chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HIBV, MMR
Symptoms: Rash maculo-papular
Clinical narrative: Information has been received from a health professional concerning a 1 year old female with no allergies or medical history who on 16-JAN-2007 was vaccinated IM with a 0.5 ml dose of MMR II (Lot# 653481/0424F). Concomitant therapy included PedvaxHIB. On 29-JAN-2007, the patient developed a maculopapular rash to the head and body. At the time of the report the patient had not yet recovered. There were no laboratory or diagnostic tests performed. Medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: MMR
Symptoms: Face oedema, Measles
Clinical narrative: Information has been received from a nurse practitioner concerning her 13-year-old son who in approximately 1996 was vaccinated with a 0.5 ml dose of MMR. Subsequently, in approximately 1998, the patient experienced breakthrough measles when he was "three to five years old," and was "covered from head to toe with 300 to 500 vesicles with a fever." Unspecified medical attention was sought. The patient recovered from breakthrough measles. No additional information to report. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Information has been received from a health professional concerning a female who on 03-JAN-2007 was vaccinated with MMR II. Concomitant therapy included Varivax. Other concomitant therapy included RECOMBIVAX on 26-Dec-2006. On approximately 17-JAN-2007 the patient experienced a fine itchy maculopapular rash on her left forearm. As of 02-Feb-2007, the patient had not recovered from the rash. Treatment has been over the counter hydrocortisone and cold compresses. Medical attention was sought. Additional information has been requested.
Age: 22.0
Sex: U
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: Information has been received from a physician concerning a 22-year-old patient with colitis ulcerative who was vaccinated with MMR which was required to work in a hospital. Concomitant therapy included immunosuppressive therapy (unspecified). Unspecified medical attention was sought. Subsequently, the patient experienced a negative measles titer. Additional information has been requested.
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from GlaxoSmithKline and was assigned manufacturer report number A06636909A for diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (INFANRIX). On an unspecified date, a patient (unspecified age and gender) was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3). Suspect vaccination included a dose of poliovirus vaccine and a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The patient's medical history and concurrent medications were not provided. At an unspecified time after vaccination, the patient experienced anaphylaxis that required an emergency department visit. the patient's outcome was unspecified. Anaphylaxis was considered to be an other important medical event by reporter. This was originally reported by a pharmacist. No further information is expected. This is in follow-up to report(s) previously submitted on 5/30/2007. Information has been received from GlaxoSmithKline and was assigned manufacturer report number A0636909A for INFANRIX. On an unspecified date a patient (unspecified age and gender) was vaccinated with a dose of MMR II. Suspect vaccination included a dose Poliovirus vaccine and a dose of DtP. The patient's medical history and concurrent medications were not provided. At an unspecified time after vaccination the patient experienced anaphylaxis that required an emergency department visit. The patient's outcome was unspecified. Anaphylaxis was considered to be an other important medical event by the reporter. This was originally reported by a pharmacist. A lot number was not provided by the agency therefore a lot check of concern cannot be completed for this report. No further information is expected.
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a pharmacist via GlaxoSmithKline (mfr no. A0636913A) concerning a patient (age and gender unknown) who was vaccinated with an unspecified dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3), an unspecified does of Diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified) and an unspecified dose of poliovirus all on an unspecified date. The subjects medical history and concurrent medications were not provided. At an unspecified time after vaccination with Diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine and measles virus vaccine (+) mumps virus vaccine live (+) rubella virus vaccine live vaccine, the subject experienced anaphylaxis that required an emergency department visit. The pharmacist considered the event clinically significant (or requiring intervention). At the time of the reporting the outcome of the event was unspecified. No further information is available.
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy, Mumps
Clinical narrative: Information has been received from a physician concerning his son, who was vaccinated "many years ago" with MMR II. Subsequently the patient experienced mumps and swelling of the neck glands. No further information is available.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a consumer concerning his approximately 2 year old daughter who in approximately 1998 was vaccinated with MMR and experienced a high fever and rash. Medical attention was sought. No further information is available.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a health professional concerning a 43 year old female with no known allergies or medical history who on 12-JUN-2006 was vaccinated with MMR. On 01-Mar-2007, the patient had a titer drawn that showed that she failed to seroconvert to measles only. The health professional reported that the patient will probably get revaccinated with the MMR. Medical attention was sought. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative, Measles antibody, Mumps antibody test negative, Rubella antibody test
Clinical narrative: Information has been received from a physician concerning a female with no allergies or medical history who on 05-SEP-1996 was vaccinated with the second dose of MMR. Subsequently the patient experienced a low titer (< .91) for mumps. Medical attention was sought. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician concerning a male child (age not reported) with no allergies or medical history who received two doses of MMR and had a low titer (< 0.91) for mumps. The second dose was given on 05-SEP-1996. Unspecified medical attention was sought. The patient's outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative, Laboratory test normal
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) who during her childhood was vaccinated with "childhood" doses of MMR. The nurse reported that on 20-FEB-1990 and 12-MAY-2006, the patient received subcutaneously 0.5 mL doses of MMR because of low titers. Concomitant therapy included alprazolam, ZYRTEC, LUNESTA and ACIPHEX. The patient still has low titers. No other symptoms or information reported. The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested. 02/11/2010 Follow up information received from the registered nurse indicated that the patient did not surovonvert in that she was immune to mumps after childhood immunizations and 2 adult doses of MMR II. No further information is expected.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Eye swelling, Pyrexia, Rash morbilliform
Clinical narrative: Information has been received from a registered pharmacist concerning a 12 month old female child with a possible allergy to penicillin who on 21-FEB-2007 was vaccinated with a dose of MMR. "Recently" in approximately March 2007, the patient developed a diffuse body rash that resembled "full blown" measles, fever and swollen eyes. The patient was treated with amoxicillin considering the possible allergy to penicillin. The patient's outcome was not reported. No further information is available.
Sex: M
Vaccine: MMR
Symptoms: Rash morbilliform
Clinical narrative: Information has been received from a physician concerning her son who was vaccinated with a second dose of MMR. The patient experienced a measles like rash after receiving his second dose of vaccine. The measles like rash resolved within a few days after receiving the vaccine. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Auricular swelling, Local swelling
Clinical narrative: Information has been received from a health professional concerning a 46 year old female with penicillin allergy who on 08-FEB-2007 was vaccinated with MMR. Approximately 10-14 days after vaccination, the patient experienced swelling in her jaw, her left neck and ear. Subsequently, the patient recovered from her experiences. Medical attention was sought. An antibody titer was drawn, but results were not available. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: Information has been received from a nurse practitioner concerning a 3-year-old male who was vaccinated with MMR (Lot # 647455/1032N). Subsequently the patient experienced mumps. Unspecified medical attention was sought. The outcome at the time of this report was not recovered. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Eye irritation, Ocular hyperaemia
Clinical narrative: Information has been received from a licensed practical nurse who was splashed with MMR; a single drop of fluid from the needle splashed her in the eye after she had injected another patient. On 20-MAR-2007, the patient experienced irritation with some redness in her eye. It was noted that the patient being vaccinated at the time received the full dose. Unspecified medical attention was sought. She flushed her eye with water. The outcome was reported as recovering. No further information available. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a 1 year old male who was vaccinated with MMR. Subsequently the patient experienced a very pronounced measles-like rash after receiving the first vaccination. The patient recovered from his rash. Medical attention was sought. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Mumps, Rubella
Clinical narrative: Information has been received from a physician concerning a 5 year old male who in approximately 2003 was vaccinated with a dose of MMR. Concomitant therapy included VARIVAX. Subsequently the patient experienced rubella and mumps (time of experience unknown). Unspecified medical attention was sought. Follow-up information received from the nurse indicating that the vaccination was given on 16-JAN-2003. It was also mentioned that the event was "Clinically Rubella and Mumps 1 week following MMR vaccine". The patient required an Emergency Room/Doctor visit. The patient had recovered from the event. No further information expected.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Conjunctivitis, Otitis media, Rash morbilliform, Rhinorrhoea
Clinical narrative: Information has been received from a physician concerning a 2 year old female, with no medical history, drug reactions or allergies, who on 08-MAR-2007 was vaccinated subcutaneously with 0.5 ml of MMR (LOT # 654983/1168F). There was no concomitant medication. One week post vaccination, approximately 15-MAR-2007, the patient developed conjunctivitis, otitis media and runny nose, which were all treated with antibiotics. Thirteen days post vaccination, on approximately 21-MAR-2007, the patient developed a head to toe morbilliform rash, that included her scalp and the palms of her hands. The symptoms have since largely resolved except for some lesions that are continuing to heal on her face. Unspecified medical attention was sought. There was no product quality complaint. The patient was considered recovering at the time of this report. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Drooling, Erythema, Ocular hyperaemia, Rhinorrhoea, Sneezing
Clinical narrative: Information has been received from a physician concerning a 4 year old male with a history of rhinorrhea, drooling, watering eyes, pain in roof of mouth, cough and redness of face after vaccination with Varivax (WAES Report 0703USA03084)  who in approximately 2006 was vaccinated with MMR. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine. In approximately 2006, the patient sneezed three times and experienced rhinorrhea, drooling and red face with red eyes. The patient was given an injection of diphenhydramine HCl, and his symptoms resolved without further treatment. Subsequently, the patient recovered from sneezed three times, rhinorrhea, drooling, red face and red eyes. The physician thought patient was allergic to gelatin. On an unspecified date, serum IgG to porcine gelatin was elevated, at 2.10 kU/L (class 2). As of 24-JAN-2007, at the age of five years old, the patient has been able to eat beef-derived gelatin for the past year, but has avoided porcine gelatin. Recently, a RAST test to porcine gelatin had fallen to 0.38 (class 1) kU/L. Egg, pork and beef have not demonstrated IgE, either by RAST testing, or by skin testing. As of 13-MAR-2007, the patient's outcome was not reported. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a 31 year old female Doctor Of Pharmacy who in approximately 2000 or 2001 was vaccinated with RECOMBIVAX series (unsure of which vaccine/manufacturer not reported) and failed to seroconvert. The patient sought medical attention and a booster was given. A PQC was not reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: High-pitched crying
Clinical narrative: Information has been received from a registered nurse concerning the mother of a patient, who as a child, was vaccinated with MMR. Subsequent to being vaccinated the patient developed a high pitched cry. It is unknown if medical attention was sought. No further information was provided. There was no product quality complaint. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 4-year-old white female with no pre-existing allergies, birth defects, or medical conditions who on 14-MAR-2007 at 1:43PM was vaccinated in the left thigh with a second dose of MMR (Lot # 654896/1180F). There was no illness at the time of vaccination. Concomitant therapy that day at 1:43PM included a dose of HAVRIX (Lot # 636320/1281F) administered in the right thigh, TRIPEDIA (Lot # C2570BA) administered in the left thigh, and a fourth dose of IPOL (Lot # Z0324) administered in the left thigh. On 16-MAR-2007 the patient's immunization site was red, swollen, and warm to the touch. No tenderness was present. At the time of the report, the site was 4 inches width by 3 and 1/2 inches in length. The patient was given OMNICEF (250/5) tsp PO qd and 10 days. There were no relevant diagnostic tests or laboratory date. There were no adverse events following prior vaccinations. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old male who was vaccinated with a first and second dose of MMR II in "1980's" and in 1994. In approximately April 2006, the patient was found to have no antibodies to mumps. It was noted that he was revaccinated on 18-APR-2006. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative, Rash, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female employee with an allergy to penicillin and "Orthocef" and who was healthy at the onset of employment (22-OCT-1996) who on 25-OCT-1996 at 08:00a.m. was vaccinated SC in the left deltoid with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3) (lot # 618456/0467D). Two months later, on 02-DEC-1996 at 11:30 a.m., she was vaccinated SC in the right deltoid with a dose of measles virus vaccine live (Enders-Edmonston) (MSD) (lot# 617277/0286D). There was no illness at the time of vaccination. Sometime post vaccination (date unspecified), the patient broke out in a rash. Unspecified medical attention was sought. Subsequently, the patient recovered from the rash. Also, an antibody titer drawn in April 2006 showed that the patient failed to seroconvert for mumps. A product quality complaint was not involved. Follow-up information was received from the registered nurse who reported that she was unsure of the exact date of onset., but the patient was referred to a physician on 13-DEC-2006 for the rash. She was seen by a dermatologist on 26-DEC-1996 and was seen one last time by a physician on 03-JAN-1997. She was diagnosed with urticaria and treated with methlyprednisolone acetate (DEPO-MEDROL) and diphenhydramine hydrochloride (BENADRYL). She recovered on an unspecified date. It was noted that she received another dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3) (MSD) on "25-OCT-2006." Urticaria was considered to be an other important medical event by the reporter. No further information is expected.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Liver function test, Liver function test abnormal
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 12-month-old female with a history of a liver transplant in June of 2005, who in November 2005, was vaccinated with a dose of MMR II. Concomitant vaccination included a dose of Varivax (Oka/Merck). In February 2005, the patient developed elevated liver function tests. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Rubella antibody negative
Clinical narrative: Information has been received from a female nurse practitioner who "as a child" was vaccinated with doses of MMR. In 2001, the patient had a negative titer (she was not considered seroconverted for measles or rubella). She was given another dose of MMR in 2003, and then received an additional dose in 2006 because she "forgot about the 2003 dose". She has had no titer drawn since the titer in 2001. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 3 year old patient who on 10-OCT-2006 was vaccinated with a 0.5 mL dose of MMR II. Concomitant medication included unspecified "anti-seizure medication". On 10-OCT-2006 the patient experienced seizure after receiving the vaccine. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Upon internal review, seizures were considered to be an other important medical event. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Cough, Erythema, Fibromyalgia, Lymphadenopathy
Clinical narrative: 3 knots on injection arm, redness 1 1/2 inch by 3 inch L-took 2 wk to go away. Cough, Lymph nodes swollen and tender, inside of nose burns. Rt side - neck and clavicle painful and stiff still at 5/14/07
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Musculoskeletal stiffness, Nasopharyngitis, Neck pain, Pain, Pain in extremity
Clinical narrative: 3 knots on injection arm, redness 1 1/2 inch by 3 inch L-took 2 wk to go away. Cough, Lymph nodes swollen and tender, inside of nose burns. Rt side - neck and clavicle painful and stiff still at 5/14/07
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: 3 knots on injection arm, redness 1 1/2 inch by 3 inch L-took 2 wk to go away. Cough, Lymph nodes swollen and tender, inside of nose burns. Rt side - neck and clavicle painful and stiff still at 5/14/07
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Cough, Injection site mass, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: 3 knots on injection arm, redness 1 1/2 inch by 3 inch L-took 2 wk to go away. Cough, Lymph nodes swollen and tender, inside of nose burns. Rt side - neck and clavicle painful and stiff still at 5/14/07
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Tenderness
Clinical narrative: 3 knots on injection arm, redness 1 1/2 inch by 3 inch L-took 2 wk to go away. Cough, Lymph nodes swollen and tender, inside of nose burns. Rt side - neck and clavicle painful and stiff still at 5/14/07
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chest discomfort, Cough, Injection site erythema, Injection site nodule, Injection site rash
Clinical narrative: 3 knots on injection arm, redness 1 1/2 inch by 3 inch L-took 2 wk to go away. Cough, Lymph nodes swollen and tender, inside of nose burns. Rt side - neck and clavicle painful and stiff still at 5/14/07
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Nasal discomfort, Pain, Pruritus
Clinical narrative: 3 knots on injection arm, redness 1 1/2 inch by 3 inch L-took 2 wk to go away. Cough, Lymph nodes swollen and tender, inside of nose burns. Rt side - neck and clavicle painful and stiff still at 5/14/07
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Respiratory disorder, Skin nodule
Clinical narrative: 3 knots on injection arm, redness 1 1/2 inch by 3 inch L-took 2 wk to go away. Cough, Lymph nodes swollen and tender, inside of nose burns. Rt side - neck and clavicle painful and stiff still at 5/14/07
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Dehydration, Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a physician concerning a 2 month old patient (gender not reported) who in February 2007, was vaccinated with first dose of Rotateq (LOT# not provided). In February 2007, "within 2 days of initial dose of ROTATEQ", the patient experienced vomiting, diarrhea, and tested positive for rotavirus. The patient was hospitalized, duration of stay not provided. The patient's outcome was not reported. The patient sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a physician concerning a 2 month old patient (gender not reported) who in February 2007, was vaccinated with first dose of Rotateq (LOT# not provided). In February 2007, "within 2 days of initial dose of ROTATEQ", the patient experienced vomiting, diarrhea, and tested positive for rotavirus. The patient was hospitalized, duration of stay not provided. The patient's outcome was not reported. The patient sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.
Age: 0.75
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Intussusception
Clinical narrative: Information has been received from the FDA (VAERS # 278006) through the CDC concerning a 9-month-old female with no history or pre-existing conditions who on 29-DEC-2006 was vaccinated with a third dose of Rotateq (Lot # 655866/1110F). Concomitant vaccinations that day included a dose of DAPTACEL (Lot # U1965AB), a third dose of Recombivax HB (Lot # 652402/0032F), a third dose of ACTHIB (Lot # UF018AD), a third dose of IPOL (Lot # Y10312), and a third dose of PREVNAR (Lot # B08646C). There were no other medications. On 26-APR-2007, 118 days post vaccination, the patient experienced intussusception and was hospitalized. Subsequently, the patient recovered. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologic Evaluation and Research and was released. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEP, HEPA, MMRV, PPV, HEP, HEPA, MMRV, PNC
Symptoms: Rash
Clinical narrative: Generalized hives and swelling.  Itching but no respiratory signs at all.  Was seen in hospital emergency room and instrucetd on Benedryl dosing after a thourough evaluation.
Age: 1.0
Sex: M
Vaccine: HEP, HEPA, MMRV, PPV, HEP, HEPA, MMRV, PNC
Symptoms: Pruritus, Radioallergosorbent test, Swelling, Urticaria
Clinical narrative: Generalized hives and swelling.  Itching but no respiratory signs at all.  Was seen in hospital emergency room and instrucetd on Benedryl dosing after a thourough evaluation.
Sex: U
Vaccine: HIBV, PNC
Symptoms: Autism
Clinical narrative: This case was considered medically important. Information regarding Prevnar was received from an attorney regarding a patient who experienced autism. The patient received the fourth dose on an unspecified date. The patient also received a dose of Hib-Titer on an unspecified date. Relevant medical history was not provided. Additional suspect medication included Hib-Titer Vaccine. Concomitant therapy included Prevnar. A legal complaint was received from an attorney. It was alleged that the patient experienced autism. The reporter questioned the mercury content of vaccines administered. Current patient status was unknown. No additional information was available at the time of this report.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster ophthalmic, Intraocular pressure increased, Neuralgia, Rash
Clinical narrative: Information has been received from a physician concerning a 64 year old female with osteoarthritis, hypertension, osteoporosis and hypercholesterolaemia and a history of breast cancer and no allergies who on 23-APR-2007 was vaccinated SC with 0.65 ml dose of Zostavax (Lot # 656609/0015U). On 07-MAY-2007 the patient was presented to office complaining of a "rash" to the right forehead and lateral right eye. It was noted that the patient developed vesicular lesions and pain in right eye and right forehead also associated with herpetic neuralgia one week prior to presenting to the office on approximately 30-APR-2007. The patient was treated with medicines for herpes zoster and was referred to an opthalmologist for further examination. Upon opthalmology examination, the patient was found to have increased eye pressure and viral lesions and was prescribed steroid opthalmic drops. The patient was seen in the office again on 15-MAY-2007 and was doing better. The doctor felt that the patient's experience was a potential threat of blindness. At the time of report the patient was not recovered. The patient's experiences were considered to be other important medical event by the reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 64 year old female with osteoarthritis, hypertension, osteoporosis and hypercholesterolaemia and a history of breast cancer and no allergies who on 23-APR-2007 was vaccinated SC with 0.65 ml dose of Zostavax (Lot # 656609/0015U). On 07-MAY-2007 the patient was presented to office complaining of a "rash" to the right forehead and lateral right eye. It was noted that the patient developed vesicular lesions and pain in right eye and right forehead also associated with herpetic neuralgia one week prior to presenting to the office on approximately 30-APR-2007. The patient was treated with medicines for herpes zoster and was referred to an opthalmologist for further examination. Upon opthalmology examination, the patient was found to have increased eye pressure and viral lesions and was prescribed steroid opthalmic drops. The patient was seen in the office again on 15-MAY-2007 and was doing better. The doctor felt that the patient's experience was a potential threat of blindness. At the time of report the patient was not recovered. The patient's experiences were considered to be other important medical event by the reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune thrombocytopenia, Evans syndrome, Leukopenia
Clinical narrative: Information has been received from a physician concerning a 15 year old female with penicillin allergy and eczematous dermatitis who on 01-NOV-2006 was vaccinated with a second dose of Gardasil (lot #656049/0187U). On 01-MAY-2007, "roughly at the end of this vaccination series," the patient developed autoimmune thrombocytopenia and leukopenia. The patient was diagnosed with Evan's Syndrome. The patient was hospitalized for 5 days treated with platelets, immunoglobulin and prednisone. At the time of the report, the patient had not recovered. The reporting physician considered Evan's syndrome and leukopenia to be immediately life-threatening and disabling events. The reporting physician reported that he was not personally certain the Gardasil of the events. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoaesthesia, Incontinence, Injection site erythema
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 20 year old female patient, who on 16-FEB-2007 was vaccinated, IM with the first dose, 0.5ml, of Gardasil (Lot #655165/1425F). Concomitant therapy included ELMIRON. On 16-FEB-2007, the patient developed a local reaction of redness and swelling at the injection site. On 19-Apr-2007, the patient was vaccinated IM with the second dose, 0.5ml, of Gardasil (Lot # 210U). Following the second vaccination, the patient again developed a local reaction of redness and swelling. Sometime following the second vaccination, the patient also became incontinent and developed numbness in her legs, feet, hands, and arms. On 03-MAY-2007, the patient was diagnosed with Guillian Barre syndrome; the next day, 04-MAY-2007 she was hospitalized. The length of the hospital stay was unknown. On 17-MAY-2007, the patient was examined by her physician with some improvement of the symptoms noted, though she continued to experienced weakness. The reporter considered one or more of the events following the second vaccination, to be significantly disabling/incapacitating, to require hospitalization, and to have required intervention as an other significant medical event. Additional information has been requested.  06/19/2007 MR received for ER visit of 4/23/07 and hospitalization 5/3-10/07. ER visit of 4/23/07 for c/o weakness, paresthesias-numbness tongue, fingers and toes, impaired swallowing, balance difficulties and light-headedness. PE:WNL.   Discharged from ED with DX of Anxiety and Dizziness.  Returned to ER on 5/3/2007 with c/o 3 week hx of numbness to her tongue and feet.  Increased paresthesias of her lower extremities including an episode of loss of bladder control. Developed anxiety/panic attack over worsening symptoms. Sent to ER for a full GBS workup.  PE WNL except for DTR's were not elicited in the lower extremities.  Admitted with assessment of Paresthesias and loss of bladder control; R/O GBS. Final DX: Guillain-Barre Syndrome.  Polycystic ovaries.  Migraine headaches.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Local reaction, Vaccine positive rechallenge
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 20 year old female patient, who on 16-FEB-2007 was vaccinated, IM with the first dose, 0.5ml, of Gardasil (Lot #655165/1425F). Concomitant therapy included ELMIRON. On 16-FEB-2007, the patient developed a local reaction of redness and swelling at the injection site. On 19-Apr-2007, the patient was vaccinated IM with the second dose, 0.5ml, of Gardasil (Lot # 210U). Following the second vaccination, the patient again developed a local reaction of redness and swelling. Sometime following the second vaccination, the patient also became incontinent and developed numbness in her legs, feet, hands, and arms. On 03-MAY-2007, the patient was diagnosed with Guillian Barre syndrome; the next day, 04-MAY-2007 she was hospitalized. The length of the hospital stay was unknown. On 17-MAY-2007, the patient was examined by her physician with some improvement of the symptoms noted, though she continued to experienced weakness. The reporter considered one or more of the events following the second vaccination, to be significantly disabling/incapacitating, to require hospitalization, and to have required intervention as an other significant medical event. Additional information has been requested.  06/19/2007 MR received for ER visit of 4/23/07 and hospitalization 5/3-10/07. ER visit of 4/23/07 for c/o weakness, paresthesias-numbness tongue, fingers and toes, impaired swallowing, balance difficulties and light-headedness. PE:WNL.   Discharged from ED with DX of Anxiety and Dizziness.  Returned to ER on 5/3/2007 with c/o 3 week hx of numbness to her tongue and feet.  Increased paresthesias of her lower extremities including an episode of loss of bladder control. Developed anxiety/panic attack over worsening symptoms. Sent to ER for a full GBS workup.  PE WNL except for DTR's were not elicited in the lower extremities.  Admitted with assessment of Paresthesias and loss of bladder control; R/O GBS. Final DX: Guillain-Barre Syndrome.  Polycystic ovaries.  Migraine headaches.
Sex: F
Vaccine: HPV4
Symptoms: Facial palsy
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with Gardasil. Subsequently, the patient developed Bell's palsy. Therapy with human papillomavirus vaccine was discontinued. The patient's Bell's palsy persisted. The nurse indicated that she was unsure whether the human papillomavirus vaccine caused the Bell's palsy. Upon internal review, Bell's palsy was determined to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Erythema, Fall, Feeling abnormal, Hypotension
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning an 18 year old female who on 31-MAY-2007 was vaccinated with Gardasil (LOT # 657736/0389U). Concomitant therapy included a cough expectorant (unspecified), which was taken on the same morning. On 31-MAY-2007, the patient went out to the reception area after she received her second Gardasil, and began "shaking and fell down". The NP reported that she thought that the patient had experienced "a short seizure that lasted about 15 seconds". The NP also reported that the patient had three red streaks running down her arm from the injection site area and that the patient stated she felt a rush down her arm at the time she was vaccinated. The patient's blood pressure was "a little low" and her lips were pale. The patient was sent to an urgent care facility to be further evaluated. The nurse indicated that the patient did not have a reaction to the first dose of Gardasil. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site streaking, Pallor, Tremor
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning an 18 year old female who on 31-MAY-2007 was vaccinated with Gardasil (LOT # 657736/0389U). Concomitant therapy included a cough expectorant (unspecified), which was taken on the same morning. On 31-MAY-2007, the patient went out to the reception area after she received her second Gardasil, and began "shaking and fell down". The NP reported that she thought that the patient had experienced "a short seizure that lasted about 15 seconds". The NP also reported that the patient had three red streaks running down her arm from the injection site area and that the patient stated she felt a rush down her arm at the time she was vaccinated. The patient's blood pressure was "a little low" and her lips were pale. The patient was sent to an urgent care facility to be further evaluated. The nurse indicated that the patient did not have a reaction to the first dose of Gardasil. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Barium enema, Chest X-ray, Full blood count, Haematochezia
Clinical narrative: Present to healthcare system on 5-19-07 with Abdominal pain. Pt had a bloody mucus stool during ER visit. Barium enema study was positive for intussusception-Was Reduced and observed overnight.  06/11/2007 MR received for o/n hospitalization 5/19-20/2007 for Intussusception. Infant developed intermittant acute abdominal pain on 5/18/2007.  Pain continued and on 5/19/07 infant passed a large bloody, mucusy, stool in the ED. Intussusception which was reduced per radiologist by air contrast Barium Enema. DX:  Intussusception-reduced.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Laboratory test, Mucous stools
Clinical narrative: Present to healthcare system on 5-19-07 with Abdominal pain. Pt had a bloody mucus stool during ER visit. Barium enema study was positive for intussusception-Was Reduced and observed overnight.  06/11/2007 MR received for o/n hospitalization 5/19-20/2007 for Intussusception. Infant developed intermittant acute abdominal pain on 5/18/2007.  Pain continued and on 5/19/07 infant passed a large bloody, mucusy, stool in the ED. Intussusception which was reduced per radiologist by air contrast Barium Enema. DX:  Intussusception-reduced.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Barium double contrast, Barium enema, Chest X-ray normal, Culture stool negative
Clinical narrative: Present to healthcare system on 5-19-07 with Abdominal pain. Pt had a bloody mucus stool during ER visit. Barium enema study was positive for intussusception-Was Reduced and observed overnight.  06/11/2007 MR received for o/n hospitalization 5/19-20/2007 for Intussusception. Infant developed intermittant acute abdominal pain on 5/18/2007.  Pain continued and on 5/19/07 infant passed a large bloody, mucusy, stool in the ED. Intussusception which was reduced per radiologist by air contrast Barium Enema. DX:  Intussusception-reduced.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Full blood count normal, Haematochezia, Intussusception, Laboratory test, Mucous stools
Clinical narrative: Present to healthcare system on 5-19-07 with Abdominal pain. Pt had a bloody mucus stool during ER visit. Barium enema study was positive for intussusception-Was Reduced and observed overnight.  06/11/2007 MR received for o/n hospitalization 5/19-20/2007 for Intussusception. Infant developed intermittant acute abdominal pain on 5/18/2007.  Pain continued and on 5/19/07 infant passed a large bloody, mucusy, stool in the ED. Intussusception which was reduced per radiologist by air contrast Barium Enema. DX:  Intussusception-reduced.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Arthralgia, Arthritis, Arthritis bacterial, Aspiration, Aspiration joint
Clinical narrative: Inflammation of knee joint. Aspiration of knee 7 day hospital stay - IV antibiotics. Child could not walk or crawl. Fever and pain in Knee. Fever spiked to 103.7 Events occurred 16 hrs after injection.  07/02/2007 MR received for 7 day hospitalization for an child with refusal to bear weight/walk on the left leg. Initial exam showed some swelling and initial dx was of toxic synovitis. Pt later developed fever and increasing swelling and warmth. Admitted to r/o septic knee and begin IV abx. Discharge DX: Resolving L knee arthritis, septic vs inflammatory.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Blood test, Gait disturbance, Inability to crawl, Joint swelling, Pyrexia
Clinical narrative: Inflammation of knee joint. Aspiration of knee 7 day hospital stay - IV antibiotics. Child could not walk or crawl. Fever and pain in Knee. Fever spiked to 103.7 Events occurred 16 hrs after injection.  07/02/2007 MR received for 7 day hospitalization for an child with refusal to bear weight/walk on the left leg. Initial exam showed some swelling and initial dx was of toxic synovitis. Pt later developed fever and increasing swelling and warmth. Admitted to r/o septic knee and begin IV abx. Discharge DX: Resolving L knee arthritis, septic vs inflammatory.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Synovitis, X-ray normal
Clinical narrative: Inflammation of knee joint. Aspiration of knee 7 day hospital stay - IV antibiotics. Child could not walk or crawl. Fever and pain in Knee. Fever spiked to 103.7 Events occurred 16 hrs after injection.  07/02/2007 MR received for 7 day hospitalization for an child with refusal to bear weight/walk on the left leg. Initial exam showed some swelling and initial dx was of toxic synovitis. Pt later developed fever and increasing swelling and warmth. Admitted to r/o septic knee and begin IV abx. Discharge DX: Resolving L knee arthritis, septic vs inflammatory.
Sex: M
Vaccine: HEP
Symptoms: Sudden infant death syndrome
Clinical narrative: undetermined/Category II SIDS. baby died in bed with parents. 6/7/06-physical in MD office-no problems noted
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Left thigh 2cm x 2cm induration, 7cm x 7cm redness with slightly increased warmth, can move left lower extremity with problems - no other discoloration. No numbness and significant tenderness. No history of trauma. She had no problems with Varicella for vaccine.
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Hypotonia, Skin discolouration
Clinical narrative: 2 - 3 Minutes after injections, was placed in care seat by mom. Turned gray and limp. Lasted 30 seconds. Responded to stimulation. Observed 90 minutes.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: C/o redness and swollen at left arm where patient received. No pain, no fever.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Eye swelling, Rash
Clinical narrative: Rash - puffy eyes
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Culture throat negative, Lymphadenopathy, Neck pain, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Sore throat/pharyngitis, fever, neck pain cervical lymphadenopathy.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Streptococcal identification test negative
Clinical narrative: Sore throat/pharyngitis, fever, neck pain cervical lymphadenopathy.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Rash generalised
Clinical narrative: Rash over abd both arms and legs-vesicles that broke and dried up lasted over 2 weeks with fatigue
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Flushing
Clinical narrative: After receiving zoster vaccine, pt's face became red/flushed and she "felt funny"-assisted her to lie down, never los consciousness or developed any other sx.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Eye pain, Full blood count, Headache, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Optic neuritis-hospitalized for 5 day course of prednisone. Onset 5/13. Hospitalized 5/18/07 (headache, eye pain, papilledema) (color blind and visually severly impaired) 7/18/07-records received from facility for DOS 5/19-5/24/07- DC DX: Optic neuritis. One week piror to admission developed pain and vision loss in left eye accompanied by headache. Seen by ophthalmologist who diagnosed disk edema and afferent pupillary defect on left side.  Fatigue for 2 months since about the time she received her tetanus and HPV vaccines. No diplopia. No viual changes in right eye. PE: Pain on left eye with ocular movements. Tender globe in periorbital region on left side, afferent pupillary defect on left.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Optic neuritis, Papilloedema, Positron emission tomogram normal
Clinical narrative: Optic neuritis-hospitalized for 5 day course of prednisone. Onset 5/13. Hospitalized 5/18/07 (headache, eye pain, papilledema) (color blind and visually severly impaired) 7/18/07-records received from facility for DOS 5/19-5/24/07- DC DX: Optic neuritis. One week piror to admission developed pain and vision loss in left eye accompanied by headache. Seen by ophthalmologist who diagnosed disk edema and afferent pupillary defect on left side.  Fatigue for 2 months since about the time she received her tetanus and HPV vaccines. No diplopia. No viual changes in right eye. PE: Pain on left eye with ocular movements. Tender globe in periorbital region on left side, afferent pupillary defect on left.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Blindness unilateral, Eye pain, Headache
Clinical narrative: Optic neuritis-hospitalized for 5 day course of prednisone. Onset 5/13. Hospitalized 5/18/07 (headache, eye pain, papilledema) (color blind and visually severly impaired) 7/18/07-records received from facility for DOS 5/19-5/24/07- DC DX: Optic neuritis. One week piror to admission developed pain and vision loss in left eye accompanied by headache. Seen by ophthalmologist who diagnosed disk edema and afferent pupillary defect on left side.  Fatigue for 2 months since about the time she received her tetanus and HPV vaccines. No diplopia. No viual changes in right eye. PE: Pain on left eye with ocular movements. Tender globe in periorbital region on left side, afferent pupillary defect on left.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Redness, swelling (almost whole arm) to L arm, applying cold compress
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Pt developed small pimple on inner side of middle phalanx of little finger left on wk after HPV vaccine #3. 2 days later developed wart at site. Within on day was the size of pts finger on same finger (8-10mm). Mom treating at home with freeze spray.
Age: 1.42
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Unevaluable event
Clinical narrative: none stated