chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Dehydration, Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive, Stool analysis abnormal
Clinical narrative: Information has been received from a health professional concerning a 12 month old male who on 10-JAN-2007, 00-MAR-2007 and 09-MAY-2007 was vaccinated PO with his first, second and third doses of Rotateq (batch# not reported, lot# not reported). Six months after the third dose, middle November 2007, the patient experienced diarrhea with severe vomiting, severe dehydration, weight decreased (1 kg). The patient was admitted to the hospital for 4 days. The patient was treated with intravenous rehydration. A stool analysis was performed which revealed a rotavirus positive result. Subsequently, the patient recovered. Other business partner numbers include: E2007-09304. No further information is available. The case is closed.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Vomiting, Weight decreased
Clinical narrative: Information has been received from a health professional concerning a 12 month old male who on 10-JAN-2007, 00-MAR-2007 and 09-MAY-2007 was vaccinated PO with his first, second and third doses of Rotateq (batch# not reported, lot# not reported). Six months after the third dose, middle November 2007, the patient experienced diarrhea with severe vomiting, severe dehydration, weight decreased (1 kg). The patient was admitted to the hospital for 4 days. The patient was treated with intravenous rehydration. A stool analysis was performed which revealed a rotavirus positive result. Subsequently, the patient recovered. Other business partner numbers include: E2007-09304. No further information is available. The case is closed.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Abscess drainage, Blood culture negative, Culture wound negative, Injection site abscess, Injection site erythema
Clinical narrative: Pt received imm 10-25-07 Pediarix, HIB, Prevnar. Admitted through the ER on 11-4-07 with abscess to right thigh. Abscess was I & D'd and pt was put on IV abx - D/C on 11-9-07. Red, swollen knot (R) thigh, hard to touch, fever 102.  2/12/2008 MR received for DOS 11/4-9/2007 with D/C DX:  Abscess to R thigh.  Urinary Tract Infection.  Leucopenia. Child presented with abscess to R thigh requiring I&D in the ER.  WBCs noted to be very low. Abscess tx with IV abx. Leucopenia to be followed as outpt  Per 60 day follow up: Pt has scar at site of abcess in thigh-has fatty defect. Underlying congenital leukopenia still present & under evaluation.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site induration, Injection site mass, Injection site swelling, Pyrexia
Clinical narrative: Pt received imm 10-25-07 Pediarix, HIB, Prevnar. Admitted through the ER on 11-4-07 with abscess to right thigh. Abscess was I & D'd and pt was put on IV abx - D/C on 11-9-07. Red, swollen knot (R) thigh, hard to touch, fever 102.  2/12/2008 MR received for DOS 11/4-9/2007 with D/C DX:  Abscess to R thigh.  Urinary Tract Infection.  Leucopenia. Child presented with abscess to R thigh requiring I&D in the ER.  WBCs noted to be very low. Abscess tx with IV abx. Leucopenia to be followed as outpt  Per 60 day follow up: Pt has scar at site of abcess in thigh-has fatty defect. Underlying congenital leukopenia still present & under evaluation.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Chest X-ray abnormal, Fluid retention, Full blood count, Liver function test normal
Clinical narrative: Congestive heart failure, fluid retention (20 lb wt gain 6 wk after vaccination).  01/10/2008 MR records received from PCP, including several f/u visits to pain specialist and hospital D/c Summary from 8/27/07 for Intractable recurrent tension headaches (prior to vax).  Pt seen 10/31/2007 for Zostavax due to family member with shingles. Wt 143. OV 12/19/2007 with c/o of swelling and wt gain.  Wt now 164.  Feels fine. Seen again 12/21/07 Wt 169.5. Weight decreased with lasix.  Down to 151 in 1/4/08. Per 60 day follow up: Continued fluid retention of new onset requiring salt restriction plus LASIX 80 BID. Echocardiogram did not indicate cardiomyopathy. Endocrine consult pending.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Metabolic function test, Protein total decreased, Pulmonary congestion, Red blood cell sedimentation rate normal, Renal function test
Clinical narrative: Congestive heart failure, fluid retention (20 lb wt gain 6 wk after vaccination).  01/10/2008 MR records received from PCP, including several f/u visits to pain specialist and hospital D/c Summary from 8/27/07 for Intractable recurrent tension headaches (prior to vax).  Pt seen 10/31/2007 for Zostavax due to family member with shingles. Wt 143. OV 12/19/2007 with c/o of swelling and wt gain.  Wt now 164.  Feels fine. Seen again 12/21/07 Wt 169.5. Weight decreased with lasix.  Down to 151 in 1/4/08. Per 60 day follow up: Continued fluid retention of new onset requiring salt restriction plus LASIX 80 BID. Echocardiogram did not indicate cardiomyopathy. Endocrine consult pending.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Weight increased, White blood cell count
Clinical narrative: Congestive heart failure, fluid retention (20 lb wt gain 6 wk after vaccination).  01/10/2008 MR records received from PCP, including several f/u visits to pain specialist and hospital D/c Summary from 8/27/07 for Intractable recurrent tension headaches (prior to vax).  Pt seen 10/31/2007 for Zostavax due to family member with shingles. Wt 143. OV 12/19/2007 with c/o of swelling and wt gain.  Wt now 164.  Feels fine. Seen again 12/21/07 Wt 169.5. Weight decreased with lasix.  Down to 151 in 1/4/08. Per 60 day follow up: Continued fluid retention of new onset requiring salt restriction plus LASIX 80 BID. Echocardiogram did not indicate cardiomyopathy. Endocrine consult pending.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Fatigue, Hypoaesthesia, Mobility decreased
Clinical narrative: 1st 3 days: fever, chills, exhaustion, left arm red, swollen and complete immobile. I was immobile mostly that time. Numbness in left arm and leg and still have swelling.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: 1st 3 days: fever, chills, exhaustion, left arm red, swollen and complete immobile. I was immobile mostly that time. Numbness in left arm and leg and still have swelling.
Age: 66.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: 10/31/07 - Hive like rash on neck and upper chest.  No shortness of breath.  Rash lasted 3-4 weeks.  Applied OTC hydrocortisone cream which reduced itching.  Did not consult physician.  Still experiencing some itching.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: 11-26-07 pm temp 102 deg F Pinpoint rash over entire body except for face and hands. rash warm to touch. Hands swollen. Dr at medical center Rx for antihistamine. No change in rash after taking Rx Dr prescribed Prednisone x 12 d plus another Rx pt did not remember name. Rash gone continues with some itching, swelling in hands.
Age: 14.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Mother reported site of varicella injection red, sore.  Next day - 12/21 - "swelled to size of softball".  12/22 - "very inflamed" - saw doctor in emergency room.  Gave steroid shot.  Remains on Prednisone 20 mg vial for 5 days.  Swelling, inflammation decreased 12/26/07.
Age: 1.5
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site induration, Injection site ulcer
Clinical narrative: Ulcer and induration at injection site. Treated with antibiotics for presumed cellulitis.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Pain, swelling and redness of injection site associated to chills and axillary adenopathy. Site to Tdap.
Age: 4.0
Sex: F
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: red swollen area size of tennis ball around shot areas. Mostly around area where flu shot would have been given. Noticed redness and swelling approx 2 days later. Resolved without meds other than mother applied Bacitracin x 1.
Age: 33.0
Sex: F
Vaccine: HEP, MMR, TD
Symptoms: Dysphagia
Clinical narrative: Had vaccines at 9:30 am - when returned home at 10:00 am "it felt like something was stuck in my throat.  I couldn't swallow".  Client went to doctor at 3 pm.  Client was given Claritin qd.  Symptoms as of 4:30 pm on 10/25/07 hasn't worsen.
Age: 0.35
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Crying, Injection site urticaria, Pyrexia
Clinical narrative: After vaccine on 11-8-07 including Comvax lot 0376U, red welt developed seen 11-12-07, low grade fever, seen again on 11-16-07. (Later found at risk of B. cereus) Red welt, resolved, but inconsolable crying all night for 6 wks, slowly improving now, by 12-24-07. 1/8/08-information received-the injection site reaction was on right thigh.
Age: 15.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: grandmother reports client achey all over-Fever 101 deg in 1st 24 hrs after receiving shots at our clinic 12-19-07 - 12-21-07 -still achey but feels some better fever decreased 99 deg with Tylenol/Advil every 4-6 hrs per grandmother's report today -12-26-07 pc from pt grandmother recovered 12-22-07 with no problems.
Age: 1.0
Sex: M
Vaccine: DTAPH, HEPA, MMR, PNC, VARCEL
Symptoms: Culture negative, Injection site erythema, Injection site mass, Injection site warmth, Pyrexia
Clinical narrative: 12-14-2007-Mother called and stated child ran low grade fever on day 2, 99 axillary, on day 8 child developed redness, warmth, and a knot on left thigh about quarter size but the child did not even flinch when touched. She spoke with Dr who told her to put a warm compress for first 24 hours then change to cold compress after that. Mother also reported a spot on his forehead, raised rash, near his hairline but said it broke out before his immunizations (child has eczema, which rash resembled). It was cultured at Dr's office and culture came back negative. 12-17-2007-Called mother back to get update on child and she reported that redness had completely resolved and knot was smaller. Reported that spot on forehead was improved after applying lotion for eczema on it.
Age: 1.0
Sex: M
Vaccine: DTAPH, HEPA, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: 12-14-2007-Mother called and stated child ran low grade fever on day 2, 99 axillary, on day 8 child developed redness, warmth, and a knot on left thigh about quarter size but the child did not even flinch when touched. She spoke with Dr who told her to put a warm compress for first 24 hours then change to cold compress after that. Mother also reported a spot on his forehead, raised rash, near his hairline but said it broke out before his immunizations (child has eczema, which rash resembled). It was cultured at Dr's office and culture came back negative. 12-17-2007-Called mother back to get update on child and she reported that redness had completely resolved and knot was smaller. Reported that spot on forehead was improved after applying lotion for eczema on it.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Red, tender, edematous area at injection site.  Warm compresses (right arm).
Age: 14.0
Sex: F
Vaccine: HIBV, HPV4
Symptoms: Wrong drug administered
Clinical narrative: PedvaxHIB given instead of meningococcal vaccine. Pt had no side effect or symptoms.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased, Crying
Clinical narrative: Child received immunizations at 6pm.  At 3:00 am child awoke with uncontrollable crying and 104 rectal temp.  Child taken to emergency room where Tylenol was administered.  Following am temperature still 101.  Parent administered Tylenol on schedule.  12 hours later, temperature and behavior returned to normal.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness left thigh, temperature, Benadryl and Tylenol.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: Diffuse macular eruption.  No pruritus, no fever.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Erythema, Pruritus, Wheezing
Clinical narrative: severe itching, red hands and feet, coughing, wheeze in less than an hour after Varivax booster. Albuterol neb tx, 2x Orapred, Epi pen given. Pulse ox 98-99%. Solumedrol 31.25 mg im x 1 Transported to ER via EMS
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: cellulitis of extremely where injection was given.
Age: 0.7
Sex: M
Vaccine: DTAP, PNC
Symptoms: Tremor
Clinical narrative: Mom reports, since vaccine pt. has shaking episodes. Patient has episodes 1-3 times a day now (post four days) mom reports after vaccine given patient episodes were 8-10 times a day for about 8 weeks.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia
Clinical narrative: Telephone call from client regarding pain at left deltoid where Hep B #2 was given.  On a scale from 1 to 10, pain is a steady 5.  Noted radiation towards the elbow.
Age: 1.52
Sex: F
Vaccine: DTAP
Symptoms: Bronchiolitis, Cough, Febrile convulsion, Pyrexia, Rhinorrhoea
Clinical narrative: Vaccines given 12-7-07.  1 week later (presumably unrelated) patient developed cough, runny nose.  12-17-07, office visit.  Bronchiolitis, Otitis media, fever.  In office: Febrile seizure.  Lasted less than 1 minute.  Recovered fully.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin induration
Clinical narrative: Wheal left arm 5 cm.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema multiforme
Clinical narrative: Patient presented with mild signs of Erythema Multiforme distributing outwards from vaccination site.  Symptoms developed 12 days post vaccination.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema multiforme
Clinical narrative: Patient presented with mild symptoms of Erythema Multiforme distributing from vaccination site 14 days post vaccination.  Patient required no treatment and spontaneously resolved within 3 days.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema multiforme
Clinical narrative: Patient presented 8 days post vaccination with mild symptoms of Erythema Multiforme distributing from vaccination site across left chest.  Patient spontaneously resolved without further complication or treatment within 4 days.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Hypoaesthesia, Nausea
Clinical narrative: Initial dizziness, nausea, weakness (all very mild, and disappeared within about 15 minutes).  Within 1/2 hour, numbness in left index finger, thumb, and small area surrounding affected digits.  Numbness eventually got slightly better, but 10 days later, slight numbness still remains in finger and thumb.  Not debilitating, but somewhat annoying. Follow up to form completed on 1/01/2008:  The numbness in index finger and thumb is still present, although some improvement has occurred as of 01/30/2008.  On the morning of 01/02/2008, I noticed that my left shoulder area (injection site) was quiet sore, and range of motion was greatly diminished (to the point where I had to alter sleeping positions and was unable to wash back in shower).  The pain was constant until just a few days ago, when probably 90 percent of the pain suddenly cleared up.  My main concerns are: Will I be able to received flu vaccinations in the future?  Should I be wary of other vaccinations such as tetanus, whooping cough, etc? If I receive vaccinations in the future, should I request a different injection site such as abdomen, buttocks or thigh?
Age: 1.9
Sex: M
Vaccine: SMALL
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase MB increased, Chest pain, Electrocardiogram abnormal, Troponin I increased
Clinical narrative: Developed chest pain on day #9. EKG with PR depression. CK-MB and Trop-I elevated. Echo normal.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Confusional state, Dry skin, Malaise, Nuclear magnetic resonance imaging normal
Clinical narrative: Received vaccine on 5/31/07 c/o confusion beginning in 6/01/07-and lasted 10 days-another 10 days didn't "feel well"-skin dry -1 month to 6 weeks later a red discoloration on both arms,  also itchy and later turned brown color. In December skin on legs turned red, itchy and then brown. Saw M.D. regarding confusion- had MRI -results negative- all other test negative. Also c/o aching all over-lasted 10 days after injection.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Skin discolouration
Clinical narrative: Received vaccine on 5/31/07 c/o confusion beginning in 6/01/07-and lasted 10 days-another 10 days didn't "feel well"-skin dry -1 month to 6 weeks later a red discoloration on both arms,  also itchy and later turned brown color. In December skin on legs turned red, itchy and then brown. Saw M.D. regarding confusion- had MRI -results negative- all other test negative. Also c/o aching all over-lasted 10 days after injection.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Audiogram abnormal, Deafness neurosensory, Deafness unilateral, Dizziness, Hypoacusis
Clinical narrative: Patient developed profound sensorineural hearing loss and mild vertigo in the left ear one week after vaccination.  This has persisted until today.  MRI showed no tumor or stroke. 1/7/08-records received-office visit 12/17/07-developed acute onset of dizziness and vertigo/room spinning as well as hearing deficit that was worse on left and slightly decreased on right. Nasal congestion since onset of symptoms. Impression: labyrinthitis. Office visit 12/28/07-Left ear hearing loss. Vertigo symptoms intermittently. Impression:sudden sensory neural hearing loss with very little improvement. Per 60 day follow up: Permanent hearing loss. 1/15/2010 I don't think her event was related. She had sudden sensorinearal hearing loss.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging normal, Vertigo
Clinical narrative: Patient developed profound sensorineural hearing loss and mild vertigo in the left ear one week after vaccination.  This has persisted until today.  MRI showed no tumor or stroke. 1/7/08-records received-office visit 12/17/07-developed acute onset of dizziness and vertigo/room spinning as well as hearing deficit that was worse on left and slightly decreased on right. Nasal congestion since onset of symptoms. Impression: labyrinthitis. Office visit 12/28/07-Left ear hearing loss. Vertigo symptoms intermittently. Impression:sudden sensory neural hearing loss with very little improvement. Per 60 day follow up: Permanent hearing loss. 1/15/2010 I don't think her event was related. She had sudden sensorinearal hearing loss.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: ON 12-28-07 PATIENT RECEIVED HEP A #2 AND VARIVAX #2. THEY WERE BOTH GIVEN IN THE LEFT ARM (1-IM, 1-SC). ON 12-31-07 PATIENT RETURNED TO OFFICE WITH LEFT ARM RED AND WARM TO TOUCH. HE WAS TREATED FOR CELLULITIS- KEFLEX 250MG TID X 7 DAYS AND TRIAMCINOLONE CREAM 0.1% TO AREA BID PRN.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Pyrexia, Vomiting
Clinical narrative: FEVER TO 102 AND VOMITING FOR 2 HOURS.
Age: 1.02
Sex: M
Vaccine: FLU3, MEA, VARCEL
Symptoms: Pyrexia, Varicella, Varicella post vaccine
Clinical narrative: Full course of chicken pox.  Fever of 104.2 began 12/28/07, lasted until 12/30/07.  Fever then went down to 102 during the day.  Chicken Pox began on 12/28/07 and continued on until 1/2/08 at which time they are fading away.  Fever broke on 12/31/07.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Heart rate normal, Hyperhidrosis, Loss of consciousness
Clinical narrative: PT PASSED OUT IN THE PARKING LOT AND WAS DIAPHORETIC AND RECOVERED IN ABOUT 1 MINUTE AND SITTING UP. SHE WAS BROUGHT INTO THE OFFICE AND HER HEART RATE WAS 80 AND BP WAS 118/70.  PT WAS MONITORED AND STABLE AT DISCHARGE.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure, Chest discomfort, Dyspnoea, Heart rate increased
Clinical narrative: 1:30pm -1:45pm estimated time of injection Patient left clinic with no concerns post injection. Then called clinic at 2:15pm estimated with on set of slight dyspnea and patient advised fast heart rate with chest tightness. 3:00-3:15pm seen in clinic for above complaint. 3:30pm IV started, IV Solu Medrol given. No local reaction noted at site of injection. Patient vitals stable running 110 systolic 70's diastolic during event. Resp rate 18-20.  Pulse 70's Not obviuos SOB noted in clinic. 4:00pm Patient stable & sent home.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Inflammation, Myalgia, Swelling
Clinical narrative: Intense swelling of upper arm slowing moving down the arm to the elbow and forearm. Severe muscle ache. Redness and inflammation on inside of bicep. I was told to apply ice to keep swelling down. One week later, swelling is reduced along with ache. Inflammation is beginning to go away.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature, Herpes zoster, Pain, Polymerase chain reaction, Rash vesicular
Clinical narrative: Information has been received from a physician concerning an adult male who on an unspecified date was vaccinated with a dose of zoster vaccine live (Oka/Merck).  A few days later the patient developed shingles on the head.  The patient had never had shingles before.  It was unspecified if medical attention was sought.  The outcome was not reported.  No product quality complaint was involved.  Follow-up information received indicates that the physician is interested in the VZV identification program.  Follow-up information indicates that the patient is a 67-year-old male with allergies to atorvastatin calcium (Lipitor) and ezetimibe (+) simvastatin (MSD) and has a past history to childhood chickenpox, colon polyp, depression, high lipids and hypertension.  On 16-Nov-2007 he received a "unit," his first dose of zoster vaccine live (Oka/Merck) (lot #658361/090U) in the left arm.  On 18-Nov-2007, the patient developed a herpetiform rash with approximately 30 lesions on the back of the skull, face, dermatome II and V and had pain.  He had a maximum temperature of 98.6.  It was reported that there was no recent exposure to chickenpox.  The outcome was reported as not recovered.  The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type strain or with the OKA/Merck vaccine VZV strain.  The sample lesion was collected on 27-Nov-2007.  The sample was taken from a crusted vesicle from the scalp.  Additional follow-up information was received.  The PCR results for the sample from a crusted vesicular lesion from the scalp site identified the presence of WT VZV.  Additional follow-up information from the reporting physician indicated that the 67 year old white male developed the onset of herpetiform rash on the forehead, back of head and the face on the morning of 19-Nov-2007 (also reported as 18-Nov-2007).  There was no illness at the time of vaccination.  The patient was not recovered at the time of this report.  The physician considered shingles to be disabling and an other important medical event (medical/surgical intervention).  Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin lesion, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning an adult male who on an unspecified date was vaccinated with a dose of zoster vaccine live (Oka/Merck).  A few days later the patient developed shingles on the head.  The patient had never had shingles before.  It was unspecified if medical attention was sought.  The outcome was not reported.  No product quality complaint was involved.  Follow-up information received indicates that the physician is interested in the VZV identification program.  Follow-up information indicates that the patient is a 67-year-old male with allergies to atorvastatin calcium (Lipitor) and ezetimibe (+) simvastatin (MSD) and has a past history to childhood chickenpox, colon polyp, depression, high lipids and hypertension.  On 16-Nov-2007 he received a "unit," his first dose of zoster vaccine live (Oka/Merck) (lot #658361/090U) in the left arm.  On 18-Nov-2007, the patient developed a herpetiform rash with approximately 30 lesions on the back of the skull, face, dermatome II and V and had pain.  He had a maximum temperature of 98.6.  It was reported that there was no recent exposure to chickenpox.  The outcome was reported as not recovered.  The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type strain or with the OKA/Merck vaccine VZV strain.  The sample lesion was collected on 27-Nov-2007.  The sample was taken from a crusted vesicle from the scalp.  Additional follow-up information was received.  The PCR results for the sample from a crusted vesicular lesion from the scalp site identified the presence of WT VZV.  Additional follow-up information from the reporting physician indicated that the 67 year old white male developed the onset of herpetiform rash on the forehead, back of head and the face on the morning of 19-Nov-2007 (also reported as 18-Nov-2007).  There was no illness at the time of vaccination.  The patient was not recovered at the time of this report.  The physician considered shingles to be disabling and an other important medical event (medical/surgical intervention).  Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Cellulitis, Cough, Decreased appetite, Headache
Clinical narrative: Information has been received from a registered nurse concerning a 55 year old female patient with allergies to metaxalone (SKELAXIN) (hives) and erythromycin who on 07-NOV-2007 at approximately 15:30, was vaccinated IM into the right deltoid with a second 0.5ml dose of Pneumovax 23 (Lot#657626/1084U). On 09-NOV-2007, the patient presented to the physician's office complaining of a bad headache, achy, lethargic and cough for 48 hours. The patient was afebrile, had abdominal pain and decreased appetite, nausea but no vomiting or diarrhea and syncope. It was reported that the patient required admission to the hospital for cellulitis. At the time of this report, the patient's outcome was unknown. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Lethargy, Nausea, Pain, Pyrexia, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 55 year old female patient with allergies to metaxalone (SKELAXIN) (hives) and erythromycin who on 07-NOV-2007 at approximately 15:30, was vaccinated IM into the right deltoid with a second 0.5ml dose of Pneumovax 23 (Lot#657626/1084U). On 09-NOV-2007, the patient presented to the physician's office complaining of a bad headache, achy, lethargic and cough for 48 hours. The patient was afebrile, had abdominal pain and decreased appetite, nausea but no vomiting or diarrhea and syncope. It was reported that the patient required admission to the hospital for cellulitis. At the time of this report, the patient's outcome was unknown. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 55 year old female patient with allergies to metaxalone (SKELAXIN) (hives) and erythromycin who on 07-NOV-2007 at approximately 15:30, was vaccinated IM into the right deltoid with a second 0.5ml dose of Pneumovax 23 (Lot#657626/1084U). On 09-NOV-2007, the patient presented to the physician's office complaining of a bad headache, achy, lethargic and cough for 48 hours. The patient was afebrile, had abdominal pain and decreased appetite, nausea but no vomiting or diarrhea and syncope. It was reported that the patient required admission to the hospital for cellulitis. At the time of this report, the patient's outcome was unknown. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Blood test, Chills, Gait disturbance, Headache
Clinical narrative: Information has been received from a female consumer who on 05-Dec-2007, was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine. On 07-Dec-2007 two days after the vaccination, the patient experienced "after effects" from the vaccine. It was reported that she developed a fever, shivers, flu like symptoms, stiffness in her neck, pain on the top of her head, and pain down the front of her legs. After receiving the vaccine the consumer was out of the country for business and stated that the pain was so bad that she had to see a physician there. She stated that blood tests were performed and she was told that she did not have meningitis and that these problems were from the vaccine. Her symptoms have lessened over the past three weeks except for the leg pain that persists. It was reported that she could not walk upstairs and that she had been crawling up the stairs. She also had trouble driving due to the leg pain. She had been taking acetaminophen (Tylenol) which was reported to give her some relief. It was also reported that the patient's first dose of pneumococcal 23v polysaccharide vaccine was administered 14 years ago. No product quality complaint was involved. Fever, shivers, flu like symptoms, stiffness in her neck, pain on the top of her head and pain down the front of her legs were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Mobility decreased, Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a female consumer who on 05-Dec-2007, was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine. On 07-Dec-2007 two days after the vaccination, the patient experienced "after effects" from the vaccine. It was reported that she developed a fever, shivers, flu like symptoms, stiffness in her neck, pain on the top of her head, and pain down the front of her legs. After receiving the vaccine the consumer was out of the country for business and stated that the pain was so bad that she had to see a physician there. She stated that blood tests were performed and she was told that she did not have meningitis and that these problems were from the vaccine. Her symptoms have lessened over the past three weeks except for the leg pain that persists. It was reported that she could not walk upstairs and that she had been crawling up the stairs. She also had trouble driving due to the leg pain. She had been taking acetaminophen (Tylenol) which was reported to give her some relief. It was also reported that the patient's first dose of pneumococcal 23v polysaccharide vaccine was administered 14 years ago. No product quality complaint was involved. Fever, shivers, flu like symptoms, stiffness in her neck, pain on the top of her head and pain down the front of her legs were considered to be disabling. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Axillary pain, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased
Clinical narrative: Dec 18, 2007 pt received Tdap (lat TD was 1/6/01. Pt experienced mild soreness in right arm (site of injection) the remainder of 18 Dec 07. On Dec 19 around 0400 the pt awoke with a sore and stiff right arm. Pt was unable to move arm due to pain (7/10) and called out sick for work. Also had pain in right shoulder and right arm pit. On Dec 20 these symptoms were unchanged and pt also had tingling down her right arm. On 21 Dec 07 the pain was still a 7/10 with limited ROM. No rash, redness, swelling or decrease in strenght. Given prednisone 20mg bid for 10days and Motrin 400mg q6. After 5 days all symptoms had resolved and pt stopped taking the medication.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Movement disorder, Musculoskeletal pain, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: Dec 18, 2007 pt received Tdap (lat TD was 1/6/01. Pt experienced mild soreness in right arm (site of injection) the remainder of 18 Dec 07. On Dec 19 around 0400 the pt awoke with a sore and stiff right arm. Pt was unable to move arm due to pain (7/10) and called out sick for work. Also had pain in right shoulder and right arm pit. On Dec 20 these symptoms were unchanged and pt also had tingling down her right arm. On 21 Dec 07 the pain was still a 7/10 with limited ROM. No rash, redness, swelling or decrease in strenght. Given prednisone 20mg bid for 10days and Motrin 400mg q6. After 5 days all symptoms had resolved and pt stopped taking the medication.
Age: 1.52
Sex: M
Vaccine: DTAP, HPVX
Symptoms: Medication error, Wrong drug administered
Clinical narrative: Wrong vaccine administered to patient.  No adverse symptoms noted.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Aggression, Erythema, Induration, Injection site swelling, Joint range of motion decreased
Clinical narrative: Extreme area of redness-5 inch oval.  Fever-101. Very bad temper, shouting, slamming doors, for 2 days after shot. Swelling of site, 1 1/2 inches bigger than other arm.  Unable to raise arm to shoulder height for 10 days. No range of motion for 5 days.  Severe pain-needed 4 ibuprofen (200mg. ea) and 3 extra strength Tylenol every 6 hours for 4 days following shot.  Arm is still red and blotchy in an oval about 4 inches by 2 inches.  In the center is still a hard lump. The site has been very itchy for the past 7 days.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Movement disorder, Pain, Pruritus, Pyrexia, Rash macular
Clinical narrative: Extreme area of redness-5 inch oval.  Fever-101. Very bad temper, shouting, slamming doors, for 2 days after shot. Swelling of site, 1 1/2 inches bigger than other arm.  Unable to raise arm to shoulder height for 10 days. No range of motion for 5 days.  Severe pain-needed 4 ibuprofen (200mg. ea) and 3 extra strength Tylenol every 6 hours for 4 days following shot.  Arm is still red and blotchy in an oval about 4 inches by 2 inches.  In the center is still a hard lump. The site has been very itchy for the past 7 days.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Activities of daily living impaired, Arthralgia, Chills, Ear discomfort, Malaise
Clinical narrative: Felt ill with sore throat, ear discomfort, chills after 3 hours of receiving vaccine on 12-13-07. Joint pain about 10 days after vaccine. Measles rash (mild) over chest upper arms and face began approx 12-26-07. Presented to place of vaccination for reporting and asks about risk of contageon. No treatment offered. Off work until rash resolved.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test positive, Pharyngolaryngeal pain, Rash morbilliform, Rubella antibody positive
Clinical narrative: Felt ill with sore throat, ear discomfort, chills after 3 hours of receiving vaccine on 12-13-07. Joint pain about 10 days after vaccine. Measles rash (mild) over chest upper arms and face began approx 12-26-07. Presented to place of vaccination for reporting and asks about risk of contageon. No treatment offered. Off work until rash resolved.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Inappropriate schedule of drug administration, Influenza like illness, Nausea
Clinical narrative: Pt states she was fune until 12/29/07 when she developed a headache and flu-like symptoms and nausea.  She states there was a quarter sized lump, then on 12/30/07 it was worse--silver dollar sized.  By 1/1/08, she states that the lump was the size of a baseball.  Symptoms are resolving now, lump is quarter sized.  Pt is taking benadryl and ibuprofen and states she starts itching when she is not on the benadryl.
Age: 9.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Erythema, Injection site mass, Swelling
Clinical narrative: Pt had lump at injection site that evening.  Redness and swelling began on 1/1/2008.
Age: 61.0
Sex: M
Vaccine: HEPA, PPV, TYP
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: Soreness/pain in right arm at site of Pneumovax 23 injection shortly after administration.  Pt had erythema and induration at site that night that progressed to shoulder and mid forearm within the next 3-4 days, chills and felt feverish x 3-4 days.  Pt took ibuprofen q 4-6 hrs and used warm compresses.  Pt called ID fellow on 12/31 to report adverse reaction.  Pt states he is improving but has not totally recovered as of report today.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Abnormal behaviour, Aggression, Autism spectrum disorder, Blood heavy metal increased, Developmental delay
Clinical narrative: A few weeks after the vaccination, 4/07 notice rash covering elbows and thighs.  Went to dermatologist who prescribed Clarinex, Hydroxyzine and a topical steroid.  The dermatologist briefly mentioned patient may be having an allergic reaction and handed me a brochure on food allergies.  In that same month (4/07) screaming and uncontrollable tantruming began, noticed by several relatives.  Also during 4/07 1) Eye contact decreased.  2) Patient began saying the same indiscernable phrase over and over.  3) Repetitive and hyperactive behaviors.  In 6/07 at pediatrician well visit, doctor noticed developmental delays, patient not answering to his name, little eye contact.  In October 2007, Dr. noted during patient visit that "Some of his features including his repetitive actions do raise the concern that he has problems along the pervasive developmental disorder spectrum."  In December of 2007, Dr. conducted a urinary porphyrin profile on patient resulting in increased porphyrinuria 5CXP, Precopro, and Coproporphyrin metabolites suggesting a mercury toxic effect.  Chelation due to start 1/08. 1/14/08-records received-HX of mild developmental delay most notably in area of expressive language. Repetitive actions with some eye contact and some interaction. Pervasive developmental disorder spectrum. Well baby office notes included. Patient still has heavy metal toxicity, rash on elbows, language delay, immune system injury, oxidative stress, metabolic disorder, neurologic abnormalities and gastrointestinal issues.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Disturbance in attention, Hypersensitivity, Metal poisoning, Porphyria, Psychomotor hyperactivity
Clinical narrative: A few weeks after the vaccination, 4/07 notice rash covering elbows and thighs.  Went to dermatologist who prescribed Clarinex, Hydroxyzine and a topical steroid.  The dermatologist briefly mentioned patient may be having an allergic reaction and handed me a brochure on food allergies.  In that same month (4/07) screaming and uncontrollable tantruming began, noticed by several relatives.  Also during 4/07 1) Eye contact decreased.  2) Patient began saying the same indiscernable phrase over and over.  3) Repetitive and hyperactive behaviors.  In 6/07 at pediatrician well visit, doctor noticed developmental delays, patient not answering to his name, little eye contact.  In October 2007, Dr. noted during patient visit that "Some of his features including his repetitive actions do raise the concern that he has problems along the pervasive developmental disorder spectrum."  In December of 2007, Dr. conducted a urinary porphyrin profile on patient resulting in increased porphyrinuria 5CXP, Precopro, and Coproporphyrin metabolites suggesting a mercury toxic effect.  Chelation due to start 1/08. 1/14/08-records received-HX of mild developmental delay most notably in area of expressive language. Repetitive actions with some eye contact and some interaction. Pervasive developmental disorder spectrum. Well baby office notes included. Patient still has heavy metal toxicity, rash on elbows, language delay, immune system injury, oxidative stress, metabolic disorder, neurologic abnormalities and gastrointestinal issues.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Rash, Repetitive speech, Screaming, Unresponsive to stimuli
Clinical narrative: A few weeks after the vaccination, 4/07 notice rash covering elbows and thighs.  Went to dermatologist who prescribed Clarinex, Hydroxyzine and a topical steroid.  The dermatologist briefly mentioned patient may be having an allergic reaction and handed me a brochure on food allergies.  In that same month (4/07) screaming and uncontrollable tantruming began, noticed by several relatives.  Also during 4/07 1) Eye contact decreased.  2) Patient began saying the same indiscernable phrase over and over.  3) Repetitive and hyperactive behaviors.  In 6/07 at pediatrician well visit, doctor noticed developmental delays, patient not answering to his name, little eye contact.  In October 2007, Dr. noted during patient visit that "Some of his features including his repetitive actions do raise the concern that he has problems along the pervasive developmental disorder spectrum."  In December of 2007, Dr. conducted a urinary porphyrin profile on patient resulting in increased porphyrinuria 5CXP, Precopro, and Coproporphyrin metabolites suggesting a mercury toxic effect.  Chelation due to start 1/08. 1/14/08-records received-HX of mild developmental delay most notably in area of expressive language. Repetitive actions with some eye contact and some interaction. Pervasive developmental disorder spectrum. Well baby office notes included. Patient still has heavy metal toxicity, rash on elbows, language delay, immune system injury, oxidative stress, metabolic disorder, neurologic abnormalities and gastrointestinal issues.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood creatine phosphokinase normal, Blood electrolytes normal, Blood urea normal, Dehydration, Diarrhoea
Clinical narrative: 12-10-07 Rc'd Rotateq and other IZ's. Diarrhea started 12-16-07, also vomiting. Seen in office 12-17-07 with dehydration, sent to medical center. + Rotavirus PCR stool culture. No fevers. 1/17/08-records received for DOS-12/17-12/22/07-DC DX: Gastroenteritis. Dehydration. Presented with 3 day history of diarrhea, vomiting irritability and decreased p.o. intake.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rotavirus test positive, Vomiting
Clinical narrative: 12-10-07 Rc'd Rotateq and other IZ's. Diarrhea started 12-16-07, also vomiting. Seen in office 12-17-07 with dehydration, sent to medical center. + Rotavirus PCR stool culture. No fevers. 1/17/08-records received for DOS-12/17-12/22/07-DC DX: Gastroenteritis. Dehydration. Presented with 3 day history of diarrhea, vomiting irritability and decreased p.o. intake.
Age: 24.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Culture negative, Rash
Clinical narrative: Skin rash consistent with Varicella started approximately 12 days post vaccination.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Abnormal behaviour, Urticaria
Clinical narrative: Within 24 hrs reported-acting "zonedout" quiet with Tylenol given 48 hrs after went to ER with hives (Lasting 4 hours given Atarax) Specific onset unknown
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Body temperature increased, Diarrhoea, Injection site dryness
Clinical narrative: 103 temp x 3 days post vacc. 100 on day 4. Skin became dry and site of injections. Had diarrhea day of vaccination
Age: 14.0
Sex: M
Vaccine: HEP, TDAP, VARCEL
Symptoms: Medication error, Wrong drug administered
Clinical narrative: no calls received, no complaints noted from pts. Mother used Tdap instead of Td for 2nd dose.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Rash
Clinical narrative: Rash on left upper arm, some pain.  Went to the doctor 12/14/07 and was diagnosed as having shingles.  Was put on Famciclovir for 7 days.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: 2 vaccines were given to her on her right leg, which were the Hib (Aventis) and PCV (Wyeth). She cried for about 10-15 min. Straight. Her leg stated to get swollen and red. We gave her Benadryl and it calmed her down.
Age: 36.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug exposure during pregnancy, Medication error
Clinical narrative: None - but pregnant woman - vaccine said not suitable for pregnancy.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool negative, Diarrhoea
Clinical narrative: 3 days after Rotateq given developed significant diarrhea with stools and for many white cells, no blood, neg cultures, OVP-no other explanation-took 6 hrs to totally resolve
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 3-4" swelling/erythema R arm at site.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pronounced swelling, redness and warmth locally
Age: 0.3
Sex: F
Vaccine: HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Rash macular
Clinical narrative: 12/11/07 w/in 5 min after injection (R) leg had redness size of quarter then blotchy macular rash all over body at 9:15am Benadryl was given. Child responded.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Brachial plexus injury, Burning sensation, Pain in extremity
Clinical narrative: Pt c/o (L) arm pain x 7 days after injection then burning to left arm with increasing severity. Loss of strength on Sat. Diagnosed with possible Brachial Plexis irritation (L) arm pain.  1/8/08 Reviewed clinic medical records which reveal patient seen 12/21/07 with left shoulder pain x 7 days.  Exam revealed limited flexion/extension of left shoulder w/pain.  DX: myalgia, myositis.  Returned to clinic on 12/27 s/p ER visit for left shoulder/arm pain, sore throat & runny nose.  Dx in ER w/brachioplexy.  Referred to neurology.  Exam on 12/27 revealed positive impingement sign w/decreased left arm strength. FINAL DX: brachial neuritis.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: The patient developed high fever about 5 min. after flu vaccine administered. Symptoms lasted about 10 hours. No GI illness or rash developed after vaccinations. No increase in URI Sx's developed (Temp reached 106 deg)
Age: 1.5
Sex: M
Vaccine: DTAPH, FLU3, HEPA
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mom took child to ER on 12/20/07 due to (R) leg being red, swollen, and warm. Diagnosed with cellulitis per mom. Give antibiotics via shot and sent home and told to see primary doctor. Also prescribed abx.
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 23.0
Sex: M
Vaccine: YF
Symptoms: Chills, Influenza like illness, Urticaria
Clinical narrative: Hive like rash over entire body lasting 3 days. Chills "flu like symptoms" Took Benadryl x 3 days after talking to physician via telephone. s/s gone after 3 days.