chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pain in extremity
Clinical narrative: Pain & swelling & heat to site Right deltoid. Awoke next morning with pain under arm & down arm to hand. Increased temp to 101.1. Saw MD that afternoon was started on Keflex. Temp reached 101.8 & were managed with alternating doses of motrin and tylenol on every 2 hr schedule.  She experienced light headedness & nausea feeling "out of sorts." Increased temps persisted for 3 days following shot. work loss was 3-1/2 days.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: DTAP ADMINISTERED ON 9/15/08 IN PATIENT'S LEFT THIGH DURING ANNUAL CHILD PHYSICAL. PATIENT CAME BACK TO THE OFFICE ON 9/18/08 WITH AN 8cm SWOLLEN RED SPOT AT INJECTION SITE.  PT REPORTS THAT IT WAS SOAR AND ITCHY.  GRANDFATHER OF PT REPORTS THE AREA BECAME RED AND SWOLLEN ON 9/17/08.  PT GIVEN WESTCORT CREAM FOR ITCH RELIEF.  REPORT OF VACCINE INCIDENT GIVEN TO VACCINE REP FROM GLAXO SMITH KLINE ON 9/18/08.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Crying, Emotional distress, Sleep disorder
Clinical narrative: Mom stated cryin "non stop" (started 18 hrs. after vaccinations) and cont. all day and not napping well (lasting about 32 hrs now).  Once done feeding would go right back to crying. Inconsolable otherwise.  no fever. No reaction to 2mo. shots. NKDA.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Abnormal behaviour, Blood test normal, Crying, Delusion, Depression
Clinical narrative: Pt had Gardasil and Fluzone vaccines on 9/15/08. 9/22/08 presented to the office crying with delusions about family members with lethal disease. Pt sent to Hospital to the ER for Neuro consult.  EEG and labwork negative. 3 admits to Hospital and neuro work up. Inconclusive and unknown etiology. 11/14/08-records received for DOS 9/22-9/24/08-DC DX: Major deprssive disorder with psychotic features. Admitted due to changes in behavior and altered  mental status. Increased irritability, staring with right sided twitching.   Follow-up: Continues with psychiatric problems.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Full blood count normal, Laboratory test normal, Neurological examination, Nuclear magnetic resonance imaging normal, Urine analysis normal
Clinical narrative: Pt had Gardasil and Fluzone vaccines on 9/15/08. 9/22/08 presented to the office crying with delusions about family members with lethal disease. Pt sent to Hospital to the ER for Neuro consult.  EEG and labwork negative. 3 admits to Hospital and neuro work up. Inconclusive and unknown etiology. 11/14/08-records received for DOS 9/22-9/24/08-DC DX: Major deprssive disorder with psychotic features. Admitted due to changes in behavior and altered  mental status. Increased irritability, staring with right sided twitching.   Follow-up: Continues with psychiatric problems.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Hypotension, Musculoskeletal stiffness, Syncope, Tremor
Clinical narrative: immunization given, waited 10 min. left clinic,then fainted in car, was stiff and shaky. ambulance was called, transported to er via ambulance.  was diagnosed with low blood pressure, had ct scan done at er
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 10/7 IMMEDIATE REDNESS AT SITE, 10/9 SWELLING REDNESS AND WARMTH, 10/10 WENT TO CLINIC LESION MEASURED AT 10 INCHES, GIVEN METHYLPREDNISOLONE PACK 10/12 SWELLING REACHED ELBOW, 10/14 SWELLING SUBSIDED.
Age: 11.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Dyspnoea, Lip swelling, Swollen tongue
Clinical narrative: patient received flu shot and boostrix vaccines. He came back to office about 30 minutes after leaving. His lips were swelling up and his tongue was swelling up. He was having some difficulty breathing.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: swollen, firm, warm to touch indurated area on triceps area of L arm ~ 2.5 inches X 2.5 inches
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Cough, Crying, Cyanosis, Dysphonia, Febrile convulsion
Clinical narrative: Following the vaccinations patient had a hoarse sounding cry.  On the evening of March 28, 2007 he was crying.  He coughed, then stopped breathing for 30-60 seconds.  It was long enough for him to turn blue, call 911 and let it ring and ring.  After flipping him over from back to belly to back again he began to take shallow breathes which turned into regular breathing patterns.  Since 911 did not answer we called his primary physicians office.  His primary physician felt we should just watch him as long as we were comfortable doing that.  It is unknown whether he had a seizure or not.  There was no fever present.  He has suffered 2 febrile seizures since that event in July and October of 2008.  Since we are not sure if the febrile seizures are caused from this event we do not know how to answer the question of whether he has fully recovered. We have stated yes, but that is arguable. 11/15/08-records received for DOS 4/19/07-apnea, etiology unknown, possibly choking due to relfux.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Hypoventilation, Respiratory arrest
Clinical narrative: Following the vaccinations patient had a hoarse sounding cry.  On the evening of March 28, 2007 he was crying.  He coughed, then stopped breathing for 30-60 seconds.  It was long enough for him to turn blue, call 911 and let it ring and ring.  After flipping him over from back to belly to back again he began to take shallow breathes which turned into regular breathing patterns.  Since 911 did not answer we called his primary physicians office.  His primary physician felt we should just watch him as long as we were comfortable doing that.  It is unknown whether he had a seizure or not.  There was no fever present.  He has suffered 2 febrile seizures since that event in July and October of 2008.  Since we are not sure if the febrile seizures are caused from this event we do not know how to answer the question of whether he has fully recovered. We have stated yes, but that is arguable. 11/15/08-records received for DOS 4/19/07-apnea, etiology unknown, possibly choking due to relfux.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: right deltoid: moderately erythematous almost down to the elbow and almost up to the shoulder
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Body temperature increased, Cold sweat, Cough, Dizziness
Clinical narrative: Received vaccine at Noon 10/21/08.  Within 2 hours, I was coughing, wheezing, short of breath, fatigued.  Severe headache and back ache set in.  At 6:30 pm, temperature was 99.6.  One Advil was taken.  At 7:30 pm, temp was 101.  At 8:00 pm, temp was 102.6 and I was getting dizzy.  I drove to local ER.  Pulse ox was low, pulse and BP high.  Full bloodwork was taken, urine, nebulizer for wheezing.  Discharged 3 hours later with diagnosis of severe reaction to flu vaccine.  Today, I still have low temp, malaise, myalgia, clammy.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Headache, Heart rate increased, Hypertension
Clinical narrative: Received vaccine at Noon 10/21/08.  Within 2 hours, I was coughing, wheezing, short of breath, fatigued.  Severe headache and back ache set in.  At 6:30 pm, temperature was 99.6.  One Advil was taken.  At 7:30 pm, temp was 101.  At 8:00 pm, temp was 102.6 and I was getting dizzy.  I drove to local ER.  Pulse ox was low, pulse and BP high.  Full bloodwork was taken, urine, nebulizer for wheezing.  Discharged 3 hours later with diagnosis of severe reaction to flu vaccine.  Today, I still have low temp, malaise, myalgia, clammy.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Immunisation reaction, Laboratory test normal, Malaise, Myalgia, Oxygen saturation decreased
Clinical narrative: Received vaccine at Noon 10/21/08.  Within 2 hours, I was coughing, wheezing, short of breath, fatigued.  Severe headache and back ache set in.  At 6:30 pm, temperature was 99.6.  One Advil was taken.  At 7:30 pm, temp was 101.  At 8:00 pm, temp was 102.6 and I was getting dizzy.  I drove to local ER.  Pulse ox was low, pulse and BP high.  Full bloodwork was taken, urine, nebulizer for wheezing.  Discharged 3 hours later with diagnosis of severe reaction to flu vaccine.  Today, I still have low temp, malaise, myalgia, clammy.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing, White blood cell count increased
Clinical narrative: Received vaccine at Noon 10/21/08.  Within 2 hours, I was coughing, wheezing, short of breath, fatigued.  Severe headache and back ache set in.  At 6:30 pm, temperature was 99.6.  One Advil was taken.  At 7:30 pm, temp was 101.  At 8:00 pm, temp was 102.6 and I was getting dizzy.  I drove to local ER.  Pulse ox was low, pulse and BP high.  Full bloodwork was taken, urine, nebulizer for wheezing.  Discharged 3 hours later with diagnosis of severe reaction to flu vaccine.  Today, I still have low temp, malaise, myalgia, clammy.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Injection site pain, Oedema peripheral, Oropharyngeal pain, Pain
Clinical narrative: I took the shot yesterday morning at 10:30 a.m.  At mid-morning, my chest began to feel very congested. I began to run fever. My left arm, where I was injected, began to hurt. Through the day my symptoms began to deteriorate. I began to hurt all over my body especially my left arm and surrounding areas. My throat is sore, coughing and sneezing. ONE INCH BELOW THE INJECTION IS A HORRIBLE RED PRICKLY RASH! IT IS VERY SWOLLEN AND VERY HOT!  I will be contacting my doctor tomorrow!  I have only taken the flu shot once before.  I became sick but nothing like this.  WAS THIS A BAD BATCH OF VACCINE?
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Pyrexia, Rash erythematous, Respiratory tract congestion, Skin warm
Clinical narrative: I took the shot yesterday morning at 10:30 a.m.  At mid-morning, my chest began to feel very congested. I began to run fever. My left arm, where I was injected, began to hurt. Through the day my symptoms began to deteriorate. I began to hurt all over my body especially my left arm and surrounding areas. My throat is sore, coughing and sneezing. ONE INCH BELOW THE INJECTION IS A HORRIBLE RED PRICKLY RASH! IT IS VERY SWOLLEN AND VERY HOT!  I will be contacting my doctor tomorrow!  I have only taken the flu shot once before.  I became sick but nothing like this.  WAS THIS A BAD BATCH OF VACCINE?
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Sneezing
Clinical narrative: I took the shot yesterday morning at 10:30 a.m.  At mid-morning, my chest began to feel very congested. I began to run fever. My left arm, where I was injected, began to hurt. Through the day my symptoms began to deteriorate. I began to hurt all over my body especially my left arm and surrounding areas. My throat is sore, coughing and sneezing. ONE INCH BELOW THE INJECTION IS A HORRIBLE RED PRICKLY RASH! IT IS VERY SWOLLEN AND VERY HOT!  I will be contacting my doctor tomorrow!  I have only taken the flu shot once before.  I became sick but nothing like this.  WAS THIS A BAD BATCH OF VACCINE?
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Migraine
Clinical narrative: Frequent Migraines
Age: 61.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Cough, Headache, Injection site erythema, Injection site swelling
Clinical narrative: 8 hours after the flu shot I developed chills, high fever, body aches, headaches, and a cough. At the site of the injection is a 3 inch band of redness that is swollen and hot to the touch. The pain runs from my collarbone and wraps around my left armpit. Today, being the third day, my fever is just below a hundred. The highest was 103. My home treatment has been ibuprofen every 4 hours and cough syrup. Over the years I have had many flu shots and this is the first bad reaction I have experienced. I would like to know if this is common for this years influenza vaccine. My doctor says no one in her practice has complained of symptoms like mine.
Age: 61.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site warmth, No reaction on previous exposure to drug, Pain, Pain in extremity, Pyrexia
Clinical narrative: 8 hours after the flu shot I developed chills, high fever, body aches, headaches, and a cough. At the site of the injection is a 3 inch band of redness that is swollen and hot to the touch. The pain runs from my collarbone and wraps around my left armpit. Today, being the third day, my fever is just below a hundred. The highest was 103. My home treatment has been ibuprofen every 4 hours and cough syrup. Over the years I have had many flu shots and this is the first bad reaction I have experienced. I would like to know if this is common for this years influenza vaccine. My doctor says no one in her practice has complained of symptoms like mine.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling hot, Oedema peripheral, Pruritus
Clinical narrative: Mild reaction on left arm swollen, not to the touch and is also itchy, advise to give BENADRYL two tsp every 4 hrs and also to apply cold compress.
Age: 32.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug exposure during pregnancy
Clinical narrative: Received MMR and VZV on 9/9/08. Client called 10/22/08 = she is pregnant. Last period 9/15/08 - she was alert by nurse to not pregnant x 1 months - call @ PC.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site pruritus, Rash
Clinical narrative: Pt brought by caregiver for acute onset rash Lt shoulder. Received DTaP at that site 10/07/08. Pt c/o itching immunization site. Skin exam notable for pmt to slight erythematous patch approx. 1.5" diameter left should, non-tender, no signs of bacterial super-infection.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria, Malaise, Nausea, Pallor
Clinical narrative: Reported to Dr immediately. Within 10 min of administration, when ready to leave office pt. told mom didn't feel well. Was pale in face, color around eyes - returned to Rm. checked injection sites - 2 hives noted in Rt leg @ MMR site, torso turning red. Over next 30 min entire body hives. Did BENADRYL 2 tsp. Waited 45 min with help ORAPRED given - within 20 min could see hives reside - watched for another. Hour: condition improved - Dr. discharged to home and mom instructed to "go to ER if problems re-occur. Called pt - next day, no further hives. Also note @ time nauseated but no vomiting. Redness noted around 3 out of 4 injection sites - not around KINRIX.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Reported to Dr immediately. Within 10 min of administration, when ready to leave office pt. told mom didn't feel well. Was pale in face, color around eyes - returned to Rm. checked injection sites - 2 hives noted in Rt leg @ MMR site, torso turning red. Over next 30 min entire body hives. Did BENADRYL 2 tsp. Waited 45 min with help ORAPRED given - within 20 min could see hives reside - watched for another. Hour: condition improved - Dr. discharged to home and mom instructed to "go to ER if problems re-occur. Called pt - next day, no further hives. Also note @ time nauseated but no vomiting. Redness noted around 3 out of 4 injection sites - not around KINRIX.
Age: 1.32
Sex: F
Vaccine: DTAP, FLU3, HIBV
Symptoms: Rash, Urticaria
Clinical narrative: Patient got shot (first ever) on 10/15/08 and next day broke out in hives. Face first, then whole body. Examined on 10/20/08, still has rash --> given Prelone, Zyrtec.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site pain, Joint range of motion decreased, Neck pain, Pain
Clinical narrative: Soreness at injection site for 10+ days with some limitation in movement of shoulder. Now has full range of motion (10 days later) but mild persistent pain. Also experienced some soreness right side of neck and 'feeling run down'- these have now elated.
Age: 23.0
Sex: F
Vaccine: ANTH, FLUN3, SMALL
Symptoms: Injection site rash, Rash, Rash pustular
Clinical narrative: SM noted pustular rash that started around her inoculation site and has since spread to other arm, legs and back.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Erythema, Joint swelling, Local reaction, Musculoskeletal pain
Clinical narrative: Local reaction, swelling redness pain on (L) shoulder, posterolateral, site of subcut. Varicella inoculation 2 1/2 inch diameter.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Cough, Fatigue, Feeling hot, Oropharyngeal pain, Pain
Clinical narrative: He felt hot, he hurts all over, slight cough sore throat and tired all the time.
Age: 1.82
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Methicillin-resistant staphylococcal aureus test positive
Clinical narrative: Redness heat and swelling at injection site, afebrile. Ultrasound - induration but no abscess trimethroprim and Sulfamethoxole.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose increased, Chest X-ray normal, Chest discomfort, Dyspnoea, Fibrin D dimer normal
Clinical narrative: Chest tightness, short of breath, fever
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Chest tightness, short of breath, fever
Sex: U
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Atrophy
Clinical narrative: DTaP, Varicella given in left arm. HPV and Meningococcal given in rt. arm on 8-11-08. Presents on 10-22-08 with atrophy of left arm noticed very recently.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Pruritus, Skin test
Clinical narrative: Per patient started itching everywhere and redness at site approx. Oct. 3rd and 4th. Sent to Allergist and received a Rx MEDROL dose pak.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Loss of consciousness, Pain
Clinical narrative: 4-6 hrs. after administration of vaccine, pt. states she had bodyaches, clammy feeling, felt light headed, denies "passing out".  Condition got worse, she was eventually taken to an urgent care on 10/19/08.  While in UC, she claims she passed out, she was then transported to an ER via 911. 10/23/08-records received with report-presented to ED 10/19/08 with C/O weakness, nausea, body ache, headache since day after flu shot. Crying.Observed in ED no fevers or chills. Depressed recently and now ready to go home.  DX: Headache resolved. Depression.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient called clinic 10/17/08 with complaint of area of redness about 4" long (L) arm 4" hardened/swollen area about size of two half dollars, after pneumococcal vaccine on 10/15/08, supportive care advice given, patient contacted on 10/20/08 and noted has complete resolution of symptoms.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness, Swelling, Warm to touch, achiness, Pt applied ice on Wednesday night- night of injection
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Cardiac failure, Cardiac pacemaker insertion, Cardiomegaly, Cytomegalovirus infection, Fatigue
Clinical narrative: (This info is from patient's father): Pt. had serious (probable) adenovirus infection in Sept. 0f 2000. Frequent fever and respiratory illness after that. Father of pt. believes this resulted in an enlarged heart and SOB. Then in May of 2004, pt had kidney infection. Received smallpox vaccine on 7/1/04. Discharged from the military in 9/2004. Was having severe fatigue, requiring over 12 hours of sleep per night. Then in Feb. of 2005, had swelling in feet. In May of 2005, had cardiomegaly. In Feb. of 2006, was vomiting blood and required a pacemaker. On 8/15/07, pt had heart transplant at Hospital. Transplanted heart was infected with CMV. Father of the patient believes that the heart failure is due to the combination of the adenovirus and the damage that it did to the patient's heart and then the smallpox vaccine. He wants the CDC and the FDA to be aware of the need to look at the relationship between the adenovirus and the smallpox vaccine.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Haematemesis, Heart transplant, Oedema peripheral, Somnolence
Clinical narrative: (This info is from patient's father): Pt. had serious (probable) adenovirus infection in Sept. 0f 2000. Frequent fever and respiratory illness after that. Father of pt. believes this resulted in an enlarged heart and SOB. Then in May of 2004, pt had kidney infection. Received smallpox vaccine on 7/1/04. Discharged from the military in 9/2004. Was having severe fatigue, requiring over 12 hours of sleep per night. Then in Feb. of 2005, had swelling in feet. In May of 2005, had cardiomegaly. In Feb. of 2006, was vomiting blood and required a pacemaker. On 8/15/07, pt had heart transplant at Hospital. Transplanted heart was infected with CMV. Father of the patient believes that the heart failure is due to the combination of the adenovirus and the damage that it did to the patient's heart and then the smallpox vaccine. He wants the CDC and the FDA to be aware of the need to look at the relationship between the adenovirus and the smallpox vaccine.
Age: 60.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Pain in extremity, Paraesthesia, Ultrasound scan
Clinical narrative: Initial non-serious case received from a health care professional on 29 August 2008 and 02 September 2008. A 60-year-old female patient had received two pre-exposure intramuscular left deltoid injections of IMOVAX RABIES vaccine (manufacturer reported as Chiron; lot number A0485) on 07 august 2008 and 14 August 2008. After the start of the series, the patient experienced symptoms of tingling in the left foot and leg, which progressed to pain. It was also reported that the patient experienced "aches and weakness" in legs with tingling, primarily in the left leg. The patient had an ultrasound and deep vein thrombosis was ruled out. The patient was re-evaluated on 29 August 2008; findings not reported. The physician was not sure if the events were vaccine related. It was indicated that no gluteal injections had been given. At the time of the report, patient outcome was unknown. Follow-up information was received 09 October 2008 from a health care professional. The reporter confirmed the patient had received a left deltoid injection of IMOVAX RABIES vaccine, lot number A0485, one dose each on 07 August 2008 and 14 August 2008. The symptoms of pain and tingling had been limited to the patient's left foot and left leg and corrective treatments were reported as unknown. The final diagnosis for the event was determined to be Sciatica. The patient subsequently received a third dose of IMOVAX RABIES vaccine, lot number A0485 on 04 September 2008 with no adverse events experienced and the patient was reported to have been recovered from the event. No additional information was provided at the time of the report. Due to this new information received, this case has been upgraded from non-serious to serious. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Muscular weakness, Pain, Pain in extremity, Paraesthesia, Sciatica
Clinical narrative: Initial non-serious case received from a health care professional on 29 August 2008 and 02 September 2008. A 60-year-old female patient had received two pre-exposure intramuscular left deltoid injections of IMOVAX RABIES vaccine (manufacturer reported as Chiron; lot number A0485) on 07 august 2008 and 14 August 2008. After the start of the series, the patient experienced symptoms of tingling in the left foot and leg, which progressed to pain. It was also reported that the patient experienced "aches and weakness" in legs with tingling, primarily in the left leg. The patient had an ultrasound and deep vein thrombosis was ruled out. The patient was re-evaluated on 29 August 2008; findings not reported. The physician was not sure if the events were vaccine related. It was indicated that no gluteal injections had been given. At the time of the report, patient outcome was unknown. Follow-up information was received 09 October 2008 from a health care professional. The reporter confirmed the patient had received a left deltoid injection of IMOVAX RABIES vaccine, lot number A0485, one dose each on 07 August 2008 and 14 August 2008. The symptoms of pain and tingling had been limited to the patient's left foot and left leg and corrective treatments were reported as unknown. The final diagnosis for the event was determined to be Sciatica. The patient subsequently received a third dose of IMOVAX RABIES vaccine, lot number A0485 on 04 September 2008 with no adverse events experienced and the patient was reported to have been recovered from the event. No additional information was provided at the time of the report. Due to this new information received, this case has been upgraded from non-serious to serious. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Ultrasound scan normal
Clinical narrative: Initial non-serious case received from a health care professional on 29 August 2008 and 02 September 2008. A 60-year-old female patient had received two pre-exposure intramuscular left deltoid injections of IMOVAX RABIES vaccine (manufacturer reported as Chiron; lot number A0485) on 07 august 2008 and 14 August 2008. After the start of the series, the patient experienced symptoms of tingling in the left foot and leg, which progressed to pain. It was also reported that the patient experienced "aches and weakness" in legs with tingling, primarily in the left leg. The patient had an ultrasound and deep vein thrombosis was ruled out. The patient was re-evaluated on 29 August 2008; findings not reported. The physician was not sure if the events were vaccine related. It was indicated that no gluteal injections had been given. At the time of the report, patient outcome was unknown. Follow-up information was received 09 October 2008 from a health care professional. The reporter confirmed the patient had received a left deltoid injection of IMOVAX RABIES vaccine, lot number A0485, one dose each on 07 August 2008 and 14 August 2008. The symptoms of pain and tingling had been limited to the patient's left foot and left leg and corrective treatments were reported as unknown. The final diagnosis for the event was determined to be Sciatica. The patient subsequently received a third dose of IMOVAX RABIES vaccine, lot number A0485 on 04 September 2008 with no adverse events experienced and the patient was reported to have been recovered from the event. No additional information was provided at the time of the report. Due to this new information received, this case has been upgraded from non-serious to serious. Documents held by sender: None.
Age: 4.7
Sex: M
Vaccine: MMR, MMR
Symptoms: Alopecia, Blood culture, Coeliac disease, Diarrhoea, Full blood count
Clinical narrative: 7 days after MMR patient developed 106 degrees temp vomiting, diarrhea, lympnodes in groin swollen, hair loss, thyroid problems.
Age: 4.7
Sex: M
Vaccine: MMR, MMR
Symptoms: Lymphadenopathy, Pyrexia, Thyroid disorder, Vomiting
Clinical narrative: 7 days after MMR patient developed 106 degrees temp vomiting, diarrhea, lympnodes in groin swollen, hair loss, thyroid problems.
Age: 4.7
Sex: M
Vaccine: MMR, MMR
Symptoms: Alopecia, Blood culture, Blood iron, Coeliac disease, Diarrhoea
Clinical narrative: 7 days after MMR patient developed 106 degrees temp vomiting, diarrhea, lympnodes in groin swollen, hair loss, thyroid problems.
Age: 4.7
Sex: M
Vaccine: MMR, MMR
Symptoms: Full blood count, Lymphadenopathy, Pyrexia, Thyroid disorder, Vomiting
Clinical narrative: 7 days after MMR patient developed 106 degrees temp vomiting, diarrhea, lympnodes in groin swollen, hair loss, thyroid problems.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Abasia, Asthenia, Cough, Headache, Lumbar puncture
Clinical narrative: Weakness in legs started Sept 29.  Weakness noted in upper and lower ext in office on 9/30.  Admitted to hospital 9/30.  Lower back pain.  No seizure.  Was transferred to inpatient rehabilitation 10/7.  Discharged from hosp 10/9 to have outpatient rehab.  He had pulmonary symptoms starting 9/10. Dxing with right middle lobe pneumonia 9/20.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Pneumonia, Vomiting
Clinical narrative: Weakness in legs started Sept 29.  Weakness noted in upper and lower ext in office on 9/30.  Admitted to hospital 9/30.  Lower back pain.  No seizure.  Was transferred to inpatient rehabilitation 10/7.  Discharged from hosp 10/9 to have outpatient rehab.  He had pulmonary symptoms starting 9/10. Dxing with right middle lobe pneumonia 9/20.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Back pain, Lobar pneumonia, Lung disorder, Muscular weakness
Clinical narrative: Weakness in legs started Sept 29.  Weakness noted in upper and lower ext in office on 9/30.  Admitted to hospital 9/30.  Lower back pain.  No seizure.  Was transferred to inpatient rehabilitation 10/7.  Discharged from hosp 10/9 to have outpatient rehab.  He had pulmonary symptoms starting 9/10. Dxing with right middle lobe pneumonia 9/20.
Age: 25.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Unevaluable event
Clinical narrative: Sudden onset of dizziness increased heart rate and blood pressure, sore an thick feeling in throat and slight shortness of breath after taking Flu vaccine onset of symptoms developed when returned to nursing unit.
Age: 25.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood pressure increased, Dizziness, Dyspnoea, Heart rate increased, Immediate post-injection reaction
Clinical narrative: Sudden onset of dizziness increased heart rate and blood pressure, sore an thick feeling in throat and slight shortness of breath after taking Flu vaccine onset of symptoms developed when returned to nursing unit.
Age: 25.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oropharyngeal pain, Pregnancy test, Throat tightness
Clinical narrative: Sudden onset of dizziness increased heart rate and blood pressure, sore an thick feeling in throat and slight shortness of breath after taking Flu vaccine onset of symptoms developed when returned to nursing unit.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Arthralgia, Body temperature increased, Chills, Headache
Clinical narrative: I received my flu shot at 0130 on Oct 21 from RN for employee health.  At 0615, I was having some muscle and joint aches. (I work the night shift)  About 1200 the pain was a 7.  I was having the chills and headache. At 1600, I had a time of 102.2 severe muscle and joint pain at pain scale of a 12 and at 2000 it has 102.8. at 1600 I took tylenol 1000 mg, and at 2000 I took tylenol 1500 mg.  On Oct 22, at 0400, I woke up was still achey but temp was 101.0 and at 0800 it was 99.1, I still felt achey and I still feel achey at 0300 on Oct 23.  I called in sick on Oct 21, I was to work 2400 to 0600.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Impaired work ability, Myalgia
Clinical narrative: I received my flu shot at 0130 on Oct 21 from RN for employee health.  At 0615, I was having some muscle and joint aches. (I work the night shift)  About 1200 the pain was a 7.  I was having the chills and headache. At 1600, I had a time of 102.2 severe muscle and joint pain at pain scale of a 12 and at 2000 it has 102.8. at 1600 I took tylenol 1000 mg, and at 2000 I took tylenol 1500 mg.  On Oct 22, at 0400, I woke up was still achey but temp was 101.0 and at 0800 it was 99.1, I still felt achey and I still feel achey at 0300 on Oct 23.  I called in sick on Oct 21, I was to work 2400 to 0600.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Electrocardiogram normal, Full blood count normal
Clinical narrative: Initial report was received 13 October 2008 from a consumer, who is also the patient.  A 37-year-old female patient with a medical history of irritable bowel syndrome, arthritis, and frequent urinary tract infections, had received an intramuscular left deltoid injection of FLUZONE, lot number U2741AA on 09 October 2008 and five hours post vaccination, the patient developed a fever, chills, aches, weakness, and her left arm was hurting and sore to touch.  The following day, 15 hours post vaccination, the patient complained of weakness, dizziness and "passed out cold".  The patient was evaluated by her physician (date not reported) and laboratory and diagnostic tests were performed (dates of testing not reported).  The patient had normal CBC, BMP, and EKG results, and an echocardiogram had been scheduled, but had not yet been performed.  Information pertaining to the patient's recovery status for fever, chills, aches, dizziness, passing out, and left arm hurting and sore was not provided, however the symptom of weakness continued.  At the time of the report, the patient had not recovered from the event.  Documents held by sender: None.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Metabolic function test normal, Pain, Pain in extremity, Pyrexia
Clinical narrative: Initial report was received 13 October 2008 from a consumer, who is also the patient.  A 37-year-old female patient with a medical history of irritable bowel syndrome, arthritis, and frequent urinary tract infections, had received an intramuscular left deltoid injection of FLUZONE, lot number U2741AA on 09 October 2008 and five hours post vaccination, the patient developed a fever, chills, aches, weakness, and her left arm was hurting and sore to touch.  The following day, 15 hours post vaccination, the patient complained of weakness, dizziness and "passed out cold".  The patient was evaluated by her physician (date not reported) and laboratory and diagnostic tests were performed (dates of testing not reported).  The patient had normal CBC, BMP, and EKG results, and an echocardiogram had been scheduled, but had not yet been performed.  Information pertaining to the patient's recovery status for fever, chills, aches, dizziness, passing out, and left arm hurting and sore was not provided, however the symptom of weakness continued.  At the time of the report, the patient had not recovered from the event.  Documents held by sender: None.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Cough, Dyspepsia, Dyspnoea
Clinical narrative: This serious case was received from a health professional on 16 October 2008.  A 48-year-old female patient received an intramuscular left deltoid injection of FLUZONE (lot number U2804AA) on 15 October 2008.  Medical history included hypothyroidism, seasonal allergies, and childhood allergies to chocolate, peanuts, Betadine, and feathers.  Concomitant medications included Zyrtec and Synthroid.  She was not ill at the time of vaccination, and had not experienced any adverse events following previous vaccinations.  Approximately three hours after vaccination, the patient developed heartburn, cough, chills, burning eyes, generalized achiness, feverish sensation, vaginal burning, nasal congestion, and post-nasal drip.  Approximately five hours after vaccination, she complained of difficulty breathing, chest tightness, shortness of breath, tongue swelling, itching, and that her "skin hurt".  She self-treated her symptoms with Benadryl, and then went to bed.  Upon awakening the next morning, she noted that her eyes were bloodshot, had drainage and were "stuck together".  She had not sought medical attention, and at the time of the report the outcome was unknown.  Documents held by sender: None.  The reporter in this case also reported an event for another patient (radiating tingling and numbness), captured in case number 2008-03234.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Eye irritation, Nasal congestion, Ocular hyperaemia, Pain
Clinical narrative: This serious case was received from a health professional on 16 October 2008.  A 48-year-old female patient received an intramuscular left deltoid injection of FLUZONE (lot number U2804AA) on 15 October 2008.  Medical history included hypothyroidism, seasonal allergies, and childhood allergies to chocolate, peanuts, Betadine, and feathers.  Concomitant medications included Zyrtec and Synthroid.  She was not ill at the time of vaccination, and had not experienced any adverse events following previous vaccinations.  Approximately three hours after vaccination, the patient developed heartburn, cough, chills, burning eyes, generalized achiness, feverish sensation, vaginal burning, nasal congestion, and post-nasal drip.  Approximately five hours after vaccination, she complained of difficulty breathing, chest tightness, shortness of breath, tongue swelling, itching, and that her "skin hurt".  She self-treated her symptoms with Benadryl, and then went to bed.  Upon awakening the next morning, she noted that her eyes were bloodshot, had drainage and were "stuck together".  She had not sought medical attention, and at the time of the report the outcome was unknown.  Documents held by sender: None.  The reporter in this case also reported an event for another patient (radiating tingling and numbness), captured in case number 2008-03234.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pain of skin, Postnasal drip, Pruritus, Pyrexia, Swollen tongue
Clinical narrative: This serious case was received from a health professional on 16 October 2008.  A 48-year-old female patient received an intramuscular left deltoid injection of FLUZONE (lot number U2804AA) on 15 October 2008.  Medical history included hypothyroidism, seasonal allergies, and childhood allergies to chocolate, peanuts, Betadine, and feathers.  Concomitant medications included Zyrtec and Synthroid.  She was not ill at the time of vaccination, and had not experienced any adverse events following previous vaccinations.  Approximately three hours after vaccination, the patient developed heartburn, cough, chills, burning eyes, generalized achiness, feverish sensation, vaginal burning, nasal congestion, and post-nasal drip.  Approximately five hours after vaccination, she complained of difficulty breathing, chest tightness, shortness of breath, tongue swelling, itching, and that her "skin hurt".  She self-treated her symptoms with Benadryl, and then went to bed.  Upon awakening the next morning, she noted that her eyes were bloodshot, had drainage and were "stuck together".  She had not sought medical attention, and at the time of the report the outcome was unknown.  Documents held by sender: None.  The reporter in this case also reported an event for another patient (radiating tingling and numbness), captured in case number 2008-03234.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Vulvovaginal burning sensation
Clinical narrative: This serious case was received from a health professional on 16 October 2008.  A 48-year-old female patient received an intramuscular left deltoid injection of FLUZONE (lot number U2804AA) on 15 October 2008.  Medical history included hypothyroidism, seasonal allergies, and childhood allergies to chocolate, peanuts, Betadine, and feathers.  Concomitant medications included Zyrtec and Synthroid.  She was not ill at the time of vaccination, and had not experienced any adverse events following previous vaccinations.  Approximately three hours after vaccination, the patient developed heartburn, cough, chills, burning eyes, generalized achiness, feverish sensation, vaginal burning, nasal congestion, and post-nasal drip.  Approximately five hours after vaccination, she complained of difficulty breathing, chest tightness, shortness of breath, tongue swelling, itching, and that her "skin hurt".  She self-treated her symptoms with Benadryl, and then went to bed.  Upon awakening the next morning, she noted that her eyes were bloodshot, had drainage and were "stuck together".  She had not sought medical attention, and at the time of the report the outcome was unknown.  Documents held by sender: None.  The reporter in this case also reported an event for another patient (radiating tingling and numbness), captured in case number 2008-03234.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Flushing, Hypoaesthesia, Hypoaesthesia facial, Immediate post-injection reaction
Clinical narrative: This serious case was received from a health professional on 16 October 2008.  A 29-year-old female patient, with a history of malignant hyperthermia, received an intramuscular right deltoid injection of FLUZONE (lot number U2804AA) on 26 September 2008.  Within five to eight minutes of vaccination, the patient began complaining of tingling in her lips and right-sided facial numbness.  Within 30 minutes of vaccination, she "felt very hot and could not cool down".  Within an hour of vaccination her face became flushed, and she complained of tingling and numbness in the right arm radiating to the neck, face, and mouth.  She was seen in the emergency room and treated with Benadryl.  The symptoms "gradually cleared", and the patient was discharged.  She denied any illness at the time of vaccination, and had not experienced any adverse events following previous vaccinations.  Concomitant medications included Tylenol and Aleve as needed.  The event was considered to be resolved.  Documents held by sender: None.  The reporter in this case also reported an event for another patient, captured in case number 2008-03233.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: This serious case was received from a health professional on 16 October 2008.  A 29-year-old female patient, with a history of malignant hyperthermia, received an intramuscular right deltoid injection of FLUZONE (lot number U2804AA) on 26 September 2008.  Within five to eight minutes of vaccination, the patient began complaining of tingling in her lips and right-sided facial numbness.  Within 30 minutes of vaccination, she "felt very hot and could not cool down".  Within an hour of vaccination her face became flushed, and she complained of tingling and numbness in the right arm radiating to the neck, face, and mouth.  She was seen in the emergency room and treated with Benadryl.  The symptoms "gradually cleared", and the patient was discharged.  She denied any illness at the time of vaccination, and had not experienced any adverse events following previous vaccinations.  Concomitant medications included Tylenol and Aleve as needed.  The event was considered to be resolved.  Documents held by sender: None.  The reporter in this case also reported an event for another patient, captured in case number 2008-03233.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site erythema, Injection site warmth
Clinical narrative: Initial report received from a health professional on 17 October 2008.  A 62-year-old female patient received a right deltoid intramuscular injection of FLUZONE SV 2008-2009 (lot number U2747AA) on 16 October 2008 (reported as 16 October 2007) and three hours later, she complained of injection site redness and "hotness".  The patient went to the emergency room later in the day due to shortness of breath.  She received Prednisone for the injection site redness and was released.  Outcome was reported as 'unknown'.  Documents held by sender: None.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia, Vomiting
Clinical narrative: Initial report received from a healthcare professional on 17 October 2008.  A 39-year-old female patient had received a left deltoid intramuscular injection of FLUZONE SV 2008-2009 (lot number U2745AA) on 15 October 2008 at 11:30 AM and that evening, she experienced fever (temperature unknown), chills, aches and vomiting.  The patient had a history of cough for one week prior to the vaccination.  She was hospitalized on 16 October 2008.  At the time of the report, outcome was 'not recovered' and the patient remained hospitalized.  No additional details were provided.  Documents held by sender: None.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Clinical narrative: Pt received 2nd ROTATEQ on 8/18/08 and was admitted and treated for intussusception on 8/27/08.  12/30/2008 Reviewed hospital medical records of 8/27-8/28/2008. FINAL DX: ileocolic intussusception, enema reduced Records reveal patient experienced decreased activity, reduced oral intake, emesis which became bilious, excessive sleepiness & fever.  Admitted overnight s/p enema reduction of IS.  Progressed well & tolerated diet w/o complication.  D/C to home.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth, Pain, Pruritus
Clinical narrative: Vaccine 10/13/08 4 pm.  10/13/08 9 pm pain, heat, itching at injection site.  10/14 AM swelling, pain, heat, itching.  ? cellulitis.  BENADRYL 50 mg and sent to ER.  Received I.V. vancomycin.  Admitted for 24 hours +.  Dc'd 10/18/08 on P.O antibiotics (KEFLEX) 10/20/08.  Denies S/S at this time. 11/17/08-records received 11/17/08-presented to ED with C/O fever and increased pain, decreased range of motion in right arm. Nausea and vomiting.  DX Right upper extremity cellulitis.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm, Swelling
Clinical narrative: Vaccine 10/13/08 4 pm.  10/13/08 9 pm pain, heat, itching at injection site.  10/14 AM swelling, pain, heat, itching.  ? cellulitis.  BENADRYL 50 mg and sent to ER.  Received I.V. vancomycin.  Admitted for 24 hours +.  Dc'd 10/18/08 on P.O antibiotics (KEFLEX) 10/20/08.  Denies S/S at this time. 11/17/08-records received 11/17/08-presented to ED with C/O fever and increased pain, decreased range of motion in right arm. Nausea and vomiting.  DX Right upper extremity cellulitis.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Syncope
Clinical narrative: Syncope (brief episode) after administration of ADACEL. Nausea, no vomiting. Good response to fluids and crackers.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Lethargy, Pyrexia, Somnolence
Clinical narrative: Sat 4 PM - fever 102 degrees - 103 degrees F (10-18-08). LAIV given to patient (10-17-08). Sleepy - lethargic (per Dad) not seen in clinic or triaged by clinic staff.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Conjunctival hyperaemia, Dyspnoea, Flushing, Headache
Clinical narrative: Fever (flushed/warm), headache, joint pain, muscle weakness, skin sensitivity to touch, lips and circumoral area numb feeling, and hard to breathing. Had to my inhaler 2x and next morning. Started 6 hrs after flu vaccine. Improved overnight but still using inhaler. Also had blood shot injected eyes which have improved.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperaesthesia, Hypoaesthesia oral, Muscular weakness, Pyrexia, Skin warm
Clinical narrative: Fever (flushed/warm), headache, joint pain, muscle weakness, skin sensitivity to touch, lips and circumoral area numb feeling, and hard to breathing. Had to my inhaler 2x and next morning. Started 6 hrs after flu vaccine. Improved overnight but still using inhaler. Also had blood shot injected eyes which have improved.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Headache, Injection site pruritus, Nausea
Clinical narrative: Pt c/o h/a, dizzy, nausea and itchy injection site (RD), laid in supine pt in exam room.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Auricular swelling, Erythema, Local swelling, Pruritus, Pyrexia
Clinical narrative: Received Tdap - 10/14/08 @ 2 pm - c/o (R) ear itching before she went home form school. 10/15/08 - (R) ear swollen/red - (L) ear swollen. Since Wed., has noticed area red, and swollen on (R) skin area, abdomen and currently has an edematous area on the back of her neck with red outline. Mother states she did run fever - area appear to disappear after several days. Currently no temperature.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Received Tdap - 10/14/08 @ 2 pm - c/o (R) ear itching before she went home form school. 10/15/08 - (R) ear swollen/red - (L) ear swollen. Since Wed., has noticed area red, and swollen on (R) skin area, abdomen and currently has an edematous area on the back of her neck with red outline. Mother states she did run fever - area appear to disappear after several days. Currently no temperature.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: The patients arm immediately swelled at the injection site. She reports no itching. It looks like the amount was not absorbed into muscle, but under skin. Gave cold compress.