chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HEPA, PNC, VARCEL
Symptoms: Multiple allergies, Rash
Clinical narrative: patient has multiple allergies.  She was  given vaccine and the next day developed skin rash.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: REDNESS, ERYTHEMA, AND SWELLING TO RIGHT THIGH. DIAGNOSED WITH ACUTE CELLULITIS RIGHT THIGH.  PATIENT TO START IBUPROFEN ON 10/24/2008 AND IF NO IMPROVEMENT BY SUNDAY(10/26/2008) START AUGMENTIN.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Diarrhoea, Fatigue, Hyperhidrosis
Clinical narrative: About six hours after the annual flu shot I woke up with severe chills, then sweats with diarrahea, and a momentary fainting, then worse chills. Felt like a bad case of the flu. Then, blessedly, a nice sleep. Whole thing lasted less than two hours. Tired, a little weak, but better the next day. No continuing reactions. Not sure which Sanofi Pasteur vaccine it was.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Syncope
Clinical narrative: About six hours after the annual flu shot I woke up with severe chills, then sweats with diarrahea, and a momentary fainting, then worse chills. Felt like a bad case of the flu. Then, blessedly, a nice sleep. Whole thing lasted less than two hours. Tired, a little weak, but better the next day. No continuing reactions. Not sure which Sanofi Pasteur vaccine it was.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and heat to right arm 3 days after vaccination.
Age: 22.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: HPV Vaccine - Incorrect interval between doses. Patient had stated this was second dose but this was the third dose.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Convulsion, Feeling hot, Postictal state
Clinical narrative: Recieved injection on morning of Aug. 7th and was given tylenol and ibuprofen alternating every 2 hours.  On Aug. 8th, mom was feeding child and felt he was really hot.  At 0925 he began to have a seizure for about 30 seconds.  Mom called clinic and brought him in.  No temp at that time.  Was post dictal.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Headache, Petechiae, Vomiting
Clinical narrative: 30 minutes following administration patient suffered vomiting.  Vomiting was severe and she had swelling of eyelids and peticheae surrounding eyes.  She also reported HA.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Amnesia, Asthenia, Blood glucose decreased, Blood test, Electrocardiogram
Clinical narrative: 4 hours after patient received vaccine she had symptoms of memory loss and weakness.  She went to ER where they could find no problems, only that her blood sugar was a little low.  The Dr there thought it was not related to vaccine and may be related to hypoglycemic episode.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Amnesia, Anxiety, Dizziness, Electrocardiogram, Full blood count
Clinical narrative: 4 hours after patient received vaccine she had symptoms of memory loss and weakness.  She went to ER where they could find no problems, only that her blood sugar was a little low.  The Dr there thought it was not related to vaccine and may be related to hypoglycemic episode.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Laboratory test, Paraesthesia, Paraesthesia oral
Clinical narrative: 4 hours after patient received vaccine she had symptoms of memory loss and weakness.  She went to ER where they could find no problems, only that her blood sugar was a little low.  The Dr there thought it was not related to vaccine and may be related to hypoglycemic episode.
Age: 44.0
Sex: F
Vaccine: DTAP, FLU3, HEP
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Employee was given 2 IM shots in Left deltoid flu shot & tdap vaccine. Employee came in on 10/24/2008 stating that 2days after the vaccine was given to her,she experienced nausea, headache & dizziness. She was then referred to Dr. for evaluation.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: PATIENT CALLED MORNING AFTER AND SHE BROKE OUT IN HIVES ON HER ABDOMEN AND WAS ITCHING.  NO OTHER SYMPTOMS REPORTED BY PATIENT.  PATIENT INSRUCTED TO TAKE BENADRYL OTC.
Age: 9.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: On 10/27/08, at another visit, the patient's mother reported that the varicella injection site had grown to approx. 10-12 cm. There was redness to the area and there was not any pain associated with this.  On 10-27-08 the physician noted that the swelling was remarkably smaller, approx. 1-2 cm, with minimal redness.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Vision blurred, Vomiting
Clinical narrative: Pass out and vomit, blurry vision
Age: 1.33
Sex: F
Vaccine: MEA
Symptoms: Complex partial seizures, Electroencephalogram normal, Epilepsy, Feeling abnormal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: 9-14-08 Mother noticed spacing out / staring spells. 9-15-08 episodes  observed in office per Dr. 9-18-08 Neurology consult,  Dx Epilepsy / complex partial vs absence seizures. Started Keppra 2 weeks later when episodes persisted. Medication changed to Trileptal on 10-11-08
Age: 1.33
Sex: F
Vaccine: MEA
Symptoms: Petit mal epilepsy, Staring
Clinical narrative: 9-14-08 Mother noticed spacing out / staring spells. 9-15-08 episodes  observed in office per Dr. 9-18-08 Neurology consult,  Dx Epilepsy / complex partial vs absence seizures. Started Keppra 2 weeks later when episodes persisted. Medication changed to Trileptal on 10-11-08
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Neuritis
Clinical narrative: Pt diagnosed with Neuritis. Pt complains of burning sensation on trunk of body. Symptoms started approx. 4 days after having flu immunization.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Influenza like illness, Lymphadenopathy, No reaction on previous exposure to drug, Pain
Clinical narrative: Pt had flu like symptoms the day following a combination of fluvirin and pneumovax given on Oct 21, 2008, both in the right arm.  Her flu like symptoms were aches/pains, fever, chills.  2 days following the vaccines, she presented to her MD with swollen lymph nodes on her right side that were both visible and swollen to touch according to the patient.  1 week after receiving the vaccines, she has no symptoms and is feeling back to normal.  Patient has had previous Flu vaccines in past.  This is her 1st pneumonia vaccine.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Pt had flu like symptoms the day following a combination of fluvirin and pneumovax given on Oct 21, 2008, both in the right arm.  Her flu like symptoms were aches/pains, fever, chills.  2 days following the vaccines, she presented to her MD with swollen lymph nodes on her right side that were both visible and swollen to touch according to the patient.  1 week after receiving the vaccines, she has no symptoms and is feeling back to normal.  Patient has had previous Flu vaccines in past.  This is her 1st pneumonia vaccine.
Age: 17.0
Sex: F
Vaccine: HEP, IPV, MMR, TD
Symptoms: Abdominal pain upper, Blood glucose increased, Heart rate irregular, Loss of consciousness, Muscle spasms
Clinical narrative: Approximately 3 months after immunizations, irregular heartbeat,pain down left arm with high salava being produced, blackouts, and severe stomach cramps began. This only accured about once a month. Didn't know what was going on and it didn't seem frequent enough to have checked out. These signs started to appear more often until 9 months later, an EEG was done by family doctor. Nothing was found, but signs continued. 1 year after the EEG, legs cramped up and was taken to emergency room where high sugar levels were found. Family doctor tried for 6 weeks to get sugar levels under control by oral meds. Was diagnosted as type 2 diabetic. By end of the 6 weeks, sugar levels were over 900 and was diagnosted as type 1 diabetic. Was told that the pancreas not producing insulin could have caused all of the signs above, which could have been caused by the immunizations given. No family history of diabetes on either side of family, and patient is not over weight. Is very active.  11/7/08 Reviewed hospital medical records of 11/27-11/30/2007. FINAL DX: no d/c summary dictated. Admitted for hyperglycemia & new onset type 1 diabetes. Records reveal patient experienced new onset DM approx 3 weeks prior when developed severe leg cramps while playing sports & seen in outlying ER w/very high blood sugar.  Unable to control BS at home on oral agent, ranging from 400-600mg/dl along w/blurry vision, HA, lethargy, weakness, nausea polyuria.  BS in current ER was 600, tx w/IVF & decreased only to 386, neg ketones.  Tx w/sliding scale insulin, oral agent d/c, additional IVF & meds.  Referred to Endocrine clinic & started on routine insulin.  11/14/08 Reviewed PCP medical records of 4/24/06-11/01/2007. FINAL DX: new type II DM Records reveal patient experienced facial poison ivy 4/06.  Seen in ER & treated w/steroid taper.  RTC 9/06 w/rapid heart beat, nausea, left arm numbness, dizziness.  EKG at that time revealed HR 58.  Referred for echocardiogram & Holter monitor.  RTC 10/2007 s/p ER visit for severe leg cramps while playing sport, polyuria, polydipsia.  BS in ER was 250 & tx w/insulin.  Started on oral agent & additional labs ordered.  RTC 11/2007 w/consistently high but improving  blood sugars.  Meds were adjusted.    11/18/08 Reviewed ER medical records of 10/17/2007. FINAL DX: leg cramps, hyperglycemia. Records reveal patient experienced leg cramps lasting approx 2 hours s/p physical activity.  Reported occ visual blurring, excessive thirstiness & excessive voiding.  Exam revealed anxiety, tachycardia, calf cramps.  Tx w/meds, improved & d/c to home to f/u w/PCP re diabetic control. 1/28/2010 Patient still has type 1 Diabetes-having to give insulin 5 times a day is having some kidney problems right now.
Age: 17.0
Sex: F
Vaccine: HEP, IPV, MMR, TD
Symptoms: Pain in extremity, Salivary hypersecretion, Type 1 diabetes mellitus, Type 2 diabetes mellitus
Clinical narrative: Approximately 3 months after immunizations, irregular heartbeat,pain down left arm with high salava being produced, blackouts, and severe stomach cramps began. This only accured about once a month. Didn't know what was going on and it didn't seem frequent enough to have checked out. These signs started to appear more often until 9 months later, an EEG was done by family doctor. Nothing was found, but signs continued. 1 year after the EEG, legs cramped up and was taken to emergency room where high sugar levels were found. Family doctor tried for 6 weeks to get sugar levels under control by oral meds. Was diagnosted as type 2 diabetic. By end of the 6 weeks, sugar levels were over 900 and was diagnosted as type 1 diabetic. Was told that the pancreas not producing insulin could have caused all of the signs above, which could have been caused by the immunizations given. No family history of diabetes on either side of family, and patient is not over weight. Is very active.  11/7/08 Reviewed hospital medical records of 11/27-11/30/2007. FINAL DX: no d/c summary dictated. Admitted for hyperglycemia & new onset type 1 diabetes. Records reveal patient experienced new onset DM approx 3 weeks prior when developed severe leg cramps while playing sports & seen in outlying ER w/very high blood sugar.  Unable to control BS at home on oral agent, ranging from 400-600mg/dl along w/blurry vision, HA, lethargy, weakness, nausea polyuria.  BS in current ER was 600, tx w/IVF & decreased only to 386, neg ketones.  Tx w/sliding scale insulin, oral agent d/c, additional IVF & meds.  Referred to Endocrine clinic & started on routine insulin.  11/14/08 Reviewed PCP medical records of 4/24/06-11/01/2007. FINAL DX: new type II DM Records reveal patient experienced facial poison ivy 4/06.  Seen in ER & treated w/steroid taper.  RTC 9/06 w/rapid heart beat, nausea, left arm numbness, dizziness.  EKG at that time revealed HR 58.  Referred for echocardiogram & Holter monitor.  RTC 10/2007 s/p ER visit for severe leg cramps while playing sport, polyuria, polydipsia.  BS in ER was 250 & tx w/insulin.  Started on oral agent & additional labs ordered.  RTC 11/2007 w/consistently high but improving  blood sugars.  Meds were adjusted.    11/18/08 Reviewed ER medical records of 10/17/2007. FINAL DX: leg cramps, hyperglycemia. Records reveal patient experienced leg cramps lasting approx 2 hours s/p physical activity.  Reported occ visual blurring, excessive thirstiness & excessive voiding.  Exam revealed anxiety, tachycardia, calf cramps.  Tx w/meds, improved & d/c to home to f/u w/PCP re diabetic control. 1/28/2010 Patient still has type 1 Diabetes-having to give insulin 5 times a day is having some kidney problems right now.
Age: 0.92
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Febrile convulsion, Grand mal convulsion, Irritability, Postictal state, Pyrexia
Clinical narrative: Fussiness and fever following, then 2 minute febrile seizure- generalized tonic clonic. Spontaneous recovery after postictal period with no complications
Age: 6.0
Sex: F
Vaccine: DTAPIPV, FLUN3, MMR
Symptoms: Urticaria, Wheezing
Clinical narrative: 10-27-08 telephone call from childs Mother.  She states on 10-20-08, child developed "hives" on his back and arms. No fever and no resp. distress at this time.  Child was seen by school nurse the next day.  RN (school nurse) reports hives were on back, stomach, arms, legs and neck.  Mom was notified and picked child up from school.  Mom took child to Emergency room immediately.  States child had "a little wheezing."  Benadryl administered by ER staff.  Mom told ER staff about previous vaccinations but states they were uncertain of what may have caused the hives. Benadryl was administered to child at E.R. Hives got better after 24 hours. Hives returned next day, child was taken back to E.R. and Benadryl administered again. Hives resolved as of 10-26-08.  Neither time the E.R. could determine cause of illness, per Mom.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Balance disorder, Blood pressure normal, Dizziness, Fall
Clinical narrative: Once patient got down from the exam bed, patient's equilibrium was completely off sending her straight into a door jamb.  She then fell to the ground of the clinic and passed out for a few seconds.  Became very pale and stayed extremely dizzy.  Blood pressure was good, but heart rate was only 58 beats per minute.  911 was called and the paramedics did a heart monitor test on her, which was normal.  Once the dizziness passed (about 30 minutes), she was able to walk on her own, but was weak, felt sick and had no energy for most of the rest of the day.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Malaise, Pallor
Clinical narrative: Once patient got down from the exam bed, patient's equilibrium was completely off sending her straight into a door jamb.  She then fell to the ground of the clinic and passed out for a few seconds.  Became very pale and stayed extremely dizzy.  Blood pressure was good, but heart rate was only 58 beats per minute.  911 was called and the paramedics did a heart monitor test on her, which was normal.  Once the dizziness passed (about 30 minutes), she was able to walk on her own, but was weak, felt sick and had no energy for most of the rest of the day.
Age: 64.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Local swelling, Tenderness
Clinical narrative: The following morning after rec. the vaccine ct. noted site of injection was a "red spot the size of an orange--with unconrollable iching--there was also swelling and tenderness in my arm pit". Pt. stated she, "applied Benadrl lotion--later taking oral Benadryl."
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3, TDAP
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: WAS IN GOOD HEALTH AT TIME OF INTRAMUSCULAR ADMINISTRATION OF INFLUENZA VACCINATION ON 10/13/08 AT RIGHT DELTOID. PAIN OVER RIGHT DELTOID ALMOST IMMEDIATELY AFTER ADMKNISTRATION.  PERSISTENT PAIN.  PAIN EXACERBATES WHEN ELEVATING RIGHT ARM > 90 DEGREES, LIFTING ANY OBJECT.  DIFFICULTY COMPLETING ADLS.  NO ERRYTHEMA, INDURATION.  NO RELIEF WITH NSAIDS, WARM MOIST HEAT, ICE.  WILL TREAT WITH FLEXERIL AND PHYSICAL THERAPY.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3, TDAP
Symptoms: Induration, Pain, Pain in extremity
Clinical narrative: WAS IN GOOD HEALTH AT TIME OF INTRAMUSCULAR ADMINISTRATION OF INFLUENZA VACCINATION ON 10/13/08 AT RIGHT DELTOID. PAIN OVER RIGHT DELTOID ALMOST IMMEDIATELY AFTER ADMKNISTRATION.  PERSISTENT PAIN.  PAIN EXACERBATES WHEN ELEVATING RIGHT ARM > 90 DEGREES, LIFTING ANY OBJECT.  DIFFICULTY COMPLETING ADLS.  NO ERRYTHEMA, INDURATION.  NO RELIEF WITH NSAIDS, WARM MOIST HEAT, ICE.  WILL TREAT WITH FLEXERIL AND PHYSICAL THERAPY.
Age: 90.0
Sex: F
Vaccine: FLUX
Symptoms: Crying, Pain
Clinical narrative: Extreme overall body pain lasting for about 2 hours. She never complains of overall body pain. She cried very hard during the pain - I've never seen her react to anything like this.
Age: 25.0
Sex: F
Vaccine: FLUN3
Symptoms: Swelling face
Clinical narrative: The patient received the Flumist at 1430 HRS and went to exercise immediately.  At around 1525 HRS, the patient experienced facial swelling with no difficulty breathing.  The patient went back to the clinic and was treated with Epinephrine, prednisone and benadryl. The patient was released to go home with prescribed after an hour.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Lymphadenopathy, Pain, Pain in extremity, Pyrexia
Clinical narrative: fever,swollen lymp node's in neck, arm and arm pit area hurt real bad, body aches
Age: 64.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Malaise, Pain in extremity
Clinical narrative: Twenty four hours after receiving the pneumonia vaccine my arm began to hurt, swell, skin around injection site turned very red and hot to the touch.  I became very sick, was in bed the full day except to go to the bathroom on the second day after receiving the vaccine.  A lump is also at the injection site.  I was told to use ice for 15 minutes, then off for 15 minutes.  I continued this for the entire weekend, every few hours.  On the following Monday I returned to the doctor, was put on antibiotics and benydryl.  The arm is still slightly red, and the lump at the injection site is still there.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: GIVEN PEDIARIX AS FOURTH DOSE.(NOT PRIMARY DOSES)
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Infection, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: The patient received the Pneumovax vaccine on Sept 26, 2008.  Approximately 1 day later, the patient developed a "red, circular, edematous area on the left upper extremity that was tender to the touch," as reported by the nurse taking care of the patient. This area was where the vaccine was administered. All other infectious causes of cellulitis were ruled out; therefore the infection was attributed to Pneumovax. Cephalexin 250 mg po q6h was initiated.
Age: 90.0
Sex: M
Vaccine: FLU3
Symptoms: Hypokinesia, Musculoskeletal stiffness
Clinical narrative: Medical history included no adverse events following receipt of previous influenza virus vaccine and  no adverse events following receipt of previous unspecified vaccinations. The subject received no other vaccinations on the day of the FLULAVAL administration. This case was reported by a healthcare professional and described the occurrence of stiff neck in a 90-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received 1st dose of FLULAVAL (.5 ml, unknown). Within hours of vaccination with FLULAVAL, the subject experienced stiff neck and restricted neck movement. The healthcare professional considered the events were disabling. At the time of reporting the outcome of the events were unspecified. The healthcare professional (a pharmacy coordinator) reported that a 90 year old male received FLULAVAL and the next morning reported neck stiffness. this required him to move his head with his hands, he could not  turn his neck. The dates of administration and onset were not known at the time of this report. Caller reports that the subject will be, if he hasn't already seen, a Chiropractor.
Sex: M
Vaccine: FLU3
Symptoms: Herpes zoster, Rash generalised, Rash pruritic, Urticaria
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of rash in an adult male subject who was vaccinated with FLUARIX (GlaxoSmithKilne). On 7 October 2008 the subject received a dose of FLUARIX at 0.5 ml. On 7 October 2008, and into the next day, the subject developed a generalized itchy rash. On 11 October 2008, four days after vaccination with FLUARIX, the subject developed hives and was seen in the emergency room. He was hospitalized overnight and diagnosed with shingles. On 21 October 2008, the events of rash, hives and itching were resolved. The healthcare professional considered these events and shingles unrelated to vaccination with FLUARIX. Similar events occurred in three additional subjects. Linked case include: A0753769A, A0753770A and A0753771A.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Computerised tomogram, Headache, Lumbar puncture, Meningitis aseptic
Clinical narrative: This case was reported by a physician and described the occurrence of aseptic meningitis in a 34-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In October 2008 (approximately two weeks prior to reporting) the subject received unspecified dose of FLULAVAL (unknown). On 11 October 2008, within weeks of vaccination with FLULAVAL, the subject was admitted to the hospital with severe headaches that were worse on movement, vomiting and a fever of 100F. He had a CT scan and a spinal tap. He was treated for 24 hours with ROCEPHIN. Aseptic meningitis was reported. The physician considered the events were clinically significant (or requiring intervention). The subject improved and was discharged on 13 October 2008. He was seen by his physician on 17 October 2008 and was given a prescription for pain relievers for the headache symptoms. At the time of reporting the events were resolved. THE subject returned to work on 22 October 2008.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: This case was reported by a physician and described the occurrence of aseptic meningitis in a 34-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In October 2008 (approximately two weeks prior to reporting) the subject received unspecified dose of FLULAVAL (unknown). On 11 October 2008, within weeks of vaccination with FLULAVAL, the subject was admitted to the hospital with severe headaches that were worse on movement, vomiting and a fever of 100F. He had a CT scan and a spinal tap. He was treated for 24 hours with ROCEPHIN. Aseptic meningitis was reported. The physician considered the events were clinically significant (or requiring intervention). The subject improved and was discharged on 13 October 2008. He was seen by his physician on 17 October 2008 and was given a prescription for pain relievers for the headache symptoms. At the time of reporting the events were resolved. THE subject returned to work on 22 October 2008.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fall, Head injury, Syncope
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of syncope in a 60-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included JUVEN, VITAMIN B3, LUCIDRIL, OMEGA 3 FISH OIL, LEXAPRO, AMBIEN, VITAMIN E, VITAMIN C, MAXIDEX, multivitamins plus zinc, LEUCINE, Folic Acid, BONIVA, CITRACAL and unspecified eye drops. On 20 October 2008 the subject received a dose of FLULAVAL at 0.5 ml in an unknown deltoid. On 20 October 2008, 30 minutes after vaccination with FLULAVAL, the subject experienced syncope. Additionally, standing at the counter, the subject felt as though she was going to faint. She fell and fainted and hit her head as she fell. It was not reported how long the subject was out. At the time of reporting syncope was improved. The healthcare professional considered the event of syncope probably related to vaccination with FLULAVAL. A statement in the text of the report read: The cold packs were not frozen upon delivery. Tag alert indicated that the product was okay. Days later at room temperature, the Tag Alert still says okay.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of syncopal attack in a 64-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included Calcium Supplements, TYLENOL, ZOCOR, BONIVA, COUMADIN, ALLEGRA and MIRALAX. On 20 October 2008 the subject received a dose of FLULAVAL at 0.5 ml in an unknown deltoid. On 20 October 2008, 30 minutes after vaccination with FLULAVAL, the subject experienced a syncopal episode. The healthcare professional considered the event was life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the event was improved. The healthcare professional considered the event was probably related to vaccination with FLULAVAL. A statement in the text of the report read: The cold packs were not frozen upon delivery. Tag alert indicated that the product was okay. Days later at room temperature, the Tag Alert still says okay. Monitored in the emergency room and released.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Convulsion
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of seizure in a 79-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included XYZAL, SYNTHROID, SIMVASTATIN, NYSTAN, ZYMAX, NEXIUM, IMDUR, GLUCOPHAGE, COZAAR, ALDACTONE, ACTOS, METAMUCIL, GLUCOSAMINE CHONDROITIN, ASPIRIN and CENTRUM SILVER. On 20 October 2008 the subject received a dose of FLULAVAL at 0.5 ml in an unknown deltoid. On 20 October 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced seizure. The healthcare professional considered the event was disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with FLULAVAL.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Chest X-ray, Drooling, Electrocardiogram, Hyperhidrosis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of seizure in a 79-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included XYZAL, SYNTHROID, SIMVASTATIN, NYSTAN, ZYMAX, NEXIUM, IMDUR, GLUCOPHAGE, COZAAR, ALDACTONE, ACTOS, METAMUCIL, GLUCOSAMINE CHONDROITIN, ASPIRIN and CENTRUM SILVER. On 20 October 2008 the subject received a dose of FLULAVAL at 0.5 ml in an unknown deltoid. On 20 October 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced seizure. The healthcare professional considered the event was disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with FLULAVAL.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoglycaemia, Scan brain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of seizure in a 79-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included XYZAL, SYNTHROID, SIMVASTATIN, NYSTAN, ZYMAX, NEXIUM, IMDUR, GLUCOPHAGE, COZAAR, ALDACTONE, ACTOS, METAMUCIL, GLUCOSAMINE CHONDROITIN, ASPIRIN and CENTRUM SILVER. On 20 October 2008 the subject received a dose of FLULAVAL at 0.5 ml in an unknown deltoid. On 20 October 2008, at an unspecified time after vaccination with FLULAVAL, the subject experienced seizure. The healthcare professional considered the event was disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with FLULAVAL.
Age: 20.0
Sex: M
Vaccine: LYME
Symptoms: Amnesia, Arthralgia, Autoimmune disorder, Blepharospasm, Cognitive disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, joint swelling, fatigue, visual problem, eye pain, eye twitching, cognitive impairment, memory loss, decreased activity level, rheumatological symptoms, neurological impairment and autoimmune disease. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 15 October 2008 via an interview conducted by a lawyer with the subject. The subject received LYMERIX on 29 June 1999, 02 August 1999, and in May 2000. On 02 August 1999 he developed knee pain. In September 1999 he developed "mental fog". In the fall of 1999 he developed restless leg syndrome. In October 1999 or November 1999 he experienced compartment syndrome. Treatment included ibuprofen, "Icy-Hot", and VIOXX. He underwent an emergency fasciectomy on an unspecified date. The events were unresolved at the time of this report. This case was assessed to be medically serious by GSK based upon follow up information.
Age: 20.0
Sex: M
Vaccine: LYME
Symptoms: Compartment syndrome, Decreased activity, Eye pain, Fasciectomy, Fatigue
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, joint swelling, fatigue, visual problem, eye pain, eye twitching, cognitive impairment, memory loss, decreased activity level, rheumatological symptoms, neurological impairment and autoimmune disease. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 15 October 2008 via an interview conducted by a lawyer with the subject. The subject received LYMERIX on 29 June 1999, 02 August 1999, and in May 2000. On 02 August 1999 he developed knee pain. In September 1999 he developed "mental fog". In the fall of 1999 he developed restless leg syndrome. In October 1999 or November 1999 he experienced compartment syndrome. Treatment included ibuprofen, "Icy-Hot", and VIOXX. He underwent an emergency fasciectomy on an unspecified date. The events were unresolved at the time of this report. This case was assessed to be medically serious by GSK based upon follow up information.
Age: 20.0
Sex: M
Vaccine: LYME
Symptoms: Feeling abnormal, Joint swelling, Nervous system disorder, Restless legs syndrome, Visual disturbance
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced joint pain, joint swelling, fatigue, visual problem, eye pain, eye twitching, cognitive impairment, memory loss, decreased activity level, rheumatological symptoms, neurological impairment and autoimmune disease. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 15 October 2008 via an interview conducted by a lawyer with the subject. The subject received LYMERIX on 29 June 1999, 02 August 1999, and in May 2000. On 02 August 1999 he developed knee pain. In September 1999 he developed "mental fog". In the fall of 1999 he developed restless leg syndrome. In October 1999 or November 1999 he experienced compartment syndrome. Treatment included ibuprofen, "Icy-Hot", and VIOXX. He underwent an emergency fasciectomy on an unspecified date. The events were unresolved at the time of this report. This case was assessed to be medically serious by GSK based upon follow up information.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Dysstasia, Pyrexia, Walking aid user
Clinical narrative: Weakness of legs and arms so she could not get up from chair or walk with walker about 5 hours after the shot. Improved in hospital. Low grade fever, treated with IV fluids. 12/1/08-records received for DOS 10/13-10/15/08-DC DX: fever, likely secondary to vaccination, resolved. Unsteady gait, multifactorial, likely from atherosclerotic cerebrovascular disease and multiple infarcts. Presented with C/O weakness and fever.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Lip swelling
Clinical narrative: Swollen lips, chest pain.  Treated at hospital 10/21-10/23, see MD report, he was supposed to send a VAERS. 12/17/08-records received for DOS 10/22-10/23/08-DC DX: Likely acute allergic reaction to Flu shot, resolved. Dyslipidemia. Leukocytosis. Admitted with throat swelling, lip swelling, difficulty breathing. Also ate shrimp on same day.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic, Urticaria
Clinical narrative: 24 hours after shot child with wheals through at skin, arms, legs, abdomen pruritic.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Chills, Erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: After receiving a Zostavax vaccine, left arm became reddened, swollen from elbow to shoulder.  Developed low grade fever, chills, aching.  Arm was warm to touch.  On 4th day after shot redness and swelling improved.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Skin warm
Clinical narrative: After receiving a Zostavax vaccine, left arm became reddened, swollen from elbow to shoulder.  Developed low grade fever, chills, aching.  Arm was warm to touch.  On 4th day after shot redness and swelling improved.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Heart rate increased
Clinical narrative: 3 pm: Patient complaint - fast heartbeat and dizziness. Patient advised to go to ER via 911. Patient stated he would go via bus.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site atrophy
Clinical narrative: Vaccine administered to (L) delt 10/13/08. Had progressive atrophy at injection site beginning 10/23/08.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Hypoaesthesia, Swollen tongue, Throat irritation
Clinical narrative: C/O burning in throat, feeling of swelling to tongue, numbness in both legs below the knees, dizziness diaphoretic. No respiratory distress. Taken by ambulance to Emergency dept. Treated with Benadryl, Solu-Medrol and Zantac.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Breast pain, Dizziness, Dyspnoea, Tachycardia
Clinical narrative: S.O.B. & pain under breast after flu shot hurt to take deep breaths. Tachycardia - dizzy & lightheaded within 15 mins after flu shot. ER via EMS.
Age: 0.72
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash generalised
Clinical narrative: Rash on face around mouth up to eye. Rash worsening to rest of body.
Age: 83.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Oedema peripheral
Clinical narrative: 12/17/ (L) arm swelling, wrist to elbow, red/tender to touch, warm, injection site at intermittent/nontender. Tx CLARITHROMYCIN 500 bid x 7d R-O All PCN
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN3, IPV
Symptoms: Discomfort, Injection site erythema
Clinical narrative: ? site has lg red circle -> Advised to apply cool compress and make take TYLENOL for discomfort
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Erythema and swelling of right arm (away from injection site).
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN3, IPV, MMR
Symptoms: Auricular swelling, Cough, Eye swelling, Oxygen saturation decreased, Pruritus
Clinical narrative: Given vaccines by myself.  When walking down hall a couple minutes later, complained of itching.  Brought back to exam room.  Covered in confluent hives, eyes and ears puffy.  Benadryl given.  Oz Sat 95%, RA briefly then 99% RA.  Never wheeze.  A few coughs after receiving Benadryl resolved.  Taken via EMS to hospital ED, where received steroids, Epi pen Jr, monitored.  Discharged home with 5 day course of steroids.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN3, IPV, MMR
Symptoms: Urticaria
Clinical narrative: Given vaccines by myself.  When walking down hall a couple minutes later, complained of itching.  Brought back to exam room.  Covered in confluent hives, eyes and ears puffy.  Benadryl given.  Oz Sat 95%, RA briefly then 99% RA.  Never wheeze.  A few coughs after receiving Benadryl resolved.  Taken via EMS to hospital ED, where received steroids, Epi pen Jr, monitored.  Discharged home with 5 day course of steroids.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given Hep A 0.5 ml, right arm and Hep A 0.5 ml, left arm.  Patient showed no signs of adverse effect.  Parent was notified.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram normal, Full blood count normal, Syncope
Clinical narrative: Witnessed syncopal event.
Age: 10.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Inflammation, Pain in extremity
Clinical narrative: Local inflammation/soreness at site right deltoid.
Age: 6.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Mumps antibody test positive, Parotid gland enlargement
Clinical narrative: Approximately 3 weeks post first MMR vaccine.  Patient had left parotid swelling, positive mumps IgM - no fever, no rash - parotid swelling resolved over 48 - 72 hours.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Red/swollen right arm in elbow area, suggested we see MD to double check reaction.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Joint swelling, Red blood cell sedimentation rate increased
Clinical narrative: Arthralgias ankles, knees, hips, hands, great toe and mild welling ankles.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Patient feeling dizzy and nauseous - doctor spoke to mom 1st day close observation.  Day 2 advised rest/push fluids/use Motrin for HA, if worsening to call back.  Telephone call received from mother with the following information: 10/15 7 pm: feeling dizzy and nauseous a few hours after getting GARDASIL.  Advised close observation and fluids tonight.  Call in am to speak with PCP if persists.  10/16 9 am: spoke with mom this am to check on patient and she was not so great last night - woke up in middle of the night and vomited.  This am had headache and went to school.  Advised to follow up with PCP re future shots.  Discussed that this is likely an intercurrent illness, not related to GARDASIL, but no way to know.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia, Rash
Clinical narrative: Mom called and reported child ran slight fever for 8 hours and then 35 hours after receiving vaccine child developed a rash from breast bone to umbilicus.  Lasted for 2 days.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Area the following day way raised, bright red extended for 2 inches around site. Skin surface was raised about 1/4 inch. 2 days later rim of "color" extended 4 inches from site.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient fainted Approx 10 minutes after vaccine. Paramedics in store - transported to hospital.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site rash, Pain, Rash, Swelling
Clinical narrative: Severe redness, swelling, pain, and rash on trunk and left arm from the injection site (Deltoid) to the elbow.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Skin warm, Tenderness
Clinical narrative: L upper arm tenderness, warmth and redness, cellulitis. Cool compress, Tylenol and Augmentin 400mg BID x 10 days.
Age: 1.4
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Redness to injection site LL - informed redness is nl. if getting worse to be seen my MD
Age: 3.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: 10/6 L arm swelling and pain advised if worsen to see MD for evaluation. 10/7 small am't redness - no c/o.
Age: 19.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Induration, Skin warm, Tenderness
Clinical narrative: L shoulder 3cm Round warm indurated, no fluctuance, mildly tender L shoulder cellulitis.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Body temperature increased, Dizziness, Injection site cellulitis
Clinical narrative: Patient received FLUVIRIN (Novartis) and PNEUMOVAX 10/03/2008 at 15:58. Her temperature was 103.5 on 10/4 with extreme dizziness. She saw Dr. 10/7. Dr reported to me that she had temp of 102.5, dizziness and 2nd degree cellulitis at site. He prescribed Cipro 500 twice a day for 10 days. On 10/12 patient reported to me she was better, still running a low-grade temperature and still very weak but no dizziness. Dr's phone number is 325 690 1500.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urticaria
Clinical narrative: Welt appeared later same day. Pt self medicated w/50 mg Benadryl; applied ice tx. No further reaction.
Age: 2.0
Sex: M
Vaccine: FLUN3, HEPA
Symptoms: Wrong drug administered
Clinical narrative: FLUMIST given to 2 y.o. male with history of asthma. Patient had wheezing that started prior to visit 10/22/08. Mother treating at home with albuterol. On day of visit, patient was clear to auscultation on exam. Patient was accidentaly given FLUMIST instead of FLUZONE. There was no immediate wheezing following FLUMIST, and prior to patient leaving office.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, TTOX
Symptoms: Erythema, Pain, Rash, Swelling
Clinical narrative: Rash, pain, swelling, redness - size of tennis ball - given SQ in rt arm flu shot given in rt arm deltoid.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Mother says client woke up with a rash and itching was given Benadryl - woke up 2nd/ morning with welps - given Benadryl and rash & welps has cleared up - information reported to clinic on 10/27/2008
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Cough, Nausea, Pyrexia, Throat irritation
Clinical narrative: Fever, nausea, scratchy throat, weakness. Constant cough, wheezing.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Wheezing
Clinical narrative: Fever, nausea, scratchy throat, weakness. Constant cough, wheezing.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Erythema, Hypersensitivity, Swelling face
Clinical narrative: Allergic reaction to "5 year immunizations".  Redness and swelling to the face; then difficulty breathing.
Age: 28.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Convulsion
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  A 28 year old female patient with no medical history reported and no known drug allergies who on 24-JUN-2008, was vaccinated with her second dose of GARDASIL (Lot # not reported) into the left arm.  There was no concomitant medication.  On 30-JUN-2008, 6 days after receiving the second dose, the patient had a seizure and was rushed to the hospital.  Before the seizure, the patient did not have any signs or symptoms of anything wrong.  The patient went to school and work as usual up until the event.  The seizure took place around 1500 PM on 30-JUN-2008.  After receiving treatment (oxygen) from the EMTs, the patient regained consciousness and was very confused.  In the emergency room, the patient had unusually high blood pressure and rapid heart beat.  The patient was admitted to the hospital where the patient has a blood test.  Electroencephalogram (EEG), Magnetic Resonance Imaging (MRI), saw a cardiologist and received a heart monitor.  All test came back normal, therefore no treatment/medication was administered by my neurologist.  Upcoming test include following up with cardiologist and a sleep Electroencephalogram (EEG) test per neurologist recommendation.  The listing also indicated that one or more of the events was life-threatening.  This was originally reported by a consumer.  VAERS ID # 319459.  No further information is available.
Age: 28.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood test, Cardiac monitoring, Confusional state, Convulsion, Electroencephalogram
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  A 28 year old female patient with no medical history reported and no known drug allergies who on 24-JUN-2008, was vaccinated with her second dose of GARDASIL (Lot # not reported) into the left arm.  There was no concomitant medication.  On 30-JUN-2008, 6 days after receiving the second dose, the patient had a seizure and was rushed to the hospital.  Before the seizure, the patient did not have any signs or symptoms of anything wrong.  The patient went to school and work as usual up until the event.  The seizure took place around 1500 PM on 30-JUN-2008.  After receiving treatment (oxygen) from the EMTs, the patient regained consciousness and was very confused.  In the emergency room, the patient had unusually high blood pressure and rapid heart beat.  The patient was admitted to the hospital where the patient has a blood test.  Electroencephalogram (EEG), Magnetic Resonance Imaging (MRI), saw a cardiologist and received a heart monitor.  All test came back normal, therefore no treatment/medication was administered by my neurologist.  Upcoming test include following up with cardiologist and a sleep Electroencephalogram (EEG) test per neurologist recommendation.  The listing also indicated that one or more of the events was life-threatening.  This was originally reported by a consumer.  VAERS ID # 319459.  No further information is available.