chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.7
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-month-old male patient who received KINRIX (batch number AC20B254AA, expiry date 4th April 2015). Previously administered products included DTAP (dose 1 and dose 2) and IPV (dose 1 and dose 2). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional information: CMA reports KINRIX was administered to a 8 month old as his 3rd DTaP and 3rd IPV dose.
Age: 61.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old male patient who received TWINRIX. Previously administered products included TWINRIX (dose 1). On an unknown date, the patient received the 2nd dose of TWINRIX. On an unknown date, an unknown time after receiving TWINRIX, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was not reported. Additional information received: Pharmacist reports that a patient received dose 1 of TWINRIX at an MD office in July 2014 and is requesting dose 2 now.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-year-old female patient who received HAVRIX adult (batch number XD72G, expiry date 5th November 2016). Previously administered products included HAVRIX pediatric (dose 1). On 6th January 2015, the patient received HAVRIX adult 1 ml. On an unknown date, an unknown time after receiving HAVRIX adult, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional information received: 15 year-old patient inadvertently received adult dose of HAVRIX (she received the 1 mL dose). Patient previously received initial dose of HAVRIX on 06/18/14; she received recommended 0.5mL dose at that time. This was patient's scheduled booster dose of product. Patient not experiencing any events from adult dose at this time. Dose administered today (01/06/15).
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Discomfort, Headache, Pain, Pyrexia
Clinical narrative: pt phoned 2/13/15 stated she believed she had a reaction to vaccine. That night she had a fever reaching 103 degrees F, chills, body aches, headache. She took ADVIL for fever/discomfort. Symptoms subsided by 2/13/15 she began to feel better.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 12-year-old female patient who received HAVRIX. On an unknown date, the patient received HAVRIX adult at an unknown date. On an unknown date, an unknown time after receiving HAVRIX adult, the patient experienced inappropriate age at vaccine administration and accidental overdose. On an unknown date, the outcome of the inappropriate age at vaccine administration and accidental overdose were unknown. Additional information received: RN reports inadvertent administration of HAVRIX to a 12 year old patient. RN did not have patient info or vaccine lot/exp date available at this time.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abasia, Dizziness
Clinical narrative: Severe dizziness I could not event wak for 5-6 hrs the day I rec'd the shot. The 2nd day I had mild dizziness.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown ages and genders. On unknown dates the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (route, lot#, dose and frequency unkonwn). No adverse effects were reported. It was unspecified if the patients sought medical attention. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Sore, red around site injection, happened day after got vaccine. Treating with BENADRYL 25mg capsule of maybe BENADRYL cream (on left arm).
Age: 9.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 9-year-old female patient who received KINRIX (batch number KJ924, expiry date 22nd October 2015). Previously administered products included DTPA IPV (dose 1,2 and 3.). On an unknown date, the patient received KINRIX. On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received: A 9YO was inadvertently given KINRIX as the 4th dose of DTap and IPV as part of her catch-up vaccinations.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a pharmacist referring to a 62 year old female patient with allergy to codeine and related (unspecified). No other information of medical history was reported. On 09-FEB-2015, the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX lot # K015308, expiry date: 17-DEC-2015, subcutaneously. Concomitant therapies included hydrochlorothiazide, ZESTORETIC, FLONASE, ZETIA, estradiol (manufacturer unknown), duloxetine hydrochloride and omeprazole. On 20-FEB-2015 (reported a 20-FEB-2015 to 21-FEB-2015), the patient experienced itching and a rash at the waist area. On unknown dates, the patient called and saw the pharmacist and then went to an urgent care and saw a physician. The patient was given prednisone (manufacturer unknown) and ATARAX for treatment. The outcome of adverse events was unknown. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No reaction to adverse event. Pt was given Hep A vaccine too early in Oct 2014. She was to have this redone it has only been 5 months between dose recommended 6 mo.
Age: 6.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No reaction to adverse event. Pt was given Hep A vaccine too early in Oct 2014. She was to have this redone it has only been 5 months between dose recommended 6 mo.
Age: 45.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administration error
Clinical narrative: A 45-year-old female health professional reporting for her self. No medical history, concomitant diseases and concomitant medications were reported for consumer. Patient had FLUMIST quadrivalent (intranasal) on an unknown date, indication was not provided. Patient thought that she had received all of the FLUMIST quadrivalent into only one nostril and some the vaccine dripped out of my nose on 02-Nov-2014. The pharmacist that administered the vaccine did remove the dose clip but patient did not feel like anything had gone in the second nostril. Action taken with FLUMIST quadrivalent was unknown. The outcome for the event of FLUMIST into only one nostril-some of the vaccine dripped out of the nose was unknown. The report was considered to be non-serious by reporter.
Age: 59.0
Sex: F
Vaccine: TTOX
Symptoms: Local swelling, Paraesthesia
Clinical narrative: Streaking in arm, swelling in axilla and neck. Since sx paresthesias in left neck and bilateral hands. Returned to ER 10/7/14.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Chills, Dizziness, Hyperhidrosis, Leukopenia
Clinical narrative: Acute joint pain beginning 2/13 and lasting several days. Chills alternating with periods of sweating beginning 2/14. Fever lasting several days. Dizziness. Blood work on 2/17 indicated viral infection. MD note: References significant leukopenia.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Viral infection, Viral test positive, White blood cell count decreased
Clinical narrative: Acute joint pain beginning 2/13 and lasting several days. Chills alternating with periods of sweating beginning 2/14. Fever lasting several days. Dizziness. Blood work on 2/17 indicated viral infection. MD note: References significant leukopenia.
Age: 1.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13, MMRV
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 17 month old female patient. No medical history, drug allergy and concurrent condition was reported. On 06-FEB-2015, the patient was vaccinated with PROQUAD (Merck) (Lot # K019101 with the expiration date of 15-APR-2016), 0.5 ml, subcutaneously. On 08-FEB-2015, 3 days after onset of therapy the patient experienced fever of 104F and a measles-type rash all over her face and trunk after receiving PROQUAD. Patient visited office and sought medical attention. No treatment was given for the events. No lab diagnostic studies were performed. The outcome of the events was reported as recovered/resolved. Causality assessment was not provided. Additional information has been requested.
Age: 1.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13, MMRV
Symptoms: Pyrexia, Rash, Rash morbilliform
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 17 month old female patient. No medical history, drug allergy and concurrent condition was reported. On 06-FEB-2015, the patient was vaccinated with PROQUAD (Merck) (Lot # K019101 with the expiration date of 15-APR-2016), 0.5 ml, subcutaneously. On 08-FEB-2015, 3 days after onset of therapy the patient experienced fever of 104F and a measles-type rash all over her face and trunk after receiving PROQUAD. Patient visited office and sought medical attention. No treatment was given for the events. No lab diagnostic studies were performed. The outcome of the events was reported as recovered/resolved. Causality assessment was not provided. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Rash, swelling, and itching at the injection site (left arm). Got better slowly over a week, but still itches.
Age: 0.44
Sex: F
Vaccine: HEP, IPV, PNC13
Symptoms: Tremor
Clinical narrative: Multiple tremors throughout the day.
Age: 2.0
Sex: M
Vaccine: IPV
Symptoms: Erythema of eyelid, Eyelid oedema, Irritability, Pyrexia
Clinical narrative: Irritable, red swelling around left eye, fever of 103.2 Fahrenheit.
Age: 7.0
Sex: F
Vaccine: DTAP, DTPIHI, HBHEPB, HEPA
Symptoms: Arthralgia, Vomiting
Clinical narrative: Vomiting. Sharp elbow pain.
Age: 1.42
Sex: F
Vaccine: DTP, HIBV, MMR, OPV
Symptoms: Abnormal behaviour, Aphasia, Autism, Communication disorder, Crying
Clinical narrative: Inconsolable crying within the week following shots. Decline of social/communication skills from this time forward. Odd behaviors. Loss of speech by 3rd year of life.
Age: 1.42
Sex: F
Vaccine: DTP, HIBV, MMR, OPV
Symptoms: Disturbance in social behaviour, Tuberculin test
Clinical narrative: Inconsolable crying within the week following shots. Decline of social/communication skills from this time forward. Odd behaviors. Loss of speech by 3rd year of life.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Dizziness, Rash, Throat tightness
Clinical narrative: Throat tightened up and experienced dizziness and developed rash all over the body. Went to ER and was treated and order given for Epi pen to be carried.
Age: 0.58
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Acute disseminated encephalomyelitis, Choreoathetosis, Decreased eye contact, Lumbar puncture normal, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: I am a pediatrician working for a hospital.  I have a case to report to CDC. I have a patient, 8 month old previously female who was dxed with ADEM (possibly from Fluzone).  Patient was noted to be "extra-sleepy" within a day (that night) per mom after receiving 2nd Sanofi Fluzone on 28 Jan 2015 (which was given 1 mo after 1st Fluzone) & developed choreoathetotic movements & was transferred to a hospital. Pt has no issues with 2,4 6 mo vaccines including 1st Fluzone.  At hospital, pt had normal spinal tap & brain MRI showed diffuse white matter signal change.  Pt was dxed with ADEM & was treated with high dose IV steroid pulse therapy.  Pt seems to be improving overall but still has persistent choreoathetotic movements & can not hold her head up. Vision seems to be returning to normal & now making some eye contacts.
Age: 0.58
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Posture abnormal, Somnolence, Visual impairment, White matter lesion
Clinical narrative: I am a pediatrician working for a hospital.  I have a case to report to CDC. I have a patient, 8 month old previously female who was dxed with ADEM (possibly from Fluzone).  Patient was noted to be "extra-sleepy" within a day (that night) per mom after receiving 2nd Sanofi Fluzone on 28 Jan 2015 (which was given 1 mo after 1st Fluzone) & developed choreoathetotic movements & was transferred to a hospital. Pt has no issues with 2,4 6 mo vaccines including 1st Fluzone.  At hospital, pt had normal spinal tap & brain MRI showed diffuse white matter signal change.  Pt was dxed with ADEM & was treated with high dose IV steroid pulse therapy.  Pt seems to be improving overall but still has persistent choreoathetotic movements & can not hold her head up. Vision seems to be returning to normal & now making some eye contacts.
Age: 0.58
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Agitation, Crying, Decreased activity, Decreased appetite, Depressed mood
Clinical narrative: I am a pediatrician working for a hospital.  I have a case to report to CDC. I have a patient, 8 month old previously female who was dxed with ADEM (possibly from Fluzone).  Patient was noted to be "extra-sleepy" within a day (that night) per mom after receiving 2nd Sanofi Fluzone on 28 Jan 2015 (which was given 1 mo after 1st Fluzone) & developed choreoathetotic movements & was transferred to a hospital. Pt has no issues with 2,4 6 mo vaccines including 1st Fluzone.  At hospital, pt had normal spinal tap & brain MRI showed diffuse white matter signal change.  Pt was dxed with ADEM & was treated with high dose IV steroid pulse therapy.  Pt seems to be improving overall but still has persistent choreoathetotic movements & can not hold her head up. Vision seems to be returning to normal & now making some eye contacts.
Age: 0.58
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Dyskinesia, Gaze palsy, Hyperhidrosis, Irritability, Posture abnormal
Clinical narrative: I am a pediatrician working for a hospital.  I have a case to report to CDC. I have a patient, 8 month old previously female who was dxed with ADEM (possibly from Fluzone).  Patient was noted to be "extra-sleepy" within a day (that night) per mom after receiving 2nd Sanofi Fluzone on 28 Jan 2015 (which was given 1 mo after 1st Fluzone) & developed choreoathetotic movements & was transferred to a hospital. Pt has no issues with 2,4 6 mo vaccines including 1st Fluzone.  At hospital, pt had normal spinal tap & brain MRI showed diffuse white matter signal change.  Pt was dxed with ADEM & was treated with high dose IV steroid pulse therapy.  Pt seems to be improving overall but still has persistent choreoathetotic movements & can not hold her head up. Vision seems to be returning to normal & now making some eye contacts.
Age: 0.58
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Somnolence
Clinical narrative: I am a pediatrician working for a hospital.  I have a case to report to CDC. I have a patient, 8 month old previously female who was dxed with ADEM (possibly from Fluzone).  Patient was noted to be "extra-sleepy" within a day (that night) per mom after receiving 2nd Sanofi Fluzone on 28 Jan 2015 (which was given 1 mo after 1st Fluzone) & developed choreoathetotic movements & was transferred to a hospital. Pt has no issues with 2,4 6 mo vaccines including 1st Fluzone.  At hospital, pt had normal spinal tap & brain MRI showed diffuse white matter signal change.  Pt was dxed with ADEM & was treated with high dose IV steroid pulse therapy.  Pt seems to be improving overall but still has persistent choreoathetotic movements & can not hold her head up. Vision seems to be returning to normal & now making some eye contacts.
Age: 0.58
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Agitation, Anti-NMDA antibody positive, Childhood disintegrative disorder, Encephalitis autoimmune, Hypophagia
Clinical narrative: I am a pediatrician working for a hospital.  I have a case to report to CDC. I have a patient, 8 month old previously female who was dxed with ADEM (possibly from Fluzone).  Patient was noted to be "extra-sleepy" within a day (that night) per mom after receiving 2nd Sanofi Fluzone on 28 Jan 2015 (which was given 1 mo after 1st Fluzone) & developed choreoathetotic movements & was transferred to a hospital. Pt has no issues with 2,4 6 mo vaccines including 1st Fluzone.  At hospital, pt had normal spinal tap & brain MRI showed diffuse white matter signal change.  Pt was dxed with ADEM & was treated with high dose IV steroid pulse therapy.  Pt seems to be improving overall but still has persistent choreoathetotic movements & can not hold her head up. Vision seems to be returning to normal & now making some eye contacts.
Age: 0.58
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Irritability
Clinical narrative: I am a pediatrician working for a hospital.  I have a case to report to CDC. I have a patient, 8 month old previously female who was dxed with ADEM (possibly from Fluzone).  Patient was noted to be "extra-sleepy" within a day (that night) per mom after receiving 2nd Sanofi Fluzone on 28 Jan 2015 (which was given 1 mo after 1st Fluzone) & developed choreoathetotic movements & was transferred to a hospital. Pt has no issues with 2,4 6 mo vaccines including 1st Fluzone.  At hospital, pt had normal spinal tap & brain MRI showed diffuse white matter signal change.  Pt was dxed with ADEM & was treated with high dose IV steroid pulse therapy.  Pt seems to be improving overall but still has persistent choreoathetotic movements & can not hold her head up. Vision seems to be returning to normal & now making some eye contacts.
Age: 0.58
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Anti-NMDA antibody positive, Dyskinesia, Encephalitis autoimmune, Encephalopathy
Clinical narrative: I am a pediatrician working for a hospital.  I have a case to report to CDC. I have a patient, 8 month old previously female who was dxed with ADEM (possibly from Fluzone).  Patient was noted to be "extra-sleepy" within a day (that night) per mom after receiving 2nd Sanofi Fluzone on 28 Jan 2015 (which was given 1 mo after 1st Fluzone) & developed choreoathetotic movements & was transferred to a hospital. Pt has no issues with 2,4 6 mo vaccines including 1st Fluzone.  At hospital, pt had normal spinal tap & brain MRI showed diffuse white matter signal change.  Pt was dxed with ADEM & was treated with high dose IV steroid pulse therapy.  Pt seems to be improving overall but still has persistent choreoathetotic movements & can not hold her head up. Vision seems to be returning to normal & now making some eye contacts.
Age: 6.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Local swelling, Lymphadenopathy, Pyrexia, Tenderness
Clinical narrative: For a couple of days after immunization low grade fever then on 25th complained of bump in groin that was tender. Child has firm swollen glands in both sides of neck and right side of groin.  No other apparent side effects.
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Extra dose administered
Clinical narrative: A report has been received from a Health Professional concerning a 12 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 10-Oct-2014. Patient received two FLUMIST quadrivalent does in 8 days which started on 10-Oct-2014. The outcome of the event of patient received two FLUMIST quadrivalent doses in 68 days is unkonwn. The report was considered to be non-serious.
Age: 4.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Decreased appetite, Pyrexia, Vomiting
Clinical narrative: Slight fever, loss of appetite and single event of vomiting.
Age: 80.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chills, Nasal congestion, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: PT HAD COLD LIKE SYMPTOMS/RUNNY NOSE/NASAL CONGESTION/FEVER/ACHES AND CHILLS.
Age: 80.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rhinorrhoea
Clinical narrative: PT HAD COLD LIKE SYMPTOMS/RUNNY NOSE/NASAL CONGESTION/FEVER/ACHES AND CHILLS.
Age: 43.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Joint swelling, Pruritus
Clinical narrative: +1 day: Swelling at injection site. +2 days: Itching at injection site. +3 days: Large reddened patch of skin surrounding injection site; mild itching; mild swelling in ankles.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Death, Pneumonia
Clinical narrative: This spontaneous report as received from a consumer, as part of a marketing research program refers to a 49 year old male patient. On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown) (dose, route and lot # not reported). The consumer reported that on an unknown date, 2 months after vaccination, the patient died from pneumonia so he had no faith in pneumococcal vaccine (manufacturer unknown). The relationship between the event and pneumococcal vaccine, (manufacturer unknown) was not reported. Additional information is not expected. There is no contact information.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Dizziness, Dysstasia, Heart rate increased, Influenza
Clinical narrative: Heartbeat fast - (2 months). Dizzy. Could not stand more than 5 min. Severe flu symptoms (2 wks).
Age: 91.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Local reaction
Clinical narrative: This is a spontaneous report from a contactable physician and from Pfizer for a contactable Pfizer sales representative and a contactable nurse on behalf of physician. This contactable physician reported different events with the same suspect product for four patients. This is the third of four reports. A 91-year-old female patient of an unspecified ethnicity received PREVNAR 13 (lot J67644, expiry date Mar2016), intramuscular at 0.5 ml single dose on 08Jan2015 13:15. The patient medical history and concomitant medications were not reported. On 08Jan2015, the patient experienced large local reaction, cellulitis was also suspected, redness and itchy at site. The outcome of the was recovered. The Pfizer sales representative mentioned that the doctor believed that the reaction was experienced by the patient because of the vaccine, PREVNAR 13. Follow up (23Jan2015): New information from Pfizer for a contactable Pfizer sales representative includes causality assessment. Follow-up (18Feb2015): New information received from a contactable nurse includes: patient's details, date of administration vaccine, anatomical location, details of the events, onset and outcome. Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer Vaccines Sales Representative. A 65 years old female patient received PREVNAR 13 at single dose on unknown date. Medical history and concomitant medications were not provided. On an unspecified date the patient's arm swelled up really bad, like real bad cellulitis and it was bright red, really red, and it was all the way around the arm. The events occurred after the patient got the vaccine shot and they did not get better after she received antibiotics. The events were not resolved at the time of the report.
Age: 1.4
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash, Seizure
Clinical narrative: Seizure, fever, rash.
Age: 31.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Feeling hot, Pain, Pruritus, Tenderness
Clinical narrative: Redness, pain, itching, tenderness, warm sensation in Left arm. Prescribed Benadryl, will follow up in 3 days (2/30/15).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: Client complained of numbness down left are and pain at injection site. in the evening after 3rd Gardasil vaccine. Arm is still numb this AM. Called MD this AM and was told to apply ice for 10 min at a time every 2 hrs. Suggested Ibuprofen also. Mother to call back Monday with update.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Injection site pain, Injection site pruritus, Injection site vesicles, Paraesthesia
Clinical narrative: Patient received Zostavax vaccine on 2/11/15. One week later, patient states pain, itching, and blisters on left arm where the vaccine was adminstered. On 2/26/15 when the adverse event was discovered, patient states itching, tingling and postinflammatory reaction.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Patient received Zostavax vaccine on 2/11/15. One week later, patient states pain, itching, and blisters on left arm where the vaccine was adminstered. On 2/26/15 when the adverse event was discovered, patient states itching, tingling and postinflammatory reaction.
Age: 0.2
Sex: M
Vaccine: DTAP, PNC13, RV5
Symptoms: Colostomy, Gastrointestinal necrosis, Intestinal resection, Intussusception, Ultrasound abdomen
Clinical narrative: Intussusception with necrotic bowels status post colon resection and colostomy.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Condition aggravated, Irritable bowel syndrome
Clinical narrative: Information has been received from business manager via a company representative referring to a 12 year old female patient with pre-existing irritable bowel syndrome. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot#, expiration date were unknown, one dose, once) intramuscularly. The patient has "exacerbated irritable bowel syndrome" after receiving the vaccine. The irritable bowel syndrome had worsened to the point that the patient was no longer able to go to school. The outcome of the event was reported as not recovered/not resolved. Upon internal review, the event of exacerbated irritable bowel syndrome was considered to be disabling. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain, Pyrexia, Syncope
Clinical narrative: Syncopal episode, fever in the evening, nausea, soreness. Had stayed under observation in medical office x 20 minutes without any reactions or complaints.
Age: 1.02
Sex: M
Vaccine: FLU4, MMR, VARCEL
Symptoms: Irritability, Rash morbilliform
Clinical narrative: Irritability. Measles like rash.
Age: 2.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 82.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Pain in arm at injection site
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to an unspecified number of patients of unknown age. On 25-FEB-2015 the patients was vaccinated with ROTATEQ (dose, lot number, was unknown), orally which was improperly stored. No adverse effects was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. No additional information was reported. Additional information has been requested.
Age: 1.23
Sex: F
Vaccine: DTAP, HEP, HIBV, MMR
Symptoms: Diarrhoea, Dyskinesia, Headache, Muscle twitching
Clinical narrative: Headache, watery bowel movements (3), twitch (raises shoulders and lowers shoulders real fast in a jerking motion) never seen in this child before.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Influenza like illness, Injection site pain, Malaise, Myalgia
Clinical narrative: FEVER, MYALGIAS, HEADACHE, MALAIASE, SORENESS AT THE SITE - FLU LIKE SYMPTOMS.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia
Clinical narrative: FEVER, MYALGIAS, HEADACHE, MALAIASE, SORENESS AT THE SITE - FLU LIKE SYMPTOMS.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: The injection site became swollen, red, itchy and tender. The affected area spread to a circumference of about 4 inches. A mild temperature of 99 degrees occurred on day 2.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm, Swelling, Tenderness
Clinical narrative: Swelling, redness, pain, hot to touch, tender to touch.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster oticus, Nuclear magnetic resonance imaging, Paralysis, Tic, VIIth nerve paralysis
Clinical narrative: Initial face sagging, full blown facial tics and paralysis set in two days later. Urgent care identified vaccine as probable cause. Neurologist believes its Ramsey Hunt Syndrome.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Area of redness at injection site, size of quarter. Cold pack was administered. Area of redness has increased to about 2 by 4 inches noted on Friday 2/27/2015. Patient told to alternate cold pack 20 min. on and off as needed for soreness/redness and PCP was notifed.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV4, MNQ
Symptoms: Anxiety, Hallucination
Clinical narrative: Mom calling and states that she is currently with child at clinic as child has been having hallucinations since last HPV on 1/15/2015. Child has had 2 prior doses of HPV up to this date. States that started about 3-4 days after last vaccinations. She sees figures hanging from ceiling, or dark shadowing figures. At home and at school. Child with severe anxiety now due to this.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Activities of daily living impaired, Rash generalised
Clinical narrative: Patient developed rash over 75% of his body and stayed in bed for approximately 2 weeks.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Activities of daily living impaired, Mobility decreased, Rash generalised
Clinical narrative: Patient developed rash over 75% of his body and stayed in bed for approximately 2 weeks.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: HIVES
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site reaction, Injection site swelling, Rash pruritic
Clinical narrative: Localized swelling and itchy rash in front of left and right thighs.
Age: 40.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Inflammation, Pyrexia
Clinical narrative: Patient had redness, inflammation down to his elbow, along with a fever.  This was increasing in severity over the course of past 3 days until he visited a doctor today.  He was diagnosed with cellulitis.
Age: 2.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site urticaria, Screaming, Urticaria
Clinical narrative: Woke up from nap screaming and mom noticed hives to left cheek and back of left thigh, brought into office at 2:15pm and hives fading without any treatment given. DTaP recorded as given to Left thigh and Varicella reported as given to Left bicep.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blood heavy metal increased, Fatigue, Guillain-Barre syndrome, Menstruation irregular
Clinical narrative: Severe abdominal pain, nausea, loss of focus, syncope up to 5 times per day w seizure like activity, skin rashes, irritations, hives, chronic fatigue, Guillain Barre irregular menstrual cycle.  2 EDTA detox treatments, daily detox, advanced spinal care, 100% raw, organic low glycemic diet
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Rash, Seizure like phenomena, Skin irritation, Syncope
Clinical narrative: Severe abdominal pain, nausea, loss of focus, syncope up to 5 times per day w seizure like activity, skin rashes, irritations, hives, chronic fatigue, Guillain Barre irregular menstrual cycle.  2 EDTA detox treatments, daily detox, advanced spinal care, 100% raw, organic low glycemic diet
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria, Vision blurred
Clinical narrative: Severe abdominal pain, nausea, loss of focus, syncope up to 5 times per day w seizure like activity, skin rashes, irritations, hives, chronic fatigue, Guillain Barre irregular menstrual cycle.  2 EDTA detox treatments, daily detox, advanced spinal care, 100% raw, organic low glycemic diet
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Arm red, hot, swollen, hard to touch and painful where shot was given.
Age: 1.01
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Chest X-ray, Cough, Pneumonia, Pyrexia
Clinical narrative: Started run low fever Sunday afternoon. Continued to run fever or approx. 102 (rectal temp) Monday, Tuesday, and Wednesday. Wednesday began coughing, fever increased to 104 that evening. Thursday cough continued to get worse. Fever went back up to 104.1 Thursday night. Friday ran fever 102-104 all day. Went to doctor's and diagnosed with small pneumonia in upper part of lung. Currently on 10 days of antibiotics.
Age: 9.0
Sex: M
Vaccine: TD
Symptoms: Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: Large circular hive-like raised patch where the tetanus shot was administered.  Itched, hot to the touch.  No treatment, just watching it.  It is one week and 2 days after the injection. It has not yet gone away.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Myalgia, Neck pain
Clinical narrative: Big red itchy and red round bump around site of injection. Sore throat, muscle aches, body pains. Lower neck pain. And pain up and down left arm which is the same arm I got the vaccine in.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Big red itchy and red round bump around site of injection. Sore throat, muscle aches, body pains. Lower neck pain. And pain up and down left arm which is the same arm I got the vaccine in.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Flushing, Malaise, Syncope
Clinical narrative: Syncope--light headed, flushed, dizzy. Patient's friend notified pharmacist that he was not feeling well only a few minutes after vaccination. We had him lie down on floor with feet elevated. He immediately stated he felt better. Had him remain laying for 10 minutes. He said he felt better so we sat him up and checked blood pressure at that time. Reading was 125/81. He remained seated until approximately 8:00pm. Store management took his statement and he was feeling fine so he got up and left the store. Advised him to notify emergency services if his condition changed.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Generalised tonic-clonic seizure, Pyrexia
Clinical narrative: Patient described grand mal seizures/convulsions, fever 101F.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Health Professional concerning a 9 year old, male subject who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that the patient experienced multiple patients received a half a dose of FLUMIST QUADRIVALENT which started on 28-Oct-2014. The outcome of the event of multiple patients received a half a dose of FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 1 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that the patient experienced patient under 2 received FLUMIST QUADRIVALENT which started on 04-Nov-2014. The outcome of the event of patient under 2 received FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Age: 68.0
Sex: F
Vaccine: TD
Symptoms: Bone pain, Injection site pain
Clinical narrative: Left arm pain from shoulder to elbow; bone pain; worsening pain. Female patient received Td on 07/14/14 due to stepping on a nail. On 07/15/14, patient reported left arm pain from shoulder to elbow; patient stated "it feels like the pain is in the bone-bone hurts." The patient's first visit to physician's office for event was on 07/21/14 and was treated with a steroid shot, anti-inflammatories and pain medication. Patient reported a mild improvement of symptoms right after receiving the treatment on 07/21/14, but indicated that the pain returned. During her follow-up visit, on 07/24/14, the patient reported worsening pain and was prescribed prednisone 10mg/6 days; she is due back at the physician's office on 7/31/14 for an additional follow-up. Follow-up on 08/12/14: Patient did not return to the physician's office for the follow-up appointment. Patient indicated she visited her primary care physician who referred her to an orthopedic doctor; no medications were prescribed. Patient indicated her condition was improved while taking steroid, however she did not specify she was recovered. Patient indicated she will not follow up with any physician for the time being. Follow-up on 09/08/14: Patient's recovery status is unknown. All attempts to obtain additional information have been unsuccessful.
Sex: F
Vaccine: FLUN4
Symptoms: Myalgia
Clinical narrative: A report has been received from a physician concerning an adult female subject, who had been receiving FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient experienced arm muscle pain. The outcome of the event of arm muscle pain is unknown. The report was considered to be non-serious.
Age: 39.0
Sex: F
Vaccine: FLUN4
Symptoms: Chest discomfort, Cough, Dyspnoea, Hypersensitivity, Wheezing
Clinical narrative: A consumer report has been received concerning a 40 year old, female patient. The patient's medical history and concomitant medications were not reported. Since an unknown date the patient had been received FLUMIST QUADRIVALENT (intranasal). The patient reported that she had FLUMIST every year for the last nine years and she had never any reaction to the vaccine. On 12-oct-2014, her husband and son received FLUMIST QUADRIVALENT. About an hour later FLUMIST she started symptoms of tightness in chest and wheezing. She was treated with albuterol. Episodes of nightly cough and shortness of breath continued for next two weeks. The doctor said she probably had inhaled some of the FLUMIST and it caused an allergic reaction. The doctor prescribed SYMBICORT, which she took daily. The outcome of the event of tightness in chest, wheezing, night cough and shortness of breath was unknown. The report was considered to be non-serious by reporter.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Bronchitis, Cough, Lymphadenopathy, Nasal congestion, Pyrexia
Clinical narrative: A report has been received from a health professional concerning an 11 year old, male patient with height: 56.5 inches and weight: 84.0 pounds. The patient's concurrent diseases included asthma, heart murmur, ADHD, anxiety and depression. Family history included anxiety, diabetes mellitus type 2, hypercholesterolemia and allergic rhinitis. Concomitant medications included azithromycin for infection, fluticasone propionate, salbutamol sulfate and sertraline.  The patient has been receiving nasal FLUMIST (intranasal), started on 29-Oct-2014. On 29-Oct-2014, the asthmatic patient received FLUMIST. On 11-Nov-2014, The patient was seen for fever cough, nasal congestion and sinus pain since one week and was diagnosed with acute bronchitis. On same day during physical examination was performed with findings of Mouth and throat Exam: Oral cavity/Oropharynx; hypersecretion. Chest and lung Exam: Expiratory wheeze-Both lung fields, Lymphatic Exam: Generalized lymphadenopathy. FLUMIST was continued. At the time of reporting, the event of acute bronchitis was ongoing and the outcome of the event of asthmatic patient received FLUMIST was unknown. At the time of reporting, the event of acute bronchitis was ongoing and the outcome of the event of asthmatic patient received FLUMIST was unknown. The report was considered to be non-serious by reporter.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Salivary hypersecretion, Sinus headache, Wheezing
Clinical narrative: A report has been received from a health professional concerning an 11 year old, male patient with height: 56.5 inches and weight: 84.0 pounds. The patient's concurrent diseases included asthma, heart murmur, ADHD, anxiety and depression. Family history included anxiety, diabetes mellitus type 2, hypercholesterolemia and allergic rhinitis. Concomitant medications included azithromycin for infection, fluticasone propionate, salbutamol sulfate and sertraline.  The patient has been receiving nasal FLUMIST (intranasal), started on 29-Oct-2014. On 29-Oct-2014, the asthmatic patient received FLUMIST. On 11-Nov-2014, The patient was seen for fever cough, nasal congestion and sinus pain since one week and was diagnosed with acute bronchitis. On same day during physical examination was performed with findings of Mouth and throat Exam: Oral cavity/Oropharynx; hypersecretion. Chest and lung Exam: Expiratory wheeze-Both lung fields, Lymphatic Exam: Generalized lymphadenopathy. FLUMIST was continued. At the time of reporting, the event of acute bronchitis was ongoing and the outcome of the event of asthmatic patient received FLUMIST was unknown. At the time of reporting, the event of acute bronchitis was ongoing and the outcome of the event of asthmatic patient received FLUMIST was unknown. The report was considered to be non-serious by reporter.
Age: 51.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 51 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on 15-Oct-2014. It was reported that the patient experienced 52 year old received FLUMIST quadrivalent which started on 15-Oct-2014. The outcome of the event of 52 year old received FLUMIST quadrivalent is unknown. The report was considered to be non-serious.
Age: 50.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 50 year old, Female subject, who had been received Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 27-Oct-2014. It was reported that a 50 year old was administered FLUMIST which started on 27-Oct-2014. The outcome of the event of ADMINISTERED FLUMIST TO a 50 YO is unknown. The report was considered to be non-serious.
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Incorrect dose administered
Clinical narrative: A report has been received from a Health Professional concerning a 12 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The patient experienced multiple patients received a half a dose of FLUMIST quadrivalent which started on 28-Oct-2014. The outcome of the event of multiple patients received a half a dose of FLUMIST quadrivalent is unknown. The report was considered to be non-serious.
Age: 66.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 86 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. It was reported that administered FLUMIST quadrivalent to a 66 year old which started on 27-Oct-2014. The outcome of the event of administered FLUMIST quadrivalent to a 66 year old is unknown. The report was considered to be non-serious.
Age: 50.0
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 50 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 15-Oct-2014. It was reported that the patient FLUMIST QUADRIVALENT was administered to a 50 year old which started 15-Oct-2014. The outcome of the event of inadvertently administered FLUMIST QUADRIVALENT to a 50 year old is unknown. The report was considered to be non-serious.
Age: 11.0
Sex: F
Vaccine: FLUN4
Symptoms: Extra dose administered
Clinical narrative: A report has been received from a Health Professional concerning a 11 year old, Female subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 05-Nov-2014. The patient experienced PATIENT RECEIVED AN INFLUENZA INJECTION AND FLUMIST ON THE SAME DAY which started on 05-Nov-2014. The outcome of the event of PATIENT RECEIVED AN INFLUENZA INJECTION AND FLUMIST ON THE SAME DAY is unknown. The report was considered to be non-serious.
Age: 57.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, Erythema, Headache, Ocular hyperaemia, Respiratory tract congestion
Clinical narrative: A report has been received from a Health Professional concerning a 57 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). Concomitant medications included vitamins and amlodipine, benazepril. FLUMIST quadrivalent (intranasal) started on 06-Nov-2014. The patient experienced FLUMIST given to a 57 year old which started on 06-Nov-2014, sneezing, redness in the eye, headache and congestion. The outcome of the event of sneezing, redness in the eye, headache, congestion and FLUMIST given to a 57 year old is unknown. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune on 14-Nov-2014 from health professional via spontaneous source: New events of headache, congestion, sneezing and redness in the eye were added. PQC was ticked. Strength of the suspect drug was added. Reporter's information was updated. Case was unsuppressed.