chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Decreased appetite, Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: TC from grandmother reports grandson received vaccinations on 10/22/07. (L) arm is red/sore and warm to touch (from armpit area to almost elbow); fever, decreased appetite and increased sleepiness. Taking to MD at hospital
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Somnolence
Clinical narrative: TC from grandmother reports grandson received vaccinations on 10/22/07. (L) arm is red/sore and warm to touch (from armpit area to almost elbow); fever, decreased appetite and increased sleepiness. Taking to MD at hospital
Age: 2.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Mother described over phone a red splotchy rash with raised area and central clearing occurred a few hours after MMR and Varivax and Hepatitis administered. Rash disappeared immediately after one dose of Benadryl
Age: 73.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Crying, Loss of consciousness, Pain
Clinical narrative: Passed out after shot, cried it hurt so much, went home, called nurse, she said take Tylenol.  Went to urgent care.  Called Dr again, said keep cold packs on, called nurse again, Dr said hot packs.  Went back to Dr, became ill, hurt so much.  Oct 18th she gave me prescription for codeine, still hurts.  Dr again Oct 18, urgent care.
Age: 0.3
Sex: F
Vaccine: HBHEPB, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: (R) lateral thigh with 2 injection sites with mild erythema around about 2 cm. 3 cm induration under site of erythema. No fever. (L) later thigh with injection site with erythema with induration about 2 cm.
Age: 0.5
Sex: M
Vaccine: HEP, HIBV, IPV, PNC
Symptoms: C-reactive protein normal, Crying, Full blood count, Pyrexia, Screaming
Clinical narrative: Screaming, inconsolable, fever 102.6 w/in 6 hours lasting >120, Rx Motrin, Tylenol.
Age: 64.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Confusional state, Delirium
Clinical narrative: We received on 14 NOV 2007 via from a healthcare professional the following information: A 64-year-old male patient born on 11 MAY 1943, was vaccinated i.m. with 0.5 ml Fluvirin (batch no. unknown) on 17 OCT 2007. The patient experienced on 05 NOV 2007 confusion and delirium. In the emergency room they have found a high ammonia level. The patient was discharged after a brief hospitalisation. The outcome is unknown. Company assessment: Seriousness criterion: hospitalisation. Causality: insufficient data There is no timely relationship (19 days p.v.) and no plausible pathomechanism to assume a relatedness. Expectedness assessment according to health authority and product information: The described symptoms are unexpected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary. Regulatory no. :NA07-006414  2/19/08 Reviewed hospital medical records which reveal patient experienced delirium & hyperammonemia.  Admitted 11/5-11/7/2007.  Improved w/med changes.  D/c to home & pcp f/u. FINAL DX: delirium due to hyperammonemia, resolved; acute prerenal azotemia; fatty liver; dementia; morbid obesity (BMI 42); Type 2 DM; carotid stenosis; dyslipidemia.
Age: 64.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Abnormal behaviour, Alcohol abuse, Ammonia increased, Blood glucose increased, Computerised tomogram abnormal
Clinical narrative: We received on 14 NOV 2007 via from a healthcare professional the following information: A 64-year-old male patient born on 11 MAY 1943, was vaccinated i.m. with 0.5 ml Fluvirin (batch no. unknown) on 17 OCT 2007. The patient experienced on 05 NOV 2007 confusion and delirium. In the emergency room they have found a high ammonia level. The patient was discharged after a brief hospitalisation. The outcome is unknown. Company assessment: Seriousness criterion: hospitalisation. Causality: insufficient data There is no timely relationship (19 days p.v.) and no plausible pathomechanism to assume a relatedness. Expectedness assessment according to health authority and product information: The described symptoms are unexpected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary. Regulatory no. :NA07-006414  2/19/08 Reviewed hospital medical records which reveal patient experienced delirium & hyperammonemia.  Admitted 11/5-11/7/2007.  Improved w/med changes.  D/c to home & pcp f/u. FINAL DX: delirium due to hyperammonemia, resolved; acute prerenal azotemia; fatty liver; dementia; morbid obesity (BMI 42); Type 2 DM; carotid stenosis; dyslipidemia.
Age: 64.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Delirium, Feeling abnormal, Hepatic steatosis, Hyperammonaemia, Laboratory test
Clinical narrative: We received on 14 NOV 2007 via from a healthcare professional the following information: A 64-year-old male patient born on 11 MAY 1943, was vaccinated i.m. with 0.5 ml Fluvirin (batch no. unknown) on 17 OCT 2007. The patient experienced on 05 NOV 2007 confusion and delirium. In the emergency room they have found a high ammonia level. The patient was discharged after a brief hospitalisation. The outcome is unknown. Company assessment: Seriousness criterion: hospitalisation. Causality: insufficient data There is no timely relationship (19 days p.v.) and no plausible pathomechanism to assume a relatedness. Expectedness assessment according to health authority and product information: The described symptoms are unexpected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary. Regulatory no. :NA07-006414  2/19/08 Reviewed hospital medical records which reveal patient experienced delirium & hyperammonemia.  Admitted 11/5-11/7/2007.  Improved w/med changes.  D/c to home & pcp f/u. FINAL DX: delirium due to hyperammonemia, resolved; acute prerenal azotemia; fatty liver; dementia; morbid obesity (BMI 42); Type 2 DM; carotid stenosis; dyslipidemia.
Age: 64.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Nausea, Pancreatic atrophy, Retching
Clinical narrative: We received on 14 NOV 2007 via from a healthcare professional the following information: A 64-year-old male patient born on 11 MAY 1943, was vaccinated i.m. with 0.5 ml Fluvirin (batch no. unknown) on 17 OCT 2007. The patient experienced on 05 NOV 2007 confusion and delirium. In the emergency room they have found a high ammonia level. The patient was discharged after a brief hospitalisation. The outcome is unknown. Company assessment: Seriousness criterion: hospitalisation. Causality: insufficient data There is no timely relationship (19 days p.v.) and no plausible pathomechanism to assume a relatedness. Expectedness assessment according to health authority and product information: The described symptoms are unexpected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary. Regulatory no. :NA07-006414  2/19/08 Reviewed hospital medical records which reveal patient experienced delirium & hyperammonemia.  Admitted 11/5-11/7/2007.  Improved w/med changes.  D/c to home & pcp f/u. FINAL DX: delirium due to hyperammonemia, resolved; acute prerenal azotemia; fatty liver; dementia; morbid obesity (BMI 42); Type 2 DM; carotid stenosis; dyslipidemia.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Heart rate increased
Clinical narrative: We received on 14 NOV 2007 via regulatory authority from a consumer the following information: A 67-year-old male patient with known coronary artery bypass graft in 2006, born on 29 OCT 1940, was vaccinated i.m. with 0.5 ml Fluvirin (batch no. unknown) on 04 NOV 2007. The patient experienced 45 minutes later increased heart rate and increased blood pressure (170 mmHg). The patient was hospitalised on 04 NOV 2007. The outcome is unknown Company assessment: Seriousness criterion: hospitalisation. Causality: not related. There is no association between Fluvirin vaccination and increased heart rate and blood pressure. It must be seen in connection with her cardiac disease. Expectedness assessment according to regulatory authority and product information: The described symptoms are unexpected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary. Regulatory authority no.: NA07-006431
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Clinical narrative: Death  10/21/08 Autopsy states COD as pneumonia, other undetermined factors, sudden unexpected infant death.  Manner of death is undetermined.  Autopsy report also states patient found unresponsive in crib in lateral position on a pillow.  X-rays revealed healing rib & clavicular fractures.  Micro revealed evidence of bronchopneumonia.  Investigation revealed patient had cough & nasal congestion x approx 10 days prior to death & had been seen in ER & by PCP for same.  Ears had been pierced day before death.   11/30/07 Reviewed pcp medical records which confirm dose & lot as reported.  Office note of 11/20 reveals patient had nasal congestion x 1 week.  Dx w/formula allergy & formula changed to soy.  Had been seen in ER 11/17 for cough with chest/nasal congestion.  Exam revealed a sore in left nostril.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral
Clinical narrative: cellultis on left arm swollen, red down to the wrist 3 IV treatments and oral antibiotics
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Irritability, Lymphadenopathy, Rash erythematous, Rash maculo-papular
Clinical narrative: Lymphadenopathy in inguinal area developed on 11-12-07. On 11-14-07 she developed a rash and was more fussy. Rash on thighs and spread to torso, was scattered, maculopapular, erythematous. No vesicles or fever appeared to be measles-like rash.
Age: 3.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Blood pressure, Choking, Dyskinesia, Heart rate, Rash
Clinical narrative: Vaccine reaction - 1-2 minutes after vaccines. (1) RASH (2) choking (3) gagging (4) sticking out tongue. Epi pen Jr and Benadryl 25 mg IM given. O2 with albuterol given. Call to EMS for transportation. O2 Sat 100% pulse 143. B/P 80/60 Alert awake.
Age: 3.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Retching
Clinical narrative: Vaccine reaction - 1-2 minutes after vaccines. (1) RASH (2) choking (3) gagging (4) sticking out tongue. Epi pen Jr and Benadryl 25 mg IM given. O2 with albuterol given. Call to EMS for transportation. O2 Sat 100% pulse 143. B/P 80/60 Alert awake.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Angioedema, Urticaria
Clinical narrative: Angioedema within 2 hours of vaccine involving hands/feet/elbow/knees.  Urticaria as well within 10-15 hours, extensive case.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Dyskinesia, Incorrect dose administered
Clinical narrative: A non-serious report of medication error has been received from a nurse concerning a three-year-old male. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The patient had a medical history of Down's Syndrome. No concomitant medications were provided. While the FluMist was being administered, the patient was jerking and moving. As a result, the patient received only a partial dose of FluMist and some went into the patient's eye. No symptoms were reported. No outcome for the event was provided by the reporter. The patient did not experience a rechallenge while receiving the suspected product. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  A non-serious report of partial dose of vaccine given and some got into eyes has been received from a nurse concerning a three-year-old male. The patient received FluMist on 11-Oct-2007. This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The nurse stated that she is not even sure that the patient actually got FLUMIST into his eyes since he did not even wipe his eyes after the FLUMIST was administered. The nurse stated that she reported the incident because the patient's mother was convinced that some of the FLUMIST went into the patient's eyes. The patient was seen in the pediatricians office on a date after the incident and did not report any adverse events. The patient had not experienced any adverse event(s) as of 21-Feb-2008. The events were resolved on 11-OCT-2007. The patient did not experience a rechallenge while receiving the suspect drug. The reporter provided no causality assessment for the event. The reporting sources of this case is spontaneous, thus the sponsor's comment is not applicable. Additional information received 27-Nov-2007: No adverse events resulted after the patient received FLUMIST; information regarding the administration. Additional information received on 21-Feb-2008 and incorporated into the case: patient demographic information corrected, date of birth, date of administration of FLUMIST, and lot number.
Age: 1.8
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, Inappropriate schedule of drug administration, Medication error, No adverse event
Clinical narrative: A non-serious event of vaccine administration error has been received from a nurse concerning a 21-month-old female child. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The child has a medical history of asthma. No drug history information has been reported for this patient. The child received Flumist intranasally. The reporter indicated this child was inadvertently administered Flumist; the child did not meet Flumist labeling requirements. No adverse events were observed. Outcome: the child had no ill effects. Further dosing with Flumist is not indicated. The reporter did not provide a causality assessment for this medication error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 4/15/08 verified no adverse event experienced; lot # 500486E and vaccine administration date is Oct 10, 2007. The child received FLUMIST on 10-OCT-2007. The reporter indicated this child was inadvertently administered FLUMIST; the child did not meet FLUMIST labeling requirements. No adverse events were observed. Outcome: the child had no ill effects. On 12-Feb-2008 it was verified the child had no adverse events. Further dosing with FLUMIST is not indicated. The reporter did not provide a causality assessment for this medication error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow up obtained on 12-Feb-2008 verified the child expereinced no adverse events; corrected the child's initials and date of birth and provided the date of FLUMIST dosing.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, Malaise, Pyrexia
Clinical narrative: A non-serious report of malaise and fever has been received from a consumer concerning a 28-month-old male. This case is submitted in accordance with Medimmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The reporter denied the child had medical conditions or took concomitant medications. The child received FluMist on 16-Oct-2007. Two days later on 18-Oct-2007, the child awoke with malaise and fever of 102-102.5 degrees Fahrenheit. The events resolved on 19-Oct-2007. FluMist rechallenged is not applicable. The reporter did not provided a causality assessment for the adverse events reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 4/15/08; Lot number of vaccine is not provided, Mar 7, 2008.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: Medi0006106 is a non-serious spontaneous case from a physician of fever concerning a two-year-old male.  This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  There was no medical history or concomitant medications for this patient.  The patient initiated Flumist on an unreported date.  Approximately 10 hours following administration of Flumist, the patient experienced fever of 102.6, that increased to 104.3 approximately 20 hours from the time of administration.  No further information was provided.  The event of fever resolved within 48 hours of onset of symptoms.  Action taken with Flumist was not provided.  The reporter did not provide a causality assessment for the adverse event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow up received 4/15/08. Patient date of birth, adverse event onset date/time, lot number for vaccine, and vaccine administration date/time are not provided, 03/07/08.
Age: 1.9
Sex: U
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: A non-serious report of vaccine administration error was received from a nurse concerning a 21-month-old. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No relevant medical or drug history information was reported. The infant was given FluMist on 29-Oct-2007. FluMist was administered to the 21-month-old in error as the vaccine is indicated in patients 2 years to 49 years of age. No adverse events were reported from this error. No additional information is available. Rechallenge is not applicable. Causality assessment is not applicable. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 4/15/08. Patient date of birth and lot # for vaccine is not provided, 03/07/08.
Age: 1.8
Sex: U
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: A non-serious report case was received from a nurse concerning a 18-month-old and a vaccine administration error. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. No relevant medical or drug history information was reported. The infant was given FluMist on 29-Oct-2007. The reporting site administrated FluMist to the 18-month-old in error as the vaccine is indicated in patients 2 years to 49 years of age. No adverse events were reported from this medication error. No additional information is available. Rechallenge and causality is not applicable. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 4/15/2008.  Patient date of birth is 01/11/06 and lot number of vaccine is not provided, 03/07/08. 13-NOV-2007 follow up information obtained and incorporated in above narrative: No adverse events after receiving vaccine.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, Medication error, No adverse reaction
Clinical narrative: A non-serious report of vaccination error has been received from a physician concerning a three year-old female. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The child has a history of allergy to eggs, no drug history information has been reported for this child. The patient received FLUMIST intranasally. On 29-Oct-2007 the reporter indicated a child with a history of allergy to eggs was inadvertently administered FLUMIST. No adverse events were observed. Outcome: the child had no ill effects verified on 04-Feb-2008. Further dosing with FLUMIST is not indicated. The reporter did not provide a causality assessment for this vaccination error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow up information was received 4-15-08. Adverse event onset date, states no adverse event reported and lot for vaccine is 500490P, 2/11/08. Follow up obtained on 06-Feb-2008 verified no adverse event was experienced and the physician approved dosing this child with FLUMIST.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Pt. woke up Saturday with a swollen arm.  Hot and red in appearance.  3 days later (Monday) swelling was gone.  Antibiotics given.  Benadryl and ibprofin given as needed
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Cough, Oedema mouth, Rash generalised
Clinical narrative: Information has been received from a physician, concerning a 15 year old female patient with drug hypersensitivity to methylphenidate (RITALIN) (involved rash, swollen mouth, chest tightness and cough), allergies (not specified), who on 11-SEP-2007 was vaccinated IM with the first dose of Gardasil (lot # invalid) with no reaction reported, and on approximately 12-NOV-2007, was vaccinated with the second dose of Gardasil (lot # 655165/1425F). Concomitant therapy included cetirizine hydrochloride (ZYRTEC). Following the second dose on 12-NOV-2007 the patient developed a rash all over her body, swelling of the mouth, tightness of her chest and coughing (treatment not specified). At the time of this report, the patient was recovering from the events. The reporting physician felt that rash all over body, swelling of the mouth, tightness of chest and coughing were considered to be immediately life-threatening. She noted that the patient had a "similar reaction" to methylphenidate (RITALIN). Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Dizziness, Electroencephalogram, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 17 year old female patient with migraines, who on an unspecified date was vaccinated with the first dose, 0.5 ml, of Gardasil (lot # not specified). Subsequently the patient experienced a seizure and dizziness. The outcome of the events was unknown. On an unspecified date, the patient was vaccinated with the second dose of gardasil (lot # not specified), and subsequently, she again experienced a seizure. An electroencephalogram was performed (results not specified). At the time of this report, the patient had not recovered from seizure. Upon internal review, seizure was considered to be serious as an other important medical event. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning a 68 year old female who on 04-OCT-2007 was vaccinated with Zostavax (lot# 658208/0886U). It was reported that on 12-OCT-2007, she developed chicken pox and was hospitalized. Current patient status was not reported. A product quality complaint was not reported. Additional information has been requested.
Age: 57.0
Sex: U
Vaccine: PPV
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Convulsion
Clinical narrative: Subject in pneumococcal vaccine trial (not blinded) was hospitalized with a COPD exacerbation and had 2 seizures while in hospital. Vaccination took place on 9/19/07 and hospital admission was 10/7/07.  Relationship to study treatment is 'Unlikely'. We would be happy to forward the Study's SAE form upon request. Subject ID number is A100099.11/30/07-records received for DOS 10/7-10/11/07-SAE report  Presented to ED with COPD exacerbation, while in ED had a seizure. Admitted to MICU where second seizure occurred.  The SAE occurred approximately 1.5 weeks before the CO2 visit. Relationship to study vaccine unlikely.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Chills, Dyspnoea, Hypotension
Clinical narrative: At 7:30 pm developed temperature to 104 F, SOB, joint pain, severe chills, sensitivity to light and migraine.  Because SOB was severe, paramedics were called and transported to ED.  BP was 88/47.  Was given Benedryl and Prednisone in ED and placed on 5 day course of prednisone.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Migraine, Photophobia
Clinical narrative: At 7:30 pm developed temperature to 104 F, SOB, joint pain, severe chills, sensitivity to light and migraine.  Because SOB was severe, paramedics were called and transported to ED.  BP was 88/47.  Was given Benedryl and Prednisone in ED and placed on 5 day course of prednisone.
Age: 77.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed Zoster outbreak one week after receiving Zoster vaccine.  Started on antiviral
Age: 25.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Flu and pneumovax administered in right deltoid on 11/21/2007. On 11/23/07 complained of tenderness and reddness at the injection site extending toward the elbow.
Age: 34.0
Sex: F
Vaccine: ANTH, FLUN3
Symptoms: Burning sensation, Hypoaesthesia, Injection site pain, Joint stiffness
Clinical narrative: Shooting pains from injection site distally with numbness in fingertips.  Stiffness in digits and elbow/wrist.  Pain is not constant, but comes and goes in "waves" every 2-3 minutes.  Patient describes the pain as a "burning" sensation.  Rated the pain a 10/10 when active, 5/10 when inactive.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Eyelid oedema, No reaction on previous exposure to drug, Pruritus, Swelling face
Clinical narrative: Patient received influenza vaccination on 11/26/2007 between 9-10am; patient has received the influenza vaccine for the past several years. At 1pm she began to experience puritis of the neck and edema of the eyelids. Difficulty with breathing and swelling of the tongue denied. Patient called her PCP for appointment but was unable to contact him and went home. Patient reports that this reaction had happen to her approximately 2 months ago when she had began a new medication (change from Avandament to Metformin) but the symptoms were worse. By 5pm the rest of her face began to swell and she had blisters on her eyelids and below her eyes; still no airway involvement. Patient denies any redness or swelling at site of injection. Patient saw her PCP 11/27/2207, at which time her symptoms had begun to subside. They did not perform any lab work or provide any treatment other than to instruct her not to ever receive the Influenza vaccine again. Patient is back to work today and states her symptoms are almost totaly resolved, with only mild puritis noted.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Urine analysis
Clinical narrative: Per report from mom during 6mo WCC, pt had temperature of 100.5 after vaccines last time. Pt went to ER for evaluation. Upon clarification, mom stated the temperature was 105. Pt was otherwise acting normally, no other symptoms. Urine was obtained - no infection.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Area 5 in. in size, red and warm on right deltoid area x 36 hrs.  Taking Tylenol and using cool compresses.  Wife sts. "better today"
Age: 18.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site abscess, Local reaction, Musculoskeletal pain, Oedema peripheral
Clinical narrative: Patient had significant local reaction with swelling over the entire deltoid area down into arm with errythema, pain and fever. Reported the "whole shoulder ached and was very painful to move." Treatment was supportive care with contrast heat/cold packs and NSAIDS.
Age: 18.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient had significant local reaction with swelling over the entire deltoid area down into arm with errythema, pain and fever. Reported the "whole shoulder ached and was very painful to move." Treatment was supportive care with contrast heat/cold packs and NSAIDS.
Age: 56.0
Sex: F
Vaccine: TTOX
Symptoms: Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: Received tetanus vaccine around 6 pm.  Same night,arm became very swollen (3 to 4 times normal size) and hot.  Patient ran high fever for 2 days,
Age: 7.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site discharge, Injection site erythema, Injection site pain, Injection site pruritus, Injection site scab
Clinical narrative: erythma at site of vaccination right deltoid about 12 hrs after shot. It progressed to vesicles in center.  I saw her at 9 pm 11/27/2007.4" erythmatous ring with raised edge central vesicles with on about 1"x1/3" denuded oozing slightly brown scabbed surrounded by slightly mor intnse red.  Area very itchy not much pain
Age: 7.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site vesicles
Clinical narrative: erythma at site of vaccination right deltoid about 12 hrs after shot. It progressed to vesicles in center.  I saw her at 9 pm 11/27/2007.4" erythmatous ring with raised edge central vesicles with on about 1"x1/3" denuded oozing slightly brown scabbed surrounded by slightly mor intnse red.  Area very itchy not much pain
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site swelling, Irritability, Pyrexia, Rash
Clinical narrative: Rash occurred on legs within 1 hour of administration of vaccine.  Fever: 103F Fussiness, swelling (lump) at site of injections
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Irritability
Clinical narrative: Received phone call from mother ~32hrs after flu shot.  Patient had been fussy all day, and arm and shoulder had become bright red and "hard", temps 100 to 100.1, got Tylenol all day. No streaking.  Had mother mark edge of erythema.  Following day, patient was much more comfortable, erythema had regressed overnight.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Erythema, Eye swelling
Clinical narrative: She had injection approx 9 AM and within 2 hours started to have cough/SOB. She took Benadryl 50mg. Then about 2 hours later her eyes started to swell and her neck was getting red. She went to the ED later that afternoon and was told to continue the Benadryl 50mg for 2 more days and was discharged, condition inproved, without further incident.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Pallor, Somnolence, Tonic clonic movements, Unresponsive to stimuli
Clinical narrative: A few hours after vaccinations administered, patient had episode of tonic neck rotation, upper extremity extension and unresponsiveness with skin color change (pallor) lasting less than 1 minute followed by 45-60 min of sleep followed by 1 hr of inconsolable crying.  No treatment administered.
Age: 0.1
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Electroencephalogram abnormal, Strabismus, Tremor
Clinical narrative: left eye turnrd in for approx 45 min. 10 days after immunization. leg tremmors on 3 different occasions for approx 4-5 seconds the week following eye incident. dr recomended eeg.  11/29/07 Received vax record which provides additional dose & lot #s.  VAERS database updated w/same.  1/8/08 Reviewed hospital medical records which reveal patient experienced abnormal eye movements & leg tremors 1 episode each in 3-4 weeks time.  Outpatient EEG was abnormal.  Referred to peds neurologist & admitted 10/31-11/1/2007.  No further activity while in hospital.  D/C to home w/neuro f/u & to have EEG repeated. FINAL DX: abnormal EEG.
Age: 9.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Anaphylactic reaction, Erythema, Lip swelling, Oral discomfort, Pruritus
Clinical narrative: Child began vomitting after the administration of the vaccines, complained of burning in her mouth, then swelling of her lips, then swelling of her face. There was no respiratory or cardiovascular compromise - 0.3ml of Epinephrine was administered and child diagnosed as having an anaphlylactic reaction and was transferred from the outpatient department to the Emergency Department.  There child developed total body redness, itching and swelling and was treated with Benadryl, corticosteroids, H2 blockers and hospitalized for observation. 12/10/07-records received for DOS 11/28-11/29/07-DC DX: anaphylactic reaction. Oral swelling, hives to face. Vomited. Admitted for observation.
Age: 9.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Swelling, Swelling face, Vomiting
Clinical narrative: Child began vomitting after the administration of the vaccines, complained of burning in her mouth, then swelling of her lips, then swelling of her face. There was no respiratory or cardiovascular compromise - 0.3ml of Epinephrine was administered and child diagnosed as having an anaphlylactic reaction and was transferred from the outpatient department to the Emergency Department.  There child developed total body redness, itching and swelling and was treated with Benadryl, corticosteroids, H2 blockers and hospitalized for observation. 12/10/07-records received for DOS 11/28-11/29/07-DC DX: anaphylactic reaction. Oral swelling, hives to face. Vomited. Admitted for observation.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Injection site abscess, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Abcess at R arm injection site; redness, swelling, warmth, hard; treatment: Clindamycin
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site abscess, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Abcess at L arm injection site; febrile, redness, swelling, warmth, hard; treatment: Augmentin
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Abcess at L arm injection site; febrile, redness, swelling, warmth, hard; treatment: Augmentin
Age: 29.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Balance disorder, Dizziness, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: 3 inch area where shot was administered is swollen, red, area is painful and itches.  Have on and off had a fever and yesterday, dizzy and no sense of balance.
Age: 29.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site swelling, Medication error, Pyrexia, Wrong drug administered
Clinical narrative: 3 inch area where shot was administered is swollen, red, area is painful and itches.  Have on and off had a fever and yesterday, dizzy and no sense of balance.
Age: 37.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Blood glucose increased, Blood pressure increased, Body temperature increased, Chest pain, Heart rate increased
Clinical narrative: EMPLOYEE REPORTED FEELING CHEST PAIN, RESTLESSNESS, PALPITATIONS AND HE SHOWED CONSISTENT DRY COUGH AT 11:55 AM. NO HIVES,WHEEZING, REDNESS SHORTNESS OF BREATH OR SWELLING OF THE FACE WERE NOTED.HIS INITIAL VITAL SIGNS BEFORE THE VACCINE WERE B/P 138/90, PULSE 76, T-96.8F,R-20. VITAL SIGNS AFTER THE ADVERSE REACTION WERE @11:55AM BP 150/100, P-107, T-99.1F,R-18. MEDICAL DIRECTOR, NOTIFIED ABOUT THE REACTION VIA PHONE AND SUGGESTED TO CALL EMS. EMS WAS CALLED @ 11:59AM.VITAL SIGNS @12:00PM WERE BP-165/109, P-126, T-99.6,R-18. EMPLOYEE PLACED ON OXYGEN VIA NASAL CANNULA @ 5L/MIN.EMS PUMPER 12 AND RESCUE 12 ARRIVED @ THE SCENE MONITORING THE OXYGEN SATURATION BEING 98%, AND THE BLOOD GLUCOSE LEVEL BEING @137 MG/DL. VITAL SIGNS @12:05PM BP-148/84, P-156,R-18. EMPLOYEE WAS TRANSPORTED TO THE HOSPITAL VIA STRETCHER BY EMS @12:06PM.  EMPLOYEE CONTACTED AT HIS CELL PHONE VERBALIZING THAT THE DOCTOR FROM THE HOSPITAL DIAGNOSED HIM WITH AN ALLERGIC REACTION TO INFLUENZA VACCINE. HE STATED THAT HE WAS DISCHARGED @ 3:30PM UNDER STABLE CONDITION FROM THE EMERGENCY ROOM,AND THAT THE DOCTOR TOLD HIM TO BE BACK TO WORK UNTLI 11/30/07.   12/7/07 Reviewed ER medical records which reveal patient transported by EMS 11/28/07 after experienced anxiety, sore throat w/swelling, nonproductive cough, red facial rash & mild SOB immediately s/p flu vax.  Tx w/IV benadryl, O2 & steroids.  Improved & d/c to home FINAL DX: acute allergic reaction.
Age: 37.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Oxygen saturation normal, Oxygen supplementation, Palpitations, Restlessness
Clinical narrative: EMPLOYEE REPORTED FEELING CHEST PAIN, RESTLESSNESS, PALPITATIONS AND HE SHOWED CONSISTENT DRY COUGH AT 11:55 AM. NO HIVES,WHEEZING, REDNESS SHORTNESS OF BREATH OR SWELLING OF THE FACE WERE NOTED.HIS INITIAL VITAL SIGNS BEFORE THE VACCINE WERE B/P 138/90, PULSE 76, T-96.8F,R-20. VITAL SIGNS AFTER THE ADVERSE REACTION WERE @11:55AM BP 150/100, P-107, T-99.1F,R-18. MEDICAL DIRECTOR, NOTIFIED ABOUT THE REACTION VIA PHONE AND SUGGESTED TO CALL EMS. EMS WAS CALLED @ 11:59AM.VITAL SIGNS @12:00PM WERE BP-165/109, P-126, T-99.6,R-18. EMPLOYEE PLACED ON OXYGEN VIA NASAL CANNULA @ 5L/MIN.EMS PUMPER 12 AND RESCUE 12 ARRIVED @ THE SCENE MONITORING THE OXYGEN SATURATION BEING 98%, AND THE BLOOD GLUCOSE LEVEL BEING @137 MG/DL. VITAL SIGNS @12:05PM BP-148/84, P-156,R-18. EMPLOYEE WAS TRANSPORTED TO THE HOSPITAL VIA STRETCHER BY EMS @12:06PM.  EMPLOYEE CONTACTED AT HIS CELL PHONE VERBALIZING THAT THE DOCTOR FROM THE HOSPITAL DIAGNOSED HIM WITH AN ALLERGIC REACTION TO INFLUENZA VACCINE. HE STATED THAT HE WAS DISCHARGED @ 3:30PM UNDER STABLE CONDITION FROM THE EMERGENCY ROOM,AND THAT THE DOCTOR TOLD HIM TO BE BACK TO WORK UNTLI 11/30/07.   12/7/07 Reviewed ER medical records which reveal patient transported by EMS 11/28/07 after experienced anxiety, sore throat w/swelling, nonproductive cough, red facial rash & mild SOB immediately s/p flu vax.  Tx w/IV benadryl, O2 & steroids.  Improved & d/c to home FINAL DX: acute allergic reaction.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Joint range of motion decreased
Clinical narrative: This case was reported by the son of a consumer and described the occurrence of reduced range of motion in a 74-year-old female subject who was vaccinated with flu vaccine unspecified, manufacturer known to be GlaxoSmithKline. A physician or other health care professional has not verified this report. On 27 October 2007 at 10:30 the subject received unspecified dose of flu vaccine in the right arm. The injection was reportedly given high on the arm at the point where the humorous meets the joint. On 30 October 2007, in the morning, 3 days after vaccination with flu vaccine, the subject experienced injection site pain and pain and swelling in her right arm. As a result, she developed a reduced range of motion in her right arm. At the time of reporting the events were unresolved.
Age: 81.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: After Flu shot, I became ill that afternoon 10/23/07 - I stayed in bed for 4 days and rested then went to hospital - On 10/30 visited doctor who put me on steroids. On 11/1 saw another doctor who put me on antihistamine. I was in bed for about 3 weeks. Follow-up: I do not wish to release my medical records, as this flu - shot was my fault. I was ill at the time I took it.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Axillary pain, Chills, Full blood count normal, Haematocrit, Headache
Clinical narrative: Body aches, headache, swelling at site, Lt axillary pain, fever, chills x 2 days. 3 IV fluid, Phenergan - nausea, Toradol - headache, given 1g Ancef, Keflex 500 qid, Motrin 800 tid. 12/14/07-records received for DOS 01/21/02/22/07-DX Cellulitis left arm secondary to smallpox vaccine.C/O body aches, headache, increased erythema around smallpox vaccination site, left axillary pain, fever and chills for 2 days. Tachycardic orthostatic.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Injection site swelling, Nausea, Pain, Pyrexia
Clinical narrative: Body aches, headache, swelling at site, Lt axillary pain, fever, chills x 2 days. 3 IV fluid, Phenergan - nausea, Toradol - headache, given 1g Ancef, Keflex 500 qid, Motrin 800 tid. 12/14/07-records received for DOS 01/21/02/22/07-DX Cellulitis left arm secondary to smallpox vaccine.C/O body aches, headache, increased erythema around smallpox vaccination site, left axillary pain, fever and chills for 2 days. Tachycardic orthostatic.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV, TD
Symptoms: Inflammation, Local swelling, Musculoskeletal pain, Neck pain, Neuralgia
Clinical narrative: Patient complained of pain and swelling left arm, shoulder, neck.  Seen by PMD and treated with anti-inflammatory meds.  Nerve relaxers and pain meds for inflamed muscle and nerve ending exposure per patient.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV, TD
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Patient complained of pain and swelling left arm, shoulder, neck.  Seen by PMD and treated with anti-inflammatory meds.  Nerve relaxers and pain meds for inflamed muscle and nerve ending exposure per patient.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site pain, Injection site papule, Limb discomfort
Clinical narrative: Approximately 3 weeks after vaccination, patient complained of sore arm and a small clean injection site lesion.  Symptoms continued.  Saw Dr who found small lesions on arm and truck - healing and shingle-like on 10/22/07. Follow-up information from the pharmacist indicated the patient developed shingles and injection site pain after receiving ZOSTAVAX (lot# 658083/0885U). The patient developed several lesions around his body. The lesions resolved, but he still had injection site pain, a lot check has been requested. Follow-up information from the pharmacist indicated that the patient's injection-site pain persisted. Follow-up information from the physician indicated that the patient called the phyician and reported he continues to have pain at the injection site and wanted to know when he could exepect relief. Additional information has been requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactoy. The lot met requirements and was released by the regulatory agency.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Approximately 3 weeks after vaccination, patient complained of sore arm and a small clean injection site lesion.  Symptoms continued.  Saw Dr who found small lesions on arm and truck - healing and shingle-like on 10/22/07. Follow-up information from the pharmacist indicated the patient developed shingles and injection site pain after receiving ZOSTAVAX (lot# 658083/0885U). The patient developed several lesions around his body. The lesions resolved, but he still had injection site pain, a lot check has been requested. Follow-up information from the pharmacist indicated that the patient's injection-site pain persisted. Follow-up information from the physician indicated that the patient called the phyician and reported he continues to have pain at the injection site and wanted to know when he could exepect relief. Additional information has been requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactoy. The lot met requirements and was released by the regulatory agency.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Pruritus
Clinical narrative: Immediate erythema surrounding injection site. Itching (mild) in area within a few minutes
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Nodule, Oedema peripheral
Clinical narrative: Patient complained of red swollen arm; with nodules at the base of her left neck arm swollen from shoulder to elbow.  Band of red about 4 inches wide around arm.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Redness and swelling to right outer arm.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU3, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Developed red area of induration, tenderness, pain and itching at site of vaccination on left arm. Area 2x3 in deg.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received Adacel vaccine due to laceration to her right leg on 11/11/07.  11/12/07 began experiencing chills, headache, fever, swelling at injection site.  Office visit on 11/14/07 showed 10x10cm red, hot, tender area at injection site.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Patient received Adacel vaccine due to laceration to her right leg on 11/11/07.  11/12/07 began experiencing chills, headache, fever, swelling at injection site.  Office visit on 11/14/07 showed 10x10cm red, hot, tender area at injection site.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, Throat tightness
Clinical narrative: 11 hours after receiving vaccine, pt reported a "scratchy" sensation in her throat with sensation of throat closing. Within 5 hours all her symptoms resolved without intervention. She noted no hives/wheezing/angioedema.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt given Gardasil immunization in left deltoid area became red and warm to touch within 5 minutes of shot, and spread on pt torso. Benadryl given symptoms relieved
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Facial palsy
Clinical narrative: Bell's palsy (R) side. 1/30/07-records received for DOS 11/23-11/30/07-C/O cough/congestion. Had dental appointment on 11/21/07 noticed face was not moving porperly. Left side Bell's Palsy. 11/30/07-face some improvement.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Arm at infection site swollen and warm, mildly tender.  No fever, no induration.
Age: 24.0
Sex: M
Vaccine: FLUN3
Symptoms: Aphonia, Bacterial infection, Pharyngitis, Pharyngolaryngeal pain, Sinusitis
Clinical narrative: Two day following administration of the Flumist, soldier developed pharyngitis, sinusitis.  Tx'd by another provider for bacterial sinusitis which soldier reports decrease ssx but still loses his voice if he has to shout at his troops c/o S/T in a.m.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Alanine aminotransferase normal, Anion gap normal, Aspartate aminotransferase increased, Basophil count decreased, Blood albumin normal
Clinical narrative: 85 year old female with acute onset of diffuse body rash this am.  On a.m. of 7 Nov 2007, after her exercises, she noticed the body rash.  Rash is non-pruritic.  No pustules or vesicles.  She denies fevers, chills, malaise, fatigue, shortness of breath, chest pains, GI or GU complaints.  Rash, diffuse, generalized (arms, trunk, back, neck, legs, face).
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood alkaline phosphatase normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood folate
Clinical narrative: 85 year old female with acute onset of diffuse body rash this am.  On a.m. of 7 Nov 2007, after her exercises, she noticed the body rash.  Rash is non-pruritic.  No pustules or vesicles.  She denies fevers, chills, malaise, fatigue, shortness of breath, chest pains, GI or GU complaints.  Rash, diffuse, generalized (arms, trunk, back, neck, legs, face).
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea increased, Carbon dioxide increased
Clinical narrative: 85 year old female with acute onset of diffuse body rash this am.  On a.m. of 7 Nov 2007, after her exercises, she noticed the body rash.  Rash is non-pruritic.  No pustules or vesicles.  She denies fevers, chills, malaise, fatigue, shortness of breath, chest pains, GI or GU complaints.  Rash, diffuse, generalized (arms, trunk, back, neck, legs, face).
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Eosinophil count decreased, Glomerular filtration rate normal, Haematocrit normal, Haemoglobin normal, Laboratory test
Clinical narrative: 85 year old female with acute onset of diffuse body rash this am.  On a.m. of 7 Nov 2007, after her exercises, she noticed the body rash.  Rash is non-pruritic.  No pustules or vesicles.  She denies fevers, chills, malaise, fatigue, shortness of breath, chest pains, GI or GU complaints.  Rash, diffuse, generalized (arms, trunk, back, neck, legs, face).