chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Anal fissure, Haematochezia
Clinical narrative: Blood tinged stools the day of vaccines & sporadically thereafter x10 days.  Baby feeling well with 14.7 wt gain in 10 days.  Likely perianal fissure on exam.
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Computerised tomogram, Head injury, Loss of consciousness, Suture insertion
Clinical narrative: Child was getting ready for school on 2/6, passed out, hit head. Mom had to take to ER and had 6 sutures put in. Child received vaccines 2/5/2008.
Age: 55.0
Sex: F
Vaccine: HEPA, IPV, MEN
Symptoms: Activities of daily living impaired, Convulsion, Dizziness, Dysphagia, Loss of consciousness
Clinical narrative: Next day dizziness, aching all over, in bed for 2 days, then 3 days later blacked out with seizure-like symptoms.  Ended up in hospital ER with face lacerations.  Diagnosis of possible sudden onset of migraines.  Continue to have weakness in legs, arms - lightheaded - trouble swallowing at times. 3/3/08 records received-laceration to nose-felt dizzy, blurry vision, visual disturbance,  passed out. Impression:Migraine headache.  3/3/08 records received-laceration to nose-felt dizzy, blurry vision, visual disturbance,  passed out. Impression:Migraine headache.Discharged home from ED.
Age: 55.0
Sex: F
Vaccine: HEPA, IPV, MEN
Symptoms: Muscular weakness, Pain, Skin laceration
Clinical narrative: Next day dizziness, aching all over, in bed for 2 days, then 3 days later blacked out with seizure-like symptoms.  Ended up in hospital ER with face lacerations.  Diagnosis of possible sudden onset of migraines.  Continue to have weakness in legs, arms - lightheaded - trouble swallowing at times. 3/3/08 records received-laceration to nose-felt dizzy, blurry vision, visual disturbance,  passed out. Impression:Migraine headache.  3/3/08 records received-laceration to nose-felt dizzy, blurry vision, visual disturbance,  passed out. Impression:Migraine headache.Discharged home from ED.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Dizziness, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Noticed pain at injection site with redness and swelling developing at both inject. sites within 15 hours after injection - unable to raise arms above waist level about 12 to 15 hours after injection; Also had dizziness, chills
Age: 59.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site swelling
Clinical narrative: Noticed pain at injection site with redness and swelling developing at both inject. sites within 15 hours after injection - unable to raise arms above waist level about 12 to 15 hours after injection; Also had dizziness, chills
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Received shingles shot 01-07-08.  Shingles broke out 01-30-08.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles (clinical) 2 days after shingles vaccine with typical rash R thorax.
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Chills, Erythema, Malaise, Pain in extremity, Pruritus
Clinical narrative: Tdap given few days ago into deltoid region, LR arm.  Developed red, itchy painful area below site of shot; that area has been progressively getting bigger and itching, until today when it's itching less than yesterday.  Had chills and malaise one day.  Recalls having childhood pertussis.  She has already made notification to VAERS.
Sex: U
Vaccine: HEPA, HPV4
Symptoms: Condition aggravated, Electroencephalogram normal, Laboratory test normal, Nuclear magnetic resonance imaging normal, Vertigo
Clinical narrative: Vertigo - in spring 07 worse since Gardasil 6/22/07 8/31/07
Age: 32.0
Sex: M
Vaccine: FLU3, TD
Symptoms: Pain in extremity
Clinical narrative: Pain in Lt arm >15 days after injection.  Denies redness, swelling, irritation, fever.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chest X-ray abnormal, Chronic obstructive pulmonary disease, Diagnostic procedure, Granuloma, Musculoskeletal chest pain
Clinical narrative: Patient seen 6/18/07 for report of chest wall pain - right side.  Patient had chest x-ray, ultrasound.  Had Zostavax 6/20/07.  Per patient had rash on right chest which started 6/22/07.  Not seen again until 9/24/07 at our office.  Patient had numerous tests and was referred to Gastro and Neuro.  Patient still reports pain right chest wall.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash, Ultrasound scan
Clinical narrative: Patient seen 6/18/07 for report of chest wall pain - right side.  Patient had chest x-ray, ultrasound.  Had Zostavax 6/20/07.  Per patient had rash on right chest which started 6/22/07.  Not seen again until 9/24/07 at our office.  Patient had numerous tests and was referred to Gastro and Neuro.  Patient still reports pain right chest wall.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chest X-ray, Musculoskeletal chest pain, Rash, Ultrasound scan
Clinical narrative: Patient seen 6/18/07 for report of chest wall pain - right side.  Patient had chest x-ray, ultrasound.  Had Zostavax 6/20/07.  Per patient had rash on right chest which started 6/22/07.  Not seen again until 9/24/07 at our office.  Patient had numerous tests and was referred to Gastro and Neuro.  Patient still reports pain right chest wall.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Bone scan, Chest X-ray, Computerised tomogram, Erythema
Clinical narrative: Patient seen 6/18/07 for report of chest wall pain - right side.  Patient had chest x-ray, ultrasound.  Had Zostavax 6/20/07.  Per patient had rash on right chest which started 6/22/07.  Not seen again until 9/24/07 at our office.  Patient had numerous tests and was referred to Gastro and Neuro.  Patient still reports pain right chest wall.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient seen 6/18/07 for report of chest wall pain - right side.  Patient had chest x-ray, ultrasound.  Had Zostavax 6/20/07.  Per patient had rash on right chest which started 6/22/07.  Not seen again until 9/24/07 at our office.  Patient had numerous tests and was referred to Gastro and Neuro.  Patient still reports pain right chest wall.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Mammogram, Pain, Pruritus, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Patient seen 6/18/07 for report of chest wall pain - right side.  Patient had chest x-ray, ultrasound.  Had Zostavax 6/20/07.  Per patient had rash on right chest which started 6/22/07.  Not seen again until 9/24/07 at our office.  Patient had numerous tests and was referred to Gastro and Neuro.  Patient still reports pain right chest wall.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure, Cough, Decreased appetite, Dyspnoea, Heart rate
Clinical narrative: 2/13/8 Zostavax injection administered; 2/14/8 Patient reports lots of yellow rhinorrhea, cough, shortness of breath, decreased appetite which progressed, worsening with fever, more shortness of breath. Almost went to ER, but called office 2/18/8 and left message. Patient in today. Fever 100.6 F; BP 118/85; Pulse 16; R 32; O2 Sat 84% rm air, O2 21, Alb neb, Solumederol 125mg IM. Rocephin 1 IM; IM. Z Pack
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oxygen saturation decreased, Oxygen supplementation, Pyrexia, Rhinorrhoea
Clinical narrative: 2/13/8 Zostavax injection administered; 2/14/8 Patient reports lots of yellow rhinorrhea, cough, shortness of breath, decreased appetite which progressed, worsening with fever, more shortness of breath. Almost went to ER, but called office 2/18/8 and left message. Patient in today. Fever 100.6 F; BP 118/85; Pulse 16; R 32; O2 Sat 84% rm air, O2 21, Alb neb, Solumederol 125mg IM. Rocephin 1 IM; IM. Z Pack
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest X-ray, Computerised tomogram, Cough, Dyspnoea
Clinical narrative: 2/13/8 Zostavax injection administered; 2/14/8 Patient reports lots of yellow rhinorrhea, cough, shortness of breath, decreased appetite which progressed, worsening with fever, more shortness of breath. Almost went to ER, but called office 2/18/8 and left message. Patient in today. Fever 100.6 F; BP 118/85; Pulse 16; R 32; O2 Sat 84% rm air, O2 21, Alb neb, Solumederol 125mg IM. Rocephin 1 IM; IM. Z Pack
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, X-ray
Clinical narrative: Joint pain right wrist.
Age: 10.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen 2" out (RA) redness in a circle.  (Varicella shot), T-Dap (Adacel) area bottom, top 1".
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Irritability, Pyrexia, Teething
Clinical narrative: Received immunization on 11-21-07, fever started that p.m. & continued through 11-25-07.  Fever got as high as 101.1 & child was fussy.  Mom rotated Tylenol & Motrin for fever.  Mom also stated child was teething at the time & he runs fever this high while teething.  Notified our medical director & he gave permission to give immunizations, including future MMR which he said could have been the cause of the fever.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, pruritis, min tender.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.  Treatment: Benadryl & Tylenol.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 6 cm erythema with induration to R tricep.
Age: 1.2
Sex: M
Vaccine: DTAP, FLU3, HEPA, MMR, PNC, VARCEL
Symptoms: Oedema, Rash pruritic, Urticaria
Clinical narrative: Immunizations given 2/14/08.  2/16 - patient developed 'red spots'.  2/17 - rash itchy, child edematous, taken to hospital.  Diagnosed with hives, given Benadryl.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Redness swelling to site, warm to touch.  Treated with antibiotics.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pustular, Skin lesion, Stomatitis
Clinical narrative: 1. Child developed stomatitis 5 days after receiving Varivax.  2. Child dev. 1 small pustular lesion on L. leg after (7d.) Varivax.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Limb discomfort, Pruritus, Rash macular, Tenderness
Clinical narrative: Very sore upper arm for over 2 days especially one area an inch and one-half in diameter.  Outside upper arm red and blotchy an area 4 1/2 inches x 6 inches.  Days 6 & 7 light pink, itchy, big spot tender.  Day 9 tenderness gone.  Day 11 slightly pink.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 4cm red raised warm reaction on upper L arm.  No fevers.  A little itching at site.  No vomiting or resp symptoms.  Symptoms noted about 20 hours after injection.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Skin lesion
Clinical narrative: Varicella #2 given 1/9/08.  Seen in clinic for indurated erythematous lesion at site of injection.  Unsure when lesion started.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: Swelling, redness, throbbing pain 48 hours after 3rd Anthrax shot.
Age: 0.35
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Feeling abnormal, Listless, Pyrexia
Clinical narrative: "Spacey for 36 hrs", fever 101.0, parents gave Ibuprofen, being not herself for 1 1/2 days (making moaning sounds, listless, "out of it"), crying, excessive.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Shot was given in left arm.  Arm became extremely painful to move.  In order to raise arm, had to pick it up with right arm.  Pain extended into neck.  Had chills and later fever.  By the next morning, all symptoms were gone except for some soreness in left shoulder which took several days to completely leave.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Left shoulder 7"x5" swollen.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: 2 weeks after receiving Varivax, has broken out in mild case of Varicella.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed a red, round, slightly raised bump/spot on right arm where varicella vaccine was administered.  It lasted for about 4-5 days.  Bump/spot was approximately 30mm x 30mm.
Age: 19.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Dysphagia, Injection site pruritus, Nasal congestion, Pharyngolaryngeal pain, Pruritus
Clinical narrative: 19y airman in good health when she received anthrax and typhoid vaccines left upper arm on 7 Dec 2007 at the immunizations clinic in preparation for deployment.  Approximately 24-36 hours after the vaccinations she developed itching on her neck and lower face that soon after showed small red bumps.  Over the next few days the rash and pruritis spread to include her torso and arms.  The rash would come and go, most individual lesions were present for about 30 minutes before resolving.  If she scratched the individual area the rash would persist longer periods of time.  The small red bumps would appear in groups.  The rash was present intermittently for approximately 2 weeks.  She did not have a rash or swelling at site of vaccine, however did have some itching at sites of vaccination.  A few days after the vaccinations she developed a mild sore throat which progressed until she went to the ER on 23 Dec 2007.  The sore throat was accompanied by difficulty swallowing and congestion.  She denies having fever, cough, nasal discharge, shortness of breath, throat tightness that caused difficulty breathing, chest tightness or joint aches.  The rash resolved without symptoms or difficulty.  Patient describes a rash consistent with urticaria within a few days of receiving both the typhoid and anthrax vaccines.  This rash could represent and IgE mediated reaction to the vaccines, but other potential causes, although less likely given the time course, could be viral infections, foods, and medications.  Assuming the vaccinations caused the urticaria, at this time unable to determine which vaccine is the likely culprit.
Age: 19.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Rash, Skin test negative, Urticaria
Clinical narrative: 19y airman in good health when she received anthrax and typhoid vaccines left upper arm on 7 Dec 2007 at the immunizations clinic in preparation for deployment.  Approximately 24-36 hours after the vaccinations she developed itching on her neck and lower face that soon after showed small red bumps.  Over the next few days the rash and pruritis spread to include her torso and arms.  The rash would come and go, most individual lesions were present for about 30 minutes before resolving.  If she scratched the individual area the rash would persist longer periods of time.  The small red bumps would appear in groups.  The rash was present intermittently for approximately 2 weeks.  She did not have a rash or swelling at site of vaccine, however did have some itching at sites of vaccination.  A few days after the vaccinations she developed a mild sore throat which progressed until she went to the ER on 23 Dec 2007.  The sore throat was accompanied by difficulty swallowing and congestion.  She denies having fever, cough, nasal discharge, shortness of breath, throat tightness that caused difficulty breathing, chest tightness or joint aches.  The rash resolved without symptoms or difficulty.  Patient describes a rash consistent with urticaria within a few days of receiving both the typhoid and anthrax vaccines.  This rash could represent and IgE mediated reaction to the vaccines, but other potential causes, although less likely given the time course, could be viral infections, foods, and medications.  Assuming the vaccinations caused the urticaria, at this time unable to determine which vaccine is the likely culprit.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Abnormal dreams, Anger
Clinical narrative: Patient stated he had a total of Anthrax vaccine x6, with the last one being in March 2000.  He was preparing to deploy next month and was told he needed another anthrax shot.  He stated he did not want to receive it because he was worried that it would cause his anger to return.  He spoke to his pcm who then contacted the healthcare center.  Patient received Anthrax vaccine #1 on 16 Sep 98 and he denied any problems with that vaccine.  He received #2 on 30 Sep 98 and again denied any pain, redness, swelling and discomfort.  He only noticed that at the beginning of Oct he was experiencing bad dreams in which he was fighting with others.  Prior to Anthrax #3 on 14 Oct 98 he stated he got into a fight in which he grabbed a guy by the throat and threw him against the wall and that he wanted to hurt him.  He did not mention the dreams or the fight when he received the 3rd shot.  These bad dreams continued to occur and he stated he was attacking people and having homicidal thoughts.  He got into his second fight towards the end of Oct and it felt like he was 'outside' his body looking back at himself attacking another person but he stated he remembers that he wanted to hurt this person very badly.  He stated he reported this to sick call (unsure when) and he was told it was not a symptom from the anthrax shot.  He did not attack anyone else until spring of 99, however he does not recall it if was before or after Anthrax #4 on 9 March 99.  He stated he had one other episode of attacking someone before he left in Jul 99 but he does not recall the date.  He received Anthrax #5 on 16 Sep 99 and later that fall he attacked 2 people.  He has had no major episodes of attacking people since that episode but he did continue to experience anger problems, in which he felt it was difficult to control his anger and he would have frequent outbursts.  He did not recall any changes in his ability to control his anger and outbreaks around the time of his Anthrax #6 on 9 Mar 00.  He stated he would have problems with anger management until he sought help early in 2001.  He stated he went to classes and saw psychiatry for a couple of months and since that time he has been able to control his anger and feelings of heightened aggression.  He currently denies homicidal or suicidal thoughts and is wanting to deploy next month with his unit.  His only concern is that if he resumes Anthrax his violent outbreaks will return.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Hypersensitivity, Oedema peripheral, Pruritus, Pyrexia, Rash generalised
Clinical narrative: Hand swelling, rash (whole body), fever, itching.  Tx: Benadryl, Solumedrol.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Erythemic area at injection site 6 cm in diameter, swollen, hot, tender, pruritic and with 3 super imposed pox like lesions still present 20 days after vaccinations.  Some resolution since onset.  Advised her to try Benadryl.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Erythemic area at injection site 6 cm in diameter, swollen, hot, tender, pruritic and with 3 super imposed pox like lesions still present 20 days after vaccinations.  Some resolution since onset.  Advised her to try Benadryl.
Sex: U
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: please correct vaccine lot # on previous report
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy, Pyrexia, Ultrasound scan normal
Clinical narrative: Initial and follow up information has been received from a certified medical assistant (CMA) in a physician office concerning a 25 year old caucasian female with no prior pregnancies, an allergy to clarithromycin (BIAXIN), and May-Thurner Syndrome (involving obstruction of the iliac vein and obstruction of the inferior vena cava), who on 23-FEB-2007 was vaccinated with the first dose of GARDASIL (lot number 655618/0186U). The patient's last menstrual period was on approximately 23-MAR-2007 (estimated date of delivery "28-DEC-2007"). On 24-APR-2007, the second dose of GARDASIL (lot number 657617/0384U) was administered. The patient had a positive pregnancy test in the office on 30-APR-2007. Follow up information from the CMA indicated that the patient had no complications during her pregnancy, but on 02-MAR-2007, the patient was prescribed ondansetron (ZOFRAN) for nausea. Due to her history of May-Thurner syndrome, the patient required heparin throughout her pregnancy and "numerous" ultrasounds, all with normal results (dates not provided). During labor and delivery, the patient experienced "maternal fever," though on 10-DEC-2007, a normal female infant, weight 5 lb 15 oz, 19 1/2, " was delivered (initial Apgar score of 2/5, details not provided). There were no congenital abnormalities. The outcome of maternal fever was not specified. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Inappropriate schedule of drug administration, Laboratory test, Ultrasound scan, Urinary tract infection
Clinical narrative: Information has been received as part of Merck's pregnancy registry from a certified medical assistant (CMA) concerning a 27 year old female patient with no medical history who on an unknown date was vaccinated with a second dose of Gardasil.  There was no concomitant medication.  Subsequently, after the second dose, she became pregnant (dates of vaccinations were not reported).  The patient's last menstrual period (LMP) was on 06-MAR-2007 and her estimated date of delivery (EDD) 11-Dec-2007.  The CMA noted that no problems were reported.  On 13-DEC-2007, the patient gave birth to a liveborn male infant, weighing seven pounds ten ounces.  The infant was reported as normal and the patient was forty weeks and two days from her last menstrual period.  There were no congenital anomalies or other complications or abnormalities.  There were no complications during the pregnancy or during labor and delivery.  Laboratory diagnostic studies included a level II ultrasound and pre-natal lab work standard for any pregnancy.  Concomitant medication during the pregnancy included prenatal vitamins taken everyday and MACROBID taken for seven days for a urinary tract infection.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure increased, Drug exposure during pregnancy, Polyhydramnios, Rash, Ultrasound scan normal
Clinical narrative: Initial and follow-up information has been received from a registered nurse for the pregnancy registry for Gardasil concerning a 25 year old black female with no medical history and no previous pregnancies who on unspecified dates was vaccinated with the first and second doses of Gardasil. On 01-JUN-2007, the patient was vaccinated with a third dose of Gardasil (lot # 653650/0702F, exp. 17-OCT-2008). Concomitant therapy included prenatal vitamins (DUET DH AEC). The nurse reported that the patient received the third dose during her first trimester of pregnancy. The patient's last menstrual period (LMP) was on 07-MAY-2007. On 25-JUN-2007, the patient had an ultrasound performed which was normal. On 23-JUL-2007, the patient had another ultrasound which was normal. During the pregnancy the patient had ultrasounds that were normal at 6 weeks, 10 weeks, 19 weeks, 33 weeks, and 36 weeks. Estimated date of delivery was reported as 13-FEB-2008. On unspecified dates during the pregnancy, the mother experienced oligohydramnios, increased blood pressure, and pruritic urticarial papules and plaque of pregnancy (PUPPS). There were no infections or illness during the pregnancy. On 23-JAN-2008, 37 weeks from LMP, the mother delivered a live normal female baby, weight 6 pounds and 6 ounces, length 19 inches, Apgar score 8/9, and head circumference 13 inches. There was no congenital anomalies. There were no complications during labor/delivery. The outcome of the increased blood pressure, and pruritic urticarial papules and plaque of pregnancy (PUPPS) was not reported. No additional information is expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Initial and follow-up information has been received from a registered nurse for the pregnancy registry for Gardasil concerning a 25 year old black female with no medical history and no previous pregnancies who on unspecified dates was vaccinated with the first and second doses of Gardasil. On 01-JUN-2007, the patient was vaccinated with a third dose of Gardasil (lot # 653650/0702F, exp. 17-OCT-2008). Concomitant therapy included prenatal vitamins (DUET DH AEC). The nurse reported that the patient received the third dose during her first trimester of pregnancy. The patient's last menstrual period (LMP) was on 07-MAY-2007. On 25-JUN-2007, the patient had an ultrasound performed which was normal. On 23-JUL-2007, the patient had another ultrasound which was normal. During the pregnancy the patient had ultrasounds that were normal at 6 weeks, 10 weeks, 19 weeks, 33 weeks, and 36 weeks. Estimated date of delivery was reported as 13-FEB-2008. On unspecified dates during the pregnancy, the mother experienced oligohydramnios, increased blood pressure, and pruritic urticarial papules and plaque of pregnancy (PUPPS). There were no infections or illness during the pregnancy. On 23-JAN-2008, 37 weeks from LMP, the mother delivered a live normal female baby, weight 6 pounds and 6 ounces, length 19 inches, Apgar score 8/9, and head circumference 13 inches. There was no congenital anomalies. There were no complications during labor/delivery. The outcome of the increased blood pressure, and pruritic urticarial papules and plaque of pregnancy (PUPPS) was not reported. No additional information is expected.
Age: 53.0
Sex: M
Vaccine: HPV4
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a male who on 08-OCT-2007 was vaccinated intramuscularly in the left deltoid with a 0.5 ml dose of Gardasil (Lot #604595/1062V).  The family was receiving flu shots and the daughter was receiving Gardasil.  The wrong syringe was picked up and administered to the patient's father by the licensed practical nurse.  No adverse experience was related to the event.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: HPV4, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 75 year old female who on 15-NOV-2007 was vaccinated IM with a dose of Gardasil instead of (diluent to reconstituted) Zostavax (Oka/Merck).  No additional information was available at the time.  There was no product quality complaint.  Information has been received from a medical assistant stating that she had no immediate knowledge of the event as she was not working that particular day.  She stated that she would check with the other nurses in the office and respond in a week, if possible.  She was faxed a B-form to submit patient details.  Follow up information was received and the physician stated "no further information to provide."
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Vaginitis bacterial
Clinical narrative: Initial and follow up information has been received via Merck pregnancy registry, from a registered nurse, concerning a 24 year old caucasian female patient with a history of an abnormal papanicolaou (PAP) smear and one prior pregnancy resulting in a full term delivery, who on 25-SEP-2007 was vaccinated IM with the first dose, 0.5 ml of GARDASIL (lot # 655503/0012U). There was no concomitant medication. On 04-OCT-2007, the patient had her LMP and subsequently became pregnant. On 26-NOV-2007, she was vaccinated IM with the second dose, 0.5 ml of GARDASIL (lot # 655618/0186U). On 28-NOV-2007, a urine pregnancy test was positive. On 05-DEC-2007, she called the physician's office. The estimated date of delivery was 10-JUL-2008. Follow up information from the nurse indicated the patient was prescribed prenatal vitamins on 29-NOV-2007, and added that the patient occasionally took acetaminophen (TYLENOL) (indication not specified) during her pregnancy. Also, on 04-DEC-2007, the patient was prescribed metronidazole (FLAGYL), 500mg twice daily for 7 days, for treatment of bacterial vaginosis. The outcome of the event was not specified. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure, Device malfunction, HIV test negative, Hepatitis B test negative, Hepatitis C test negative
Clinical narrative: Information has been received from an office manager at a physician's office concerning a 27 year old female medical assistant who on 12-DEC-2007 was administering a dose of prefilled Gardasil (Lot #1287U) and the safety device on the syringe did not fully activate and the needle did not pull back into the cylinder. After the dose was administered, when the medical assistant reached for the syringe to remove the lot number label to put it into the patients records, she accidentally pricked her right index finger. The syringe and packaging did not appear to be damaged. The syringe was sealed in it's package when received. She immediately cleaned her finger. She, and the patient who received the Gardasil vaccine, were both given blood tests at the hospital to screen for HIV and Hepatitis. The results of the blood tests were not available at the time of reporting. The medical assistant reported that her finger was tender. Additional information has been requested. A follow up was received and the first results of the HEP B and HEP C for the patient who received the Gardasil vaccine and the medical assistant were negative. The HIV test results were negative as well. Physician's office wants to retest both in 6 months to be certain of no disease. This is one of several reports with the same source.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Tenderness
Clinical narrative: Information has been received from an office manager at a physician's office concerning a 27 year old female medical assistant who on 12-DEC-2007 was administering a dose of prefilled Gardasil (Lot #1287U) and the safety device on the syringe did not fully activate and the needle did not pull back into the cylinder. After the dose was administered, when the medical assistant reached for the syringe to remove the lot number label to put it into the patients records, she accidentally pricked her right index finger. The syringe and packaging did not appear to be damaged. The syringe was sealed in it's package when received. She immediately cleaned her finger. She, and the patient who received the Gardasil vaccine, were both given blood tests at the hospital to screen for HIV and Hepatitis. The results of the blood tests were not available at the time of reporting. The medical assistant reported that her finger was tender. Additional information has been requested. A follow up was received and the first results of the HEP B and HEP C for the patient who received the Gardasil vaccine and the medical assistant were negative. The HIV test results were negative as well. Physician's office wants to retest both in 6 months to be certain of no disease. This is one of several reports with the same source.
Sex: F
Vaccine: HPV4
Symptoms: Accidental needle stick, Medical device complication
Clinical narrative: Information has been received from a medical assistant concerning another medical assistant who was administering Gardasil (lot#655154/1210U) to a patient, and upon removal of the needle from the patient's arm, the shield did not work properly to cover the needle and the medical assistant was stuck with the needle in her finger.  No adverse reactions were reported.  No other information was provided.  SR# is 1-2021175912.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Pain, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 29 year old female who on 17-NOV-2006 was vaccinated subcutaneously on the right thigh with the first dose of Gardasil.  On 17-NOV-2006 the patient experienced drug administered via inappropriate route.  The reporter felt that drug administered via inappropriate route was not related to therapy with Gardasil.  No problems were reported and no further information was available.  Follow-up information received 23-JAN-2008: Per the reporter, on 17-NOV-2006 the patient experienced a painful welt which lasted a couple of hours.  Subsequently, the patient recovered from the welt.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2008. Information has been received from a health professional concerning a 29 year old female who on 17-NOV-2006 was vaccinated subcutaneously on the right thigh with the first dose of GARDASIL. On 17-NOV-2006 the patient experienced drug administered via inappropriate route. The reporter felt that drug administered via inappropriate route was not related to therapy with GARDASIL. No problems were reported and no further information was available. Follow-up information received 23-JAN-2008: Per the reporter, on 17-NOV-2006 the patient experienced a painful welt which lasted a couple of hours. Subsequently the patient recovered from the welt. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received concerning a 21 year old female who on 04-JUN-2004 was vaccinated with her first dose of Gardasil (lot 657617/0384U) and her second dose of Gardasil (lot 658222/0927U) on 23-AUG-2007 without any ill effects.  Concomitant therapy included ADVAIR and albuterol.  On 28-DEC-2007 the patient was vaccinated with her third dose of Gardasil (lot 659437/1266U) and experienced a full body rash.  She was sent to her primary health care provider.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Information has been received from a physician concerning an approximately 13 year old female who on 07-NOV-2007 was vaccinated with her first dose of Gardasil (Lot # 659435/1265U. Concomitant therapy included MENACTRA. On 07-NOV-2007 the patient experienced a headache, sore arm and nausea. "About 2 weeks after the shot", the patient recovered from the headache, sore arm and nausea. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Pain in extremity, Syncope
Clinical narrative: Information has been received from a physician concerning a female who on 07-NOV-2007 was vaccinated with the first dose of GARDASIL (659435/1265U). Concomitant therapy included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (-) tetanus toxoid. On 07-NOV-2007 the patient fainted and experienced headache, nausea and a sore arm. Subsequently, the patient recovered from the fainting, headache, nausea and sore arm. The patient sought unspecified medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Loss of consciousness, Wrong technique in drug usage process
Clinical narrative: Initial and follow up information has been received from a certified medical assistant concerning a 19 year old female student with no pertinent medical history, drug reactions/allergies or concomitant medication usage, who on 03-JAN-2008 at 9:05 am was vaccinated intramuscularly in the right hip with the first 0.5ml dose of Gardasil (lot#: 655154/1210U).  On 03-JAN-2008 5 minutes post vaccination, the patient passed out as she stood at the receptionist's desk in the hallway.  No seizure activity noted.  Staff used smelling salt to revive patient.  She was given orange juice and crackers.  She was left on floor and propped up against a wall.  The patient's blood pressure was checked at 9:20 am and was 94/60.  No diagnostic lab test was performed.  The patient stated that she had not eaten breakfast prior to receiving the vaccination.  The patient was instructed to eat prior to receiving the next injection.  The patient was driven home from the office by her mother at 09:25 AM.  It was reported that she recovered on 03-JAN-2008.  Additional information is not expected.
Age: 0.34
Sex: M
Vaccine: HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: Information has been received from a registered nurse concerning a 4 month old male who on 21-DEC-2007 was vaccinated with the second dose Rotateq.  On 27-DEC-2007, because of a clerical error the patient received another dose of Rotateq.  No problems were noted.  Additional information has been requested. 06/02/2008 Information has been received from a registered nurse concerning a 17 week old male, with no medical history and no allergies, who on 21-DEC-2007 was vaccinated with a second PO dose ROTATEQ (Lot# 657359/0507U). Concomitant vaccine administered on 21-DEC-2007 included a second intramuscular dose of PEDIARIX (Lot# AC21B125BB). On 27-DEC-2007, because of a clerical error the patient received another PO dose of ROTATEQ (Lot# 657359/0507U). Concomitant vaccinations administered on 27-DEC-2007 included a second intramuscular dose of PEDVAXHIB (MSD) (Lot# 652502/0719R) and a second intramuscular dose of PREVNAR (Lot# 8539868). There was no illness at the time of vaccination and no adverse events following prior vaccination. No problems were noted. There were no laboratory or diagnostic tests performed. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse (RN) concerning a patient who on 03-JAN-2008 was vaccinated with the first dose of Rotateq 25 days later than 12 weeks of age. It was unknown if medical attention was sought. NO adverse symptoms were noted. Additional information has been requested. 02/11/2010 Information has been received from a registered nurse concerning a 16-week-old patient with no known drug alliergies who on 03-JAN-2008 was vaccinatied PO with the first does of GARDASIL (Lot #656379/0505U). Concomitant therapy administered on that same day included the first IM dose in the right leg of (OMPC) (Lot #657174/0497U),  the first IM dose in the left leg of PEDIARIX (Lot #AC21B130AA) and the first dose in the right leg of PREVENAR (Lot #6540150). Medical attention was not sought. No adverse symptoms/events were reported.  No further information is available.
Age: 1.0
Sex: F
Vaccine: PNC, RV5, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a healthcare worker concerning a 12 month old female who on 04-JAN-2008 was vaccinated with her first dose of Rotateq.  Concomitant vaccinations administered on that same day included a dose of Varivax (MSD) and a dose of PREVNAR.  Medical attention was sought in the physician's office.  There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DPP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Initial and follow-up information has been received from a physician and office manager concerning a 2 month old male with no pertinent medical history or drug allergies who on 06-DEC-2007 was vaccinated PO with his first dose of ROTATEQ (no lot number given). Concomitant vaccinations administered "within the same visit" included a dose of Hib conj vaccine (OMPC) (manufacturer unknown), a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of poliovirus vaccine activated (unspecified) and a dose of PREVNAR. On 12-DEC-2007 the patient had "vomited five times" and was "admitted to the ER." The patient was not admitted to the hospital. No labs or diagnostic studies were performed. Subsequently, the patient recovered. There was no product quality complaint. Follow-up information from the reporting physician indicated that on 06-DEC-2007 the 9 week old male was vaccinated with a dose of Hib conj vaccine (tet toxoid) (ACTHIB) (no lot# available). Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 2 month old female with no pertinent medical history, who on 07-JAN-2008 was vaccinated with Rotateq (lot#657521/0768U). Concomitant vaccination included poliovirus vaccine, RECOMBIVAX HB, PREVANR, PEDVAXHIB and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. It was reported that the patient developed vomiting following administration of the vaccine (date unspecified). Unspecified medical attention was sought. No laboratory diagnostic studies were performed. A product quality complaint was not reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female with no known allergies and no pertinent medical history who on 23-AUG-2007 was vaccinated intramuscularly in the left deltoid with a second dose of Gardasil.  There was no concomitant medication.  The patient stated that when she got back to her office after the second injection she became "very, very dizzy" and had to sit down and wait till it passed.  Patient had something to eat and the feeling passed.  The patient recovered on 23-AUG-2007.  Additional information has been requested. Follow-up received 04/16/2008. No further information is expected.
Age: 0.9
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning a 9 month old patient who was vaccinated with a third dose of ROTATEQ. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Haematology test, No adverse reaction, Pregnancy
Clinical narrative: Information has been received from a health professional concerning a 21 year old female patient with no medical history and no allergies who on 08-NOV-2006 and 10-JAN-2007, was vaccinated with a first(Lot# 653978/0955F) and second dose of GARDASIL (Lot# 655619/1427F). There was no concomitant medication. It was reported that the patient received the vaccine while she was pregnant. No adverse side effects were reported as a result of this. Unspecified medical attention was sought. Laboratory diagnostic studies performed was prenatal blood work. On 20-NOV-2007, the patient gave birth to a normal live born infant female. The infant weighed 7 pounds and 10 ounces. There were no congenital anomalies and no complications or abnormalities. It is unknown if the products of conception were examined. There were no complications during pregnancy or labor and delivery. It was also reported that in 2006 to the present, the patient was placed on (VALTREX), 500 mg as needed for genital herpes and on 06-SEP-2007, the patient was placed on (RHOGRAM), "full strength" for RH negative. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Sex: M
Vaccine: RV5, UNK
Symptoms: Crying, Irritability
Clinical narrative: Information has been received from a health professional concerning a 6 to 12 week old make with gastrooesophageal reflux disease who as vaccinated with a first 2 ml oral dose of Rotateq.  Concomitant therapy included "other recommended vaccines at two months of age".  Subsequently the patient experienced fussiness and crying for about 24 hours after receiving Rotateq.  Subsequently, the patient recovered.  Medical attention was not sought.  No product quality complaint was involved.  This is one of two reports from the same source.  Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 6 month-old patient with gastrooesophageal reflux who on 08-JAN-2008 received their first 2.0 ml oral dose of Rotateq. The nurse is planning on giving the patient a second dose in the next 4 to 8 weeks. No adverse experience (AE) reported. A product quality complaint was not involved. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Gastrooesophageal reflux disease
Clinical narrative: Information has been received from a pharmacist concerning an approximate 10-week-old female who in November 2007 received his first oral dose of Rotateq.  In DEC-2007, "about one month later", the patient developed acid reflux.  The patient sough unspecified medical attention.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient who was vaccinated with a first and second dose of Gardasil.  Concomitant therapy included another vaccination (unspecified) at the time when she received the first injection.  The nurse reported that the patient fainted after receiving the second dose of Gardasil.  She indicated that the patient lost consciousness for about twenty seconds within an hour of receiving her second injection.  She reported that the patient woke up then and was fine before leaving the physician's office.  She mentioned that the patient fainted after receiving the first dose of Gardasil.  Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: Information has been received from a registered nurse concerning a 23-week-old patient who on 04-DEC-2007 received a first dose of Rotateq. No adverse symptoms. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Regurgitation, Underdose
Clinical narrative: Information has been received from a licensed practical nurse concerning a pre-term infant who on an unspecified date received their first dose of ROTATEQ but the child regurgitated most of it. The patient sought medical attention via an office visit. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Secondary transmission
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a breast feeding female who on an unspecified date, developed diarrhea after her child was vaccinated with the first dose of Rotateq.  The mother did not inform anyone of her diarrhea but mentioned it to the nurse when she brought the child in for the second dose of Rotateq.  The mother recovered from the diarrhea.  No adverse experience occurred with the child.  No product quality complaint was involved.  Additional information has been requested.