chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Burning sensation, Dizziness, Fatigue, Headache
Clinical narrative: Severe dizziness and unable to function. Severe headache. Fatigue and pain in arm at injection site. Burning on the front of the forehead. This is her second injection.  1/14/09 Reviewed GYN medical records of 12/22/2008. FINAL DX: candida vaginitis; uti; (+) Chlamydia & trichomonas 10/08, resolved. Records reveal patient tx for UTI on day of vaccination.  Parent stated previously via voicemail message that patient not seen by PCP or ER for treatment & has fully recovered from HA following HPV vaccination of 12/22/08.  Has back spasms couple of times/wk only & treats w/OTC meds.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Severe dizziness and unable to function. Severe headache. Fatigue and pain in arm at injection site. Burning on the front of the forehead. This is her second injection.  1/14/09 Reviewed GYN medical records of 12/22/2008. FINAL DX: candida vaginitis; uti; (+) Chlamydia & trichomonas 10/08, resolved. Records reveal patient tx for UTI on day of vaccination.  Parent stated previously via voicemail message that patient not seen by PCP or ER for treatment & has fully recovered from HA following HPV vaccination of 12/22/08.  Has back spasms couple of times/wk only & treats w/OTC meds.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diet refusal, Insomnia, Irritability
Clinical narrative: since receiving immunizations has been fussy, not himeself, not sleeping, not eating well.
Age: 80.0
Sex: F
Vaccine: RV5
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: The day following the shot my arm began swelling and turning red.  The swelling, above the elbow only,was considerable and was sensitive to the touch.  The swelling and redness lasted for two days and then began subsiding slowly.  It took several days and is still not completely gone.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Irritability
Clinical narrative: fussy since immunizations on 12/18/2008.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase increased, Mobility decreased, Pain in extremity
Clinical narrative: Persistant Arm pain with difficulty lifting arm and pain when grasping objects
Age: 16.0
Sex: F
Vaccine: HEPAB, HPVX, MMR
Symptoms: Arthralgia, Loss of consciousness, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: She was given the HPV Vaccine and passed out. She never fell or hit anything. she came to and had sever pain in her ankle. she has had xrays and a MRI and they show nothing wrong BUT she still has the pain.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema
Clinical narrative: PT NOTICED HER LEFT ARM (WHERE VACINNE WAS ADMINISTERED) BECAME DISCOLORED 2 DAYS AFTER RECEIVING THE VACCINATION.  THE AREA OF DISCOLORATION WAS UNIFORM & APPROXIMATELY 3 INCHES BY 2 INCHES.  THE COLOR WENT FROM BEET RED TO A LIGHTER RED OVER THE COURSE OF 2 DAYS.  THE DISCOLORATION WAS NOT ACCOMPANIED BY PAIN, WEAKNESS, SWELLING, SKIN ERUPTIONS NOR TENDERNESS.  THE REDNESS IS NOW COMPLETLEY GONE AFTER ABOUT 2 WEEKS.  THE PATIENT AT NO TIME FELT ILL.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLUX, PNC, RV5
Symptoms: Erythema multiforme, Pyrexia, Rash generalised, Sleep disorder
Clinical narrative: Received routine 6 month vaccinations on 10/3/2008 plus a flu shot (HepB, DTap, Rota, PCV, IPV, flu).  Had a cold or respiratory virus 2 days prior to receiving shots.  Patient ran a fever after receiving the shots and then consistently ran fevers for 6 days despite receiving tylenol alternating with motrin around the clock. By Sunday patient had a rash. at first looked like mosquito bites, then looked like flea bites as rash spread.  On Monday rash was all over patients body.  We took her to her pediatricians office who diagnosed her as having erythema multiforme. MD did not prescribe any meds at this time.  After trip to ER after patient would not sleep still no medicine prescribed.  on Thursday 10/9 we went back to pediatricians office and were given prescriptions for zantac and orapred.  After one dose of steroid rash disappeared
Age: 1.0
Sex: M
Vaccine: HEP, MMRV
Symptoms: Abnormal faeces, Diarrhoea, Listless, Poor quality sleep, Pyrexia
Clinical narrative: Patient received ProQuad and Hep B on May 1, 2006 and became increasingly listless and developed a fever that lasted over one week and spiked as high as 105. On May 11, 2006 he was prescribed an antibiotic that did not help.  He developed chronic diarrhea and has had 2-4 runny, foul bowel movements per day since onset after his vaccination.  He began fitfully scratching and crawling in his sleep.  He began having "staring spells." Patient suffered with acute encephalopathy/significantly decreased level of consciousness as manifested by his decreased response to the environment, his absence of eye contact and his significantly inconsistent and often completely absent responses to even familiar stimuli;  today patient still suffers from everything described above, except the fever, which broke after ten days.  He now has chronic encephalopathy, as he has not regained his normal state of consciousness since his vaccination.  1/20/2009 Consultant records received dated 5/22/08 for eval of developmental delays, especially in communication. Impression: Language delay in a child who presents with immature socialization skills and cognitive skills close to age level. Speech therapy recommended. 1/22/2009 Neurodiagnostic records received dated 6/30/08 and 7/14/08 with impression: Clearly meets diagnostic criteria for autism. 1/23/08 Additional records received including neurology consults 6/26/08 and 8/14/08 for eval of staring spells to r/o absence seizures. Pt will respond to tactile stim during spell.  EEG (-) for epileptiform activity but some slowing of posterior basic rhythm. Staring spells attributed to dx of Autism.
Age: 1.0
Sex: M
Vaccine: HEP, MMRV
Symptoms: Staring
Clinical narrative: Patient received ProQuad and Hep B on May 1, 2006 and became increasingly listless and developed a fever that lasted over one week and spiked as high as 105. On May 11, 2006 he was prescribed an antibiotic that did not help.  He developed chronic diarrhea and has had 2-4 runny, foul bowel movements per day since onset after his vaccination.  He began fitfully scratching and crawling in his sleep.  He began having "staring spells." Patient suffered with acute encephalopathy/significantly decreased level of consciousness as manifested by his decreased response to the environment, his absence of eye contact and his significantly inconsistent and often completely absent responses to even familiar stimuli;  today patient still suffers from everything described above, except the fever, which broke after ten days.  He now has chronic encephalopathy, as he has not regained his normal state of consciousness since his vaccination.  1/20/2009 Consultant records received dated 5/22/08 for eval of developmental delays, especially in communication. Impression: Language delay in a child who presents with immature socialization skills and cognitive skills close to age level. Speech therapy recommended. 1/22/2009 Neurodiagnostic records received dated 6/30/08 and 7/14/08 with impression: Clearly meets diagnostic criteria for autism. 1/23/08 Additional records received including neurology consults 6/26/08 and 8/14/08 for eval of staring spells to r/o absence seizures. Pt will respond to tactile stim during spell.  EEG (-) for epileptiform activity but some slowing of posterior basic rhythm. Staring spells attributed to dx of Autism.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and mild swollen at injection site, left deltoid noted the day after injection.
Age: 3.0
Sex: F
Vaccine: HEPA, VARZOS, VARZOS
Symptoms: Cold sweat, Inappropriate schedule of drug administration, Rash
Clinical narrative: Information has been received from a medical assistant concerning a 36 months old female who was on 01-JUL-2008 vaccinated with ZOSTAVAX (Merck) (lot# is reported as 659324/1835U) in the arm instead of VARIVAX (Merck) which was indicated by a medical assistant due to human error.  The lids are different colors and she did not consider this to be a case of product confusion.  Within 24 hours the parents were called and they found out that the parents reported that the child had a fever up to 102 degrees and had a rash on the trunk area.  The office did attempt to follow-up with the parents and had not heard back from them.  Follow-up information from the medical assistant via telephone call.  The mother reported her daughter had a rash and felt "clammy".  It was reported that patient's temperature was not taken, but the mother felt that she had a fever.  The rash had no pustules and therefore no sampling was performed and the medical assistant noted that the physician indicated that there were no plans for spinal tap.  No further information was available.
Age: 3.0
Sex: F
Vaccine: HEPA, VARZOS, VARZOS
Symptoms: Body temperature increased, Cold sweat, Pyrexia, Rash, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 36 months old female who was on 01-JUL-2008 vaccinated with ZOSTAVAX (Merck) (lot# is reported as 659324/1835U) in the arm instead of VARIVAX (Merck) which was indicated by a medical assistant due to human error.  The lids are different colors and she did not consider this to be a case of product confusion.  Within 24 hours the parents were called and they found out that the parents reported that the child had a fever up to 102 degrees and had a rash on the trunk area.  The office did attempt to follow-up with the parents and had not heard back from them.  Follow-up information from the medical assistant via telephone call.  The mother reported her daughter had a rash and felt "clammy".  It was reported that patient's temperature was not taken, but the mother felt that she had a fever.  The rash had no pustules and therefore no sampling was performed and the medical assistant noted that the physician indicated that there were no plans for spinal tap.  No further information was available.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 73 year old female "currently under stress caring for her child undergoing chemotherapy" and with a history of shingles who at noon on 10-SEP-2008 (also reported as approximately 11-SEP-2008) was vaccinated with a first dose of ZOSTAVAX (Merck) (lot # 659323/1613U) SQ.  On 12-SEP-2008 the patient experienced injection site red, injection site discomfort and developed a shingles like rash.  The pharmacist stated the site later "looked bruised and turned to a brownish color".  The patient had put ice on the arm for the pain with little relief.  The patient described it as an 'odd sensation."  The rash was completely flat with no raised areas.  The patient had 3 lesions on each leg and 1 lesion on each arm (also reported as about 10 dots on her bilateral arms and legs).  The lesions started as bright red and turned brown.  The patient remarked that it "looked like small cigarette burns on her skin".  A PCR analysis was declined.  After lots of discussion, the patient was told to go to see her dermatologist.  Her dermatologist stated it was not a herpes rash and she was fine.  Subsequently, the patient recovered from the injection site red, injection site discomfort and flat shingles like rash.  Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discolouration, Injection site discomfort, Injection site erythema, Injection site haematoma, Rash erythematous
Clinical narrative: Information has been received from a pharmacist concerning a 73 year old female "currently under stress caring for her child undergoing chemotherapy" and with a history of shingles who at noon on 10-SEP-2008 (also reported as approximately 11-SEP-2008) was vaccinated with a first dose of ZOSTAVAX (Merck) (lot # 659323/1613U) SQ.  On 12-SEP-2008 the patient experienced injection site red, injection site discomfort and developed a shingles like rash.  The pharmacist stated the site later "looked bruised and turned to a brownish color".  The patient had put ice on the arm for the pain with little relief.  The patient described it as an 'odd sensation."  The rash was completely flat with no raised areas.  The patient had 3 lesions on each leg and 1 lesion on each arm (also reported as about 10 dots on her bilateral arms and legs).  The lesions started as bright red and turned brown.  The patient remarked that it "looked like small cigarette burns on her skin".  A PCR analysis was declined.  After lots of discussion, the patient was told to go to see her dermatologist.  Her dermatologist stated it was not a herpes rash and she was fine.  Subsequently, the patient recovered from the injection site red, injection site discomfort and flat shingles like rash.  Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash macular, Skin lesion
Clinical narrative: Information has been received from a pharmacist concerning a 73 year old female "currently under stress caring for her child undergoing chemotherapy" and with a history of shingles who at noon on 10-SEP-2008 (also reported as approximately 11-SEP-2008) was vaccinated with a first dose of ZOSTAVAX (Merck) (lot # 659323/1613U) SQ.  On 12-SEP-2008 the patient experienced injection site red, injection site discomfort and developed a shingles like rash.  The pharmacist stated the site later "looked bruised and turned to a brownish color".  The patient had put ice on the arm for the pain with little relief.  The patient described it as an 'odd sensation."  The rash was completely flat with no raised areas.  The patient had 3 lesions on each leg and 1 lesion on each arm (also reported as about 10 dots on her bilateral arms and legs).  The lesions started as bright red and turned brown.  The patient remarked that it "looked like small cigarette burns on her skin".  A PCR analysis was declined.  After lots of discussion, the patient was told to go to see her dermatologist.  Her dermatologist stated it was not a herpes rash and she was fine.  Subsequently, the patient recovered from the injection site red, injection site discomfort and flat shingles like rash.  Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Erythema, Rash vesicular, Scab
Clinical narrative: Information has been received from a 70 year old female with blood pressure high and allergic reaction to tetracycline who on 10-SEP-2008 was vaccinated with ZOSTAVAX. Concomitant therapy included Prevacid, Losartan potassium-HCTZ (MSD) and FEMHRT. On 12-SEP-2008 the patient experienced "broke out on her spine from just below the collar to her waist". One week later she developed red spots which looked like little red dots with a crust on the top on the left side of her back and she also experienced a low grade fever. The patient was recovering at the time of reporting. The patient sought medical attention. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash erythematous, Scab
Clinical narrative: Information has been received from a 70 year old female with blood pressure high and allergic reaction to tetracycline who on 10-SEP-2008 was vaccinated with ZOSTAVAX. Concomitant therapy included Prevacid, Losartan potassium-HCTZ (MSD) and FEMHRT. On 12-SEP-2008 the patient experienced "broke out on her spine from just below the collar to her waist". One week later she developed red spots which looked like little red dots with a crust on the top on the left side of her back and she also experienced a low grade fever. The patient was recovering at the time of reporting. The patient sought medical attention. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Fatigue, Influenza like illness, Platelet count decreased, Rash papular
Clinical narrative: Information has been received from a physician concerning a 71 year old male with a history of hypertension, high cholesterol, normal pressure hydrocephalus, no known allergies and no recent exposure to chickenpox nor shingles who on 25-JUL-2008, was vaccinated with ZOSTER (Oka/Merck) (LOT # 659760/0159X) 0.65mL subcutaneously into the right arm.  Concomitant therapy included MSD, RHINOCORT and ACIPHEX.  On 11-AUG-2008 (previously reported as 12-AUG-2008), Varicella Day #17, the patient experienced a "full blown' case of chicken pox.  The patient was enrolled in the Varicella ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  The patient experienced flu-like symptoms on Varicella day 14 and a diffuse rash at day 17 at the site of the injection with a maximum temperature of 102F.  It was noted the patient's Varicella rash has more than 100 lesions distributed across his trunk and extremities.  The patient recovered from chicken pox.  No further information is available.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic, Rash vesicular, White blood cell count decreased
Clinical narrative: Information has been received from a physician concerning a 71 year old male with a history of hypertension, high cholesterol, normal pressure hydrocephalus, no known allergies and no recent exposure to chickenpox nor shingles who on 25-JUL-2008, was vaccinated with ZOSTER (Oka/Merck) (LOT # 659760/0159X) 0.65mL subcutaneously into the right arm.  Concomitant therapy included MSD, RHINOCORT and ACIPHEX.  On 11-AUG-2008 (previously reported as 12-AUG-2008), Varicella Day #17, the patient experienced a "full blown' case of chicken pox.  The patient was enrolled in the Varicella ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  The patient experienced flu-like symptoms on Varicella day 14 and a diffuse rash at day 17 at the site of the injection with a maximum temperature of 102F.  It was noted the patient's Varicella rash has more than 100 lesions distributed across his trunk and extremities.  The patient recovered from chicken pox.  No further information is available.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Influenza like illness, Injection site rash, Varicella
Clinical narrative: Information has been received from a physician concerning a 71 year old male with a history of hypertension, high cholesterol, normal pressure hydrocephalus, no known allergies and no recent exposure to chickenpox nor shingles who on 25-JUL-2008, was vaccinated with ZOSTER (Oka/Merck) (LOT # 659760/0159X) 0.65mL subcutaneously into the right arm.  Concomitant therapy included MSD, RHINOCORT and ACIPHEX.  On 11-AUG-2008 (previously reported as 12-AUG-2008), Varicella Day #17, the patient experienced a "full blown' case of chicken pox.  The patient was enrolled in the Varicella ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  The patient experienced flu-like symptoms on Varicella day 14 and a diffuse rash at day 17 at the site of the injection with a maximum temperature of 102F.  It was noted the patient's Varicella rash has more than 100 lesions distributed across his trunk and extremities.  The patient recovered from chicken pox.  No further information is available.
Age: 78.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Burning sensation, Rash
Clinical narrative: This is in follow-up to report(s) previously submitted on 12/23/2008. Information has been received from a nurse practitioner concerning a 78 year old female patient with high cholesterol and osteopenia, no known drug or food allergies and no other adverse reactions to vaccines in past who on 08-OCT-2008 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# 662970/1207). Concomitant therapy included SIMVASTATIN (manufacturer unknown), alendronate sodium (MSD) and Calcium.  The patient also received FLUZONE (SANOFI, LOT # U2809AA) on 08-OCT-2008.  On 10-OCT-2008 the patient experienced red, itchy, pinpoint confluent rash on her thighs. The patient went into hot tub thinking it would improve rash.  On 11-OCT-2008 the patient also had the same nature rash on arms and back. The patient has been taken BENADRYL, Oatmeal Bath, and calamine lotion for treatment of rash.  There was no drainage and no other adverse effects noted.  At the time of this report, the adverse event was not improving, but not getting any worse since 11-OCT-2008.  The patient sought medical attention via returning to clinic.  No further information is available.
Age: 78.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Erythema, Rash pruritic
Clinical narrative: This is in follow-up to report(s) previously submitted on 12/23/2008. Information has been received from a nurse practitioner concerning a 78 year old female patient with high cholesterol and osteopenia, no known drug or food allergies and no other adverse reactions to vaccines in past who on 08-OCT-2008 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# 662970/1207). Concomitant therapy included SIMVASTATIN (manufacturer unknown), alendronate sodium (MSD) and Calcium.  The patient also received FLUZONE (SANOFI, LOT # U2809AA) on 08-OCT-2008.  On 10-OCT-2008 the patient experienced red, itchy, pinpoint confluent rash on her thighs. The patient went into hot tub thinking it would improve rash.  On 11-OCT-2008 the patient also had the same nature rash on arms and back. The patient has been taken BENADRYL, Oatmeal Bath, and calamine lotion for treatment of rash.  There was no drainage and no other adverse effects noted.  At the time of this report, the adverse event was not improving, but not getting any worse since 11-OCT-2008.  The patient sought medical attention via returning to clinic.  No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: This is in follow-up to report(s) previously submitted on 12/23/2008. Information has been received from a registered nurse concerning a 61 years or older female who on the morning of 14-OCT-2008 was vaccinated with a dose of ZOSTAVAX subcutaneously. In October 2008, the patient developed an unspecified rash after receiving the vaccine. The patient's unspecified rash persisted. No other information is available at this time. Follow-up information was received from registered nurse who reported that on the morning of 17-OCT-2008 patient complained of redness, slight rash, itch and soreness at injection site. The patient was encouraged to take Advil and ice on same and it not improved or worse go to the doctor. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Rash
Clinical narrative: This is in follow-up to report(s) previously submitted on 12/23/2008. Information has been received from a registered nurse concerning a 61 years or older female who on the morning of 14-OCT-2008 was vaccinated with a dose of ZOSTAVAX subcutaneously. In October 2008, the patient developed an unspecified rash after receiving the vaccine. The patient's unspecified rash persisted. No other information is available at this time. Follow-up information was received from registered nurse who reported that on the morning of 17-OCT-2008 patient complained of redness, slight rash, itch and soreness at injection site. The patient was encouraged to take Advil and ice on same and it not improved or worse go to the doctor. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain in extremity, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 63 year old female with cardiac disease, a history of chickenpox and allergies to COUMADIN and PENILILLIN who on 03-OCT-2008 was vaccinated with ZOSTER (Oka-Merck) (lot # 662970/1207X) 0.65ml SQ into the left arm.  Concomitant therapy included LOVENOX, ASACOL, omega-3 marine triglycerides, calcium (manufacture unspecified) and red rice yeast.  On 10-OCT-2008 (also was reported with 14-OCT-2008) the patient developed shingles described as a vesicular rash on right shin area with approximately 50 vesicles.  Affected area included right leg area 2 x 3 and 1x1 inch area to right shin area.  The patient also developed "right leg-shin area with foot swelling".  No fever was noted.  The patient reported pain as "9" on a scale of 1 to 10.  It was not sure that there was recent exposure to chickenpox or herpes ZOSTER.  The patient's shingles persisted.  The patient was enrolled in the VARICELLA ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Oedema peripheral, Pain, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 63 year old female with cardiac disease, a history of chickenpox and allergies to COUMADIN and PENILILLIN who on 03-OCT-2008 was vaccinated with ZOSTER (Oka-Merck) (lot # 662970/1207X) 0.65ml SQ into the left arm.  Concomitant therapy included LOVENOX, ASACOL, omega-3 marine triglycerides, calcium (manufacture unspecified) and red rice yeast.  On 10-OCT-2008 (also was reported with 14-OCT-2008) the patient developed shingles described as a vesicular rash on right shin area with approximately 50 vesicles.  Affected area included right leg area 2 x 3 and 1x1 inch area to right shin area.  The patient also developed "right leg-shin area with foot swelling".  No fever was noted.  The patient reported pain as "9" on a scale of 1 to 10.  It was not sure that there was recent exposure to chickenpox or herpes ZOSTER.  The patient's shingles persisted.  The patient was enrolled in the VARICELLA ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: Information has been received from a pharmacist concerning a 72 year old female with drug allergy to DARVON and no recent exposure to chicken pox or shingles who on 12-NOV-2008 was vaccinated with ZOSTER (Oka/Merck) (Lot #663195/1416X), SQ.  There was no concomitant medication.  On 14-NOV-2008 the patient developed a slightly raised rash the size of a quarter at the site of injection.  The reporter might be interested in VARICELLA-ZOSTER Virus (VZV) Analysis by PCR (Polymerase Chain Reaction).  The patient's a slightly raised rash the size of a quarter at the site of injection persisted.  Unspecified medical attention was sought.  Follow up information was received from the physician who indicated that the patient did not have shingles.  The rash was a localized injection reaction to ZOSTER (Oka/Merck) that was not administered in this physician's office.  The distribution of lesions was not dermatomal.  Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a 72 year old female with drug allergy to DARVON and no recent exposure to chicken pox or shingles who on 12-NOV-2008 was vaccinated with ZOSTER (Oka/Merck) (Lot #663195/1416X), SQ.  There was no concomitant medication.  On 14-NOV-2008 the patient developed a slightly raised rash the size of a quarter at the site of injection.  The reporter might be interested in VARICELLA-ZOSTER Virus (VZV) Analysis by PCR (Polymerase Chain Reaction).  The patient's a slightly raised rash the size of a quarter at the site of injection persisted.  Unspecified medical attention was sought.  Follow up information was received from the physician who indicated that the patient did not have shingles.  The rash was a localized injection reaction to ZOSTER (Oka/Merck) that was not administered in this physician's office.  The distribution of lesions was not dermatomal.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 48 hrs after administration of Vaccine the injection site became very red and swollen.  Within a few minutes the redness radiated down her arm near her wrist.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: 48 hrs after administration of Vaccine the injection site became very red and swollen.  Within a few minutes the redness radiated down her arm near her wrist.
Age: 24.0
Sex: M
Vaccine: FLU3, PPV, TD, FLUX, PPV, TD
Symptoms: Blood immunoglobulin E increased, Lymphadenitis, Lymphadenopathy, Pain in extremity
Clinical narrative: Patient with PMH of asthma and significantly elevated IgE 2159 was admitted with the right axilla pain after the PNEUMOVAX and the flu shot in the right arm yesterday earlier during the day. He was also given Td in left arm. Patient had exquisitely tender anterior aspect of right axilla when moving adducting and abducting the right shoulder. Patient was seen by the neurology, general surgery and orthopedic, and was also discussed with allergy immunology team. He was empirically given abx. pain meds and IVF MRI of the right shoulder was obtained that confirmed cluster of enhancing masses in the right axilla most consistent with lymph nodes with surrounding mild inflammation. No abscess, therefore it was believed that patient has had reactive lymphadenitis to the immunization (flu, PNEUMOVAX) that he received in the right arm on 11/25/08. Symptoms: 1. lymphadenitis, pain  1/27/2009 MR received for DOS 1/26-27/2008 with D/C DX:  Reactive Lymphadenitis of R axilla. Pt presented with excrutiating pain and swelling of R axillary lymph nodes which began 4-5 hrs after receiving vax. Low grade temp and tenderness upon movement of shoulder and palpation as well as some swelling and redness of R arm. Asthma exacerbation in ER which responded to nebs. Tx with abx, pain meds and IVF. To f/u as outpt.
Age: 24.0
Sex: M
Vaccine: FLU3, PPV, TD, FLUX, PPV, TD
Symptoms: Axillary pain, Inflammation, Injected limb mobility decreased, Lymphadenitis, Mass
Clinical narrative: Patient with PMH of asthma and significantly elevated IgE 2159 was admitted with the right axilla pain after the PNEUMOVAX and the flu shot in the right arm yesterday earlier during the day. He was also given Td in left arm. Patient had exquisitely tender anterior aspect of right axilla when moving adducting and abducting the right shoulder. Patient was seen by the neurology, general surgery and orthopedic, and was also discussed with allergy immunology team. He was empirically given abx. pain meds and IVF MRI of the right shoulder was obtained that confirmed cluster of enhancing masses in the right axilla most consistent with lymph nodes with surrounding mild inflammation. No abscess, therefore it was believed that patient has had reactive lymphadenitis to the immunization (flu, PNEUMOVAX) that he received in the right arm on 11/25/08. Symptoms: 1. lymphadenitis, pain  1/27/2009 MR received for DOS 1/26-27/2008 with D/C DX:  Reactive Lymphadenitis of R axilla. Pt presented with excrutiating pain and swelling of R axillary lymph nodes which began 4-5 hrs after receiving vax. Low grade temp and tenderness upon movement of shoulder and palpation as well as some swelling and redness of R arm. Asthma exacerbation in ER which responded to nebs. Tx with abx, pain meds and IVF. To f/u as outpt.
Age: 24.0
Sex: M
Vaccine: FLU3, PPV, TD, FLUX, PPV, TD
Symptoms: Nuclear magnetic resonance imaging abnormal, Tenderness
Clinical narrative: Patient with PMH of asthma and significantly elevated IgE 2159 was admitted with the right axilla pain after the PNEUMOVAX and the flu shot in the right arm yesterday earlier during the day. He was also given Td in left arm. Patient had exquisitely tender anterior aspect of right axilla when moving adducting and abducting the right shoulder. Patient was seen by the neurology, general surgery and orthopedic, and was also discussed with allergy immunology team. He was empirically given abx. pain meds and IVF MRI of the right shoulder was obtained that confirmed cluster of enhancing masses in the right axilla most consistent with lymph nodes with surrounding mild inflammation. No abscess, therefore it was believed that patient has had reactive lymphadenitis to the immunization (flu, PNEUMOVAX) that he received in the right arm on 11/25/08. Symptoms: 1. lymphadenitis, pain  1/27/2009 MR received for DOS 1/26-27/2008 with D/C DX:  Reactive Lymphadenitis of R axilla. Pt presented with excrutiating pain and swelling of R axillary lymph nodes which began 4-5 hrs after receiving vax. Low grade temp and tenderness upon movement of shoulder and palpation as well as some swelling and redness of R arm. Asthma exacerbation in ER which responded to nebs. Tx with abx, pain meds and IVF. To f/u as outpt.
Age: 0.8
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: PATIENT HAD FEBRILE SEIZURE THE SAME NIGHT AFTER VACCINE ADMINISTRATION.  2/2/09 MR received for ER visit 12/23/08 with D/C DX:  Febrile Seizure.   Pt presented after an episode of generalized rigidity with eyes rolling back with LOC, lasting ~2 minutes.  Temp 99'F at home,  104'F in ER.  PE otherwise WNL. D/C to f/u with PCP
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC
Symptoms: Asphyxia, Autopsy, Death
Clinical narrative: Death - Mom discovered infant's head wedged between pillow and bed Thursday morning. 1/2/09-autopsy report received-COD 1. Compressive asphyxia. Compressive markings of skin of chest, shoulders and sides of face. Pulmonary atelectasis. Dilated heart, hypoxic myocardium. Congested cyanotic brain and viscera. Petechiae in epicardium, pleurae and thymus glad. Aspiration of gastric contents. Bilateral enlarged renal pelves, stenotic ureteropelvic junctions, right more than left.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MMR
Symptoms: Blood culture, Chest X-ray, Chest pain, Culture urine, Full blood count
Clinical narrative: Admit ER 12/11/08 with fever, chest pain transfer to hospital, infectious disease consent, tested for viruses. Discharge diagnosis likely acute viral respiratory tract disease.  12/29/08 VAERS report submitted with medical records attached. Pt received 3 vax on 12/11/08.  Had been feeling poorly at time of vax, but felt progressively worse afterward with headache, myalgias, fever and sore throat. Dehydrated on admission. Tx with IVF. Sx likely due to vaccine side effect and/or virus.  DX: Fever. Immunosupression.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MMR
Symptoms: Pyrexia, Respiratory tract infection viral, Viral test
Clinical narrative: Admit ER 12/11/08 with fever, chest pain transfer to hospital, infectious disease consent, tested for viruses. Discharge diagnosis likely acute viral respiratory tract disease.  12/29/08 VAERS report submitted with medical records attached. Pt received 3 vax on 12/11/08.  Had been feeling poorly at time of vax, but felt progressively worse afterward with headache, myalgias, fever and sore throat. Dehydrated on admission. Tx with IVF. Sx likely due to vaccine side effect and/or virus.  DX: Fever. Immunosupression.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chondrocalcinosis pyrophosphate, Polymyalgia rheumatica
Clinical narrative: Polymyalgia Rheumatica ( see attached page) Pseudo - Gout
Age: 1.1
Sex: M
Vaccine: DTAP, FLUX, HIBV, PNC
Symptoms: Lipoatrophy, Pain, Skin discolouration, Skin disorder
Clinical narrative: This case was reported by a physician and described the occurrence of fat atrophy in a 13-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline), ACTHIB. The subject's medical history included cleft lip, cleft lip repair and renal problems. Previous and/or concurrent vaccination included influenza virus vaccine; manufacturer unspecified; unknown given on 29 September 2008; PREVNAR (non-gsk); Wyeth Labs; unknown given on 29 September 2008. Concurrent medications included ENALAPRIL. On 29 September 2008 the subject received 4th dose of INFANRIX (.5 ml, unknown, right thigh), unspecified dose of ACTHIB (unknown, right thigh). On 29 September 2008, less than one day after vaccination with INFANRIX, at an unspecified time after vaccination with ACTHIB, the subject experienced fat atrophy, skin discoloration, skin indentation and pain. This case was assessed as medically serious by GSK. A physician reported that he gave a 13-month old subject his 4th dose of INFANRIX vaccine and the subject developed a small purple spot that enlarged and became pitted over the course of one month. There may have even some pain associated with the area, but the physician was not certain. The subject also received an ACTHIB vaccine in the same thigh and separate location that day. The physician is not certain if the site was of the INFANRIX or of the ACTHIB. At the time of the report, the area had not improved or worsened but currently appeared to be a discolored, indentured area where the subcutaneous fatty tissue had atrophied leaving muscle directly covered with "thin parchment like skin". At the time of reporting the events were unresolved. The physician considered the events were possibly related to vaccination with INFANRIX and ACTHIB.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Initial information was received from a health care professional on 08 October 2008. A 32 year old female patient with a history of depression, hypothyroidism, and one previous pregnancy resulting in a full term delivery received an intramuscular booster dose of ADACEL in the right deltoid on 26 September 2008 (lot number C2998BA). The patient was "two to five weeks pregnant". It was not reported whether the patient was two to five weeks pregnant at the time of the report or at the time of vaccination. The patient's date of her last menstrual period was unknown. The patient's estimated due date was reported as "30 June 2009 to 10 June 2009". The patient did not experience any adverse events at the time of the report. No further information was provided. Follow-up information received on 22 December 2008 from a physician. The patient has past obstetrical history of one previous pregnancy that resulted in one live birth with no congenital anomalies. The patient was reported to have miscarried, the current pregnancy on 26 November 2008 at seven weeks gestation. It was not reported whether the patient had any other adverse events since being vaccinated with ADACEL on 26 September 2008. No other information was provided. Documents held by sender: none.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperaesthesia, Oedema peripheral, Tenderness
Clinical narrative: Pt received her second GARDASIL vaccine in June on her left arm. Patient states that her arm is stills swollen and feel very tender. She is sensitive to touch.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Disorientation, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: Patient was given the GARDASIL shot at county health dept.  She had two other shots done in her right arm, before the GARDASIL shot was given on the left side.  Patient immediately fainted.  When the nurse and I got her back up onto the table, she seized  for about 30-60 seconds.  It scared the nurse and I both.  When she finally "came to" she was extremely disoriented.  She said that her legs felt really "heavy"  and that her head hurt.  It took her about 30 minutes to be able to just stand up.  She was then really tired and exhausted all day the rest of that day.   This really scared both of us.  She really doesn't want to take the next 2 series of the shots because she is scared to death the same thing will happen again.  Frankly, so am I.  Is this going to be a possibility? Or do we not take the shots now?  Please let us know as we are both really concerned.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Sensation of heaviness, Syncope
Clinical narrative: Patient was given the GARDASIL shot at county health dept.  She had two other shots done in her right arm, before the GARDASIL shot was given on the left side.  Patient immediately fainted.  When the nurse and I got her back up onto the table, she seized  for about 30-60 seconds.  It scared the nurse and I both.  When she finally "came to" she was extremely disoriented.  She said that her legs felt really "heavy"  and that her head hurt.  It took her about 30 minutes to be able to just stand up.  She was then really tired and exhausted all day the rest of that day.   This really scared both of us.  She really doesn't want to take the next 2 series of the shots because she is scared to death the same thing will happen again.  Frankly, so am I.  Is this going to be a possibility? Or do we not take the shots now?  Please let us know as we are both really concerned.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Swollen tongue, Tinnitus
Clinical narrative: About 15 seconds S/P FLUZONE 0.5ml IM;  Dyspnea, tongue swelling, tinnitus.  50 mg BENADRYL IM and 0.3 ml EPINEPHRINE SQ given - Transported stable condition to ER
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV1
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: ROTARIX given at age 27 weeks.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discharge, Injection site swelling
Clinical narrative: School RN contacted outreach clinic RN to let me know this patient's mother stated her daughter's TIV injection site had some oozing and was swollen up to 2 days after injection.  Patient was seen by her PCP, topical antibiotic cream given per mom, and was fine by next day.
Age: 14.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Injection site erythema
Clinical narrative: 5X4 cm area of redness on left upper arm
Age: 13.0
Sex: F
Vaccine: FLUN3, HPV4, VARCEL
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Within 24 hrs arm itchy and red-swollen-size of tennis ball.  2nd day redness and swelling doubled in size.  3rd day still red and swollen size - 15X16 cm at office.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Vision blurred
Clinical narrative: Pt reported dizziness, blurry vision 15 min after injection.  Pt laying down X 15 min. Pt stated "feeling better".
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Lip swelling, Pruritus, Swollen tongue, Urticaria
Clinical narrative: Approx. 20 minutes following the vaccination, pt  began experiencing hives across both shoulders and neck.  Hives were red and "itchy."  Pt began experiencing swelling of the tongue and eventually of the lips as well.  Treatment was administered by ER.
Age: 17.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patent received TWINRIX vaccine.
Age: 15.0
Sex: M
Vaccine: FLUN3
Symptoms: Epistaxis, Immediate post-injection reaction
Clinical narrative: Nosebleed immediately after FLUMIST for 3-5 minutes, resolved spontaneously.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Hypoaesthesia, Nausea, Syncope, Tremor
Clinical narrative: Dizziness and nausea.  Numbness of arms, legs and head, shaking, fainting.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Immediately after injection with fine rash to deltoid region, then 5 days later with bright red rash to ankles which was less in 2 days-non pruritic-8 days after injection with fine maculopapular rash to anterior deltoid/chest. No acute allergic event.
Age: 43.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chest X-ray abnormal, Chills, Cough, Fatigue
Clinical narrative: PNEUMOVAX given 12-18-08.  Patient became ill 2-20-08 with symptoms, fever, chills, sweating, cough, fatigue and weakness.  Office visit 12-22-08 CXR showed extensive left lower lobe Pneumonia treated in office 1000mg ROCEPHIN IM, nebulizer treatment and Rx's for AVELOX 400mg 8d and ROBITUSSIN AC after 4 hrs PRN.
Age: 43.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hyperhidrosis, Lobar pneumonia, Pyrexia
Clinical narrative: PNEUMOVAX given 12-18-08.  Patient became ill 2-20-08 with symptoms, fever, chills, sweating, cough, fatigue and weakness.  Office visit 12-22-08 CXR showed extensive left lower lobe Pneumonia treated in office 1000mg ROCEPHIN IM, nebulizer treatment and Rx's for AVELOX 400mg 8d and ROBITUSSIN AC after 4 hrs PRN.
Age: 38.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Red ring of elevation, itchy and very sore
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Condition aggravated, Dizziness, Rhinitis allergic
Clinical narrative: Intermittent dizziness and elevated temps (98.9-99.9) starting one week after injection and lasting one week.  Simultaneously experienced exacerbation of allergic rhinitis.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Myalgia, Oral pain, Oropharyngeal pain, Rash
Clinical narrative: General low energy, rash on front of body, pain in throat/mouth.  Sudden symptoms, muscle pain.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hive in a 21-year-old male subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  On 1 July 2005 at 11:58, the subject received 3rd dose of ENGERIX B, (1 ml, unknown, left arm).  On 1 July 2005, less than one day after vaccination with ENGERIX B, the subject experienced hive and welts all over body.  The pharmacist reported that a male subject received his 3rd dose of ENGERIX B and developed large welts all over his body.  The subject went to the emergency room and was treated with epinephrine for hives.  The symptoms resolved within 24 hours.  No further information was available at the time of the report.  The pharmacist considered the events were clinically significant (or requiring intervention).  The subject was treated with adrenaline (Epinephrine).  On 2 July 2005, the events were resolved.  The pharmacist considered the events were possibly related to vaccination with ENGERIX B.
Age: 16.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ
Symptoms: Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Patient given FLUMIST and GARDASIL and subsequently noted urine HCG was positive.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Full blood count normal, Irritability, Pyrexia, Urine analysis
Clinical narrative: Fever 102.5  Irritable difficult to console
Age: 2.0
Sex: F
Vaccine: DTAP, FLU3, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right thigh swelling, redness, warm to touch.  Reminded mother to rub area every 2 hrs. and apply ice pack first 24 hours then warm compress.  Call PRN if increased redness & swelling.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Dyspnoea, Headache, Malaise
Clinical narrative: Started 2000 10/07/08. Severe pain in joints, chills, fever 101 degrees. Took EXCEDRIN for H/A, SOB, took nebulizer 3xs in less than 12hrs. General malaise.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Started 2000 10/07/08. Severe pain in joints, chills, fever 101 degrees. Took EXCEDRIN for H/A, SOB, took nebulizer 3xs in less than 12hrs. General malaise.