chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Bradycardia, Bundle branch block left, C-reactive protein increased, Cardioactive drug level decreased, Catheterisation cardiac abnormal
Clinical narrative: A report has been received from Regulatory concerning a 41 year old, female patient. The patient's past medical history included morphine, KEFLEX, LORTAB, gynecological problems, heart problems. Concomitant medications included digoxin, vitamins NOS, ramipril, calcium and fish oil. On 22-Oct-2008 the patient received nasal FLUMIST. On 23-Oct-2008 the patient experienced body aches, fever (temperature 102), chills, and temp returned to normal with TYLENOL and MOTRIN. (The 1 day interval shown refers to myalgias, but it was 13 days before admission with discharged dx of rhabdo.) The patient improved with intravenous fluids and was discharged to home. On 23-Oct-2008 patient had all over body aches T-102, chills, temp returned to normal with TYLENOL and MOTRIN. On 27-Oct-2008 finally felt well enough to go to work. Was shaky with walking, heavy head, hands, feet, tired. On 04-Nov-2008 the patient had chest pain radiating up to neck and left arm, nausea diarrhea x5 decreased heart rate and B/P. On 17-Feb-2009 the patient was admitted to the hospital. Suspect viral syndrome possibly secondary to nasal flu vaccine, left bundle branch block, mild congestive cardiomyopathy with left ventricular dysfunction, bradycardia, diarrhea. Records reveal patient experienced chest pressure, nausea, lightheadedness, general discomfort. Cardio and Neuro consult done. On 05-Nov-2008 laboratory values was as follows: heart cath with Ef of 45-50%, ana-neg, rheumatoid factor <5, CBC-nonsign, BMP-NL, 11/4-CK-4280, LDH- 278, AST-95, CRP-52, digoxin level-0.5, TSH-2.05, T3-1.11, urine-neg, CTA chest-mild atelectasis negative for PE, GB sono-Nl, echo-nonsignif. According to the reporter the assessment of the Serious criteria for the report was as follows: Hospitalised.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Chest discomfort, Chest pain, Chills, Computerised tomogram thorax normal, Congestive cardiomyopathy
Clinical narrative: A report has been received from Regulatory concerning a 41 year old, female patient. The patient's past medical history included morphine, KEFLEX, LORTAB, gynecological problems, heart problems. Concomitant medications included digoxin, vitamins NOS, ramipril, calcium and fish oil. On 22-Oct-2008 the patient received nasal FLUMIST. On 23-Oct-2008 the patient experienced body aches, fever (temperature 102), chills, and temp returned to normal with TYLENOL and MOTRIN. (The 1 day interval shown refers to myalgias, but it was 13 days before admission with discharged dx of rhabdo.) The patient improved with intravenous fluids and was discharged to home. On 23-Oct-2008 patient had all over body aches T-102, chills, temp returned to normal with TYLENOL and MOTRIN. On 27-Oct-2008 finally felt well enough to go to work. Was shaky with walking, heavy head, hands, feet, tired. On 04-Nov-2008 the patient had chest pain radiating up to neck and left arm, nausea diarrhea x5 decreased heart rate and B/P. On 17-Feb-2009 the patient was admitted to the hospital. Suspect viral syndrome possibly secondary to nasal flu vaccine, left bundle branch block, mild congestive cardiomyopathy with left ventricular dysfunction, bradycardia, diarrhea. Records reveal patient experienced chest pressure, nausea, lightheadedness, general discomfort. Cardio and Neuro consult done. On 05-Nov-2008 laboratory values was as follows: heart cath with Ef of 45-50%, ana-neg, rheumatoid factor <5, CBC-nonsign, BMP-NL, 11/4-CK-4280, LDH- 278, AST-95, CRP-52, digoxin level-0.5, TSH-2.05, T3-1.11, urine-neg, CTA chest-mild atelectasis negative for PE, GB sono-Nl, echo-nonsignif. According to the reporter the assessment of the Serious criteria for the report was as follows: Hospitalised.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Diarrhoea, Discomfort, Dizziness, Echography normal, Ejection fraction decreased
Clinical narrative: A report has been received from Regulatory concerning a 41 year old, female patient. The patient's past medical history included morphine, KEFLEX, LORTAB, gynecological problems, heart problems. Concomitant medications included digoxin, vitamins NOS, ramipril, calcium and fish oil. On 22-Oct-2008 the patient received nasal FLUMIST. On 23-Oct-2008 the patient experienced body aches, fever (temperature 102), chills, and temp returned to normal with TYLENOL and MOTRIN. (The 1 day interval shown refers to myalgias, but it was 13 days before admission with discharged dx of rhabdo.) The patient improved with intravenous fluids and was discharged to home. On 23-Oct-2008 patient had all over body aches T-102, chills, temp returned to normal with TYLENOL and MOTRIN. On 27-Oct-2008 finally felt well enough to go to work. Was shaky with walking, heavy head, hands, feet, tired. On 04-Nov-2008 the patient had chest pain radiating up to neck and left arm, nausea diarrhea x5 decreased heart rate and B/P. On 17-Feb-2009 the patient was admitted to the hospital. Suspect viral syndrome possibly secondary to nasal flu vaccine, left bundle branch block, mild congestive cardiomyopathy with left ventricular dysfunction, bradycardia, diarrhea. Records reveal patient experienced chest pressure, nausea, lightheadedness, general discomfort. Cardio and Neuro consult done. On 05-Nov-2008 laboratory values was as follows: heart cath with Ef of 45-50%, ana-neg, rheumatoid factor <5, CBC-nonsign, BMP-NL, 11/4-CK-4280, LDH- 278, AST-95, CRP-52, digoxin level-0.5, TSH-2.05, T3-1.11, urine-neg, CTA chest-mild atelectasis negative for PE, GB sono-Nl, echo-nonsignif. According to the reporter the assessment of the Serious criteria for the report was as follows: Hospitalised.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Fatigue, Full blood count normal, Gait disturbance, Head discomfort, Heart rate decreased
Clinical narrative: A report has been received from Regulatory concerning a 41 year old, female patient. The patient's past medical history included morphine, KEFLEX, LORTAB, gynecological problems, heart problems. Concomitant medications included digoxin, vitamins NOS, ramipril, calcium and fish oil. On 22-Oct-2008 the patient received nasal FLUMIST. On 23-Oct-2008 the patient experienced body aches, fever (temperature 102), chills, and temp returned to normal with TYLENOL and MOTRIN. (The 1 day interval shown refers to myalgias, but it was 13 days before admission with discharged dx of rhabdo.) The patient improved with intravenous fluids and was discharged to home. On 23-Oct-2008 patient had all over body aches T-102, chills, temp returned to normal with TYLENOL and MOTRIN. On 27-Oct-2008 finally felt well enough to go to work. Was shaky with walking, heavy head, hands, feet, tired. On 04-Nov-2008 the patient had chest pain radiating up to neck and left arm, nausea diarrhea x5 decreased heart rate and B/P. On 17-Feb-2009 the patient was admitted to the hospital. Suspect viral syndrome possibly secondary to nasal flu vaccine, left bundle branch block, mild congestive cardiomyopathy with left ventricular dysfunction, bradycardia, diarrhea. Records reveal patient experienced chest pressure, nausea, lightheadedness, general discomfort. Cardio and Neuro consult done. On 05-Nov-2008 laboratory values was as follows: heart cath with Ef of 45-50%, ana-neg, rheumatoid factor <5, CBC-nonsign, BMP-NL, 11/4-CK-4280, LDH- 278, AST-95, CRP-52, digoxin level-0.5, TSH-2.05, T3-1.11, urine-neg, CTA chest-mild atelectasis negative for PE, GB sono-Nl, echo-nonsignif. According to the reporter the assessment of the Serious criteria for the report was as follows: Hospitalised.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Left ventricular dysfunction, Metabolic function test normal, Myalgia, Nausea, Neck pain
Clinical narrative: A report has been received from Regulatory concerning a 41 year old, female patient. The patient's past medical history included morphine, KEFLEX, LORTAB, gynecological problems, heart problems. Concomitant medications included digoxin, vitamins NOS, ramipril, calcium and fish oil. On 22-Oct-2008 the patient received nasal FLUMIST. On 23-Oct-2008 the patient experienced body aches, fever (temperature 102), chills, and temp returned to normal with TYLENOL and MOTRIN. (The 1 day interval shown refers to myalgias, but it was 13 days before admission with discharged dx of rhabdo.) The patient improved with intravenous fluids and was discharged to home. On 23-Oct-2008 patient had all over body aches T-102, chills, temp returned to normal with TYLENOL and MOTRIN. On 27-Oct-2008 finally felt well enough to go to work. Was shaky with walking, heavy head, hands, feet, tired. On 04-Nov-2008 the patient had chest pain radiating up to neck and left arm, nausea diarrhea x5 decreased heart rate and B/P. On 17-Feb-2009 the patient was admitted to the hospital. Suspect viral syndrome possibly secondary to nasal flu vaccine, left bundle branch block, mild congestive cardiomyopathy with left ventricular dysfunction, bradycardia, diarrhea. Records reveal patient experienced chest pressure, nausea, lightheadedness, general discomfort. Cardio and Neuro consult done. On 05-Nov-2008 laboratory values was as follows: heart cath with Ef of 45-50%, ana-neg, rheumatoid factor <5, CBC-nonsign, BMP-NL, 11/4-CK-4280, LDH- 278, AST-95, CRP-52, digoxin level-0.5, TSH-2.05, T3-1.11, urine-neg, CTA chest-mild atelectasis negative for PE, GB sono-Nl, echo-nonsignif. According to the reporter the assessment of the Serious criteria for the report was as follows: Hospitalised.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Pain, Pain in extremity, Pyrexia, Rhabdomyolysis, Rheumatoid factor negative
Clinical narrative: A report has been received from Regulatory concerning a 41 year old, female patient. The patient's past medical history included morphine, KEFLEX, LORTAB, gynecological problems, heart problems. Concomitant medications included digoxin, vitamins NOS, ramipril, calcium and fish oil. On 22-Oct-2008 the patient received nasal FLUMIST. On 23-Oct-2008 the patient experienced body aches, fever (temperature 102), chills, and temp returned to normal with TYLENOL and MOTRIN. (The 1 day interval shown refers to myalgias, but it was 13 days before admission with discharged dx of rhabdo.) The patient improved with intravenous fluids and was discharged to home. On 23-Oct-2008 patient had all over body aches T-102, chills, temp returned to normal with TYLENOL and MOTRIN. On 27-Oct-2008 finally felt well enough to go to work. Was shaky with walking, heavy head, hands, feet, tired. On 04-Nov-2008 the patient had chest pain radiating up to neck and left arm, nausea diarrhea x5 decreased heart rate and B/P. On 17-Feb-2009 the patient was admitted to the hospital. Suspect viral syndrome possibly secondary to nasal flu vaccine, left bundle branch block, mild congestive cardiomyopathy with left ventricular dysfunction, bradycardia, diarrhea. Records reveal patient experienced chest pressure, nausea, lightheadedness, general discomfort. Cardio and Neuro consult done. On 05-Nov-2008 laboratory values was as follows: heart cath with Ef of 45-50%, ana-neg, rheumatoid factor <5, CBC-nonsign, BMP-NL, 11/4-CK-4280, LDH- 278, AST-95, CRP-52, digoxin level-0.5, TSH-2.05, T3-1.11, urine-neg, CTA chest-mild atelectasis negative for PE, GB sono-Nl, echo-nonsignif. According to the reporter the assessment of the Serious criteria for the report was as follows: Hospitalised.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Sensation of heaviness, Tremor, Tri-iodothyronine decreased, Ultrasound biliary tract, Ultrasound scan normal
Clinical narrative: A report has been received from Regulatory concerning a 41 year old, female patient. The patient's past medical history included morphine, KEFLEX, LORTAB, gynecological problems, heart problems. Concomitant medications included digoxin, vitamins NOS, ramipril, calcium and fish oil. On 22-Oct-2008 the patient received nasal FLUMIST. On 23-Oct-2008 the patient experienced body aches, fever (temperature 102), chills, and temp returned to normal with TYLENOL and MOTRIN. (The 1 day interval shown refers to myalgias, but it was 13 days before admission with discharged dx of rhabdo.) The patient improved with intravenous fluids and was discharged to home. On 23-Oct-2008 patient had all over body aches T-102, chills, temp returned to normal with TYLENOL and MOTRIN. On 27-Oct-2008 finally felt well enough to go to work. Was shaky with walking, heavy head, hands, feet, tired. On 04-Nov-2008 the patient had chest pain radiating up to neck and left arm, nausea diarrhea x5 decreased heart rate and B/P. On 17-Feb-2009 the patient was admitted to the hospital. Suspect viral syndrome possibly secondary to nasal flu vaccine, left bundle branch block, mild congestive cardiomyopathy with left ventricular dysfunction, bradycardia, diarrhea. Records reveal patient experienced chest pressure, nausea, lightheadedness, general discomfort. Cardio and Neuro consult done. On 05-Nov-2008 laboratory values was as follows: heart cath with Ef of 45-50%, ana-neg, rheumatoid factor <5, CBC-nonsign, BMP-NL, 11/4-CK-4280, LDH- 278, AST-95, CRP-52, digoxin level-0.5, TSH-2.05, T3-1.11, urine-neg, CTA chest-mild atelectasis negative for PE, GB sono-Nl, echo-nonsignif. According to the reporter the assessment of the Serious criteria for the report was as follows: Hospitalised.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Urine analysis normal, Viral infection
Clinical narrative: A report has been received from Regulatory concerning a 41 year old, female patient. The patient's past medical history included morphine, KEFLEX, LORTAB, gynecological problems, heart problems. Concomitant medications included digoxin, vitamins NOS, ramipril, calcium and fish oil. On 22-Oct-2008 the patient received nasal FLUMIST. On 23-Oct-2008 the patient experienced body aches, fever (temperature 102), chills, and temp returned to normal with TYLENOL and MOTRIN. (The 1 day interval shown refers to myalgias, but it was 13 days before admission with discharged dx of rhabdo.) The patient improved with intravenous fluids and was discharged to home. On 23-Oct-2008 patient had all over body aches T-102, chills, temp returned to normal with TYLENOL and MOTRIN. On 27-Oct-2008 finally felt well enough to go to work. Was shaky with walking, heavy head, hands, feet, tired. On 04-Nov-2008 the patient had chest pain radiating up to neck and left arm, nausea diarrhea x5 decreased heart rate and B/P. On 17-Feb-2009 the patient was admitted to the hospital. Suspect viral syndrome possibly secondary to nasal flu vaccine, left bundle branch block, mild congestive cardiomyopathy with left ventricular dysfunction, bradycardia, diarrhea. Records reveal patient experienced chest pressure, nausea, lightheadedness, general discomfort. Cardio and Neuro consult done. On 05-Nov-2008 laboratory values was as follows: heart cath with Ef of 45-50%, ana-neg, rheumatoid factor <5, CBC-nonsign, BMP-NL, 11/4-CK-4280, LDH- 278, AST-95, CRP-52, digoxin level-0.5, TSH-2.05, T3-1.11, urine-neg, CTA chest-mild atelectasis negative for PE, GB sono-Nl, echo-nonsignif. According to the reporter the assessment of the Serious criteria for the report was as follows: Hospitalised.
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Epistaxis, Wheezing
Clinical narrative: A non-serious spontaneous report of wheezing and nose bleed has been received from a health professional concerning an eight-year-old female, subsequent to FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on 18-Nov-2011. The patient started complaining of wheezing and nose bleed all day on and off on 20-Nov-2011. The outcome of the events wheezing and nose bleed was resolved on 20-Nov-2011.
Sex: U
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: CSF test, Guillain-Barre syndrome, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal
Clinical narrative: A spontaneous report of serious hospitalization and important medical event of Guillain-Barre syndrome after FLUMIST has been received from a physician concerning a child, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on an unknown date in school. On an unknown date, the patient experienced Guillain-Barre syndrome and was hospitalized. The outcome of the event Guillain-Barre syndrome after FLUMIST was unknown.
Sex: U
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Guillain-Barre syndrome
Clinical narrative: A spontaneous report of serious hospitalization and important medical event of Guillain-Barre syndrome after FLUMIST has been received from a physician concerning a child, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on an unknown date in school. On an unknown date, the patient experienced Guillain-Barre syndrome and was hospitalized. The outcome of the event Guillain-Barre syndrome after FLUMIST was unknown.
Sex: U
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: A spontaneous report of serious hospitalization and important medical event of Guillain-Barre syndrome after FLUMIST has been received from a physician concerning a child, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on an unknown date in school. On an unknown date, the patient experienced Guillain-Barre syndrome and was hospitalized. The outcome of the event Guillain-Barre syndrome after FLUMIST was unknown.
Age: 4.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of two doses of FLUMIST given one week apart was received from a health professional concerning a four-year-old female. Medical history and concomitant medications were not reported. The patient was brought to the clinic by her mother. One of the nurses asked the patient's mother, if she was there for a flu vaccine and she said yes and the patient was given FLUMIST. The staff later found out that the mother did not speak the language and was not there for a vaccine. Reporter said they have not seen the family again. The patient was vaccinated on 29-Sep-2011 and then received a second dose on 04-Oct-2011, one week later. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was obtained on 01-Mar-2010 to suspect vaccine information and incorporated in the narrative.
Age: 7.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of inadvertent administration of second dose was received from a health professional concerning a seven-year-old male. Neither relevant past medical history nor concomitant medications had been reported for this patient. The patient received the first dose of FLUMIST on 11-Oct-2011 and was again inadvertently administered the second dose of FLUMIST on 18-Oct-2011. There was no adverse event associated with this medication error; therefore, treatment and sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 13-Mar-2012: It was reported that the patient did not experience any late occurring adverse events.
Age: 1.74
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: A non-serious spontaneous report of "FLUMIST administration to a 21-month-old" was received from a physician concerning a 20-month-old female. Neither relevant past medical history nor concomitant medications had been reported for this patient. The patient accidentally received FLUMIST on 29-Sep-2011. There was no adverse event associated with this medication error; therefore, treatment and sponsor causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 26-Mar-2012: No late occurring adverse events were reported.
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Headache, Influenza like illness, Joint stiffness, Oral pain, Oropharyngeal pain
Clinical narrative: A non-serious spontaneous report of stiff jaw and flu like symptoms manifested by sore throat, headache, body ache and mouth sore has been received from a health professional concerning an adult female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 18-Oct-2011. On 20-Oct-2011, the patient had flu like symptoms which included sore throat, headaches, mouth sores, body aches and stiff jaw. The outcome of the events stiff jaw and flu like symptoms was resolved. Additional information was received on 13-Mar-2012 and incorporated in the narrative: outcome of the events.
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Pain
Clinical narrative: A non-serious spontaneous report of stiff jaw and flu like symptoms manifested by sore throat, headache, body ache and mouth sore has been received from a health professional concerning an adult female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 18-Oct-2011. On 20-Oct-2011, the patient had flu like symptoms which included sore throat, headaches, mouth sores, body aches and stiff jaw. The outcome of the events stiff jaw and flu like symptoms was resolved. Additional information was received on 13-Mar-2012 and incorporated in the narrative: outcome of the events.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 years old female with mediastinal teratoma and a history of renal insufficiency who was vaccinated IM on the left arm with a dose of (lot # 668262/0841AA, 08-APR-2013) GARDASIL on 19-MAR-2012. Concomitant therapies included Amlodipine 5 mg and daily on. On 26-MAR-2012 the patient experienced painful, swollen and lump in left arm deltoid. Patient was prescribed ice packs and TYLENOL. Patient had been watchful waiting and would call office if the status of patient had been worsens. Additional information is not expected. The original reporting source was not provided.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 years old male patient with no medical history was vaccinated IM on the left arm with the first dose of GARDASIL (lot # 672547/1745AA, Exp Date: 13-SEP-2014) on 28-MAR-2012. No other co-suspects were reported. No concomitant medications were reported. On 29-MAR-2012 the patient's entire body covered in hives. The patient took one dose of BENADRYL and hives went away that same day. The patient had sore throat at time of vaccination. No lab was performed. The original reporting source was not provided. The VAERS ID # is 452906. It was reported that the patient's experience was considered non-serious. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Influenza, Injection site pain, Malaise, Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with no pertinent medical history or previous illness was vaccinated intramuscularly into the left arm with first dose of GARDASIL (lot # 671463/1359AA) on 16-APR-2012. Flu swab was pending (taken 20-APR-2012) as this possible differential diagnosis at time of the report. Patient received vaccine and on 17-MAR-2012 had symptoms of: headache, fever, nausea, malaise, left arm pain (site of injection) without swelling or redness to same. The listing indicated that one or more of the events required ER visit but were not serious. The case of the patient's brother was captured in MARRS# 1208USA006626. No further information is available. The original reporting source was not provided. VAERS ID is 454100-1.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with no pertinent medical history or previous illness was vaccinated intramuscularly into the left arm with first dose of GARDASIL (lot # 671463/1359AA) on 16-APR-2012. Flu swab was pending (taken 20-APR-2012) as this possible differential diagnosis at time of the report. Patient received vaccine and on 17-MAR-2012 had symptoms of: headache, fever, nausea, malaise, left arm pain (site of injection) without swelling or redness to same. The listing indicated that one or more of the events required ER visit but were not serious. The case of the patient's brother was captured in MARRS# 1208USA006626. No further information is available. The original reporting source was not provided. VAERS ID is 454100-1.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Injection site pain, Malaise, Nausea, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with no pertinent medical history or previous illness was vaccinated intramuscularly into the left arm with first dose of GARDASIL (lot # 671463/1359AA) on 16-APR-2012. Flu swab was pending (taken 20-APR-2012) as this possible differential diagnosis at time of the report. Patient received vaccine and on 17-MAR-2012 had symptoms of: headache, fever, nausea, malaise, left arm pain (site of injection) without swelling or redness to same. The listing indicated that one or more of the events required ER visit but were not serious. The case of the patient's brother was captured in MARRS# 1208USA006626. No further information is available. The original reporting source was not provided. VAERS ID is 454100-1.
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Neck mass
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient received her second dose of GARDASIL experienced "flu-like symptoms" and "a lump in her neck". The reporter indicated that the patient received her first dose at the office in "January" and that she did not know where or when the unspecified patient received the second dose of GARDASIL, she also did not specify if the AE was reported previously. The patient sought medical attention by notifying the physician. At the time of the report, the outcome was unknown. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site vesicles, Injection site warmth
Clinical narrative: Redness, whelps/blisters, warmth swelling at inj site.
Age: 13.0
Sex: F
Vaccine: UNK
Symptoms: Computerised tomogram abnormal, Computerised tomogram head normal, Contusion, Gaze palsy, Jaw fracture
Clinical narrative: Minutes after vaccine, while walking to car, "syncope" with "shaking & eyes rolling all over" lasting 1-2 minutes. Arms still shaking 3 hrs later (+) wrist injury required splinting (+) chin lac required sutures contusion & other facial contusion.
Age: 13.0
Sex: F
Vaccine: UNK
Symptoms: Joint injury, Laceration, Splint application, Suture insertion, Syncope
Clinical narrative: Minutes after vaccine, while walking to car, "syncope" with "shaking & eyes rolling all over" lasting 1-2 minutes. Arms still shaking 3 hrs later (+) wrist injury required splinting (+) chin lac required sutures contusion & other facial contusion.
Age: 13.0
Sex: F
Vaccine: UNK
Symptoms: Tremor, X-ray limb
Clinical narrative: Minutes after vaccine, while walking to car, "syncope" with "shaking & eyes rolling all over" lasting 1-2 minutes. Arms still shaking 3 hrs later (+) wrist injury required splinting (+) chin lac required sutures contusion & other facial contusion.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Hardness/redness at injection site warm to the touch.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Injection site swelling, Moaning, Pyrexia, Vomiting
Clinical narrative: High fever up to 104.6, moaning, swelling at injection site, vomiting (sx 12 hours). Baby did also have fever up to 102 after 4 month shots but no other symptoms.
Age: 1.11
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Skin lesion
Clinical narrative: Mother reports at leg quarter size lesion red warm 4 days after injection 2 days after office visit for leg eval improved.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain, at site of injection at left upper arm. No fever.  Seen in office 8/17/2012 and treated with prn Benadryl and ibuprofen.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness
Clinical narrative: Dizziness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Rash erythematous
Clinical narrative: 2&12 INCH RED RASH, FIRM TO THE TOUCH. RESOLVED WITH BENADRYL AND TOPICAL BENADRYL.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Heart rate increased, Heart rate irregular
Clinical narrative: Fast and irregular heartbeat that went on for 8 hours-up to 130 beats a minute when standing, 88-100 resting- 2 very strong beats then 2-3 very rapid soft beats- increased with exertion, even just standing up-took 1 cetirizine tab and rest-slept- woke up at 11:30 still having rapid & irregular heartrate- woke up at 4 AM and heart rate was normal and regular- 70 - has remained normal since then- no other symptoms.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Body temperature increased, Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: First extreme tenderness in injection site, several hrs. later upper arm reddened, swelling of upper r arm/bicep area, area became hot/firm & more tender, by am axillary nodes in r arm palpable & tender.  Also temp to 100F x 24hrs. Arm difficult to use because of extreme tenderness with use.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site swelling, Injection site warmth, Lymph node pain, Lymph node palpable, Tenderness
Clinical narrative: First extreme tenderness in injection site, several hrs. later upper arm reddened, swelling of upper r arm/bicep area, area became hot/firm & more tender, by am axillary nodes in r arm palpable & tender.  Also temp to 100F x 24hrs. Arm difficult to use because of extreme tenderness with use.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site nodule, Oedema peripheral
Clinical narrative: Pt right arm with area approx 2 1/2 inches wid that is swollen and slightly pink. Small knot noted in center. Arm is not warm to touch. Pt is afebrile. No tx given. Told family to moniter for s/s of infection. Fever, arm becomes red and warm to touch.  May use ice or warm compress for comfort.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Injection site scab, Oedema peripheral, Tenderness
Clinical narrative: The arm is red, swollen, tender, and the injection sites are scabbed and red.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Swelling of left upper arm 16cm X 14cm with redness, tenderness.  Systemic fever.  Gave ibuprofen, Benadryl and ice.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Culture, Flushing, Rash, Rash papular
Clinical narrative: Facial flushing followed by rash with oozing sore on forehead.  Over time rash has abated and then returned and now has spread to extremities with papillar eruptions, including oozing sore on hand which developed staph infection.  Rash continues to this date.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Staphylococcal infection, Wound secretion
Clinical narrative: Facial flushing followed by rash with oozing sore on forehead.  Over time rash has abated and then returned and now has spread to extremities with papillar eruptions, including oozing sore on hand which developed staph infection.  Rash continues to this date.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Reddened, swollen, tender "welt" to (L) posterior upper arm mother reports approximately the size of an orange. Reports no improvement yet at this time.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood glucose normal, Fall, Gaze palsy, Head injury, Headache
Clinical narrative: 8-17-12 at 09:40 patient received tdap and MCV-4, after receiving vaccine pt. alert & oriented. Walked approx. 65 ft. to front office and was talking to staff. At approx. 9:45 father reports pt's eyes rolled back into head, Pt. felt after becoming unconscious hitting head on floor, B/P 107/55 BS=104, HR-55, Pt. regained consciousness - talking oriented. C/O headache and tingling to neck. Transported via ambulance to hospital.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness, Paraesthesia
Clinical narrative: 8-17-12 at 09:40 patient received tdap and MCV-4, after receiving vaccine pt. alert & oriented. Walked approx. 65 ft. to front office and was talking to staff. At approx. 9:45 father reports pt's eyes rolled back into head, Pt. felt after becoming unconscious hitting head on floor, B/P 107/55 BS=104, HR-55, Pt. regained consciousness - talking oriented. C/O headache and tingling to neck. Transported via ambulance to hospital.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Blindness, Dizziness, Hypotonia, Pallor
Clinical narrative: Client very anxious prior to vaccines given. After administering vaccines client became pale and c/o feeling dizzy and loss of vision. Client became limp and lowered to floor with knees elevated. Client remained conscious and talking. Cool compress applied and juice given.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Swelling face, Urticaria
Clinical narrative: Patient received vaccine 7/27/12. Patient developed red ring at administration site which lasted till 8/5/12. Patient develop hives, swollen face on 8/9/12 MD diagnosed patient has developed shingles.
Age: 54.0
Sex: F
Vaccine: RAB
Symptoms: Fatigue, Headache, Muscle twitching, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Case number PHEH2012US015704 is an initial spontaneous report received from a nurse on 06 Aug 2012. This case refers to a 54-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with the last dose of post exposure series of RABAVERT vaccine (batch number: 502011A) intramuscularly on 03 Aug 2012. Later (dates not specified) she experienced high fever of 102 F, stiff neck, muscle twitches, fatigue and headache. The outcome of these events was reported as condition unchanged at the time of this report. The causality of the events was not reported. No other information was available.
Age: 23.0
Sex: M
Vaccine: MNQ
Symptoms: Anxiety, Gingival bleeding, Insomnia, Paranoia
Clinical narrative: Case number PHEH2012US016064 is an initial spontaneous report received from a physician on 15 Aug 2012. This case refers to a 23-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: X11064) intramuscularly on 14 Aug 2012. On the same day after vaccination he experienced paranoia and was anxious. He also had bleeding gums after brushing teeth, and was not able to sleep all the night. The patient's outcome was reported as unknown. No other information was available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Broke out in red, itchy bumps all over arms and legs. Saw nurse practitioner on 08/14 and began taking Zantac, Zyrtec, and Benadryl. New hives still occurring but not as frequently. Older ones are fading.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Induration, Mass, Pruritus
Clinical narrative: Redness, itching, hard lump, warmth. 2 weeks.
Age: 70.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Injection site reaction -redness 6 inches in diameter.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Redness, pain, warmth and swelling.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Hives noted around mouth, chin, forehead, cheeks and arms. Pt scratching. Admin. epinephrine 0.15 mL LD @ 1135 am. Rash improved at 1138, pt transported to ER by EMS.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: That night she had hives on face, stomach and chest.
Age: 0.71
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Insomnia, Irritability
Clinical narrative: Has been really fussy since receiving immunizations. More fussy then was when teething. Patient has had TYLENOL pre injection and has been given routinely since. Rides in car calm pt down. No redness, swelling or fever. Not sleeping well pt scratching & pinching and mom states "seems irritated. Not herself."
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site pruritus, Nausea, Rash
Clinical narrative: Day after shot given noted quarter size rash on left arm, site of varicella itchy. Using BENADRYL. Did feel nausea day of shot. Improving when called about shot.
Age: 0.22
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Aggression, Crying, Learning disability, Opisthotonus, Screaming
Clinical narrative: Screaming, Arching of back, Inconsolable crying, Developed strabismus's, Extreme temper, Delayed speech, Learning disabilities.
Age: 0.22
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Speech disorder developmental, Strabismus
Clinical narrative: Screaming, Arching of back, Inconsolable crying, Developed strabismus's, Extreme temper, Delayed speech, Learning disabilities.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Mom noted right thigh was red, hot to touch on 8/8/2012. C/O itching and child was scratching it.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Pain and swelling in (R) arm, treated with TORADOL injection for pain and Rx for NAPROXEN.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Pain & swelling in arm on 7/16/12 fever/chills. Sent to local ER admission x 1 day given Doxycycline 100mg PO (7 days Rx).
Age: 11.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site reaction, Oedema peripheral
Clinical narrative: Upper arm swollen, red tender from shoulder to elbow. Skin tight, shiny, red, very painful. Began at VARIVAX site.
Age: 11.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Pain of skin, Skin tightness
Clinical narrative: Upper arm swollen, red tender from shoulder to elbow. Skin tight, shiny, red, very painful. Began at VARIVAX site.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, Vision blurred
Clinical narrative: C/O left leg pain & blurred vision from date of injection 7/25/12 to 7/31/12 also c/o numbness & tingling in left leg. No treatment ordered.
Age: 4.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a physician concerning a four-year-old patient. Neither relevant medical history nor concomitant medications have been reported for these patient. The product expired in 11-Dec-2011. The patient received the expired FLUMIST 20-Dec-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. There was no late occurring adverse event reported was added.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administered expired FLUMIST was received from a health professional concerning a 36-month-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 04-Mar-2012. On 09-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 16-Apr-2012: No late occurring adverse events were reported.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administered expired FLUMIST was received from a health professional concerning a 25-month-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 04-Mar-2012. On 08-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 16-Apr-2012: No late occurring adverse events were reported.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 35-month-old female. Neither the patient's past medical history.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Breast tenderness, Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Patient in for routine annual exam on July 25, 2012.  Received a PPSV23 vaccine IM injection in the left deltoid.  She followed-up with routine labs. Patient in on August 17, 2012 with complaint of left arm, hand, & shoulder tingling & numbness since getting the PPSV23 vaccine. Notes from 8/17/12 office visit:  (Patient) States started after getting PPV in this arm (left) 7-25-12.  No erythema or swelling at injection site.  Has tenderness on anterior deltoid on Left.  Has full ROM of left shoulder, arm, hand.  States has tingling in 2-3-4-5th fingertips.  Is right handed.  No OTC use.  Denies repetitive motions, except using computer at work. Slight tenderness on anterior deltoid on left.  Strong equal hand grips and resisted arm extension. Dx: parethesisa skin & neuropathy.  EMG ordered.  Naproxen 500mg, 1 BID PRN.  Patient to return after testing.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Cyanosis, Pain
Clinical narrative: Pain, perioral cyanosis. Patient called 911. Taken to Hospital for evaluation. Tylenol given for pain.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Adenocarcinoma of the cervix, Cervical dysplasia
Clinical narrative: CIN 3 Adnocarcinoma, possible cervical cancer.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Red rash, hives generalized on body. Treatment:  Benadryl and Prednisone given in the ER.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Nausea, dizzy and then vomited within minutes of receiving the vaccination, resolved quickly after she vomited, applied ice to face/neck, she lay on the floor for recovery, sipped water.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain, Rash vesicular, Skin warm
Clinical narrative: Patient reported to pharmacy with a large red, warm area that had a varicella type rash (small vesicles) in teh center.  Patient reported that it had gotten bigger since the previous day, but had not grown at all the day of presentation. Physician was contacted and prescribed Lyrica for 5 days and Tylenol to treat pain.  Instructed patient to apply a warm compress to the site.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient reported to pharmacy with a large red, warm area that had a varicella type rash (small vesicles) in teh center.  Patient reported that it had gotten bigger since the previous day, but had not grown at all the day of presentation. Physician was contacted and prescribed Lyrica for 5 days and Tylenol to treat pain.  Instructed patient to apply a warm compress to the site.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: The night of the vaccination pain got bad and was constant. The patient described it as a throbbing pain and She described is as "It felt like someone punched me in the arm." The patient has been continuous since onset. She has limited range of motion. Injection site didn't appear reddened warm to touch or swollen. She was referred to the Emergency Dept. for further evaluation.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Communication disorder, Diarrhoea, Disorientation, Dizziness, Hypoaesthesia
Clinical narrative: Faint, feverish, vomited twice, diarrhea, blurred vision, ringing in ears, numb arm, disoriented and difficulty communicating.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Tinnitus, Vision blurred, Vomiting
Clinical narrative: Faint, feverish, vomited twice, diarrhea, blurred vision, ringing in ears, numb arm, disoriented and difficulty communicating.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Arthritis, Blood test, Influenza virus test, Local swelling, Mononucleosis heterophile test
Clinical narrative: Fever, arthritis flare up, body aches and pains, sore throat, swelling of neck and throat.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Oropharyngeal pain, Pain, Pharyngeal oedema, Pyrexia, Streptococcus test
Clinical narrative: Fever, arthritis flare up, body aches and pains, sore throat, swelling of neck and throat.