chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Aspiration bone marrow, Biopsy bone marrow, Blood culture negative, Coagulation test, Coombs indirect test negative
Clinical narrative: Postpartum month 6. Menorrhagia and purpuric rash over legs and oral mucosa about 1 week after vaccine administration. Thrombocytopenia on labs - 1000 platelet count. Given prednisone 100 mg by mouth daily. Platelet count rose to 37,000 in 10 days, but then started dropping again and in another 11 days was down to 8000. Given Anti-D Immune globulin- platelets rose to 87,000 2 days later and to 421,000 1 week after the Anti-D.  1/18/08 Reviewed hospital medical records which reveal patient experienced extremely heavy menstrual flow beginning on 11/6/07.  Next day she noted red spots on legs & oral mucosa, called her pcp who sent her to ER.  Exam revealed petechial rash & bruises.  Heme consult obtained.  Tx w/IV steroids w/improvement.  D/C to home on oral steroids w/heme f/u. FINAL DX: thrombocytopenia, possibly idiopathic thrombocytopenic purpura; hypocalcemia, resolved.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Haematuria, Menorrhagia, Platelet count decreased, Postpartum state, Purpura
Clinical narrative: Postpartum month 6. Menorrhagia and purpuric rash over legs and oral mucosa about 1 week after vaccine administration. Thrombocytopenia on labs - 1000 platelet count. Given prednisone 100 mg by mouth daily. Platelet count rose to 37,000 in 10 days, but then started dropping again and in another 11 days was down to 8000. Given Anti-D Immune globulin- platelets rose to 87,000 2 days later and to 421,000 1 week after the Anti-D.  1/18/08 Reviewed hospital medical records which reveal patient experienced extremely heavy menstrual flow beginning on 11/6/07.  Next day she noted red spots on legs & oral mucosa, called her pcp who sent her to ER.  Exam revealed petechial rash & bruises.  Heme consult obtained.  Tx w/IV steroids w/improvement.  D/C to home on oral steroids w/heme f/u. FINAL DX: thrombocytopenia, possibly idiopathic thrombocytopenic purpura; hypocalcemia, resolved.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Red blood cells urine positive, Thrombocytopenia, Urine analysis abnormal, Virus serology test negative
Clinical narrative: Postpartum month 6. Menorrhagia and purpuric rash over legs and oral mucosa about 1 week after vaccine administration. Thrombocytopenia on labs - 1000 platelet count. Given prednisone 100 mg by mouth daily. Platelet count rose to 37,000 in 10 days, but then started dropping again and in another 11 days was down to 8000. Given Anti-D Immune globulin- platelets rose to 87,000 2 days later and to 421,000 1 week after the Anti-D.  1/18/08 Reviewed hospital medical records which reveal patient experienced extremely heavy menstrual flow beginning on 11/6/07.  Next day she noted red spots on legs & oral mucosa, called her pcp who sent her to ER.  Exam revealed petechial rash & bruises.  Heme consult obtained.  Tx w/IV steroids w/improvement.  D/C to home on oral steroids w/heme f/u. FINAL DX: thrombocytopenia, possibly idiopathic thrombocytopenic purpura; hypocalcemia, resolved.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Barium enema, Intussusception, Urinary system X-ray, X-ray gastrointestinal tract, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Had an intussusception 3 days after the Rotateq was given.  Pt did require surgery to reduce it. 12/31/07-records received for DOS 12/13/07-ER visit C/O choking on sputum, coughs up yellowish color sputum. 1/22/08-records received for DOS 12/13-12/16/07-DC DX: Intussusception. Presented with 1 day history of nausea and vomiting.
Age: 13.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received a Dtap vaccine instead of Tdap
Age: 13.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Patient received a Dtap insteaad of a Tdap
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Vomiting
Clinical narrative: Received shot on 12/14/07 at 12:00 P.M.  Ate a meal at 4:00 P.M. that afternoon. 40 minutes later began vomiting and started having problems breathing.  Went to the emergency room at hospital because conditions only got worse.  Was given a breathing treatment and something for the vomiting.
Age: 13.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received a Dtap instead of a Tdap
Age: 1.5
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Body temperature increased
Clinical narrative: 102.3-102.8 temp
Age: 4.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Body temperature increased, Computerised tomogram, Fasciitis, Lymphocyte count decreased, Neutrophil count increased
Clinical narrative: Facitus-Left leg, Temperature 104,12/28/07 Reviewed hospital medical records which reveal patient experienced low grade fever irritability.  Saw pcp & receiced pneumo vax.  Developed fever of 104 that evening & injection site pain.  Saw pcp on 12/12 & dx w/acute myositis s/p vaccine.  Tx w/pain med but continued to have severe left leg pain, difficulty walking & fever. Admitted 12/15-12/16/2007 & treated w/IV antibiotics then transferred to higher level of care for eval by peds orthopedist who felt patient improving on current IV antibiotics & returned to initial hospital for admission. FINAL DX: myositis & cellulitis
Age: 4.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Facitus-Left leg, Temperature 104,12/28/07 Reviewed hospital medical records which reveal patient experienced low grade fever irritability.  Saw pcp & receiced pneumo vax.  Developed fever of 104 that evening & injection site pain.  Saw pcp on 12/12 & dx w/acute myositis s/p vaccine.  Tx w/pain med but continued to have severe left leg pain, difficulty walking & fever. Admitted 12/15-12/16/2007 & treated w/IV antibiotics then transferred to higher level of care for eval by peds orthopedist who felt patient improving on current IV antibiotics & returned to initial hospital for admission. FINAL DX: myositis & cellulitis
Age: 4.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood creatine phosphokinase, Blood culture, Body temperature increased, C-reactive protein, Fasciitis
Clinical narrative: Facitus-Left leg, Temperature 104,12/28/07 Reviewed hospital medical records which reveal patient experienced low grade fever irritability.  Saw pcp & receiced pneumo vax.  Developed fever of 104 that evening & injection site pain.  Saw pcp on 12/12 & dx w/acute myositis s/p vaccine.  Tx w/pain med but continued to have severe left leg pain, difficulty walking & fever. Admitted 12/15-12/16/2007 & treated w/IV antibiotics then transferred to higher level of care for eval by peds orthopedist who felt patient improving on current IV antibiotics & returned to initial hospital for admission. FINAL DX: myositis & cellulitis
Age: 4.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Full blood count, Injection site pain, Injection site reaction, Injection site swelling, Pain in extremity
Clinical narrative: Facitus-Left leg, Temperature 104,12/28/07 Reviewed hospital medical records which reveal patient experienced low grade fever irritability.  Saw pcp & receiced pneumo vax.  Developed fever of 104 that evening & injection site pain.  Saw pcp on 12/12 & dx w/acute myositis s/p vaccine.  Tx w/pain med but continued to have severe left leg pain, difficulty walking & fever. Admitted 12/15-12/16/2007 & treated w/IV antibiotics then transferred to higher level of care for eval by peds orthopedist who felt patient improving on current IV antibiotics & returned to initial hospital for admission. FINAL DX: myositis & cellulitis
Age: 4.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia, Red blood cell scan, Tenderness, Weight bearing difficulty
Clinical narrative: Facitus-Left leg, Temperature 104,12/28/07 Reviewed hospital medical records which reveal patient experienced low grade fever irritability.  Saw pcp & receiced pneumo vax.  Developed fever of 104 that evening & injection site pain.  Saw pcp on 12/12 & dx w/acute myositis s/p vaccine.  Tx w/pain med but continued to have severe left leg pain, difficulty walking & fever. Admitted 12/15-12/16/2007 & treated w/IV antibiotics then transferred to higher level of care for eval by peds orthopedist who felt patient improving on current IV antibiotics & returned to initial hospital for admission. FINAL DX: myositis & cellulitis
Age: 14.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received a Dtap instead of a Tdap
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis, Erythema, Hypersensitivity, Hypoaesthesia, Pain
Clinical narrative: Anthrax shot RX W/Redness, Swelling, Pain, Numbness.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Swelling
Clinical narrative: Anthrax shot RX W/Redness, Swelling, Pain, Numbness.
Age: 9.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site ulcer, Injection site vesicles, Oedema peripheral
Clinical narrative: Patient received varicella vaccine in lower left deltoid on 13 Dec 07, at which time influenza vaccine was given in left upper deltoid.  This was her second varicella vaccine, the first was given on 9 Dec 99.  Earlier that day she had been seen by her primary pediatrician for rhinorrhea and fever of 100, she was diagnosed with allergic rhinitis.  Her pediatrician directed her to the immunization clinic to get influenza and varicella shot since she has asthma.  The following day about 24 hours after vaccination she was noted to have a blister rash on her arm at the site of the varicella vaccine.  She was seen at a satellite pediatric clinic where she was prescribed (per Mom) oral antibiotic and topical antibiotic.  The following day the blistering rash was larger and then it popped.  Mom states the erythema extended from her elbow to shoulder, and her fingers were swollen.  The following day she returned to the satellite peds clinic and they recommended an infectious disease referral.  Today (4 days after vaccination) she has a shallow ulceration with minimal erythema just at vaccination site.  Mom reports that the antibioitic ointment causes itching when they put it on so we will investigate possible neomycin sensitivity.
Age: 9.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Pyrexia, Rhinitis allergic, Rhinorrhoea
Clinical narrative: Patient received varicella vaccine in lower left deltoid on 13 Dec 07, at which time influenza vaccine was given in left upper deltoid.  This was her second varicella vaccine, the first was given on 9 Dec 99.  Earlier that day she had been seen by her primary pediatrician for rhinorrhea and fever of 100, she was diagnosed with allergic rhinitis.  Her pediatrician directed her to the immunization clinic to get influenza and varicella shot since she has asthma.  The following day about 24 hours after vaccination she was noted to have a blister rash on her arm at the site of the varicella vaccine.  She was seen at a satellite pediatric clinic where she was prescribed (per Mom) oral antibiotic and topical antibiotic.  The following day the blistering rash was larger and then it popped.  Mom states the erythema extended from her elbow to shoulder, and her fingers were swollen.  The following day she returned to the satellite peds clinic and they recommended an infectious disease referral.  Today (4 days after vaccination) she has a shallow ulceration with minimal erythema just at vaccination site.  Mom reports that the antibioitic ointment causes itching when they put it on so we will investigate possible neomycin sensitivity.
Sex: M
Vaccine: HEP
Symptoms: Blood glucose decreased, Body temperature increased, Hypoglycaemia, Irritability, Tremor
Clinical narrative: Inc temp 38.5 (rectally), irritability, tremulous, hypoglycemia (<46).  12/31/2007 MR received for DOS 12/7/2007.  Newborn infant with newborn exam WNL noted to have developed temperture elevation of 38.5'C and tremulousness of feet bilat.  Initially hypoglycemic but tremors did not resolve with improvement in BS.  Tonic-clonic tremors of L foot >R foot, progressed to R arm. Transfered to higher level of care on date of birth. 01/14/2008 MR received for DOS 12/07-10/2007 with D/C Dx: Fever.  Hypertonia. Newborn infant admitted from hospital of birth with fever and seizure like activity (hypertonia/hyperreflexia with ? of myoclonus). Txd with empiric abx x 48hrs.  Neuro status greatly improved
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Rash papular, Rash pruritic, Urticaria
Clinical narrative: Papular urticaria.  Patient presented to office on 12/17/07 with onset of rash on 11/27/07 - still with diffuse, pruritic papular urticaria.  Had been self-treated with Benadryl.  Today started on Prednisone and Xyzal.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site streaking
Clinical narrative: Area of vaccine administration red and sore to touch and without heat(according to PA notes) with red streak running from it.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injected limb mobility decreased, Lymphadenopathy, Oedema peripheral, Pain in extremity
Clinical narrative: 13 Dec 4 pm received injection; by 10 pm right arm was painful and it was difficult to sleep.  14Dec 6:30 am Advil not helping the pain; swelling started; couldn't raise arm above shoulder. Through out that evening and night pain and edema worsened.  15 Dec early morning red, blotchy marks appeared over upper forearm and into shoulder area.  Pain radiated down the arm, up into shoulder and across the back.  Later that am was seen by local MD; right axillary lymphnodes were reportedly swollen, afebrile, Omnicef started. Continued to take Advil to help with pain.  Red blotchy marks were gone after two days of Omnicef (17 Dec). Today (17 Dec) Still continues Advil.  Pain and edema are still present but improving.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash macular, Sleep disorder, Swelling
Clinical narrative: 13 Dec 4 pm received injection; by 10 pm right arm was painful and it was difficult to sleep.  14Dec 6:30 am Advil not helping the pain; swelling started; couldn't raise arm above shoulder. Through out that evening and night pain and edema worsened.  15 Dec early morning red, blotchy marks appeared over upper forearm and into shoulder area.  Pain radiated down the arm, up into shoulder and across the back.  Later that am was seen by local MD; right axillary lymphnodes were reportedly swollen, afebrile, Omnicef started. Continued to take Advil to help with pain.  Red blotchy marks were gone after two days of Omnicef (17 Dec). Today (17 Dec) Still continues Advil.  Pain and edema are still present but improving.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, CSF protein increased, Drug hypersensitivity, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Guillane Barre including lower extremity numbness and inability to walk. Elevated spinal protein at 410.  6 plasma exchanges with improvement.  Transfer to Rehab hospital 12/14. Lyrica for new neuropathy symptoms. 12/31/07-records received for DOS 12/3-12/18/07-DC DX: Guillain-Barre syndrome. Status post total plasma exchange times six.   Neruopathic pain. Serratia marcescens urinary tract infection. Benign prostatic hypertrophy. Prior to admission seen in ED 11/23/07 for C/O difficulty breathing with DX of primary acute and chronic dyspnea, D.M. leg edema. ED 11/24/07-C/O weakness-low potassium, chronic shortness of breath. edema improved. ED 11/27/07-C/O back pain. Developed progressive weakness and numbness in hands and feet and unable to stand.  At time of discharge able to move arms and legs but unable to walk. Weaker proximally than distally. Developed significant neurpathic pain related to nerve regeneration. Discharged to transitional care.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Neuropathy
Clinical narrative: Guillane Barre including lower extremity numbness and inability to walk. Elevated spinal protein at 410.  6 plasma exchanges with improvement.  Transfer to Rehab hospital 12/14. Lyrica for new neuropathy symptoms. 12/31/07-records received for DOS 12/3-12/18/07-DC DX: Guillain-Barre syndrome. Status post total plasma exchange times six.   Neruopathic pain. Serratia marcescens urinary tract infection. Benign prostatic hypertrophy. Prior to admission seen in ED 11/23/07 for C/O difficulty breathing with DX of primary acute and chronic dyspnea, D.M. leg edema. ED 11/24/07-C/O weakness-low potassium, chronic shortness of breath. edema improved. ED 11/27/07-C/O back pain. Developed progressive weakness and numbness in hands and feet and unable to stand.  At time of discharge able to move arms and legs but unable to walk. Weaker proximally than distally. Developed significant neurpathic pain related to nerve regeneration. Discharged to transitional care.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Induration, Muscle swelling, Nuclear magnetic resonance imaging, Oedema peripheral, Pain
Clinical narrative: Patient had a flu shot - thereafter has suffered an unknown condition that includes swelling of the fat tissue, pain and hardening of the tissue in the upper vaccinated arm and forearm region, which caused intramuscular edema and related systems.  No doctor has been able to identify a remedy to date.  12/31/207 MR received for DOS 12/16-18/2007 with DX:  Panniculitis of R arm s/p flu shot.  Pt presented with induration of the R arm.  Pt had previously had erythema and swelling of the hand and forearm as well, was txd with abx and redness resolved. However induration progressed and includes most of the triceps, some of biceps, and down to and including some of the forearm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Eczema, Injection site erythema, Injection site pruritus, Injection site swelling, Rash papular
Clinical narrative: Patient had usual discomfort at time of injection with quick recovery.  Mother reports that patient complained "a day later" that his arm (left deltoid) was itching and mother subsequently she noticed an area of redness around the injection site (8-10cm by her tracing on patient's arm) and the area looked swollen.  The area did not hurt but continued to itch.  It did not interfere with his usual activities and he had no fever, headache, or other symptoms.  Mother presumed that the itching, redness and swelling was a typical reaction to the DTaP administered; however the redness lasted more than a day and the itching persisted for over two weeks which prompted mother to call.  At an office visit on 12-17-07 the left arm appeared normal except for a 1-2mm crusted lesion at the central part of the deltoid area and presumably the injection site.  He was observed to make superficial scratching of the shoulder but in general did not seem to cause any distress.  Located on the postero-lateral aspect of both arms, in a symmetrical fashion were some dry crusted palpable papules consistent with dry skin eczema.  The right deltoid, where MMR and IPV were administered, had no lesions or itching. He had no axillary lymph nodes and small, about 1cm, non-tender anterior cervical lymph nodes.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Skin lesion
Clinical narrative: Patient had usual discomfort at time of injection with quick recovery.  Mother reports that patient complained "a day later" that his arm (left deltoid) was itching and mother subsequently she noticed an area of redness around the injection site (8-10cm by her tracing on patient's arm) and the area looked swollen.  The area did not hurt but continued to itch.  It did not interfere with his usual activities and he had no fever, headache, or other symptoms.  Mother presumed that the itching, redness and swelling was a typical reaction to the DTaP administered; however the redness lasted more than a day and the itching persisted for over two weeks which prompted mother to call.  At an office visit on 12-17-07 the left arm appeared normal except for a 1-2mm crusted lesion at the central part of the deltoid area and presumably the injection site.  He was observed to make superficial scratching of the shoulder but in general did not seem to cause any distress.  Located on the postero-lateral aspect of both arms, in a symmetrical fashion were some dry crusted palpable papules consistent with dry skin eczema.  The right deltoid, where MMR and IPV were administered, had no lesions or itching. He had no axillary lymph nodes and small, about 1cm, non-tender anterior cervical lymph nodes.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: RN reports call describing red itchy upper arm near injection site for Td given 10 days prior to call.
Age: 66.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Reports to RN that she has a red ichy arm near site of TD injection given 9 days prior. Reports her husband had the same injection but does not report any reaction.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information has been received from a physician concerning a large female who received one dose of Gardasil. Subsequently, the patient was found dead in her truck from a blood clot that traveled from her legs to her lungs. The cause of death was reported to be a blood clot. Additional information has been requested.    3/5/08 Autopsy states COD as pulmonary thromboembolus w/deep vein thrombosis of right leg & obesity as contributing factor.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Respiratory arrest
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female who was vaccinated with a third dose of Gardasil. Subsequently, three minutes later she passed out and stopped breathing for short period of time. Unspecified medical attention was sought. At the time of the report the patient had recovered. It was unknown whether or not she had the same experience with the first and second dose of Gardasil. Upon internal review, stopped breathing for a short period of time was considered to be an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Depression, Drug exposure during pregnancy, Pre-eclampsia, Pregnancy test positive, Ultrasound scan normal
Clinical narrative: Initial and follow up information has been received via the Merck pregnancy registry, from a consumer concerning her 16 year old daughter who on 22-DEC-2006 was vaccinated with the first dose Gardasil (Lot #654885/1424F). Concomitant therapy included PROZAC. The date of the patient's LMP was approximately 11-JAN-2007 ("approximately 16 weeks pregnant"), though the patient was not aware that she was pregnant, and on 28-FEB-2007, she was vaccinated with the second dose of Gardasil. The estimated date of delivery was 18-OCT-2007. Follow up information from a healthcare professional (HCP), indicated that on 12-JUN-2007, an ultrasound was performed and was normal. The HCP noted that during the pregnancy, the patient had experienced multiple urinary tract infections that were treated with MACROBID (12-JUL-2007 and 04-OCT-2007), as well as preeclampsia (details not provided). On 03-AUG-2007, therapy with ZOLOFT was initiated for depression. On 27-OCT-2007, at 39 weeks after the LMP, a normal, female infant (weight not provided) was born. Following the delivery (time duration not specified), the infant had a seizure, and was sent to tertiary care center to evaluate if she had a seizure disorder. No etiology was found, and the infant had no recurrence of symptoms. No treatment was required. Upon internal review, seizure was considered to be serious as an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary tract infection
Clinical narrative: Initial and follow up information has been received via the Merck pregnancy registry, from a consumer concerning her 16 year old daughter who on 22-DEC-2006 was vaccinated with the first dose Gardasil (Lot #654885/1424F). Concomitant therapy included PROZAC. The date of the patient's LMP was approximately 11-JAN-2007 ("approximately 16 weeks pregnant"), though the patient was not aware that she was pregnant, and on 28-FEB-2007, she was vaccinated with the second dose of Gardasil. The estimated date of delivery was 18-OCT-2007. Follow up information from a healthcare professional (HCP), indicated that on 12-JUN-2007, an ultrasound was performed and was normal. The HCP noted that during the pregnancy, the patient had experienced multiple urinary tract infections that were treated with MACROBID (12-JUL-2007 and 04-OCT-2007), as well as preeclampsia (details not provided). On 03-AUG-2007, therapy with ZOLOFT was initiated for depression. On 27-OCT-2007, at 39 weeks after the LMP, a normal, female infant (weight not provided) was born. Following the delivery (time duration not specified), the infant had a seizure, and was sent to tertiary care center to evaluate if she had a seizure disorder. No etiology was found, and the infant had no recurrence of symptoms. No treatment was required. Upon internal review, seizure was considered to be serious as an other important medical event. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Erythema, Nausea, Rash, Skin burning sensation
Clinical narrative: Information has been received from a pharmacist concerning a 70-year-old female with no pertinent medical history or allergies, who on 23-NOV-2007 was vaccinated subcutaneously with a dose of Zostavax (Oka/Merck). There was no concomitant medication. Subsequently, on an unknown date, the patient developed "red spots" (hive like) all over her body, skin burning sensation, nausea and dysphagia. Medical attention was sought via the telephone. No laboratory or diagnostic studies were performed. The outcome is reported as not recovered. There was no product quality complaint involved. It is not known if the physician would be interested in VZV analysis. Upon internal review, dysphagia was considered an other important medical event. Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Culture wound, Herpes zoster, Pain, Rash
Clinical narrative: Information has been received from a health professional concerning an 84 year old male patient with type 2 diabetes mellitus who on 28-NOV-2007 was vaccinated with zoster vaccine live (Oka/Merck), 0.65 ml subcutaneously in left deltoid.  On 03-DEC-2007 the patient notified the physician of a painful rash on the left side of the chest.  On 04-DEC-2007, the patient was admitted to the hospital via the emergency room for treatment of the shingles and pain control.  The patient is incapacitated by the shingles pain.  The patient continues to be hospitalized and received 1 gram of VALTREX three times daily (route unspecified).  The health care professional is interested in VZV analysis by PCR. No other symptoms were reported.  The event of the patient developed shingles after zoster vaccine persisted, was considered to be disabling.  Additional information was received via a telephone call on 06-DEC-2007 from the nurse.  The nurse indicated that the patient was still hospitalized for pain control.  The nurse explained that the physician was thinking that the patient might have been on the verge of getting shingles prior to vaccination since he developed shingles so quickly after vaccination.  She reported that the patient had a wound culture done at the hospital, however did not have any results.  She stated the plan was to possibly discharge him from the hospital on 06-DEC-2007.  The VZVIP program was discussed, and she indicated she would discuss sending a specimen with the physician.  No further information is available.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Aphasia, General physical health deterioration, Immunisation reaction, Rash
Clinical narrative: Information has been received from a consumer concerning her 73-year-old mother who has constant urinary tract infections and a history of lung cancer in 2005 (at that time she had about 16 to 18 chemo sessions) who on 21-May-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck) (lot #652966/0623F).  The daughter seems to think that the physician did not tell her mother she should not get the shot.  The patient's cancer is now in remission.  Concomitant therapy included sertraline HC1 (Zoloft).  Around late June or July the patient developed a rash that "kept growing up her arm".  She went to the dermatologist and they thought she was having a reaction to the vaccine.  They did a biopsy and found out that it was lupus.  The physician gave the patient medication that would make her get severe headaches, nausea and diarrhea (medication was not specified).  The patient has been deteriorating ever since.  The patient has been in and out of the hospital weeks at a time.  She was doing okay and feeding herself and walking and talking and now has lost a lot of weight, can not feed herself and does not talk.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  No further information is available.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Systemic lupus erythematosus rash, Weight decreased
Clinical narrative: Information has been received from a consumer concerning her 73-year-old mother who has constant urinary tract infections and a history of lung cancer in 2005 (at that time she had about 16 to 18 chemo sessions) who on 21-May-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck) (lot #652966/0623F).  The daughter seems to think that the physician did not tell her mother she should not get the shot.  The patient's cancer is now in remission.  Concomitant therapy included sertraline HC1 (Zoloft).  Around late June or July the patient developed a rash that "kept growing up her arm".  She went to the dermatologist and they thought she was having a reaction to the vaccine.  They did a biopsy and found out that it was lupus.  The physician gave the patient medication that would make her get severe headaches, nausea and diarrhea (medication was not specified).  The patient has been deteriorating ever since.  The patient has been in and out of the hospital weeks at a time.  She was doing okay and feeding herself and walking and talking and now has lost a lot of weight, can not feed herself and does not talk.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Rhabdomyolysis
Clinical narrative: Information has been received from a physician concerning a male with coronary disease who "about two months ago (approx October 2007), was vaccinated with Zostavax. Concomitant therapy included a "Statin". The patient developed rhabdomolysis. Laboratory and diagnostics studies were not reported. It was reported that no medical attention was sought by the patient. A product quality complaint was not reported. Rhabdomyolysis was considered by the reporting physician to be life threatening. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC, RV5
Symptoms: Asthenia, Barium enema, Dehydration, Enema administration, Haematemesis
Clinical narrative: Information has been received from a physician concerning a 6 month old male, that was born with a fractured left clavicle because he was big at birth, and who had no other history other than sniffles, who was vaccinated with a first, second, and third 2 ml oral dose of rotavirus reassortant vaccine live (human-bovine) on 02-Jul-2007 (Lot# 656845/0409U), 05-Sep-2007 (Lot# 656845/0409U), and 14-Nov-2007 (Lot# 657665/1460U), respectively.  Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, Hib conj vaccine (OMPC) (manufacturer unknown), pneumococcal conj vaccine (unspecified) and influenza virus vaccine (unspecified).  "Eleven days later," on 25-Nov-2007 the patient was throwing up what looked like the color of coffee granules and continued to throw up.  The patient's mother called the physician.  On 26-Nov-2007 the patient's mother took the patient to the hospital and was hospitalized.  At the time the patient was experiencing vomiting and had on loose stool.  It was noted that all kinds of tests were performed.  Blood work showed a high white blood count.  The patient was put on IV fluids and was dehydrated.  The patient had an x-ray of the intestine and an ultrasound.  On 28-Nov-2007, at 9:00 a.m., the patient was rushed to a second hospital and was diagnosed with intussusception.  It was noted that all types of tests were performed, and finally a jelly-like mucuos blood stool was expelled.  The patient's mother stated that seven barium enema procedures were performed on the patient, and the last one worked.  There was no surgery.  The patient was discharged from the hospital on 30-Nov-2007 at 12:00 p.m.  The patient's mother indicated that she was nursing the child and he seemed okay, but later started bucking and thrashing like he was in pain.  The patient's mother took the patient back to the hospital and they observed him for several hours and then he was released, not hospitalized.  The patient's mother indicated that the child was recovering but was still somewhat traumatized by all the events and was weak and clinging.  The physician did not think that the patient's intussusception was realted to rotavirus reassortant vaccine live (human-bovine).  No product quality complaint was involved.  No other information was provided.  The patient's intussusception was considered to be an other important medical event.  Additional information has been requested. 1/16/08-records received for DOS 11/28-11/29/07 and 11/29-11/30/07-DC DX: Intussusception. Successful reduction by barium enema. Returned the same evening for C/O crying and vomiting. Observed and discharged. illness began 3 days prior to admission with vomiting, fussy, resless and crying out in sleep. Low grade fever. Emesis became dark brown and guaiac positive. Passed blood mucousy stool.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC, RV5
Symptoms: Haematochezia, Intussusception, Irritability, Mucous stools, Pain
Clinical narrative: Information has been received from a physician concerning a 6 month old male, that was born with a fractured left clavicle because he was big at birth, and who had no other history other than sniffles, who was vaccinated with a first, second, and third 2 ml oral dose of rotavirus reassortant vaccine live (human-bovine) on 02-Jul-2007 (Lot# 656845/0409U), 05-Sep-2007 (Lot# 656845/0409U), and 14-Nov-2007 (Lot# 657665/1460U), respectively.  Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, Hib conj vaccine (OMPC) (manufacturer unknown), pneumococcal conj vaccine (unspecified) and influenza virus vaccine (unspecified).  "Eleven days later," on 25-Nov-2007 the patient was throwing up what looked like the color of coffee granules and continued to throw up.  The patient's mother called the physician.  On 26-Nov-2007 the patient's mother took the patient to the hospital and was hospitalized.  At the time the patient was experiencing vomiting and had on loose stool.  It was noted that all kinds of tests were performed.  Blood work showed a high white blood count.  The patient was put on IV fluids and was dehydrated.  The patient had an x-ray of the intestine and an ultrasound.  On 28-Nov-2007, at 9:00 a.m., the patient was rushed to a second hospital and was diagnosed with intussusception.  It was noted that all types of tests were performed, and finally a jelly-like mucuos blood stool was expelled.  The patient's mother stated that seven barium enema procedures were performed on the patient, and the last one worked.  There was no surgery.  The patient was discharged from the hospital on 30-Nov-2007 at 12:00 p.m.  The patient's mother indicated that she was nursing the child and he seemed okay, but later started bucking and thrashing like he was in pain.  The patient's mother took the patient back to the hospital and they observed him for several hours and then he was released, not hospitalized.  The patient's mother indicated that the child was recovering but was still somewhat traumatized by all the events and was weak and clinging.  The physician did not think that the patient's intussusception was realted to rotavirus reassortant vaccine live (human-bovine).  No product quality complaint was involved.  No other information was provided.  The patient's intussusception was considered to be an other important medical event.  Additional information has been requested. 1/16/08-records received for DOS 11/28-11/29/07 and 11/29-11/30/07-DC DX: Intussusception. Successful reduction by barium enema. Returned the same evening for C/O crying and vomiting. Observed and discharged. illness began 3 days prior to admission with vomiting, fussy, resless and crying out in sleep. Low grade fever. Emesis became dark brown and guaiac positive. Passed blood mucousy stool.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC, RV5
Symptoms: Ultrasound scan, White blood cell count increased, X-ray, X-ray with contrast lower gastrointestinal tract
Clinical narrative: Information has been received from a physician concerning a 6 month old male, that was born with a fractured left clavicle because he was big at birth, and who had no other history other than sniffles, who was vaccinated with a first, second, and third 2 ml oral dose of rotavirus reassortant vaccine live (human-bovine) on 02-Jul-2007 (Lot# 656845/0409U), 05-Sep-2007 (Lot# 656845/0409U), and 14-Nov-2007 (Lot# 657665/1460U), respectively.  Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, Hib conj vaccine (OMPC) (manufacturer unknown), pneumococcal conj vaccine (unspecified) and influenza virus vaccine (unspecified).  "Eleven days later," on 25-Nov-2007 the patient was throwing up what looked like the color of coffee granules and continued to throw up.  The patient's mother called the physician.  On 26-Nov-2007 the patient's mother took the patient to the hospital and was hospitalized.  At the time the patient was experiencing vomiting and had on loose stool.  It was noted that all kinds of tests were performed.  Blood work showed a high white blood count.  The patient was put on IV fluids and was dehydrated.  The patient had an x-ray of the intestine and an ultrasound.  On 28-Nov-2007, at 9:00 a.m., the patient was rushed to a second hospital and was diagnosed with intussusception.  It was noted that all types of tests were performed, and finally a jelly-like mucuos blood stool was expelled.  The patient's mother stated that seven barium enema procedures were performed on the patient, and the last one worked.  There was no surgery.  The patient was discharged from the hospital on 30-Nov-2007 at 12:00 p.m.  The patient's mother indicated that she was nursing the child and he seemed okay, but later started bucking and thrashing like he was in pain.  The patient's mother took the patient back to the hospital and they observed him for several hours and then he was released, not hospitalized.  The patient's mother indicated that the child was recovering but was still somewhat traumatized by all the events and was weak and clinging.  The physician did not think that the patient's intussusception was realted to rotavirus reassortant vaccine live (human-bovine).  No product quality complaint was involved.  No other information was provided.  The patient's intussusception was considered to be an other important medical event.  Additional information has been requested. 1/16/08-records received for DOS 11/28-11/29/07 and 11/29-11/30/07-DC DX: Intussusception. Successful reduction by barium enema. Returned the same evening for C/O crying and vomiting. Observed and discharged. illness began 3 days prior to admission with vomiting, fussy, resless and crying out in sleep. Low grade fever. Emesis became dark brown and guaiac positive. Passed blood mucousy stool.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a registered nurse concerning a 6 month old white male with no pre-existing allergies, birth defects, medical conditions, who on 14-AUG-2007 at 9:15 AM was vaccinated po with a third dose of Rotateq (lot number: 653661/0138F). The patient was hospitalized for intussusception. There were no relevant diagnostic tests and laboratory data. There was no illness at time of vaccination. There were no adverse events following prior vaccinations. The outcome was reported as recovered. There was no product quality complaint. Additional information has been requested. 12/26/07-records received for DOS 10/4-10/5/07- DC DX: Intussusception of large bowel, reduced. Viral gastroenteritis. Mild dehyrdation. Successfully reduced by barium enema. Presented to ED with nausea, projectile vomiting and stomach cramps. In ED one small bloody diarrheal stool.
Sex: F
Vaccine: HEP
Symptoms: Accidental overdose, Inappropriate schedule of drug administration, Medication error
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of inappropriate schedule of drug administration in a 2-day-old female subject who was vaccinated with Engerix B for prophylaxis. Concurrent vaccinations included Engerix B 1st dose, given on 06 December 2007. Concurrent medications included Vitamin K, Ampicillin Ceftazidime, Erythromycin and Eye medication. On 7 December 2007 the subject inadvertently received a 2nd dose of Engerix B at 10 mcg. This was considered to be a medication error and an inappropriate schedule of drug administration. The subject received a dose of Engerix B one day following the first administration. It was reported that the subject was hospitalised. No adverse events were reported.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Malaise, Pyrexia, Vomiting
Clinical narrative: Fever, Vomit, Malaise, Headache. 12/28/2007 MR received for DOS 12/78/2007 with Final Dx:  Fever of Unknown origin.  2' Dx: Abdominal pain.  Lymphadenopathy.  Pt admitted for w/u of FOU  x 1 month.  Pt developed injection site pain and muscle aches following flu shot.  Pt has developed diffuse body aches, abdominal pain, night sweats, malaise, nausea, vomiting and fatigue.  Pt has been seen multiple times and txd with multiple abx with persistant sx. 5 lb weight loss.  Pt also had 1 week of intermittant L-sided numbness of head, face, neck, chest, arm and fingers. PMH:  none. PE (+) for cervical lymph node swelling. Per consultant- "pt may have  mononucleosis picture".
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site infection, Injection site swelling
Clinical narrative: Patient reports swollen "nickel size" infection at site of injection
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Metabolic function test, Pain in extremity
Clinical narrative: Left hand/arm pain - unable to grasp objects, called PMD - on 12/2/07 - advised to use warm compress and take ibuprofen. Visited PMD on 12/3/7. No change in condition. 2nd PMD visit on 12/13/07 - Rx Ibuprofen 600mg BID and 300mg Neurontin TID given by doctor. 1/9/08-records received-12/3/07 seen for C/O left hand very weak and having a hard time picking up things. Impression:peripheral neurtiis. 12/13/07-C/O pain left hand, cramp of fingers. Weakness, numbness and tingling.  1/9/08-non-compliant patient, did not return for follow-up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Rash
Clinical narrative: Extreme pain, redness left side with rash.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Biopsy skin abnormal, Chest X-ray, Dermatitis, Diarrhoea, Eye swelling
Clinical narrative: Description: 28 y/o Asian male who received primary SPV (left arm), Typhoid IM (left arm) and first dose AVA(right arm) on 10/24/2007. 48 hours later he experienced 'flu-like' symptoms - mild nausea without vomiting, diarrhea, malaise and fatigue. On 11/1/2007 (8 days after vaccination), he developed itching at the back of his lower legs, followed by the appearance of a few itchy non-tender red eruptions covering his legs, back and chest. By 11/2/2007 both the itching and skin eruptions worsened to involve his face, neck, scalp and arms. On 11/3/2007, he had increased itching with swelling of his eyes, lips and ears with non-tender palmar lesions as well. There were no blisters, oral lesions, fever/chills, or cardio-pulmonary symptoms. He was seen at Hospital ER 11/1/2007 and 11/3/2007, diagnosed with dermatitis and treated with antihistamines. On 11/5/2007, he was seen at Medical Center, by Allergy and Infectious Disease (12 days post vaccination), and diagnosed with allergic urticaria vs EM. On 11/6/2007, he was seen by MC Dermatology for a skin punch biopsy - results below. SM was started on Zyrtec with gradual improvement in symptoms. Symptom: Nausea w/o vomiting Start: 10/26/2007 End: 10/28/2007; Symptom: Diarrhea Start: 10/26/2007 End: 10/28/2007; Symptom: Fatigue, Malaise <60 Days Start: 10/26/2007 End: 10/28/2007; Symptom: Muscle Pain Start: 10/26/2007 End: 10/28/2007 Comment: generalized aches; Symptom: Pruritis Start: 11/01/2007 Comment: starting posterior legs, later generalized; Symptom: Lesions, wheal Start: 11/03/2007 Comment: ID: maculopapular rash; A/I: lesions, raised; Derm: papules
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Fatigue, Influenza like illness, Laboratory test, Lip swelling, Malaise
Clinical narrative: Description: 28 y/o Asian male who received primary SPV (left arm), Typhoid IM (left arm) and first dose AVA(right arm) on 10/24/2007. 48 hours later he experienced 'flu-like' symptoms - mild nausea without vomiting, diarrhea, malaise and fatigue. On 11/1/2007 (8 days after vaccination), he developed itching at the back of his lower legs, followed by the appearance of a few itchy non-tender red eruptions covering his legs, back and chest. By 11/2/2007 both the itching and skin eruptions worsened to involve his face, neck, scalp and arms. On 11/3/2007, he had increased itching with swelling of his eyes, lips and ears with non-tender palmar lesions as well. There were no blisters, oral lesions, fever/chills, or cardio-pulmonary symptoms. He was seen at Hospital ER 11/1/2007 and 11/3/2007, diagnosed with dermatitis and treated with antihistamines. On 11/5/2007, he was seen at Medical Center, by Allergy and Infectious Disease (12 days post vaccination), and diagnosed with allergic urticaria vs EM. On 11/6/2007, he was seen by MC Dermatology for a skin punch biopsy - results below. SM was started on Zyrtec with gradual improvement in symptoms. Symptom: Nausea w/o vomiting Start: 10/26/2007 End: 10/28/2007; Symptom: Diarrhea Start: 10/26/2007 End: 10/28/2007; Symptom: Fatigue, Malaise <60 Days Start: 10/26/2007 End: 10/28/2007; Symptom: Muscle Pain Start: 10/26/2007 End: 10/28/2007 Comment: generalized aches; Symptom: Pruritis Start: 11/01/2007 Comment: starting posterior legs, later generalized; Symptom: Lesions, wheal Start: 11/03/2007 Comment: ID: maculopapular rash; A/I: lesions, raised; Derm: papules