chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Back pain, Guillain-Barre syndrome, Hyporeflexia, Muscular weakness
Clinical narrative: 10/30/06 admitted with increased back pain and increased inability to walk.  2 weeks prior experienced viral illness (low grade temp, cough, URI). Neurology determined probable Guillain-Barre' syndrome and transferred to tertiary center for care. Areflexic, progressive weakness.  Has been transferred to nursing home now. 01/12/07-records received and reviewed from hospital.  DC and Transfer Summary:DOS 10/30-11/6/06 Seen in ER for C/O neck and shoulder pain, back and chest pain. Myocardial infarction ruled out. Day after admission had difficulty moving left arm along with pain. On subsequent exam she had clear areflexia in lower extremities with good distal strength and 3/5 strength at best in proximal lower extremities.  Neuro consult:intial assessment GBS syndrome. CT head unremarkable.  No SOB. FVC 1.5 liters respiratory alkalosis. In ICU became a bit more confused Transferred to another hospital.  PMH: diabetes and mild dementia. Several months of shoulder and low back pain gradually getting worse. Prior to admission decreased ability to walk. Weakness in extremities more proximal than distal. 2-3 weeks ago developed URI with low grade fever and coughing. Week ago had diarrhea. C/O numbness and tingling of hands and feet 1 week ago. However, family states this is old since she has a history of diabetes. 01/30/07-records received and reviewed from receiving hospital for DOS: 11/6-12/6/06 DC DX: Guillain-Barr Syndrome Anorexia LUE DVT DM Iron deficiency anemia LP:glucose 89, protein 164, 2 RBC no WBC.  Initially started on IVIG.  PMH:Alzheimer's demetia Type 2 diabetes Diabetic neuropathy with a history of left toe ulcer peripheral vascular disease history of cholelithiasis depression. Transferred to SNF.
Age: 1.54
Sex: F
Vaccine: FLU3
Symptoms: Cough, Pyrexia, Rhinorrhoea
Clinical narrative: Mild clear nasal drainage, slight cough, temp 100.7  2/20/07 Received autopsy report which reveals COD as complications of pneumonitis.
Sex: U
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: She has chicken pox.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Client called HD and reported that he had pneumonia shot in a.m. Arm was sore and red and swelling. Was told to apply warm compress take Benadryl and/or Tylenol and report if no better or gets worse. Pt denied fever. Unable to follow up as phone number is disconnected according to nurse at health department.
Age: 1.9
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Decreased appetite, Difficulty in walking, Injection site warmth, Irritability, Lethargy
Clinical narrative: Aunt called on 12/20/2006 to report that his right leg was swollen, warm to touch with moderate pain. She said that it was hard for him to walk for one day and he did't walk on that leg. He was irritable and lethargic with decreased appetite as well. She also said that he had a fever the next day although it was not taken. Was given Motrin but unsure of number of doses. Instructed to apply warm compresses, soak in worm tub, take motrin or tylenol for pain, watch for s/s infection and follow up with primary MD or hospital if not resolved.
Age: 1.9
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Aunt called on 12/20/2006 to report that his right leg was swollen, warm to touch with moderate pain. She said that it was hard for him to walk for one day and he did't walk on that leg. He was irritable and lethargic with decreased appetite as well. She also said that he had a fever the next day although it was not taken. Was given Motrin but unsure of number of doses. Instructed to apply warm compresses, soak in worm tub, take motrin or tylenol for pain, watch for s/s infection and follow up with primary MD or hospital if not resolved.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Site reaction...red hot sore to the touch...swelling size of large egg that began on day two after injection and remains inflamed on day four.(today)
Age: 2.0
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Mother called 12/29/2006 to report that her daughter had redness and a hard knot at the site of injection for the Hib and Prevnar, L Leg. Mother was advised to use warm compress, give Tylenol, Benadryl, and observe the child for increased swelling, redness, and if desired, could bring child to the health department that the nurse could observe the leg.
Age: 37.0
Sex: F
Vaccine: MMR, TD
Symptoms: Bacterial infection, Drug ineffective, Lymphadenopathy, Pruritus, Rash
Clinical narrative: Pt vaccinated w/MMR in R upper arm and Dip/Tet in L upper arm 12/19/6.  Rxn occurred approximately 9-10 days after injection.  Seen at MD for rxn which was diagnosed as measles; also was cultured positive for Strep & prescribed Z-pak.  Rash began on back of R hand & spread constantly up arm, across trunk, and by 1/4/6 covered legs and feet.  Also has swollen itching lymph node behind R ear.
Age: 0.41
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, HIBV
Symptoms: Unevaluable event
Clinical narrative: Unexplained death within 24 hours of 4 month vaccines in the office. 3/26/07 Received Autopsy Report which reveals COD as SIDS.  Patient had colostomy in place s/p surgical formation of rectum at birth & site was considered unremarkable.  Child had been examined by PCP on 12/22/06 & received vax.  Found to be well at that time.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Myalgia, Pain, Urticaria
Clinical narrative: Received influenza immunization on 11/09/06.  Patient reported that at 6pm noted "whelp the size of a lemon".  Right arm warm, sore, raised area.  Took Ibuprofen for relief without improvement.  Whelp remained approximately one week.  Muscle soreness continues without improvement.  Worsens with use.  Ibuprofen provides very little relief.
Age: 0.39
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Crying, Hypersensitivity, Urticaria
Clinical narrative: CRYING, HIVES APROX 2 HOURS AFTER RECEIVING VACCINES. SEEN @ ER DX WITH ALLERGIC RXN TO VACCINES TREATED WITH BENADRYL AND PRELONE.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash
Clinical narrative: - local reaction: ice pack et. ibuprofen 800 mg. - 12/18/06 itchy rash all over body: was RX prednisone x 7 days
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Neck pain, Pyrexia, Syncope
Clinical narrative: Severe neck and left arm pain (vaccine administered in left arm), associated with low-grade fever (99.9), neck stiffness, and syncopal episode.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Developed sparse varicella rash, no other sx.  Treated symptomatically w/ Benadryl.
Age: 1.31
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: Received 4th DaPT on 1/5/07 and within hours developed swollen right shoulder and redness that extended from clavicle to elbow.  Shoulder was soft, nontender.  No streaking.
Age: 1.0
Sex: F
Vaccine: FLUX, MMRV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 12 month old female who on an unspecified date was vaccinated with a dose of ProQuad. Concomitant vaccination included influenza virus vaccine (unspecified) (manufacturer unknown). Subsequently, on the same day, the patient experienced a "local reaction at the injection site while she was in the office". Medical attention was sought and the patient received diphenhydramine hydrochloride (Benadryl). The patient's status was not reported. No further information was available. There was no product quality complaint involved. The patient receiving diphenhydramine hydrochloride (Benadryl) for an injection site reaction was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: FLUX, MMRV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 12 month old female with no allergies or pertinent medical history, who "this past week", on approximately 04 Oct 2006 was vaccinated SC with a 0.5 ml dose of Proquad (lot # 654041/0662F). Concomitant vaccination included influenza virus vaccine (unspecifed) (manufacturer unknown). Subsequently, on the same day, the patient experienced a "local reaction at the injection site while she was in the office". Medical attention was sought and the patient received Benadryl. Subsequently, the patient recovered. No further information was available. There was no product quality complaint involved. The patient receiving Benadryl for an injection site reaction, was considered to be an other important medical event. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old patient who on an unspecified date was vaccinated with dose of Proquad. It was reported that the Proquad was administered as the second dose of varicella virus vaccine live, the date of the first dose was not specified. Two hours after vaccination the patient developed shingles. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of drug administration, Injection site nodule
Clinical narrative: Information has been received from a physician concerning a 3 year old patient who on 31 Aug 2006 was vaccinated once IM with a 0.5mL dose of Proquad. Concomitant vaccination administered the same day included six other unspecified vaccines. Two of these vaccines were given in the same site as the measles virus vaccine (Enders Edmonston) (+) mumps virus vaccine live (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live. On 12 Sep 2006 the patient "develop a node near the injection site in the left leg". Unspecified medical attention was sought. It was reported that the patient was receiving these vaccines for "catch up vaccination" and that they are not discontinuing the series. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: MMRV
Symptoms: Conjunctivitis, Erythema, Eye irritation, Oedema, Vaccination complication
Clinical narrative: Information has been received from a registered nurse and the consumer a 41 year old white female with hypertension, sulfonamide allergy, drug hypersensitivity to codeine and acetaminophen (+) Vicodin and a history of mumps and chicken pox twice (initial case was mild, second case in 6th grade) no history of immunocompromise who on 14 Sep 2006 at 11:00 am was preparing a dose of Proquad (Lot # 653463/0463F) and the rubber stopper "blew off " the vial and the solution splashed into her eye. Previous therapy included 1 dose of Proquad. Concomitant therapy included blood pressure medication (therapy unspecified). The eye was flushed with running water and a saline solution. She initially experienced burning in the affected eye with erythema and edema of the eyelids, no discharge but this gradually improved. Debris from the vial did not enter the patient's eyes. The patient was seen by an ophthalmologist who further irrigated and cleaned her eyes. The patient was seen at 1:40pm and diagnosed with conjunctivitis. The patient received medication to numb her eyes and was prescribed Tobradex. No laboratory diagnostic tests were performed. A product quality complaint was involved. Follow up information from the consumer, who was also the administering health care professional indicated that when she was injecting the diluent into the vaccine vial, the vaccine and diluent exploded causing the stopper on the vaccine vial to shift and the hub of the syringe blew from needle. The vaccine then went into her eyes. The glass did not break. The patient recovered on 15 Sep 2006. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning an "almost 1 year old" female who in September 2006 was vaccinated SC with a dose of PROQUAD (lot number 653668/0518F). In September 2006, the patient had an immediate reaction with swelling upon injection. Subsequently, the patient was recovering from the swelling upon injection. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Abdominal pain upper
Clinical narrative: Information has been received from a mother concerning a 3 year old male with a penicillin allergy who in July 2004 was vaccinated with Proquad. There was no concomitant medication. In July 2004 the patient had stomach cramps. The patient sought unspecified medical attention. As of 19 Sep 2006 the patient was recovering. It was also noted that the patient's brother experienced an adverse reaction after vaccination with Proquad. (WAES#0609USA05264). Additional info is not expected.
Age: 3.0
Sex: U
Vaccine: HEPA, MMRV
Symptoms: Injection site nodule, Rash
Clinical narrative: Information has been received from a nurse concerning a 12 month old patient who was vaccinated with a dose of Proquad. Concomitant therapy included a dose of hepatitis A vaccine (inactive) (manufacturer unspecified). "Within the last month," in approximately August 2006, the patient experienced "a rash of 20-30 pox about 2 weeks after receiving Proquad. Unspecified medical attention was sought. No product quality compaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/5/2007. Information has been received from a physician concerning a 3 year old patient who on 31-AUG-2006 was vaccinated once IM with a 0.5 mL dose of PROQUAD (Merck). Concomitant vaccination administered the same day included six other unspecified vaccines. Two of these vaccines were given in the same site as the MMR II (Merck). On 12-SEP-2006 the patient "developed a node near the injection site in the left leg". Unspecified medical attention was sought. It was reported that the patient was receiving these vaccines for "catch up vaccination" and that they are not discontinuing the series. No further information was provided. There was no product quality complaint involved. Additional information received from a certified medical assistant indicated that the node must have resolved within one weeks time since they instructed the patient's parent to call back if it had not gone away in one week. She stated that they never heard back from them. Additional information is not expected, the physician cannot be contatcted.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old patient who on 18 Sep 2006 was vaccinated with MMR II/Varicella vaccine. On 19 Sept 2006 the patient experienced a rash. The patient sought unspecified medical attention. The outcome was not reported. No further information is available.
Sex: M
Vaccine: MMRV
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a mother concerning her son with a penicillin allergy who in July 2004 was vaccinated with MMR II/Varicella vaccine. There was no concomitant medications. In July 2004 the patient had stomach cramps. The patient sought unspecified medical attention. As of 19 Sept 2006 the patient was recovering. It was also noted that the patient's brother experienced an adverse reaction after vaccination with MMR II/Varicella vaccine (WAES0609USA04260). Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: MMRV, UNK
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a health professional concerning a 12 month old female who was vaccinated with a 0.5ml dose of MMR II/Varicella vaccine. Suspect vaccination that day included other shots (unspecified). Subsequently the patient experienced an adverse experience/effect (unknown). There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who on an unspecified date was vaccinated SC with a 0.5ml dose of MMR II/Varicella. Shortly after vaccination, the patient developed several small red bumps near the injection site. No other symptoms were noted. Unspecified medical attention was sought and the patient recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: MMRV
Symptoms: Eye irritation, Incorrect route of drug administration
Clinical narrative: Information has been received from a 20 year old female certified medical assistant with migraines and a history of congenital immunodeficiency abnormality with no "memory cells", fibromyalgia and a full case of varicella at one year who on 13 Oct 2006 was sprayed in the eyes (left greater than right) with Proquad. Concomitant therapy included propranolol HCl and hormonal contraceptives (unspecified). Unspecified medical attention was sought. She flushed her eyes with warm water. She experienced a burning sensation in the eyes that lasted 5 minutes and resolved following flushing. No redness was noted. The patient's physician indicated that the patient "manages most infections' quite well. Her immune status "may be akin to chronic fatigue." There was no product quality complaint involved. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 12 month old white female with cold symptoms (no fever) and no other medical history or allergies who on 28 Sep 2006 was vaccinated with a first dose in the left upper leg of Proquad (lot#654040/0661F). On 06 Oct 2006 the patient broke out with pox. The patient was seen by the physician on 10 Oct 2006. No laboratory diagnostic tests were performed. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: PYREXIA  Information has been received from a registered nurse concerning a 12 month old black female with on known drug allergies who on 11-AUG-200 was vaccinated with a first dose of measles virus vaccine live (Enders-Edmonston) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (lot# 652332/1122R). On 11-AUG-2006 the patient developed a fever. On 15-AUG-2006 the patient recovered. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Flatulence, Pyrexia, Rash erythematous, Rash morbilliform
Clinical narrative: RASH MORBILLIFORM; PYREXIA; RASH ERYTHEMATOUS; FLATULENCE  Information has been received from a licensed practical nurse concerning a 12 month old male with no medical history or allergies who on 22-SEP-2006 was vaccinated with a 0.5 mL SC dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (lot # 654474/0815F). Suspect therapy on the same date included a dose of Hib conj vaccine (OMPC) (MSD) (lot # 652863/0401F. On 12-OCT-2006, the patient developed a fever of 99F, and a red measles like rash on his upper body on the trunk, face, arms, chest, and back and was gassy with no diarrhea.  He was seen in the clinic on 13-OCT-2006 with diffuse slightly erythematous papules, pea sized to dime size. He was treated with acetaminophen (TYLENOL).  He underwent a urine test and blood test and an abdominal X-ray, results not reported. On 16-OCT-2006, most of the patient's rash was gone and he had a good intake of food and liquids.  The patient's outcome was recovering.  There was no product quality complaint involved.  Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Exposure to communicable disease, Varicella
Clinical narrative: VARICELLA  Information has been received from a physician concerning a 6 year old male who on 29-SEP-2006 was vaccinated with a 0.5 mL dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process). About a week after vaccination, on approximately 06-OCT-2006, the patient developed "varicella minor." Unspecified medical attention was sought.  The patient's outcome was not reported. There was no product quality complaint involved.  It was reported that the patient's sister (WAES #0612USA01595) developed chickenpox after exposure to her vaccinated brother.  Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: FLUX, MMRV
Symptoms: Conjunctivitis, Nasopharyngitis, Pyrexia, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 month old patient who on "ten days ago" approximately 13-OCT-2006 was vaccinated with a 0.5 mL dose of Proquad. Suspect vaccination administered that day included a dose of influenza virus vaccine (unspecified). "Ten days ago" on approximately 13-OCT-2006 the patient developed a fever, rash, cold symptoms and conjunctivitis.  Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: PYREXIA  Information has been received from a physician concerning a female who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process). Subsequently the patient developed a very high fever of 104 five days post-vaccination.  Unspecified medical attention was sought. The patient's outcome was not reported.  There was no product quality complaint involved.  Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: MMRV
Symptoms: Injection site oedema, Injection site swelling, Medication error
Clinical narrative: INJECTION SITE OEDEMA; INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION  Information has been received from a physician concerning an approximately 4-month-old patient who on unspecified dates was vaccinated with two 0.5 mL doses of measles virus vaccine live (Enders-Edmonston 9+) mumps virus live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck update process). Subsequently, the patient experienced swelling at the injection site after the second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine liver (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process). Unspecified medical attention was sought.  The patient recovered on an unspecified date. No product quality complaint was involved.  Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: INJECTION SITE RASH; INJECTION SITE ERYTHEMA; INJECTION SITE SWELLING  Information has been received from a physician concerning a 4 year old female who on 10-OCT-2006 was vaccinated with a 0.5 ml dose of measles virus vaccine live (Enders-Edmonston0 (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (Lot# 654041/0662F). Subsequently the patient experienced redness, swelling, and small bumps at the injection site. It was reported that the patient recovered.  Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Infection transmission via personal contact, Injection site erythema, Injection site rash, Injection site swelling, Injection site vesicles
Clinical narrative: INJECTION SITE VESICLES; INJECTION SITE ERYTHEMA; INJECTIONSITE RASH; INJECTION SITE SWELLING  Information has been received from a physician concerning a 4 year old female who on 07-OCT-2006 was vaccinated with a 0.5 ml dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (Lot# 654041/0662F). On 08-OCT-2006 the patient experienced redness and swelling at the injection site and bumps and blisters.  It was reported that one of her blisters burst and her younger sister experienced bumps from possible transmission (WAES # 0612USA01410).  Unspecified medical attention was sought.  No product quality complaint was involved.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Blister, Injection site erythema, Injection site swelling
Clinical narrative: INJECTION SITE VESICLES; INJECTION SITE ERYTHEMA; INJECTIONSITE RASH; INJECTION SITE SWELLING  Information has been received from a physician concerning a 4 year old female who on 07-OCT-2006 was vaccinated with a 0.5 ml dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (Lot# 654041/0662F). On 08-OCT-2006 the patient experienced redness and swelling at the injection site and bumps and blisters.  It was reported that one of her blisters burst and her younger sister experienced bumps from possible transmission (WAES # 0612USA01410).  Unspecified medical attention was sought.  No product quality complaint was involved.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Infection transmission via personal contact, Injection site erythema, Injection site rash, Injection site swelling, Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a female patient who's sister was vaccinated with a 0.5 ml dose of ProQuad (upgrade process) (Lot#654041/0662F) on 07-Oct-2006, and experienced redness and swelling at the injection site, and bumps and blisters (WAES#0611USA01106). It was reported that one of her sister's blisters burst and the patient experienced bumps from possible transmission. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Blister, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female patient who's sister was vaccinated with a 0.5 ml dose of ProQuad (upgrade process) (Lot#654041/0662F) on 07-Oct-2006, and experienced redness and swelling at the injection site, and bumps and blisters (WAES#0611USA01106). It was reported that one of her sister's blisters burst and the patient experienced bumps from possible transmission. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Oedema peripheral, Pyrexia, Rash morbilliform
Clinical narrative: Information has been received from a physician concerning her approximately 1 year old daughter who on an unspecified date was vaccinated in her thigh with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck update process). Concomitant vaccination included a dose of hepatitis A vaccine (inactive) (MSD).  Subsequently, the patient developed a fever, a measles-like rash and her hands swelled.  The patient had a follow-up visit with her treating physician.  The patient's mother did take pictures of the patient's condition. The patient recovered 4-5 days later. No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Mobility decreased, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: PAIN IN EXTREMITY; MOBILITY DECREASED; ERYTHEMA; SKIN WARM; PYREXIA; OEDEMA PERIPHERAL   Information has been received from a physician concerning a 5  year old white male with no known allergies or medical history, who on the morning of 21-SEP-2006 was vaccinated SC in the left tricep with a first dose of measles virus vaccine live (Enders Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine (Oka/Merck upgrade process). There was no illness at the time of vaccination. On the morning o 22-SEP-2006 the patient was seen at the physician's office with a low grade fever, swollen and tender arm, new redness on arm, the patient's arm felt warm to the touch and the child was not using his arm. On 23-SEP-2006 the patient returned with increased swelling and redness in his arm.  He had a temperature of 100 degrees, his elbow was swollen and the patient continued to not use his arm.  The physician advised to have the arm monitored.  There were no diagnositc tests performed.  The patient did not return to the office.  It was reported that the patient and his siblings had not had any adverse events following prior vaccination. No further information was provided.  Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Skin warm
Clinical narrative: PAIN IN EXTREMITY; MOBILITY DECREASED; ERYTHEMA; SKIN WARM; PYREXIA; OEDEMA PERIPHERAL   Information has been received from a physician concerning a 5  year old white male with no known allergies or medical history, who on the morning of 21-SEP-2006 was vaccinated SC in the left tricep with a first dose of measles virus vaccine live (Enders Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine (Oka/Merck upgrade process). There was no illness at the time of vaccination. On the morning o 22-SEP-2006 the patient was seen at the physician's office with a low grade fever, swollen and tender arm, new redness on arm, the patient's arm felt warm to the touch and the child was not using his arm. On 23-SEP-2006 the patient returned with increased swelling and redness in his arm.  He had a temperature of 100 degrees, his elbow was swollen and the patient continued to not use his arm.  The physician advised to have the arm monitored.  There were no diagnositc tests performed.  The patient did not return to the office.  It was reported that the patient and his siblings had not had any adverse events following prior vaccination. No further information was provided.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12 month old male who "last month", in October 2006, was vaccinated with a 0.5 mL dose of Proquad. Subsequently, 10 days after the patient was vaccinated he developed a fever of 103 degrees which subsided after 24 hours. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: MMRV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning an approximately 4 month old patient who on unspecified dates was vaccinated with two 0.5 ml doses of Proquad. Subsequently, the patient experienced swelling at the injection site after the second dose of Proquad. Unspecified medical attention was sought. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning an approximately 4 month old patient who on unspecified dates was vaccinated with two 0.5 ml doses of Proquad. Subsequently, the patient experienced swelling at injection site after the second dose of Proquad. Unspecified medical attention was sought. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Information has been received from a physician concerning a 5 year old female who on 09 Nov 2006 was vaccinated with a 0.5 mL dose of Proquad. Subsequently, the patient developed a red swollen arm after vaccination. Unspecified medical attention was sought. There were no labs or diagnostic tests performed. Subsequently, on an unspecified date the patient recovered. No further informatoin was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site rash, Irritability, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12 month old female who was vaccinated SC with a dose of Proquad (Lot # 651814/0771R). Subsequently, 7-10 days post vaccination, the patient experienced a fever, rash at the injection site, and irritability. Subsequently, the patient recovered. There was no other information. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV, UNK
Symptoms: Swelling
Clinical narrative: Information has been received from a physician concerning a 4 year old male who was vaccinated subcutaneously in the arm with a 0.5 ml dose of Proquad. Concomitant unspecified vaccinations were given in the other arm. Subsequently, the patient's arm swelled up like there was a band around it, the arm size increased by 4-5 inches across. Unspecifed medical attention was sought. No product quality complaint was involved. Additional information has been requested.  Follow-up information not provided.
Age: 1.03
Sex: F
Vaccine: MMRV
Symptoms: Condition aggravated, Injection site reaction, Pyrexia, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 12 month old female who on approximately 28 Jun 2006 was vaccinated subcutaneously with a dose of Proquad (lot# 653357/0303F). A week and a half later, on 08 Jul 2006 the patient developed lesions on the injection site and had a low grade fever. Two days later the lesions spread to her legs, back, hands and feet. In total the patient had 8 lesions. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested. Follow-up information has been received from a physican concerning this 12-month old female who on 16-JUN-2006 was vaccinated with a first dose of MMR II (Wistar PA 27/3) + varicella (Oka/Merck). Subsequently, about a week after vaccination on approximately 23-JUN-2006, the patient developed a vesivcular injection site rash. It was reported that the patient was treated to relieve the symptoms. At the time of the reprot, the patient recovered. It was noted that the rash occurred over 2 years ago. There wasno product quality complaint involved.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Rash vesicular, Urticaria
Clinical narrative: Information has been received from a physician concerning a 5 year old male who was vaccinated with a 0.5 mL dose of Proquad. Twenty one days post-vaccination the patient developed about 15-20 hive and chicken pox like blisters on the stomach. Unspecified medical attention was sought. The patient's outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
Age: 1.05
Sex: F
Vaccine: MMRV
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 13 month old female who on 24 Oct 2006 at 13:40 pm was vaccinated subcutaneously in the right arm with a first dose of Proquad (lot# 655141/0833F). Subsequently, the patient experienced "chickenpox at site of injection." It was unspecified if medical attention was sought. No further information was reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMRV, PNC
Symptoms: Skin lesion
Clinical narrative: Information has been received from a certified medical assistant concerning a 12 month old male with a chronic lung disorder and no allergies, who on 14 Nov 2006 was vaccinated subcutaneously in the right arm with a 0.5 ml dose of Proquad (lot #655266/0975F). Concomitant vaccinations given on 14 Nov 2006 included: a dose of Prevnar, a dose of Vaqta and a dose of Fluzone. Other concomitant medications included: Pulmicort and Zantac. On 24 Nov 2006 the patient developed an unspecified number of lesions on his abdomen, chest and neck. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Age: 1.17
Sex: F
Vaccine: MMRV
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 14-month-old female on 20-Jul-2006 was vaccinated with a 0.5 ml dose of ProQuad (upgrade process). On 28-Nov-2006 the patient experienced outbreak of shingles after vaccination. Unspecified medical attention was sought. The patient had not recovered at the time of the report. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a 0.5 ml dose of ProQuad (upgrade process). Subsequently the patient developed a fever. Unspecified medical attention was sought. There were no labs performed. The patient recovered. There was no product quality complaint involved. No additional information was provided.
Age: 4.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a pharmacist concerning a 4 year old male, with no medical history, who on 05-Dec-2006 was vaccinated with a dose of ProQuad (upgrade process). Suspect vaccination administered on the same day included a dose of hepatitis A virus vaccine inactivated. It was reported that on 05-Dec-2006 the patient had an allergic reaction to ProQuad (upgrade process) or hepatitis A virus vaccine inactivated. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: FLUX, MMRV
Symptoms: Conjunctivitis, Nasopharyngitis, Pyrexia, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 month old patient who on "ten days ago" approximately 13-Oct-2006 was vaccinated with a 0.5 ml dose of ProQuad (upgrade process). Suspect vaccination administered that day included a dose of influenza virus vaccine (unspecified). "Ten days ago" on approximately 13-Oct-2006 the patient developed a fever, rash, cold symptoms and conjunctivitis. Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: MMRV
Symptoms: Secondary transmission, Skin lesion, Varicella
Clinical narrative: Information has been received from a physician concerning a female patient who's 6 year old brother was vaccinated on 29-Oct-2006 with a 0.5 ml ProQuad (upgrade process). Subsequently the patient was exposed to her brother and developed full blown chickenpox with over 300 lesions. It was not reported if medical attention was sought. The patient's outcome was not reported. There was no product quality complaint involved. It was reported that the patient's brother (WAES#0610USA10769) developed chickenpox after vaccination with ProQuad (upgrade process). Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Dyspnoea
Clinical narrative: Received shot at 10:49 am did from office at 11 pm. Return to office screen child having problem breathing at 1140 am.
Age: 24.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Dermatitis acneiform, Erythema, Pallor
Clinical narrative: Ten minutes after immunization, presented with flushed face and pale red rash over chest and abdomen. Vital signs BP 154/90, Pulse 60, Respiration T 98.6, medicated with Benadryl 50 mg PO.
Age: 0.31
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Hypotonia, Pyrexia, Sepsis
Clinical narrative: Hypotonic and fever event enough for  hospital to do a full septic w/u and given Ceftriaxime x 2 days.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia, Tenderness
Clinical narrative: Shot Given on 1/3/07. Arm sore on 1/4/07 fever of 101 on 1/4/07 in evening. Patient returned to MD's office on 1/5/07 had temp of 100.9. Also R upper arm 7 1/2 cm x 7cm red, warm and tender. MD rxd with Keflex and Vicodin.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dyskinesia, Headache, Hyperhidrosis, Hypotension
Clinical narrative: Information has been received from a nurse at a physician's office concerning a 14 year old female with no medical history reported. On 05-Dec-2006, the patient was vaccinated with the first single dose vial of HPV vaccine (yeast) (Lot#653978/0955F). It was reported that the patient was "alright at the time of the vaccination". However, the patient on her way out of the physician's office stated that she wasn't feeling well (conflicting information reported as "almost immediately after being vaccinated"), the patient developed a bad headache within seconds and began to turn white, The nurse reported that the patient left the office and by the time she got back out to the parking lot, the patient passed out. The physician's office brought the patient back to the office to be examined. The nurse reported that the patient had developed hypotension, tremors, a bad headache, involuntary movement of her upper and lower extremities which lasted about ten minutes along with some additional symptoms which were not specifically specified. The patient became pale, diaphoretic and felt weak. The patient had no vomiting and had no fever. The physician stated that the patient's experience was not an active seizure. Her blood pressure was initially 60/40 mmHg, then later 80/60 mmHg. The patient was not tachycardic. The patient developed pain at the office site of injection. The physician noted that the patient had not eaten for awhile and the patient felt better after eating. The patient was not seen in the emergency room and was fine the next day. Unspecified medical attention was sought. The physician stated that she did not see the "involuntary movement of her upper and lower extremities", which was reported by the nurse. The physician was not in the from at that time to see that, however, she stated again this was not a seizure. The nurse reported that the patient stayed home from school on 06-Dec-2006 because she still was not feeling herself but was "doing better". The nurse reported that the patient was not planning to receive additional vaccinations in the series. No lot number was provided. The physician noted that the patient had no adverse reactions after receiving her hepatitis B virus vaccine (unspecified) and tetanus toxoid vaccinations. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Loss of consciousness, Malaise, Pallor, Tremor
Clinical narrative: Information has been received from a nurse at a physician's office concerning a 14 year old female with no medical history reported. On 05-Dec-2006, the patient was vaccinated with the first single dose vial of HPV vaccine (yeast) (Lot#653978/0955F). It was reported that the patient was "alright at the time of the vaccination". However, the patient on her way out of the physician's office stated that she wasn't feeling well (conflicting information reported as "almost immediately after being vaccinated"), the patient developed a bad headache within seconds and began to turn white, The nurse reported that the patient left the office and by the time she got back out to the parking lot, the patient passed out. The physician's office brought the patient back to the office to be examined. The nurse reported that the patient had developed hypotension, tremors, a bad headache, involuntary movement of her upper and lower extremities which lasted about ten minutes along with some additional symptoms which were not specifically specified. The patient became pale, diaphoretic and felt weak. The patient had no vomiting and had no fever. The physician stated that the patient's experience was not an active seizure. Her blood pressure was initially 60/40 mmHg, then later 80/60 mmHg. The patient was not tachycardic. The patient developed pain at the office site of injection. The physician noted that the patient had not eaten for awhile and the patient felt better after eating. The patient was not seen in the emergency room and was fine the next day. Unspecified medical attention was sought. The physician stated that she did not see the "involuntary movement of her upper and lower extremities", which was reported by the nurse. The physician was not in the from at that time to see that, however, she stated again this was not a seizure. The nurse reported that the patient stayed home from school on 06-Dec-2006 because she still was not feeling herself but was "doing better". The nurse reported that the patient was not planning to receive additional vaccinations in the series. No lot number was provided. The physician noted that the patient had no adverse reactions after receiving her hepatitis B virus vaccine (unspecified) and tetanus toxoid vaccinations. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, FLUX, HPV4, MNQ, FLU3, HPV4, MNQ
Symptoms: Erythema, Flushing, Pruritus
Clinical narrative: Information has been received from a physician concerning a 19 year old female with depression, anxiety and hypercholesterolaemia and no history of drug reactions/allergies, who on 20 Nov 2006 was vaccinated intramuscularly with the first dose of Gardasil (yeast) (0.5 mL) (lot #653938/0954F). Concomitant therapy included Seasonale, Mevacor, Celexa, and Xlonopin. Concomitant vaccinations on 20 Nov 2006 included Menactra and influenza virus vaccine (unspecified). 0n 22 Nov 2006, the patient developed facial flushing and chin itching and burning. On 23 Nov 2006, the patient developed red spots on both hands and abdomen. On 23 Nov 2006, the patient sought medical attention at an emergency room while out of town. The patient was diagnosed with having an allergic reaction and administered Benadryl. The patient fully recovered on an unspecified date. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, FLUX, HPV4, MNQ, FLU3, HPV4, MNQ
Symptoms: Erythema, Flushing, Hypersensitivity, Pruritus, Skin burning sensation
Clinical narrative: Information has been received from a physician concerning a 19 year old female with depression, anxiety and hypercholesterolaemia and no history of drug reactions/allergies, who on 20 Nov 2006 was vaccinated intramuscularly with the first dose of Gardasil (yeast) (0.5 mL) (lot #653938/0954F). Concomitant therapy included Seasonale, Mevacor, Celexa, and Xlonopin. Concomitant vaccinations on 20 Nov 2006 included Menactra and influenza virus vaccine (unspecified). 0n 22 Nov 2006, the patient developed facial flushing and chin itching and burning. On 23 Nov 2006, the patient developed red spots on both hands and abdomen. On 23 Nov 2006, the patient sought medical attention at an emergency room while out of town. The patient was diagnosed with having an allergic reaction and administered Benadryl. The patient fully recovered on an unspecified date. Additional information has been requested.