chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: HEPA, MMR, TYP
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Starting 1st oral Typhoid in January approx 1-30-14 and completed the series, but returned to the clinic on 2-29-14 and stated he took all the pills with meals. A second series of pills was ordered and started on 1-25-14. Second pill taken 1-22-14. Came to our clinic on 1-28-14 with c/o rash. The rash started on hands, but is most noticeable on (R) underarm, abdomen and (R) leg. Rash is fine, red spots, no bumps and mildly itchy. No medications used. No recent infectious disease symptoms. Generally feeling well. No changes in detergents or personal care products. No other new meds. Denies lip and tongue swelling, difficulty swallowing or breathing. Pt seen by NP for rash and ZYRTEC ordered daily until rash is resolved.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 14 year old patient of unknown gender. On 05-MAR-2014 the 14 year old patient was vaccinated with a dose of PROQUAD (lot# unspecified) injection (dose, route, location and frequency unspecified). No adverse symptoms reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a 26 year old female patient for GARDASIL, a Pregnancy Registry product, concerning herself with no drug reaction/allergy and a medical history of O negative who on 26-OCT-2011 was vaccinated with a 0.5 ml dose of GARDASIL. Concomitant therapy included iron (unspecified) (+) minerals (unspecified) (+) vitamins (unspecified) (reported as prenatal Vitamins). Subsequently the patient was found pregnant. There was a laboratory studies performed on 23-NOV-2011 and the result was unknown. The patient sought unspecified medical attention and was given no treatment for AE. At the time of the report, the patient was 6 weeks and 3 days pregnant. The LMP was 17-OCT-2011 (also reported as 15-OCT-2011), estimated delivery date is 24-JUL-2012. The therapy of GARDASIL was discontinued. Follow up was received that this case had mail that was returned as non-deliverable and a memo that noted the physician was not with the practice and the patient was not registered with the practice. Pregnancy outcome was lost to follow up. The case was lost of follow up. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix, Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: Information has been received from an advanced practice registered nurse for GARDAIL, a Pregnancy Registry product, concerning a 23 year old female patient with a history of loop electrosurgical excision procedures, Papanicolaou smear abnormal and cervical intraepithelial neoplasia II (CIN2) and no drug reactions/allergies who on 22-DEC-2011, was vaccinated intramuscularly with a first dose of GARDASIL (Lot number: 006642 is an invalid lot number for GARDASIL, expiration date: 30-SEP-2012, dose and route not reported). There was no concomitant medication. It was reported that on 22-DEC-2011, the patient went to the office for annual exam and cervical smear (Pap smear) visit and during the visit was given GARDASIL. Automatically, the patient was given a pregnancy test and learned after she was given the shot that she was actually pregnant. Cervical biopsy was performed. The patient's last menstrual period (LMP) was on 23-NOV-2011, according this, Estimated Delivery Date (EDD) would be on 29-AUG-2012. Follow up information was received from the same advanced practice registered nurse that EDD was 01-SEP-2012. Pregnancy outcome: normal infant, no congenital anomaly. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, No adverse event
Clinical narrative: Information has been received from a 26 year old female patient consumer reporting on herself for GARDASIL, a Pregnancy Registry product, who on 23-SEP-2011, was vaccinated with a first dose of GARDASIL (lot number, dose and route not reported. The consumer reported that she became pregnant one month after the initial dose of vaccine in the administration series. No adverse effect was reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female patient with no pertinent medical history and no drug reactions/allergies. The Last Menstrual Period was 19-NOV-2011. On 07-DEC-2011, the patient was vaccinated with her third dose of GARDASIL, injection 120 Y, (dose, route, lot number and expiration date not reported) while pregnant. Concomitant therapy included prenatal vitamins. The patient called the office to report the pregnancy. The office estimates her date of conception about 03-DEC-2011. No adverse effects were reported. The Estimated Date of Delivery would be 25-AUG-2012. There was no laboratory tests performed. The pregnancy outcome was outcome pending. Follow up information has been received from the physician via the Certified Nurse Midwife (CNM) for GARDASIL, a Pregnancy Registry product, concerning the patient who was vaccinated with her third dose of GARDASIL. Concomitant therapy included ONE-A-DAY WOMEN'S PRENATAL. The nurse reported that the pregnancy was confirmed on 16-JAN-2012 by ultrasound, with gestation of 8 weeks and 2 days. Follow-up information has been received for GARDASIL, a Pregnancy Registry product, concerning the patient. All telephone attempts to obtain follow-up information had been unsuccessful. The pregnancy outcome was changed to lost to f/u. The Estimated Date of Delivery was also reported as 28-AUG-2012. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown demographics. No relevant medical history was reported. On 04-MAR-2014, the patient was in office to receive a third dose of GARDASIL (dose and route of administration were not provided). No concomitant medications were reported. On 04-MAR-2014, the patient was a month late for the third dose of GARDASIL. The exact dates of first and second doses of GARDASIL were unspecified. No adverse event was reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Abnormal behaviour, Confusional state, Lymphadenopathy, Pyrexia
Clinical narrative: High fever (102 F) starting 3/6/14 evening into 3/7/14. Still febrile today (3/10/14). Behavioral changes beginning 3/6/14; confusion 3/7/14. Cervical adenopathy.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Immediate post-injection reaction, Injection site bruising, Injection site erythema, Injection site inflammation
Clinical narrative: Red hives, redness and inflammation at injection site, large bruise right by injection site that she said appeared immediately. Was not feeling well next day. Headache 2 days later.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Malaise
Clinical narrative: Red hives, redness and inflammation at injection site, large bruise right by injection site that she said appeared immediately. Was not feeling well next day. Headache 2 days later.
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from an office manager via a company representative, refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/ allergies were provided. On unknown dates, the patients were vaccinated with PROQUAD INJ (lot numbers, dose and route not reported). No c0-suspect or concomitant therapies were reported. The office manager reported that the physician's office had stopped administering PROQUAD several years ago due to a higher incidence of the patients reporting and experiencing fever. NO patient details were provided. At the time of the report, the outcomes were not provided. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Bursitis, C-reactive protein normal, Injected limb mobility decreased, Injection site pain, Laboratory test normal
Clinical narrative: (L) shoulder pain w/in 3 hours after injection. By that night (approximately 6 hours) she started to get pain in the (L) side of the neck. The next day (L) arm pain too severe to move the arm. Trial of NSAIDs and muscle relaxer for dx tendonitis vs bursitis of shoulder.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pain in extremity, Tendonitis
Clinical narrative: (L) shoulder pain w/in 3 hours after injection. By that night (approximately 6 hours) she started to get pain in the (L) side of the neck. The next day (L) arm pain too severe to move the arm. Trial of NSAIDs and muscle relaxer for dx tendonitis vs bursitis of shoulder.
Age: 18.0
Sex: F
Vaccine: YF
Symptoms: Arthralgia, Chest discomfort, Dyspnoea, Nausea, Pain
Clinical narrative: Late evening on 3-7-14 pt experienced racing heart, chest tightness/SOB, hives, vomiting and low grade fever and generalized body/joint aches. Pt seen in ER at hospital on 3/8/14 - given injections of BENADRYL and anti nausea med. Immediate relief of N/V. Sx completely resolved by 3/9/14.
Age: 18.0
Sex: F
Vaccine: YF
Symptoms: Palpitations, Pyrexia, Urticaria, Vomiting
Clinical narrative: Late evening on 3-7-14 pt experienced racing heart, chest tightness/SOB, hives, vomiting and low grade fever and generalized body/joint aches. Pt seen in ER at hospital on 3/8/14 - given injections of BENADRYL and anti nausea med. Immediate relief of N/V. Sx completely resolved by 3/9/14.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Borrelia test, Full blood count, VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 83 year old female patient. The patient's medical history included hypertension, GERD (Gastroesophageal reflux disease), glaucoma and hypothyroidism. Patient had no known allergies. In November 2013 the patient was vaccinated with ZOSTAVAX (at another unspecified site) (lot number not reported). Concomitant therapies included citalopram, aspirin, folic acid, DIOVAN, EVISTA, fish oil, levothyroxine sodium, vitamins (unspecified) (multivitamin OTC), PRILOSEC and vitamin D (unspecified). On 01-MAR-2014, the patient experienced Bell's Palsy (medically significant). No product quality complaints were involved. Treatment included prednisone and VALTREX. Lyme disease titer and CBC (complete blood count) were performed on an unknown date. The outcome of Bell's Palsy was reported as not recovered. Patient sought medical attention on 03-MAR-2014 by contacting office. The causality of the event was not reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pruritus, Skin warm
Clinical narrative: Injection site is swollen, red, fluid dropped to elbow site. Doctor recommended hydrocortisone cream but it made her itchy. SARNA recommended by RPh. Very warm to touch for a couple of days.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Gastrooesophageal reflux disease, Headache, Local swelling, Nausea
Clinical narrative: Arm sore, swollen, Temp 2-28-14 101.8. HA, nausea Bad GERD. Pt treated with Prednisone and NORCO as needed.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Arm sore, swollen, Temp 2-28-14 101.8. HA, nausea Bad GERD. Pt treated with Prednisone and NORCO as needed.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pain in extremity
Clinical narrative: Patient has hardness at site of injection, is red and hot to touch. She said entire arm up to shoulder is sore.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Decreased appetite, Injection site mass, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: High fevers (T max 104). Fussy, irritable, not feeding well. Swelling, warmth, bump at injection site.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: High fevers (T max 104). Fussy, irritable, not feeding well. Swelling, warmth, bump at injection site.
Age: 0.39
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash generalised, Urticaria, Viral infection
Clinical narrative: Vaccines administered 9:41 am on 3-01-14. Developed hives on face 3-02-14 at 10 am, by evening rash was all over her body. To ER - given oral dose of prelone in ER. ER doctors suspected a virus. No symptoms of illness. Sibling ill with vomiting on 3-03-14 no fever. Rash comes and goes - diffuse. Rash on face 3-03-14 with few patches on body.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unkonwn age and gender. On 05-MAR-2014 the patient was vaccinated with an expired PNEUMOVAX 23 (Lot# was reported as H018944, expiration date 01-MAR-2014), 0.5 ml, intramuscular (indication unspecified), which was expired on 01-MAR-2014. No symptoms reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reaction, patient was administered FLUCELVAX and he is under 18 years old.
Age: 75.0
Sex: F
Vaccine: PNC
Symptoms: Erythema, Pain in extremity, Rash, Skin warm
Clinical narrative: Rash to arm. Received injection 2/20/14. Arm rashed, red, sore, warm. No fever.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Hives on body, (both sides of body) arms, legs, face, trunk of body; Pt went to physician, dr said it was allergic reaction, prescribed cetirizine and "topical cream".
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Headache
Clinical narrative: After 1 hour of flu shot, pt experienced headache, little chest pain.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Pyrexia, Throat irritation
Clinical narrative: Vaccine - given 2-11-14. Symptoms started evening 2-11-14. Feverish, achy joints, raspy throat.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Speech disorder
Clinical narrative: Father reports child's inability to pronounce "A", "E", "O" sounds without hesitation. Father states he did not have any speech issues prior to the immunization.
Age: 10.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reaction, patient was given FLUCELVAX and she is under 18 years old.
Age: 8.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reaction patient was given FLUCELVAX and he is under 18 years old.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant concerning a female patient of unknown age. On 04-MAR-2013, the patient was vaccinated with her first dose of GARDASIL, 0.5 ml, intramuscular. On 03-SEP-2013, the patient received her second dose of GARDASIL, 0.5 ml, intramuscular, and on 03-OCT-2013 the patient received her third dose of GARDASIL, 0.5 ml, intramuscular. No adverse effect was reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reaction, patient was given FLUCELVAX and he is under 18 years old.
Age: 49.0
Sex: M
Vaccine: HEPA, TD, TYP
Symptoms: Rash
Clinical narrative: 3 vaccines administered 2/14/14 - Rash occurred on trunk and neck - progressing to both arms and Rash - resolved without medical intervention by 2/19/14. Rash described by pt as Flat, no itching or burning sensation. Called back after trip on 3/3/14 - reports he has completely recovered without medical intervention.
Age: 7.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reaction, patient was given FLUCELVAX and she is under 18 years old.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Rash macular, Rash pruritic, Skin plaque
Clinical narrative: Smallpox vaccine was administered on 29Dec2013 and by report, pt developed multiple pruritic erythematous macule vs plaques (? hives) that resolved with topical steroids. I evaluated this pt for the first time on 3Feb2014 where he was asymptomatic except for multiple hyperpigmented macules presumably at site of prior ? hives.
Age: 16.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reaction, patient was given FLUCELVAX and she is under 18 years old.
Age: 0.85
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Injection site nodule
Clinical narrative: Prolonged crying (12 hrs); knot at the site of injection.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse who reported that 9 patients received VAQTA (lot number not reported) exposed to minus 1 degree C for 3.5 days (84 hours), an excursion that was unsupported by in-house stability data. No adverse symptoms reported. Nurse stated these patients received the product in question between 03-MAR-2014 and 04-MAR-2014. This is one of two reports from the same reporter source (linked MARRS# 1403USA003463). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse who reported that 3 patients received GARDASIL exposed to minus 1 degree C for 3.5 days (84 hours), an excursion that was unsupported by in-house stability data. No adverse symptoms reported. Nurse stated these patients received the product in question between 03-MAR-2014 and 04-MAR-2014. This is one of two report from the same reporter source (linked case MARRS# 1403USA004558). Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Urticaria
Clinical narrative: Red raised whelps at site of injection - > 2 inches below on left arm, came up 3 after vaccine is sore, no itching, not bitten anything and don't need anything as of now (no need to go to MD).
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, No adverse event
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female with no pertinent medical history, drug reactions or allergies who on 02-SEP-2011 was vaccinated intramuscularly with the first dose of GARDASIL (Lot#: 669313/0692AA, Exp.: 13-AUG-2013) 0.5mL and on 04-NOV-2011 was administered the second dose of GARDASIL (Lot# not reported). There was no concomitant medication. After receiving the first dose of GARDASIL, the patient completed a urine pregnancy test on unspecified date and found out she was 8 weeks pregnant. The patient's last menstrual period was 08-SEP-2011 (also reported 24-SEP-2011 by a nurse who was mother-in-law of the patient), and estimated delivery date was 14-Jun-2012. When received the second dose of GARDASIL, the patient informed the nurse who administered the vaccine that she was pregnant. The patient had not seen a physician yet. No adverse symptoms were reported. Follow up information has been received from a registered nurse who stated that she remember the patient, and stated "everything was fine, no complications, and the baby was without any congenital anomalies." The R.N. also stated she did not know if the patient completed the GARDASIL series and did not know where she received the first dose. No further information is available at this time. Additional information is not expected.
Age: 0.56
Sex: M
Vaccine: PNC13, RV1
Symptoms: Incorrect route of drug administration
Clinical narrative: Rotarix vaccine administered by injection instead of orally.
Age: 1.5
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Abnormal behaviour, Anxiety, Blood test normal, Crying, Drooling
Clinical narrative: Son starting acting strange, uncontrollable babbling, yelling, crying.  Could not relax, wouldn't stop moving his hands and legs.  Glazed over look in his eyes, eyes were dilated.  Wouldn't sleep or calm down for almost 24 hours.  Excessive drooling, strange breathing, trouble walking, weakening in legs.
Age: 1.5
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Gait disturbance, Glassy eyes, Insomnia, Lumbar puncture normal, Movement disorder
Clinical narrative: Son starting acting strange, uncontrollable babbling, yelling, crying.  Could not relax, wouldn't stop moving his hands and legs.  Glazed over look in his eyes, eyes were dilated.  Wouldn't sleep or calm down for almost 24 hours.  Excessive drooling, strange breathing, trouble walking, weakening in legs.
Age: 1.5
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Muscular weakness, Mydriasis, Respiration abnormal, Restlessness, Screaming
Clinical narrative: Son starting acting strange, uncontrollable babbling, yelling, crying.  Could not relax, wouldn't stop moving his hands and legs.  Glazed over look in his eyes, eyes were dilated.  Wouldn't sleep or calm down for almost 24 hours.  Excessive drooling, strange breathing, trouble walking, weakening in legs.
Age: 1.5
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Speech disorder, Staring, Ultrasound scan normal, Urine analysis normal
Clinical narrative: Son starting acting strange, uncontrollable babbling, yelling, crying.  Could not relax, wouldn't stop moving his hands and legs.  Glazed over look in his eyes, eyes were dilated.  Wouldn't sleep or calm down for almost 24 hours.  Excessive drooling, strange breathing, trouble walking, weakening in legs.
Age: 1.5
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Agitation, Irritability
Clinical narrative: Son starting acting strange, uncontrollable babbling, yelling, crying.  Could not relax, wouldn't stop moving his hands and legs.  Glazed over look in his eyes, eyes were dilated.  Wouldn't sleep or calm down for almost 24 hours.  Excessive drooling, strange breathing, trouble walking, weakening in legs.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Cardiac disorder, Cerebrovascular accident, Death
Clinical narrative: I have to confirm the dates with her Nursing school, but approximately two weeks after receiving the shot my sister experienced stroke like symptoms, she went to the doctors and had to take off from school.  Her heart was not checked, but had never been diagnosed with heart problems about a year later she died in her sleep from a heart problem that was misdiagnosed.
Age: 1.01
Sex: F
Vaccine: MMR
Symptoms: Erythema, Miliaria
Clinical narrative: Started with a rash that resembled a heat rash on the neck, stomach, and back. By 11pm that night, it had spread and reddened to her arms, legs, face, back, and stomach. The following morning, it spread to her diaper area.
Age: 1.39
Sex: F
Vaccine: DTAP
Symptoms: Convulsion, Dyskinesia, Gaze palsy, Heart rate increased, Hypopnoea
Clinical narrative: Around 11:30 pm I noticed patient had a rash on her face.  At midnight I noticed she was breathing weird and had a rapid heart beat. While nursing her at 12:30 she started moving weird which turned into spasms and convulsions.  I quickly stopped nursing her but she was lifeless and unresponsive she would open her eyes and then they would roll back in her head I couldn't get her to "wake up" the fever was 104 o called the on call dr who said "it wasnt a symptom from vaccines" she finally started responding a little more but was shaking so bad when reaching for toy she couldn't stop shaking enough to grab it. Episode lasted over 2 hours. Rapid heart rate and shallow breathing lasted hours.
Age: 1.39
Sex: F
Vaccine: DTAP
Symptoms: Muscle spasms, Pyrexia, Rash, Respiration abnormal, Somnolence
Clinical narrative: Around 11:30 pm I noticed patient had a rash on her face.  At midnight I noticed she was breathing weird and had a rapid heart beat. While nursing her at 12:30 she started moving weird which turned into spasms and convulsions.  I quickly stopped nursing her but she was lifeless and unresponsive she would open her eyes and then they would roll back in her head I couldn't get her to "wake up" the fever was 104 o called the on call dr who said "it wasnt a symptom from vaccines" she finally started responding a little more but was shaking so bad when reaching for toy she couldn't stop shaking enough to grab it. Episode lasted over 2 hours. Rapid heart rate and shallow breathing lasted hours.
Age: 1.39
Sex: F
Vaccine: DTAP
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Around 11:30 pm I noticed patient had a rash on her face.  At midnight I noticed she was breathing weird and had a rapid heart beat. While nursing her at 12:30 she started moving weird which turned into spasms and convulsions.  I quickly stopped nursing her but she was lifeless and unresponsive she would open her eyes and then they would roll back in her head I couldn't get her to "wake up" the fever was 104 o called the on call dr who said "it wasnt a symptom from vaccines" she finally started responding a little more but was shaking so bad when reaching for toy she couldn't stop shaking enough to grab it. Episode lasted over 2 hours. Rapid heart rate and shallow breathing lasted hours.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Rash
Clinical narrative: Pt states he started developing rash around trunk, arms, legs but not on face/feet and genital area.  Pt presented to Urgent Care Clinic and is taking Benadryl and Allegra.
Age: 30.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Disorientation, Dizziness, Pharyngeal oedema, Swollen tongue
Clinical narrative: Hives, clammy, dizziness, tongue/throat swelling, facial swelling, disoriented.
Age: 30.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives, clammy, dizziness, tongue/throat swelling, facial swelling, disoriented.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, No adverse event
Clinical narrative: Information has been received from a healthcare professional concerning an 18 year old female patient with no drug reaction or allergies and no pertinent medical history, who on 27-OCT-2011 was vaccinated with the first dose of GARDASIL (lot no. not reported) 0.5 ml, intramuscular. On 14-FEB-2012, the patient was vaccinated with the second dose of GARDASIL (batch No. 1229AA, lot No. 670050/1229AA, Expiration date 12-NOV-2013), 0.5 ml, intramuscular. There was no concomitant medication. It was reported that the patient received the second dose of GARDASIL while pregnant. Her last menstrual period was on 27-JAN-2012 and estimate delivery date was on 02-NOV-2012. Positive urine beta-human chorionic gonadotropin test was performed. No treatment was given. No adverse effect reported. It was reported that the patient sought unspecified medical attention. Follow-up information has been received from physician concerning a 18 year old female patient. The patient was a healthy adolescent. All telephone attempts to obtain follow up had been unsuccessful. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Mass
Clinical narrative: Received chicken pox inj SC on Rt leg on 3-8-14. Developed a red raised lump. Measurement today 1" x 1/2" diameter.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt. is having dull pain at injection site after 5 weeks of receiving vaccination.
Age: 81.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: Pt presented at Clinic on 3/9/14 because she has redness, swelling and warmth of her entire upper arm starting the day after her vaccination; the arm has also been very itchy also. She did research online and came in to request a VAERS form to be completed. Medical director notified. Treatment with oral antibiotics started for cellulitis on 3/9/14. She was instructed to follow up with her PCP.
Sex: U
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 30-APR-2013, the patient was vaccinated with the first dose of GARDASIL. Dose, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. Never was administered a second dose. NO adverse effects reported. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, Pregnancy test negative
Clinical narrative: Information has been received from a nurse, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female patient with asthma, migraines, depression, irregular heartbeat, high blood pressure, penicillin allergy and diphenhydramine allergy and a childhood history of anemia who on 29-SEP-2009 was vaccinated IM with her first dose of GARDASIL (lot # 663452/0671Y, expiration date 18-SEP-2011). On 07-DEC-2009, the patient was vaccinated IM with her second dose of GARDASIL (lot # 661952/1129X, expiration date 12-MAR-2011). On 22-FEB-2012, the patient was vaccinated IM with her third dose of 0.5 ml GARDASIL (lot # 670049/1261AA, expiration date 11-NOV-2013). There was no concomitant medication. A pregnancy test was done on 22-FEB-2012 before the patient received dose 3 and it was negative. On 06-MAR-2012, the patient had a positive urine pregnancy test. Her last menstrual period (LMP) was on 03-FEB-2012, and delivery date (EDD) was on 09-NOV-2012. The patient had sought medical attention by office visit. No treatment was given to the patient. A phone call was placed to the registered nurse who indicated the baby was born at 40 weeks gestational age. No complications during pregnancy. On 11-FEB-2014, the baby was seen at a facility and was diagnosed with flu (MARRS case no 1403USA004648). The R.N. also noted in the baby's chart that the baby was experiencing behavior problems and was scheduled for an autism review once the baby reaches 18 months of age. Significant information. This case is related to MARRS case no 1403USA004648 (parent-child link). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Exposure during pregnancy, Haematology test abnormal, No adverse event, Prenatal screening test
Clinical narrative: Information has been received from a nurse practitioner, for VARIVAX (Merck) and GARDASIL, Pregnancy Registry Products, concerning a 16 year old female patient with no pertinent medical history or drug reactions/allergies who on 28-APR-2000 was vaccinated SQ with a first 0.5 mL dose of VARIVAX (Merck) (lot # not provided), on 22-MAR-2012 with a second 0.5 mL dose of VARIVAX (Merck) (lot # not provided) and on the same date with a first dose of GARDASIL (dose, route and lot # not provided). There was no concomitant medication. The nurse practitioner reported that on 09-APR-2012, the patient was found to be pregnant. There was no concomitant medication. The nurse practitioner reported that on 09-APR-2012, the patient was found to be pregnant. The patient's last menstrual period (LMP) was on 31-DEC-2011 and her estimated delivery date (EDD) was on 06-OCT-2012. Laboratory tests included prenatal blood work. The patient sought medical attention at the physician's office. No adverse effects were reported. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: HPV4
Symptoms: Abnormal behaviour, Foetal exposure during pregnancy, Influenza
Clinical narrative: Information has been received from a nurse, for GARDASIL, a Pregnancy Registry product, concerning an approximately 15 months old child from a 20 year old female patient with asthma, migraines, depression, irregular heartbeat, high blood pressure, penicillin allergy and diphenhydramine allergy and a childhood history of anemia who on 22-FEB-2012 was vaccinated IM with her third dose of GARDASIL (lot # 670049/1261AA, EXP 11-NOV-2013). There was no concomitant medication. A pregnancy test was done on 22-FEB-2012 before the patient received dose 3 and it was negative. On 06-MAR-2012, the patient had a positive urine pregnancy test (MARRS case no. 1203USA01156). Her last menstrual period (LMP) was on 03-FEB-2012, and delivery date (EDD) was on 09-NOV-2012. The patient had sought medical attention by office visit. No treatment was given to the patient. On 11-FEB-2014, the baby was seen and was diagnosed with flu. The R.N. also noted in the baby's chart that the baby was experiencing behavior problems and was scheduled for an autism review once the baby reaches 18 months of age. The outcome of the events was unknown. This case is related to MARRS case no. 1203USA01156 (parent-child link). Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Hypersensitivity, Skin warm
Clinical narrative: Allergic reaction to (L) arm erythema, warmth, and approximately 2 cm by 2 cm.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient with no medical history and no drug allergies who on an unknown date in December 2011, was vaccinated with the first dose of GARDASIL injection (route and lot number not reported). The physician reported that the patient was pregnant. On an unspecified date an ultrasound was performed to confirm the pregnancy. Pregnancy was normal to date. The patient sought medical attention by seeing the physician. On 27-FEB-2014, phone call was received from a registered nurse. The baby weighed 3380 grams (7.4lbs). It was a vaginal birth with no complications. Gestational age was 40 weeks and pregnancy had no complications. Additional information is not expected.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Pain
Clinical narrative: Injection site raised/red and warm to the touch. Pt appears in pain, crying constantly. Pt is handicap and cannot speak. The patient is a 15 year old male who is brought to the office today by his mother and grandmother. He presents for evaluation for recheck. He was seen on 02/28/14 for received vaccines (MENVEO, Tdap and VARIVAX all in RT arm) and now areas where vaccines were given are raised and warm to the touch. Oral intake of liquids: normal. There are no other symptoms noted. The following symptoms are denied: fever, vomiting, and diarrhea.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a nurse via a company representative referred to unspecified patients of unknown age and gender. On an unknown date unspecified patients were vaccinated with ZOSTAVAX (Lot # unspecified) (dose, route and indication unspecified). The reporter stated that the physician's practice, was "seeing more cases in which patients were complaining that ZOSTAVAX elicited headaches" on unspecified dates. Action taken and outcome of the event was unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this reported. Additional information will be provided if available. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Foetal heart rate, Pregnancy test positive, Ultrasound antenatal screen
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry Product, concerning a 17 year old female patient. No medical history was provided. On 12-JAN-2012, the patient was vaccinated with the first dose of GARDASIL (dose and route not provided) (lot # 669795/1317AA, expiration date on 13-OCT-2013). On 12-MAR-2012, the patient received the second dose of GARDASIL (dose and route not provided) (lot # 671006/1291AA, expiration date on 12-APR-2014). Concomitant vaccination administered on 12-JAN-2012 included HAVRIX and FLUVIRIN. Concomitant therapy included albuterol. The nurse reported that the patient was "spotting" monthly since November 2011, and on an unspecified date "about 3 weeks ago" (approximately on 28-MAR-2012), the normal monthly spotting did not occur. Subsequently, the patient was found to be pregnant. Ultrasound and fetal heart sounds were performed on an unknown date (approximately in 2012). The patient's last menstrual period was approximately on 16-NOV-2011, she was "presently 22 weeks pregnant" and her estimated delivery date was on 22-AUG-2012. The patient sought unspecified medical attention. Information was received on 27-FEB-2014. Telephone attempts to obtain follow-up information on 25-FEB-2014 and on 27-FEB-2014 were unsuccessful. Information was received on 04-MAR-2014. The pregnancy outcome was reported as normal infant with no congenital anomaly. No more details provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: FLUN4, HEPA, HPV4, MNQ, TDAP, FLUN4, HEPA, HPV4, MNQ, TDAP
Symptoms: Coagulopathy, Contusion, Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: Patient developed ITP. Bruising over entire body. Patient's blood was unable to clot properly due to low platelet count exactly a week to the day the HPV vaccine was administered. Symptoms showed up on within 12 hr. period on the 7th day. Rushed to urgent care and to hospital by ambulance.
Age: 11.0
Sex: F
Vaccine: FLUN4, HEPA, HPV4, MNQ, TDAP, FLUN4, HEPA, HPV4, MNQ, TDAP
Symptoms: Blood creatinine normal, Blood urea normal, Coagulation test normal, Contusion, Haematocrit
Clinical narrative: Patient developed ITP. Bruising over entire body. Patient's blood was unable to clot properly due to low platelet count exactly a week to the day the HPV vaccine was administered. Symptoms showed up on within 12 hr. period on the 7th day. Rushed to urgent care and to hospital by ambulance.
Age: 11.0
Sex: F
Vaccine: FLUN4, HEPA, HPV4, MNQ, TDAP, FLUN4, HEPA, HPV4, MNQ, TDAP
Symptoms: Haemoglobin, Liver function test normal, Mouth haemorrhage, Petechiae, Platelet count decreased
Clinical narrative: Patient developed ITP. Bruising over entire body. Patient's blood was unable to clot properly due to low platelet count exactly a week to the day the HPV vaccine was administered. Symptoms showed up on within 12 hr. period on the 7th day. Rushed to urgent care and to hospital by ambulance.
Age: 11.0
Sex: F
Vaccine: FLUN4, HEPA, HPV4, MNQ, TDAP, FLUN4, HEPA, HPV4, MNQ, TDAP
Symptoms: White blood cell count increased
Clinical narrative: Patient developed ITP. Bruising over entire body. Patient's blood was unable to clot properly due to low platelet count exactly a week to the day the HPV vaccine was administered. Symptoms showed up on within 12 hr. period on the 7th day. Rushed to urgent care and to hospital by ambulance.
Age: 11.0
Sex: F
Vaccine: FLUN4, HEPA, HPV4, MNQ, TDAP, FLUN4, HEPA, HPV4, MNQ, TDAP
Symptoms: Coagulopathy, Contusion, Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: Case number PHHY2014US012660 is an initial spontaneous report received from a consumer (patient's father) via the vaccine adverse event reporting system (VAERS reference number: 513651) on 03 Feb 2014 with follow-up information from the Quality Assurance Department (reference number: 279320) on 03 Mar 2014 and 06 Mar 2014. This report refers to an 11-year-old female patient. She did not have any allergies or chronic illness. She had a loose tooth for few days. Her concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M13014), HAVRIX (other manufacturer, batch number: 494G5) and GARDASIL (other manufacturer, batch number: J011272); all the three vaccines administered intramuscularly in the right arm on 25 Oct 2013. She also received FLUMIST (other manufacturer, batch number: BJ2154) via intranasal route and BOOSTRIX (other manufacturer, batch number: B5X7M) intramuscularly in the left arm on the same date. On 26 Oct 2013, she woke up in the morning and noticed bleeding from mouth before going to school. It was stated that the bleeding appeared more than usual. It was reported that over course of day in school, bruising and petechiae were noticed. She was taken to urgent care and her platelet count was reported as decreased to 2000 (units and normal values were not reported). She was transferred to hospital for admission and treatment. Her white blood cell count (WBC) was increased to 12.1 (units and normal values were not reported). Her hemoglobin (Hb) was 11.9 and hematocrit (Hct) was 35.1 (units and normal values were not reported for Hb and Hct). Her coagulation test, blood urea nitrogen (BUN), creatinine and liver enzymes were reported as normal (results were not reported). The outcome was reported as complete recovery. The seriousness and causality of the event were not reported. Based on the investigation performed by the QA department, it was confirmed that MENVEO batch number M13014, was manufactured in accordance with approved internal procedures and it is was in compliance with the requirements. Non-significant follow-up received from a Quality Assurance Department (reference number: 279320) on 06 Feb 2014: Updated QA reference number. Follow-up received from the Quality Assurance Department (reference number: 279320) on 06 Mar 2014: Updated batch review report.
Age: 11.0
Sex: F
Vaccine: FLUN4, HEPA, HPV4, MNQ, TDAP, FLUN4, HEPA, HPV4, MNQ, TDAP
Symptoms: Blood creatinine normal, Blood urea normal, Coagulation test normal, Contusion, Haematocrit
Clinical narrative: Case number PHHY2014US012660 is an initial spontaneous report received from a consumer (patient's father) via the vaccine adverse event reporting system (VAERS reference number: 513651) on 03 Feb 2014 with follow-up information from the Quality Assurance Department (reference number: 279320) on 03 Mar 2014 and 06 Mar 2014. This report refers to an 11-year-old female patient. She did not have any allergies or chronic illness. She had a loose tooth for few days. Her concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M13014), HAVRIX (other manufacturer, batch number: 494G5) and GARDASIL (other manufacturer, batch number: J011272); all the three vaccines administered intramuscularly in the right arm on 25 Oct 2013. She also received FLUMIST (other manufacturer, batch number: BJ2154) via intranasal route and BOOSTRIX (other manufacturer, batch number: B5X7M) intramuscularly in the left arm on the same date. On 26 Oct 2013, she woke up in the morning and noticed bleeding from mouth before going to school. It was stated that the bleeding appeared more than usual. It was reported that over course of day in school, bruising and petechiae were noticed. She was taken to urgent care and her platelet count was reported as decreased to 2000 (units and normal values were not reported). She was transferred to hospital for admission and treatment. Her white blood cell count (WBC) was increased to 12.1 (units and normal values were not reported). Her hemoglobin (Hb) was 11.9 and hematocrit (Hct) was 35.1 (units and normal values were not reported for Hb and Hct). Her coagulation test, blood urea nitrogen (BUN), creatinine and liver enzymes were reported as normal (results were not reported). The outcome was reported as complete recovery. The seriousness and causality of the event were not reported. Based on the investigation performed by the QA department, it was confirmed that MENVEO batch number M13014, was manufactured in accordance with approved internal procedures and it is was in compliance with the requirements. Non-significant follow-up received from a Quality Assurance Department (reference number: 279320) on 06 Feb 2014: Updated QA reference number. Follow-up received from the Quality Assurance Department (reference number: 279320) on 06 Mar 2014: Updated batch review report.
Age: 11.0
Sex: F
Vaccine: FLUN4, HEPA, HPV4, MNQ, TDAP, FLUN4, HEPA, HPV4, MNQ, TDAP
Symptoms: Haemoglobin, Liver function test normal, Mouth haemorrhage, Petechiae, Platelet count decreased
Clinical narrative: Case number PHHY2014US012660 is an initial spontaneous report received from a consumer (patient's father) via the vaccine adverse event reporting system (VAERS reference number: 513651) on 03 Feb 2014 with follow-up information from the Quality Assurance Department (reference number: 279320) on 03 Mar 2014 and 06 Mar 2014. This report refers to an 11-year-old female patient. She did not have any allergies or chronic illness. She had a loose tooth for few days. Her concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M13014), HAVRIX (other manufacturer, batch number: 494G5) and GARDASIL (other manufacturer, batch number: J011272); all the three vaccines administered intramuscularly in the right arm on 25 Oct 2013. She also received FLUMIST (other manufacturer, batch number: BJ2154) via intranasal route and BOOSTRIX (other manufacturer, batch number: B5X7M) intramuscularly in the left arm on the same date. On 26 Oct 2013, she woke up in the morning and noticed bleeding from mouth before going to school. It was stated that the bleeding appeared more than usual. It was reported that over course of day in school, bruising and petechiae were noticed. She was taken to urgent care and her platelet count was reported as decreased to 2000 (units and normal values were not reported). She was transferred to hospital for admission and treatment. Her white blood cell count (WBC) was increased to 12.1 (units and normal values were not reported). Her hemoglobin (Hb) was 11.9 and hematocrit (Hct) was 35.1 (units and normal values were not reported for Hb and Hct). Her coagulation test, blood urea nitrogen (BUN), creatinine and liver enzymes were reported as normal (results were not reported). The outcome was reported as complete recovery. The seriousness and causality of the event were not reported. Based on the investigation performed by the QA department, it was confirmed that MENVEO batch number M13014, was manufactured in accordance with approved internal procedures and it is was in compliance with the requirements. Non-significant follow-up received from a Quality Assurance Department (reference number: 279320) on 06 Feb 2014: Updated QA reference number. Follow-up received from the Quality Assurance Department (reference number: 279320) on 06 Mar 2014: Updated batch review report.