chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, MMR, MNQ, HPVX
Symptoms: Immediate post-injection reaction, Syncope, Vision blurred
Clinical narrative: The patient received 7 vaccines. Immediately after the 7th vaccines which was HPV. The patient complained of blurry vision and fainted. She jerked for a few seconds around at 10:39 AM and awake again. She was alert and oriented. BP= 107/65, P=70 at 10:39 AM. She was observed for 20 mins. BP= 109/87, P= 68 at 11:01 AM. The patient left the clinic in a stable condition.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, MMR, MNQ, HPVX
Symptoms: Dyskinesia, Immediate post-injection reaction, Syncope, Vision blurred
Clinical narrative: The patient received 7 vaccines. Immediately after the 7th vaccines which was HPV. The patient complained of blurry vision and fainted. She jerked for a few seconds around at 10:39 AM and awake again. She was alert and oriented. BP= 107/65, P=70 at 10:39 AM. She was observed for 20 mins. BP= 109/87, P= 68 at 11:01 AM. The patient left the clinic in a stable condition.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Strabismus
Clinical narrative: Acute (R) eye esotropia.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthropod bite, Dry skin, Erythema, Pruritus, Skin discolouration
Clinical narrative: Insect bite like spots, itch will scab over, worsen after bathing. Have occurred from shoulders down to toes. Extremely dry skin. Started to occur 3 days after receiving vaccine. Red at first, some leave brown spots on skin. Has been seen by MD. Seeing Derm in 9/2012.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Anal pruritus, Asthenia, Biopsy, Biopsy skin, Blood test
Clinical narrative: Insect bite like spots, itch will scab over, worsen after bathing. Have occurred from shoulders down to toes. Extremely dry skin. Started to occur 3 days after receiving vaccine. Red at first, some leave brown spots on skin. Has been seen by MD. Seeing Derm in 9/2012.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Diarrhoea, Dyspnoea, Fatigue, Rash, Skin disorder
Clinical narrative: Insect bite like spots, itch will scab over, worsen after bathing. Have occurred from shoulders down to toes. Extremely dry skin. Started to occur 3 days after receiving vaccine. Red at first, some leave brown spots on skin. Has been seen by MD. Seeing Derm in 9/2012.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Stool analysis, Urticaria pigmentosa, Vulvovaginal pruritus
Clinical narrative: Insect bite like spots, itch will scab over, worsen after bathing. Have occurred from shoulders down to toes. Extremely dry skin. Started to occur 3 days after receiving vaccine. Red at first, some leave brown spots on skin. Has been seen by MD. Seeing Derm in 9/2012.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Anal pruritus, Biopsy skin, Culture stool negative, Diarrhoea, Dry skin
Clinical narrative: Insect bite like spots, itch will scab over, worsen after bathing. Have occurred from shoulders down to toes. Extremely dry skin. Started to occur 3 days after receiving vaccine. Red at first, some leave brown spots on skin. Has been seen by MD. Seeing Derm in 9/2012.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Parasite stool test negative, Rash, Vulvovaginal pruritus, White blood cells stool negative
Clinical narrative: Insect bite like spots, itch will scab over, worsen after bathing. Have occurred from shoulders down to toes. Extremely dry skin. Started to occur 3 days after receiving vaccine. Red at first, some leave brown spots on skin. Has been seen by MD. Seeing Derm in 9/2012.
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Urticarial rash on face and upper body. BENADRYL oral.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Hypotension, Loss of consciousness
Clinical narrative: After leaving the office pt failed with brief LOC and low BP. Pt was brought back to examining room and monitored for 1 hr until symptom free.
Age: 1.59
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Patient developed fever up to 101-1-02 degrees F 6 days after the vaccine. Then developed a rash on the legs, arms and face. Fever subsided to low grade about 99 degrees F.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Redness and hard egg size lump at injection site.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient fainted.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Full blood count, Metabolic function test, Vision blurred
Clinical narrative: Dizziness, blurred vision, weakness.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: - Localized redness and swelling around inj (round about the diameter of a golf ball).  - Felt warm to the touch. - Did not itch or hurt.
Age: 29.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Electrocardiogram normal, Full blood count normal, Metabolic function test normal, Pregnancy test urine negative, Syncope
Clinical narrative: 3 syncopal episodes within 24 hours of receiving vaccine in patient with no known history on syncope in her life.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Erythema, Injection site rash, Myalgia, Rash
Clinical narrative: Day 2 - rash on arm w/ big red circle, Day 3 - took CLARITIN, Day 4 - rash on arm started to fade, broke out w/ rash on chin/fingers, muscle of arm really sure and radiated toward back. Day 5 - breaking out w/rash on both legs inside where knee caps are. Day 6 - Pt went to ER, more dots on arms, fingers, but rash at injection site much better. No new meds taken or treatment. Day 8 - better.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site hot, large amount of swelling, and itching. No treatment.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Injection site erythema, Injection site swelling, Rash macular
Clinical narrative: Right thigh redness and swelling/macular patch occurred within 1 hour of immunization. Pt. was completely asymptomatic.
Age: 1.25
Sex: M
Vaccine: HEP, HEPA
Symptoms: Abnormal behaviour, Activities of daily living impaired, Arthropathy, Back disorder, Confusional state
Clinical narrative: Patient just stopped running and fell and couldn't get up, seemed dizzy and confused. Lay crying on floor as I called pediatrician's office to see if I should bring to ER. They said give him hot bath and see. He was tired after that and slept off and on, but crying. Once husband was home from travel, early morning he wouldn't sit up to eat (his favorite activity). Took him to see Dr. again and said very concerned something wrong with his back and reported him not able to sit up to eat, Dr. said something wrong with his knee and sent us to Orthopaedic. Orthopaedic X-ray his hips, again not listening to me say something with his back, his legs aren't moving, like paralyzed. Sent home without instruction of what to do or look for. By Monday had blood in his diaper from stool so hard from no movement. Saw Dr. at same office. She listened to whole story and sent us immediately to Hospital and saved patient's life.
Age: 1.25
Sex: M
Vaccine: HEP, HEPA
Symptoms: Crying, Dizziness, Faeces hard, Fall, Fatigue
Clinical narrative: Patient just stopped running and fell and couldn't get up, seemed dizzy and confused. Lay crying on floor as I called pediatrician's office to see if I should bring to ER. They said give him hot bath and see. He was tired after that and slept off and on, but crying. Once husband was home from travel, early morning he wouldn't sit up to eat (his favorite activity). Took him to see Dr. again and said very concerned something wrong with his back and reported him not able to sit up to eat, Dr. said something wrong with his knee and sent us to Orthopaedic. Orthopaedic X-ray his hips, again not listening to me say something with his back, his legs aren't moving, like paralyzed. Sent home without instruction of what to do or look for. By Monday had blood in his diaper from stool so hard from no movement. Saw Dr. at same office. She listened to whole story and sent us immediately to Hospital and saved patient's life.
Age: 1.25
Sex: M
Vaccine: HEP, HEPA
Symptoms: Inflammation, Mobility decreased, Myelitis transverse, Nuclear magnetic resonance imaging spinal cord abnormal, Posture abnormal
Clinical narrative: Patient just stopped running and fell and couldn't get up, seemed dizzy and confused. Lay crying on floor as I called pediatrician's office to see if I should bring to ER. They said give him hot bath and see. He was tired after that and slept off and on, but crying. Once husband was home from travel, early morning he wouldn't sit up to eat (his favorite activity). Took him to see Dr. again and said very concerned something wrong with his back and reported him not able to sit up to eat, Dr. said something wrong with his knee and sent us to Orthopaedic. Orthopaedic X-ray his hips, again not listening to me say something with his back, his legs aren't moving, like paralyzed. Sent home without instruction of what to do or look for. By Monday had blood in his diaper from stool so hard from no movement. Saw Dr. at same office. She listened to whole story and sent us immediately to Hospital and saved patient's life.
Age: 1.25
Sex: M
Vaccine: HEP, HEPA
Symptoms: Rectal haemorrhage, X-ray abnormal
Clinical narrative: Patient just stopped running and fell and couldn't get up, seemed dizzy and confused. Lay crying on floor as I called pediatrician's office to see if I should bring to ER. They said give him hot bath and see. He was tired after that and slept off and on, but crying. Once husband was home from travel, early morning he wouldn't sit up to eat (his favorite activity). Took him to see Dr. again and said very concerned something wrong with his back and reported him not able to sit up to eat, Dr. said something wrong with his knee and sent us to Orthopaedic. Orthopaedic X-ray his hips, again not listening to me say something with his back, his legs aren't moving, like paralyzed. Sent home without instruction of what to do or look for. By Monday had blood in his diaper from stool so hard from no movement. Saw Dr. at same office. She listened to whole story and sent us immediately to Hospital and saved patient's life.
Age: 56.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Death, Road traffic accident
Clinical narrative: Case number PHHY2012US053726 is an initial literature report received on 20 Jun 2012. Authors searched for adverse events following H1N1, which were reported to the Vaccine Adverse Event Reporting System from 01 Oct 2009 to 31 Jan 2010. This case refers to a 56-year-old female patient. She was vaccinated with H1N1 (manufacturer and batch number: unknown) on an unspecified date. On the same day after vaccination, the patient died of motor vehicle accident. The causality of the event motor vehicle accident was not reported. Authors stated that the adverse event profile after H1N1 in VAERS was consistent with that of seasonal influenza vaccines, although the reporting rate was higher after H1N1 than seasonal influenza vaccines, this may be, at least in part, a reflection of stimulated reporting. Death, Guillain Barre Syndrome and anaphylaxis reports after H1N1 vaccination were rare (each <2 per million doses administered).
Age: 56.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Death, Injury, Road traffic accident
Clinical narrative: Case number PHHY2012US053726 is an initial literature report received on 20 Jun 2012. Authors searched for adverse events following H1N1, which were reported to the Vaccine Adverse Event Reporting System from 01 Oct 2009 to 31 Jan 2010. This case refers to a 56-year-old female patient. She was vaccinated with H1N1 (manufacturer and batch number: unknown) on an unspecified date. On the same day after vaccination, the patient died of motor vehicle accident. The causality of the event motor vehicle accident was not reported. Authors stated that the adverse event profile after H1N1 in VAERS was consistent with that of seasonal influenza vaccines, although the reporting rate was higher after H1N1 than seasonal influenza vaccines, this may be, at least in part, a reflection of stimulated reporting. Death, Guillain Barre Syndrome and anaphylaxis reports after H1N1 vaccination were rare (each <2 per million doses administered).
Age: 6.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Death, Respiratory disorder
Clinical narrative: Case number PHHY2012US053731 is an initial literature report received on 20 Jun 2012. Authors searched for adverse events following H1N1, which were reported to the Vaccine Adverse Event Reporting System from 01 Oct 2009 to 31 Jan 2010. This case refers to a 06-year-old female child. She was vaccinated with H1N1 (manufacturer and batch number: unknown) on an unspecified date. Six days after vaccination the child died of respiratory disorder (not specified). The causality of the event respiratory disorder was not reported. Authors stated that the adverse event profile after H1N1 in VAERS was consistent with that of INFLUENZA, although the reporting rate was higher after H1N1 than INFLUEZA, this may be, at least in part, a reflection of stimulated reporting. Death, Guillain Barre Syndrome and anaphylaxis reports after H1N1 vaccination were rare (each <2 per million doses administered).
Age: 29.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Complication of pregnancy, Death, Maternal exposure during pregnancy
Clinical narrative: Case number PHHY2012US052893 is an initial literature report received on 20 Jun 2012. Authors searched for adverse events following influenza A (H1N1) 2009 monovalent vaccines, which were reported to the Vaccine Adverse Event Reporting System from 01 Oct 2009 to 31 Jan 2010. This case refers to a 29-year-old pregnant female patient who was vaccinated with inactivated H1N1 vaccine (manufacturer and batch number: unknown) on an unspecified date at an unknown gestational age. Three days after vaccination the patient died of pregnancy complication. The causality of the event pregnancy complication was not reported. Authors stated that the adverse event profile after 2009-H1N1 vaccine in VAERS was consistent with that of seasonal influenza vaccines, although the reporting rate was higher after 2009-H1N1 than seasonal influenza vaccines, this may be, at least in part, a reflection of stimulated reporting. Death, Guillain Barre Syndrome and anaphylaxis reports after 2009-H1N1 vaccination were rare (each <2 per million doses administered).
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash, Ultrasound scan
Clinical narrative: Received shingles vaccine on Monday June 4, 2012. Two days later the area around my upper left arm where Dr.'s PA gave me the shot was red, swollen & quite sore. Went to Dr. & he prescribed BENADRYL topically & by mouth if needed. (I only used topical BENADRYL). The "rash" lasted 2 weeks and the upper arm is still slightly sore.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Started within one hour of vaccine administration - redness at injection site three inches wide almost down to elbow. Some itching.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Pruritus, Swelling
Clinical narrative: LOCAL REDNESS, TO UPPER OUTER LEFT ARM, AND 5-6 CM SWELLING, AND ITCHING.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash erythematous, Rash pruritic
Clinical narrative: Pt has reported small blisters, about 16, all over her body (legs, knee, breast, axilla, back) that started as small itchy red bumps. She states they are itchy and has been using Benadryl cream on them. I instructed her to contact her physician to have them looked at to make sure they are not related to vaccine.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 75 year old patient who on 07-FEB-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (dose and route not reported) (lot number 671139/1265AA). On 20-APR-2012 the patient developed mild vesicular shingles rash on back of her neck, left upper chest, and upper arm. VALTREX and prednisone were given for the treatment. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. Follow up information has been received from a physician concerning the 75 year old female with no known drug allergy and illness at time of vaccination who on 07-FEB-2012 was vaccinated with a 0.7 ml dose of ZOSTAVAX (Merck) in right deltoid. Concomitant therapy included Tdap. On 20-APR-2012 the patient experienced zoster outbreak, vesicular on left back of her neck, left upper chest near clavicle and upper arm. The distribution of lesion was on left T1-T2. The maximum temperature was 98 C. The quantity of the pain was 4. There was no other systemic symptom. No direct fluorescent antibody was done. No specimen collected for PCR. No photo was taken. Subsequently, the patient recovered from the adverse events. No further information is available.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Gastrostomy tube insertion, Surgery
Clinical narrative: Information has been received from a physician concerning a 16 weeks old patient with down's syndrome and gastrooesophageal reflux who on an unspecified date was vaccinated PO with the first dose of ROTATEQ (lot# not reported). The physician stated that after the child had a surgery (unspecified time) and at the time of the report, the child had a gastrostomy tube (G tube). The physician did not believe the surgery and tube had anything to do with ROTATEQ, but due to the patient having gastrointestinal (GI) reflux. At the time of the report, the patient's outcome was unknown. Upon internal review surgery was considered as an other important medical event. Additional information has been requested.
Sex: U
Vaccine: FLUX(H1N1)
Symptoms: Cardiomyopathy, Death
Clinical narrative: Case number PHHY2012US053744 is an initial literature report received on 20 Jun 2012. Authors searched for adverse events following H1N1, which were reported to the the Vaccine Adverse Event Reporting System from 01 Oct 2009 to 31 Jan 2010. This case refers to a patient (age and sex not reported). The patient was vaccinated with H1N1 (manufacturer and batch number: unknown) on an unspecified date. On an unknown date after vaccination the patient died due to cardiomyopathy. The causality of the event cardiomyopathy was not reported. Authors stated that the adverse event profile after H1N1 in VAERS was consistent with that of seasonal influenza vaccines, although the reporting rate was higher after H1N1 than seasonal influenza vaccines, this may be, at least in part, a reflection of stimulated reporting. Death, Guillain Barre Syndrome and anaphylaxis reports after H1N1 vaccination were rare (each <2 per million doses administered).
Age: 37.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Ataxia, Cerebellar syndrome, Gait disturbance, Maternal exposure during pregnancy, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Case number PHHY2012AU053470 is an initial literature report received on 20 Jun 2012: The authors presented a case of acute ataxia syndrome associated with H1N1 2009 influenza vaccination. This report refers to a 30-week pregnant 37-year-old female patient. She was vaccinated with a pandemic H1N1 influenza vaccine (manufacturer and batch number: unknown) on an undetermined date. Fourteen days after vaccination she developed an acute ataxia syndrome. On examination, there was horizontal opsoclonus (ocular flutter) and disrupted smooth pursuit in the horizontal plane. There was marked dysmetria in the upper limbs and broad-based ataxic gait. The patient exhibited tremor and myoclonus, and the remainder of the examination was normal. MRI (magnetic resonance imaging) of the brain and spine was unremarkable, as were serologic investigations for infective etiologies. A diagnosis of opsoclonus myoclonus syndrome was made and methylprednisolone was administered intravenously for five days. Symptoms improved and had resolved by day 14 of her illness. The authors commented that while definitive identification of antecedent causes was usually not possible in this condition, the temporal association and exclusion of alternative etiologies raised the possibility that this patient's neuroinflammatory disorder might be related to H1N1 2009 vaccination.
Age: 37.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Nuclear magnetic resonance imaging spinal cord normal, Opsoclonus myoclonus, Tremor
Clinical narrative: Case number PHHY2012AU053470 is an initial literature report received on 20 Jun 2012: The authors presented a case of acute ataxia syndrome associated with H1N1 2009 influenza vaccination. This report refers to a 30-week pregnant 37-year-old female patient. She was vaccinated with a pandemic H1N1 influenza vaccine (manufacturer and batch number: unknown) on an undetermined date. Fourteen days after vaccination she developed an acute ataxia syndrome. On examination, there was horizontal opsoclonus (ocular flutter) and disrupted smooth pursuit in the horizontal plane. There was marked dysmetria in the upper limbs and broad-based ataxic gait. The patient exhibited tremor and myoclonus, and the remainder of the examination was normal. MRI (magnetic resonance imaging) of the brain and spine was unremarkable, as were serologic investigations for infective etiologies. A diagnosis of opsoclonus myoclonus syndrome was made and methylprednisolone was administered intravenously for five days. Symptoms improved and had resolved by day 14 of her illness. The authors commented that while definitive identification of antecedent causes was usually not possible in this condition, the temporal association and exclusion of alternative etiologies raised the possibility that this patient's neuroinflammatory disorder might be related to H1N1 2009 vaccination.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: Tdap - ADACEL- vaccine voluntarily administered IM to employee into Left upper extremity. Following afternoon patient came to report swelling, redness, pain, itch at vaccination site. This increased as day went on without relief from OTC treatment. She saw her Primary Physician who ordered oral Prednisone 30mg daily x 3 days.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: Per PCRS: Chief Complaint: Patient having rash, welting on upper portion of body, arms, buttocks. No shortness of breath, feeling in throat. Itching started last night on arms, but became worse at 04:00 am. Assessment/Plan: Allergic reaction likely on Flu vaccine; DEPOMEDROL 40mg IM now, add BENADRYL 25-50mg QID PRN. No more flu vaccine! To ER if sxs. worsens. Symptoms: Symptoms: 2. Urticarial Pruritus. Treatment Drug Used: 1 - Methylprednisolone Dose: 40 Units: MG Freq: ONCE Route: IM. 2 - Diphenhydramine Dose: 25 Units: MG Freq: PRN Route: PO.
Sex: U
Vaccine: FLUX(H1N1)
Symptoms: Condition aggravated, Death, Heart disease congenital
Clinical narrative: Case number PHHY2012US053750 is an initial literature report received on 20 Jun 2012. Authors searched for adverse events following H1N1, which were reported to the Vaccine Adverse Event Reporting System from 01 Oct 2009 to 31 Jan 2010. This case refers to a patient (age and sex not reported). The patient's medical history included of congenital heart disease (not specified). The patient was vaccinated with H1N1 (manufacturer and batch number: unknown) on an unspecified date. On an unknown date after vaccination the patient died to congenital heart disease. No other information was available. Authors stated that the adverse event profile after 2009-H1N1 in VAERS was consistent with that of INFLUENZA, although the reporting rate was higher after 2009-H1N1 than INFLUENZA, this may be, at least in part, a reflection of stimulated reporting. Death, Guillain Barre Syndrome and anaphylaxis reports after 2009-H1N1 vaccination were rare (each <2 per million doses administered).
Age: 0.23
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyspnoea
Clinical narrative: Time - approximately 5 hours. Symptoms - Difficulty breathing. Went to the emergency room about 1700. Was told if it persisted or got worse to come back.
Age: 1.29
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous
Clinical narrative: Rash (red bumps) on trunk, arms, face, genital area and upper legs, I think as a result of the chicken pox vaccine.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Pallor, Unresponsive to stimuli
Clinical narrative: After 3rd immunization was administered pt. became pale, unresponsive.  Was slowly lowered to floor with help of pt's mother who was in room.  Cool cloth applied to forehead & back of neck. Regained consciousness almost immediately after lying down.  Remained on floor aproximately 10 minutes.  2 remaining injections given, slightly pale again & assisted to lying position on exam table.  No LOC. Rested x5min. Assisted to sitting, observed in office x 10-15min. Left office at 12:05 PM.
Age: 76.0
Sex: F
Vaccine: DT
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling at the site of tetanus/diphtheria injection administered 6/15/2012. Cephalexin prescribed, returned to hospital 6/21/2012 due to increase redness, swelling and tenderness at injection site.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Minor itching rash both arms and legs.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site papule
Clinical narrative: 5cm area of fine skin-colored papules on left thigh around immunization site. Mom reports this also happened with his 2 month vaccines.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injury, Loss of consciousness
Clinical narrative: Case number PHEH2012US012340 is an initial combined spontaneous report received from a consumer on 20 Jun 2012 with a follow up information received on 21 Jun 2012. This report refers to a 51-years-old female patient whose medical history, past drugs, current conditions and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1101201) through unspecified route and site on 26 Feb 2012. On the same day a few minutes afterwards she passed out after standing up to walk out. The pharmacist administered EPIPEN and the called an ambulance for the patient. It was reported that she was hospitalized twice on unspecified dates following immunization. She also had an injury claim for the injury received following immunization. The outcome of the event was not reported. No further information was available.
Sex: U
Vaccine: FLUX
Symptoms: Infection
Clinical narrative: Case number PHHY2012US053152 is an initial literature report received on 20 Jun 2012. This intent of the article was to discuss on a retrospective cohort study conducted to determine whether individuals who were revaccinated (exposed cohorts) with a second dose of trivalent influenza vaccine (TIV) experienced a higher rate of medically attended events (MAE) than those received only one TIV dose (unexposed cohorts). The designed study had two groups; exposed cohort group who received initial TIV dose between 14 Oct 2008 and 21 Oct 2008 and who were revaccinated within 28 days and unexposed cohort group who received an initial TIV dose between 22 Oct 2008 and 07 Nov 2008. This report refers to a patient whose age, gender, medical history, past drugs, current conditions and concomitant medications were not reported. The patient's vaccination history included administration of a dose of possible temperature compromised seasonal influenza vaccine (manufacturer and batch number: not reported) in Oct 2008 (see related case: PHHY2012US052676). On an unspecified date, the patient received a second dose of seasonal influenza vaccine (manufacturer and batch number: not reported) through unspecified route and site of an unknown date. On an unknown date the patient experienced infection following vaccination. The outcome of the event was not reported. The author concluded the article stating that the study demonstrated no increased occurrence of MAE among patients who received a second TIV dose within 28 days of the first.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Activities of daily living impaired, Asthenia, Decreased appetite, Headache, Heart rate increased
Clinical narrative: Nausea, fever, severe weakness, lost of appetite, fast heart beating, sensitivity to light, insomnia. Next day: Headache, strong muscle ache, severe weakness, no appetite, must be in bed.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Insomnia, Myalgia, Nausea, Photophobia, Pyrexia
Clinical narrative: Nausea, fever, severe weakness, lost of appetite, fast heart beating, sensitivity to light, insomnia. Next day: Headache, strong muscle ache, severe weakness, no appetite, must be in bed.
Age: 23.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Varicella post vaccine
Clinical narrative: Large rash at injection site and developing "pox" spots on trunk, arms, legs, and neck.  Visited doctor who confirmed chicken pox.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Lymphadenopathy, Malaise, Oedema peripheral, Skin warm
Clinical narrative: From shoulder to elbow swollen, red, and hot; general maliase, hives the next day, increased lymph nodes (possibly related).
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: From shoulder to elbow swollen, red, and hot; general maliase, hives the next day, increased lymph nodes (possibly related).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash erythematous, Skin warm
Clinical narrative: Slightly elevated erythematous area. Pins and needle feeling when the area is touched. Slightly warm to the touch.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: From injection site to elbow - very sore.
Age: 31.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Itching at injection site approximately 1 hour after shot; developed pain 2-3 hours after injection; swelling, redness, warm to touch near injection sight; increased malaise and nausea.
Age: 31.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Nausea, Pain
Clinical narrative: Itching at injection site approximately 1 hour after shot; developed pain 2-3 hours after injection; swelling, redness, warm to touch near injection sight; increased malaise and nausea.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injected limb mobility decreased, Injection site pruritus, Injection site swelling, Nausea
Clinical narrative: Later in the evening- pain in arm, restless sleep, body aches, inc. temp; nausea, severe swelling at injection site; hot to touch; itching; nausea.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Poor quality sleep
Clinical narrative: Later in the evening- pain in arm, restless sleep, body aches, inc. temp; nausea, severe swelling at injection site; hot to touch; itching; nausea.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site was swollen, red & hot on palpation, > 10 cm (+) area on left deltoid.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: After a bath several red bumps were noted on trunk, neck and back.  That evening bumps looked fluid filled and noted more spots.  No fever or other complaints.  A few new spots on head and limbs the next morning.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Two days following vaccination, pt presented with red, swollen rash surrounding injection site. (about 4 inches in diameter) Was not itchy or painful. Recommended BENADRYL and doctor visit.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Received TDAP then developed cellulitis at the injection site. Treated with Cephalexin 500mg one po QID x 7 days.
Age: 19.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: States woke up next am with small red patch to right arm. Then woke up this am (06/22/2012) with red ring around patch. Square red swollen are approximately 1 inch x 1 inch with red ring approximately 3 inch x 3 inch noted to right deltoid. To be seen by PMD today (06/22/2012).
Age: 22.0
Sex: M
Vaccine: TTOX
Symptoms: Dizziness
Clinical narrative: Lightheadedness. No loss of consciousness. 10-15 minutes to recover. Water given orally.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site erythema, Mobility decreased, Oropharyngeal pain, Pain
Clinical narrative: Patient explained she was feeling soreness in the tissue that connects from under her breast to her left armpit; causing her to not be able to raise her arm. She is also experiencing body aches, headaches, and a sore throat. There is a red ring around the bottom injection site.
Age: 61.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site pruritus, Injection site rash, Pruritus, Rash
Clinical narrative: Rash/itchiness began around the injection site. Rash and redness began appearing in various areas of my arms, legs and torso. Rash accompanied by intense itching. I went to the Emergency Room. The Dr. and staff took my vitals and gave me Prednisone and Benadryl.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Aphasia, Dysphemia
Clinical narrative: Stuttering and "trouble finding words" for 2 weeks after LAIV.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Aphasia, Dysphemia
Clinical narrative: Stuttering and "trouble finding words" for 2 weeks after LAIV this year and last year.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: SWOLLEN, HARD, TENDER TO TOUCH, REDNESS AND HOT TO TOUCH.   LEFT THIGH CELLULITIS.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site warmth
Clinical narrative: SWOLLEN, HARD, TENDER TO TOUCH, REDNESS AND HOT TO TOUCH.   LEFT THIGH CELLULITIS.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Had MCV4 vaccine 12-21-11. On 12-24-11 had "bad" head ache, dizzy and vomiting, no fever. Better next day but still nausea. Some days later (12-27-11). On 12-28-11, was back to usual self. No v/d. Reg urination. Good appetite.
Age: 11.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: L deltoid swelling and erythema.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 12/2 Saw client at local store and informed me that she had developed red swollen area part vaccines and had to be seen in ER. Was given Benadryl injectable and orally. Was also given oral medication to take but did not remember name. States NUMEROUS in response to No. of Previous Doses given, for Influenza.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Amylase increased, Full blood count normal, Pyrexia, Swelling face
Clinical narrative: Facial swelling and fever.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site anaesthesia, Lethargy, Weight bearing difficulty
Clinical narrative: Lethargy, left leg numbness, inability to bear weight - evaluated by primary care pediatrician next day, no problem found.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Urticaria
Clinical narrative: A large welt 4 inches by 6 inches developed and hot to touch.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Muscle twitching, Pain, Pain in extremity, Swelling
Clinical narrative: Golf ball sized swelling in armpit. Muscle twitching in face. Arm painful and hurts to move it.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Broke out with hive starting on chest and spread all over body.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Raised red wheal about 2 inches across around injection site.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Bradykinesia, Tremor
Clinical narrative: Right arm tremor and bradykinesia.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 7 hours after injection given noticed pain, redness and swelling. 8 inches x 3 inches inner aspect of left upper arm. Warm to touch. Placed on KEFLEX 500mg 1 capsule every 6 hrs x 7 days.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, IPV, PNC13, RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Nothing, the child accidentally got a PEDIARIX and IPV in same day. So she got a double dose of polio vaccine. No reaction occurred. We asked CDC about this and they asked us to report it to you.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen, hot to touch.
Age: 31.0
Sex: M
Vaccine: HIBV, PPV, HIBV, PPV
Symptoms: Full blood count abnormal, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt developed fever up to 103, red, swollen tender area around the vaccine spot that then spreaded to the elbow with mild movement limitation, Pt developed possible cellulitis, required antibiotic treatment.
Age: 31.0
Sex: M
Vaccine: HIBV, PPV, HIBV, PPV
Symptoms: Neutrophil count increased, Pyrexia, White blood cell count increased
Clinical narrative: Pt developed fever up to 103, red, swollen tender area around the vaccine spot that then spreaded to the elbow with mild movement limitation, Pt developed possible cellulitis, required antibiotic treatment.
Age: 31.0
Sex: M
Vaccine: HIBV, PPV, HIBV, PPV
Symptoms: Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Pt developed fever up to 103, red, swollen tender area around the vaccine spot that then spreaded to the elbow with mild movement limitation, Pt developed possible cellulitis, required antibiotic treatment.
Age: 1.36
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Hive within 2-3 hours after vaccines given without other trigger.
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: None - vaccine error extra dose.
Age: 6.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Redness swelling and firmness to injection site.
Age: 6.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Redness swelling and firmness to injection site.
Sex: U
Vaccine: HEPAB
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: 1. Family practice clinic. 2. Hepatitis A vaccine, 0.5 ml given in (R) thigh IM 3. I was notified by my lead supervisor that an 18 month old patient was given her 2nd dose of the Hepatitis A vaccine a week too early. This was found out through the XX State Child Profile website. I failed to check the last date when this patient's 1st Hepatitis A vaccine was given. I have notified the patient's mother and advised her to bring the patient back in to the office 6 months on/after this last dose was given. I advised her this 2nd Hepatitis A vaccine given in error will not help to boost the patient's immunity against the Hepatitis A virus. She verbalized understanding. The patient is doing fine. 4. I plan on checking the XX State Child Profile website for each vaccine date patients have received their vaccines to ensure accurate dosing and scheduled immunizations.
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: I have a primary care office the Medical assistant give by mistake vaccine for 5 days old which suppose to be given at 2 months the vaccines were given PEDIARIX Hib, PREVENAR, ROTATEQ. Can please let me known if anything need to be done.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: Local Health Department used expired vaccine for 11 patients. Vaccine: FluMIST manufactured by MedImmune. Lot: YK2014, Expiration date: 1/8/12. 5 patients were given vaccine on X/X/12 (1 day after expiration); 1 was given vaccine on X/XX/12 (2 days after expiration); one was given vaccine on X/XX/12; the others were given the vaccine after that time. All patients were contacted and given opportunity to be revaccinated. Expiration dates are now being more closely watched with expiration date in computer and monitored. All vaccine is tagged if close expiration date. (This was already being done, but somehow this vaccine was not caught in time.).
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered
Clinical narrative: I work in a hospital based clinic setting as a float nurse. A 12 month old patient was given an adult dose of Hepatitis A vaccine instead of a pediatric dose of Hepatitis A vaccine. Pt should have been given a dosage of 0.5 ml and Instead was administered a dosage of 1 ml.
Sex: F
Vaccine: TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Patient came in for a re-check appointment. I usually quickly assess last office visits, vital signs, & then assess immunization status before taking a patient back. In the exam room I confirm needed immunizations with the patients verbally. Patient informed me she could not remember the last time she had a tetanus booster. I had her fill out the immunization Questionnaire form & I administered the TDaP before the provider went in to see her. After provider went in to see her. After I documented the vaccine in EMR I clicked on the EMR Immunization Report & to my horrid surprise, I saw she had a TDaP about 3.5 years ago. I'm not sure when the immunization assessment failure. I might have just opened the EMR immunization section which does not show all the immunizations (like TDaP) at a glance though normally I open the Immunization Report section which does show the whole record at a glance. Practice: Community Health Center Product: Tdap, ADACEL Dose: 0.5 mL EMR: XXXXX, unable to see full shot record on the imms home page. The page must be opened to see the full vaccine record.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Incorrect dose administered
Clinical narrative: A HIB vaccine and PENTACEL vaccine was given to a patient during the same visit. During administration of vaccines, always check for the right dose, right medication, right route, right time, and right patient. Also, if available ask another health care provider to double check the vaccines prior to giving them.
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Private office (1) DTaP immunization. When balancing our shots for the health department, they called back stating that 5 patients were given DTaP instead of Tdap. New staff was unaware that the system did not specify which shot was to be given at any certain time, or of patient age range. No adverse reactions were reported by patients, the shots were all given months ago. Discussed with the health department and they suggested to put a sticker on the boxes with age ranges to remedy the situation so it does not happen again.
Sex: U
Vaccine: MNQ
Symptoms: Expired drug administered
Clinical narrative: Patient was given a dose of MENACTRA Vaccine on X.XX.12 in a Clinic. Upon entering the information into the VFC website - the lot number had an expiration date of 2.9.12. Reported the incident in house. Memo has been sent out to check expiration dates before giving vaccine.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Incorrect dose administered
Clinical narrative: Vaccination error occurred because the administrator of the vaccines did not notice that the EMR records and the stated vaccine registry did not match. The EMR record indicated that the patient received the third dose of PEDIARIX (DTaP-IPV-Hep B) XX-XX-2011 at 6 months of age and the state vaccine registry did not . The patient did not need DTaP-IPV-Hep B at the visit, but one was administered. In actuality the patient received a 4th dose of PEDIARIX 2 1/2 months after the third dose which did not allow for the 6 month or more interval required between the #3 dose of PEDIARIX and the #4 DTaP. Administered at a XXXX product: PEDIARIX, GlaxoSmithKline Dose: 0.5 mL report done in the training of another nurse.
Age: 15.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 15 year old female given intradermal influenza vaccine which is licensed for 19 and older. Was sent by her OBgyn to clinic under a program we have offering free flu to pregnant women/family members with out insurance to cover. Qualified for VFC and should have received IM flu vaccine.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, IPV, PNC13
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 2 month old was due for vaccines. He needed Dtap, IPV, HIB, PCV 13 and rotavirus, a PENTACEL and an IPV and PCV 13 was given. This resulted in the child getting a double dose of the IPV vaccines. The mistake was discovered when the nurse was filling out the vaccine records and she then realized she had given the wrong vaccine. The child had no adverse effects. The mistake was reported to the local health department.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Urticaria
Clinical narrative: Pt rec'd ZOSTAVAX 6/25/12. Over next 2 days pt developed large red welt. Pt says is sore to touch; it is red.
Sex: U
Vaccine: RV1
Symptoms: Incorrect route of drug administration
Clinical narrative: "We had an error in administration with ROTARIX which should be given orally after reconstitution, but it was given IM. No harm to patient, except that an injection was given when it shouldn't have been. Attached pictures depict differences in syringes...the one with the diluent is a small glass syringe, very similar to many syringes for IM/SC injections, i.e. flu shot. The oral syringe for medications is substantially bigger. Reconstitution of the ROTARIX is cumbersome. The process of mixing up the diluent, adding it to the vial of virus via an adapter to reconstitute the solution is very similar to reconstituting a parenteral medication. Even one of our Pharmacists said that they would have "put a needle on it" to complete the reconstitution instead of using the adapter enclosed in the packaging. Since this occurred, we have labeled the ROTARIX supply "For Oral administration."
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Insomnia
Clinical narrative: ZOSTAVAX administered 6/25/12. Pt had no complaints to provider. Pt called provider on 6/27/12 stating he has felt dizzy since time vaccine was given. Also having difficulty sleeping for which he took BENADRYL last night. Advised to see his primary provider for full evaluation of dizziness.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Dermatitis contact, Pruritus, Urticaria
Clinical narrative: Onset of generalized urticaria facial, arms, legs, some truncal this a.m. with itching for one day given prescription for BENADRYL orally and betamethasone cream for follow-up in 24 hour possible contact dermatitis foliage.
Age: 15.0
Sex: F
Vaccine: HPV2, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: -Edema, redness, warm to touch at site - approx 6 inch area. Temp up to 101.8 F. - TYLENOL & BENADRYL given. - MOTRIN & ice prescribed also.