chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood creatine phosphokinase increased, Lymphadenopathy, Myalgia, Red blood cell sedimentation rate normal, Trismus
Clinical narrative: Information has been obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 23 year old female patient with allergic rhinitis, asthma, and TMJ treatment with night guard and a history of nightmares with CELEXA, "lymph swelling in neck post Gardasil (June, 2007), mono, and suppressed immune system who on 07-AUG-2007, was vaccinated IM in right arm with a second dose of Gardasil, lot #658100/0525U). Concomitant therapy included ALLEGRA, ZOLOFT, FLONASE, BCP and albuterol. The report was as follows: "This was pt's second GARDASIL vaccine on 8/7/07. She developed symptoms 8/14 and was seen at hospital 8/20, 8/21, 8/22/07. She was suffering from myalgias, trismus, 'lockjaw', and slight neck adenopathy. Her neck CT was normal. 9/18/07 Received hospital medical records which reveal patient experienced severe neck pain and swelling w/inability to open her mouth. After 1st vax 6/07 had tenderness in right clavicle and neck area. Saw pcp and dx w/reaction to vax. Resolved over approx 1-2 mos. Received 2nd vax on 8/07. Approx 1 week later developed severe pain in right neck and axilla w/enlarged lymph nodes. States pain was so severe that she could not open her mouth. Saw pcp who again dx w/reaction to vax but referred to ER due to severity. Exam revealed full ROM of neck w/tenderness and palpable tender lymph noes of neck and right axillary. D/C to home. No improvement and returned to ER on 9/21. Tx w/IVF, pain med and IV steroids. Improved in ER and d/c to home. Returned to ER on 8/22 for repeat labs and recheck of symptoms. CPK improved but continued w/same symptoms but no adenopathy noted on exam. Right arm exam WNL but w/increased tone to bicep/tricep area w/good ROM, strength and sensation. Tx w/pain med and benzodiazepam w/excellent relief. D/C to home and f/u w/pcp. Final ER DX: 8/20/07 reactive lymphadenopathy, probable viral illness, ? TMJ syndrome, questionable AE to vaccine. Final ER DX: 8/21/07 myalgias w/extremely low grade rhabdomyalisis and ? serum immune complex type hypersensitivity reaction to vaccine. Final ER DX: 8/22/07 myalgias w/low grade rhabdomyolysis. Lymphadenopathy, myalgia, trismus and "lockjaw" were considered to be immediately life-threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released. The VAERs ID number is 290331. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood creatine phosphokinase increased, Computerised tomogram abnormal, Dyskinesia, Epstein-Barr virus antibody negative, Hypersensitivity
Clinical narrative: Information has been obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 23 year old female patient with allergic rhinitis, asthma, and TMJ treatment with night guard and a history of nightmares with CELEXA, "lymph swelling in neck post Gardasil (June, 2007), mono, and suppressed immune system who on 07-AUG-2007, was vaccinated IM in right arm with a second dose of Gardasil, lot #658100/0525U). Concomitant therapy included ALLEGRA, ZOLOFT, FLONASE, BCP and albuterol. The report was as follows: "This was pt's second GARDASIL vaccine on 8/7/07. She developed symptoms 8/14 and was seen at hospital 8/20, 8/21, 8/22/07. She was suffering from myalgias, trismus, 'lockjaw', and slight neck adenopathy. Her neck CT was normal. 9/18/07 Received hospital medical records which reveal patient experienced severe neck pain and swelling w/inability to open her mouth. After 1st vax 6/07 had tenderness in right clavicle and neck area. Saw pcp and dx w/reaction to vax. Resolved over approx 1-2 mos. Received 2nd vax on 8/07. Approx 1 week later developed severe pain in right neck and axilla w/enlarged lymph nodes. States pain was so severe that she could not open her mouth. Saw pcp who again dx w/reaction to vax but referred to ER due to severity. Exam revealed full ROM of neck w/tenderness and palpable tender lymph noes of neck and right axillary. D/C to home. No improvement and returned to ER on 9/21. Tx w/IVF, pain med and IV steroids. Improved in ER and d/c to home. Returned to ER on 8/22 for repeat labs and recheck of symptoms. CPK improved but continued w/same symptoms but no adenopathy noted on exam. Right arm exam WNL but w/increased tone to bicep/tricep area w/good ROM, strength and sensation. Tx w/pain med and benzodiazepam w/excellent relief. D/C to home and f/u w/pcp. Final ER DX: 8/20/07 reactive lymphadenopathy, probable viral illness, ? TMJ syndrome, questionable AE to vaccine. Final ER DX: 8/21/07 myalgias w/extremely low grade rhabdomyalisis and ? serum immune complex type hypersensitivity reaction to vaccine. Final ER DX: 8/22/07 myalgias w/low grade rhabdomyolysis. Lymphadenopathy, myalgia, trismus and "lockjaw" were considered to be immediately life-threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released. The VAERs ID number is 290331. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypertonia, Immune system disorder, Lymphadenopathy, Lymphocyte count decreased, Myalgia
Clinical narrative: Information has been obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 23 year old female patient with allergic rhinitis, asthma, and TMJ treatment with night guard and a history of nightmares with CELEXA, "lymph swelling in neck post Gardasil (June, 2007), mono, and suppressed immune system who on 07-AUG-2007, was vaccinated IM in right arm with a second dose of Gardasil, lot #658100/0525U). Concomitant therapy included ALLEGRA, ZOLOFT, FLONASE, BCP and albuterol. The report was as follows: "This was pt's second GARDASIL vaccine on 8/7/07. She developed symptoms 8/14 and was seen at hospital 8/20, 8/21, 8/22/07. She was suffering from myalgias, trismus, 'lockjaw', and slight neck adenopathy. Her neck CT was normal. 9/18/07 Received hospital medical records which reveal patient experienced severe neck pain and swelling w/inability to open her mouth. After 1st vax 6/07 had tenderness in right clavicle and neck area. Saw pcp and dx w/reaction to vax. Resolved over approx 1-2 mos. Received 2nd vax on 8/07. Approx 1 week later developed severe pain in right neck and axilla w/enlarged lymph nodes. States pain was so severe that she could not open her mouth. Saw pcp who again dx w/reaction to vax but referred to ER due to severity. Exam revealed full ROM of neck w/tenderness and palpable tender lymph noes of neck and right axillary. D/C to home. No improvement and returned to ER on 9/21. Tx w/IVF, pain med and IV steroids. Improved in ER and d/c to home. Returned to ER on 8/22 for repeat labs and recheck of symptoms. CPK improved but continued w/same symptoms but no adenopathy noted on exam. Right arm exam WNL but w/increased tone to bicep/tricep area w/good ROM, strength and sensation. Tx w/pain med and benzodiazepam w/excellent relief. D/C to home and f/u w/pcp. Final ER DX: 8/20/07 reactive lymphadenopathy, probable viral illness, ? TMJ syndrome, questionable AE to vaccine. Final ER DX: 8/21/07 myalgias w/extremely low grade rhabdomyalisis and ? serum immune complex type hypersensitivity reaction to vaccine. Final ER DX: 8/22/07 myalgias w/low grade rhabdomyolysis. Lymphadenopathy, myalgia, trismus and "lockjaw" were considered to be immediately life-threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released. The VAERs ID number is 290331. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Neck pain, Red blood cell sedimentation rate normal, Rhabdomyolysis, Streptococcal identification test negative, Swelling
Clinical narrative: Information has been obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 23 year old female patient with allergic rhinitis, asthma, and TMJ treatment with night guard and a history of nightmares with CELEXA, "lymph swelling in neck post Gardasil (June, 2007), mono, and suppressed immune system who on 07-AUG-2007, was vaccinated IM in right arm with a second dose of Gardasil, lot #658100/0525U). Concomitant therapy included ALLEGRA, ZOLOFT, FLONASE, BCP and albuterol. The report was as follows: "This was pt's second GARDASIL vaccine on 8/7/07. She developed symptoms 8/14 and was seen at hospital 8/20, 8/21, 8/22/07. She was suffering from myalgias, trismus, 'lockjaw', and slight neck adenopathy. Her neck CT was normal. 9/18/07 Received hospital medical records which reveal patient experienced severe neck pain and swelling w/inability to open her mouth. After 1st vax 6/07 had tenderness in right clavicle and neck area. Saw pcp and dx w/reaction to vax. Resolved over approx 1-2 mos. Received 2nd vax on 8/07. Approx 1 week later developed severe pain in right neck and axilla w/enlarged lymph nodes. States pain was so severe that she could not open her mouth. Saw pcp who again dx w/reaction to vax but referred to ER due to severity. Exam revealed full ROM of neck w/tenderness and palpable tender lymph noes of neck and right axillary. D/C to home. No improvement and returned to ER on 9/21. Tx w/IVF, pain med and IV steroids. Improved in ER and d/c to home. Returned to ER on 8/22 for repeat labs and recheck of symptoms. CPK improved but continued w/same symptoms but no adenopathy noted on exam. Right arm exam WNL but w/increased tone to bicep/tricep area w/good ROM, strength and sensation. Tx w/pain med and benzodiazepam w/excellent relief. D/C to home and f/u w/pcp. Final ER DX: 8/20/07 reactive lymphadenopathy, probable viral illness, ? TMJ syndrome, questionable AE to vaccine. Final ER DX: 8/21/07 myalgias w/extremely low grade rhabdomyalisis and ? serum immune complex type hypersensitivity reaction to vaccine. Final ER DX: 8/22/07 myalgias w/low grade rhabdomyolysis. Lymphadenopathy, myalgia, trismus and "lockjaw" were considered to be immediately life-threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released. The VAERs ID number is 290331. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Temporomandibular joint syndrome, Tenderness, Trismus, Viral infection, White blood cell count
Clinical narrative: Information has been obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 23 year old female patient with allergic rhinitis, asthma, and TMJ treatment with night guard and a history of nightmares with CELEXA, "lymph swelling in neck post Gardasil (June, 2007), mono, and suppressed immune system who on 07-AUG-2007, was vaccinated IM in right arm with a second dose of Gardasil, lot #658100/0525U). Concomitant therapy included ALLEGRA, ZOLOFT, FLONASE, BCP and albuterol. The report was as follows: "This was pt's second GARDASIL vaccine on 8/7/07. She developed symptoms 8/14 and was seen at hospital 8/20, 8/21, 8/22/07. She was suffering from myalgias, trismus, 'lockjaw', and slight neck adenopathy. Her neck CT was normal. 9/18/07 Received hospital medical records which reveal patient experienced severe neck pain and swelling w/inability to open her mouth. After 1st vax 6/07 had tenderness in right clavicle and neck area. Saw pcp and dx w/reaction to vax. Resolved over approx 1-2 mos. Received 2nd vax on 8/07. Approx 1 week later developed severe pain in right neck and axilla w/enlarged lymph nodes. States pain was so severe that she could not open her mouth. Saw pcp who again dx w/reaction to vax but referred to ER due to severity. Exam revealed full ROM of neck w/tenderness and palpable tender lymph noes of neck and right axillary. D/C to home. No improvement and returned to ER on 9/21. Tx w/IVF, pain med and IV steroids. Improved in ER and d/c to home. Returned to ER on 8/22 for repeat labs and recheck of symptoms. CPK improved but continued w/same symptoms but no adenopathy noted on exam. Right arm exam WNL but w/increased tone to bicep/tricep area w/good ROM, strength and sensation. Tx w/pain med and benzodiazepam w/excellent relief. D/C to home and f/u w/pcp. Final ER DX: 8/20/07 reactive lymphadenopathy, probable viral illness, ? TMJ syndrome, questionable AE to vaccine. Final ER DX: 8/21/07 myalgias w/extremely low grade rhabdomyalisis and ? serum immune complex type hypersensitivity reaction to vaccine. Final ER DX: 8/22/07 myalgias w/low grade rhabdomyolysis. Lymphadenopathy, myalgia, trismus and "lockjaw" were considered to be immediately life-threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released. The VAERs ID number is 290331. No further information is available.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, PNC, RV5
Symptoms: Abnormal faeces, Diarrhoea, Nasal congestion
Clinical narrative: Fould smelling loose stools, associated with nasal congestion. No fever or vomiting noted.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: AREA RED APPROX. 10 CM WITH 5CM INDURATION AREA WARM AND SWOLLEN.  MOTRIN EVERY 4-6HRS AND BENADRYL 50 MG EVERY 6 HRS AND ICE PRN.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient reports that she broke out in a rash, three hours after receiving the flu vaccine.  Rash was on face, arms, and neck.  It appeared as small raised red bumps that did not itch or cause any other discomfort.  Vaccine administrator recommended that the patient see her primary care physician.  To date the patient has not seen a physician.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: none.  Adacel given instead of Td.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Headache, Oedema peripheral, Skin warm
Clinical narrative: Left arm reddened and swollen. Warm to touch.Has had a headache since administration
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Cough, Dyspnoea, Oxygen supplementation, Throat tightness, Wheezing
Clinical narrative: Cough, difficulty breathing, tight throat, severe wheezing on auscultation. Treated with Epi-pen autoinjection, oxygen via mask
Age: 14.0
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Injection site reaction
Clinical narrative: REDNESS AND BUMP ON SHOT AREA
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hyperhidrosis
Clinical narrative: Diaphoretic and reports dyspnea 15 minute after Fluarix flu vaccine administration. Lot# AFLUA298BA. Treated with Epinephrine 0.3 mg IM injection and transported by ambulance to Emergency Room.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature normal, Chills, Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Within a few hours the patient developed soreness, erythema, edema and tenderness at the injection site, which was the left deltoid muscle. On the evening of the day of the injection the patient was aware of chills and a feverish feeling.  The temperature has been normal and the feverish feeling/chills resolved in less the 18 hours.  The soreness, tenderness and erythema have improved approx. 75 % at this point (less than 48 hours). Subsequent to the VAERS report filed, utilizing the Web-form, the patient recalled that she had received on influenza immunization at approximately the same site on the same arm, on approximately October 7.She did not state who administered that injection and she was not an established patient at this office at the time. She does not recall having an adverse reactionof any sort after the influenza immunization.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, No reaction on previous exposure to drug
Clinical narrative: Within a few hours the patient developed soreness, erythema, edema and tenderness at the injection site, which was the left deltoid muscle. On the evening of the day of the injection the patient was aware of chills and a feverish feeling.  The temperature has been normal and the feverish feeling/chills resolved in less the 18 hours.  The soreness, tenderness and erythema have improved approx. 75 % at this point (less than 48 hours). Subsequent to the VAERS report filed, utilizing the Web-form, the patient recalled that she had received on influenza immunization at approximately the same site on the same arm, on approximately October 7.She did not state who administered that injection and she was not an established patient at this office at the time. She does not recall having an adverse reactionof any sort after the influenza immunization.
Age: 1.33
Sex: M
Vaccine: TDAP
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: none was indiciated, no signs or symptoms were indicated as well.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Pain in extremity, Pruritus, Skin warm
Clinical narrative: On 11-1-07 received flu vaccine and noted left arm with pain, burning, itching, warm to touch area of 6 X 2 cm.  Advil taken with ice applied.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Croup infectious
Clinical narrative: Croup began the evening he received the flumist vaccine. 11/09/2007 MR received for DOS 10/31/2007 for D/C DX of Croup.  Pt presented to ER with abrupt onset of inspiratory stridor which responded quickly to racemic epinephrine and steroids. Transfered to current facilty where pt has not required any additional epi. Discharged on steroid taper. PE (+) respiratory stridor, otherwise WNL. Impression: Croup
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Nodule, Pain, Skin warm
Clinical narrative: On 11-1-07 pt. received flu vaccine and noted pain, redness, nodule, warm to touch 5 X 4 cm area to left arm.  On 11-2-07 reassessed area and noted 4 X 2 cm area remains painful, nodule and warm to touch.
Age: 13.0
Sex: F
Vaccine: FLUN3, MNQ, TDAP
Symptoms: Blister, Erythema, Skin lesion, Tenderness
Clinical narrative: Pt. awoke 11/01/2007 approximately 0700 to discover 1cm bulla-appearing lesion on L upper arm which had a small rim of erythema surrounding it. Entire area of upper arm tender to touch.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Lip swelling, Urticaria
Clinical narrative: 24 hours after vaccine the person developed hives over entire body to include palms of hands and feet. 48 hours later body hives continued and developed hives on face and tongue, eyes and lips swollen.  Took Benadryl with some releif of symptoms Denied any use of new products or food or changes in enviroment.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Electrocardiogram, Heart rate increased, Oxygen supplementation, Sinus tachycardia
Clinical narrative: After administration of the flu vaccine, my heart rate escalated into the 130s within 5-7 minutes.  I was very short of breath and my throat felt as if it was "closing off". An IV was started at the clinic and Benadryl 50mg IM was given, O2 per mask was given, all without relief of symptoms. 911 was called and the paramedic took me to the local hospital with an EKG reading of sinus tachycardia 150-160s.  I had uncontrollable shaking and trembling throughout the entire time.  I was given additional Benadryl 50mg IV, Solumedrol, Albuterol treatment and Ativan 2mg at the hospital where I remained on the heart monitor for 4 hours with heart rate remaining in the 140s.  Was discharged after my heart rate dropped to 91.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness, Tremor
Clinical narrative: After administration of the flu vaccine, my heart rate escalated into the 130s within 5-7 minutes.  I was very short of breath and my throat felt as if it was "closing off". An IV was started at the clinic and Benadryl 50mg IM was given, O2 per mask was given, all without relief of symptoms. 911 was called and the paramedic took me to the local hospital with an EKG reading of sinus tachycardia 150-160s.  I had uncontrollable shaking and trembling throughout the entire time.  I was given additional Benadryl 50mg IV, Solumedrol, Albuterol treatment and Ativan 2mg at the hospital where I remained on the heart monitor for 4 hours with heart rate remaining in the 140s.  Was discharged after my heart rate dropped to 91.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Nodule, Pain in extremity, Skin warm
Clinical narrative: on 11-1-07 pt. recevied flu vaccine and noted     3 X 1 1/4 redden, nodule, warm to touch, and painful to left arm.  No relief with Mobic or ice. On 11-2-07 reassessed area; now 4 X 2 cm.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site cellulitis, Pain
Clinical narrative: Pt. went to emergency department 2 days after receiveing pneumovax in R arm.  Treated with Rocephin 1 gm. IM for cellulitis.  Instructed to take Cephalexin 500 mg. TID for 10 days and was given vicodin for pain.  Cellulitis extended from injection site down to elbow.
Age: 56.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: Broke out with shingles at the injection site. Treated with Famvir 500 mg tid for 7 days.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received Tdap on 10/30/2007.  Later that evening, patient experienced extreme pain in her arm, fever 101 F, swelling, and redness.  Reports left leg pain, but has a history of backpain.  Today, no fever present, redness at injection site and area of Width 9 cm X Length 8 cm which is warm/painful to touch and swelling present below injection site.  Patient prescribed Cipro 500 mg one tablet twice a day for 7 days for cellulitis.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity, Pyrexia, Swelling
Clinical narrative: Received Tdap on 10/30/2007.  Later that evening, patient experienced extreme pain in her arm, fever 101 F, swelling, and redness.  Reports left leg pain, but has a history of backpain.  Today, no fever present, redness at injection site and area of Width 9 cm X Length 8 cm which is warm/painful to touch and swelling present below injection site.  Patient prescribed Cipro 500 mg one tablet twice a day for 7 days for cellulitis.
Age: 1.17
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Patient was given flu mist. Patient has no symptoms at this time.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, PPV, RVX
Symptoms: Culture stool, Diarrhoea
Clinical narrative: Constant Diarrhea for almost 1 month since administering the rotavirus vaccine.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: PT REPORTED AFTER RECEIVING 3RD DOSE OF GARDASIL STARTED TO EXPERIENCE FEVER,FLU-LIKE SYMPTOMS ABOUT 3 HOURS AFTER INJECTION LASTING ABOUT 12 HOURS. NO OTHER SYMPTOMS AFTER THAT 12 HOUR PERIOD.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Headache, Pharyngolaryngeal pain, Pyrexia, Streptococcal identification test negative
Clinical narrative: Child received immunization (Hep A #2) about 1015 and sent back to school. States he was fine during lunch. LAter in the afternoon, c/o headache and sore throat. Sent to school nurse. Had fever 102.5. Sent back to us. No signs of infection. Advised to treat with Acetiminophen/Ibuprofen and to call if any further symptoms or no improvement.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nodule, Pruritus, Tenderness
Clinical narrative: hard red knot approximately 3" in diameter;very tender and itched for approximately 7 days
Age: 0.25
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Discomfort, Inappropriate schedule of drug administration
Clinical narrative: Child is uncomfortable and having diarrhea. Was seen back in Clinic on November 2nd. CDC adverse effects for vaccines were reviewed with mother.Mother was informed that child was given flu shot earlier than the 6 month recommended age.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Oedema peripheral, Skin warm
Clinical narrative: Patient's right arm became swollen, red, and hot several hours after receiving her flu vaccine. She returned to the clinic the next morning and was given 80 mg of depomedrol, IM, for the inflammation.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received flu shot 2 weeks apart instead of 1 month apart
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Unevaluable event, Wrong drug administered
Clinical narrative: UNKNOWN
Age: 1.6
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Tdap given insted of Dtap, clinic R.N. called the CDC hot line and was told that the Tdap as the fourth dose would be sufficient coverage, the fifth dose does need to be Dtap.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Diarrhoea, Hyperhidrosis, Vomiting
Clinical narrative: Nov 1st patient experienced chills, diarrhea, vomiting, temperature 100' the evening after receiving vaccination. 911 was called and patient evaluated by emergency response team. Nov 2nd patient experiencing sweating. Instructed daughter to increase patients fluid intake to prevent dehydration and monitor condition.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema multiforme, Injection site rash, Laboratory test, Rash
Clinical narrative: Information has been received from a physician concerning a 75 year old female with no allergies who on 17-SEP-2007 was vaccinated with a single dose series of Zostavax (lot # 658211/0884U). Concomitant therapy included unspecified therapies. There was no illness at the time of vaccination. On 20-SEP-2007 the patient developed "irothemas" rash that started in the webbing of the patient's fingers. The rash was also at the injection site and then went from the patient's arm, legs, palms and lips. The physician treated with patient with ZYRTEC. A product quality complaint was not involved. Additional information has been received from a physician who stated that the patient was diagnosed with erythema multiforme and was referred to a dermatologist. At the time of report the patient had recovered. The patient's experience was considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: HIBV
Symptoms: Biopsy lung abnormal, Chest X-ray abnormal, Cyanosis, Diarrhoea, Haemophilus infection
Clinical narrative: Information has been received from a medical assistant (MA), concerning her 2 month old son with no allergies with a history of premature birth and respiratory distress who on 27-SEP-2006, was vaccinated with the first dose of PEDVAXHIB. On 10-NOV-2007, the patient was vaccinated with the second dose of PEDVAXHIB and on 07-AUG-2007, was vaccinated with the third dose of PEDVAXHIB. Concomitant therapy included vitamins, unspecified, XOPENEX and "PULLMICORT". The MA reported that her son experienced respiratory distress with cyanosis within one hour of each dose of PEDVAXHIB on 27-SEP-2006, 10-NOV-2006 and 07-AUG-2007. On 27-SEP-2006, the MA transported her son to the physician's office but no therapy was recommended. The respiratory symptoms recurred on 10-NOV-2006, after the second dose of PEDVAXHIB, and the patient was transported to the local emergency room. The MA stated no therapy was prescribed. The patient received a third dose of PEDVAXHIB on 07-AUG-2007, and experienced immediate cyanosis, bilateral cervical lymph node swelling, vomiting and diarrhea. The patient was transported to the local emergency room but the MA was unable to recall if treatment was provided at that time. The patient experienced a cyanotic episode on 10-SEP-2007, and was hospitalized. A chest x-ray revealed pneumonia and a lung biopsy on 13-SEP-2007 revealed haemophilus influenzae type b. The patient was started on oral antibiotics and discharged on 16-SEP-2007. The patient was recovering and was now taking, XOPENEX and "PULMICORT" as needed. No further details were available. The reporter considered respiratory distress with cyanosis, bilateral cervical lymph node swelling, vomiting and diarrhea, pneumonia and haemophilus influenzae type b as other important medical events. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: HIBV
Symptoms: Lymphadenopathy, Pneumonia, Respiratory distress, Vomiting
Clinical narrative: Information has been received from a medical assistant (MA), concerning her 2 month old son with no allergies with a history of premature birth and respiratory distress who on 27-SEP-2006, was vaccinated with the first dose of PEDVAXHIB. On 10-NOV-2007, the patient was vaccinated with the second dose of PEDVAXHIB and on 07-AUG-2007, was vaccinated with the third dose of PEDVAXHIB. Concomitant therapy included vitamins, unspecified, XOPENEX and "PULLMICORT". The MA reported that her son experienced respiratory distress with cyanosis within one hour of each dose of PEDVAXHIB on 27-SEP-2006, 10-NOV-2006 and 07-AUG-2007. On 27-SEP-2006, the MA transported her son to the physician's office but no therapy was recommended. The respiratory symptoms recurred on 10-NOV-2006, after the second dose of PEDVAXHIB, and the patient was transported to the local emergency room. The MA stated no therapy was prescribed. The patient received a third dose of PEDVAXHIB on 07-AUG-2007, and experienced immediate cyanosis, bilateral cervical lymph node swelling, vomiting and diarrhea. The patient was transported to the local emergency room but the MA was unable to recall if treatment was provided at that time. The patient experienced a cyanotic episode on 10-SEP-2007, and was hospitalized. A chest x-ray revealed pneumonia and a lung biopsy on 13-SEP-2007 revealed haemophilus influenzae type b. The patient was started on oral antibiotics and discharged on 16-SEP-2007. The patient was recovering and was now taking, XOPENEX and "PULMICORT" as needed. No further details were available. The reporter considered respiratory distress with cyanosis, bilateral cervical lymph node swelling, vomiting and diarrhea, pneumonia and haemophilus influenzae type b as other important medical events. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a physician who reported to his distributor that, "several patients experienced adverse reactions with Pneumovax 23. He did not specify the reaction. The physician will call to report more information. No additional information was provided. Follow-up information was received on 22-OCT-2007 from the physician concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with Pneumovax 23 (lot# 655152/0889F). On an unspecified date the patient developed severe injection site reactions with cellulitis, pain and redness and on an unspecified date the patient was hospitalized for an unspecified length of time. At the time of reporting it was unknown if the patient had recovered. The physician is requesting a lot check of 655152/0889F. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician who reported to his distributor that, "several patients experienced adverse reactions with Pneumovax 23. He did not specify the reaction. The physician will call to report more information. No additional information was provided. Follow-up information was received on 22-OCT-2007 from the physician concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with Pneumovax 23 (lot# 655152/0889F). On an unspecified date the patient developed severe injection site reactions with cellulitis, pain and redness and on an unspecified date the patient was hospitalized for an unspecified length of time. At the time of reporting it was unknown if the patient had recovered. The physician is requesting a lot check of 655152/0889F. This is one of several reports from the same source. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Blood culture negative, Chills, Erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a pharmacist and a physician's assistant, concerning a 17 year old male patient, who on 11-SEP-2007 was vaccinated in the right arm with the third dose of Pneumovax 23 (lot # not reported). Concomitant vaccine therapy at the visit included a dose in the right arm, of Menactra. Following the vaccination, he experienced pain and swelling at the injection site (right arm), and that night he could not sleep as the swelling had increased. On 12-SEP-2007, the arm swelling was significant and along with redness in the arm, the patient had developed a fever (value not specified) with rigors. On that day, treatment in the clinic included diphenhydramine HCl (BENADRYL) and methylprednisolone sodium succinate (SOLUMEDROL), and the patient was admitted to the hospital. Treatment in the hospital included IV ceftriaxone sodium (ROCEPHIN), and the patient had improved within 24 hours. Blood cultures were negative. On 14-SEP-2007, the patient was discharged from the hospital and was completely recovered. The pharmacist indicated that the patient had no reactions with the previous vaccinations of Pneumovax 23. The physician's assistant felt that Pneumovax 23 had a causal relationship to the events. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Insomnia, Oedema peripheral, Pyrexia
Clinical narrative: Initial and follow up information has been received from a pharmacist and a physician's assistant, concerning a 17 year old male patient, who on 11-SEP-2007 was vaccinated in the right arm with the third dose of Pneumovax 23 (lot # not reported). Concomitant vaccine therapy at the visit included a dose in the right arm, of Menactra. Following the vaccination, he experienced pain and swelling at the injection site (right arm), and that night he could not sleep as the swelling had increased. On 12-SEP-2007, the arm swelling was significant and along with redness in the arm, the patient had developed a fever (value not specified) with rigors. On that day, treatment in the clinic included diphenhydramine HCl (BENADRYL) and methylprednisolone sodium succinate (SOLUMEDROL), and the patient was admitted to the hospital. Treatment in the hospital included IV ceftriaxone sodium (ROCEPHIN), and the patient had improved within 24 hours. Blood cultures were negative. On 14-SEP-2007, the patient was discharged from the hospital and was completely recovered. The pharmacist indicated that the patient had no reactions with the previous vaccinations of Pneumovax 23. The physician's assistant felt that Pneumovax 23 had a causal relationship to the events. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Dizziness, Headache, Muscular weakness, Myalgia
Clinical narrative: Information has been received from a nurse, concerning a 62 year old male patient who on 19-OCT-2007 was vaccinated with a dose, 0.5 ml, of Pneumovax 23 (lot #655765/0061U). There was no concomitant medication. Following the vaccination, the patient became lightheaded, had a headache, had severe muscle weakness, developed a fever of 100 degrees and was "so sore he could not even walk up the steps." The following day, 20-OCT-2007, the patient recovered. The patient sought unspecified medical attention. The reporting nurse considered the events to be clinically significant disabling/incapacitating. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Information has been received from a nurse, concerning a 62 year old male patient who on 19-OCT-2007 was vaccinated with a dose, 0.5 ml, of Pneumovax 23 (lot #655765/0061U). There was no concomitant medication. Following the vaccination, the patient became lightheaded, had a headache, had severe muscle weakness, developed a fever of 100 degrees and was "so sore he could not even walk up the steps." The following day, 20-OCT-2007, the patient recovered. The patient sought unspecified medical attention. The reporting nurse considered the events to be clinically significant disabling/incapacitating. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Activated partial thromboplastin time, Antinuclear antibody, Contusion, Epistaxis, Full blood count
Clinical narrative: The patient states that over the last one to two days she has noticed a marked proliferation of tiny red spots all over her body. She also points out a blood blister on the buccal mucosa and she has had some nosebleeds. She is also bruising more easily. There is no prior history of this. She has a granddaughter who has had platelet disorder. Appears in no acute distress. Temp-97.7. Pulse-80. Blood pressure-130/80. The patient has diffuse petechial rash most marked on the lower extremities. There is an approximately silver-dollar sized hematoma in the right buccal mucosa. There was some purplish discoloration on the back of one hand, but no frank ecchymoses. Probable thrombocytopenia. 11/6/07 Reviewed hospital medical records which reveal patient experienced diffuse petechiae, blood blisters x 3-4 days & nose bleed x 1 day when seen in clinic 10/24/2007.  Admitted 11/2-11/4/2007.  Tx w/IVIG x 2 & steroids. FINAL DX: ITP. 12/21/07 Reviewed pcp medical records which reveal patient experienced marked proliferation of tiny red spots all over body x 2 days when seen in office 10/23/07.  Also w/blood blister on buccal mucosa, nosebleeds & easy bruising.  Dx of probable thrombocytopenia.  Referred to hematologist & labs done. When seen 11/13 had be on IVIG & steroids for ITP, possibly related to flu vax.  IVIG failed by 11/29 visit & was being tx w/Rituxan x 4 doses & steroids.  Initially responded to tx but by 12/6/07 splenectomy recommended.  When seen initially by hematologist on 10/24, direct admit to hospital for IVIG x 2.  Bone marrow biopsy done.  D/c home on continued steroids & home infused IVIG weekly. Referred to surgeon for possible splenectomy. FINAL DX: severe thrombocytopenia.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Haematoma, Mouth ulceration, Petechiae, Prothrombin time, Rash macular
Clinical narrative: The patient states that over the last one to two days she has noticed a marked proliferation of tiny red spots all over her body. She also points out a blood blister on the buccal mucosa and she has had some nosebleeds. She is also bruising more easily. There is no prior history of this. She has a granddaughter who has had platelet disorder. Appears in no acute distress. Temp-97.7. Pulse-80. Blood pressure-130/80. The patient has diffuse petechial rash most marked on the lower extremities. There is an approximately silver-dollar sized hematoma in the right buccal mucosa. There was some purplish discoloration on the back of one hand, but no frank ecchymoses. Probable thrombocytopenia. 11/6/07 Reviewed hospital medical records which reveal patient experienced diffuse petechiae, blood blisters x 3-4 days & nose bleed x 1 day when seen in clinic 10/24/2007.  Admitted 11/2-11/4/2007.  Tx w/IVIG x 2 & steroids. FINAL DX: ITP. 12/21/07 Reviewed pcp medical records which reveal patient experienced marked proliferation of tiny red spots all over body x 2 days when seen in office 10/23/07.  Also w/blood blister on buccal mucosa, nosebleeds & easy bruising.  Dx of probable thrombocytopenia.  Referred to hematologist & labs done. When seen 11/13 had be on IVIG & steroids for ITP, possibly related to flu vax.  IVIG failed by 11/29 visit & was being tx w/Rituxan x 4 doses & steroids.  Initially responded to tx but by 12/6/07 splenectomy recommended.  When seen initially by hematologist on 10/24, direct admit to hospital for IVIG x 2.  Bone marrow biopsy done.  D/c home on continued steroids & home infused IVIG weekly. Referred to surgeon for possible splenectomy. FINAL DX: severe thrombocytopenia.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Skin discolouration, Thrombocytopenia
Clinical narrative: The patient states that over the last one to two days she has noticed a marked proliferation of tiny red spots all over her body. She also points out a blood blister on the buccal mucosa and she has had some nosebleeds. She is also bruising more easily. There is no prior history of this. She has a granddaughter who has had platelet disorder. Appears in no acute distress. Temp-97.7. Pulse-80. Blood pressure-130/80. The patient has diffuse petechial rash most marked on the lower extremities. There is an approximately silver-dollar sized hematoma in the right buccal mucosa. There was some purplish discoloration on the back of one hand, but no frank ecchymoses. Probable thrombocytopenia. 11/6/07 Reviewed hospital medical records which reveal patient experienced diffuse petechiae, blood blisters x 3-4 days & nose bleed x 1 day when seen in clinic 10/24/2007.  Admitted 11/2-11/4/2007.  Tx w/IVIG x 2 & steroids. FINAL DX: ITP. 12/21/07 Reviewed pcp medical records which reveal patient experienced marked proliferation of tiny red spots all over body x 2 days when seen in office 10/23/07.  Also w/blood blister on buccal mucosa, nosebleeds & easy bruising.  Dx of probable thrombocytopenia.  Referred to hematologist & labs done. When seen 11/13 had be on IVIG & steroids for ITP, possibly related to flu vax.  IVIG failed by 11/29 visit & was being tx w/Rituxan x 4 doses & steroids.  Initially responded to tx but by 12/6/07 splenectomy recommended.  When seen initially by hematologist on 10/24, direct admit to hospital for IVIG x 2.  Bone marrow biopsy done.  D/c home on continued steroids & home infused IVIG weekly. Referred to surgeon for possible splenectomy. FINAL DX: severe thrombocytopenia.
Age: 21.0
Sex: F
Vaccine: FLUN3, HEPA
Symptoms: Abdominal discomfort, Headache
Clinical narrative: Headache/ GI upset
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Facial palsy, Swollen tongue, Tremor
Clinical narrative: Patient received vaccine then 5 minutes later developed shaking, anxiety and tongue swelling. Within 24 hours, the patient developed bells palsy.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site urticaria, No reaction on previous exposure to drug
Clinical narrative: Local development of itching/ hives 10cm diameter around the injection site. No known allergies or reactions in previous years I am not allergic to eggs.
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, swelling at injection site - left deltoid. Area was slightly bruised. Patient was feeling ok after injection and BP 102/62 Pulse 64 Resp. normal instructed client on 5/5 of allergic reaction and if injection site swelling or edema does not improve to see MD - called patient 3 hours after injection site given and patient said "injection site had improved - not as swollen and was feeling fine.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Musculoskeletal stiffness, Pain in extremity, Skin warm
Clinical narrative: Pain and stiffness of left deltoid warm erythematous circular area measures 5cm approximately 4cm inferior to the injection site.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pain in extremity, Skin warm
Clinical narrative: According to the mother, she saw redness around the injection site about 24 hours after the Flu shot was given. On Thursday 11/1 the girl complain of her arm hurting. A baseball size area of redness was noted and it was warm to touch.
Age: 0.7
Sex: F
Vaccine: FLU3
Symptoms: Culture positive, Pain, Rash erythematous, Skin exfoliation, Staphylococcal skin infection
Clinical narrative: Developed red, painful rash which then developed peeling in flexor surfaces on face. Presumed staph scalded skin syndrome. + staph culture skin, but scant. Rx'd with Keflex. Presumed duration 10 days
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Pain, soreness, swelling left arm - redness - left upper arm extended to forearm. Persisted up to 5 - 7 days. No symptoms at present 10-18-07 onset within 1-2 hours after the vaccines.
Sex: F
Vaccine: FLU3
Symptoms: Blood culture, Full blood count, Metabolic function test, Rash erythematous, Rash generalised
Clinical narrative: Red rash all over body.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection with swelling to size of a "one ball", purple in color, warm and tender to touch on 11/01/07 after receiving injection on 10/31/07. 11/2/07: states decrease today. Called MD but couldn't get in.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Received Flu vaccine on 10/26/07 during day. On 10/29/07 reported she developed hives on the evening of 10/26/07. 10/29/07 hives observed on both arms with itching. Tr: Medrol dose pack, Claritin, Benadryl. Resolved.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, HIBV, MMRV, PNC
Symptoms: Scab, Skin lesion
Clinical narrative: On 19 October 2007 patient received MMRV, on 26 October 2007. Generalized lesions developed, on 2 November 2007 lesions have scabbed over.
Age: 6.0
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Pruritus, Urticaria, Wheezing
Clinical narrative: 5:10pm noted to be scratching with single hive on back, diphenhydramine given 5:20pm noted to be wheezing, Albuterol nebulizer given 5:45pm wheezing continues, Prednisone given 6:00pm wheezing improved but still present, transported to ER from clinic
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy skin abnormal, Dermatitis, Pain in extremity, Rash
Clinical narrative: Developed raised rash on legs, feet, axilla, under breast with "excruciating pain" in legs and feet.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain, erythema injection site x 4 days. No treatment.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site pain, Injection site warmth
Clinical narrative: Pain, ecchymosis, erythema, warmth at injection site. Tylenol for pain prn.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Injection site erythema, Injection site oedema, Injection site vesicles, Injection site warmth
Clinical narrative: Erythema, edema, warmth, fluid filled vesicles at injection site. Clear fluid in vesicles saw PCP- offered antibiotic - never took. Blisters resolved.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: After receiving shot, patient became very light-headed and dizzy. She actually lost consciousness for a few seconds. Paramedics were called and her blood pressure was 74/49. They took her to the hospital and gave IV fluids. Her blood pressure stabilized and she was sent home.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Injection site erythema, Rash macular
Clinical narrative: 10 minutes after administering vaccine noted redness approximately 5-6 cm at site no edema or respiratory distress noted - noted blotchy redness on arms and flushed cheeks at 1300 spoke with mother redness resolved
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Developed annular erythema and edema and pain inferior to injection site 2 days after vaccination which increased in size on day 3. Referred to primary MD. To be seen by doctor on 10/19/07.
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Urinary incontinence
Clinical narrative: Syncope/ incontinence of urine/ possible seizure (unwitnessed by medical staff) within 15 minutes of administration.