chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Blood potassium decreased, Dizziness, Dysgeusia, Dyspnoea, Heart rate increased
Clinical narrative: Rec'd Imm around 11:30.  Also received meds in clinic.  Around 8:30pm heavy breathing, dizzy, rapid heart beat, iron taste on back of tongue.  Went to ER, symptoms worsened esp. dizziness.  Stated MD said K+ level borderline low.  S were WNL.  Told to eat bananas & OJ.  Told to f/u with MD.  Has appt in January at hospital.  Pt continues to have tingling feeling & rapid heart rate intermittently.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Large erythmatous plaque developed around site of MMR injection 24 hours after vaccine administration.  Patient has pruritis at site of swelling.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash
Age: 9.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: 8yo pt given DTaP instead of Td.  Age out of range for DTaP.  Pt did not suffer adverse event.
Age: 10.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: None, no adverse event.  10yo given DTaP instead of Td.  Out of range for DTaP.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac failure, Death, Vaccination complication, Viral infection
Clinical narrative: oct.28.2007 treated for upper respritory viral infected.sept.10 2007recieved influensa vaccine.sept.17 2007treated for viral infection complecated by influensa vaccine.oct.27 2007died heart failer complecated by virial infection  11/16/07 Reviewed vaccine record from pcp & VAERS database updated w/same.   11/27/07 ER Final dx: cardiac arrest, expired. Reviewed hospital medical records which reveal patient experienced chest & left arm pain, cold & clammy, skin mottled, nauseated, felt faint & passed out when EMS arrived.  EMS rhythm strip revealed BBB w/ST segment depression.  In ER, vomited & had diarrhea.  EKG revealed atrial fib w/rapid ventricular response.  DX w/acute bronchitis & atrial fib w/RVR.  Became unresponsive & developed cardiac arrest.  Resuscitated & intubated.  While being tansferred to higher level of care via helicopter, coded again.  Returned to ER & unable to resuscitate.  3/7/2008 Judge states he signed death certificate as directed by state law when patient is not in hospital & only seen in ER but paper copy no longer available. States COD as undetermined & manner of death natural.  3/11 Death certificate reviewed & states COD as undetermined & manner of death as natural.
Age: 42.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Body temperature increased, Chills, Fatigue, Hyperhidrosis, Injected limb mobility decreased
Clinical narrative: Received pneumovax vaccine on thursday 11/8 @5pm in right arm, on friday 11/9 @5pm, started with violent chills, shakes, fatigued, spiked temp to 102.0 during night, diaphoretic, violent shakes, chills, right arm swelling, unable to move arm due to severe pain,unable to sleep due to symptoms, took tylenol pm at 5am to sleep! Slept til 10am, temp 101.0, took ibuprofen, unable to move arm/severe swelling/reddened--size of grapefruit, took benadryl on sat night to see if it would calm down "reaction", slept all night, temp 100.6 on sunday, cont with ibuprofen q6 atc, severe arm pain, by monday 11/12--was able to move arm by monday afternoon, continued with ibuprofen and by tuesday, redness was gone, still wild mild mod swelling, painful to touch but able to move arm.
Age: 42.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral, Pain in extremity
Clinical narrative: Received pneumovax vaccine on thursday 11/8 @5pm in right arm, on friday 11/9 @5pm, started with violent chills, shakes, fatigued, spiked temp to 102.0 during night, diaphoretic, violent shakes, chills, right arm swelling, unable to move arm due to severe pain,unable to sleep due to symptoms, took tylenol pm at 5am to sleep! Slept til 10am, temp 101.0, took ibuprofen, unable to move arm/severe swelling/reddened--size of grapefruit, took benadryl on sat night to see if it would calm down "reaction", slept all night, temp 100.6 on sunday, cont with ibuprofen q6 atc, severe arm pain, by monday 11/12--was able to move arm by monday afternoon, continued with ibuprofen and by tuesday, redness was gone, still wild mild mod swelling, painful to touch but able to move arm.
Age: 42.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Sleep disorder, Tremor
Clinical narrative: Received pneumovax vaccine on thursday 11/8 @5pm in right arm, on friday 11/9 @5pm, started with violent chills, shakes, fatigued, spiked temp to 102.0 during night, diaphoretic, violent shakes, chills, right arm swelling, unable to move arm due to severe pain,unable to sleep due to symptoms, took tylenol pm at 5am to sleep! Slept til 10am, temp 101.0, took ibuprofen, unable to move arm/severe swelling/reddened--size of grapefruit, took benadryl on sat night to see if it would calm down "reaction", slept all night, temp 100.6 on sunday, cont with ibuprofen q6 atc, severe arm pain, by monday 11/12--was able to move arm by monday afternoon, continued with ibuprofen and by tuesday, redness was gone, still wild mild mod swelling, painful to touch but able to move arm.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Axillary pain, Chills, Injection site pain, Nausea, Pain
Clinical narrative: I started with chills the night of 11/05.  By the time I went to bed, I was nauseated and achy.  I was chilling so badly that I couldn't stop shaking.  My arm where the injections were given was sore down to my elbow and sore under my arm.  It was so sore that between my other symptoms I was unable to sleep that night.  The next morning the symptoms continued and my fever broke.  My skin had red bloches all over.  I continued to take Ibuprofen and got enough relief to go to work the next day.  The same symptoms contined until 11/7.  My arm was no longer tender after 11/8.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Rash macular, Sleep disorder, Tremor
Clinical narrative: I started with chills the night of 11/05.  By the time I went to bed, I was nauseated and achy.  I was chilling so badly that I couldn't stop shaking.  My arm where the injections were given was sore down to my elbow and sore under my arm.  It was so sore that between my other symptoms I was unable to sleep that night.  The next morning the symptoms continued and my fever broke.  My skin had red bloches all over.  I continued to take Ibuprofen and got enough relief to go to work the next day.  The same symptoms contined until 11/7.  My arm was no longer tender after 11/8.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Drug hypersensitivity, Headache, Pyrexia
Clinical narrative: This is my first Flu vaccine which was administered at 10:15am on Monday, Nov 5th.  Within an hour I started experiencing a moderately severe headache and spent two days in bed with fever and chills.  Note:  I am extremely sensitive to medication.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Oedema peripheral, Vaccination complication
Clinical narrative: 0800 11/06/07 Shortly after receiving flu vaccination in left deltoid. Pt described swelling in left hand unable to make a fist. No nausea, dizzness, difficulty breathing, tightness in chest or throat. Only Sx experienced was swelling in left hand. Pt. states went to personal physician who told him it was a reaction to the flu shot and gave him an "anti-inflammatory medication", P.O.. Pt. states swelling subsided by approx 2330 on the  6th and has had no other effect from the flu shot. States that he is back to normal again.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Encephalitis, Neck pain, Pyrexia, Vaccination complication, Vomiting
Clinical narrative: Patient developed Fever 101 or above neck pain and vomiting on the day after recieving the vaccine. Patients daughter called to report symptoms she was advised to toake the patient to the ER for emergent evaluation of symptoms. The patients was taken for evaluation several days later to Dr. I donot have any of the information as far as test or treament which was rendered. Patient was seen by a neurologist and found to have encephalitis thought to be a result of the flu immunization
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: none, realized too late that client too old to have HPV
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: REDDNESS, ITCHING, PAIN AND EDEMA AT INJECTION SITE FIRST REPORTED BY PATIENT 24 HRS. POST INJECTION; PATIENT REFERRED TO ORDERING DR.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Patient developed a local reaction at the site of where the vaccine was administered.  It is a raised are approximately 3cm x 7cm and patient decribes it as "itchy".
Age: 12.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Erythema, Lymphadenopathy, Pyrexia, Swelling
Clinical narrative: MOTHER IS A NURSE PRACTITIONER AND REQUESTED A VAERS BE COMPLETED ON HER CHILD.STATES THE MORNING OF 11/9/7  LYMP GLANDS OF LT ARM PIT SWOLLEN AND LARGE AMT OF REDDNESS AND   SWELLING.STATES HE RAN A FEVER OF 103 FOR 3 DAYS.CLIENT DID CALL THE CHILD MD BUT CHILD NOT SEEN BY A MD.MOTHER DESCRIBED REDDENESS AS 10-12CM SIZE AND SWELLING DOUBLE THE SIZE OF HIS ARM
Age: 24.0
Sex: F
Vaccine: HPV4, TD, HPV4, TTOX
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: 2 weeks after administration of vaccine, client complained of left arm tingling and fingers and toes numb  She saw er M.D. and no treatment nor diagnosis made
Age: 24.0
Sex: F
Vaccine: HPV4, TD, HPV4, TTOX
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia, Laboratory test
Clinical narrative: 2 weeks after administration of vaccine, client complained of left arm tingling and fingers and toes numb  She saw er M.D. and no treatment nor diagnosis made
Age: 24.0
Sex: F
Vaccine: HPV4, TD, HPV4, TTOX
Symptoms: Paraesthesia, Paralysis
Clinical narrative: 2 weeks after administration of vaccine, client complained of left arm tingling and fingers and toes numb  She saw er M.D. and no treatment nor diagnosis made
Age: 17.0
Sex: F
Vaccine: FLUN3
Symptoms: Full blood count, Laboratory test, Local swelling, Oedema peripheral, Swelling face
Clinical narrative: Pt presented to office on 11/5/07 following the 10/26/07 administration of flumist.  Pt presented with a swollen face and neck, as well as swelling in one limb.  Pt seen for second follow up on 11/9/07.  At this time was determined to possibly have a flumist reaction.  Pt's sx improving.
Age: 17.0
Sex: F
Vaccine: FLUN3
Symptoms: Vaccination complication, X-ray
Clinical narrative: Pt presented to office on 11/5/07 following the 10/26/07 administration of flumist.  Pt presented with a swollen face and neck, as well as swelling in one limb.  Pt seen for second follow up on 11/9/07.  At this time was determined to possibly have a flumist reaction.  Pt's sx improving.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Pruritus, Swelling face
Clinical narrative: Rec.'d shot at 11:40 a.m. Noticed adverse event at 1:00 p.m. c/o burning and itching of the face. Stated that she felt her face swelling. 3:00 p.m. Reported to the school nurse. c/o itching and facial burning. Minimum amount of redness noted. temp - 98.4 / pulse -72 & regular. No difficulty breathing. 4:05 p.m. To ER with a family member.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Phlebitis, Skin warm, Tenderness
Clinical narrative: Phlebitis (warm,red,tender) appromiately 10x10 inches in upper right deltoid extending around back of arm. Observed 48 hours after vaccine, symptoms still present. Patient consulted family physician and placed on antibiotics and to follow-up in 5-7 days.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: vaccination was given in the evening. the following AM she had a rash on face and over torso
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site irritation
Clinical narrative: About two days following the injection I noticed a red area below the site.  The area was sensitive to touch  and felt like it ws burning.  The size of the site was about 1/2" by 1 1/2" with irregular edges. This red area lasted for about a week. I also had some discomfort around a nerve trunk area.  This lasted only for about an hour.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Nodule on extremity, Pain in extremity
Clinical narrative: 3 to 4 days after vaccine administration, left arm became sore with a nickel-sized knot.  After three weeks, knot is still there and the area is sore.  Did not feel feverish or tired.  Patient put ice on area yesterday.  This is not the first flu vaccine that the client received. She denies being allergic to eggs.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cold compress therapy, Injection site swelling
Clinical narrative: PATIENT EXPERIENCED SWELLING AT INJECTION SITE, NO PAIN OR ITCHING OR REDNESS.  PATIENT WAS ASKED TO BE OBSERVED FOR 40 MINUTES AND THE SWELLING DECREASED SLIGHTLY.  PATIENT WAS CONTACTED 2 HOURS LATER, THE SWELLING HAD SUBSIDED SLIGHTLY MORE.  PATIENT WAS ADVISED TO USE COOL COMPRESSES AT THE INJECTION SITE AND TO TAKE BENADRYL AND OR TYLENOL.  PATIENT'S PRIMARY CARE PHYSICIAN  (MEDICAL NURSE) WAS INFORMED OF THE REACTION.  THE DR. WAS FAXED THE COPY OF THE VACCINE ADMINISTRATION CONSENT FORM.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: PATIENT EXPERIENCED REDNESS AND ITCHING AT INJECTION SITE.  PATIENT INFORMED ADMINISTRATOR OF THE VACCINE ADVERSE REACTION ON 11-9-07 (2 DAYS AFTER THE INJECTION.)  DR. WAS INFORMED OF THE REACTION AND SUGGESTED WARM COMPRESS AND BENADRYL. FOLLOW-UP WITH THE PATIENT ON THE 11-11-07, THE PATIENT REPORTED THE REDNESS WAS ALMOST GONE AND NO ITCHING. THE VACCINE ADMINSRATION CONSENT FORM WAS FAXED TO THE DR.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: The evening of 11/12, pt's right leg became red and swollen.  The swelling continued on 11/13 and was from her hip to her knee.  It is warm to the touch and "itchy".
Age: 1.5
Sex: F
Vaccine: DTAP, FLU3, MMR, PNC
Symptoms: Abasia
Clinical narrative: pt unable to walk 24 hours after vaccine, attempted to stand and could not bear weight, after, 36 hours after vaccine was administerd pt able to walk
Age: 0.5
Sex: F
Vaccine: DT, HEP, HIBV, IPV
Symptoms: Erythema, Injection site nodule, Oedema peripheral
Clinical narrative: Right Leg was swollen and red with a large lump under her skin at the injection site.
Age: 19.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Dysphagia, Erythema, Hypersensitivity, Local swelling, Skin tightness
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female with penicillin allergy and ZITHROMAX allergy who on 01-OCT-2007 was vaccinated IM with a 0.5 ml dose of Gardasil (lot# 657006/0188U).  Concomitant therapy given the same day in a different site included a dose of influenza virus vaccine (unspecified). CLARINEX and benzoyl peroxide.  On 04-OCT-2007, the patient experienced shortness of breath, generalized itching and facial redness.  The nurse believed that the patient went to the emergency room but no other details were provided.  At the time of this repot, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Skin warm, Swelling, Throat irritation, Throat tightness, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female with penicillin allergy and ZITHROMAX allergy who on 01-OCT-2007 was vaccinated IM with a 0.5 ml dose of Gardasil (lot# 657006/0188U).  Concomitant therapy given the same day in a different site included a dose of influenza virus vaccine (unspecified). CLARINEX and benzoyl peroxide.  On 04-OCT-2007, the patient experienced shortness of breath, generalized itching and facial redness.  The nurse believed that the patient went to the emergency room but no other details were provided.  At the time of this repot, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Dyspnoea, Erythema, Pruritus generalised
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female with penicillin allergy and ZITHROMAX allergy who on 01-OCT-2007 was vaccinated IM with a 0.5 ml dose of Gardasil (lot# 657006/0188U).  Concomitant therapy given the same day in a different site included a dose of influenza virus vaccine (unspecified). CLARINEX and benzoyl peroxide.  On 04-OCT-2007, the patient experienced shortness of breath, generalized itching and facial redness.  The nurse believed that the patient went to the emergency room but no other details were provided.  At the time of this repot, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Petechiae, Rash pruritic, Urticaria
Clinical narrative: Initial report received on 23 October 2006 from a health care professional. A three-year-old male patient, with no past medical history, had received a fourth dose, intramuscular, right thigh injection of Fluzone No Preservative 2006-2007, lot number U2166KA, on 21 October 2006. Six hours later, the patient developed large hive like patches between his neck and knees and throughout his trunk area. The welts were also on his arms. The welts were large, raised, itchy bumps occurring in patches (patches were four to eight inches in diameter). His eating was slightly decreased. The parents spoke with the pediatrician on the phone. The event did not require examination by the physician. The patient was treated with Claritin, Benadryl, and an oatmeal bath. The patient recovered from the event. Follow-up received on 21 November 2006 from a health care professional. The patient had no illness at the time of vaccination. As per the reporter, there was no diagnosis for the event, as the patient was not seen by a physician. Further information is not anticipated.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Strabismus
Clinical narrative: Initial report received on 28 November 2006, from a health care professional.  A 2.5 year old male patient received on 20 November 2006 Fluzone (lot number 02191BA), intramuscular into the left thigh.  On 20 November 2006, within 2 hours of receiving Fluzone, the patient's right eye began to deviate, so as appear "cross-eyed".  The problem occurred intermediately for 24 hours.  The patient was seen on 28 November 2006; the patient's mother reported that he continued to have occasional right eye deviation "cross-eyed".  No other signs and symptoms reported.  Gait stable, neuro exam (performed).  Not seen by ophthalmologist.  No treatment prescribed.  At the time of this report (28 November 2006), the patient had not recovered.  The patient did not receive Fluzone previously.  A corrective version was created with the same latest received date as the previous version (28 November 2006) for the sole purpose of amending the vaccine given on 20 November 2006 from FLUZONE SV '2006-'2007 USP to FLUZONE No Preservative '2006-'2007.  No new medical information was provided.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: Initial report received from a nurse on 07 December 2006. A 66 year old, female patient experienced a sore arm, nodule at the injection site and began flu-like signs and symptoms (non-specific) on the evening after she received an injection of Fluzone (lot number U2165DA, route not reported) in the left deltoid on 09 October 2006. She had 1 previous dose of Fluzone in the past and she did not have any illness at the time of vaccination. At the time of the report, she had pain and nodule at the injection site was still persisting; she was unable to sleep on her left arm. She was not recovered. Follow-up information received on 22 January 2007 from a health care professional. The patient was 46-years-old (not 66 as documented in the above narrative). Fluzone No Preservative 2006-2007 had been administered intramuscularly in the left deltoid. The patient had experienced pain at the injection site and entire arm which is worse in the morning and at the end of the day. The patient never had a nodule at the site or flu-like symptoms. She had physical therapy four times "since this report" and has experienced a little relief with "iontophoresis and Advil." At the time of this report. the patient continued to have intermittent pain.
Age: 0.9
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Initial report received from a nurse on 08 December 2006.  A 10 month old, female patient (with a medical history of asthma) developed a generalized, red, flat rash within 3 hours after she received Fluzone (lot number U2200KA) intramuscularly in her left thigh on 30 November 2006.  She did not have any illness at the time of vaccination.  The rash lasted for 3 days and Benadryl was given.  The patient recovered.
Age: 1.0
Sex: M
Vaccine: FLU3
Symptoms: Aggression, Emotional distress, Insomnia, Irritability
Clinical narrative: Initial report received from a physician on 21 December 2006.  A 1 year old, male patient (with no medical history) was difficult to console, had difficulty getting to sleep, had increasing tantrums and irritability, in the evening after he received his second dose of Fluzone (lot number UT2191KA) intramuscularly in the left thigh in the morning on 18 December 2006.  He received his first dose of Fluzone (lot number U2220BB) intramuscularly in the left thigh on 18 November 2006.  On 08 December 2006, he received Hep A (Merck, lot number 1209F) intramuscularly in the right thigh and ProQuad (Merck, lot number 0970F) intramuscularly in the right arm.  He was not on any medications and did not have any illness at the time of vaccination.  At the time of the report, the patient had not recovered.  Follow-up information received on 02 April 2007 from a health care professional.  No treatment was provided or needed.  The duration of the events was four to five days.  The patient recovered from the event.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Erythema, Feeling hot, Immediate post-injection reaction, Pruritus generalised
Clinical narrative: Initial information received on 20 October 2006 from the patient.  A 63-year-old female patient, with a history of allergies and hypertension, had received a left deltoid injection of Fluzone SV, lot number unknown, on 06 October 2006.  The reporter believes that she had also received an injection of Pneumovax, manufacturer Merck, lot number unknown, on 06 October 2006.  Immediately post-vaccination, the patient felt warm and itchy all over.  Three days later, she began self treating with Benadryl.  Seven days post-vaccination, the patient experienced shortness of breath, and redness in her skin all over.  She was examined in an emergency room and treated with epinephrine.  She is currently taking a methylprednisolone dose pack.  The patient continues to experience itchiness and redness. On 19 October 2006, the patient was examined by an allergist.  Findings of that visit were not provided.  At the time of this report, the patient had not recovered.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Induration, Oedema peripheral, Pruritus
Clinical narrative: Initial report received from a health care professional on 10 January 2007.  A 5 year old, male patient (with a history of local induration with other vaccines and no known allergies) developed swelling, erythema, induration and pruritus extending from the top of the shoulder to the mid arm anteriorly to the lateral edge of the scapula, within one day of receiving Fluzone (lot number U2169NA) intramuscularly in the left deltoid on 09 November 2006.  It extended posteriorly involving the bicep and tricep area.  It was further described as being "circumferential".  He denied any systemic symptoms.  There were no other vaccines administered at that time or within 4 weeks.  He had no medical conditions and did not have any illness at the time of vaccination.  The reaction was reported to be completely resolved by 13 November 2006.  Follow-up information received on 26 January 2007.  There was no treatment therapy.  The parents are physicians and reported to the reporter on 10 January 2007 that the area was just observed and since there was no systemic reaction, they were not concerned.  This child, as the mother reported, had had localized reaction to other vaccines.  There were no labs/no diagnostics performed.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing
Clinical narrative: A 56 year old female patient received on 26 October 2006, the yearly vaccination of Fluzone (lot number unknown), into the left deltoid. Within 24 hours on 27 October 2006, before noon, the patient was feeling flush/feverish on her face with no other signs and symptoms. No corrective treatment was reported. At the time of the repot (27 October 2006) the patient had not recovered. The patient did not received concomitant vaccinations and the patient did not have any illness at the time of vaccination. The patient's medical history was not reported. No information about prior exposure to Fluzone was provided.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Increased upper airway secretion, Infection, Sinus congestion
Clinical narrative: Initial report received from a patient on 08 November 2006.  A 64 year old, female patient experienced persistent sinus congestion, infection, phlegm and mucous that began on the same day, after she received Fluzone (lot number unknown, route of administration not reported) in the left deltoid on 07 October 2006.  At the time of the vaccination, she had a post nasal drip; she was on medications but they were unknown.  At the time of the report, the signs and symptoms were continuing.  Augmentin was prescribed, but it did not help.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Headache, Pharyngolaryngeal pain, Sinus congestion, Sneezing
Clinical narrative: Initial report received on 16 November 2006, from a consumer, the patient. A 30 year old female patient received on 13 November 2006, in the afternoon, Fluzone (lot number unknown) (unknown site, dose and route of administration). She had a sore throat that morning (13 November 2006), prior to vaccination. She continued to experience the sore throat after the vaccination. She also experienced after vaccination, cough, sneezing, sinus congestion and headache. At the time of the report, 16 November 2006, the signs and symptoms were still persisting and the patient had not recovered. No corrective treatment was reported. The patient did not receive any concomitant vaccines or medications. No information on prior exposure was reported.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Chest discomfort, Lymphadenopathy, Urticaria
Clinical narrative: Initial report received from a patient on 06 December 2006.  A 32 year old, female patient (with a medical history of seasonal allergies and allergies to antibiotics, but no egg allergy) developed hives around eyes and legs, slight tightness with breathing and her skin on her face felt like burning, on the evening after receiving an injection of Fluzone (lot number unknown, site of administration not reported) in the right deltoid on 18 November 2006.  She did not have any illness at the time of vaccination.  4-5 days post dose, she had right axillary lymphadenopathy.  Her signs and symptoms resolved in 5 days and the patient recovered.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site haemorrhage, Muscular weakness, Oedema peripheral, Pain in extremity
Clinical narrative: Initial report received from a patient on 03 January 2007.  A 60 year old, female patient (with no known allergies) developed an ecchymotic area about 1-2 inches below the site 3-4 days after she received Fluzone (lot number unknown, route of administration not reported) in the deltoid on 20 November 2006.  She also stated her muscle appeared to be "bulging" and complained of soreness and weakness in the arm.  At the time of the vaccination, she was fatigued.  At the time of the report, it was reported the ecchymotic area resolved.  The patient had not recovered.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Dyspepsia, No reaction on previous exposure to drug
Clinical narrative: Initial report received from a patient on 15 March 2007. A 73 year old, female patient complained of "pressure on chest" and "feeling indigestion", approximately 6 hours (1010 PM) after she received Fluzone (lot number, site and date of administration unknown) intramuscularly in November 2006 at 4PM. The symptoms lasted approximately 2 hours then subsided. She had never experienced this prior to or after this event. She received Fluzone 2 years prior. At the time of the vaccination, she denied any illness and was taking Natalol. She was not treated with any medications. It was reported that she recovered. Follow up information received from a consumer, the patient on 20 July 2007: The patient had her first flu shot (an unspecified manufacturer) on November 2004, given on the side of the arm. The next day she experienced severe injection site swelling about 3" x 3". In the middle of November 2006, she received another flu shot (Fluzone), approximately at 16:00 hours. At about 22:00 hours she started shivering, felt cool with no fever. Then experienced slight pressure on the chest and feeling of indigestion. She was able to breathe normally. The patient never felt like this before. It subsided after 2 hours, she fell asleep and woke up fine the next morning. The patient was taking Nadolol (previously reported as Natalol) as concomitant medication.
Age: 41.0
Sex: M
Vaccine: FLU3, IPV, MEN, TD
Symptoms: Dark circles under eyes, Drug hypersensitivity, Eye swelling
Clinical narrative: A 41-year-old male patient had received an injection of Decavac, lot number not reported; an injection of IPOL, lot number not reported; an injection of Menommune, lot number not reported; an injection of Typhim VI, lot number not reported; an injection of Fluzone SV 2006-2007, lot number not reported; and an injection of Hepatitis A Vaccine, manufacturer GSK, lot number not reported; on 20 December 2006. Routes and site of administration were not reported. The patient had received the vaccinations for travel to foreign country where he visited for two weeks. Illness at the time of vaccination was unknown. "Almost immediately" post-vaccination, the patient complained of dark circles under his eyes, bags under his eyes, and a permanent tired line in his face. Per a letter from the patient dated 13 Augusut 2007, "These side effects have not improved or diminished to date." At the time of this report, the patient had not recovered. A new version was created for this case on 31 August 2007 to add that the reporter for this case is the same as for case 2007-03017. No relevant medically significant information was added.
Sex: F
Vaccine: FLU3, IPV, MEN, TD
Symptoms: Alopecia, Dark circles under eyes, Eye swelling, Skin wrinkling
Clinical narrative: This case was reported by a health professional on 04 September 2007.  A female patient with no reported medical history received injections of Decavac, Fluzone, IPOL, Menomune, Typhim Vi, and hepatitis A (manufacturers and lot numbers not reported) on 20 December 2006.  "Almost immediately", the patient reported that she experienced "dark circles under my eyes, bags under my eyes, a permanent tired line on my face, and hair loss".  Per the reporter, the events were ongoing.  The patient's husband also reported experiencing dark circles under eyes, bags under eyes, and a permanent tired line in the face after receiving the above vaccines; this information is captured in case number 2007-02806.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody negative, Blood creatine phosphokinase normal, Blood test, Borrelia burgdorferi serology negative, Hypokinesia
Clinical narrative: A 74 year old, female patient complained of generalized stiffness and body aches, beginning 1 1/2 days after she received an injection of Fluzone (lot number U2212AA), intramuscularly in the deltoid (side not reported) on 21 November 2006. She had a dose of Fluzone in 2005, she did not have any illness at the time of vaccination and she was not on any medications. She saw a rheumatologist on 31 January 2007, with signs and symptoms with 75% improvement but still trouble lifting arms and getting out of the chair. She returned to the family practice on 16 February 2007 and her sedimentation rate was still elevated. The stiffness and aches still persist, mainly in the hands. Her laboratory results were still elevated. The stiffness and aches still persist, mainly in the hands. Her laboratory results were the following: sedimentation rates on 31 January 2007- 24, on 16 February 2007-26. On 31 January 2007: negative for Lyme; negative for ANA negative for Rheumatoid factor; normal CK. Follow-up information received on 21 May 2007 from a health care profession. Per the reporter, it is confirmed that the patient received the Fluzone injection on 21 November 2006 intramuscularly in the deltoid, but the exact site in the deltoid was "unknown." Exact duration of the event was not provided. Reportedly, the subject had pain in her arm when she received a Fluzone vaccination in 2005. No other medical information was provided for that adverse event. No further information is expected.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity, Red blood cell sedimentation rate increased, Rheumatoid factor negative
Clinical narrative: A 74 year old, female patient complained of generalized stiffness and body aches, beginning 1 1/2 days after she received an injection of Fluzone (lot number U2212AA), intramuscularly in the deltoid (side not reported) on 21 November 2006. She had a dose of Fluzone in 2005, she did not have any illness at the time of vaccination and she was not on any medications. She saw a rheumatologist on 31 January 2007, with signs and symptoms with 75% improvement but still trouble lifting arms and getting out of the chair. She returned to the family practice on 16 February 2007 and her sedimentation rate was still elevated. The stiffness and aches still persist, mainly in the hands. Her laboratory results were still elevated. The stiffness and aches still persist, mainly in the hands. Her laboratory results were the following: sedimentation rates on 31 January 2007- 24, on 16 February 2007-26. On 31 January 2007: negative for Lyme; negative for ANA negative for Rheumatoid factor; normal CK. Follow-up information received on 21 May 2007 from a health care profession. Per the reporter, it is confirmed that the patient received the Fluzone injection on 21 November 2006 intramuscularly in the deltoid, but the exact site in the deltoid was "unknown." Exact duration of the event was not provided. Reportedly, the subject had pain in her arm when she received a Fluzone vaccination in 2005. No other medical information was provided for that adverse event. No further information is expected.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Mass, Urticaria
Clinical narrative: Initial report received on 21 March 2007 from a healthcare professional.  A 54 year old female patent received on 11 October 2006 a dose of Fluzone (lot #U2177AA) and developed generalized hives and raised lump on elbow.  Treated with Benadryl and Tagament.  The event resolved and the patient recovered.  No other vaccines were given concomitantly.  At the time of vaccination the patient had vertigo.  The patient's medical history included multiple environmental life threatening allergies and asthma.  Concomitant medications included ASA, fish oil, sprionolactone, terbutaline prn, Benadryl prn, Singulair, Combavent, and Advair.  The reporter is the same as in case 2007-00863.
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial report received from a health care professional on 17 April 2007.  A male patient (date of birth, age not specified) complained of pain and soreness in the limb where he was vaccinated with Fluzone (lot number, route, site and date of administration not reported).  The symptoms have lasted "almost a year".  The patient's recovery status was unknown.
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial report received from a pharmacist on 13 December 2006. A female patient (age not reported) experienced sharp, stabbing pain at the injection site after she received Fluzone (lot number, route and site of administration unknown) on 28 November 2006. It was reported that she 'can't lift her arm" and she had the pain since vaccination. The patient's recovery status was not reported.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Local swelling
Clinical narrative: Initial report received from a nurse on 14 December 2006. A 55 year old, female patient (with a history of allergy to PCN) developed a large 'budge" in her neck - left side clavicle bone and her shoulder was large, red and warm at the injection site, the next morning after she received Fluzone (lot number U2550AA) intramuscularly in the left deltoid on 12 December 2006. She was seen by a physician - Advil and heat were prescribed. She did not have any illness at the time of vaccination. At the time of the report, she was not recovered. Follow-up information received on 22 January 2007 from a health care professional. The patient was seen by a physician on 13 December 2006 with a chief complaint of swelling on the left side of the neck anteriorly, just under the clavicle near the left shoulder. The patient stated that she noticed the swelling that morning. She could palpate it, and it was not associated with any injury or pain. At the time of examination the swelling was noted to have extended somewhat below the clavicle near the shoulder. She had no fever, shortness of breath, wheezing, chills or rashes. She had no chest or abdominal pain. She had some general aches and pains, but no specific left-sided pain. Upon examination, the area of swelling was noted to be just lateral to the sternocleidomastoid muscle and just in front of the trapezius muscle. The swelling measured 8 x 7 cm just inferior to the clavicle. There was an area of swelling measuring 8 x 6 cm just inferior to the clavicle and laterally near the shoulder. There was no redness or warmth to either of the involved areas. No tenderness was noted. At the injection site there was some swelling and warmth. The area of swelling measured 2.5 x 3 cm. There was no lymphatic streaking or axillary lymph node involvement noted. There were no neck masses or lymph nodes noted. There was no thyromegaly. The patient was advised to use Aleve and apply ice to the involved areas. No laboratory tests or diagnostics were performed. The events lasted for one week. The patient has recovered from the events. Additional information is not anticipated.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Initial report received from a health care professional on 26 December 2006. A 71 year old, male patient (who was taking chemotherapy) experienced aching of his left upper arm, about 2 hours after he received Fluzone (lot number U2245AA) intramuscularly, in the left arm on 22 December 2006. There was no redness or bruising noted. 24 hours post injection, the patient noticed swelling in the left arm extending from the left upper arm through left forearm. There was slight residual edema noticed in the left arm on 26 December 2006. No redness was noticed. The patient no longer has pain in the arm. He did not have any illness at the time of vaccination. Follow-up information received on 08 March 2007 from a health care professional. The case was reviewed, there is no additional information to add. No further information is expected.
Age: 6.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Eye movement disorder
Clinical narrative: Initial report received from a pharmacist on 28 December 2006. A 6 year old, male patient, developed "eye tics" approximately 2 weeks post vaccination with Fluzone (U2180AA, route of administration not reported) in the right thigh on 10 October 2006. It was not known if the patient had any illness at the time of vaccination. At the time of the report, it was unknown if the patient recovered. No other information was available at the time of the report. Follow-up information received on 30 April 2007. The patient did not have any illness at the time of the vaccinations. It was reported the patient received a hepatitis injection (not specified) 2 weeks after the flu vaccine.
Sex: U
Vaccine: FLU3
Symptoms: Injection site discolouration
Clinical narrative: Initial report received from a physician on 26 January 2007. A patient (age and gender not reported) experienced a black dot after receiving Fluzone (lot number unknown, site, route and date of administration not reported). The patient's black dot persisted over a month. Additional information was not provided.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received on 16 October 2006 from a health care professional. A 51-year-old female patient had received an intramuscular, left deltoid injection of Fluzone, lot number U2194AA, on 12 October 2006. Two days later, the patient experienced swelling, redness, itching, and warmth to touch at the injection site. The event did not require medical examination. At the time of this report, the patient had not recovered.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Initial report received on 17 October 2006 from a health care professional. A 34-year-old female patient had received an intramuscular injection of Fluzone SV 2006-2007, lot number U2239AA, on 17 October 2006. The patient had no illness at the time of vaccination. Within one hour following vaccination, the patient complained of difficulty breathing and chest tightness. Vital signs were "within normal limits." Oxygen saturation was 100%. The patient had no visible symptoms, no hives and no stridor. She was treated with Benadryl. The reporter indicated that the event did not require any emergency room or doctor visit. Recovery status was unknown. Follow-up information received on 05 March 2007 from a health care professional. It was unknown whether the patient had any diagnostic testing performed. The reporter noted "questionable anxiety."
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: Three patients with no current illnesses, had received a left deltoid, intra-muscular injection of FLUZONE SV '2006-2007 USP, lot number U2193AA, on 16 October 2006 at 16:00 pm. The next day, they experienced a metallic taste in their mouths. Past medical history and use of other medications were not provided for any the the patients. Diagnostics and treatments received were not reported. The recovery status of patients is unknown. Follow-up information received on 06 March 2007. One (I) female patient, 41 years of age was identified. She did not have any illness at the time of vaccination and was not on any medications. She did not have any other vaccinations within 4 weeks of receiving Fluzone.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Initial report received on 18 October 2006 from a health care professional.  A 54-year-old female patient, with no current illnesses, had received a right arm dose of FLUZONE SV '2006-'2007 USP, lot number U2197AA, on 16 October 2006.  The reporter was not sure if the injection was administered intra-muscular or subcutaneous.  Approximately one day later, the patient developed a reddened area at the injection site that was about two inches in diameter and tender.  The patient was treated by a physician and diagnosed with mild cellulitis.  Diagnostics and treatments received were not reported.  The patient's recovery status is unknown.
Sex: U
Vaccine: FLU3
Symptoms: Oral herpes
Clinical narrative: Initial report received on 19 October 2006 from a health care provider.  A patient (age and gender not reported) had received an injection of Fluzone SV, lot number not reported, on an unspecified date.  At an unknown time post-vaccination, the patient developed fever blisters.  Additional information was not provided.  Recovery status was unknown.
Sex: U
Vaccine: FLU3
Symptoms: Injection site discolouration
Clinical narrative: Initial report received on 19 October 2006 from a health care professional.  Approximately five to six patient had received a deltoid injection of Fluzone SV 2006-2007, lot number U2193AA, on 18 October 2006.  Immediately post-immunization, a black dot appeared at the injection site.  The administration products used included a 3ml, BD syringe (#309585) with a 23 gauge, one inch needle (#305902).  Per the reporter, following their own testing, the silicone on the needle was suspected as the cause.  Outcome for these patients was reported as unknown.  Follow-up information received on 21 November 2006.  The patients (no individual patient identification provided) did not have any illness at the time of vaccination.  The vaccine was purchased with private funds.  Follow-up information received on 11 December 2006 from a health care professional.  The case was reviewed, and there was no additional information at this time.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: Pain localized injection site reaction
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Fatigue, Gait disturbance, Malaise, Muscle spasms
Clinical narrative: Initial report received on 24 October 2006 from the patient who is also a health care professional.  A 56-year-old female patient, with a past medical history of asthma, had received an intramuscular, left deltoid injection of Fluzone SV 2006-2007, lot number U2240AA, on 05 October 2006.  Six hours later, she developed a fever of 101 degrees Fahrenheit, body aches, and malaise.  Over the next two days, her temperature was 99 degrees Fahrenheit, and she continued to have body aches.  Four days post-vaccination, she experienced severe shoulder spasms which was treated with Motrin.  On 11 October 2006, the patient had severe muscle aches, muscle weakness in her back and sacrum, and difficulty walking due to muscle aches.  She was examined by her physician and treated with Motrin, and muscle relaxers x three days.  The patient was home from work due to fatigue from 06 October 2006 to 21 October 2006.  On 21 October 2006 and 22 October 2006, her toes and fingers were tingling.  As of 24 October 2006, the patient continued to have fatigue and muscle weakness in her back.  At the time of this report, the patient had not recovered.  Follow-up information received on 09 March 2007 from the patient who is also a health care professional.  The patient had no illness at the time of vaccination.  No diagnostic testing was performed.  The patient "has returned to work".  Recovery took several weeks.  Per the reporter, she is now recovered.