chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Rash pustular, Skin striae, Skin ulcer
Clinical narrative: 24 yo male seen on 10-26 for smallpox immunization screen. Immunization applied to right arm.  Reaction began about day 7 with redness and swelling at primary site. Fever (did not task temp) and malaise developed by day 9. Seen at 0700 temp 100.5 po, thought to have cellultitis on right arm with localized swelling redness and red streaking toward shoulder. Stared onm Amoxicillin 875 mg po BID, Acetominophen 325 mg po q6h and Naprosyn BID. Swelling in arm has improved over last three days.  Skin symptoms; noted pustular eruption on arms and trunk that began on Monday 11-06 at time of cellulits sick call visit. No change in pattern with Amoxicillin. Tues-WED was last day with emergence of new lesions. Still feelng warm with malaise this week. No shaking chills since 11-05-06   No neck symptoms No stiff neck  °  No previous history of concerns about reproductive health  °  No musculoskeletal symptoms  °  No neurological symptoms  °  No psychological symptoms    Generalized smallpox vaccination reaction (self-limited): Lesions c/w follicular eruption of small pox vaccination. Lesions are not suggestive of generalized vaccinia. This occurs in approximately 2% of patients with the vaccination. pt educated on contact precautions, wound care and follow up.  Pt received small pox vaccine on 26Oct2006.  f/up on rxn to vaccine.  no symptoms today.  reports lesions all dry and initial site improved dramatically  Skin: lesions on torso and upper arms - all are either resolved or dry with no erythema.  lesion of right arm from initial immunizations site now shows 4mm by 4m dry eschar with no erythema or induration. Normal except as noted.
Age: 44.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Abdominal discomfort, Amnesia, Anaemia, Anxiety, Back pain
Clinical narrative: HYPERVENTILATION (WHEN A PANIC ATTACK OCURRS) SLEEP TROUBLES (UNABLE TO SLEEP WITHOUT MEDICATION) LIBIDO DECREASE, BAD MEMORY (TROUBLE REMEMBERING RECENT INFORMATION-SHORT TERM MEMORY LOSS)MENOPAUSE, DEPRESSION, MIGRAINE, MOOD; (ANXIOUS, ANGRY, IRRITABLE) NUMBNESS AND TINGLING FINGERS, ABDOMEN; (BURNING SENSATION, ACID REFLUX)ANEMIA, APPETITE LOSS, VERTIGO & DIZZINESS, HIGH CHOLESTEROL, BRADYCARDIA, DIFFICULTY TO CONCENTRATE, CONSTIPATION, COSTOCHONDRITIS, THINKING ABNORMALITY, POOR TOLERANCE FOR BRIGHTS LIGHTS, BLURRED VISION, WEIGHT GAIN, WEIGHT LOSS. DX:  major depressive disorder, recurrent, moderate migraine lumbago hypercholesterolemia sensorineural hearing loss of combined types dyspepsia anxiety gastroesophageal reflux disorder vitamin B 12 deficiency. Same as I reported initially.
Age: 44.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Blood cholesterol increased, Bradycardia, Constipation, Costochondritis, Deafness neurosensory
Clinical narrative: HYPERVENTILATION (WHEN A PANIC ATTACK OCURRS) SLEEP TROUBLES (UNABLE TO SLEEP WITHOUT MEDICATION) LIBIDO DECREASE, BAD MEMORY (TROUBLE REMEMBERING RECENT INFORMATION-SHORT TERM MEMORY LOSS)MENOPAUSE, DEPRESSION, MIGRAINE, MOOD; (ANXIOUS, ANGRY, IRRITABLE) NUMBNESS AND TINGLING FINGERS, ABDOMEN; (BURNING SENSATION, ACID REFLUX)ANEMIA, APPETITE LOSS, VERTIGO & DIZZINESS, HIGH CHOLESTEROL, BRADYCARDIA, DIFFICULTY TO CONCENTRATE, CONSTIPATION, COSTOCHONDRITIS, THINKING ABNORMALITY, POOR TOLERANCE FOR BRIGHTS LIGHTS, BLURRED VISION, WEIGHT GAIN, WEIGHT LOSS. DX:  major depressive disorder, recurrent, moderate migraine lumbago hypercholesterolemia sensorineural hearing loss of combined types dyspepsia anxiety gastroesophageal reflux disorder vitamin B 12 deficiency. Same as I reported initially.
Age: 44.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Decreased appetite, Depression, Disturbance in attention, Dizziness, Dyspepsia
Clinical narrative: HYPERVENTILATION (WHEN A PANIC ATTACK OCURRS) SLEEP TROUBLES (UNABLE TO SLEEP WITHOUT MEDICATION) LIBIDO DECREASE, BAD MEMORY (TROUBLE REMEMBERING RECENT INFORMATION-SHORT TERM MEMORY LOSS)MENOPAUSE, DEPRESSION, MIGRAINE, MOOD; (ANXIOUS, ANGRY, IRRITABLE) NUMBNESS AND TINGLING FINGERS, ABDOMEN; (BURNING SENSATION, ACID REFLUX)ANEMIA, APPETITE LOSS, VERTIGO & DIZZINESS, HIGH CHOLESTEROL, BRADYCARDIA, DIFFICULTY TO CONCENTRATE, CONSTIPATION, COSTOCHONDRITIS, THINKING ABNORMALITY, POOR TOLERANCE FOR BRIGHTS LIGHTS, BLURRED VISION, WEIGHT GAIN, WEIGHT LOSS. DX:  major depressive disorder, recurrent, moderate migraine lumbago hypercholesterolemia sensorineural hearing loss of combined types dyspepsia anxiety gastroesophageal reflux disorder vitamin B 12 deficiency. Same as I reported initially.
Age: 44.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Gastrooesophageal reflux disease, Gastrooesophageal reflux disease, Hypercholesterolaemia, Hyperventilation, Hypoaesthesia
Clinical narrative: HYPERVENTILATION (WHEN A PANIC ATTACK OCURRS) SLEEP TROUBLES (UNABLE TO SLEEP WITHOUT MEDICATION) LIBIDO DECREASE, BAD MEMORY (TROUBLE REMEMBERING RECENT INFORMATION-SHORT TERM MEMORY LOSS)MENOPAUSE, DEPRESSION, MIGRAINE, MOOD; (ANXIOUS, ANGRY, IRRITABLE) NUMBNESS AND TINGLING FINGERS, ABDOMEN; (BURNING SENSATION, ACID REFLUX)ANEMIA, APPETITE LOSS, VERTIGO & DIZZINESS, HIGH CHOLESTEROL, BRADYCARDIA, DIFFICULTY TO CONCENTRATE, CONSTIPATION, COSTOCHONDRITIS, THINKING ABNORMALITY, POOR TOLERANCE FOR BRIGHTS LIGHTS, BLURRED VISION, WEIGHT GAIN, WEIGHT LOSS. DX:  major depressive disorder, recurrent, moderate migraine lumbago hypercholesterolemia sensorineural hearing loss of combined types dyspepsia anxiety gastroesophageal reflux disorder vitamin B 12 deficiency. Same as I reported initially.
Age: 44.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Insomnia, Libido decreased, Major depression, Menopause, Migraine
Clinical narrative: HYPERVENTILATION (WHEN A PANIC ATTACK OCURRS) SLEEP TROUBLES (UNABLE TO SLEEP WITHOUT MEDICATION) LIBIDO DECREASE, BAD MEMORY (TROUBLE REMEMBERING RECENT INFORMATION-SHORT TERM MEMORY LOSS)MENOPAUSE, DEPRESSION, MIGRAINE, MOOD; (ANXIOUS, ANGRY, IRRITABLE) NUMBNESS AND TINGLING FINGERS, ABDOMEN; (BURNING SENSATION, ACID REFLUX)ANEMIA, APPETITE LOSS, VERTIGO & DIZZINESS, HIGH CHOLESTEROL, BRADYCARDIA, DIFFICULTY TO CONCENTRATE, CONSTIPATION, COSTOCHONDRITIS, THINKING ABNORMALITY, POOR TOLERANCE FOR BRIGHTS LIGHTS, BLURRED VISION, WEIGHT GAIN, WEIGHT LOSS. DX:  major depressive disorder, recurrent, moderate migraine lumbago hypercholesterolemia sensorineural hearing loss of combined types dyspepsia anxiety gastroesophageal reflux disorder vitamin B 12 deficiency. Same as I reported initially.
Age: 44.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Panic attack, Paraesthesia, Photophobia, Thinking abnormal, Vertigo
Clinical narrative: HYPERVENTILATION (WHEN A PANIC ATTACK OCURRS) SLEEP TROUBLES (UNABLE TO SLEEP WITHOUT MEDICATION) LIBIDO DECREASE, BAD MEMORY (TROUBLE REMEMBERING RECENT INFORMATION-SHORT TERM MEMORY LOSS)MENOPAUSE, DEPRESSION, MIGRAINE, MOOD; (ANXIOUS, ANGRY, IRRITABLE) NUMBNESS AND TINGLING FINGERS, ABDOMEN; (BURNING SENSATION, ACID REFLUX)ANEMIA, APPETITE LOSS, VERTIGO & DIZZINESS, HIGH CHOLESTEROL, BRADYCARDIA, DIFFICULTY TO CONCENTRATE, CONSTIPATION, COSTOCHONDRITIS, THINKING ABNORMALITY, POOR TOLERANCE FOR BRIGHTS LIGHTS, BLURRED VISION, WEIGHT GAIN, WEIGHT LOSS. DX:  major depressive disorder, recurrent, moderate migraine lumbago hypercholesterolemia sensorineural hearing loss of combined types dyspepsia anxiety gastroesophageal reflux disorder vitamin B 12 deficiency. Same as I reported initially.
Age: 44.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Vision blurred, Vitamin B12 deficiency, Weight decreased, Weight increased
Clinical narrative: HYPERVENTILATION (WHEN A PANIC ATTACK OCURRS) SLEEP TROUBLES (UNABLE TO SLEEP WITHOUT MEDICATION) LIBIDO DECREASE, BAD MEMORY (TROUBLE REMEMBERING RECENT INFORMATION-SHORT TERM MEMORY LOSS)MENOPAUSE, DEPRESSION, MIGRAINE, MOOD; (ANXIOUS, ANGRY, IRRITABLE) NUMBNESS AND TINGLING FINGERS, ABDOMEN; (BURNING SENSATION, ACID REFLUX)ANEMIA, APPETITE LOSS, VERTIGO & DIZZINESS, HIGH CHOLESTEROL, BRADYCARDIA, DIFFICULTY TO CONCENTRATE, CONSTIPATION, COSTOCHONDRITIS, THINKING ABNORMALITY, POOR TOLERANCE FOR BRIGHTS LIGHTS, BLURRED VISION, WEIGHT GAIN, WEIGHT LOSS. DX:  major depressive disorder, recurrent, moderate migraine lumbago hypercholesterolemia sensorineural hearing loss of combined types dyspepsia anxiety gastroesophageal reflux disorder vitamin B 12 deficiency. Same as I reported initially.
Age: 11.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Severe body aches, headache, mild sore throat, site of vaccine red, hard, hot to touch, swollen to about the size of a baseball.  Fevers from 101.5 to 103.1 over three days that would not break with Tylenol or Motrin.  Nausea and vomiting for one day.
Age: 11.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Pain, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Severe body aches, headache, mild sore throat, site of vaccine red, hard, hot to touch, swollen to about the size of a baseball.  Fevers from 101.5 to 103.1 over three days that would not break with Tylenol or Motrin.  Nausea and vomiting for one day.
Age: 15.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Face oedema, Rash erythematous
Clinical narrative: 20 minutes after the injection, the patient's first ever flu shot, she developed generalised erythema rash, facial sweeling and shortness of breath. This flu shot was done at a school site. Volunteer doctors (unspecified) and was attended by ER physician. She was given oral prednisolone for 4 days and albuterol inhalation at ER. 5 days after this episode in my clinic, she is well and normal peak flow.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Blood pressure increased, Flushing, Heart rate increased, Throat tightness
Clinical narrative: 5:58pm received fluzone, IM, L deltoid  6:10pm became flushed and began to feel tightness in throat - pt self administered one puff of albuterol inhaler.   6:12pm pt c/o stomach cramps and ongoing throat tightness, she self anministered epi-pen L thigh. BP 200/100 pulse=100 6:38 pt feeling "a little better",and did not want ambulance called,but then stomach cramps started again, 911 was called. 6:45 2nd dose of IM epinepherine given as pt cramps getting worse (her typical symptom with anaphylaxis)sx subsiding by the time ambulance crew arrived at 7:00pm-pt transported to hospital.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: 0.5 ml of flu vaccine given of the 36 months and older vacc.  Pt is only 24 months.  No reactions occurred as of yet.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Sluggishness
Clinical narrative: Had shot at 330pm, went home and nose started terrific itching, and continued for 1 day. Called Pharmacist, and he thought reaction was from flu vaccine.That night felt drugged and almost called 911. Next am took Benadryl. Helped some. On 11\12 stopped Benadryl, itching subsided.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: CELLULITIS AT THE INJECTION SITE.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: CELLULITIS AT THE INJECTION SITE.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: CELLULITIS AT THE INJECTION SITE.
Age: 1.42
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Diarrhoea, Febrile convulsion, Pyrexia
Clinical narrative: 2 DAYS OF RECEIVING HEPATITIS A AND DTAP VACCINE PT STARTED WITH FEVER, DIARRHEA. MOM TOOK PT TO HOSP ON 10/28/2006 PT HAD A FEBRILE SEIZURE.
Age: 45.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Muscle spasms
Clinical narrative: WITHIN 6HRS OF INJECTION: VERTIGO/SYNCOPE, FEVER, EXTREME CHILLS/SHIVERS, NAUSEA, SIGNIFICANT SWELLING AT INJECTION SITE, HEADACHE, MUSCLE SPASM/WEAKNESS. TX'D WITH 800MG IBUPROFEN Q4-6H PRN PAIN/FEVER. WARM COMPRESS TO INJECTION SITE, PUSHED FLUIDS AS TOLERATED TILL NAUSEA SUBSIDED. VERTIGO/SYCOPE - 48HRS CHILLS/SHIVERS/FEVER - 72HRS MUSCLE SPASM/WEAKNESS - 48 HRS NAUSEA - 48 HRS SWELLING AT INJECTION SITE - 72 HRS PAIN AT INJECTION SITE - 96 HRS AND STILL PAINFUL HEADACHES - 96HRS AND STILL PAINFUL
Age: 45.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Muscular weakness, Pyrexia, Syncope, Vertigo
Clinical narrative: WITHIN 6HRS OF INJECTION: VERTIGO/SYNCOPE, FEVER, EXTREME CHILLS/SHIVERS, NAUSEA, SIGNIFICANT SWELLING AT INJECTION SITE, HEADACHE, MUSCLE SPASM/WEAKNESS. TX'D WITH 800MG IBUPROFEN Q4-6H PRN PAIN/FEVER. WARM COMPRESS TO INJECTION SITE, PUSHED FLUIDS AS TOLERATED TILL NAUSEA SUBSIDED. VERTIGO/SYCOPE - 48HRS CHILLS/SHIVERS/FEVER - 72HRS MUSCLE SPASM/WEAKNESS - 48 HRS NAUSEA - 48 HRS SWELLING AT INJECTION SITE - 72 HRS PAIN AT INJECTION SITE - 96 HRS AND STILL PAINFUL HEADACHES - 96HRS AND STILL PAINFUL
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Injection site erythema, Injection site hypersensitivity, Pruritus
Clinical narrative: Was administered DTaP and MMR on left lateral leg resulting in redness to area with intermittent itching.  Bruise in area developed a few days later.  Currently, (i month later) continues with dark circle 2-6 cm in diameter.  Denies pain or discomfort.
Age: 1.17
Sex: F
Vaccine: DTAPH, FLU3
Symptoms: Erythema, Irritability, Pyrexia, Swelling
Clinical narrative: Mother states child with temperature of 100.9Ax on 11/13/2006.  RLE "swollen, red, tight" with no tenderness to touch. Child s/w 'fussy' today, with no temperature elevation. Recommended that child continue to receive Tylenol as needed and to apply ice to the site.  If no improvement within 2 days, child should be seen by physician.
Age: 66.0
Sex: F
Vaccine: TD
Symptoms: Contusion, Injection site pain, Injection site swelling
Clinical narrative: Bruise, painful swollen injection site.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Shoulder pain
Clinical narrative: Patient developed left shoulder pain at the deltoid corresponding to the site of injection.  This began about 1 week after injection and has lasted for 3 weeks.  It is 7/10 in severity and requires anti-inflammatories.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Lacrimation increased, Nasal congestion, Pyrexia, Rhinorrhoea
Clinical narrative: 3 days after flu shot, She developed headache, running nose, watery eyes, phlegm, sneezing and 1 day fever of 100 F. Up to today 11/14/06, she still has very bad running nose and watery eyes.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Sneezing
Clinical narrative: 3 days after flu shot, She developed headache, running nose, watery eyes, phlegm, sneezing and 1 day fever of 100 F. Up to today 11/14/06, she still has very bad running nose and watery eyes.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Clinical narrative: UNKNOWN: RECEIVED CALL FROM MEDICAL EXAMINER OF BABYS DEATH TODAY. 3/22/07 Received Autopsy Report which reveals COD as undetermined & manner of death undetermined.  Autopsy findings: single conjoined kidney; diffuse mild cerebral white matter gliosis; neg tox, micro & metabolic testing; focal glomerulosclerosis of unknown significance.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Vertigo
Clinical narrative: TEN SECOND PERIODS OF VERTIGO, NAUSEA, AND HEADACHES, S/S HAVE PERSISTED FOR OVER A WEEK.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema multiforme, Pruritus
Clinical narrative: One day after vaccination, developed diffuse erythema multiforme with mild pruritis.  No other symptoms.  Not otherwise ill.  Still has the condition 5 days after the vaccination.
Age: 16.0
Sex: M
Vaccine: HEP
Symptoms: Cough, Dyspnoea, Pharyngolaryngeal pain
Clinical narrative: Received Hepatitis B vaccine #1 on 11/13/2006 around 4:15 pm. Mom called AM of 11/14/2006. Reports patient began having problems breathing between 6 and 6:15 PM on 11/13/2006. Returned home around 6:30 PM. Had difficulty breathing and a cough. Patient's mom called a nurse friend of hers and she was instructed to give benadryl. Benadryl was given around 7 PM  and repeated around 8 PM as he was still having difficulties. Patient fell asleep around 8:30 PM. This AM, patient reported a sore throat, but was able to go to school. A physician was consulted who determined patient had an allergic reaction to Hepatitis B. Patient was given advair diskus.
Age: 0.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site necrosis, Injection site pain, Injection site warmth
Clinical narrative: PATIENT INITIALLY PRESENTED WITH LARGE BRUISE APPROXIMATELY 2 INCHES IN DIAMETER, AND COMPLAINED OF SORENESS AND "FEVER" AT INJECTION SITE ABOUT 2 DAYS AFTER RECEIVING VACCINE.  I INSTRUCTED PATIENT TO CONTINUE TO MONITOR.  WITHIN A FEW DAYS, THE BRUISE WAS GONE , BUT AN INDENTION IN THE SKIN REMAINED AT THE SITE.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Day after receiving shingles vaccine, pt developed shingles-type pain.  4 days after vaccine pt developed full zoster outbreak.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Day after receiving shingles vaccine, pt developed shingles-type pain.  4 days after vaccine pt developed full zoster outbreak.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: In the evening after the immunization was administered, patient developed pain, swelling and reddness at the site.  No c/o fever.  Patient went to ER and was put on antibiotic and Benadryl.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Child developed shingles 6 weeks after having the chickenpox vaccine.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Complete L arm numbness from shoulder to fingers for 2 hours beginning at 10:00 am the day after administration, then L arm numbness from the shoulder to elbow until 10:00 pm.  Arm was normal except for sore the next morning.
Age: 0.75
Sex: M
Vaccine: DTAP, FLUX, HEP, HIBV
Symptoms: Injection site inflammation
Clinical narrative: Local inflammatory reaction at vaccination site.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Erythema, Injection site inflammation, Pain, Rash maculo-papular
Clinical narrative: SHORTLY UPON RECIEVING THE FLU MIST ONE OF HER CHEEKS SHOWED QUARTER SIZE RED MARK, THE NEXT DAY THERE WAS RED SPLOTCHES ON BOTH CHEEKS WAR TO THE TOUCH, BOTH ARMS WERE ALSO INFLAMMED AND SHE EXPERIENCED SLIGHT PAIN, NEXT DAY EVERYTHING WAS CLEARED UP, PT WAS GIVEN ZYRTEC AND COLD PACKS WERE ADMINISTERED BY MOM AT HOME.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Cough, Dysarthria, Guillain-Barre syndrome, Hyponatraemia
Clinical narrative: Immediately following vaccination the patient reported having a fever and feeling achy all over.  Her illness progressed over the next few day into a 'flu like syndrome'.  This never resolved and continued to progress.  Patient admitted to another hospital 17 days after receiving her annual influenza vaccination with total paralysis.  Patient was diagnosed by a neurologist with Guillian-Barre syndrome.  She received 5 days of IVIG and has experienced improvement in the paralysis.  12 days after hospital admission, she was transfered to an inpatient rehab unit.  11/16/06 Received medical records from hospital which reveal patient admitted 11/04/06 to acute floor of hospital with GBS.  She had developed cold & cough s/s, facial weakness & upper back pain approx 1 week s/p flu shot.  Speech with mild dysarthria & right 7th peripheral nerve impairment.  Dysesthesias in BLEs, DTRs areflexic in UE & LEs & decreased motor strength in RLE.  Patient also had complaints of N/V & RUQ epigastric pain.  Cardiac w/u was neg.  Consults by neuro, cardio & GI.  No D/C summary included with records.  Patient transferred to rehab unit for continued PT/OT/ST. PMH: HTN, migraine headaches, thyroidectomy,  Final Dx: GBS, mild per neuro consult./ss
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Muscular weakness, Pain, Paralysis, Pyrexia
Clinical narrative: Immediately following vaccination the patient reported having a fever and feeling achy all over.  Her illness progressed over the next few day into a 'flu like syndrome'.  This never resolved and continued to progress.  Patient admitted to another hospital 17 days after receiving her annual influenza vaccination with total paralysis.  Patient was diagnosed by a neurologist with Guillian-Barre syndrome.  She received 5 days of IVIG and has experienced improvement in the paralysis.  12 days after hospital admission, she was transfered to an inpatient rehab unit.  11/16/06 Received medical records from hospital which reveal patient admitted 11/04/06 to acute floor of hospital with GBS.  She had developed cold & cough s/s, facial weakness & upper back pain approx 1 week s/p flu shot.  Speech with mild dysarthria & right 7th peripheral nerve impairment.  Dysesthesias in BLEs, DTRs areflexic in UE & LEs & decreased motor strength in RLE.  Patient also had complaints of N/V & RUQ epigastric pain.  Cardiac w/u was neg.  Consults by neuro, cardio & GI.  No D/C summary included with records.  Patient transferred to rehab unit for continued PT/OT/ST. PMH: HTN, migraine headaches, thyroidectomy,  Final Dx: GBS, mild per neuro consult./ss
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Panic reaction
Clinical narrative: Patient c/o: dizziness, lightheaded, feels as if she is going to have a panic attack, very fatigued.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Contusion, Cough, Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: Difficulty breathing (for 4 days immediately following vaccination), wheezing cough, increased irritability,low grade fever (100.2) for two days, red - swollen shot site & bruising; called doctor's office & made appointment for patient -- prescribed Xopenex 1.25 mg/3 ml for wheezing cough (persisted until 10-25-06).
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Irritability, Pyrexia, Wheezing
Clinical narrative: Difficulty breathing (for 4 days immediately following vaccination), wheezing cough, increased irritability,low grade fever (100.2) for two days, red - swollen shot site & bruising; called doctor's office & made appointment for patient -- prescribed Xopenex 1.25 mg/3 ml for wheezing cough (persisted until 10-25-06).
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives over most of body 4 days after immunization.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Arm swelled, very red.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pharyngolaryngeal pain
Clinical narrative: Initial report received from a health care provider on 10/13/05. A 54 year old female received an IM, left deltoid, injection of Fluzone, lot number U1803AA, on 10/12/2005 at 12:00pm. Six hours later, she developed a sore throat and general malaise. She had no shortness of breath, no rash and no weakness. the pt was seen in an ER, but no treatments were given. Pre existing medical conditions, illness at the time of vaccination and number of previous doses were not reported. Information regarding other medications was unk. At the time of this report, the pt had recovered. the reporter in this case is the same as for cases 2005-02095, 2005-02110 and 2005-021111. Follow up information received on 12/5/05 from a health care provider. The case was reviewed, and there is no additional information. Further information is not expected.
Age: 3.0
Sex: U
Vaccine: FLU3
Symptoms: Hypersensitivity, Vomiting
Clinical narrative: A two year old patient received a .25ml injection on 05/Oct/2005. One hour and thirty minutes post-vaccination, the patient began vomiting. The patient vomited every 15 minutes for four hours. The patient was treated with emetrol and the vomiting stopped. Pre existing medical conditions, gender, illness at the time of vaccination, and route and site of administration were not reported. No diagnostic test were reported. At the time of this report, the patient had recovered. Follow up information received on 24 Jan 2006: Per the reporter, the patient received the Fluzone vaccination in the left thigh and this was his first dose. The patient had a Radioallergosorbent Test (RAST) completed (date not reported) and the result was 0.10, Class 1 or mild allergy. No further information is expected.
Age: 1.02
Sex: M
Vaccine: FLU3, HIBV, MMRV
Symptoms: Irritability, Pyrexia
Clinical narrative: Initial report received on 11/Nov/2005 from a health care professional. A 12 month old male patient, with no significant medical history, had received an intra-muscular injection of FLUZONE No Preservative '2005-'2006, lot number U17431A, in the left thigh, a subcutaneous injection of another manufacturer's vaccine, PROQUAD, lot number 0769R in the left thigh and an intra muscular injection of another manufacturer's vaccine, PEDVAX, lot number 0482R, in the right thigh on 07/Nov/2005. Per the mother, the patient developed a fever of 100.4 degrees Fahrenheit on 08/Nov/2005. His fever went down to 102.8 degrees Farenheit on 09/Nov/2005. The patient was seen in the physicians office that day and his temperature was measured at 103.0 degrees Farenheit. The patient was again seen by the physician on 10/Nov/2005 and his temperature was measured at 99.0 degrees Farenheit. Per the reporter, the patient was still irritable when seen by the physician on 10/Nov/2005. Relevant diagnostic test/laboratory data were collected (date not reported).The urinalysis was normal, the complete blood count was within normal limits and the urine culture results were not back at the time of this report. The irritability was still persisting at the time of this report. Follow up information received on 30/Jan/2006 from a health care professional. Per the reporter, the patient did recover from these events  (date not reported). The reporter reviewed the case and there is no additional information to provide at this time. No further information is expected.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, PPV, FLUX, PPV, FLU3, MNQ, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pallor
Clinical narrative: An 11-year-old male patient with a pre-existing medical history, allergy to Ibuprofen/Aspirin and shellfish and who was taking Singulair, Advair, and Zyrtec D had received his third intramuscular injection of Fluzone SV 2005-2006 USP, manufacturer Sanofi Pasteur, Inc, lot numberU1753AA, in the left deltoid; his first dose of Menactra, manufacturer Sanofi Pasteur, Inc., lot number 1782AA in the right deltoid and his first dose of another manufacturer's Pneumoccocal vaccine, lot number 0605R, in the left deltoid.  Six and a half hours later, he developed a 16 x 20 cm induration with an edge of erythema, central pallor, and warmth to the left arm.  Seven and a half hours post vaccination, he additionally developed left arm swelling.  Twenty four hours post-vaccination he developed a four x four cm of erythema, swelling, and warmth at the Menactra vaccination site on the right arm.  The following day the symptoms on the left arm were unchanged.  No relevant diagnostic tests/laboratory data were collected.  At the time of this report, the patient had recovered from these events.  Follow-up information received on 21/Feb/2006 As per reporter the patient had no previous reaction to Fluzone in the past.  The swelling of the left arm stopped at the elbow and did not go past the joint.  Treatment included Zyrtec and cool compresses.  Since the date of the initial report the patient has had skin test for allergies.  As per reporter, the patient has recovered.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, PPV, FLUX, PPV, FLU3, MNQ, PPV
Symptoms: Dizziness, Erythema, Injection site oedema, Medication error, Nausea
Clinical narrative: An 11-year-old male patient with a pre-existing medical history, allergy to Ibuprofen/Aspirin and shellfish and who was taking Singulair, Advair, and Zyrtec D had received his third intramuscular injection of Fluzone SV 2005-2006 USP, manufacturer Sanofi Pasteur, Inc, lot numberU1753AA, in the left deltoid; his first dose of Menactra, manufacturer Sanofi Pasteur, Inc., lot number 1782AA in the right deltoid and his first dose of another manufacturer's Pneumoccocal vaccine, lot number 0605R, in the left deltoid.  Six and a half hours later, he developed a 16 x 20 cm induration with an edge of erythema, central pallor, and warmth to the left arm.  Seven and a half hours post vaccination, he additionally developed left arm swelling.  Twenty four hours post-vaccination he developed a four x four cm of erythema, swelling, and warmth at the Menactra vaccination site on the right arm.  The following day the symptoms on the left arm were unchanged.  No relevant diagnostic tests/laboratory data were collected.  At the time of this report, the patient had recovered from these events.  Follow-up information received on 21/Feb/2006 As per reporter the patient had no previous reaction to Fluzone in the past.  The swelling of the left arm stopped at the elbow and did not go past the joint.  Treatment included Zyrtec and cool compresses.  Since the date of the initial report the patient has had skin test for allergies.  As per reporter, the patient has recovered.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, PPV, FLUX, PPV, FLU3, MNQ, PPV
Symptoms: Erythema, Feeling hot, Injection site induration, Injection site inflammation, Injection site reaction
Clinical narrative: An 11-year-old male patient with a pre-existing medical history, allergy to Ibuprofen/Aspirin and shellfish and who was taking Singulair, Advair, and Zyrtec D had received his third intramuscular injection of Fluzone SV 2005-2006 USP, manufacturer Sanofi Pasteur, Inc, lot numberU1753AA, in the left deltoid; his first dose of Menactra, manufacturer Sanofi Pasteur, Inc., lot number 1782AA in the right deltoid and his first dose of another manufacturer's Pneumoccocal vaccine, lot number 0605R, in the left deltoid.  Six and a half hours later, he developed a 16 x 20 cm induration with an edge of erythema, central pallor, and warmth to the left arm.  Seven and a half hours post vaccination, he additionally developed left arm swelling.  Twenty four hours post-vaccination he developed a four x four cm of erythema, swelling, and warmth at the Menactra vaccination site on the right arm.  The following day the symptoms on the left arm were unchanged.  No relevant diagnostic tests/laboratory data were collected.  At the time of this report, the patient had recovered from these events.  Follow-up information received on 21/Feb/2006 As per reporter the patient had no previous reaction to Fluzone in the past.  The swelling of the left arm stopped at the elbow and did not go past the joint.  Treatment included Zyrtec and cool compresses.  Since the date of the initial report the patient has had skin test for allergies.  As per reporter, the patient has recovered.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, PPV, FLUX, PPV, FLU3, MNQ, PPV
Symptoms: Oedema peripheral, Swelling
Clinical narrative: An 11-year-old male patient with a pre-existing medical history, allergy to Ibuprofen/Aspirin and shellfish and who was taking Singulair, Advair, and Zyrtec D had received his third intramuscular injection of Fluzone SV 2005-2006 USP, manufacturer Sanofi Pasteur, Inc, lot numberU1753AA, in the left deltoid; his first dose of Menactra, manufacturer Sanofi Pasteur, Inc., lot number 1782AA in the right deltoid and his first dose of another manufacturer's Pneumoccocal vaccine, lot number 0605R, in the left deltoid.  Six and a half hours later, he developed a 16 x 20 cm induration with an edge of erythema, central pallor, and warmth to the left arm.  Seven and a half hours post vaccination, he additionally developed left arm swelling.  Twenty four hours post-vaccination he developed a four x four cm of erythema, swelling, and warmth at the Menactra vaccination site on the right arm.  The following day the symptoms on the left arm were unchanged.  No relevant diagnostic tests/laboratory data were collected.  At the time of this report, the patient had recovered from these events.  Follow-up information received on 21/Feb/2006 As per reporter the patient had no previous reaction to Fluzone in the past.  The swelling of the left arm stopped at the elbow and did not go past the joint.  Treatment included Zyrtec and cool compresses.  Since the date of the initial report the patient has had skin test for allergies.  As per reporter, the patient has recovered.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug ineffective, Influenza like illness
Clinical narrative: Initial report received on 01/Jun/2006 from a health care professional. A 42 year old female patient with no reported concurrent illness had received an intramuscular dose of Fluzone SV 2005-2006 USP, lot number U1772AA, in the left arm on 10/Oct/2005 at 16:30 pm. 218 days, post-immunization, the patient was diagnosed with influenza type A via a flu test performed in the physicians office on 17/May/2006 at 10:00 am. On 19/May/2006, an antibody titer level was drawn on the patient and the results showed influenza type A and B with Ab less than eight on both. At the time of this report, the patient had recovered from the event. Follow-up report received on 23/Jun/2006 from a health care professional. As per the reporter, the patient had no history of adverse events following influenza vaccination. Concomitant medications at the time of vaccination included Armour Thyroid 60mg. and Z-max 2gm. per os, which was given on 10/10/2005. Following the onset of the symptoms on 17/May/2006,the patient was treated with supportive care. She had sequaleae of bronchitis, which was treated with axithromycin. A copy of the patient's laboratory report was provided. Antibody testing for influenza type A and type B were both determined to be in the range and were less than eight, which is the reference range. The patient recovered from the events on 31/May/2006. Further information is not anticipated.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bronchitis, Influenza like illness, Laboratory test abnormal
Clinical narrative: Initial report received on 01/Jun/2006 from a health care professional. A 42 year old female patient with no reported concurrent illness had received an intramuscular dose of Fluzone SV 2005-2006 USP, lot number U1772AA, in the left arm on 10/Oct/2005 at 16:30 pm. 218 days, post-immunization, the patient was diagnosed with influenza type A via a flu test performed in the physicians office on 17/May/2006 at 10:00 am. On 19/May/2006, an antibody titer level was drawn on the patient and the results showed influenza type A and B with Ab less than eight on both. At the time of this report, the patient had recovered from the event. Follow-up report received on 23/Jun/2006 from a health care professional. As per the reporter, the patient had no history of adverse events following influenza vaccination. Concomitant medications at the time of vaccination included Armour Thyroid 60mg. and Z-max 2gm. per os, which was given on 10/10/2005. Following the onset of the symptoms on 17/May/2006,the patient was treated with supportive care. She had sequaleae of bronchitis, which was treated with axithromycin. A copy of the patient's laboratory report was provided. Antibody testing for influenza type A and type B were both determined to be in the range and were less than eight, which is the reference range. The patient recovered from the events on 31/May/2006. Further information is not anticipated.
Age: 0.11
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, RV5
Symptoms: Coma, Sudden infant death syndrome
Clinical narrative: Information has been received concerning a 9 week old male, who was born as a twin at 37 week of gestation, who on 9/20/06 was vaccinated with a first oral dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine) (lot 655153/0847F). concomitant vaccines administered on the same day included a first IM dose of Tripedia, a first SC dose of Ipol, a first IM dose of Comvax, and a first IM dose of Prevnar. Concomitant vaccine administered with in four weeks of 9/20/06 included a first dose of Hep B vaccine, recomb (manufacturer unk). It was reported that on 10/13/06 the pt was fed normally at 1:00am and was found unresponsive at 5:30am and experienced apparent sudden infant death syndrome. On 10/13/06 the pt died. It was noted that a post mortem was pending. Unspecified medical attention was sought. Additional information is not expected.
Age: 0.11
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, RV5
Symptoms: Sudden infant death syndrome
Clinical narrative: Information has been received concerning a 9 week old male, who was born as a twin at 37 week of gestation, who on 9/20/06 was vaccinated with a first oral dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine) (lot 655153/0847F). concomitant vaccines administered on the same day included a first IM dose of Tripedia, a first SC dose of Ipol, a first IM dose of Comvax, and a first IM dose of Prevnar. Concomitant vaccine administered with in four weeks of 9/20/06 included a first dose of Hep B vaccine, recomb (manufacturer unk). It was reported that on 10/13/06 the pt was fed normally at 1:00am and was found unresponsive at 5:30am and experienced apparent sudden infant death syndrome. On 10/13/06 the pt died. It was noted that a post mortem was pending. Unspecified medical attention was sought. Additional information is not expected.
Sex: F
Vaccine: RV, IPV, RV5, RV5, RV5
Symptoms: Diarrhoea, Haematochezia, Intussusception
Clinical narrative: Information has been received from a physician concerning a female baby who was vaccinated PO with the second dose of rotavirus vaccine. the physician reported that on 10/26/06, the pt developed intussusception and was hospitalized (length of hospitalization not provided). At the time of this report, the pt was noted to be recovering on therapy (not further specified). Additional information has been requested.
Sex: F
Vaccine: RV, IPV, RV5, RV5, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a female baby who was vaccinated PO with the second dose of rotavirus vaccine. the physician reported that on 10/26/06, the pt developed intussusception and was hospitalized (length of hospitalization not provided). At the time of this report, the pt was noted to be recovering on therapy (not further specified). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Hypoaesthesia
Clinical narrative: Information has been received from a neurologist concerning a female pt who was vaccinated with one dose of HPV vaccine. Subsequently the pt developed neuropathy and pain in the legs. The pt was diagnosed with Guillain Barre syndrome. The pts Guillain Barre syndrome persisted. Upon internal review, Guillain Barre syndrome was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Neuropathy, Pain
Clinical narrative: Information has been received from a neurologist concerning a female pt who was vaccinated with one dose of HPV vaccine. Subsequently the pt developed neuropathy and pain in the legs. The pt was diagnosed with Guillain Barre syndrome. The pts Guillain Barre syndrome persisted. Upon internal review, Guillain Barre syndrome was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 10 week old male pt who experienced death. At 10 weeks of age, the pt received a dose on 10/17/2006. Relevant medical history was not provided. Indication for Prevnar was immunisation. Product was administered on 10/17/06. Dose regimen was 1 dose 1 time per day IM. Concomitant medications were not reported. The pt expired (death) on 10/22/06. The cause of death was reported as unk. NO additional information was available at the time of this report.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Unevaluable event
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 10 week old male pt who experienced death. At 10 weeks of age, the pt received a dose on 10/17/2006. Relevant medical history was not provided. Indication for Prevnar was immunisation. Product was administered on 10/17/06. Dose regimen was 1 dose 1 time per day IM. Concomitant medications were not reported. The pt expired (death) on 10/22/06. The cause of death was reported as unk. NO additional information was available at the time of this report.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dehydration, Diarrhoea, Vomiting
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 10 week old male pt who experienced death. At 10 weeks of age, the pt received a dose on 10/17/2006. Relevant medical history was not provided. Indication for Prevnar was immunisation. Product was administered on 10/17/06. Dose regimen was 1 dose 1 time per day IM. Concomitant medications were not reported. The pt expired (death) on 10/22/06. The cause of death was reported as unk. NO additional information was available at the time of this report.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site warmth
Clinical narrative: Patient complained of inflamed and hot left arm at site of injection.  Patient did not specify when the onset of these symptoms occured, but he required medical treatment from an urgent care facility 3 days after the vaccine was administered.
Age: 1.5
Sex: F
Vaccine: HBHEPB
Symptoms: Arthritis, Arthritis reactive, Disability, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning an 18 month old female child with pertinent medical history and drug reactions/allergies reported as none on 8/2/06 was vaccinated with Hep B + Hib vaccine. Concomitant medication was reported as none. On 9/10/06, the pt developed reactive arthritis shortly after completing the series of Hep B + Hib conj vaccine. A titer on the pt was 1000 for hepatitis which the physician considered to be very high. The pt was said to have a disability because the arthritis was in both knees. The physician reported that the Hep B + Hib conj vaccine was given at another practice and no specifics were known. The pts reactive arthritis persisted and was considered to be disabling. Additional information has been requested. As of 10-Sep-06 reactive arthritis persists and was considered to be disabling.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Oedema, Pruritus
Clinical narrative: Information has been received from a licensed practical nurse concerning a 71 year old male with penicillin allergy and a history of diabetes mellitus and coronary artery disease who on 10/16/06 was vaccinated with Pneumococcal 23v polysaccharide vaccine (lot 651404/0352F). Concomitant therapy included influenza virus vaccine (manufacturer unspecified). On 10/16/06, the pt experienced swelling and itching over the injection site after vaccination with Pneumococcal 23v polysaccharide vaccine. This was the pts second vaccination with Pneumococcal 23v polysaccharide vaccine. The pt was treated with antibiotics and antihistamines. Subsequently on an unspecified date, the pt recovered from swelling and itching over injection site. Swelling and itching over the injection site were considered to be other important medical events (OMIC). Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Decreased appetite, Fatigue, Injection site erythema, Injection site swelling, Oedema
Clinical narrative: Information has been received from a licensed practical nurse concerning a 68 year old female with sulfa, amoxicillin and Cephalexin monohydrate allergy and a history of pulmonary embolism who on 10/30/06 was vaccinated with Pneumococcal 23v polysaccharide vaccine (lot 651404/0352F). Concomitant therapy included influenza virus vaccine (manufacturer unspecified). On 10/30/2006, the pt experienced an injection site reaction with fever, swelling, achiness, decreased appetite, erythema and fatigue. The pt had been previously vaccinated with Pneumococcal 23v polysaccharide vaccine in 1995. The pt was treated with antibiotics, antihistamines and steroids. At the time of the report, the pts injection site reaction with fever, swelling, achiness, decreased appetite, erythema and fatigue persisted. Injection site reaction with fever, swelling, achiness, decreased appetite, erythema and fatigue were considered to be other important medical events (OMIC). Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 68 year old female with sulfa, amoxicillin and Cephalexin monohydrate allergy and a history of pulmonary embolism who on 10/30/06 was vaccinated with Pneumococcal 23v polysaccharide vaccine (lot 651404/0352F). Concomitant therapy included influenza virus vaccine (manufacturer unspecified). On 10/30/2006, the pt experienced an injection site reaction with fever, swelling, achiness, decreased appetite, erythema and fatigue. The pt had been previously vaccinated with Pneumococcal 23v polysaccharide vaccine in 1995. The pt was treated with antibiotics, antihistamines and steroids. At the time of the report, the pts injection site reaction with fever, swelling, achiness, decreased appetite, erythema and fatigue persisted. Injection site reaction with fever, swelling, achiness, decreased appetite, erythema and fatigue were considered to be other important medical events (OMIC). Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC
Symptoms: Cough, Febrile convulsion, Feeling hot, Pyrexia, Rhinorrhoea
Clinical narrative: Information has been received from an investigator concerning a 12 month old male who was teething who on 10/4/06 the pt was vaccinated in the right arm with a 0.5 ml SC first dose of MMR II/Varicella. Suspect vaccination administered that day in the right thigh included in IM Third dose of Prevnar. it was noted that the pt was enrolled in a study. The subject received three doses of study vaccines (HCP 015 IPV and ActHib), the last doses prior to the event were administered on 4/17/06. Concomitant vaccination administered on 4/17/06 included a third IM dose in the right thigh of Hep B vaccine (manufacturer unk). The subject developed a fever with an axillary temp of 100 degs F and the same day had a febrile seizure 171 days post immunization with the study vaccines. According to the subjects mother, he felt hot to touch upon waking up. No antipyretics were administered before the seizure episode, which started 22 hours post vaccination with MMR II/Varicella and Prevnar. Lowering the body temp was attempted with a cool shower and reportedly the seizure stopped. Following the seizure, the subject had a runny nose and cough that were symptoms of an upper respiratory infection. The subject recovered and continued in the clinical trial. He had another episode of febrile seizure 20 days earlier. The subject was not to received any further MMR II/Varicella vaccine. The subject received no treatment for the event of febrile seizure and was not scheduled for any further evaluation. The event of febrile seizure was not reported by the investigator as unrelated to the study vaccine, and related to the MMR II/Varicella and Prevnar vaccine. The pts febrile seizure was considered to be an other important medical event (OMIC). Additional information has been requested.