chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation, Pain in extremity
Clinical narrative: Red/inflamed/pain "mid arm".
Age: 30.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: Red/warm/inflamed below injection site.
Age: 0.79
Sex: F
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Seizure went to hospital ER, given TRILEPTAL po 60mg/mL; give 1ml po BID x 4days then 2ml po BID.
Age: 6.0
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Cough, Injection site haematoma, Injection site pruritus, Pyrexia
Clinical narrative: Fever Tmax 101.1, mild cough, (L) deltoid bruise and itching at injection site starting day 1 and still present at day 4 - improving. No rash or SOB.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Flushing, Hypertension, Immediate post-injection reaction, Malaise
Clinical narrative: Immediately after injection, patient stated he did not feel well (like "something was surging through his body"), that he "felt flushed". Taken to hospital via ambulance (paramedic stated his blood pressure was high and suggested he be checked).
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Flushing, Immediate post-injection reaction
Clinical narrative: Immediately after injection, patient stated he did not feel well (like "something was surging through his body"), that he "felt flushed". Taken to hospital via ambulance (paramedic stated his blood pressure was high and suggested he be checked).
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cold sweat, Dizziness, Dizziness postural, Dysgeusia, Hyperhidrosis
Clinical narrative: Dizzy/light-headed upon standing (within minutes after injection) - Hands shaky/sweaty/clammy - "Medicine-like" taste in mouth within minutes after injection - Taken to hospital via ambulance and checked. Wife notified pharmacist that patient is fine and home.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Tremor
Clinical narrative: Dizzy/light-headed upon standing (within minutes after injection) - Hands shaky/sweaty/clammy - "Medicine-like" taste in mouth within minutes after injection - Taken to hospital via ambulance and checked. Wife notified pharmacist that patient is fine and home.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Dysgeusia, Hyperhidrosis, Immediate post-injection reaction, Tremor
Clinical narrative: Dizzy/light-headed upon standing (within minutes after injection) - Hands shaky/sweaty/clammy - "Medicine-like" taste in mouth within minutes after injection - Taken to hospital via ambulance and checked. Wife notified pharmacist that patient is fine and home.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pt. received vaccine at 10:59 1/29/11. On 1/31/11 she came to pharmacy to inquire transmission to grandson. She did not have any reac at inj. site at that time. On 2/1/11 she came to show me the inj site - reddened with small purple center. Area is warm to touch & slightly hardened. Advised her to not let grandson touch area & to see MD if it does not improve.
Age: 26.0
Sex: F
Vaccine: TYP, YF
Symptoms: Chills, Cough, Dizziness, Dysphonia, Fatigue
Clinical narrative: ER visit for allergic reaction complaints see attached.
Age: 26.0
Sex: F
Vaccine: TYP, YF
Symptoms: Hypersensitivity, Pain, Pyrexia
Clinical narrative: ER visit for allergic reaction complaints see attached.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Large area of erythema 3 x 4 inches with warmth, woke up with sore on left deltoid. Said was sore night of vaccination.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy abnormal, Human papilloma virus test positive, Loop electrosurgical excision procedure, Neoplasm malignant, Nervousness
Clinical narrative: Information has been received from a consumer's mother concerning her 18 year old female daughter who in approximately 2008 was vaccinated with a dose of GARDASIL (dose, route and Lot# not reported). The consumer's mother stated that in November 2010, her daughter was diagnosed with cancer after receiving GARDASIL and could no specify what type of cancer it was. A colposcopy was performed (no results reported). At the time of the report the patient's outcome was unknown. Upon internal review cancer was considered to be an other important medical event. The patient sought unspecified medical attention. Additional information was received from the consumer concerning her daughter had the GARDASIL shot's from her pediatrician when she was 15 1/2 to 16 years of age. She became sexually active at the age of 17 1/4 years old. She did not use a condom with this particular partner. She had been with her same boyfriend since 25-MAY-2010. In September her and the consumer went to their family doctor to get her birth control pills so, she had her first pap smear. It came back abnormal, so she went back again and had a second and it came back human papilloma virus test (HPV) positive high risk. They were told to see an obstetrics and Gynecologist (OBGYN) which they did, and the patient did a colposcopy (also reported as colonscopy) which confirmed she had three infected areas.  She was under a loop electrosurgical excision procedure (LEEP) procedure on 24-JAN-2011 (no results reported). She was 5' 8" and 111 Ibs. She started at 117 but she could not eat from nerves as she felt like her life was ruined forever now. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Prostatic acid phosphatase abnormal, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer's mother concerning her 18 year old female daughter who in approximately 2008 was vaccinated with a dose of GARDASIL (dose, route and Lot# not reported). The consumer's mother stated that in November 2010, her daughter was diagnosed with cancer after receiving GARDASIL and could no specify what type of cancer it was. A colposcopy was performed (no results reported). At the time of the report the patient's outcome was unknown. Upon internal review cancer was considered to be an other important medical event. The patient sought unspecified medical attention. Additional information was received from the consumer concerning her daughter had the GARDASIL shot's from her pediatrician when she was 15 1/2 to 16 years of age. She became sexually active at the age of 17 1/4 years old. She did not use a condom with this particular partner. She had been with her same boyfriend since 25-MAY-2010. In September her and the consumer went to their family doctor to get her birth control pills so, she had her first pap smear. It came back abnormal, so she went back again and had a second and it came back human papilloma virus test (HPV) positive high risk. They were told to see an obstetrics and Gynecologist (OBGYN) which they did, and the patient did a colposcopy (also reported as colonscopy) which confirmed she had three infected areas.  She was under a loop electrosurgical excision procedure (LEEP) procedure on 24-JAN-2011 (no results reported). She was 5' 8" and 111 Ibs. She started at 117 but she could not eat from nerves as she felt like her life was ruined forever now. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram head, Computerised tomogram normal, Convulsion, Electroencephalogram normal, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner (N.P.) and follow up information has been received from a registered nurse (R.N.) concerning a 12 year old female with no concurrent conditions, no known drug reaction and no pertinent medical history who on 08-NOV-2010 was intramuscularly vaccinated with the first 0.5ml dose of GARDASIL (lot# 663573/0969Y). There was no concomitant medication. On 08-DEC-2010 the patient experienced a seizure and was sent to ER. EEG and CT scan of head were performed with negative results reported. The patient was not admitted to hospital. On 21-JAN-2011, the patient was intramuscularly vaccinated with the second 0.5ml dose of GARDASIL (lot# 663573/0969Y). There was no concomitant medication. On 24-JAN-2011 the patient experienced a seizure again. The patient was sent to ER and not admitted. On an unknown date, the patient recovered from seizure and came back to school but being followed by neurology (no contact information available). No other vaccines was given at the time of the two GARDASIL doses. Seizure was determined to be an other important medical event. No further information is available.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Cardiac disorder, Nausea
Clinical narrative: Information was received from a 74 year-old male patient who was vaccinated with a dose of PNEUMOVAX 23. The patient reported that in September "my heart was bothering me, and I had nausea after receiving PNEUMOVAX 23. The patient was hospitalized. Additional information is expected.
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pyrexia, Skin sensitisation, Skin warm
Clinical narrative: Information has been received from a physician concerning a male patient with no medical history who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number not reported) (therapy reason for use was also reported as "sinusitis"). There was no concomitant medication. The patient was not indicated for PNEUMOVAX 23, and received a dose of PNEUMOVAX  23. On an unspecified date the patient's arm swelled and became hot and sensitive. The patient also got a fever. On an unspecified date the patient was admitted to hospital for 3 days. The patient sought unspecified medical attention. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Rash vesicular, Varicella virus test negative
Clinical narrative: Information has been received from a 31 year old female, for VARIVAX (Merck), a Pregnancy Registry product, who on 22-OCT-2010 was vaccinated with a dose of VARIVAX (Merck) (route, dose and lot # not reported). On 14-NOV-2010 the patient developed "2-3 lesions" which she showed to her physician. The patient believed she was pregnant. The patient's date of last menstrual period was 18-OCT2010. The estimated delivery date would be 25-JUL-2011. Follow-up information was received from a physician. A 31 year old female with a history of 0 pregnancy and 0 premature birth and a negative test for varicella antibodies on 21-OCT-2010, on 22-OCT-2010 at 16:29 PM was vaccinated in the deltoid of her right arm with a first dose of VARIVAX (Merck) (lot # 660214/0439X). On 14-NOV-2010 the patient experienced mild varicella like illness post vaccination. On 07-JAN-2011 the patient experienced spontaneous abortion. Upon internal review, spontaneous abortion was determined to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: FLUX
Symptoms: Basal cell carcinoma, Histology, Injection site reaction, Wound
Clinical narrative: Initial serious case received from a physician via health authority on 19 Jan 2011: This patient with unknown medical history received influenza virus vaccine (batch number and manufacturer unknown) on left upper arm on 01 Oct 2009. The patient developed wound on the upper arm. Also it was stated that the patient developed basal cell carcinoma at the application site. No event onset dates were reported. The histology examination was performed on an unknown date but no results were reported. Outcome of the events was reported as unknown.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Influenza A virus test positive, Influenza like illness, Product quality issue
Clinical narrative: Combine initial and follow up information received from the health care professional on 19 Jan 2011 and 24 Jan 2011: This patient with unknown medical history vaccinated with FLUVIRIN (batch number unknown), on an unknown date. The patient experienced the flu-like symptoms on an unknown date. The outcome of the event was not reported. Combined following an internal review for the data received on 19 Jan 2011 and follow up report received from a nurse on 20 Jan 2011: This was also a quality complaint. This patient was vaccinated with 0.5ml of FLUVIRIN (batch number 11625A01) intramuscularly on 16 Nov 2010. Vaccination was uneventful and no adverse reactions were detected after vaccination. On 13 Jan 2011, she became sick with flu-like symptoms and tested positive for influenza A. Outcome of event was reported as condition unchanged. She was also vaccinated with another dose of FLUVIRIN on 20 Jan 2011.
Age: 23.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of arm pain in a 23-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 18 January 2011 at 18:15 the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm). On 19 January 2011, 1 day after vaccination with FLULAVAL, the subject experienced arm pain and pain in arm on lifting. The subject received FLULAVAL and experienced arm pain the day after, which improved and then got worse. On 28 January 2011, 10 days later, she had to use her other hand to assist in taking off a sweater because it hurt her to raise her injected arm past her shoulder. The pharmacist reported the subject was referred her physician for prolonged pain. The pharmacist considered the events were disabling. At the time of reporting the arm pain was worse; pain in arm on lifting was unresolved. The pharmacist considered the events were possibly related to vaccination with FLULAVAL.
Age: 23.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of arm pain in a 23-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 18 January 2011 at 18:15 the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm). On 19 January 2011, 1 day after vaccination with FLULAVAL, the subject experienced arm pain and pain in arm on lifting. The subject received FLULAVAL and experienced arm pain the day after, which improved and then got worse. On 28 January 2011, 10 days later, she had to use her other hand to assist in taking off a sweater because it hurt her to raise her injected arm past her shoulder. The pharmacist reported the subject was referred her physician for prolonged pain. The pharmacist considered the events were disabling. At the time of reporting the arm pain was worse; pain in arm on lifting was unresolved. The pharmacist considered the events were possibly related to vaccination with FLULAVAL.
Age: 1.18
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Immediately after vaccines were administered pt had redness, heat, swelling at site of injection as well as some induration. Pt. was observed for 30-45 min for SOB or changes in his skin. Pt finally was released w/ decrease in symptoms. Advised to apply compress (cool) and rtn if worse or seek ER.
Age: 16.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Youth has approx. 2 inch red area to (R) upper arm, c/o pain. Slight swelling to area. Recommended Ibuprofen, ice pack to site.
Age: 23.0
Sex: F
Vaccine: FLUN3
Symptoms: Acoustic stimulation tests, Anaemia, Blood test, Dizziness, Echocardiogram
Clinical narrative: I received the FluMist early in the day on Nov 4, 2008.  That evening, approximately between 6PM-8PM, I began feeling really dizzy.  The room was not spinning, but internally I felt like I was spinning.  I thought I was going to faint.  I laid down on the couch, prayed, and fell asleep (I'm not sure if I naturally fell asleep or fainted).  I have been internally spinning/dizzy and physically off balance every day since then.  I am dizzy 24hrs, 7 days a week, 365 days a year.  It has been over two years now and no one can tell me what is wrong. During my visit with the doctor immediately following the onset of dizziness, it was discovered that I am anemic.  I had never been told that I was anemic before.  I'm not sure if I always was anemic and my doctors just failed to inform me.  Nevertheless, over the past few months (August 2010-present Feb 2011), my overall health has been rapidly declining.  The main complaints, among many, are dizziness, fatigue, migraines, brain fog and malaise.  I am not on any treatments currently because no one knows how to help me.  I've had two brain MRIs, an echocariogram, balance testing, hearing tests, physical therapy, and blood work.
Age: 23.0
Sex: F
Vaccine: FLUN3
Symptoms: Fatigue, Feeling abnormal, General physical health deterioration, Laboratory test, Malaise
Clinical narrative: I received the FluMist early in the day on Nov 4, 2008.  That evening, approximately between 6PM-8PM, I began feeling really dizzy.  The room was not spinning, but internally I felt like I was spinning.  I thought I was going to faint.  I laid down on the couch, prayed, and fell asleep (I'm not sure if I naturally fell asleep or fainted).  I have been internally spinning/dizzy and physically off balance every day since then.  I am dizzy 24hrs, 7 days a week, 365 days a year.  It has been over two years now and no one can tell me what is wrong. During my visit with the doctor immediately following the onset of dizziness, it was discovered that I am anemic.  I had never been told that I was anemic before.  I'm not sure if I always was anemic and my doctors just failed to inform me.  Nevertheless, over the past few months (August 2010-present Feb 2011), my overall health has been rapidly declining.  The main complaints, among many, are dizziness, fatigue, migraines, brain fog and malaise.  I am not on any treatments currently because no one knows how to help me.  I've had two brain MRIs, an echocariogram, balance testing, hearing tests, physical therapy, and blood work.
Age: 23.0
Sex: F
Vaccine: FLUN3
Symptoms: Migraine, Nuclear magnetic resonance imaging brain, Presyncope, Vertigo
Clinical narrative: I received the FluMist early in the day on Nov 4, 2008.  That evening, approximately between 6PM-8PM, I began feeling really dizzy.  The room was not spinning, but internally I felt like I was spinning.  I thought I was going to faint.  I laid down on the couch, prayed, and fell asleep (I'm not sure if I naturally fell asleep or fainted).  I have been internally spinning/dizzy and physically off balance every day since then.  I am dizzy 24hrs, 7 days a week, 365 days a year.  It has been over two years now and no one can tell me what is wrong. During my visit with the doctor immediately following the onset of dizziness, it was discovered that I am anemic.  I had never been told that I was anemic before.  I'm not sure if I always was anemic and my doctors just failed to inform me.  Nevertheless, over the past few months (August 2010-present Feb 2011), my overall health has been rapidly declining.  The main complaints, among many, are dizziness, fatigue, migraines, brain fog and malaise.  I am not on any treatments currently because no one knows how to help me.  I've had two brain MRIs, an echocariogram, balance testing, hearing tests, physical therapy, and blood work.
Age: 0.59
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a 36 month old patient who on an unspecified date, when he/she was an infant, received the full 3 doses 2ml regimen for ROTATEQ. The nurses in the pediatric department of the office advised that the patient reported intussusception at the 3 years of age. The patient sought medical attention and was referred out to another physician from their primary doctor. At the time of the report the patient outcome was unknown. Upon internal review, intussusception was considered to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
Age: 0.36
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Fatigue, Haematochezia, Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 19 weeks old male with mild dilation of kidney and no drug allergies who on 20-JAN-2011 was vaccinated with the first dose of ROTATEQ (lot # 669073/1525Z). The reporter stated that the patient had a couple drops of red blood in his stool about 4 days ("24-JAN-2011") after vaccination with the first dose of ROTATEQ. The patient also had loose stool, fatigue, fever of 100 F and did not sleep well. This first dose was given at 16 weeks of age. On 25-JAN-2011 the patient recovered from a couple drops of red blood in his stool, loose stool, fatigue, fever of 100 F and did not sleep well. The patient was seen in office to seek medical attention. Upon internal review, a couple of drops of red blood in his stool was determined to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.36
Sex: M
Vaccine: RV5
Symptoms: Sleep disorder
Clinical narrative: Information has been received from a physician concerning a 19 weeks old male with mild dilation of kidney and no drug allergies who on 20-JAN-2011 was vaccinated with the first dose of ROTATEQ (lot # 669073/1525Z). The reporter stated that the patient had a couple drops of red blood in his stool about 4 days ("24-JAN-2011") after vaccination with the first dose of ROTATEQ. The patient also had loose stool, fatigue, fever of 100 F and did not sleep well. This first dose was given at 16 weeks of age. On 25-JAN-2011 the patient recovered from a couple drops of red blood in his stool, loose stool, fatigue, fever of 100 F and did not sleep well. The patient was seen in office to seek medical attention. Upon internal review, a couple of drops of red blood in his stool was determined to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning 2 or 3 patients who on unknown dates were vaccinated with ROTATEQ (lot # not reported). Patients had a small amount of blood in their stool after vaccination with ROTATEQ. At the time of reporting, the outcomes of the patients were unknown. It was unknown if patients sought medical attention. Upon internal review, a small amount of blood in their stool was determined to be an other important medical event. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a 36 month old patient who on an unspecified date, when he/she was an infant, received the full 3 doses 2ml regimen for ROTATEQ. The nurses in the pediatric department of the office advised that the patient reported intussusception at the 3 years of age. The patient sought medical attention and was referred out to another physician from their primary doctor. At the time of the report the patient outcome was unknown. Upon internal review, intussusception was considered to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Moderate to severe pain in entire right arm. This pain is still persistent as of 2/2/2011.
Age: 0.65
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Local reaction, Vaccination site nodule
Clinical narrative: Local reaction to (R) thigh, knot small (pea size).
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Headache, Pyrexia, Swelling, Vomiting
Clinical narrative: Vomiting, fever 103, headaches, redness, swelling size of an egg.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Rash on Face, pt came to Student Health Clinic @ 11:30 am to be evaluated. Pt prescribed Benadryl 25mg one every 6 hours prn. Return to clinic or ER if symptoms worsen.
Age: 1.4
Sex: U
Vaccine: DTAP, HIBV
Symptoms: Allergy test, Erythema, Lip swelling, Oedema mouth, Rash
Clinical narrative: Rash, mouth lip swelling, peeling erythema. Treatment given BENADRYL.
Age: 1.4
Sex: U
Vaccine: DTAP, HIBV
Symptoms: Skin exfoliation
Clinical narrative: Rash, mouth lip swelling, peeling erythema. Treatment given BENADRYL.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient states that they have had arm pain since injection.
Age: 20.0
Sex: M
Vaccine: PPV
Symptoms: Chest X-ray normal, Culture urine positive, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Received vaccine 1/30/11 around 11AM. Right deltoid. On 2/1/11 pt noted to have red blotchy areas. Flat but tender. Ice packs applied. 2/2/11 11AM still red, blotchy patches around deltoid area of arm. Tender. Not raised.
Age: 20.0
Sex: M
Vaccine: PPV
Symptoms: Rash macular, White blood cell count increased
Clinical narrative: Received vaccine 1/30/11 around 11AM. Right deltoid. On 2/1/11 pt noted to have red blotchy areas. Flat but tender. Ice packs applied. 2/2/11 11AM still red, blotchy patches around deltoid area of arm. Tender. Not raised.
Age: 1.73
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site nodule
Clinical narrative: 5 x 10 mm firm intramuscular nodule at injection site - not resolved after 3 wks from vaccination. Tx = warm compresses with massage (started today).
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: C-reactive protein normal, Dyskinesia, Streptococcus test, Streptococcus test negative
Clinical narrative: Patient developed jerking of all extremities while at school. EMS called and taken to the ER at Hospital. Labs negative. Sent home with Rx for DIASTAT & Neurology referral.
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Monoplegia
Clinical narrative: Initial report received from a consumer who is a physician on 25 January 2011. A male patient (date of birth not reported) had received in a hospital setting a dose of Influenza vaccine (reported as FLUZONE) on an unknown date. The lot number and route of administration were unknown. Per the patient, the vaccine was administered at an incorrect site and was administered into the nerve. Following vaccination he developed paralysis of the injected arm. Per the patient, an adverse event report was completed by the hospital but he had no other information regarding that report. The patient did not wish to be contacted. No further information is expected. Documents held by sender: None.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Influenza A virus test positive, Influenza B virus test positive
Clinical narrative: Initial report received from a health care professional on 26 January 2011. A 7-year-old male child, with an allergy to amoxicillin, received on 04 October 2010 an intramuscular injection (site not reported) of FLUZONE SV, lot number U3655AA. The patient has no medical history, takes no concomitant medications, had no illness at the time of vaccination and had no adverse events following prior vaccinations. On 26 January 2011, the patient required a doctor visit where a Quidel QuickVue test for influenza resulted in a positive test for A & B. The outcome was reported as not recovered. The reporter is the same as case 2011-000395. Documents held by sender: None.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Influenza A virus test positive, Influenza B virus test positive
Clinical narrative: Initial report received from a health care professional on 26 January 2011.  A 10-year-old male child received on 04 October 2010 an intramuscular injection (site not reported) of FLUZONE SV 2010-2011, lot number U3655AA.  The patient had no medical history, takes no concomitant medications, had no illness at the time of vaccination, had no other vaccinations within 4 weeks of the FLUZONE and had no adverse events following prior vaccinations.  On 26 January 2011, the patient required a doctor visit where a Quidel QuickVue test for influenza resulted in a positive test for A & B.  The outcome was reported as not recovered.  The reporter is the same as case 2011-000392.  Documents held by sender: None.
Age: 32.0
Sex: M
Vaccine: YF
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Profuse perspiration, lightheadedness, & dizziness. B/P 86/68 10 min later 144/94 30 mins later 110/70.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Abasia, Injection site pain, Pyrexia
Clinical narrative: Pain in the shot site and fever for 3 days unable to walk
Age: 41.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Chills, Lymphadenopathy, Pyrexia, Testicular pain, Testicular swelling
Clinical narrative: FIRST DEVELOPED A FINE RASH LIKE HIVES PER PATIENT AND THEN 1 WEEK LATER DEVELOPED CHILLS AND A FEVER 1/28/2011 AND SWELLING OF HIS TESTICLES WITH SORENESS ALSO STATES SOME SWELLING OF LYMPH NODES IN HIS NECK AREA
Age: 41.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Urticaria
Clinical narrative: FIRST DEVELOPED A FINE RASH LIKE HIVES PER PATIENT AND THEN 1 WEEK LATER DEVELOPED CHILLS AND A FEVER 1/28/2011 AND SWELLING OF HIS TESTICLES WITH SORENESS ALSO STATES SOME SWELLING OF LYMPH NODES IN HIS NECK AREA
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling at injection site approx. 4 in x 3 in. No other distal symptoms itching present at site.
Age: 12.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt had previously received a TDAP 5/20/10 & was recorded on a separate IZ record. Original IZ record didn't have date recorded. Pt was then given a TDAP with assumption she had not rcd. one in past.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: 89 yo male requested flu IZ. Immunization given. When secretary went to enter vz date, it appeared that pt had received flu immunization already 10/10. Notified advisor & pt. family. No reaction/voiced from pt.
Age: 37.0
Sex: M
Vaccine: DTAP
Symptoms: Body temperature increased, Chills, Tenderness
Clinical narrative: Developed cold chills, T=102.8F, arm tender.  Took liquid Iburofen.
Age: 47.0
Sex: M
Vaccine: HEPAB, IPV, TDAP, TYP
Symptoms: Night sweats, Pruritus, Rash erythematous
Clinical narrative: R elbow and forearm itching red rash lasting up to 2 1/2 weeks, also itching red rash on R elbow one week later.  Both releaved with Benadryl. Night of vaccine administration, woke sweating as if fever broke.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Gait disturbance, Oedema peripheral
Clinical narrative: Legal guardian stated that childs legs were swollen all the way down to ankles and "walking funny". RN instructed guardian to take to pediatrician office.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Adenovirus test, Alanine aminotransferase normal, Aspartate aminotransferase normal, Band neutrophil percentage increased, Blood albumin decreased
Clinical narrative: This female subject was enrolled in the study 112957 (HIB-097).  On 13 September 2010 and 17 November 2010 she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po).  On 19 January 2011, she received a 3rd dose of HIBERIX, PEDIARIX and PREVNAR 13.  This subject received HIBERIX (lot AHIBVC292A and AD02VB365A).  On 19 January 2011, 63 days after the 2nd dose of ROTARIX, on the same day after the 3rd dose of PEDIARIX, on the same day after the 3rd dose of HIBERIX, on the same day after the 3rd dose of PREVNAR 13, this six-month-old subject developed Kawasaki disease.  The subject was hospitalised.  The subject was treated with paracetamol, intravenous fluid(s), normal immunoglobulin, diphenhydramine and aspirin.  The event improved on an unspecified date.  The investigator considered that there was a reasonable possibility that the Kawasaki disease may have been caused by ROTARIX, PEDIARIX, HIBERIX and PREVNAR 13 and that the event was possibly due to disease under study.  Investigator Comments : Subject with fever for 5 days (101-102 axillary), conjunctivitis, red lips, and body rash.  Admitted to rule out Kawasakis.  Received 6 month shots 19Jan2011- developed fever that day, rash started 22Jan2011- erythmatous, maculopapular blanching and discrete conjunctival injection developed night prior to admission.  Lips bright red but not cracked.  No hand/feet swelling or skin changes but small blanching red spots on palms and soles, no lymph adenopathy noted.  Patient started on IV fluids and acetaminophen for fever and pain.  24Jan2011 patient with swollen hands and feet, cracked lips.  Nasopharynx Swab - negative for Influenza A and B and RSV.  Patient had normal echocardiogram 26Jan2011.  Patient tolerated treatment IV immunoglobulin 24Jan2011 for Kawasakis Disease with dramatic responses with near complete resolution of rash, conjunctivitis, hand/foot changes and mucositis.  High dose Aspirin started on 25Jan2011 following negative swab for Influenza A, B and RSV.  Slight waxing/waning of rash/conjunctivial erythema/lip redness but not considered significant enough for second dose of IV immunoglobulin.  Patient afebrile for greater than 48 hours prior to discharge.  Patient discharged on 27Jan2011 on low dose Aspirin 40.5 mg a day and acetaminiophen 120 mg suppositories prn pain or fever.  28Jan2011 follow-up clinic visit exam / assessment - resolving Kawasakis, neg echo, improving appetite though weight down 7.5 ounces, resolving conjunctivitis no rash, normal extremities purulent nasal discharge and normal mouth and throat.  Repeat echocardiogram in 6 weeks.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture negative, Chapped lips, Cheilitis, Conjunctival hyperaemia, Conjunctivitis
Clinical narrative: This female subject was enrolled in the study 112957 (HIB-097).  On 13 September 2010 and 17 November 2010 she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po).  On 19 January 2011, she received a 3rd dose of HIBERIX, PEDIARIX and PREVNAR 13.  This subject received HIBERIX (lot AHIBVC292A and AD02VB365A).  On 19 January 2011, 63 days after the 2nd dose of ROTARIX, on the same day after the 3rd dose of PEDIARIX, on the same day after the 3rd dose of HIBERIX, on the same day after the 3rd dose of PREVNAR 13, this six-month-old subject developed Kawasaki disease.  The subject was hospitalised.  The subject was treated with paracetamol, intravenous fluid(s), normal immunoglobulin, diphenhydramine and aspirin.  The event improved on an unspecified date.  The investigator considered that there was a reasonable possibility that the Kawasaki disease may have been caused by ROTARIX, PEDIARIX, HIBERIX and PREVNAR 13 and that the event was possibly due to disease under study.  Investigator Comments : Subject with fever for 5 days (101-102 axillary), conjunctivitis, red lips, and body rash.  Admitted to rule out Kawasakis.  Received 6 month shots 19Jan2011- developed fever that day, rash started 22Jan2011- erythmatous, maculopapular blanching and discrete conjunctival injection developed night prior to admission.  Lips bright red but not cracked.  No hand/feet swelling or skin changes but small blanching red spots on palms and soles, no lymph adenopathy noted.  Patient started on IV fluids and acetaminophen for fever and pain.  24Jan2011 patient with swollen hands and feet, cracked lips.  Nasopharynx Swab - negative for Influenza A and B and RSV.  Patient had normal echocardiogram 26Jan2011.  Patient tolerated treatment IV immunoglobulin 24Jan2011 for Kawasakis Disease with dramatic responses with near complete resolution of rash, conjunctivitis, hand/foot changes and mucositis.  High dose Aspirin started on 25Jan2011 following negative swab for Influenza A, B and RSV.  Slight waxing/waning of rash/conjunctivial erythema/lip redness but not considered significant enough for second dose of IV immunoglobulin.  Patient afebrile for greater than 48 hours prior to discharge.  Patient discharged on 27Jan2011 on low dose Aspirin 40.5 mg a day and acetaminiophen 120 mg suppositories prn pain or fever.  28Jan2011 follow-up clinic visit exam / assessment - resolving Kawasakis, neg echo, improving appetite though weight down 7.5 ounces, resolving conjunctivitis no rash, normal extremities purulent nasal discharge and normal mouth and throat.  Repeat echocardiogram in 6 weeks.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Haematocrit decreased, Haemoglobin normal, Immunoglobulin therapy, Kawasaki's disease, Lymphocyte morphology abnormal
Clinical narrative: This female subject was enrolled in the study 112957 (HIB-097).  On 13 September 2010 and 17 November 2010 she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po).  On 19 January 2011, she received a 3rd dose of HIBERIX, PEDIARIX and PREVNAR 13.  This subject received HIBERIX (lot AHIBVC292A and AD02VB365A).  On 19 January 2011, 63 days after the 2nd dose of ROTARIX, on the same day after the 3rd dose of PEDIARIX, on the same day after the 3rd dose of HIBERIX, on the same day after the 3rd dose of PREVNAR 13, this six-month-old subject developed Kawasaki disease.  The subject was hospitalised.  The subject was treated with paracetamol, intravenous fluid(s), normal immunoglobulin, diphenhydramine and aspirin.  The event improved on an unspecified date.  The investigator considered that there was a reasonable possibility that the Kawasaki disease may have been caused by ROTARIX, PEDIARIX, HIBERIX and PREVNAR 13 and that the event was possibly due to disease under study.  Investigator Comments : Subject with fever for 5 days (101-102 axillary), conjunctivitis, red lips, and body rash.  Admitted to rule out Kawasakis.  Received 6 month shots 19Jan2011- developed fever that day, rash started 22Jan2011- erythmatous, maculopapular blanching and discrete conjunctival injection developed night prior to admission.  Lips bright red but not cracked.  No hand/feet swelling or skin changes but small blanching red spots on palms and soles, no lymph adenopathy noted.  Patient started on IV fluids and acetaminophen for fever and pain.  24Jan2011 patient with swollen hands and feet, cracked lips.  Nasopharynx Swab - negative for Influenza A and B and RSV.  Patient had normal echocardiogram 26Jan2011.  Patient tolerated treatment IV immunoglobulin 24Jan2011 for Kawasakis Disease with dramatic responses with near complete resolution of rash, conjunctivitis, hand/foot changes and mucositis.  High dose Aspirin started on 25Jan2011 following negative swab for Influenza A, B and RSV.  Slight waxing/waning of rash/conjunctivial erythema/lip redness but not considered significant enough for second dose of IV immunoglobulin.  Patient afebrile for greater than 48 hours prior to discharge.  Patient discharged on 27Jan2011 on low dose Aspirin 40.5 mg a day and acetaminiophen 120 mg suppositories prn pain or fever.  28Jan2011 follow-up clinic visit exam / assessment - resolving Kawasakis, neg echo, improving appetite though weight down 7.5 ounces, resolving conjunctivitis no rash, normal extremities purulent nasal discharge and normal mouth and throat.  Repeat echocardiogram in 6 weeks.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Lymphocyte percentage decreased, Mean cell volume normal, Monocyte count increased, Mucosal inflammation, Neutrophil count decreased
Clinical narrative: This female subject was enrolled in the study 112957 (HIB-097).  On 13 September 2010 and 17 November 2010 she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po).  On 19 January 2011, she received a 3rd dose of HIBERIX, PEDIARIX and PREVNAR 13.  This subject received HIBERIX (lot AHIBVC292A and AD02VB365A).  On 19 January 2011, 63 days after the 2nd dose of ROTARIX, on the same day after the 3rd dose of PEDIARIX, on the same day after the 3rd dose of HIBERIX, on the same day after the 3rd dose of PREVNAR 13, this six-month-old subject developed Kawasaki disease.  The subject was hospitalised.  The subject was treated with paracetamol, intravenous fluid(s), normal immunoglobulin, diphenhydramine and aspirin.  The event improved on an unspecified date.  The investigator considered that there was a reasonable possibility that the Kawasaki disease may have been caused by ROTARIX, PEDIARIX, HIBERIX and PREVNAR 13 and that the event was possibly due to disease under study.  Investigator Comments : Subject with fever for 5 days (101-102 axillary), conjunctivitis, red lips, and body rash.  Admitted to rule out Kawasakis.  Received 6 month shots 19Jan2011- developed fever that day, rash started 22Jan2011- erythmatous, maculopapular blanching and discrete conjunctival injection developed night prior to admission.  Lips bright red but not cracked.  No hand/feet swelling or skin changes but small blanching red spots on palms and soles, no lymph adenopathy noted.  Patient started on IV fluids and acetaminophen for fever and pain.  24Jan2011 patient with swollen hands and feet, cracked lips.  Nasopharynx Swab - negative for Influenza A and B and RSV.  Patient had normal echocardiogram 26Jan2011.  Patient tolerated treatment IV immunoglobulin 24Jan2011 for Kawasakis Disease with dramatic responses with near complete resolution of rash, conjunctivitis, hand/foot changes and mucositis.  High dose Aspirin started on 25Jan2011 following negative swab for Influenza A, B and RSV.  Slight waxing/waning of rash/conjunctivial erythema/lip redness but not considered significant enough for second dose of IV immunoglobulin.  Patient afebrile for greater than 48 hours prior to discharge.  Patient discharged on 27Jan2011 on low dose Aspirin 40.5 mg a day and acetaminiophen 120 mg suppositories prn pain or fever.  28Jan2011 follow-up clinic visit exam / assessment - resolving Kawasakis, neg echo, improving appetite though weight down 7.5 ounces, resolving conjunctivitis no rash, normal extremities purulent nasal discharge and normal mouth and throat.  Repeat echocardiogram in 6 weeks.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Neutrophil toxic granulation present, Oedema peripheral, Pallor, Platelet count increased, Platelet morphology
Clinical narrative: This female subject was enrolled in the study 112957 (HIB-097).  On 13 September 2010 and 17 November 2010 she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po).  On 19 January 2011, she received a 3rd dose of HIBERIX, PEDIARIX and PREVNAR 13.  This subject received HIBERIX (lot AHIBVC292A and AD02VB365A).  On 19 January 2011, 63 days after the 2nd dose of ROTARIX, on the same day after the 3rd dose of PEDIARIX, on the same day after the 3rd dose of HIBERIX, on the same day after the 3rd dose of PREVNAR 13, this six-month-old subject developed Kawasaki disease.  The subject was hospitalised.  The subject was treated with paracetamol, intravenous fluid(s), normal immunoglobulin, diphenhydramine and aspirin.  The event improved on an unspecified date.  The investigator considered that there was a reasonable possibility that the Kawasaki disease may have been caused by ROTARIX, PEDIARIX, HIBERIX and PREVNAR 13 and that the event was possibly due to disease under study.  Investigator Comments : Subject with fever for 5 days (101-102 axillary), conjunctivitis, red lips, and body rash.  Admitted to rule out Kawasakis.  Received 6 month shots 19Jan2011- developed fever that day, rash started 22Jan2011- erythmatous, maculopapular blanching and discrete conjunctival injection developed night prior to admission.  Lips bright red but not cracked.  No hand/feet swelling or skin changes but small blanching red spots on palms and soles, no lymph adenopathy noted.  Patient started on IV fluids and acetaminophen for fever and pain.  24Jan2011 patient with swollen hands and feet, cracked lips.  Nasopharynx Swab - negative for Influenza A and B and RSV.  Patient had normal echocardiogram 26Jan2011.  Patient tolerated treatment IV immunoglobulin 24Jan2011 for Kawasakis Disease with dramatic responses with near complete resolution of rash, conjunctivitis, hand/foot changes and mucositis.  High dose Aspirin started on 25Jan2011 following negative swab for Influenza A, B and RSV.  Slight waxing/waning of rash/conjunctivial erythema/lip redness but not considered significant enough for second dose of IV immunoglobulin.  Patient afebrile for greater than 48 hours prior to discharge.  Patient discharged on 27Jan2011 on low dose Aspirin 40.5 mg a day and acetaminiophen 120 mg suppositories prn pain or fever.  28Jan2011 follow-up clinic visit exam / assessment - resolving Kawasakis, neg echo, improving appetite though weight down 7.5 ounces, resolving conjunctivitis no rash, normal extremities purulent nasal discharge and normal mouth and throat.  Repeat echocardiogram in 6 weeks.