASIL on 03-AUG-2012. No symptoms reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 60 years old patient. The patient was vaccinated subcutaneously with a single dose of ZOSTAVAX (Lot# and dose not reported) on an unspecified date. "10 to 14 days later" on an unspecified date the patient experienced rash on the forehead bilaterally. The patient visited office for medical attention. No treatment was given. At the time of this report the patient had recovered, date unknown. Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered nurse refers to an approximately 9 years old female patient with no pertinent medical history and no drug reactions/allergies who was vaccinated with the first dose of VARIVAX on an unspecified date in 2001. There was no concomitant medication. On an unspecified date in 2010 the patient developed the shingles. The patient sought medical attention by office visit. No lab diagnostics studies were performed. The outcome of shingles was unknown. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Antibiotic resistant Staphylococcus test, Blood cholesterol normal, Exposure to vaccinated person, Full blood count normal, Groin pain
Clinical narrative: This spontaneous report as received from a consumer refers to her husband of 67 years old with allergy to fish. Her husband's medical history included rheumatoid arthritis and heart stent surgery about 3 to 4 years ago, for heart problems and methicillin-resistant Staphylococcus aureus (MRSA) infection 3 years ago. The patient's wife was vaccinated with a dose of ZOSTAVAX on 25-JUL-2012. It was reported that the patient started to complain of very bad groin pain, (reporter stated she thought her husband had a pulled muscle in his groin). In addition, her husband developed very painful muscle aches, and pains in his shoulders, arms, headache, low grade fever running about 99 F to 100 F, vomiting. He was very sick. Her husband went for office visit to the doctor this week on Monday but did not have a rash at that time. All kinds of test performed, full blood count (CBC Chemistry), cholesterol all with excellent outcome results. MRSA (methicillin-resistant Staphylococcus aureus) test was still pending results. She stated her husband now had the shingles rash on left thigh and groin area and it was very painful. Her husband was put on an unspecified antiviral medication but she stated the medication made him nauseous. The reporter stated her husband was not on any "immuno compromising medications for his rheumatoid arthritis, not on ENBREL or anything like that." Her husband was not hospitalized. Caller stated she did not expect to transmit the shingles virus to her husband. The outcome of the her husband was unknown. Additional information is not expected. This is one of reports from same source.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Malaise, Musculoskeletal pain, Myalgia
Clinical narrative: This spontaneous report as received from a consumer refers to her husband of 67 years old with allergy to fish. Her husband's medical history included rheumatoid arthritis and heart stent surgery about 3 to 4 years ago, for heart problems and methicillin-resistant Staphylococcus aureus (MRSA) infection 3 years ago. The patient's wife was vaccinated with a dose of ZOSTAVAX on 25-JUL-2012. It was reported that the patient started to complain of very bad groin pain, (reporter stated she thought her husband had a pulled muscle in his groin). In addition, her husband developed very painful muscle aches, and pains in his shoulders, arms, headache, low grade fever running about 99 F to 100 F, vomiting. He was very sick. Her husband went for office visit to the doctor this week on Monday but did not have a rash at that time. All kinds of test performed, full blood count (CBC Chemistry), cholesterol all with excellent outcome results. MRSA (methicillin-resistant Staphylococcus aureus) test was still pending results. She stated her husband now had the shingles rash on left thigh and groin area and it was very painful. Her husband was put on an unspecified antiviral medication but she stated the medication made him nauseous. The reporter stated her husband was not on any "immuno compromising medications for his rheumatoid arthritis, not on ENBREL or anything like that." Her husband was not hospitalized. Caller stated she did not expect to transmit the shingles virus to her husband. The outcome of the her husband was unknown. Additional information is not expected. This is one of reports from same source.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a consumer refers to her husband of 67 years old with allergy to fish. Her husband's medical history included rheumatoid arthritis and heart stent surgery about 3 to 4 years ago, for heart problems and methicillin-resistant Staphylococcus aureus (MRSA) infection 3 years ago. The patient's wife was vaccinated with a dose of ZOSTAVAX on 25-JUL-2012. It was reported that the patient started to complain of very bad groin pain, (reporter stated she thought her husband had a pulled muscle in his groin). In addition, her husband developed very painful muscle aches, and pains in his shoulders, arms, headache, low grade fever running about 99 F to 100 F, vomiting. He was very sick. Her husband went for office visit to the doctor this week on Monday but did not have a rash at that time. All kinds of test performed, full blood count (CBC Chemistry), cholesterol all with excellent outcome results. MRSA (methicillin-resistant Staphylococcus aureus) test was still pending results. She stated her husband now had the shingles rash on left thigh and groin area and it was very painful. Her husband was put on an unspecified antiviral medication but she stated the medication made him nauseous. The reporter stated her husband was not on any "immuno compromising medications for his rheumatoid arthritis, not on ENBREL or anything like that." Her husband was not hospitalized. Caller stated she did not expect to transmit the shingles virus to her husband. The outcome of the her husband was unknown. Additional information is not expected. This is one of reports from same source.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a healthcare student refers to a 54 years old female patient with allergic to penicillin and allergic to cephalosporins. The patient had no pertinent medical history. The patient was vaccinated with ZOSTAVAX (lot umber 0562AE, expired date was unknown) (dose and injection site were not reported) subcutaneously on 08-AUG-2012. No other co-suspects were reported. There were no concomitant medications. At some unspecified time point after this vaccination in August 2012, the patient experienced a "red, golf ball sized swollen area at the site of injection". No treatment information was reported. The patient current status was unknown. There was no laboratory diagnostics performed. The patient's family had called the pharmacy for medical attention. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 years old female patient. The patient's medical history included stomach issues. The patient's relevant past drug history included a steroidal eye drop "a month ago". The patient was vaccinated SQ with, 1 DF ZOSTAVAX (lot number reported as H009779, expired on 27-MAR-2013) on 03-AUG-2012. Concomitant medications included: DEXILANT. On 03-AUG-2012, the patient noticed redness and swelling about the size of a half dollar around injection site, some pain and tenderness and minor itching. On 05-AUG-2012 the patient reported that her whole underarm was swollen and hard. There was no relevant laboratory data. As of 05-AUG-2012 she continued to experience hardening and swelling. It was unknown of the patient would continue on the ZOSTAVAX. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 years old female patient. The patient's medical history included stomach issues. The patient's relevant past drug history included a steroidal eye drop "a month ago". The patient was vaccinated SQ with, 1 DF ZOSTAVAX (lot number reported as H009779, expired on 27-MAR-2013) on 03-AUG-2012. Concomitant medications included: DEXILANT. On 03-AUG-2012, the patient noticed redness and swelling about the size of a half dollar around injection site, some pain and tenderness and minor itching. On 05-AUG-2012 the patient reported that her whole underarm was swollen and hard. There was no relevant laboratory data. As of 05-AUG-2012 she continued to experience hardening and swelling. It was unknown of the patient would continue on the ZOSTAVAX. Additional information has been requested.
Age: 0.08
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 6 weeks old patient. The patient was vaccinated with an expired RECOMBIVAX HB (lot number 665619/1251Y, expired date 16-JUN-2012) on 03-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a nurse concerning unknown number of female patients of unknown age was vaccinated with IM, 0.5 ml GARDASIL on month 0,2,6. The nurse reported that syncope occurs more in girls than boys. The patients sought unspecified medical attention. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning unspecified patients who on an unspecified date were vaccinated with VAQTA that stored at colder that recommended temperatures. No adverse symptoms noted. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a nurse concerning unknown number of male patients of unknown age was vaccinated IM with 0.5 ml GARDASIL on month 0, 2, 6. The nurse reported that syncope occurs more in girls than boys. The patients sought unspecified medical attention. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 20.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 20 years old male patient with no pertinent medical history and no drug reactions/allergies. The patient was subcutaneously vaccinated with first dose of 0.5 ml VARIVAX (Lot# and expiration unspecified) on 22-MAY-2002, second dose (route, dose, Lot# and expiration unspecified) co-suspects were reported. Concomitant medications were included oral acne medication and topical acne medication. The registered nurse reported that the patient who received 2 doses of VARIVAX was found to have immunity to chickenpox that was lacking. The patient had sought medical attention via phone call. No treatment information was reported. The outcome was unknown. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old male patient was vaccinated intramuscularly with a first dose of GARDASIL (Lot # 669313/0692AA) in his left arm on 29-FEB-2012. Concomitant therapy included a first dose of ADACEL (Lot # U4104BA) and a first dose of MENVEO (Lot# M10126S) given intramuscularly in right arm. On 02-MAR-2012 the patient experienced redness and swelling to injection site. The patient visited emergency room for medical attention. Final outcome was not reported. The original reporting source was not provided. The VAERS ID # is 451206-1. No further information is available.