chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: DTAP
Symptoms: Asthenia, Headache, Injection site mass, Neck pain, Oedema peripheral
Clinical narrative: shot given 1600(Sun) by 1100 next day(mon) 1/2" lump on right arm also entire arm and hand swelled,fever 99.5,weakness,extreme headache. Fever throught out night accompanied with itcy skin entire body, went to military sick call, told I am havinf severe allergic reaction to dtap, given loratine 10 mg for swelling and itching. stayed in bed next day felt better went to office, by noon fever started again. went home. layed in bed fever increased to 101.0 and headache much worse and now very sore neck. fever will not go down even after taking otc pain releiver. will return to Dr tommorrow if fever persist which will be 4th day after shot.(Thur) Currently at 7pm Wed, fever 99.5 neck very sore and very pinpointed headach in left side of head about 2 " above ear.
Age: 47.0
Sex: M
Vaccine: DTAP
Symptoms: Pruritus, Pyrexia
Clinical narrative: shot given 1600(Sun) by 1100 next day(mon) 1/2" lump on right arm also entire arm and hand swelled,fever 99.5,weakness,extreme headache. Fever throught out night accompanied with itcy skin entire body, went to military sick call, told I am havinf severe allergic reaction to dtap, given loratine 10 mg for swelling and itching. stayed in bed next day felt better went to office, by noon fever started again. went home. layed in bed fever increased to 101.0 and headache much worse and now very sore neck. fever will not go down even after taking otc pain releiver. will return to Dr tommorrow if fever persist which will be 4th day after shot.(Thur) Currently at 7pm Wed, fever 99.5 neck very sore and very pinpointed headach in left side of head about 2 " above ear.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Antibody test abnormal, Antinuclear antibody increased, Arthralgia, Convulsion, Diarrhoea
Clinical narrative: Patient received Merck's Gardasil vaccine 2 weeks ago and since has been experiencing a variety of symptoms, headaches, seizures, tingling, numbness, joint pain, diarrhea, n/v, coughing up blood, etc. etc.  She was seen by the PCP and in the ER twice.  Labs revealed elevated lymphocytes, an elevated ANA, and an abnormal antibody response.  She has since been dx with Lupus.  The GYN has contacted Merck and we are continuing with the recommended course of treatment however the symptoms have not subsided.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Haemoptysis, Headache, Hypoaesthesia, Lymphocyte count increased, Nausea
Clinical narrative: Patient received Merck's Gardasil vaccine 2 weeks ago and since has been experiencing a variety of symptoms, headaches, seizures, tingling, numbness, joint pain, diarrhea, n/v, coughing up blood, etc. etc.  She was seen by the PCP and in the ER twice.  Labs revealed elevated lymphocytes, an elevated ANA, and an abnormal antibody response.  She has since been dx with Lupus.  The GYN has contacted Merck and we are continuing with the recommended course of treatment however the symptoms have not subsided.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Paraesthesia, Systemic lupus erythematosus, Vomiting
Clinical narrative: Patient received Merck's Gardasil vaccine 2 weeks ago and since has been experiencing a variety of symptoms, headaches, seizures, tingling, numbness, joint pain, diarrhea, n/v, coughing up blood, etc. etc.  She was seen by the PCP and in the ER twice.  Labs revealed elevated lymphocytes, an elevated ANA, and an abnormal antibody response.  She has since been dx with Lupus.  The GYN has contacted Merck and we are continuing with the recommended course of treatment however the symptoms have not subsided.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Disturbance in attention, Fatigue, Haemoptysis, Lymphocyte count increased, Migraine
Clinical narrative: Patient received Merck's Gardasil vaccine 2 weeks ago and since has been experiencing a variety of symptoms, headaches, seizures, tingling, numbness, joint pain, diarrhea, n/v, coughing up blood, etc. etc.  She was seen by the PCP and in the ER twice.  Labs revealed elevated lymphocytes, an elevated ANA, and an abnormal antibody response.  She has since been dx with Lupus.  The GYN has contacted Merck and we are continuing with the recommended course of treatment however the symptoms have not subsided.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea, Neurological symptom, Systemic lupus erythematosus, Vomiting
Clinical narrative: Patient received Merck's Gardasil vaccine 2 weeks ago and since has been experiencing a variety of symptoms, headaches, seizures, tingling, numbness, joint pain, diarrhea, n/v, coughing up blood, etc. etc.  She was seen by the PCP and in the ER twice.  Labs revealed elevated lymphocytes, an elevated ANA, and an abnormal antibody response.  She has since been dx with Lupus.  The GYN has contacted Merck and we are continuing with the recommended course of treatment however the symptoms have not subsided.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: CSF test abnormal, Culture negative, Headache, Meningitis aseptic, Visual impairment
Clinical narrative: This case was reported by a physician and described the occurrence of aseptic meningitis in a 16-year-old male subject who was vaccinated with HAVRIX. The subject had no concomitant medications, relevant medical history or adverse events following previous vaccinations. On 31 December 2008 the subject received 2nd dose of HAVRIX (.5ml, unknown). On 10 January 2009, 10 days after vaccination with HAVRIX, the subject experienced aseptic meningitis, headache, weakness of left vision and elevated white blood cells. The subject was hospitalised for aseptic meningitis 10 days after vaccination with the second dose of HAVRIX. The physician considered the events were clinically significant (or requiring intervention). The subject had abnormal cerebrospinal fluid (CSF) laboratory values indicative of meningitis. All cultures were negative. On an unspecified date, the subject was discharged from the hospital and all symptoms resolved within five days. On 15 January 2009, the events were resolved. The physician considered the events were possibly related to vaccination with HAVRIX.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: White blood cell count increased
Clinical narrative: This case was reported by a physician and described the occurrence of aseptic meningitis in a 16-year-old male subject who was vaccinated with HAVRIX. The subject had no concomitant medications, relevant medical history or adverse events following previous vaccinations. On 31 December 2008 the subject received 2nd dose of HAVRIX (.5ml, unknown). On 10 January 2009, 10 days after vaccination with HAVRIX, the subject experienced aseptic meningitis, headache, weakness of left vision and elevated white blood cells. The subject was hospitalised for aseptic meningitis 10 days after vaccination with the second dose of HAVRIX. The physician considered the events were clinically significant (or requiring intervention). The subject had abnormal cerebrospinal fluid (CSF) laboratory values indicative of meningitis. All cultures were negative. On an unspecified date, the subject was discharged from the hospital and all symptoms resolved within five days. On 15 January 2009, the events were resolved. The physician considered the events were possibly related to vaccination with HAVRIX.
Age: 1.24
Sex: M
Vaccine: FLU3, HEPA, MMRV
Symptoms: Aphasia, Autism, Developmental coordination disorder, Psychomotor skills impaired, Pyrexia
Clinical narrative: Fever 102.3 (r) for 2 days morning after vaccinations. Child later diagnosed with Autism, aphasia, developmental coordination disorder.  2/24/09 Developmental assessment received dated 1/12/2009. Pt in for eval of develpmental delays and atypical behaviors.  Pt had a few words prior to 2nd birthday at which time his language and toileting skills regressed. By age 2 most vocab lost. Pt had persistant loose stools with unpleant odor which improved on gluten free diet. Becomes fixated on lights and ceiling fans, tunes parents out and acts like pt cannot hear them. Developmental course c/w Autism.   DX:  Congenital Encephalopathy manifesting as High Functioning Autism with emerging features of Asperger Syndrome. Aphasia manifesting as a moderate pragmatic language d/o. Developmental Coordination d/o manifesting as delayed fine motor and sensory processing skills leading to dysgraphia-d/o of written output.  Symptoms of anxiety.  Patient had fever response up to 102. Obviously the fever recovered, but the father's main concern was a change in his son's development noted at later well checks. He was diagnosed with Autism. I did not report the fever to VARES system because I feel this is a common reaction to vaccines especially now that we have the knowledge that Proqued has more often caused fever than MMR & VAR separately. Dad was upset that we had not reported his fever t the VARES system, so I welcomed him to report it. He is no longer our patient, so I am not aware of
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Crying
Clinical narrative: Inconsolable crying for 3 days after getting 1st set of vaccines at physician's office.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Burning sensation
Clinical narrative: From shot 1-3 of ANTHRAX I felt hands burning and unable to write.  From shot 4-6 felt burning at both hands, arms, chest, face & back of head.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Rash maculo-papular
Clinical narrative: Maculopapular rash over trunk, face & extremities.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Systemic lupus erythematosus
Clinical narrative: Information has been received from a physician concerning a 10 year old female patient who was vaccinated with a dose of GARDASIL (lot# not provided) 0.5ml intramuscularly. Subsequently the patient developed lupus. Patient sought unspecified medical attention and is currently under the care of a pediatric rheumatologist. Upon internal review lupus was considered to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Gastric disorder, Grip strength decreased, Joint swelling, Rheumatoid arthritis
Clinical narrative: Ref # 339290- Gradual/increasing symptoms of pain in joints/swelling initially in hand. Seen 7/18/08 DX Synovitis/Tenosynovitis. Labs ordered - normal - seen 8/1/08 increasing pain/edema (R) hand + (R) toes - referred to Orthopedist and he referred to Rheumatology
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Antinuclear antibody negative, Arthralgia, Blood immunoglobulin A, C-reactive protein normal, Full blood count normal
Clinical narrative: Ref # 339290- Gradual/increasing symptoms of pain in joints/swelling initially in hand. Seen 7/18/08 DX Synovitis/Tenosynovitis. Labs ordered - normal - seen 8/1/08 increasing pain/edema (R) hand + (R) toes - referred to Orthopedist and he referred to Rheumatology
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Joint swelling, Metabolic function test normal, Oedema peripheral, Pain in extremity, Rheumatoid factor negative
Clinical narrative: Ref # 339290- Gradual/increasing symptoms of pain in joints/swelling initially in hand. Seen 7/18/08 DX Synovitis/Tenosynovitis. Labs ordered - normal - seen 8/1/08 increasing pain/edema (R) hand + (R) toes - referred to Orthopedist and he referred to Rheumatology
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Synovitis, Tenosynovitis, Thyroid function test normal
Clinical narrative: Ref # 339290- Gradual/increasing symptoms of pain in joints/swelling initially in hand. Seen 7/18/08 DX Synovitis/Tenosynovitis. Labs ordered - normal - seen 8/1/08 increasing pain/edema (R) hand + (R) toes - referred to Orthopedist and he referred to Rheumatology
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema normal, Crying, Dehydration, Diarrhoea, Immunology test
Clinical narrative: Information has been received from a physician concerning a 55 day old male who on 20-JAN-2009 was vaccinated orally with a 2 ml first dose of ROTATEQ (lot# 659916/0964X).  Concomitant therapy included PREVNAR, PEDIARIX and ACTHIB.  On 26-JAN-2009 the patient developed vomiting, diarrhea, fever and was hospitalized.  Rotavirus test and barium enema were performed and the patient came out positive for rotavirus.  The patient was hospitalized for the third time on 04-FEB-2009.  At the time of this report, as 05-FEB-2009, the patient had not recovered from the rotavirus.  Additional information has been requested.
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Immunology test abnormal, Pyrexia, Rotavirus test positive, Vomiting, Vomiting projectile
Clinical narrative: Information has been received from a physician concerning a 55 day old male who on 20-JAN-2009 was vaccinated orally with a 2 ml first dose of ROTATEQ (lot# 659916/0964X).  Concomitant therapy included PREVNAR, PEDIARIX and ACTHIB.  On 26-JAN-2009 the patient developed vomiting, diarrhea, fever and was hospitalized.  Rotavirus test and barium enema were performed and the patient came out positive for rotavirus.  The patient was hospitalized for the third time on 04-FEB-2009.  At the time of this report, as 05-FEB-2009, the patient had not recovered from the rotavirus.  Additional information has been requested.
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Enema administration, Pyrexia, Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 55 day old male who on 20-JAN-2009 was vaccinated orally with a 2 ml first dose of ROTATEQ (lot# 659916/0964X).  Concomitant therapy included PREVNAR, PEDIARIX and ACTHIB.  On 26-JAN-2009 the patient developed vomiting, diarrhea, fever and was hospitalized.  Rotavirus test and barium enema were performed and the patient came out positive for rotavirus.  The patient was hospitalized for the third time on 04-FEB-2009.  At the time of this report, as 05-FEB-2009, the patient had not recovered from the rotavirus.  Additional information has been requested.
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 55 day old male who on 20-JAN-2009 was vaccinated orally with a 2 ml first dose of ROTATEQ (lot# 659916/0964X).  Concomitant therapy included PREVNAR, PEDIARIX and ACTHIB.  On 26-JAN-2009 the patient developed vomiting, diarrhea, fever and was hospitalized.  Rotavirus test and barium enema were performed and the patient came out positive for rotavirus.  The patient was hospitalized for the third time on 04-FEB-2009.  At the time of this report, as 05-FEB-2009, the patient had not recovered from the rotavirus.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Balance disorder, Culture throat, Dehydration, Headache
Clinical narrative: Taken to ER for syncope and vomiting shortly after receiving shot. Needed I/V fluids
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Malaise, Mononucleosis heterophile test positive, Pyrexia, Vomiting
Clinical narrative: Taken to ER for syncope and vomiting shortly after receiving shot. Needed I/V fluids
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope, Vomiting
Clinical narrative: Taken to ER for syncope and vomiting shortly after receiving shot. Needed I/V fluids
Age: 58.0
Sex: U
Vaccine: PPV
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 12/30/2008 for COPD exacerbation. Vaccination took place on 12/11/2008.  According to the physician, the relationship to treatment is 'None'. We would be happy to forward the Study's SAE reporting form upon request.  2/13/09 MR received for DOS 12/30/2008-1/3/2009 with D/C DX:  Acute COPD exacerbation. Pt presented with c/o SOB and pain all over. CO2 narcosis seen on ABGs. Increasing difficulty with breathing and intubated. Tx with steroids and abx. Hypotensive- tx with fluids. Extubated next day and returned to baseline by 1/3/09.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Immediate post-injection reaction, Oropharyngeal pain, Pruritus, Urticaria
Clinical narrative: 5 MIN AFTER GETTING VARICELLA VACCINE SAID HIS THROAT HURT, COUGHING, ITCHING.  IMMEDIATELY GIVEN ALBUTEROL, BENEDRYL AND DECADRON. DEVELOPED HIVES WIDE SPREAD. PT TRANSPORTED TO ED FOR OBSERVATION.  SENT HOME IN GOOD CONDITION.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Pruritus generalised, Respiratory distress, Skin discolouration
Clinical narrative: Client called and reported L arm "purple"  all the way down and "itching all over" with tingling of L arm.  Began approx 30-45 minutes after vaccine--took po Benadryl at work.  Was evaluated @ ER--was treated with IV solumedrol and SQ epinephrine.  States upon arrival to ER began with respiratory distress.  States MD advised avoid tetanus vaccination in future unless given in hospital or clinic.
Sex: M
Vaccine: HEP
Symptoms: Lethargy, Screaming
Clinical narrative: Extreme lethargy after Hepatitis B vaccination that was administered at approximately 24 hours after delivery of child.  When performing metabolic tests afterward where heel was pierced to draw blood there was no reaction to the needle at all nor to the strong pressure that had to be put on his heel to extract the blood.  There was no motion of his body, limbs or facial muscles during this whole process.  For days following the vaccination he was lethargic with bouts of screaming fits.  His first 24 hours of life he was very responsive to even light touch.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Choking, Condition aggravated, Erythema, Swelling face, Swollen tongue
Clinical narrative: On 10/25/08, @ 8-9AM, mom observed infant to start to choke and exhibited redness all over his face and swelling observed by mom on tongue and cheeks.  this occured after mom had conpleted bottle feeding and approx 30 hr after infant received immunizations. on 10/24/08 @ 2PM.  Mom called EMS and was advised to have infant taken to ER.  Was told infant was OK then.  They left for ER approx 9-10PM and left ER @ 2-3AM.  Mom took infant to PMD @ 8:30 AM 10/26/08--mom reported that EMS observed the swelling.  Mom also said MD said he was OK then.  Mom did report a prior episode of choking before the above instance--also reported swelling on tongue, face--seen in ED also for that episode and was told infant was fine.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: vaccine given 02/09/09. on 02/10/09 mother reported swelling and redness at injection site, RN advised mom to alternate cool and warm compresses to site and give diphenhydramine Q 6 hours as needed. mom to monitor site and report if worse on 02/11/09. on 2/11/09 mother reports that swelling and redness circle arm and warm to touch. RN offered mom appts on 2/11/09 and mother declined. Appt set for 2/12/09. Seen in office with irregular borders covering deltoid area of upper L ext measuring 20cm X 18cm at largest area. Advised mother to continue above care she verbalized understanding and is to call if site worsens or no better in 3-5 days.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Herpes zoster, Rash
Clinical narrative: On 1/16/09, two days after vaccine administration, the patient developed a rash on her left lower extremity and was diagnosed with shingles. This is a follow-up to report(s) previously submitted on 3/27/2003. Information has been received from a registered nurse concerning a 71 year old female with hypertension, hypocholesterolaemia, hypothyroidism, migraine, solfonamide allergy, codeine allergy and shellfish allergy who on 14-JAN_2009 was vaccinated with ZOSTAVAX (lot # 66317/15553X). 0.65ml subcutaneously on left arm, concomitant therapy included SYNTHROID, LIPITOR, DIOVAN, and FIORINAL. It was reported that the patient developed a rash that was diagnosed as shingles after receiving the vaccine. the nurse stated that the rash is on the patient's left lower back, buttocks, and left upper leg and groin. The patient required an office visit on 17-JAN-2009. Patient recovered. Follow up information has been received from a physician concerning the patient who also had a lisinopril (manufacturer not reported) allergy (WAES # 0909USA00866). Shingles developed on 16-JAN-2009 along the left LI dermatome. The rash was described as a full bown shingles episode with numerous lesions. The patient did not remember if there was a history of chicken pox, however there was no recent exposure to chicken pox. The patient's recovery was "In progress'. The patient was enrolled in the Varicella Identification program to identify if VZV is present, and if present, to identify whether it is associated with the wild type (WT) VZV strain or whether it is identified with the Oka/Merck vaccine VZV strain. The sample of the lesion was collected on 23-JAN-2009. The sample was sent to the laboratory on 26-JAN-2009. Follow up infomation has been received from the registered nurse concerning the female patient who on 14-JAN-2009 at 09:30 a.m was vaccinated in the physician's office with ZOSTAVAX (lot # 663195/15553X). Subcutaneously, on 14-JAN-2009 in the night, the patient experienced an uncomfortable feeling and was given FAMUIR, VIREX and PERCOCET. The patient broke out in rash on 17-JAN-2009, time was unknown. Rash developed on buttocks and genital area. The patient was seen in the physician's office on 19-JAN-2009 since she still had pain and was prescribed gabapentin. On 10-FEB-2009 the patient was seen again in the physician's office, she had recovered. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Viral DNA test positive
Clinical narrative: On 1/16/09, two days after vaccine administration, the patient developed a rash on her left lower extremity and was diagnosed with shingles. This is a follow-up to report(s) previously submitted on 3/27/2003. Information has been received from a registered nurse concerning a 71 year old female with hypertension, hypocholesterolaemia, hypothyroidism, migraine, solfonamide allergy, codeine allergy and shellfish allergy who on 14-JAN_2009 was vaccinated with ZOSTAVAX (lot # 66317/15553X). 0.65ml subcutaneously on left arm, concomitant therapy included SYNTHROID, LIPITOR, DIOVAN, and FIORINAL. It was reported that the patient developed a rash that was diagnosed as shingles after receiving the vaccine. the nurse stated that the rash is on the patient's left lower back, buttocks, and left upper leg and groin. The patient required an office visit on 17-JAN-2009. Patient recovered. Follow up information has been received from a physician concerning the patient who also had a lisinopril (manufacturer not reported) allergy (WAES # 0909USA00866). Shingles developed on 16-JAN-2009 along the left LI dermatome. The rash was described as a full bown shingles episode with numerous lesions. The patient did not remember if there was a history of chicken pox, however there was no recent exposure to chicken pox. The patient's recovery was "In progress'. The patient was enrolled in the Varicella Identification program to identify if VZV is present, and if present, to identify whether it is associated with the wild type (WT) VZV strain or whether it is identified with the Oka/Merck vaccine VZV strain. The sample of the lesion was collected on 23-JAN-2009. The sample was sent to the laboratory on 26-JAN-2009. Follow up infomation has been received from the registered nurse concerning the female patient who on 14-JAN-2009 at 09:30 a.m was vaccinated in the physician's office with ZOSTAVAX (lot # 663195/15553X). Subcutaneously, on 14-JAN-2009 in the night, the patient experienced an uncomfortable feeling and was given FAMUIR, VIREX and PERCOCET. The patient broke out in rash on 17-JAN-2009, time was unknown. Rash developed on buttocks and genital area. The patient was seen in the physician's office on 19-JAN-2009 since she still had pain and was prescribed gabapentin. On 10-FEB-2009 the patient was seen again in the physician's office, she had recovered. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: DPP, PPV
Symptoms: Body temperature increased, Fatigue, Injection site pain, Lymph node pain, Urticaria
Clinical narrative: temperature 102 deg. - hives - severe pain at site and lymph nodes under arm - fatigue
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Hyperaesthesia, Induration, Mass, Skin warm
Clinical narrative: client returned to clinic 2/9/09 stating she noted small lump left tricep region appr. 10 days prior.  reports area getting progressively larger. area appr. 25cm. slightly reddened, warm, sensitive to touch, hard.  denies fever, other systemic signs/symptoms.  referred to primary care provider.  placed on antibiotics for 7 days with follow up visit scheduled 12/16/09.
Age: 14.0
Sex: F
Vaccine: DTAP, HEPA, HPV4
Symptoms: Chest pain, Dizziness, Hyperhidrosis, Pallor, Palpitations
Clinical narrative: After the third dose my daughter got very pale, sweaty, aand dizzy.  The nurse and I layed her back on the exam table.  She became unresponsive for 10-20 seconds and stayed laying down for about 10 minutes after that until she was no longer dizzy.  My daughter started having heart palpitations after this and still has them today.  Starting in February 2009, they are accompanied by chest pains.  4/8/09  PCP records received from 7/15/08 to 2/10/09. Seen for 14 yr WCC on 7/15/08 with c/o heavy periods.  ROS (+) for headaches QOD.  PE WNL with acne. Started on Concerta of ADD and OCs to regulate periods.  Seen again 9/9/08 and 9/12/08 with c/o racing heart and irregular heartbeats associated with some anxiety.  PE WNL.  HR 95-105.  Assess:  Palpitations and/or tachycardia while on Concerta.  Nausea from OCPs. Referred to cardiology for Holter. Returned 2/10/09 for c/o chest pain with skipped beats and feeling like the heart is beating hard.  4-6 episodes in last 2 weeks. Assessment:  Likely precordial catch syndrome.  Palpitations. Holter to be scheduled.  4/29/09 Received Cardiology medical records of  10/7/08-3/5/2009. FINAL DX: Palpitations Records reveal patient experienced palpitations w/chest pain & dizziness.  Concerta had been d/c approx 1 mo prior to initial eval & palpitations had improved; however, patient needed to restart meds to maintain academic performance.  When seen 3/5/09 palpitations had recurred while on Concerta esp when exercising. No further records available.
Age: 14.0
Sex: F
Vaccine: DTAP, HEPA, HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: After the third dose my daughter got very pale, sweaty, aand dizzy.  The nurse and I layed her back on the exam table.  She became unresponsive for 10-20 seconds and stayed laying down for about 10 minutes after that until she was no longer dizzy.  My daughter started having heart palpitations after this and still has them today.  Starting in February 2009, they are accompanied by chest pains.  4/8/09  PCP records received from 7/15/08 to 2/10/09. Seen for 14 yr WCC on 7/15/08 with c/o heavy periods.  ROS (+) for headaches QOD.  PE WNL with acne. Started on Concerta of ADD and OCs to regulate periods.  Seen again 9/9/08 and 9/12/08 with c/o racing heart and irregular heartbeats associated with some anxiety.  PE WNL.  HR 95-105.  Assess:  Palpitations and/or tachycardia while on Concerta.  Nausea from OCPs. Referred to cardiology for Holter. Returned 2/10/09 for c/o chest pain with skipped beats and feeling like the heart is beating hard.  4-6 episodes in last 2 weeks. Assessment:  Likely precordial catch syndrome.  Palpitations. Holter to be scheduled.  4/29/09 Received Cardiology medical records of  10/7/08-3/5/2009. FINAL DX: Palpitations Records reveal patient experienced palpitations w/chest pain & dizziness.  Concerta had been d/c approx 1 mo prior to initial eval & palpitations had improved; however, patient needed to restart meds to maintain academic performance.  When seen 3/5/09 palpitations had recurred while on Concerta esp when exercising. No further records available.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms
Clinical narrative: Client states approximately ten days after receiving Zostavax vaccine, she had severe muscle cramps 5 to 10 times a day in the following areas of her body; the lower rib cage, abdomen, back, arms and legs. No c/o GI symptoms. Denies taking medication for muscle cramps. She states muscle cramps have decrease one to two times daily and cramps are not as painful or severe. Presently, client is vacationing and will return home on March 3, 2009.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Culture stool negative, Diarrhoea, Rotavirus test negative, Vaccine positive rechallenge
Clinical narrative: The patient developed diarrhea (10 watery stools per day, 2 days after to Rotavirus vaccine.  He also developed diarrhea after the rotavirus vaccine given at 4 months of age.  The diarrhea at that time had blood in it.  A stool culture and rotavirus test were negative.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site haematoma
Clinical narrative: 40mm x 35mm area of "bruising", erythema right upper outer arm (area of injection site). No systemic symptoms.
Age: 1.5
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: MOM STATES "HAD FULL BODY RASH, NO FEVER."
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC, RV5
Symptoms: Urticaria
Clinical narrative: urticarial rash onset 5 days after vaccines ?rotavirus vac.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Echocardiogram
Clinical narrative: Vaccine given 2/20/08.  On about 2/26 pt went into CHF, symptomatic. She recovered spontaneously by about 3/12/08.  Background:  Severe mital regurgitation due to mitral valve prolapse and prior bacterial endocarditis about 30 years ago.  Echo after this episode unchanged from preimmunization.
Age: 0.92
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: PARENT CALLED AND REPORTED HIVES STARTING 30 MINUTES AFTER DTAP WAS ADMINISTERED.BENADRYL WAS GIVEN.  CONTINUED TO HAVE HIVES OFF AND ON OVER NEXT 72 HOURS.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Asthenia, Blood test normal, Brain scan normal, Cardiac flutter
Clinical narrative: I received the TDAP vaccine on the morning of Jan. 26. That night, I was unable to sleep, felt very dry, and consumed a large amount of water. The next day, I felt faint, weak and nauseated, and heart fluttering. The following morning, I went by ambulance to the ER because I felt very close to fainting, and my heart was racing, and I felt that I was about to throw up. My heart rate was high, and the doctor noted that I was pale. I had a strong feeling of doom. The ER found nothing peculiar in my bloodwork, and nothing abnormal on a brain scan. They said I was dehydrated, gave me IV fluid, and sent me home. Two days later, despite having consumed large amounts of fluid, I went to an urgent care center for the same symptoms. I collapsed at the center while signing for the co-pay but did not lose consciousness. My blood pressure was not high, but my heart rate was. They said I was orthostatic, gave me IV fluids, and sent me home. The following day, Saturday, I went back to the ER with the same symptoms. They ran blood and urine tests - all normal - said I had a "virus," and provided no treatment. On Monday, one week after the vaccination, I went to see my regular physician, where I had received the vaccine. There I was orthostatic, except my blood pressure was not high; I was sent to urgent care and given IV fluids and sent home. This pattern continued until I had received four different IV fluid infusions. Urgent care referred me to cardiology, which did an echocardiogram (nothing), and which provided me with a 24-hour heart monitor, (also nothing.) With symptoms of racing heart, weakness, nausea and near-fainting continuing, I went to see my endocrinologist, who ran a test for adrenal gland insufficiency (nothing) and who ordered a 24-hour urine sample, to test for various other potential hormonal problems. Not all of these results are in yet, but no results received so far have identified a cause. I have been markedly better since about Feb. 8/9, but still experiencing some symptoms. My doctors have said they do not think this is related to the vaccine because my symptoms continued for several days (more than 48 hours) and because many people receive this vaccine without significant incident. I felt it should be reported anyway, since my symptoms appeared shortly after I received the vaccine, are consistent with potential adverse reaction to the vaccine per the CDC flyer, and the doctors cannot find an alternative cause except for a theoretical virus.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Dehydration, Dizziness, Echocardiogram normal, Heart rate increased, Heart rate normal
Clinical narrative: I received the TDAP vaccine on the morning of Jan. 26. That night, I was unable to sleep, felt very dry, and consumed a large amount of water. The next day, I felt faint, weak and nauseated, and heart fluttering. The following morning, I went by ambulance to the ER because I felt very close to fainting, and my heart was racing, and I felt that I was about to throw up. My heart rate was high, and the doctor noted that I was pale. I had a strong feeling of doom. The ER found nothing peculiar in my bloodwork, and nothing abnormal on a brain scan. They said I was dehydrated, gave me IV fluid, and sent me home. Two days later, despite having consumed large amounts of fluid, I went to an urgent care center for the same symptoms. I collapsed at the center while signing for the co-pay but did not lose consciousness. My blood pressure was not high, but my heart rate was. They said I was orthostatic, gave me IV fluids, and sent me home. The following day, Saturday, I went back to the ER with the same symptoms. They ran blood and urine tests - all normal - said I had a "virus," and provided no treatment. On Monday, one week after the vaccination, I went to see my regular physician, where I had received the vaccine. There I was orthostatic, except my blood pressure was not high; I was sent to urgent care and given IV fluids and sent home. This pattern continued until I had received four different IV fluid infusions. Urgent care referred me to cardiology, which did an echocardiogram (nothing), and which provided me with a 24-hour heart monitor, (also nothing.) With symptoms of racing heart, weakness, nausea and near-fainting continuing, I went to see my endocrinologist, who ran a test for adrenal gland insufficiency (nothing) and who ordered a 24-hour urine sample, to test for various other potential hormonal problems. Not all of these results are in yet, but no results received so far have identified a cause. I have been markedly better since about Feb. 8/9, but still experiencing some symptoms. My doctors have said they do not think this is related to the vaccine because my symptoms continued for several days (more than 48 hours) and because many people receive this vaccine without significant incident. I felt it should be reported anyway, since my symptoms appeared shortly after I received the vaccine, are consistent with potential adverse reaction to the vaccine per the CDC flyer, and the doctors cannot find an alternative cause except for a theoretical virus.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Insomnia, Loss of consciousness, Nausea, Pallor, Palpitations
Clinical narrative: I received the TDAP vaccine on the morning of Jan. 26. That night, I was unable to sleep, felt very dry, and consumed a large amount of water. The next day, I felt faint, weak and nauseated, and heart fluttering. The following morning, I went by ambulance to the ER because I felt very close to fainting, and my heart was racing, and I felt that I was about to throw up. My heart rate was high, and the doctor noted that I was pale. I had a strong feeling of doom. The ER found nothing peculiar in my bloodwork, and nothing abnormal on a brain scan. They said I was dehydrated, gave me IV fluid, and sent me home. Two days later, despite having consumed large amounts of fluid, I went to an urgent care center for the same symptoms. I collapsed at the center while signing for the co-pay but did not lose consciousness. My blood pressure was not high, but my heart rate was. They said I was orthostatic, gave me IV fluids, and sent me home. The following day, Saturday, I went back to the ER with the same symptoms. They ran blood and urine tests - all normal - said I had a "virus," and provided no treatment. On Monday, one week after the vaccination, I went to see my regular physician, where I had received the vaccine. There I was orthostatic, except my blood pressure was not high; I was sent to urgent care and given IV fluids and sent home. This pattern continued until I had received four different IV fluid infusions. Urgent care referred me to cardiology, which did an echocardiogram (nothing), and which provided me with a 24-hour heart monitor, (also nothing.) With symptoms of racing heart, weakness, nausea and near-fainting continuing, I went to see my endocrinologist, who ran a test for adrenal gland insufficiency (nothing) and who ordered a 24-hour urine sample, to test for various other potential hormonal problems. Not all of these results are in yet, but no results received so far have identified a cause. I have been markedly better since about Feb. 8/9, but still experiencing some symptoms. My doctors have said they do not think this is related to the vaccine because my symptoms continued for several days (more than 48 hours) and because many people receive this vaccine without significant incident. I felt it should be reported anyway, since my symptoms appeared shortly after I received the vaccine, are consistent with potential adverse reaction to the vaccine per the CDC flyer, and the doctors cannot find an alternative cause except for a theoretical virus.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Presyncope, Syncope, Urine analysis normal, Viral infection
Clinical narrative: I received the TDAP vaccine on the morning of Jan. 26. That night, I was unable to sleep, felt very dry, and consumed a large amount of water. The next day, I felt faint, weak and nauseated, and heart fluttering. The following morning, I went by ambulance to the ER because I felt very close to fainting, and my heart was racing, and I felt that I was about to throw up. My heart rate was high, and the doctor noted that I was pale. I had a strong feeling of doom. The ER found nothing peculiar in my bloodwork, and nothing abnormal on a brain scan. They said I was dehydrated, gave me IV fluid, and sent me home. Two days later, despite having consumed large amounts of fluid, I went to an urgent care center for the same symptoms. I collapsed at the center while signing for the co-pay but did not lose consciousness. My blood pressure was not high, but my heart rate was. They said I was orthostatic, gave me IV fluids, and sent me home. The following day, Saturday, I went back to the ER with the same symptoms. They ran blood and urine tests - all normal - said I had a "virus," and provided no treatment. On Monday, one week after the vaccination, I went to see my regular physician, where I had received the vaccine. There I was orthostatic, except my blood pressure was not high; I was sent to urgent care and given IV fluids and sent home. This pattern continued until I had received four different IV fluid infusions. Urgent care referred me to cardiology, which did an echocardiogram (nothing), and which provided me with a 24-hour heart monitor, (also nothing.) With symptoms of racing heart, weakness, nausea and near-fainting continuing, I went to see my endocrinologist, who ran a test for adrenal gland insufficiency (nothing) and who ordered a 24-hour urine sample, to test for various other potential hormonal problems. Not all of these results are in yet, but no results received so far have identified a cause. I have been markedly better since about Feb. 8/9, but still experiencing some symptoms. My doctors have said they do not think this is related to the vaccine because my symptoms continued for several days (more than 48 hours) and because many people receive this vaccine without significant incident. I felt it should be reported anyway, since my symptoms appeared shortly after I received the vaccine, are consistent with potential adverse reaction to the vaccine per the CDC flyer, and the doctors cannot find an alternative cause except for a theoretical virus.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Flushing, Injection site erythema, Injection site pain, Pruritus
Clinical narrative: pain at injection sight up into shoulder, erythema, entire arm itching, face flushed.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Flushing, Injection site pain, Pruritus, Pyrexia
Clinical narrative: Erythema, pain at injection sight up to shoulder and down arm, entire arm itching, flushing in face, vomitting, and fever. itching, pain, flushing started within 15 minutes. vomitting started approx 3 hours after injection.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Erythema, pain at injection sight up to shoulder and down arm, entire arm itching, flushing in face, vomitting, and fever. itching, pain, flushing started within 15 minutes. vomitting started approx 3 hours after injection.
Age: 55.0
Sex: F
Vaccine: DTAP
Symptoms: Body temperature increased, Erythema, Induration, Pain, Skin warm
Clinical narrative: 6.5 x 12 cm area of erythema, induration, hot to the touch, and sharply demarcated. Patient complained of pain... tender to touch.Patient had a low grade temperature of 99.6
Age: 55.0
Sex: F
Vaccine: DTAP
Symptoms: Tenderness
Clinical narrative: 6.5 x 12 cm area of erythema, induration, hot to the touch, and sharply demarcated. Patient complained of pain... tender to touch.Patient had a low grade temperature of 99.6
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: CSF test normal, Computerised tomogram normal, Drug screen positive, Full blood count normal, Insomnia
Clinical narrative: 2/6/2009  7:00 p.m.  To E.R. by ambulance for sudden onset altered loss of consciousness.  Obtained labs, CT, lumbar puncture.  Had been c/o insomnia over 3 weeks prior to event, but also documented in pt. record as having 'troubles getting to sleep at night' in 4/2008.  3/23/08 MR received for ER visit 2/6/08 with DX:  Vomiting, unclear etiology.  Altered LOC, unclear etiology. Pt presented with acute onset of vomiting with altered LOC.  Pt recently reporting H/As and near syncopal episode.  PE WNL. Given KCl for mild hypokalemia and d/c home for outpt f/u.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Loss of consciousness, Urine analysis normal
Clinical narrative: 2/6/2009  7:00 p.m.  To E.R. by ambulance for sudden onset altered loss of consciousness.  Obtained labs, CT, lumbar puncture.  Had been c/o insomnia over 3 weeks prior to event, but also documented in pt. record as having 'troubles getting to sleep at night' in 4/2008.  3/23/08 MR received for ER visit 2/6/08 with DX:  Vomiting, unclear etiology.  Altered LOC, unclear etiology. Pt presented with acute onset of vomiting with altered LOC.  Pt recently reporting H/As and near syncopal episode.  PE WNL. Given KCl for mild hypokalemia and d/c home for outpt f/u.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Discomfort, Erythema, Injection site swelling, Skin warm
Clinical narrative: Four inches long by three inches wide swelling of injection site - 24-48 hours from injection.  Red & hot to the touch. Tylenol for discomfort.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Debridement, Gram stain negative, Necrotising fasciitis
Clinical narrative: We received from a health care professional via the Medical Communication the following information on 30 JAN 2009: A 52-year-old male patient was vaccinated with FLUVIRIN, batch-no. 881292P, i.m. into the right upper arm on 27 JAN 2009. Additionally he was vaccinated with PNEUMOVAX in the right upper arm on the same day. On 28 JAN 2009 he was admitted to the hospital with necrotizing fasciitis in the right shoulder. The patient was surgically debrided. Vaccination history: previous vaccination (s) was (were) given, no information about tolerance. On 04 FEB 2009 we received the following information by phone from the reporting physician: The injection was given by a registered nurse and the reaction started approximately 6 to 8 hours after injection. Laboratory result: wound culture, gram stain negative after 48 hours. The patient's status did not recover and he is to be discharged home on oral antibiotics. No change in assessment. Review of manufacturing protocols on 06 FEB 2009 demonstrated that there were no concerns about sterility.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acute myeloid leukaemia, Dyspnoea, Nausea, Vomiting
Clinical narrative: 12/17/08 mom took patient to ER for nausea and vomiting. 12/19/08 mom took patient to ER for shortness of breath. Diagnosed with acute myeloid leukemia.  2/18/09 Received ER medical records of 12/17/2008. FINAL DX: vomiting w/o dehydration. Records reveal patient experienced N/V x 3 days, no BM x 2 days.  Able to tolerate oral fluids.  Tx w/antinausea meds & d/c home on additional antinausea meds.  3/23/09 Received hospital medical records of 12/19/08-remains inpatient. FINAL DX: acute myeloblastic leukemia; respiratory failure; severe thrombocytopenia & anemia w/severe neutropenia; pneumonia; renal failure. Records reveal patient experienced flu-like symptoms, bone aching, bruising & petechial rash, pale, fatigue, SOB, low grade fever & abdominal pain w/vomiting x 3-5 days w/conjunctival hemorrhage.  Developedencephalopathy, respiratory distress, renal failure, tumor lysis syndrome, metabolic derangements, ARDS, labile BP.   Heme/onc, Pulm, ID, Nephro consult.  Admitted PICU, intubated followed by tracheostomy, initially CVVH followed by peritoneal dialysis, multiple transfusions, antibiotics, chemotherapy. Developed pancytopenia secondary to chemotherapy.   10/1/09 Hospital discharge summary received DOS 12/19/08 to 8/4/09. Additional information abstracted. Assessment: Acute myeloid leukemia. Acute Respiratory distress syndrome with pulmonary fibrosis, refractory thrombocytopenia, recurrent infections and bacteremia, muscle contractures, renal insufficiency. Patient on TPN. Chemotherapy. Physical therapy. Discharged to rehab center. 11/5/2009 MR dated 7/30 is aprogress note stating that patient is in remission per bone marrow done 7/1/2009. Patient had a tracheostomy 2/2009 and now wears a trach collar. Patient underwent Chemotherapy x 3 cycles with remission. Patient is off TPN 7/2009 and is eating and drinking. Patient still has low paltelet and hemoglobin counts and is transfused for this on a regular basis. Patient is now undergoing intense rehab.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient fainted within 2 minutes of vaccine administration. Patient obs x 45 minutes. BP checked after 10min. BS checked-88. Drank water. Walked out of office escorted
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Local rxn both sites - Erythema no fluctuance. (R) arm ~2-5cm; (L) arm ~8cm. TX - BENADRYL + TYLENOL.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Pt's face and neck turned red with a rash and itch - symptoms ongoing
Age: 9.0
Sex: F
Vaccine: FLU3, IPV
Symptoms: Blood pressure normal, Bronchospasm, Dyspnoea, Oxygen saturation normal
Clinical narrative: Pt had severe bronchospasm and shortness of breath 40 minutes after vaccine. No EPi needed; Stable Bp and O2 SAT, 911 to ER -discharged home.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Pyrexia
Clinical narrative: Patient started temp 1:30 am 2/12/09. Mom gave MOTRIN temp was 100.8 at highest, no sore at injection site.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Oedema peripheral, Tenderness
Clinical narrative: 2nd shot left deltoid swollen and tender.  1st GARDASIL injection given 8/16/08 and no reaction.  2nd GARDASIL injection given 2/4/09 and above reaction occurred