chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Diarrhoea, Headache, Influenza like illness, Pain in extremity
Clinical narrative: Mild Headache, Pain in entire left arm (not at injection site), general weakness, mild diarrhea, mild flu like symptoms.  Symptoms began the day after the injection and lasted for 4-7 days.
Age: 33.0
Sex: F
Vaccine: LYME
Symptoms: Abnormal sensation in eye, Arthralgia, Burning sensation, Cardiac flutter, Chest pain
Clinical narrative: This case was reported by a lawyer and described the occurrence of fainting episode in a 33-year-old female subject who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included automobile accident, foot fracture and shoulder pain. Concurrent medical conditions included back pain. On 12 July 1999 and 25 August 1999 the subject received 1st dose and 2nd dose of LYMERIX (unknown). According to an interview between the subject and attorney(s), on 12 July 1999, less than one day after the first vaccination with LYMERIX, the subject experienced fainting episode (attributed to lightheadedness after blood was drawn prior to receiving LYMERIX. A "few days" after the second vaccination with LYMERIX, in August 1999, the subject developed flu-like symptoms (including "severe" vomiting). In the winter of 1999/2000, she developed joint pain, lightheadedness, and "numbness on exertion". In approximately 2002/2003, she developed swollen glands, fatigue, achiness, diarrhea, muscle pain, muscle twitching, cognitive problems (difficulty with concentration, memory, and word recall), and sleep disturbance. In approximately 2003 she experienced chest fluttering, chest pain, facial numbness, burning sensation, migraine, eye pressure, and light sensitivity. Treatment included PLAQUENIL, glucosamine chondroitin, and antibiotics, as well as massage therapy and chiropractic treatment. This case was assessed as medically serious by GSK. At the time of reporting the events, with the exception of fainting spell and flu-like symptoms, were unresolved.
Age: 33.0
Sex: F
Vaccine: LYME
Symptoms: Cognitive disorder, Diarrhoea, Disturbance in attention, Dizziness, Fatigue
Clinical narrative: This case was reported by a lawyer and described the occurrence of fainting episode in a 33-year-old female subject who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included automobile accident, foot fracture and shoulder pain. Concurrent medical conditions included back pain. On 12 July 1999 and 25 August 1999 the subject received 1st dose and 2nd dose of LYMERIX (unknown). According to an interview between the subject and attorney(s), on 12 July 1999, less than one day after the first vaccination with LYMERIX, the subject experienced fainting episode (attributed to lightheadedness after blood was drawn prior to receiving LYMERIX. A "few days" after the second vaccination with LYMERIX, in August 1999, the subject developed flu-like symptoms (including "severe" vomiting). In the winter of 1999/2000, she developed joint pain, lightheadedness, and "numbness on exertion". In approximately 2002/2003, she developed swollen glands, fatigue, achiness, diarrhea, muscle pain, muscle twitching, cognitive problems (difficulty with concentration, memory, and word recall), and sleep disturbance. In approximately 2003 she experienced chest fluttering, chest pain, facial numbness, burning sensation, migraine, eye pressure, and light sensitivity. Treatment included PLAQUENIL, glucosamine chondroitin, and antibiotics, as well as massage therapy and chiropractic treatment. This case was assessed as medically serious by GSK. At the time of reporting the events, with the exception of fainting spell and flu-like symptoms, were unresolved.
Age: 33.0
Sex: F
Vaccine: LYME
Symptoms: Hypoaesthesia, Hypoaesthesia facial, Influenza like illness, Lymphadenopathy, Memory impairment
Clinical narrative: This case was reported by a lawyer and described the occurrence of fainting episode in a 33-year-old female subject who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included automobile accident, foot fracture and shoulder pain. Concurrent medical conditions included back pain. On 12 July 1999 and 25 August 1999 the subject received 1st dose and 2nd dose of LYMERIX (unknown). According to an interview between the subject and attorney(s), on 12 July 1999, less than one day after the first vaccination with LYMERIX, the subject experienced fainting episode (attributed to lightheadedness after blood was drawn prior to receiving LYMERIX. A "few days" after the second vaccination with LYMERIX, in August 1999, the subject developed flu-like symptoms (including "severe" vomiting). In the winter of 1999/2000, she developed joint pain, lightheadedness, and "numbness on exertion". In approximately 2002/2003, she developed swollen glands, fatigue, achiness, diarrhea, muscle pain, muscle twitching, cognitive problems (difficulty with concentration, memory, and word recall), and sleep disturbance. In approximately 2003 she experienced chest fluttering, chest pain, facial numbness, burning sensation, migraine, eye pressure, and light sensitivity. Treatment included PLAQUENIL, glucosamine chondroitin, and antibiotics, as well as massage therapy and chiropractic treatment. This case was assessed as medically serious by GSK. At the time of reporting the events, with the exception of fainting spell and flu-like symptoms, were unresolved.
Age: 33.0
Sex: F
Vaccine: LYME
Symptoms: Migraine, Muscle twitching, Myalgia, Pain, Photophobia
Clinical narrative: This case was reported by a lawyer and described the occurrence of fainting episode in a 33-year-old female subject who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included automobile accident, foot fracture and shoulder pain. Concurrent medical conditions included back pain. On 12 July 1999 and 25 August 1999 the subject received 1st dose and 2nd dose of LYMERIX (unknown). According to an interview between the subject and attorney(s), on 12 July 1999, less than one day after the first vaccination with LYMERIX, the subject experienced fainting episode (attributed to lightheadedness after blood was drawn prior to receiving LYMERIX. A "few days" after the second vaccination with LYMERIX, in August 1999, the subject developed flu-like symptoms (including "severe" vomiting). In the winter of 1999/2000, she developed joint pain, lightheadedness, and "numbness on exertion". In approximately 2002/2003, she developed swollen glands, fatigue, achiness, diarrhea, muscle pain, muscle twitching, cognitive problems (difficulty with concentration, memory, and word recall), and sleep disturbance. In approximately 2003 she experienced chest fluttering, chest pain, facial numbness, burning sensation, migraine, eye pressure, and light sensitivity. Treatment included PLAQUENIL, glucosamine chondroitin, and antibiotics, as well as massage therapy and chiropractic treatment. This case was assessed as medically serious by GSK. At the time of reporting the events, with the exception of fainting spell and flu-like symptoms, were unresolved.
Age: 33.0
Sex: F
Vaccine: LYME
Symptoms: Sleep disorder, Syncope, Vomiting
Clinical narrative: This case was reported by a lawyer and described the occurrence of fainting episode in a 33-year-old female subject who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included automobile accident, foot fracture and shoulder pain. Concurrent medical conditions included back pain. On 12 July 1999 and 25 August 1999 the subject received 1st dose and 2nd dose of LYMERIX (unknown). According to an interview between the subject and attorney(s), on 12 July 1999, less than one day after the first vaccination with LYMERIX, the subject experienced fainting episode (attributed to lightheadedness after blood was drawn prior to receiving LYMERIX. A "few days" after the second vaccination with LYMERIX, in August 1999, the subject developed flu-like symptoms (including "severe" vomiting). In the winter of 1999/2000, she developed joint pain, lightheadedness, and "numbness on exertion". In approximately 2002/2003, she developed swollen glands, fatigue, achiness, diarrhea, muscle pain, muscle twitching, cognitive problems (difficulty with concentration, memory, and word recall), and sleep disturbance. In approximately 2003 she experienced chest fluttering, chest pain, facial numbness, burning sensation, migraine, eye pressure, and light sensitivity. Treatment included PLAQUENIL, glucosamine chondroitin, and antibiotics, as well as massage therapy and chiropractic treatment. This case was assessed as medically serious by GSK. At the time of reporting the events, with the exception of fainting spell and flu-like symptoms, were unresolved.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Disorientation, Dizziness, Dysphasia, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Pt reported 6 wks ago flu shot received. Guillian-Barre syndrome developed. 12/12-weakness developed. Admitted 12/13/08 to hosp for weakness, dysphasia, dizzy, disoriented.  12/31/08 Reviewed hospital medical records of 12/13-12/18/2008. FINAL DX: no d/c summary available.  Neuro consult states likely GBS. Records reveal patient experienced flu like syndrom approx 1 week after the flu shot.  Lives out of country & was visiting.  Nine days prior to admission fell while rollerblading & injured shoulder tx w/NSAIDS.  Three days prior to admission developed weakness of LEs & paresthesias of hands.  Weakness progressed to UEs, difficulty swallowing, difficulty walking, speech impairment.  Admitted to ICU Neuro consult done.  Areflexic on exam.  LP done.  Tx w/IVIG, improved & d/c to home.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Mononucleosis heterophile test, Scan brain
Clinical narrative: Pt reported 6 wks ago flu shot received. Guillian-Barre syndrome developed. 12/12-weakness developed. Admitted 12/13/08 to hosp for weakness, dysphasia, dizzy, disoriented.  12/31/08 Reviewed hospital medical records of 12/13-12/18/2008. FINAL DX: no d/c summary available.  Neuro consult states likely GBS. Records reveal patient experienced flu like syndrom approx 1 week after the flu shot.  Lives out of country & was visiting.  Nine days prior to admission fell while rollerblading & injured shoulder tx w/NSAIDS.  Three days prior to admission developed weakness of LEs & paresthesias of hands.  Weakness progressed to UEs, difficulty swallowing, difficulty walking, speech impairment.  Admitted to ICU Neuro consult done.  Areflexic on exam.  LP done.  Tx w/IVIG, improved & d/c to home.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dizziness, Palpitations
Clinical narrative: Lightheaded, dizzy, palpitations, patient went to ER and was given fluids.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: L leg with rash, redness and swelling. 15cmx13cm area of redness and swelling on left thigh.
Age: 17.0
Sex: F
Vaccine: HEP, IPV, MMR, TD, VARCEL
Symptoms: Anxiety, Heart rate decreased, Pallor, Unresponsive to stimuli
Clinical narrative: Pt. became unresponsive to verbal commands after receiving 5 immunizations. Pulse 48, BP 100/68; O2 given, face pale. 911 responded, pt. taken to E.R. via ambulance. Contributing factors - room warm, pt. anxious after 5 shots.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives urticaria -seen in ER - given BENADRYL, EPIPEN Jr, PRELONE, and ZANTAC.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Pt. received BOOTRIX (Tdap) vaccination instead of DTaP. Per Glaxo-Smith - no treatment needed. Pt. has no symptoms at this time.
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Patient given Tdap, should have been DTap. None known adverse events  none known not noticed of any adverse events. (patient was scheduled for 5th dose of DTap) not notified of any adverse events.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Sensation of heaviness
Clinical narrative: Throbbing in deltoid area on and off.  Heaviness and pain from left deltoid region extending to left palm intermittent since getting FLUZONE.  Once above where injection was asymptomatic.
Age: 0.6
Sex: M
Vaccine: HIBV, IPV, RV5
Symptoms: Body temperature increased, Vomiting
Clinical narrative: Mom and Dad reported on 12-3-08 that infant ran 103 degree temp for 3 days starting the following day after 7-28-08 vaccinations. Also reported some vomiting. Parents took infant to see Doctor at clinic the next day and then saw Doctor in clinic 2 weeks later and both thought it was related to vaccine.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Vaccination complication
Clinical narrative: Pt. diagnosed with bursitis due to flu vaccine. Going into joint spur and not muscle. Required multiple MD visits and physical therapy due to illness.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Lip blister, Lip swelling, Swelling face
Clinical narrative: App 4 hours after immunization, the pt. reportedly developed blisters on her lips, and her lips and face were swollen.  Pt. refused to seek medical care.  Symptoms completely resolved within 24 hrs, without treatment.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous, Rash papular
Clinical narrative: Red, raised rash under arms and on buttock. Appeared approximately 1 pm on 11-18-08, almost 24 hours after Rash itching resolved within 12 hours after taking baking soda bath.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Pyrexia
Clinical narrative: As per mother - states that son had fever of 98.8 - 100 degrees F. At  4:30 am 12/18/08. States he passed out x2. Had previous complaint of dizziness. Vaccine administered 12/16/08 approximately 6:00pm. Patient seen by pediatrician , he recommended he see a cardiologist to rule out heart disease. EMS called responded with vitals check and no hospital required.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness noted to LA where injections were given.  Advised to apply cool compresses and TYLENOL for discomfort
Age: 1.3
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Arthralgia, Weight bearing difficulty, X-ray normal
Clinical narrative: Vaccine received 11/21/08. Pt presented 12/3/08 with inability to bear weight on (L) leg - no trauma, no recent illness, no fever, (-) X-ray, on 12/8 had wrist pain post MMR Arthralgia.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Pruritus
Clinical narrative: Patient given ZOSTAVAX 12/17/08 at clinic. C/O right lip swelling and itching spreading to right jaw approximately 18 hours later. Took BENADRYL which helped. No SOB, CD. Says " It's still swollen. I will take another BENADRYL." If s/s continue f/u PCP. If s/s worsen, E.R. or Urgent care.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Patient presented redness about quarter size around vaccine area. VARICELLA was given in this extremity.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Injected limb mobility decreased, Nausea, Pyrexia
Clinical narrative: Patient states she received PNEUMOVAX on 11/20/08. Arm became extremely sore to the point that she could not lift it. Developed fever of 101, diarrhea, nausea.
Age: 1.2
Sex: F
Vaccine: HEPA, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Large area of induration and erythema, mild warmth on (R) thigh surrounding injection site mark. Walks and uses leg completely normally.
Age: 1.6
Sex: M
Vaccine: DTAP, IPV
Symptoms: Varicella
Clinical narrative: Chicken Pox
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Had swelling redness. notice 12/12/2008
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, erythema, non painful at the injection site measuring 5-6" in diameter.
Age: 1.8
Sex: U
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: A non-serious spontaneous report of administration to 20-month-old was received from a registered pharmacist. Medical history and concomitant medications were not reported. On 08-Nov-2008, a 20-month-old child (gender not reported) received FluMist, There was no adverse event associated with third medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: A non-serious spontaneous report of back is covered with a rash has been received from a consumer in the USA concerning a 4-year-old male subsequent to FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The patient has no known allergies.  Medical history and concomitant medications were not reported.  On 12-NOV-2008, at 12:00 noon, the patient received FLUMIST at a military naval base.  On 13-NOV-2008, the patient woke up with a rash from his neck to his waist both front and back itched. The rash was described as "little red bumps". He had no other symptom and no problem breathing. The patient experienced the same reaction when he was one year old from the varicella vaccine. The patient was seen by a physician in a navy clinic but was not treated with anything. The following day, the rash was better and fully resolved by 15-Nov-2008. Additional information received on 05-Dec-2008 was incorporated into the narrative and included date of birth additional details about the event and outcome.  The patient had no problems breathing.  The outcome of the event was not reported. This is in follow-up to report(s) previously submitted on 11/13/2008. The patient has no known allergies but did experience the same reaction when he was one-year-old from the Varicella vaccine. The patient was not taking any concomitant medications. Additional information received on 07-Jan-2009 from a nurse in the immunization clinic included the lot number and expiration date at the FLUMIST and confirmation that the patient was seen in the clinic and was not treated.
Age: 1.6
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of FLUMIST administered to a 20-month-old was received from a registered nurse in the USA.  The reporter confirmed that there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  The case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  Additional information was obtained on 21-Nov-2008 and incorporated into the narrative: patient demographics, FLUMIST administration date and route of administration, event outcome and other authorities informed.
Age: 1.5
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious, spontaneous report of FLUMIST given by mistake to an 18 month-old infant girl was received from a consumer.  There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: A non-serious spontaneous report of vomiting has been received from a consumer concerning a four-year-old male subsequent to FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  Medical history and concomitant medications were not provided.  On 10-Nov-2008, the patient received FLUMIST.  Forty minutes after receiving FLUMIST, the patient "threw up"/experienced vomiting.  The outcome of the event was not reported.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure
Clinical narrative: A non-serious spontaneous report of "FLUMIST got in her eye" was received from a registered nurse concerning a three-year-old female. Medical history and concomitant medications were not reported. On 06-Nov-2008, during administration of FLUMIST, the patient moved and experienced exposure of the vaccine into her eyes. The reporter inquired about what to expect from this exposure. The reporter states that the medication error occurred at another clinic and no additional information is available, however, the nurse did submit a VARES report for this case. There was no adverse event associated with this medication error; therefore, treatment and reporter / sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Excessive eye blinking
Clinical narrative: A non-serious, spontaneous report of eye blinking was received from a nurse, concerning a three year-old male subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 04-Nov-2008. Twenty four hours after administration the patient's eye started blinking and has not stopped. The outcome for the event was not resolved.
Age: 1.9
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious spontaneous report of administration to a 23-month-old was received from a nurse.  The patient received FLUMIST on 06-Nov-2008.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Crepitations, Nasal congestion, Pneumonia mycoplasmal, Pyrexia
Clinical narrative: A non-serious unlabeled spontaneous report of mycoplasma pneumonia and accompanying symptoms has been received from a nurse concerning a 33 month-old female; 33 days after the infant received FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The only medical history reported was a language delay, the patient is on no concomitant medications.  The patient received FLUMIST nasally on 25-Sep-2008 for flu vaccination.  On 23-Oct-2008 the experienced a fever up to 101 degrees Fahrenheit.  On 28-Oct-2008 the patient was seen by her pediatrician, she had cough and stuffy nose with nasal discharge.  Her pediatrician diagnosed probable mycoplasma pneumonia, no lab testing or chest x-ray was done.  The physician also noted crackles in the infant's chest.  She was treated with ZITHROMAX for 5 days.  According to the infant's mother the infant is doing better.  The event of mycoplasma pneumonia and the accompanying symptoms are resolving as of 06-Nov-2008.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhinorrhoea
Clinical narrative: A non-serious unlabeled spontaneous report of mycoplasma pneumonia and accompanying symptoms has been received from a nurse concerning a 33 month-old female; 33 days after the infant received FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The only medical history reported was a language delay, the patient is on no concomitant medications.  The patient received FLUMIST nasally on 25-Sep-2008 for flu vaccination.  On 23-Oct-2008 the experienced a fever up to 101 degrees Fahrenheit.  On 28-Oct-2008 the patient was seen by her pediatrician, she had cough and stuffy nose with nasal discharge.  Her pediatrician diagnosed probable mycoplasma pneumonia, no lab testing or chest x-ray was done.  The physician also noted crackles in the infant's chest.  She was treated with ZITHROMAX for 5 days.  According to the infant's mother the infant is doing better.  The event of mycoplasma pneumonia and the accompanying symptoms are resolving as of 06-Nov-2008.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Medication error
Clinical narrative: A non-serious, spontaneous report of FLUMIST given to a child taking aspirin, in a two year-old male patient was received from a consumer. There was no adverse event associated with this medication error as of seventeen days after administration; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: A non serious labeled spontaneous report of fever and cold symptoms has been received from a registered nurse concerning a four-year-old male, three days after receiving FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. According to the reporter the patient has no past medical history; no concomitant medications were provided. The patient received FLUMIST on 01-Oct-2008. On 04-Oct-2008 the patient experienced a fever of 103 degrees Fahrenheit and cold symptoms. No treatment information was provided. The fever resolved on 05-Oct-2008 and the cold symptoms resolved one week later on 11-Oct-2008. The patient's physician indicated they did not believe the event was related to FLUMIST.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthma, Chest discomfort, Cough
Clinical narrative: A non-serious, spontaneous report of acute asthma exacerbation, chest tightness and cough was received from a military nurse concerning a four year-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's past medical history includes asthma. No concomitant medications have been reported for this patient. The patient received FLUMIST on 22-Oct-2008. On 26-Oct-2008 the child experienced coughing and acute exacerbation attack of asthma and was taken to the emergency room. The child was seen at the clinic on 27-Oct-2008 and 31-Oct-2008 for continuing symptoms of coughing and chest tightness. As of 03-Nov-2008 the child was stable with no symptoms.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Auricular swelling, Local swelling, Lymphadenopathy, Swelling face
Clinical narrative: A non-serious, spontaneous report of swollen lymph nodes was received from a nurse concerning a four year-old female subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST during the week of 27-Oct-2008 through 31-Oct-2008. On 02-Nov-2008 the child's left side of face, neck and behind the ear was swollen. The area is not sore to touch. The patient was being taken for treatment at a local health care provider. The outcome for the reported adverse event was not reported.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered
Clinical narrative: A spontaneous non-serious report of administration of half dose has been received from a medical assistant in a doctor's office concerning a 36-month-old female subsequent to FLUMIST. Medical history and concomitant medications were not reported. There was no adverse event associated with this event; therefore, treatment and reporter/sponsorcausality assessments are not applicable, and the event is considered resolved. This case is admitted in accordance with edImmune's post-marketing commitment on accelarated reporting for the newly indicated population of 2 years to 55 months of age for FLUMIST.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: A non-serious report of vomited twice has been received from a nurse concerning a four-year-old female. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history nor concomitant medications were provided. The patient received FLUMIST for the first time on 25-Nov-2008. One hour after the dose of FLUMIST, the patient experienced two episodes of vomiting. Per the child's parents, there were no other problems and the patient was doing well. The events resolved on 26-Nov-2008.
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of expired FLUMIST administered was received from a pharmacist concerning a female child. No medical history was provided for the child. The patient was inadvertently given FLUMIST that had expired four days prior. There was no adverse event associated with this medication error: therefore treatment and causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of two years to 59 months of age for FLUMIST.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Age: 3.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of administered expired FLUMIST has been received from a nurse concerning a 36-month-old of unknown gender. No medical history nor concomitant medications were provided. On 26-Nov-2008, the country health department inadvertently administered expired FLUMIST to ten patients. The product was expired by one day. The patient did not experience any adverse events and will be re vaccinated in four weeks. There  was no adverse event associated with this medication error; therefore, treatment and reporter / sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. This is in follow-up to report(s) previously submitted on 11/26/2008. Based on the results of the investigation, this root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 04-Apr-2009: product complaint investigation results.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Oropharyngeal pain, Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: A non-serious spontaneous report of fever, vomiting, chills sore throat, and runny nose has been received from a nurse concerning a four- year old female subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither past medical history nor concomitant medications were reported. The patient received FLUMIST on 25-Nov-2008. The patient woke up on 26-Nov-2008 with a fever, vomiting, chills, sore throat, and runny nose. The outcome was not reported. The events of fever, vomiting, chills, sore throat, and runny nose resolved on approximately 03-Dec-2008, within one week after the onset of the events. Additional information received 08-Jan-2009 and incorporated into the case outcome and resolution date.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: A non-serious labeled spontaneous report of vomiting has been received from a registered nurse concerning a 4-year-old female, subsequent to receiving FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 year to 59 month of age for FLUMIST.  No medical history or concomitant medication information was provided.  The patient received her first dose of FLUMIST on 25-Nov-2008.  On 25-Nov-2008, one hour after receiving FLUMIST the patient experienced two vomiting episodes, each episode was one hour apart.   No other problems were reported.  The vomiting resolved and the patient was doing fine the day after the event.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure
Clinical narrative: Incorrect route of drug administration (Incorrect route of drug administration) A non-serious report of FLUMIST sprayed in eyes has been received from a consumer concerning a 38-month-old female.  During administration of FLUMIST on 25-Nov-2008, the patient was accidentally sprayed in the eyes.  Her eyes were washed with warm water.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Sex: U
Vaccine: FLUN3
Symptoms: Facial palsy
Clinical narrative: A serious spontaneous report of important medical event BELL's Palsy with facial symptoms has been received from a physician, concerning a child of unspecified age and gender subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of  2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on an unspecified date. A physician reported a child experienced BELL's Palsy with facial symptoms after FLUMIST. The symptoms resolved on an unspecified date.
Age: 0.7
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered
Clinical narrative: Incorrect dose administered (Incorrect dose administered) A non-serious, spontaneous report was received from a nurse involving the administration of one-half dose of FLUMIST to an eight month-old female patient.  There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Sex: M
Vaccine: FLUN3
Symptoms: Epistaxis
Clinical narrative: A non-serious spontaneous report of nose bleed has been received from a medical assistant concerning a child, male patient subsequent to FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  No medical or drug history was reported for this patient.  The patient received FLUMIST at a pediatric clinic on 13-Nov-2008.  The patient experienced nose bleed while still in the office.  The outcome of the adverse event was not reported.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure
Clinical narrative: A non-serious spontaneous report of FLUMIST was sprayed into the patient's eye was received from a Registered Nurse concerning a 24-month-old female.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for Medical history and concomitant medications were not reported.  On 12-Nov-2008, the patient received FLUMIST.  The patient jumped while FLUMIST was being administered and the vaccine was sprayed into one eye.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. On 05-Dec-2008, the reporting nurse confirmed that there were no late - occuring advere events repoted.
Age: 1.5
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, Wheezing
Clinical narrative: A non-serious spontaneous report of FLUMIST administered to an 18-month-old and wheezing has been received from a pharmacist, subsequent to FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  Neither past medical history nor concomitant medication were reported.  The patient received FLUMIST intranasally on 30-Oct-2008.  The 18-month-old patient was given FLUMIST inadvertently. The patient returned to the clinic on 15-Nov-2008 and the the mother reported wheezing.  The patient has an appointment to be evaluated by a health care professional.  The outcome for the events is unknown.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium double contrast, Intussusception
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. On 25-JUN-2008, a 2 month old female who two weeks prior developed upper respiratory infection with runny nose and slight cough, was vaccinated with the first dose of ROTATEQ (Lot # 657510/0970U) on an unknown site by mouth. Concomitant therapy included the first dose of PREVENAR (Lot # C57538), given intramuscularly into the right leg, the first dose of OMNIHIB (Lot # UF345AC) given intramuscularly into the left leg and the first dose of PEDIARIX (Lot # AC21B142AA), given intramuscularly into the left leg. On 29-SEP-2008, the patient experienced intussusception reduced with air contrast enema. On 08-OCT-2008, records received for DOS 20-SEP-2008 presented with vomiting, lethargy and cough. On day of admission, the patient began vomiting 1 to 15 times and greenish in color with dark material in it. Diapers not wet, decreased urine output. Not interested in drinking. The patient weight loss, pale with decreased capillary refill and decreased responsiveness to stimulation and pain. The patient was tachycardic, with abdomen distended infrequent bowel sounds. The patient was transferred to another facility. On 08-OCT-2008 ED report for DOS 08-OCT-2008 C/O lethargy, pale and bilious forming again. Probably recurrent intussusception. The patient was previously hospitalized for intussusception and lung infection on 29-SEP-2008. On 28-OCT-2008, records received from receiving facility for DOS 30-SEP-2008 and 08-OCT-2008 and 09-OCT-2008, DC DX: Reduced Intussusception. Laboratory tests were performed which reported that on 20-SEP-2008 records for an air contrast enema for diagnostic and therapeutic were received. CXR showed increased density in right middle lobe. An abdominal x-ray was normal. On 28-OCT-2008 records received reported a Barium enema reduction with air enema. WBC was 21. The listing indicated that one or more of the events required ER visit, hospitalization, and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 327133. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the research center and was released.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal distension, Barium double contrast, Chest X-ray abnormal, Condition aggravated
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. On 25-JUN-2008, a 2 month old female who two weeks prior developed upper respiratory infection with runny nose and slight cough, was vaccinated with the first dose of ROTATEQ (Lot # 657510/0970U) on an unknown site by mouth. Concomitant therapy included the first dose of PREVENAR (Lot # C57538), given intramuscularly into the right leg, the first dose of OMNIHIB (Lot # UF345AC) given intramuscularly into the left leg and the first dose of PEDIARIX (Lot # AC21B142AA), given intramuscularly into the left leg. On 29-SEP-2008, the patient experienced intussusception reduced with air contrast enema. On 08-OCT-2008, records received for DOS 20-SEP-2008 presented with vomiting, lethargy and cough. On day of admission, the patient began vomiting 1 to 15 times and greenish in color with dark material in it. Diapers not wet, decreased urine output. Not interested in drinking. The patient weight loss, pale with decreased capillary refill and decreased responsiveness to stimulation and pain. The patient was tachycardic, with abdomen distended infrequent bowel sounds. The patient was transferred to another facility. On 08-OCT-2008 ED report for DOS 08-OCT-2008 C/O lethargy, pale and bilious forming again. Probably recurrent intussusception. The patient was previously hospitalized for intussusception and lung infection on 29-SEP-2008. On 28-OCT-2008, records received from receiving facility for DOS 30-SEP-2008 and 08-OCT-2008 and 09-OCT-2008, DC DX: Reduced Intussusception. Laboratory tests were performed which reported that on 20-SEP-2008 records for an air contrast enema for diagnostic and therapeutic were received. CXR showed increased density in right middle lobe. An abdominal x-ray was normal. On 28-OCT-2008 records received reported a Barium enema reduction with air enema. WBC was 21. The listing indicated that one or more of the events required ER visit, hospitalization, and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 327133. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the research center and was released.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cough, Diet refusal, Enema administration, Gastrointestinal sounds abnormal, Intussusception
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. On 25-JUN-2008, a 2 month old female who two weeks prior developed upper respiratory infection with runny nose and slight cough, was vaccinated with the first dose of ROTATEQ (Lot # 657510/0970U) on an unknown site by mouth. Concomitant therapy included the first dose of PREVENAR (Lot # C57538), given intramuscularly into the right leg, the first dose of OMNIHIB (Lot # UF345AC) given intramuscularly into the left leg and the first dose of PEDIARIX (Lot # AC21B142AA), given intramuscularly into the left leg. On 29-SEP-2008, the patient experienced intussusception reduced with air contrast enema. On 08-OCT-2008, records received for DOS 20-SEP-2008 presented with vomiting, lethargy and cough. On day of admission, the patient began vomiting 1 to 15 times and greenish in color with dark material in it. Diapers not wet, decreased urine output. Not interested in drinking. The patient weight loss, pale with decreased capillary refill and decreased responsiveness to stimulation and pain. The patient was tachycardic, with abdomen distended infrequent bowel sounds. The patient was transferred to another facility. On 08-OCT-2008 ED report for DOS 08-OCT-2008 C/O lethargy, pale and bilious forming again. Probably recurrent intussusception. The patient was previously hospitalized for intussusception and lung infection on 29-SEP-2008. On 28-OCT-2008, records received from receiving facility for DOS 30-SEP-2008 and 08-OCT-2008 and 09-OCT-2008, DC DX: Reduced Intussusception. Laboratory tests were performed which reported that on 20-SEP-2008 records for an air contrast enema for diagnostic and therapeutic were received. CXR showed increased density in right middle lobe. An abdominal x-ray was normal. On 28-OCT-2008 records received reported a Barium enema reduction with air enema. WBC was 21. The listing indicated that one or more of the events required ER visit, hospitalization, and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 327133. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the research center and was released.