chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: 5x6 cm erythema & redness (L) upper arm.
Age: 3.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PCV 13 (4th Pneumococcal vaccine) injected (L) thigh on 4/18/11. Pt was seen on 4/21/11 - swelling and tenderness (L) thigh - 1/2 the circumference with mild redness.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: Blood tinged stools x 3-4 in one day (3/11/11) continued for 2-3 days & resolved on it's own without treatment - last episodes of bowel movements were all blood.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Cough, Dysgeusia, Hyperhidrosis, Immediate post-injection reaction, Increased upper airway secretion
Clinical narrative: Patient complained of injection site itching immediately after injection, itching spread until generalized, red splotches appeared on site arm, pt rapidly progressed to uncontrolled coughing, diaphoresis, metallic taste in mouth, sore throat, phlegm in throat. Vital signs were monitored, patient never became short of breath, liquid Benadryl given orally, symptoms did not decrease, so DepoMedrol was administered intramuscularly. Pt's symptoms resolved 15 min following administration. Pt was contacted 3 hrs later, symptoms had not returned, patient reported feeling fine.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site pruritus, Oropharyngeal pain, Pruritus generalised, Rash macular
Clinical narrative: Patient complained of injection site itching immediately after injection, itching spread until generalized, red splotches appeared on site arm, pt rapidly progressed to uncontrolled coughing, diaphoresis, metallic taste in mouth, sore throat, phlegm in throat. Vital signs were monitored, patient never became short of breath, liquid Benadryl given orally, symptoms did not decrease, so DepoMedrol was administered intramuscularly. Pt's symptoms resolved 15 min following administration. Pt was contacted 3 hrs later, symptoms had not returned, patient reported feeling fine.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Oropharyngeal pain, Pruritus generalised
Clinical narrative: Patient complained of injection site itching immediately after injection, itching spread until generalized, red splotches appeared on site arm, pt rapidly progressed to uncontrolled coughing, diaphoresis, metallic taste in mouth, sore throat, phlegm in throat. Vital signs were monitored, patient never became short of breath, liquid Benadryl given orally, symptoms did not decrease, so DepoMedrol was administered intramuscularly. Pt's symptoms resolved 15 min following administration. Pt was contacted 3 hrs later, symptoms had not returned, patient reported feeling fine.
Age: 29.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Rash macular
Clinical narrative: Patient complained of injection site itching immediately after injection, itching spread until generalized, red splotches appeared on site arm, pt rapidly progressed to uncontrolled coughing, diaphoresis, metallic taste in mouth, sore throat, phlegm in throat. Vital signs were monitored, patient never became short of breath, liquid Benadryl given orally, symptoms did not decrease, so DepoMedrol was administered intramuscularly. Pt's symptoms resolved 15 min following administration. Pt was contacted 3 hrs later, symptoms had not returned, patient reported feeling fine.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Oedema peripheral
Clinical narrative: 2 WEEKS POST VACCINE - JOINT PAIN BEGAN WITH EDEMA RIGHT WRIST.  EDEMA HAS BEEN INTERMITTENT.  PAIN IN JOINTS CONSTANT BUT INTENSITY CHANGES (JOINTS AFFECTED WRISTS AND KNEES).
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Blood test, Gait disturbance, Joint swelling, Rheumatoid factor
Clinical narrative: 2 WEEKS POST VACCINE - JOINT PAIN BEGAN WITH EDEMA RIGHT WRIST.  EDEMA HAS BEEN INTERMITTENT.  PAIN IN JOINTS CONSTANT BUT INTENSITY CHANGES (JOINTS AFFECTED WRISTS AND KNEES).
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Aphonia, Incorrect dose administered, Oedema peripheral
Clinical narrative: Information has been received from a consumer concerning her approximately 12 month old granddaughter with nuts and seeds allergy and no pertinent medical history who in approximately 2007 (about a year old), was vaccinated with "1/8 of a cc" of MMR II (route and lot# not reported). There was no concomitant medication. Subsequently the patient's "arm blew up". The patient received the full dose of MMR II (route and lot# not reported) when she was 17 or 18 months old. The patient went from a lively young child who was starting to talk to not talking at all. The patient was silent. The patient saw a physician. After received early intervention and the patient was now doing great and talking a lot. Upon internal review, aphonia was considered to be an other important event. This is an amended report. Upon review of the file, the AE code of taciturnity was changed to aphonia. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Electromyogram normal, Guillain-Barre syndrome, Laboratory test normal, Muscular weakness
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient with Gilbert's syndrome (benign syndrome with normal variance) and no known drug allergies who received GARDASIL series (first dose on 10-Sep-2007, lot # 658554/0928U; second dose on 26-Nov-2007, lot # 659439/1267U; third dose on 29-Apr-2008, lot # 659964/1978U). There was no concomitant medication. In approximately February 2011 ("about 1 1/2 months before diagnosis date of 31-MAR-2011"), the patient experienced weakness, trembling and pain in her legs. So she went to the emergency department at a hospital. The symptoms had been processing to her arms. Blood tests were ordered at the emergency department but the results were not available for him to review. Lab work performed (unknown which tests were done) was normal according to the patient's mother. It was believed that no cerebrospinal fluid (CSF) analysis was performed. ON 31-MAR-2011 the patient was diagnosed with Guillain-Barre syndrome by the reporting physician. The physician referred the patient to a neurologist on 31-MAR-2011 who confirmed his diagnosis of Guillain-Barre syndrome. At the time of reporting, the patient had not recovered from Guillain-Barre syndrome. Follow up information has been received from the neurologist who reported that no vaccine was given to the student patient at his office. The patient was seen in office for neurological evaluation secondary to lower extremity weakness and was diagnosed with idiopathic cryptogenic neuromuscular disorder. There was no history of vaccine exposure given at that time related/unrelated. No evidence vaccine. Electromyography (EMG) and nerve conduction velocity (NCV) were performed and both were normal. On 13-APR-2011, the patient recovered from the adverse event. Guillain-Barre syndrome was not life threatening, but was disabling in the fact that the patient needed assistance with walking. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Nerve conduction studies normal, Neurological examination abnormal, Neuromyopathy, Pain in extremity, Tremor
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient with Gilbert's syndrome (benign syndrome with normal variance) and no known drug allergies who received GARDASIL series (first dose on 10-Sep-2007, lot # 658554/0928U; second dose on 26-Nov-2007, lot # 659439/1267U; third dose on 29-Apr-2008, lot # 659964/1978U). There was no concomitant medication. In approximately February 2011 ("about 1 1/2 months before diagnosis date of 31-MAR-2011"), the patient experienced weakness, trembling and pain in her legs. So she went to the emergency department at a hospital. The symptoms had been processing to her arms. Blood tests were ordered at the emergency department but the results were not available for him to review. Lab work performed (unknown which tests were done) was normal according to the patient's mother. It was believed that no cerebrospinal fluid (CSF) analysis was performed. ON 31-MAR-2011 the patient was diagnosed with Guillain-Barre syndrome by the reporting physician. The physician referred the patient to a neurologist on 31-MAR-2011 who confirmed his diagnosis of Guillain-Barre syndrome. At the time of reporting, the patient had not recovered from Guillain-Barre syndrome. Follow up information has been received from the neurologist who reported that no vaccine was given to the student patient at his office. The patient was seen in office for neurological evaluation secondary to lower extremity weakness and was diagnosed with idiopathic cryptogenic neuromuscular disorder. There was no history of vaccine exposure given at that time related/unrelated. No evidence vaccine. Electromyography (EMG) and nerve conduction velocity (NCV) were performed and both were normal. On 13-APR-2011, the patient recovered from the adverse event. Guillain-Barre syndrome was not life threatening, but was disabling in the fact that the patient needed assistance with walking. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Walking aid user
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient with Gilbert's syndrome (benign syndrome with normal variance) and no known drug allergies who received GARDASIL series (first dose on 10-Sep-2007, lot # 658554/0928U; second dose on 26-Nov-2007, lot # 659439/1267U; third dose on 29-Apr-2008, lot # 659964/1978U). There was no concomitant medication. In approximately February 2011 ("about 1 1/2 months before diagnosis date of 31-MAR-2011"), the patient experienced weakness, trembling and pain in her legs. So she went to the emergency department at a hospital. The symptoms had been processing to her arms. Blood tests were ordered at the emergency department but the results were not available for him to review. Lab work performed (unknown which tests were done) was normal according to the patient's mother. It was believed that no cerebrospinal fluid (CSF) analysis was performed. ON 31-MAR-2011 the patient was diagnosed with Guillain-Barre syndrome by the reporting physician. The physician referred the patient to a neurologist on 31-MAR-2011 who confirmed his diagnosis of Guillain-Barre syndrome. At the time of reporting, the patient had not recovered from Guillain-Barre syndrome. Follow up information has been received from the neurologist who reported that no vaccine was given to the student patient at his office. The patient was seen in office for neurological evaluation secondary to lower extremity weakness and was diagnosed with idiopathic cryptogenic neuromuscular disorder. There was no history of vaccine exposure given at that time related/unrelated. No evidence vaccine. Electromyography (EMG) and nerve conduction velocity (NCV) were performed and both were normal. On 13-APR-2011, the patient recovered from the adverse event. Guillain-Barre syndrome was not life threatening, but was disabling in the fact that the patient needed assistance with walking. Additional information has been requested.
Age: 1.18
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Rash
Clinical narrative: Rash appeared on abdomen and back about 10 minutes after administration. Instructed to give BENADRYL.
Age: 1.59
Sex: M
Vaccine: DTAP
Symptoms: Lethargy, Oedema peripheral
Clinical narrative: Lethargy, swelling of feet, ? wheezing.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Headache, Migraine, Vision blurred, Vomiting
Clinical narrative: Case number PHHY2011US36774 is an initial spontaneous report received from a health care professional on 26 Apr 2011. This report refers to a 12 years old male patient. He was vaccinated with MENVEO (batch number: unknown) intramuscularly on 25 Apr 2011. Three to four hours after vaccination, he experienced severe headache, dizziness, blurriness and emesis. He was taken to emergency room with complaints of a migraine headache and continuous vomiting. He experienced headache until 24 hours after vaccination. The health care professional assessed the events as serious (medically significant and hospitalization) and the outcome of the events was reported as complete recovery. This case was also reported to the VAERS.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Pt started vomiting, unable to hold any fluids down, fever, headache
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid function disorder, Hypoaesthesia facial, VIIth nerve paralysis
Clinical narrative: Rt & Lt side of face numb x3 days. Then could not close left eye or smile on left side. No change in vision, hearing, swallowing. No weakness in arms or legs. No HA or trauma. "Looks stable. Classic 7th facial paralysis w/ 30% inability to close eye. Inability to crinkle forehead. Inabilty to curl up left."
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site macule, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Red warm tender macular ring developed around the site of the injection which increased in size over the 2 days after the injection.  Patient also got a fever.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site urticaria, Local reaction
Clinical narrative: Local Reaction, redness around injection site quarter size with 2 small whelps inside red area each the about 1/2 size of a dime in diameter
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Painful left thigh. Slight swelling. Tx - cold compresses and ibuprofen.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site macule, Injection site pain, Injection site warmth
Clinical narrative: Red warm tender macular firm area developed around the innocuation site.  No fever or systemic symptoms.
Age: 13.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Hyperhidrosis, Nausea, Pallor
Clinical narrative: Patient became pale, diaphoretic and nauseated.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash papular, Unresponsive to stimuli
Clinical narrative: Fever 103.5 on 5/5/11, rash, unresponsive x 1-2 minutes, ? febrile seizure
Age: 0.24
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain, Immediate post-injection reaction
Clinical narrative: Immediately after receiving Rotateq Oral Vaccine patient suffered from severe colic for 30 minutes.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Erythema, Swelling
Clinical narrative: Redness, swelling, increased skin temperature
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm red and swollen. Not itchy but warm to touch. Dr. examined it and gave Mom instructions.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Swelling of the left arm with progression down the arm, with well demarcated dollar sized erythema on the right.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient received HPV (#3) injection 3-6-11. Patient came to office 4-7-11. C/O pain at injection site. No redness. No swelling. No fever.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Physical examination, Presyncope
Clinical narrative: Received HPV vaccine, went to the lab to get blood drawn, after blood drawn, he got on the elevator and started getting dizzy with c/o near fainting episode.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Chest discomfort, Pain, Throat tightness, Toothache
Clinical narrative: Left side body pain, hip, ankle, thigh involved teeth hurt, chest tight, felt throat closing.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: PCV 13 vaccines was given on 4/28/11 and pt came 4/29/11 w/c/o redness & swelling on left deltoid area. Pt had no fever. KELFEX was given to pt 250mg/5ml 8 ml PO BID x 10 days. Diagnosed w/cellulitis. Pt seen for a follow up 5/6/11. Cellulitis resolved.
Age: 4.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine given 5/3/11 at 1002AM mom called 5/4 at 812pm, c/o redness, swollen, painful, warm to touch left arm where pt was given Hep A and PCV 13.
Age: 1.36
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Swelling and bump over site of DTaP vaccine given.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Rash (light pink & raised) to Abd, bilateral lower extremities starting morning of 5-6-11 BENADRYL.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Computerised tomogram head, Computerised tomogram normal, Febrile convulsion, Influenza virus test negative, Streptococcus test
Clinical narrative: Febrile seizure.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient was given MENACTRA and Tdap in right deltoid 5/4/11. This morning 5/6 awoke with large amount of swelling and redness in bicep and deltoid.
Age: 9.0
Sex: M
Vaccine: HEPA, MMR, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling & redness to left upper arm. Instructed to use warm compresses prn. Call if worse.
Age: 16.0
Sex: F
Vaccine: HEPA, MMR, MNQ, TDAP, VARCEL
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Local swelling & redness & pain in rt arm. Gave prescription for MOTRIN 600mg 1 po q 6hours-8 hours. Call if worse or not better by 5-9-11.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Bone pain, Mobility decreased, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: Severe pain in shoulder and down arm. Could not lift arm pass heart level.  Burning pain in muscle in bone. Today is 5/7/11, Im able to lift my arm but it is still painful. The injection was tetanus with pertussis.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Severe pain in shoulder and down arm. Could not lift arm pass heart level.  Burning pain in muscle in bone. Today is 5/7/11, Im able to lift my arm but it is still painful. The injection was tetanus with pertussis.
Age: 26.0
Sex: F
Vaccine: DTAP
Symptoms: Dizziness, Erythema, Feeling abnormal, Injection site pain, Mobility decreased
Clinical narrative: Sore spot at injection, the next morning pinching feeling at sight of injection, at 9am 5/6/11 the sore red spot was the about the size of the back of a spoon, at 9pm 5/6/11 it was the diameter of a coke can, at 12pm 5/7/11 it was the diameter of a baseball, at 8:30pm 5/7/11 it was the diameter of a soft ball.  My arm is very sore and tender and hard to move at times.  I'm nauseated and light headed.
Age: 26.0
Sex: F
Vaccine: DTAP
Symptoms: Nausea, Pain, Pain in extremity, Tenderness
Clinical narrative: Sore spot at injection, the next morning pinching feeling at sight of injection, at 9am 5/6/11 the sore red spot was the about the size of the back of a spoon, at 9pm 5/6/11 it was the diameter of a coke can, at 12pm 5/7/11 it was the diameter of a baseball, at 8:30pm 5/7/11 it was the diameter of a soft ball.  My arm is very sore and tender and hard to move at times.  I'm nauseated and light headed.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Reaction to (L) SQ area with redness, fever to touch, raised measured approximately 40mm x 40mm Dr. notified and gave patients' mother instructions to apply cold compresses and take BENADRYL and ER warning given if any complications.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Papilloma viral infection
Clinical narrative: Shot site for first vaccination in series of three of Gardasil was very swollen, red and painful; I am reporting this because less than 4 years after the shots were given the patient has contract HPV strain that can lead to cancer.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Death, Guillain-Barre syndrome, Lumbar puncture abnormal, Malaise
Clinical narrative: Started complaining of not feeling well a few days after the injection onto pin and needles effect in hands & feet. Bells palsy on one side of face then onto the other side onto Severe weakness throughout entire body to being on a ventilator severly paralyzed for over 6 months until death on 5/20/08
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Mechanical ventilation, Paraesthesia, Paralysis, VIIth nerve paralysis
Clinical narrative: Started complaining of not feeling well a few days after the injection onto pin and needles effect in hands & feet. Bells palsy on one side of face then onto the other side onto Severe weakness throughout entire body to being on a ventilator severly paralyzed for over 6 months until death on 5/20/08
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: C/O AT INJECTION SITE AND NEIGHBORING AREAS SORENESS, WARMTH, RED BLOTCHINESS, SWELLING. PT TOOK 2 BENADRYLS. NO RESULTS. NOTICES SPREAD TO NEARBY AREAS AT 8PM. STARTED FROM POINT OF INJECTION SITE T 3 MORE AREAS MEASURING ABOUT 1.5 TO 2 INCHES IN DIAMETER. CAME TO PHARMACY SUNDAY WITH EFFECTS UNCHANGED.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular, Skin warm, Swelling
Clinical narrative: C/O AT INJECTION SITE AND NEIGHBORING AREAS SORENESS, WARMTH, RED BLOTCHINESS, SWELLING. PT TOOK 2 BENADRYLS. NO RESULTS. NOTICES SPREAD TO NEARBY AREAS AT 8PM. STARTED FROM POINT OF INJECTION SITE T 3 MORE AREAS MEASURING ABOUT 1.5 TO 2 INCHES IN DIAMETER. CAME TO PHARMACY SUNDAY WITH EFFECTS UNCHANGED.
Age: 31.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Aggression, Erythema, Myalgia, Pyrexia, Rash
Clinical narrative: Aggressive take with surrounding erythema approx 10 cm. Dozen + papules/pustules to chest/neck.  Fever to 103.1. Myalgias.
Age: 31.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Rash papular, Rash pustular
Clinical narrative: Aggressive take with surrounding erythema approx 10 cm. Dozen + papules/pustules to chest/neck.  Fever to 103.1. Myalgias.
Age: 31.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Erythema, Myalgia, Papule, Pyrexia, Rash pustular
Clinical narrative: Aggressive take with surrounding erythema approx 10 cm. Dozen + papules/pustules to chest/neck.  Fever to 103.1. Myalgias.
Age: 31.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Robust take following exposure to vaccinia virus
Clinical narrative: Aggressive take with surrounding erythema approx 10 cm. Dozen + papules/pustules to chest/neck.  Fever to 103.1. Myalgias.
Age: 1.03
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Varicella
Clinical narrative: 105 fever developed moderate chicken pox
Age: 1.03
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Papule, Pyrexia, Varicella
Clinical narrative: 105 fever developed moderate chicken pox
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt needed IPV and Varicella. He was given KINRIX (DTAP-IPV). This was his 6th DTAP. 45hrs after receiving it, he had 9 cm diameter area of redness & swelling surrounding the injection site.
Age: 30.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Atrial septal defect, Blood bilirubin abnormal, Blood creatine phosphokinase normal, Catheterisation cardiac normal, Chest discomfort
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 02 May 2011. A 30-year-old male subject received on 27 August 2010 an injection of ACAM2000 (lot number not reported), and 07 August 2010 a Anthrax vaccine (manufacturer and lot number not reported). The subject had no medical history. On 08 September 2010 the subject had an abnormal troponin I of 29.01 and an abnormal electrocardiogram (ECG). On 27 September 2010 the patient had an echocardiogram which was normal. On 15 September 2010 the subject was diagnosed with carditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 30.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Chills, Cough, Decreased appetite, Diarrhoea
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 02 May 2011. A 30-year-old male subject received on 27 August 2010 an injection of ACAM2000 (lot number not reported), and 07 August 2010 a Anthrax vaccine (manufacturer and lot number not reported). The subject had no medical history. On 08 September 2010 the subject had an abnormal troponin I of 29.01 and an abnormal electrocardiogram (ECG). On 27 September 2010 the patient had an echocardiogram which was normal. On 15 September 2010 the subject was diagnosed with carditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 30.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Dysuria, Echocardiogram, Echocardiogram abnormal, Ejection fraction normal, Electrocardiogram abnormal
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 02 May 2011. A 30-year-old male subject received on 27 August 2010 an injection of ACAM2000 (lot number not reported), and 07 August 2010 a Anthrax vaccine (manufacturer and lot number not reported). The subject had no medical history. On 08 September 2010 the subject had an abnormal troponin I of 29.01 and an abnormal electrocardiogram (ECG). On 27 September 2010 the patient had an echocardiogram which was normal. On 15 September 2010 the subject was diagnosed with carditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 30.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Exercise test normal, Fatigue, Headache, Influenza like illness, Liver function test abnormal
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 02 May 2011. A 30-year-old male subject received on 27 August 2010 an injection of ACAM2000 (lot number not reported), and 07 August 2010 a Anthrax vaccine (manufacturer and lot number not reported). The subject had no medical history. On 08 September 2010 the subject had an abnormal troponin I of 29.01 and an abnormal electrocardiogram (ECG). On 27 September 2010 the patient had an echocardiogram which was normal. On 15 September 2010 the subject was diagnosed with carditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 30.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Lymphadenopathy, Musculoskeletal chest pain, Myocarditis, Myopericarditis, Nuclear magnetic resonance imaging
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 02 May 2011. A 30-year-old male subject received on 27 August 2010 an injection of ACAM2000 (lot number not reported), and 07 August 2010 a Anthrax vaccine (manufacturer and lot number not reported). The subject had no medical history. On 08 September 2010 the subject had an abnormal troponin I of 29.01 and an abnormal electrocardiogram (ECG). On 27 September 2010 the patient had an echocardiogram which was normal. On 15 September 2010 the subject was diagnosed with carditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 30.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pain, Pyrexia, Stress echocardiogram normal, Troponin, Troponin I increased
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 02 May 2011. A 30-year-old male subject received on 27 August 2010 an injection of ACAM2000 (lot number not reported), and 07 August 2010 a Anthrax vaccine (manufacturer and lot number not reported). The subject had no medical history. On 08 September 2010 the subject had an abnormal troponin I of 29.01 and an abnormal electrocardiogram (ECG). On 27 September 2010 the patient had an echocardiogram which was normal. On 15 September 2010 the subject was diagnosed with carditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 30.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Tympanic membrane disorder, Ultrasound liver
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 02 May 2011. A 30-year-old male subject received on 27 August 2010 an injection of ACAM2000 (lot number not reported), and 07 August 2010 a Anthrax vaccine (manufacturer and lot number not reported). The subject had no medical history. On 08 September 2010 the subject had an abnormal troponin I of 29.01 and an abnormal electrocardiogram (ECG). On 27 September 2010 the patient had an echocardiogram which was normal. On 15 September 2010 the subject was diagnosed with carditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 30.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Carditis, Echocardiogram normal, Electrocardiogram abnormal, Troponin I
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 02 May 2011. A 30-year-old male subject received on 27 August 2010 an injection of ACAM2000 (lot number not reported), and 07 August 2010 a Anthrax vaccine (manufacturer and lot number not reported). The subject had no medical history. On 08 September 2010 the subject had an abnormal troponin I of 29.01 and an abnormal electrocardiogram (ECG). On 27 September 2010 the patient had an echocardiogram which was normal. On 15 September 2010 the subject was diagnosed with carditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 25.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL, ANTH, FLUN3, SMALL
Symptoms: Angiogram pulmonary normal, Back pain, C-reactive protein normal, Chest pain, Computerised tomogram normal
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 02 May 2011. A 25-year-old male subject received the following vaccinations on 13 December 2010: ACAM2000 (lot number not reported), anthrax (manufacturer and lot number not reported) and intranasal Influenza, live (lot number not reported). The patient had no medical history. On 22 December 2010, he had abnormal troponin I of 0.08 and an abnormal electrocardiogram (ECG). The results of his echocardiogram and magnetic resonance imaging (MRI) of the heart were not available. On 29 December 2010, the subject was diagnosed with acute myocarditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 25.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL, ANTH, FLUN3, SMALL
Symptoms: Dyspnoea, Echocardiogram normal, Ejection fraction, Ejection fraction normal, Electrocardiogram abnormal
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 02 May 2011. A 25-year-old male subject received the following vaccinations on 13 December 2010: ACAM2000 (lot number not reported), anthrax (manufacturer and lot number not reported) and intranasal Influenza, live (lot number not reported). The patient had no medical history. On 22 December 2010, he had abnormal troponin I of 0.08 and an abnormal electrocardiogram (ECG). The results of his echocardiogram and magnetic resonance imaging (MRI) of the heart were not available. On 29 December 2010, the subject was diagnosed with acute myocarditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 25.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL, ANTH, FLUN3, SMALL
Symptoms: Fatigue, Fibrin D dimer increased, Left ventricular hypertrophy, Mitral valve incompetence, Myocarditis
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 02 May 2011. A 25-year-old male subject received the following vaccinations on 13 December 2010: ACAM2000 (lot number not reported), anthrax (manufacturer and lot number not reported) and intranasal Influenza, live (lot number not reported). The patient had no medical history. On 22 December 2010, he had abnormal troponin I of 0.08 and an abnormal electrocardiogram (ECG). The results of his echocardiogram and magnetic resonance imaging (MRI) of the heart were not available. On 29 December 2010, the subject was diagnosed with acute myocarditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 25.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL, ANTH, FLUN3, SMALL
Symptoms: Nuclear magnetic resonance imaging normal, Palpitations, Pyrexia, Troponin
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 02 May 2011. A 25-year-old male subject received the following vaccinations on 13 December 2010: ACAM2000 (lot number not reported), anthrax (manufacturer and lot number not reported) and intranasal Influenza, live (lot number not reported). The patient had no medical history. On 22 December 2010, he had abnormal troponin I of 0.08 and an abnormal electrocardiogram (ECG). The results of his echocardiogram and magnetic resonance imaging (MRI) of the heart were not available. On 29 December 2010, the subject was diagnosed with acute myocarditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 25.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL, ANTH, FLUN3, SMALL
Symptoms: Echocardiogram, Electrocardiogram abnormal, Myocarditis, Nuclear magnetic resonance imaging, Troponin I increased
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 02 May 2011. A 25-year-old male subject received the following vaccinations on 13 December 2010: ACAM2000 (lot number not reported), anthrax (manufacturer and lot number not reported) and intranasal Influenza, live (lot number not reported). The patient had no medical history. On 22 December 2010, he had abnormal troponin I of 0.08 and an abnormal electrocardiogram (ECG). The results of his echocardiogram and magnetic resonance imaging (MRI) of the heart were not available. On 29 December 2010, the subject was diagnosed with acute myocarditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced pain in multiple joints, knees, hips, elbows, ankles from 10 pm on 5/3 to the evening of 5/5/11. Took Ibuprofen q 4 hours. Resolved 5/5. Onset of pain at injection site immediately after shot. Onset of redness & swelling at site - 5/6/11. Reported to FMD 5/6. Ordered ice to local site, MOTRIN and BENADRYL.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Emotional distress, Injection site erythema, Injection site induration, Injection site urticaria, Injection site warmth
Clinical narrative: 30cm wheal to Left thigh with redness, induration, and warm to touch.  Patient unconsolable.
Age: 26.0
Sex: M
Vaccine: ANTH, HEP, SMALL
Symptoms: Cardiomyopathy, Echocardiogram abnormal, Electrocardiogram abnormal, Troponin I
Clinical narrative: This study case was received from the investigator (MILVAX) in the above mentioned trial on 02 May 2011. A 26-year-old male subject received on 27 August 2010 the following vaccinations: an injection of ACAM2000 (lot number not reported), Anthrax Vaccine (manufacturer and lot number not reported) and Hepatitis B Vaccine (manufacturer and lot number not reported). The subject had no medical history. The subject also received a Hepatitis B vaccine on 19 August 2010. On 13 September 2010 the subject had an abnormal electrocardiogram (ECG) and an abnormal echocardiogram. His troponin I level was not available. He was diagnosed with cardiomyopathy on 14 September 2010. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 39.0
Sex: M
Vaccine: SMALL
Symptoms: Acute myocardial infarction, Echocardiogram normal, Electrocardiogram normal, Troponin I
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 02 May 2011. A 39 year-old male subject with a history of high blood pressure, elevated cholesterol, heart attack and asthma was found to have an acute myocardial infarction, unspecified site and a subendocardial infarction 13 and 15 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 15 September 2010. Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 09.16, a normal ECG and a normal Echocardiogram. A lumbar puncture (spinal tap), MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram, Electrocardiogram abnormal, Laboratory test abnormal, Nuclear magnetic resonance imaging normal, Pericarditis
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 02 May 2011. A 22-year-old male subject received on 24 August 2010 an injection of ACAM2000 (lot number not reported), and the following vaccinations on 26 July 2010: Anthrax (manufacturer and lot number not reported) and Hepatitis B (lot number not reported). The subject had no medical history. On 04 September 2010 the subject had an abnormal troponin I of 17.30 and an abnormal electrocardiogram (ECG). On 05 September 2010 he had a normal magnetic resonance imaging (MRI) of the heart. The result of the echocardiogram was not available. On 13 September 2010 the subject was diagnosed with acute pericarditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Troponin I
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 02 May 2011. A 22-year-old male subject received on 24 August 2010 an injection of ACAM2000 (lot number not reported), and the following vaccinations on 26 July 2010: Anthrax (manufacturer and lot number not reported) and Hepatitis B (lot number not reported). The subject had no medical history. On 04 September 2010 the subject had an abnormal troponin I of 17.30 and an abnormal electrocardiogram (ECG). On 05 September 2010 he had a normal magnetic resonance imaging (MRI) of the heart. The result of the echocardiogram was not available. On 13 September 2010 the subject was diagnosed with acute pericarditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram, Pericarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator MILVAX in the above mentioned trail on 02 May 2011. A 22-year-old male subject received on 17 September 2010 the following vaccinations: an injection of a ACAM2000 (lot number not reported), Anthrax vaccine (manufacturer and lot number not reported), Influenza vaccine (manufacturer and lot number not reported) and TYPHOID VI (lot not reported). The subject had no medical history. On 28 September 2010 the subject had an abnormal troponin I of 0.25. His electrocardiogram (ECG) results were not available. On 28 September 2010 the patient had an echocardiogram which was normal. On 28 September 2010 the subject was diagnosed with acute pericarditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: FLUX, SMALL
Symptoms: Angina pectoris, Carditis, Echocardiogram normal, Electrocardiogram abnormal, Myocarditis
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 02 May 2011. A 22-year-old male subject received on 28 September 2010 the following vaccinations: an injection of ACAM2000 (lot number not reported), and Influenza Split Virus Vaccine (manufacturer and lot number not reported). The subject had no medical history. On 09 October 2010 the subject had an abnormal troponin I of 0.69, an abnormal electrocardiogram (ECG) and a normal echocardiogram. He was diagnosed with angina pectoris on 09 October 2010 and non-specific myocarditis on 10 October 2010 with the final diagnosis being carditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: FLUX, SMALL
Symptoms: Troponin I increased
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 02 May 2011. A 22-year-old male subject received on 28 September 2010 the following vaccinations: an injection of ACAM2000 (lot number not reported), and Influenza Split Virus Vaccine (manufacturer and lot number not reported). The subject had no medical history. On 09 October 2010 the subject had an abnormal troponin I of 0.69, an abnormal electrocardiogram (ECG) and a normal echocardiogram. He was diagnosed with angina pectoris on 09 October 2010 and non-specific myocarditis on 10 October 2010 with the final diagnosis being carditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Sex: U
Vaccine: MMR
Symptoms: Injected limb mobility decreased, Vaccination complication
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated IM with a split dose of MMR II which was given in both arms. Subsequently, the patient had a reaction (arm locking up) in one arm only. The physician stated that the patient received the immunization from another physician's office, (the other physician's name and contact information was not reported). As of 12-APR-2011, the patient had recovered. It was unspecified if the patients sought medical attention. Arm locking up was considered to be disabling by the reporter. This is one of several reports received from the same source. Additional information is not expected.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Confusional state, Cough, Headache, Hyperaesthesia
Clinical narrative: I was forced to have a second Adacel injection by administration in health system because they could not locate the documents for the first injection I claimed to have in the same system 2 yrs ago. They assured me two years is an acceptable safe window have I had an undocumented injection in past. 10 hours after the injection I became violently sick which lasted for three days. My skin was mottled, I bounced between hours of painful chills, had to keep my jaw preventing shattering my teeth to fever of 102 and drenching sweats. I was confused and restless and with severe headache and body pain and very hypersensetive skin with dry cough and congested sinuses. The site of injection was extremly hard, warm to touch and erythematous and twice and swollen with spontaneous twitching of muscles all around it. I have never been sick with any vaccinations and I had multiple of them in near past. In case of doubt and facing undocumented vaccination I do not think the current recommendation of TWO years is a real safe and sound one for TD /Adacel injections.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperhidrosis, Inappropriate schedule of drug administration, Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: I was forced to have a second Adacel injection by administration in health system because they could not locate the documents for the first injection I claimed to have in the same system 2 yrs ago. They assured me two years is an acceptable safe window have I had an undocumented injection in past. 10 hours after the injection I became violently sick which lasted for three days. My skin was mottled, I bounced between hours of painful chills, had to keep my jaw preventing shattering my teeth to fever of 102 and drenching sweats. I was confused and restless and with severe headache and body pain and very hypersensetive skin with dry cough and congested sinuses. The site of injection was extremly hard, warm to touch and erythematous and twice and swollen with spontaneous twitching of muscles all around it. I have never been sick with any vaccinations and I had multiple of them in near past. In case of doubt and facing undocumented vaccination I do not think the current recommendation of TWO years is a real safe and sound one for TD /Adacel injections.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Livedo reticularis, Malaise, Muscle twitching
Clinical narrative: I was forced to have a second Adacel injection by administration in health system because they could not locate the documents for the first injection I claimed to have in the same system 2 yrs ago. They assured me two years is an acceptable safe window have I had an undocumented injection in past. 10 hours after the injection I became violently sick which lasted for three days. My skin was mottled, I bounced between hours of painful chills, had to keep my jaw preventing shattering my teeth to fever of 102 and drenching sweats. I was confused and restless and with severe headache and body pain and very hypersensetive skin with dry cough and congested sinuses. The site of injection was extremly hard, warm to touch and erythematous and twice and swollen with spontaneous twitching of muscles all around it. I have never been sick with any vaccinations and I had multiple of them in near past. In case of doubt and facing undocumented vaccination I do not think the current recommendation of TWO years is a real safe and sound one for TD /Adacel injections.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Restlessness, Sinus congestion
Clinical narrative: I was forced to have a second Adacel injection by administration in health system because they could not locate the documents for the first injection I claimed to have in the same system 2 yrs ago. They assured me two years is an acceptable safe window have I had an undocumented injection in past. 10 hours after the injection I became violently sick which lasted for three days. My skin was mottled, I bounced between hours of painful chills, had to keep my jaw preventing shattering my teeth to fever of 102 and drenching sweats. I was confused and restless and with severe headache and body pain and very hypersensetive skin with dry cough and congested sinuses. The site of injection was extremly hard, warm to touch and erythematous and twice and swollen with spontaneous twitching of muscles all around it. I have never been sick with any vaccinations and I had multiple of them in near past. In case of doubt and facing undocumented vaccination I do not think the current recommendation of TWO years is a real safe and sound one for TD /Adacel injections.