chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: Approx 6 inch diameter area of swelling, tenderness, and warm to touch. Area of redness and swelling 15 cm x 1 cm provider notified see medical record.
Age: 1.08
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Diarrhoea, Pyrexia, Rash, Respiratory disorder, Vomiting
Clinical narrative: 3/19/07 child presented with vomiting and diarrhea for 3 days. Day 3 fever and respiratory-Dr. visit with treatment of Albuterol and Amoxicilin. Then on the 26th Dr gave Zithromax. 3/27/07 presented with approx 30 raised spots-pin point-?blistery. No drainage. 3/30/07 Dr visit-Dr reported "if the puss" they are chicken pox. They did not.
Age: 85.0
Sex: F
Vaccine: PPV, TD
Symptoms: Rash macular
Clinical narrative: diffuse macular rash-arms and legs-"few days" after shots. Resolved without treatment.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large area of erythema and warmth at site of Dtap injection 7cmx9cm over L deltoid
Age: 1.04
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Skin lesion, Vaccination failure, Varicella
Clinical narrative: Breakthrough Varicella rash (12 lesions on torso)
Age: 27.0
Sex: F
Vaccine: ANTH, HEP, TYP
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling, Palpitations, Pruritus
Clinical narrative: Redness and swelling at sight of injection spreading down arm lasting approximately one week. Palpitations, mild shortness of breath at night. Severe itching not responsive to antihistamines. No wheezing or choking.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Body temperature increased, Exposure to communicable disease, Pain, Pruritus
Clinical narrative: 3-8-07 AM rash on forehead-went away; 3-4-07 runny nose, sneezing; 3-13-07 severe body and joint pain, temp 100.4F; 3-14-07 no symptoms; 3-15-07 widespread pruritis, vesicular lesions on back, trunk and limbs consistent with Varicella; 3-19-07 no symptoms.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash vesicular, Rhinorrhoea, Skin lesion, Sneezing
Clinical narrative: 3-8-07 AM rash on forehead-went away; 3-4-07 runny nose, sneezing; 3-13-07 severe body and joint pain, temp 100.4F; 3-14-07 no symptoms; 3-15-07 widespread pruritis, vesicular lesions on back, trunk and limbs consistent with Varicella; 3-19-07 no symptoms.
Age: 0.19
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Prolonged diarrhea for several weeks after 1st Rota. Vomited after 2nd Rota. Vomited most of 3rd dose and diarrhea for 1 week after
Age: 0.42
Sex: M
Vaccine: RV5
Symptoms: Rotavirus test positive
Clinical narrative: Information has been received from a pharmacist concerning a 5 month old male who in approximately March 2007 ("3 weeks ago"), was vaccinated with his second dose of Rotateq. Subsequently (date unspecified) the patient has tested positive for Rotateq and was hospitalized. The patient sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Ileus
Clinical narrative: Information has been received from a physician concerning a 3 month old male who was a premature baby who was vaccinated with a 2 mL oral dose of Rotateq. It was noted that it was "not certain that the patient had only one dose prior" to the adverse event. Concomitant therapy included SYNAGIS. Subsequently the patient developed ileus and was hospitalized for approximately 4 days. Subsequently, the patient recovered. The physician stated that he dose not believe that the ileus is related to Rotateq. There was no product quality complaint involved. Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Dehydration, Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 3 month old female who was vaccinated with the first dose of Rotateq (Lot # not provided). Subsequently after receiving the first dose of Rotateq the patient experienced diarrhea, vomiting and dehydration three weeks post-vaccination and had to be hospitalized to treat the condition. The patient was hospitalized for 24 hours. Subsequently, the patient fully recovered from diarrhea, vomiting and dehydration and has been discharged from the hospital. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Hypotonia, Laboratory test
Clinical narrative: Information has been received from a physician concerning a 2-month-old female who was vaccinated PO with a first dose of Rotateq. Subsequently the patient experienced 6 weeks of diarrhea (6-10 watery stools per day). The physician also reported that the patient experienced "three 15 second episodes of limp and was put on a abda monitor". The second and third doses of Rotateq were discontinued. The outcome was recovered on 24-MAR-2007. No further information was provided. There was no product quality complaint. The events were considered to be other important medical events by the reporter. Additional information has been requested.
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a registered nurse concerning an infant female who was vaccinated with oral Rotateq. Subsequently, the patient experienced blood in stool after receiving Rotateq. Unspecified medical attention was sought. Upon internal review blood in the stool was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Anion gap normal, Blood calcium increased, Blood chloride normal, Blood creatinine decreased, Blood culture negative
Clinical narrative: Information has been received from a registered nurse concerning an infant female who was vaccinated with oral Rotateq. Subsequently, the patient experienced blood in stool after receiving Rotateq. Unspecified medical attention was sought. Upon internal review blood in the stool was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood glucose normal, Blood potassium increased, Blood sodium normal, Blood urea normal, Carbon dioxide normal
Clinical narrative: Information has been received from a registered nurse concerning an infant female who was vaccinated with oral Rotateq. Subsequently, the patient experienced blood in stool after receiving Rotateq. Unspecified medical attention was sought. Upon internal review blood in the stool was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool negative, Culture urine negative, Diarrhoea, Haematochezia, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an infant female who was vaccinated with oral Rotateq. Subsequently, the patient experienced blood in stool after receiving Rotateq. Unspecified medical attention was sought. Upon internal review blood in the stool was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Urine analysis normal, Virus serology test
Clinical narrative: Information has been received from a registered nurse concerning an infant female who was vaccinated with oral Rotateq. Subsequently, the patient experienced blood in stool after receiving Rotateq. Unspecified medical attention was sought. Upon internal review blood in the stool was considered to be an other important medical event. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Blood iron, Blood thyroid stimulating hormone, Dizziness, Fatigue, Full blood count
Clinical narrative: Information has been received from a registered nurse concerning a 63 year old female with rheumatoid arthritis, hypothyroidism, cataracts, rhinitis allergic, depression, anaemia and IVP dye allergy who on 16-MAR-2007 was vaccinated with Pneumovax (lot #655587/0882F), 0.5 ml, IM in the left deltoid. Concomitant therapy included CALTRATE, LEXAPRO, montelukast sodium, ADVAIR and ULTRAM. On 17-MAR-2007, the day after receiving the vaccination, the patient experienced symptoms of body aches, fever between 100-102F, flu-like symptoms, nausea, fatigue, and a sore left arm. The patient also "felt faint" and stayed in bed from 17-MAR-2007 through 20-MAR-2007. The patient sought unspecified medication attention. On an unspecified date, the patient had the following laboratory tests performed comprehensive metabolic panel (CMP), complete blood count (CBC) with differential, "usual blood work" (including iron, ferritin and TSH) results were not reported. Subsequently on an unspecified date, the patient recovered from body aches, fever between 100-102F, flu-like symptoms, nausea, fatigue, sore left arm and "felt faint". Body aches, fever between 100-102F, flu-like symptoms, nausea, fatigue, sore left arm and "felt faint" were considered to be disabling. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Haematology test, Influenza like illness, Laboratory test, Nausea, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 63 year old female with rheumatoid arthritis, hypothyroidism, cataracts, rhinitis allergic, depression, anaemia and IVP dye allergy who on 16-MAR-2007 was vaccinated with Pneumovax (lot #655587/0882F), 0.5 ml, IM in the left deltoid. Concomitant therapy included CALTRATE, LEXAPRO, montelukast sodium, ADVAIR and ULTRAM. On 17-MAR-2007, the day after receiving the vaccination, the patient experienced symptoms of body aches, fever between 100-102F, flu-like symptoms, nausea, fatigue, and a sore left arm. The patient also "felt faint" and stayed in bed from 17-MAR-2007 through 20-MAR-2007. The patient sought unspecified medication attention. On an unspecified date, the patient had the following laboratory tests performed comprehensive metabolic panel (CMP), complete blood count (CBC) with differential, "usual blood work" (including iron, ferritin and TSH) results were not reported. Subsequently on an unspecified date, the patient recovered from body aches, fever between 100-102F, flu-like symptoms, nausea, fatigue, sore left arm and "felt faint". Body aches, fever between 100-102F, flu-like symptoms, nausea, fatigue, sore left arm and "felt faint" were considered to be disabling. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Serum ferritin
Clinical narrative: Information has been received from a registered nurse concerning a 63 year old female with rheumatoid arthritis, hypothyroidism, cataracts, rhinitis allergic, depression, anaemia and IVP dye allergy who on 16-MAR-2007 was vaccinated with Pneumovax (lot #655587/0882F), 0.5 ml, IM in the left deltoid. Concomitant therapy included CALTRATE, LEXAPRO, montelukast sodium, ADVAIR and ULTRAM. On 17-MAR-2007, the day after receiving the vaccination, the patient experienced symptoms of body aches, fever between 100-102F, flu-like symptoms, nausea, fatigue, and a sore left arm. The patient also "felt faint" and stayed in bed from 17-MAR-2007 through 20-MAR-2007. The patient sought unspecified medication attention. On an unspecified date, the patient had the following laboratory tests performed comprehensive metabolic panel (CMP), complete blood count (CBC) with differential, "usual blood work" (including iron, ferritin and TSH) results were not reported. Subsequently on an unspecified date, the patient recovered from body aches, fever between 100-102F, flu-like symptoms, nausea, fatigue, sore left arm and "felt faint". Body aches, fever between 100-102F, flu-like symptoms, nausea, fatigue, sore left arm and "felt faint" were considered to be disabling. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: PPV
Symptoms: Electrocardiogram QT prolonged, Heart rate increased, Loss of consciousness
Clinical narrative: Information has been received from a nurse practitioner concerning a 13 year old female who on an unspecified date was vaccinated with first dose, single dose vial, of Gardasil (lot # not reported) IM injection. On an unspecified date, within 10 minutes of receiving the vaccination, the patient passed out. The patient's heart rate was over 200. The patient passed out a total of three times. Medical attention was sought. The patient was hospitalized as a result of the experience. At the time of reporting, the patient had prolonged Q-T and was being seen by a cardiologist for the condition. The outcome of the events was unknown. The reporter considered the events to be immediately life-threatening. Additional information has been requested.
Sex: M
Vaccine: FLU3
Symptoms: Erythema multiforme
Clinical narrative: This case was reported by a pharmacist and described the occurrence of erythema multiforme in an adult male subject who was vaccinated with influenza virus vaccine (Influenza vaccine, manufacturer unspecified) for prophylaxis. On an unspecified date in 2006, on or before 01 December 2006, the subject received unspecified dose of Influenza vaccine. At an unspecified time following the administration of influenza vaccine, on an unspecified date in 2006, on or before 01, December 2006, less than one year after vaccination with influenza vaccine, the subject experienced erythema multiforme, The outcome of the event was not reported. Comment: Erythema multiforme was assessed as medically serious by GSK.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in a 55 year old male subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. Concurrent medications included Ramelteon (Rozerem). The Subject had received influenza virus vaccine in previous years with no subsequent adverse events. On 09, November 2006 the subject received unspecified dose of Fluarix in the left deltoid. On 09, November 2006, less than one day after vaccination with Fluarix, the subject experienced injection site pain. The subject described the pain as "constant and five out of ten for the 1st three days, then 3 out of 10 since that time." At the time of initial reporting, 05, December 2006, the event was improved. Follow-up received on 28, December 2006 indicated that the subject's relevant medical history included chronic interstitial cystitis and chronic prostatitis. The subject has taken other influenza vaccines without problems. the reporter considered that the events were possibly related to the use of Fluarix.
Sex: F
Vaccine: FLU3
Symptoms: Adverse event, Unevaluable event
Clinical narrative: On 12 December 2006 the subject received unspecified dose of Influenza vaccine. On 12, December 2006, less than one day after vaccination with Influenza vaccine, the subject experienced an unspecified adverse event. At the time of initial reporting. 12, December 2006, the event was worse.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in an adult female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. The subject received influenza virus vaccine in previous years with no subsequent adverse events. On 07, December 2006 the subject received unspecified dose of Fluarix, On an unspecified date in December 2006, within one week after vaccination with Fluarix, the subject experience injection site pain. At the time of initial reporting, 18, December 2006, the event was ongoing and the healthcare professional reported that the injection site pain, "has lasted for a week" The healthcare professional considered the event was probably related to vaccination with Fluarix.
Sex: F
Vaccine: FLU3
Symptoms: Fall, Injection site pain
Clinical narrative: this subject received influenza virus vaccine in previous years with no subsequent adverse events. On 07, December 2006 the subject received unspecified dose of Fluarix. On an unspecified date in December 2006, within one week after vaccination with Fluarix, the subject experienced injection site pain. The subject subsequently fell and "aggravated the injection site." The subject was seen at a physician's office and was prescribed ibuprofen At the time of initial reporting, 18, December 2006, the event was ongoing and the healthcare professional reported that the injection site pain, "has lasted for a week. " The healthcare professional considered the event was probably related to vaccination with Fluarix.
Age: 43.0
Sex: F
Vaccine: FLU3, MEN
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a healthcare professional and describe the occurrence of injection site pain in a 43 year old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis, The reporter is the subject. Concurrent medications included Thyroxine sodium (Synthroid). On an unspecified date in 2005, the subject received unspecified dose of Fluarix. On an unspecified date in 2005, less than one year after vaccination with Fluarix, the subject experienced injection site pain. The injection site pain resolved on an unspecified date before 03, November 2006. On 03, November 2006 the subject received another dose of Fluarix in the left arm. On 03, November 2006 the subject also received vaccination with meningococcal vaccine (unspecified, non-GSK manufacturer). The site of administration of the meningococcal vaccine was not provided. On an unspecified date in 2006, on or after 03, November 2006 and on or before 18, December 2006, less than one year after vaccination with Fluarix, the subject again experienced pain at the injection site of Fluarix. The injection site pain resolved on an unspecified date on or after 03, November 2006 and on or before 18, December 2006. The professional considered the events were probably related to vaccination with Fluarix.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of rash in a 32 year old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) and later her spouse was vaccinated with influenza virus vaccine for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medical conditions included drug allergy to gentamician. In November 2006, the subject received unspecified dose of Fluarux (unknown) and experienced rash and itching. Treated with Benadryl. events resolved within two weeks. On 09, December 2006 the subject's husband received unspecified dose of Influenza virus vaccine (manufacturer unknown). The reporter stated that the following day she had intercourse with her husband and she began to experience rash and itching on her back. legs and chest like she did following her vaccination with Fluarix. The reporter stated that she believed "that she may have had a reaction from her husband's bodily fluids which may have carried gentaician into her system form the flu vaccine. She received treatment with diphenhydramine hydrochloride (Benadryl). At the time of reporting the outcome of the events were unresolved. she considered that the events jeopardized/required intervention.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Lymph node pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site soreness in a 60 year old female subject who was vaccinated wit influenza virus vaccine (Influenza vaccine, manufacturer unspecified) for prophylaxis. On an unspecified date in December 2006 the subject received unspecified dose of Influenza vaccine in the right arm. On an unspecified date in December 2006, less than one month after vaccination with Influenza vaccine, the subject experienced injection site soreness, and soreness to the "top of the right arm" and soreness to the lymph nodes under the right arm. At the time of initial reporting, 04, January 2007, the events were ongoing.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Lacrimation increased, Pain in extremity, Rhinitis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of cough in a 55 year old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. Previous and /or concurrent vaccination included hepatitis A vaccine (Havrix); GlaxoSmithKline given on 4, January 2007. concomitant medications were not provided. On 4, January 2007 the subject received and unspecified dose of Fluarix (.5 ml, unknown, left arm). On 6, January 2007  2 days after vaccination with Fluarix, the subject experienced cough, watery eyes, sneezing, rhinitis, arm soreness and fatigue. She received no specific treatment for these events. The subject reported that she experiences cough watery eyes, sneezing, rhinitis, soreness in arm, and fatigue once or twice a year, even without vaccination. On 8, January 2006 the events were resolved. Follow-up received on 01, February 2007: The events resolved on 19, January 2007. The reporting healthcare professional considered the events were possibly related to vaccination with Fluarix.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Sneezing
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of cough in a 55 year old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. Previous and /or concurrent vaccination included hepatitis A vaccine (Havrix); GlaxoSmithKline given on 4, January 2007. concomitant medications were not provided. On 4, January 2007 the subject received and unspecified dose of Fluarix (.5 ml, unknown, left arm). On 6, January 2007  2 days after vaccination with Fluarix, the subject experienced cough, watery eyes, sneezing, rhinitis, arm soreness and fatigue. She received no specific treatment for these events. The subject reported that she experiences cough watery eyes, sneezing, rhinitis, soreness in arm, and fatigue once or twice a year, even without vaccination. On 8, January 2006 the events were resolved. Follow-up received on 01, February 2007: The events resolved on 19, January 2007. The reporting healthcare professional considered the events were possibly related to vaccination with Fluarix.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Joint stiffness
Clinical narrative: This case was reported by a nurse via a sales representative and described the occurrence of injection site pain in a 25 year old female subject who was vaccinated with FLUARIX, GlaxoSmithKline. On an unspecified date on or prior to 17, January 2007, the subject received unspecified dose of FLUARIX (0.5 ml, unknown, right arm). On 18 October 2006 after vaccination with FLUARIX, the subject experienced injection site pain, joint stiffness and unable to raise arm. At the time of reporting the outcome of the events was unspecified. Follow-up information received - The events completely resolved by 18 November 2006. In the reporter's opinion, the events were possibly related to treatment with FLUARIX.
Sex: U
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Joint stiffness
Clinical narrative: This case was reported by a nurse via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with influreza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On an unspecified date on or prior to 17, January 2007, the subject received unspecified dose of Fluarix (0.5 ml, unknown, right arm). On an unspecified date after vaccination with Fluarix, the subject experienced injection site pain, joint stiffness and unable to raise arm. At the time of reporting the outcome of the events was specified.
Sex: U
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Joint stiffness
Clinical narrative: This case was reported by a nurse via a sales representative and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On an unspecified date on or prior to 17, January 2007, the subject received unspecified dose of Fluarix (0.5 ml, unknown, right arm). On an unspecified date after vaccination with Fluarix, the subject experienced injection site pain, joint stiffness and unable to raise arm. At the time of reporting the outcome of the events was unspecified.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity, Reaction to preservatives
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of sore arm in a 45 year old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. The subject had not previously received an influenza virus vaccine. The subject had not previously received an influenza virus vaccine immunization. On 16, November 2006 at 8;36 p.m the subject received a dose of Fluarix in an unspecified arm. On an unspecified date on or after 16, November 2006, less than one week after vaccination with Fluarix, the subject experienced injection site redness, heat at injection site. and "her entire arm was sore. "The subject was seen at a physician's office. The healthcare professional reported that, " the patient's doctor stated that she may be allergic to the preservative in the vaccination." The events resolved in approximately one week on an unspecified date in 2006. The healthcare professional considered the events were probably related to vaccination with Fluarix. Follow-up information received on 26 February 2007 indicated that the events began on 17, November 2006, the day after vaccination with Fluarix. The events completely resolved by 24, November 2006. An additional event of arm swelling was reported. In the reporter's opinion, the events were related to treatment with Fluarix.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of unspecified adverse reaction in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Flu vaccine, manufacturer unspecified) for prophylaxis. On an unspecified date, approximately four years ago, the subject received unspecified dose of Flu vaccine (unknown) and experienced an unspecified adverse reaction in 2001. The healthcare professional reported that the subject reacted to the neomycin component of the flu vaccine. At the time of reporting the outcome of the event was unspecified.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Angioedema, Drug hypersensitivity, Face oedema, Laryngeal oedema, Pruritus generalised
Clinical narrative: This case was reported by a physician and described the occurrence of hives in a 29 year old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. The subject's medical history included exposure to tuberculosis and penicillin allergy - urticaria. Concurrent medications included Ortho Tri-Cyclen (Orthotricyclen), Pantoprazole (Protonix), Methylphenidate hydrochloride (Ritalin)Methylphenidate hydrochloride (Concerta) and pyridoxine hydrochloride (Vitamin B6). Concurrent medication also included "9 months of Isoniazid therapy which will conclude in May 2007." The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On 19, October 2006 at 12:00 p.m., the subject received unspecified dose of Fluarix in the left arm. the "evening of " 19, October 2006, less than one day after vaccination with Fluarix, the subject experienced hives and itching all over her body and angioedema. The physician considered the events were life threatening and clinically significant (or requiring intervention). The subject was treated with diphenhydramine (Benadryl). Approximately one month after receipt of Fluarix, on an unspecified date in November 2006, the subject was seen by an physician for skin testing. The skin testing revealed positive skin reactions to Fluarix and to gentamicin. The physician stated that the subject "cannot recall ever having an exposure to gentamicin" and that gentamicin is, "contained within Fluarix." The events resolved on an unspecified date on or before 24, January 2007. Follow-up was received from the reporting physician on 09, February 2007. Medical history also included non-smoker and non-drinker. The event of angioedema was clarified to facial and laryngeal edema. The events resolved on 20 October 2006. The physician considered the events to possibly be related to vaccination with Fluarix.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Skin test positive, Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of hives in a 29 year old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. The subject's medical history included exposure to tuberculosis and penicillin allergy - urticaria. Concurrent medications included Ortho Tri-Cyclen (Orthotricyclen), Pantoprazole (Protonix), Methylphenidate hydrochloride (Ritalin)Methylphenidate hydrochloride (Concerta) and pyridoxine hydrochloride (Vitamin B6). Concurrent medication also included "9 months of Isoniazid therapy which will conclude in May 2007." The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On 19, October 2006 at 12:00 p.m., the subject received unspecified dose of Fluarix in the left arm. the "evening of " 19, October 2006, less than one day after vaccination with Fluarix, the subject experienced hives and itching all over her body and angioedema. The physician considered the events were life threatening and clinically significant (or requiring intervention). The subject was treated with diphenhydramine (Benadryl). Approximately one month after receipt of Fluarix, on an unspecified date in November 2006, the subject was seen by an physician for skin testing. The skin testing revealed positive skin reactions to Fluarix and to gentamicin. The physician stated that the subject "cannot recall ever having an exposure to gentamicin" and that gentamicin is, "contained within Fluarix." The events resolved on an unspecified date on or before 24, January 2007. Follow-up was received from the reporting physician on 09, February 2007. Medical history also included non-smoker and non-drinker. The event of angioedema was clarified to facial and laryngeal edema. The events resolved on 20 October 2006. The physician considered the events to possibly be related to vaccination with Fluarix.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of raised red lump at injection site in a 54 year old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. Concurrent medical conditions included drug allergy, high blood pressure, hypothyroidism and subdural hematoma. The subject smoked 1/2 pack a day and did not drink alcohol. concurrent medications included phenytoin (Dilantin), Thyroxine sodium (Levothyroxine and Atenolo1. On 17, October 2006 at 14:30 the subject received unspecified dose of Fluarix intramuscularly in the right deltoid. A day later, on 18, October 2006, the subject developed an almond sized, red, swollen, hard, painful lump at the injection site. Then the area became blistered. The subject developed fever blisters on her nose and lips. a stuffy head and nose and had head congestion. The subject physician advised her never to get the flu vaccine again. At the time of reporting the outcome of the events was unspecified. Follow-up information was received from the healthcare provider on 03 April 2007. According to follow-up, the subject received flu vaccine (unspecified manufacturer) in past years. "Four years ago, she had soreness at injection site" at unspecified time after receiving the flu vaccine. It was also reported that the subject had soreness at injection site "previous years". The outcome of the soreness at injection site was not provided. With events that subject experienced on 18 October 2007, the healthcare profesional reported diagnosis as a vaccine reaction. The vaccine reaction and associated symptoms resolved on an unspecified date. The reporter considered it possible that the vaccine reaction was related to vaccination with FLUARIX. Treatment included unspecified antibiotics on four occasions for "respiratory and/ or sinus" since receiving vaccination with FLUARIX. The FLUARIX was not reintroduced to the subject.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site vesicles, Nasal congestion, Oral herpes, Upper respiratory tract congestion
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of raised red lump at injection site in a 54 year old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. Concurrent medical conditions included drug allergy, high blood pressure, hypothyroidism and subdural hematoma. The subject smoked 1/2 pack a day and did not drink alcohol. concurrent medications included phenytoin (Dilantin), Thyroxine sodium (Levothyroxine and Atenolo1. On 17, October 2006 at 14:30 the subject received unspecified dose of Fluarix intramuscularly in the right deltoid. A day later, on 18, October 2006, the subject developed an almond sized, red, swollen, hard, painful lump at the injection site. Then the area became blistered. The subject developed fever blisters on her nose and lips. a stuffy head and nose and had head congestion. The subject physician advised her never to get the flu vaccine again. At the time of reporting the outcome of the events was unspecified. Follow-up information was received from the healthcare provider on 03 April 2007. According to follow-up, the subject received flu vaccine (unspecified manufacturer) in past years. "Four years ago, she had soreness at injection site" at unspecified time after receiving the flu vaccine. It was also reported that the subject had soreness at injection site "previous years". The outcome of the soreness at injection site was not provided. With events that subject experienced on 18 October 2007, the healthcare profesional reported diagnosis as a vaccine reaction. The vaccine reaction and associated symptoms resolved on an unspecified date. The reporter considered it possible that the vaccine reaction was related to vaccination with FLUARIX. Treatment included unspecified antibiotics on four occasions for "respiratory and/ or sinus" since receiving vaccination with FLUARIX. The FLUARIX was not reintroduced to the subject.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Injection site erythema, Injection site induration, Upper respiratory tract congestion, Vomiting
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site redness in a 40 year old female subject who was vaccinated with influenza virus (Fluarix, GlaxoSmithskline) for prophylaxis. The subject's medical history included allergy to nsaids, cellulitis, dyspareunia,dysthymia, gastroesophageal reflux disease, hyperlipidemia, knee osteoarthritis and neck abscess. Concurrent medications included Moxifloxacin hydrochloride (Moxifloxacin), Rosuvastatin, calcium (Crestor), Vicodin, Lormetazepam, Omeprazole (Prilosec), Nortriptyline, Trazodone and Capsaicin (Capsaicin cream). The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On 29, January 2007 the subject received unspecified dose of Fluarix in the right deltoid. On 29, January 2007, the subject also received and administration of tetanus and diphtheria toxoids adsorbed (Adventis Pasteur) at an unspecified site of injection. On 01, February 2007, 3 days after vaccination with Fluarix, the subject experienced redness and hardening at the injection site of Fluarix "in an area if 8 mm, " chest pain, chest congestion, and vomiting. The redness and hardening at the injection site resolved on 06 February 2007. On 12 February 2007, the subject was seen at a physician's office and the chest pain , chest congestion and vomiting were resolved. The pharmacist considered the events were possible related to vaccination with Fluarix. Follow-up information received on 26, February 2007 indicated that the event actually resolved by 06 February 2007 as opposed to the originally reported date of 12 February 2007. The events were not considered to be life threatening. A history of smoking , 1 pack per day was reported. No additional information was reported.
Sex: U
Vaccine: FLU3
Symptoms: Mental status changes
Clinical narrative: This case was reported by a pharmacist and described the occurrence of mental status changes in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Influenza vaccine, manufacturer unspecified) for prophylaxis. There were no concurrent medications. On an unspecified date before 15, February 2007, the subject received unspecified dose of Influenza vaccine. At an unspecified time after vaccination with Influenza vaccine. On an unspecified date on or before 15, February 2007, the subject experienced mental status changes. At the time of initial reporting, 15, February 2007, the event was ongoing
Sex: F
Vaccine: FLUX
Symptoms: Erythema
Clinical narrative: This case was reported by a consumer and described the occurrence of erythema of leg in an adult female subject who was vaccinated with influenza virus vaccine (Flu vaccine, manufacturer unspecified for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medical conditions included egg allergy. On an unspecified date, 50 years ago when the subject was a child, she received an unspecified dose of Flu vaccine (unknown) At an unspecified time after vaccination with Flu vaccine, both the subject's legs became "beet red" The subject did not recall who made the Flu vaccine she received and did not recall any further information about the incident. At the time of reporting, the outcome of the event was specified.
Sex: U
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a physician and described the occurrence of anaphylactic reaction in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Flu vaccine) for prophylaxis. On an unspecified date, 30 to 40 years ago, the subject received unspecified dose of Flu vaccine and experienced and anaphylactic reaction. This case was assessed as medically serious by GSK. At the time of reporting the event was resolved.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Skin burning sensation, Urticaria
Clinical narrative: Patient went tanning at tanning booth, has tanned previous to vaccine. Did not use sun tanning lotion. 2 hrs post tanning after showering noticed hives on chest, breasts and armpits. C/O burning and itching, pt instructed no tanning until further notice per doctor. No other c/o symptoms. Hives lasted 8 hr then disappeared.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyspnoea, Erythema, Hypersensitivity, Palpitations
Clinical narrative: Mom called the office and said she was going to bring patient to the clinic because he was turning red, short of breath, and fast heart palpitations. Doctor said that she need to take him to ER. Mom took him to ER. Pt was managed with steroids and albuterol via nebulizer.
Age: 20.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Loss of consciousness, Syncope, Syncope vasovagal, Urinary incontinence
Clinical narrative: within 10 seconds after received both vaccines pt experienced syncopal episode which included bladder incontinence, loc of 5-10S. After pt was oriented x 3. Transferred to local ER. CT scan of head nl and pt dx'ed with vasovagal rxn.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster, Injection site rash, Injection site vesicles, Vaccination failure, Varicella
Clinical narrative: Patient Received Varivax #2 right upper arm 03/28/07. Rash developed at injection site 03/31/07 and patches of vesicles spread to the entire right arm. Classic herpes zoster.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Swelling
Clinical narrative: Received 4 year old vaccinations left upper arm has some swelling. No fever, pain, here for shots only today 3/22/07
Age: 9.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Vaccination failure, Varicella
Clinical narrative: Modified Varicella-50 lesions
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Skin lesion, Vaccination failure, Varicella
Clinical narrative: Modified varicella-50 lesions
Sex: U
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella
Clinical narrative: Modified Varicella-50 lesions
Age: 15.0
Sex: F
Vaccine: HIBV
Symptoms: Blood test, Computerised tomogram, Dizziness, Fatigue, Fluid replacement
Clinical narrative: Initial report received from a nurse (who is the patient's  mother) in the USA on 19, December 2006. A 15 year old, female patient experienced dizziness, three hours after she received 0.5 cc of Act-HIB (lot number UE994AB, route of administration not reported) in the left shoulder on 13, December 2006. The patient received the vaccine because her "titers were low" No fever was noted. On Friday, 15, December 2006, the patient was seen by a pediatrician. On Monday, 18, December 2006, she was seen by and ENT since the dizziness was still persisting. The patient continued to experience dizziness, severe headaches and nausea and was taken to the emergency room on Tuesday, 19, December 2006. In the ER, blood work was drawn and a CAT scan and MRI were completed; the results were not provided. The patient was treated with fluids and anti-nauses medication Phenergah and was released. As of 20, December 2006, the patient is still tired.
Age: 15.0
Sex: F
Vaccine: HIBV
Symptoms: Headache, Nausea, Nuclear magnetic resonance imaging
Clinical narrative: Initial report received from a nurse (who is the patient's  mother) in the USA on 19, December 2006. A 15 year old, female patient experienced dizziness, three hours after she received 0.5 cc of Act-HIB (lot number UE994AB, route of administration not reported) in the left shoulder on 13, December 2006. The patient received the vaccine because her "titers were low" No fever was noted. On Friday, 15, December 2006, the patient was seen by a pediatrician. On Monday, 18, December 2006, she was seen by and ENT since the dizziness was still persisting. The patient continued to experience dizziness, severe headaches and nausea and was taken to the emergency room on Tuesday, 19, December 2006. In the ER, blood work was drawn and a CAT scan and MRI were completed; the results were not provided. The patient was treated with fluids and anti-nauses medication Phenergah and was released. As of 20, December 2006, the patient is still tired.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Rash maculo-papular, Rash pruritic
Clinical narrative: Patient developed itchy, maculopapular rash on the palms 2 days after Gardasil was administered.  Sje also had temp of 102 which lasted less than 1 day duration.  Po benadryl given.
Age: 1.33
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration, Medication error, Wrong drug administered
Clinical narrative: Tdap administered in error- DTap should have been given.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: pain with redness and warmth at immunization site with swelling extending underarm to upper lateral rib area.  generalized muscle aches, with temperature x 2 days of 100.4- medicated with ibuprofen and tylenol and rest
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Oedema peripheral
Clinical narrative: pain with redness and warmth at immunization site with swelling extending underarm to upper lateral rib area.  generalized muscle aches, with temperature x 2 days of 100.4- medicated with ibuprofen and tylenol and rest
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Reaction on both thighs from Hep A, Daptacel, and Prevnar.  All three sites were red, swollen, and warm to touch. On the left thigh, they measured 2 x 1 1/2cm and 3 1/2 x 1 1/2 cm.  On the right thigh, it measured 3 x 2 1/2 cm. Treated with benadryl and tylenol and ibuprofen.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: patient developed localized hives on left deltoid at injection site, hives spread to face. no respiratory distress. Benadryl 25mg given. No other sequelae
Age: 41.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity, Physiotherapy
Clinical narrative: 3/19/07 PATIENT REPORTED TO WALK IN CLINIC WITH C/O CONTINUED LT UE PAIN AND IMMOBILITY. WAS PRESCRIBED A PREDNISONE TAPER. ON 3/20/07 PATIENT RETURNED TO REPORT NOT TAKING PREDNISONE AND SEEKING RESOLUTION OF LEFT ARM PAIN AND IMMOBILITY. WAS REFERRED TO ORTHOPEDIC CLINIC AT  MEDICAL CENTER AND WAS PROVIDED WITH A PHYSICAL THERAPY APPOINTMENT.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction, Refusal of treatment by relative
Clinical narrative: Local reaction. Mother declined for child to be seen by doctor. She described area size of a baseball, swollen, red, and warm to touch
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Rash papular
Clinical narrative: patient developed a skin collored papular nonpruritic rash on arms and face 5 days after receiving hpv and tdap vaccines. came to the doctors to be evalauted for the rash. no other symptoms or sequelae
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: complained of a hive reaction on the upper extremities 2 days after administered
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: PATIENT PRESENTED AT OFFICE WITH C/O FEVER OF 102.7 ONSET OF 04\03\2007
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Local reaction, Urticaria
Clinical narrative: LOCAL REACTION WITH URTICARIA
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Local reaction, Pruritus, Skin warm
Clinical narrative: Large local reaction palm size very ichy and warm to touch
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Zoster 4 1/2 years after single dose Varicella
Sex: F
Vaccine: DTAP
Symptoms: Convulsion
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of seizures in a female child subject (who was 17 years old at the time of reporting) who was vaccinated with Dtap for prophylaxis. On an unknown date during the subject's childhood, she received unspecified dose(s) of DTAP vaccine. At an unspecified time after vaccination with DTAP, the subject experienced seizures. This case was assessed as medically serious by manufacturer. At the time of reporting, the outcome of the event was unspecified. Of note, the report from the manufacture noted that the adverse event descriptions cited "only a history of seizures after receiving DTAP as a child." No further information was available.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Injection site erythema, Injection site vesicles, Oedema peripheral, Pyrexia
Clinical narrative: Localised erythema and swelling for 2 days. Fever 101 x 1 day. Localised chicken pox lesion (one at the site of injection) site-left upper arm
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Swelling, Varicella
Clinical narrative: Localised erythema and swelling for 2 days. Fever 101 x 1 day. Localised chicken pox lesion (one at the site of injection) site-left upper arm