chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: DTAP
Symptoms: Injected limb mobility decreased, Lymphadenopathy, Pain in extremity
Clinical narrative: Spoke to patient. States had pain right away from TDap vaccine. Awoke next day with swollen lymph nodes. Now 8 days later pain is worse in arm. Cannot lift arm without having severe pain. Advised follow up with medical provider.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site urticaria, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt received HPV4 vaccine injection on 8/7/09 at about 4:30pm. She developed a 4-5 inch diameter area if hives around the injection site at about 9pm. She also has had a sore arm and shoulder. However, her mother said she had been jet sking all day the day before and that may account for the shoulder/arm discomfort. Mother gave her Benadryl at home and the hives went away. No other sx were noted.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Crying, Dizziness, Excoriation, Syncope
Clinical narrative: Pt was given kindergarden immunizations, ( did not even cry) we talkesd about what she was going to do now . I left the room as I was finished. father was filling out a denver form in the room and per dad Pt "fainted" she was sitting next to him in a chair . He than carried her to our desk . I put her in a exam room had her lay down and elevated her legs because she dizzy , she recieved an abrasion around her RT eye. I went to get her doctor to look at her. Than ice was appied to her eye area we than gave her some juice. she sat up for a few minniets and said she was still dizzy ,I had asked if she had eaten breakfast ( as this happened around 11:20am ) and she said she had minni pancakes ,but couldn't tell me how many .  I had her lay back down for a few more minutes. than had her sit up slowly,  at this point she was crying and I asked her if she was still dizzy and she said no, I than asked her if she was scared she yes. pt sat in room for a little longer and had her blood presure check by another Patient care staff and reported back to the doctor . Abrasion was dressed with bactorban and a band aid and sent home .
Age: 18.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Headache, Malaise, Nausea, Pyrexia
Clinical narrative: Two episodes of malaise, headache, nausea, fever, joint pain starting about 8 hours after vaccine administration.  Second vaccine was given with Benadryl pre-treatment and Tylenol afterward.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia, Urine analysis
Clinical narrative: rt arm red and very warm to touch. small amount of swelling.    Fever of 101 degrees F.  Girl just wants to lay on couch states mother.
Age: 24.0
Sex: U
Vaccine: FLU3
Symptoms: Arrhythmia, Dehydration, Drug exposure during pregnancy, Dyspnoea, Heart rate increased
Clinical narrative: Arrythmia, Rapid Heart Rate, Excessive Sweating, Shortness of breath. Dehydration. Had to go to hospital and have my baby montored as I was pregnant. I was told I was dehydrated per the excessive sweating. Also was at the cardiologist numerous times after vaccination. Was diagnosed with arrythmia am still being treated for it. This all happened 4 days after vaccination.
Age: 24.0
Sex: U
Vaccine: FLU3
Symptoms: Hyperhidrosis
Clinical narrative: Arrythmia, Rapid Heart Rate, Excessive Sweating, Shortness of breath. Dehydration. Had to go to hospital and have my baby montored as I was pregnant. I was told I was dehydrated per the excessive sweating. Also was at the cardiologist numerous times after vaccination. Was diagnosed with arrythmia am still being treated for it. This all happened 4 days after vaccination.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: received hepatitis B vaccine at employee health and 15 minutes later developed urticaria.  Was treated at the ED which is adjacent to employee health. She received oral diphenhydramine and oral prednisone.
Age: 1.4
Sex: F
Vaccine: DTAP, MMR
Symptoms: Bacterial culture negative, Influenza serology negative, Pyrexia, Rash
Clinical narrative: 8th and 9th day after shot patient ran fever during the day and very high fever during the night. 10th day after shot she began to have a rash along with the fever. 11th day after shot she woke up with terrible looking rash covering her face and upper extremities along with the fever during day and high fever during the night. Doctor saw her on the 11th day post shot to rule out bacterial infection and flu (both bacterial infection and flu came back negative) No treatment given said it should run its course.
Age: 15.0
Sex: F
Vaccine: DTAP
Symptoms: Anxiety, Dizziness, Dyskinesia, Feeling abnormal, Loss of consciousness
Clinical narrative: APPROX 3-4 MIN AFTER ADMINISTRATION PT STATED SHE WAS DIZZY THEN SLUMPED OVER HER CHAIR FOR 5-10 SEC. SAT BACK UP AND ASKED IF SHE BLACKED OUT. RPH ASKED HOW SHE FELT, (IF SOB, ITCHING) SHE SAID NO BUT FELT WIERD AND HER EARS WERE RINGING. TOLD HER TAKE A FEW DEEP BREATHS. ABOUT 1 MIN LATER SHE SLUMPED OVER HER CHAIR AGAIN AND ARMS JERKED SLIGHTLY. CONSCIOUS AGAIN IN ABOUT 10 SEC. APPEARED VERY PALE. EMS ARRIVED AND TOOK HER TO HOSPITAL.  MOTHER CONTACTED PHARMACY SEVERAL HRS LATER AND REPORTED HER DAUGHTER WAS FINE THAT IT WAS AN ANXIETY ATTACK.
Age: 15.0
Sex: F
Vaccine: DTAP
Symptoms: Pallor, Tinnitus
Clinical narrative: APPROX 3-4 MIN AFTER ADMINISTRATION PT STATED SHE WAS DIZZY THEN SLUMPED OVER HER CHAIR FOR 5-10 SEC. SAT BACK UP AND ASKED IF SHE BLACKED OUT. RPH ASKED HOW SHE FELT, (IF SOB, ITCHING) SHE SAID NO BUT FELT WIERD AND HER EARS WERE RINGING. TOLD HER TAKE A FEW DEEP BREATHS. ABOUT 1 MIN LATER SHE SLUMPED OVER HER CHAIR AGAIN AND ARMS JERKED SLIGHTLY. CONSCIOUS AGAIN IN ABOUT 10 SEC. APPEARED VERY PALE. EMS ARRIVED AND TOOK HER TO HOSPITAL.  MOTHER CONTACTED PHARMACY SEVERAL HRS LATER AND REPORTED HER DAUGHTER WAS FINE THAT IT WAS AN ANXIETY ATTACK.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, RV5
Symptoms: Abdominal pain, Anorexia, Barium double contrast, Enema administration, Vomiting
Clinical narrative: Vomiting.  Bile stained.  Abdominal pain. Anorexia. Air contrast enema + Abd. X ray + Abd ultra-sound.  8/24/09 Hospital records received DOS 8/6/09 to 8/7/09. Assessment Intussusception.  Patient presents with 2 days emesis. Barium air contrast enema (+) for IS and successful at reduction.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Barium double contrast, Blood gases, Blood pH
Clinical narrative: Vomiting.  Bile stained.  Abdominal pain. Anorexia. Air contrast enema + Abd. X ray + Abd ultra-sound.  8/24/09 Hospital records received DOS 8/6/09 to 8/7/09. Assessment Intussusception.  Patient presents with 2 days emesis. Barium air contrast enema (+) for IS and successful at reduction.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, RV5
Symptoms: Culture urine negative, Decreased appetite, Enema administration, Intussusception, Laboratory test abnormal
Clinical narrative: Vomiting.  Bile stained.  Abdominal pain. Anorexia. Air contrast enema + Abd. X ray + Abd ultra-sound.  8/24/09 Hospital records received DOS 8/6/09 to 8/7/09. Assessment Intussusception.  Patient presents with 2 days emesis. Barium air contrast enema (+) for IS and successful at reduction.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, RV5
Symptoms: Ultrasound abdomen, Urinary system X-ray, Vomiting
Clinical narrative: Vomiting.  Bile stained.  Abdominal pain. Anorexia. Air contrast enema + Abd. X ray + Abd ultra-sound.  8/24/09 Hospital records received DOS 8/6/09 to 8/7/09. Assessment Intussusception.  Patient presents with 2 days emesis. Barium air contrast enema (+) for IS and successful at reduction.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, C-reactive protein increased, Complement factor C3 decreased, Complement factor C4 decreased
Clinical narrative: Received vaccine 7/16/09. Dev rash on back 7/25 with malaise, body aches. Developed fevers to 103 on 7/28 which persisted, then developed rash on legs. The rash spread 8/3 to hands. Pain in muscles worsened. Rash became widespread by 8/10 fever, pain persisted.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Epstein-Barr virus antibody positive, Hepatitis A antibody negative, Hepatitis B antibody negative, Malaise, Metabolic function test normal
Clinical narrative: Received vaccine 7/16/09. Dev rash on back 7/25 with malaise, body aches. Developed fevers to 103 on 7/28 which persisted, then developed rash on legs. The rash spread 8/3 to hands. Pain in muscles worsened. Rash became widespread by 8/10 fever, pain persisted.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Myalgia, Mycoplasma serology, Pain, Pyrexia, Rash
Clinical narrative: Received vaccine 7/16/09. Dev rash on back 7/25 with malaise, body aches. Developed fevers to 103 on 7/28 which persisted, then developed rash on legs. The rash spread 8/3 to hands. Pain in muscles worsened. Rash became widespread by 8/10 fever, pain persisted.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Red blood cell sedimentation rate increased, Virus culture negative
Clinical narrative: Received vaccine 7/16/09. Dev rash on back 7/25 with malaise, body aches. Developed fevers to 103 on 7/28 which persisted, then developed rash on legs. The rash spread 8/3 to hands. Pain in muscles worsened. Rash became widespread by 8/10 fever, pain persisted.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase increased, Body temperature increased, C-reactive protein increased
Clinical narrative: Received vaccine 7/16/09. Dev rash on back 7/25 with malaise, body aches. Developed fevers to 103 on 7/28 which persisted, then developed rash on legs. The rash spread 8/3 to hands. Pain in muscles worsened. Rash became widespread by 8/10 fever, pain persisted.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Complement factor C3, Complement factor C4 decreased, Drug eruption, Gamma-glutamyltransferase increased, Hepatitis A antibody negative
Clinical narrative: Received vaccine 7/16/09. Dev rash on back 7/25 with malaise, body aches. Developed fevers to 103 on 7/28 which persisted, then developed rash on legs. The rash spread 8/3 to hands. Pain in muscles worsened. Rash became widespread by 8/10 fever, pain persisted.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Hepatitis B antibody, Hepatitis C antibody negative, Hepatomegaly, Hypersensitivity, Malaise
Clinical narrative: Received vaccine 7/16/09. Dev rash on back 7/25 with malaise, body aches. Developed fevers to 103 on 7/28 which persisted, then developed rash on legs. The rash spread 8/3 to hands. Pain in muscles worsened. Rash became widespread by 8/10 fever, pain persisted.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pain, Pyrexia, Red blood cell sedimentation rate increased, Splenomegaly, Ultrasound scan abnormal
Clinical narrative: Received vaccine 7/16/09. Dev rash on back 7/25 with malaise, body aches. Developed fevers to 103 on 7/28 which persisted, then developed rash on legs. The rash spread 8/3 to hands. Pain in muscles worsened. Rash became widespread by 8/10 fever, pain persisted.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Urticaria, Virus culture negative
Clinical narrative: Received vaccine 7/16/09. Dev rash on back 7/25 with malaise, body aches. Developed fevers to 103 on 7/28 which persisted, then developed rash on legs. The rash spread 8/3 to hands. Pain in muscles worsened. Rash became widespread by 8/10 fever, pain persisted.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Acute disseminated encephalomyelitis, Convulsion, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Received vaccine 7/16/09. Dev rash on back 7/25 with malaise, body aches. Developed fevers to 103 on 7/28 which persisted, then developed rash on legs. The rash spread 8/3 to hands. Pain in muscles worsened. Rash became widespread by 8/10 fever, pain persisted.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Joint swelling
Clinical narrative: A couple of hours after 1st shot, my left knee (which I've had 9 surgeries on, synvisc injection, and is arthritic) swelled up very large far 5 days straight and was unresponsive to wrapping,  , electrodes + elevation.
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 4 1/2 X 4 cm left arm swollen with redness - ice arm every 2 hours per provider - RX given (TYLENOL).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pharyngeal oedema, Pyrexia, Swollen tongue
Clinical narrative: "3 days after vaccination pt developed a fever and her tongue and throat began to swell." TX: "Prednisone, cimetadine". - Pt tx in ER. - Pt reported this information.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abscess, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Approximately 24 hours after receiving both TDAP and MENACTRA in left arm patient presented to clinic with 8 cm X 8 cm area of induration, warmth, pain and redness to site (L biceps) consistent with sterile abscess.  Treatment = cool compresses, supportive care only.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction- 1/2 dollar sized, warm to touch, itchy.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site reaction - 2.5 inch diameter, hot, itchy, red.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Lip swelling
Clinical narrative: Pt had erythema of head, chest, arms and swelling of lips within 10min of receiving vaccine. He was given 20mg BENDRYL p.o. and EPI-PEN JR 0.15 ml sub Q. Pt never had wheezing. Erythema and swelling significantly decreased 45min later and he was sent home.
Age: 1.4
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Within 10-15 min's developed hives at the injection sites. Resolved with ice and BENADRYL.
Age: 3.0
Sex: M
Vaccine: FLUN3, VARCEL
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Given R upper lat leg - VARIVAX - 4 d ago. Redness- serpentigenous.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Localized erythema/induration w/ spread.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Injection site urticaria, Nausea, Pyrexia, Rash, Urticaria
Clinical narrative: Received 7/31/09- R. arm hives that spread to back and around down legs. Sat and Sunday felt nauseous and feverish. No documented fever. Monday fine rash on face and chest. And still some achiness.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythematous, indurated are 4.5 x 4.5" on R arm with no tenderness.  No fluctuence.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Cough, Oxygen saturation decreased, Swelling face, Urticaria, Wheezing
Clinical narrative: Patient started coughing, wheezing, had facial swelling, hives.  Pulse 0X 93%.  Given 1 1/2 Tap BENADRYL, ORAPRED 2 TAP X1, EPINEPHRINE 0.13 mg x1.  Hives, swelling improved, (-) wheeze pulse 0X 99% after Epi.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: 5 X 7 erythematous swelling of the left arm.
Age: 73.0
Sex: F
Vaccine: TD, VARCEL, TD, VARZOS
Symptoms: Injection site erythema, Pain, Pyrexia
Clinical narrative: Localized redness at injection site.  Fever X one day and body aches.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Localised oedema
Clinical narrative: Localized edema/erythema.
Age: 1.56
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: - Pt developed swelling of and erythema around injection site on right thigh. Swelling at maximum ~ 5 inches by 4 inches on 8-7-09. Erythema began to improve on 8-8-09. Only local ice was applied. No other treatment.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Head injury, Neck pain, Syncope
Clinical narrative: Approximately 5 minutes after vaccines were given, child collapsed to the floor.  She took a hard blow to the back of her head.  Regained consciousness quickly.  She was transported to the ER (ambulance) after complaining of neck pain.  No treatment given - Released.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Bacterial culture negative, Injection site erythema, Injection site vesicles, Virus culture negative
Clinical narrative: Pt. rev'd 3 vaccines on left arm (DTAP, IPV, VARICELLA) 7/28/09.  Mom reported one day later adverse reaction.  Nurse practitioner examined and notes large area of erythema w/ central vesicles & smaller area of deeper erythema.  Subsequent visit 7/31/09 notes improvement.  Pt prescribed SULFATRIM 40 mg - 200 mg / 5 ml, 1/2 tsp BID.
Age: 78.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Chills, Culture urine negative, Death, Electrocardiogram, Feeling cold
Clinical narrative: This report was identified from a line listing obtained on request by the Company under the Freedom of Information Act. A 78 year old  female patient with hyperlipidemia, mild bronchiectasis, chronic kidney disease III and degenerative joint disease, and a medical history of osteopenia, osteoporosis, minimal change disease nephritic syndrome with acute renal dysfunction (resolved in 2005), chronic loss stools, quit smoking in 2004, muscle cramps while using quinine and magnesium, chronic airway obstruction, pulmonary insufficiency and diastolic heart dysfunction, who on 26-JUL-2007 was vaccinated SQ in her right arm with a first dose of ZOSTAVAX (Merck) (lot # 657675/0618U). On 26-JUL-2007, the patient concomitantly received IM in her left arm a dose of (lot# U1952DA) (DECAVAC). On 28-JUL-2007, the patient experienced aches, chills and could not get warm. Per family members  the patient did not contact medical personnel nor feel need to seek emergency care. In the morning of 29-JUL-2007, the patient was found within a few hours after death by a family member. It was reported that the patient had been seen in the physician office for right foot pain and right upper quadrant abdominal pain in May 2007 and on 26-JUL-2007. X-ray of right foot revealed arthritic changes. An ultrasound of gallbladder revealed sludge. Other laboratory test revealed decreased kidney function compatible with kidney disease III. Urine cultures and sensitivity were negative. Lipids were significantly increased as patient had stopped on her won the statin drug prescribed. Chest X-ray results were within normal limits with streaking due to scarring. EKG unchanged from prior tracings revealed right axis deviation and borderline R-wave progression. The patient was last seen by a neurologist in April 2006, and was discharged from service due to resolution of condition. Records included vaccination records which confirm doses a lot numbers reported. On 11-SEP-2007, the autopsy report received which stated that the cause of death was hemopericardium with cardiac tamponade due to acute myocardial infarction rupture due to arteriosclerotic heart disease. Pathological diagnosis included: I, Arteriosclerotic heart disease; A. Arteriosclerotosis of coronary arteries with acute thrombus; B. Arteriosclerosis of aorta; III. Nephrosclerosis; IV. Fibroma of ovary; V. Hyperlipidemia by clinical history. VI. Irritable  bowel syndrome by clinical history' VII. Osteoporosis by clinical history. The listing indicated that one or more of the events resulted in death. NO further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. This was original reporting source provided. The VAERS ID # is 286402. No further information is available.
Age: 78.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Laboratory test abnormal, Lipids increased, Nephrosclerosis, Ovarian fibroma, Pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company under the Freedom of Information Act. A 78 year old  female patient with hyperlipidemia, mild bronchiectasis, chronic kidney disease III and degenerative joint disease, and a medical history of osteopenia, osteoporosis, minimal change disease nephritic syndrome with acute renal dysfunction (resolved in 2005), chronic loss stools, quit smoking in 2004, muscle cramps while using quinine and magnesium, chronic airway obstruction, pulmonary insufficiency and diastolic heart dysfunction, who on 26-JUL-2007 was vaccinated SQ in her right arm with a first dose of ZOSTAVAX (Merck) (lot # 657675/0618U). On 26-JUL-2007, the patient concomitantly received IM in her left arm a dose of (lot# U1952DA) (DECAVAC). On 28-JUL-2007, the patient experienced aches, chills and could not get warm. Per family members  the patient did not contact medical personnel nor feel need to seek emergency care. In the morning of 29-JUL-2007, the patient was found within a few hours after death by a family member. It was reported that the patient had been seen in the physician office for right foot pain and right upper quadrant abdominal pain in May 2007 and on 26-JUL-2007. X-ray of right foot revealed arthritic changes. An ultrasound of gallbladder revealed sludge. Other laboratory test revealed decreased kidney function compatible with kidney disease III. Urine cultures and sensitivity were negative. Lipids were significantly increased as patient had stopped on her won the statin drug prescribed. Chest X-ray results were within normal limits with streaking due to scarring. EKG unchanged from prior tracings revealed right axis deviation and borderline R-wave progression. The patient was last seen by a neurologist in April 2006, and was discharged from service due to resolution of condition. Records included vaccination records which confirm doses a lot numbers reported. On 11-SEP-2007, the autopsy report received which stated that the cause of death was hemopericardium with cardiac tamponade due to acute myocardial infarction rupture due to arteriosclerotic heart disease. Pathological diagnosis included: I, Arteriosclerotic heart disease; A. Arteriosclerotosis of coronary arteries with acute thrombus; B. Arteriosclerosis of aorta; III. Nephrosclerosis; IV. Fibroma of ovary; V. Hyperlipidemia by clinical history. VI. Irritable  bowel syndrome by clinical history' VII. Osteoporosis by clinical history. The listing indicated that one or more of the events resulted in death. NO further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. This was original reporting source provided. The VAERS ID # is 286402. No further information is available.
Age: 78.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Pain in extremity, Pericardial haemorrhage, Ultrasound scan abnormal, X-ray abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company under the Freedom of Information Act. A 78 year old  female patient with hyperlipidemia, mild bronchiectasis, chronic kidney disease III and degenerative joint disease, and a medical history of osteopenia, osteoporosis, minimal change disease nephritic syndrome with acute renal dysfunction (resolved in 2005), chronic loss stools, quit smoking in 2004, muscle cramps while using quinine and magnesium, chronic airway obstruction, pulmonary insufficiency and diastolic heart dysfunction, who on 26-JUL-2007 was vaccinated SQ in her right arm with a first dose of ZOSTAVAX (Merck) (lot # 657675/0618U). On 26-JUL-2007, the patient concomitantly received IM in her left arm a dose of (lot# U1952DA) (DECAVAC). On 28-JUL-2007, the patient experienced aches, chills and could not get warm. Per family members  the patient did not contact medical personnel nor feel need to seek emergency care. In the morning of 29-JUL-2007, the patient was found within a few hours after death by a family member. It was reported that the patient had been seen in the physician office for right foot pain and right upper quadrant abdominal pain in May 2007 and on 26-JUL-2007. X-ray of right foot revealed arthritic changes. An ultrasound of gallbladder revealed sludge. Other laboratory test revealed decreased kidney function compatible with kidney disease III. Urine cultures and sensitivity were negative. Lipids were significantly increased as patient had stopped on her won the statin drug prescribed. Chest X-ray results were within normal limits with streaking due to scarring. EKG unchanged from prior tracings revealed right axis deviation and borderline R-wave progression. The patient was last seen by a neurologist in April 2006, and was discharged from service due to resolution of condition. Records included vaccination records which confirm doses a lot numbers reported. On 11-SEP-2007, the autopsy report received which stated that the cause of death was hemopericardium with cardiac tamponade due to acute myocardial infarction rupture due to arteriosclerotic heart disease. Pathological diagnosis included: I, Arteriosclerotic heart disease; A. Arteriosclerotosis of coronary arteries with acute thrombus; B. Arteriosclerosis of aorta; III. Nephrosclerosis; IV. Fibroma of ovary; V. Hyperlipidemia by clinical history. VI. Irritable  bowel syndrome by clinical history' VII. Osteoporosis by clinical history. The listing indicated that one or more of the events resulted in death. NO further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. This was original reporting source provided. The VAERS ID # is 286402. No further information is available.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood test normal, Carpal tunnel decompression, Carpal tunnel syndrome, Hypoaesthesia
Clinical narrative: On March 18, 2008, I had a shingles vaccine.  Within 2 days, numbness in the left hand developed, then extreme pain developed(shooting pain and deep aches), weakness and swelling of the hand (both joints and muscles) within 2 weeks.  At that time I could not sleep the pain was so severe.  I could not life anything with that hand or arm as it was too weak.  After 2 months, I had acute symptoms of Carpel Tunnel since I failed the muscle and nerve tests.  They did Carpel Tunnel Release surgery on May 20, 2008.  This lessened the symptoms but did not solve the problem.  4 months from the vaccine, symptoms started to develop in my right hand and arm.  The symptoms became more severe and the pain so extreme that In September of 2008. I took my self to the Emergency room.  They said that they did not treat pain and referred me to another Dr.  I have been to 5 different doctors and no one can determine what is causing the pain or problems.  All autoimmune tests have come back negative as do the Rheumatoid Arthritis tests.  I have been tested for Tick Borne diseases, diabetes, and all are negative.  My sed. rate is normal and no tests can point to any one cause of the continued pain and swelling.  One Dr. thought I had polymyalgia rheumatica and started me on prednisone.  When they try to wean me off of it, my symptoms return: severe pain, swelling of the hands, unable to make a fist with my right hand, no strength in either hand.  My Rheumatologist treated me for RA even though I tested negative for it.  The Arave that I took for 2+ months had no benefit, only the prednisone works to diminish the symptoms.  I am currently taking 10 mg. prednisone and have for the past year.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Mobility decreased, Muscle swelling, Nerve conduction studies, Oedema peripheral
Clinical narrative: On March 18, 2008, I had a shingles vaccine.  Within 2 days, numbness in the left hand developed, then extreme pain developed(shooting pain and deep aches), weakness and swelling of the hand (both joints and muscles) within 2 weeks.  At that time I could not sleep the pain was so severe.  I could not life anything with that hand or arm as it was too weak.  After 2 months, I had acute symptoms of Carpel Tunnel since I failed the muscle and nerve tests.  They did Carpel Tunnel Release surgery on May 20, 2008.  This lessened the symptoms but did not solve the problem.  4 months from the vaccine, symptoms started to develop in my right hand and arm.  The symptoms became more severe and the pain so extreme that In September of 2008. I took my self to the Emergency room.  They said that they did not treat pain and referred me to another Dr.  I have been to 5 different doctors and no one can determine what is causing the pain or problems.  All autoimmune tests have come back negative as do the Rheumatoid Arthritis tests.  I have been tested for Tick Borne diseases, diabetes, and all are negative.  My sed. rate is normal and no tests can point to any one cause of the continued pain and swelling.  One Dr. thought I had polymyalgia rheumatica and started me on prednisone.  When they try to wean me off of it, my symptoms return: severe pain, swelling of the hands, unable to make a fist with my right hand, no strength in either hand.  My Rheumatologist treated me for RA even though I tested negative for it.  The Arave that I took for 2+ months had no benefit, only the prednisone works to diminish the symptoms.  I am currently taking 10 mg. prednisone and have for the past year.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Sleep disorder
Clinical narrative: On March 18, 2008, I had a shingles vaccine.  Within 2 days, numbness in the left hand developed, then extreme pain developed(shooting pain and deep aches), weakness and swelling of the hand (both joints and muscles) within 2 weeks.  At that time I could not sleep the pain was so severe.  I could not life anything with that hand or arm as it was too weak.  After 2 months, I had acute symptoms of Carpel Tunnel since I failed the muscle and nerve tests.  They did Carpel Tunnel Release surgery on May 20, 2008.  This lessened the symptoms but did not solve the problem.  4 months from the vaccine, symptoms started to develop in my right hand and arm.  The symptoms became more severe and the pain so extreme that In September of 2008. I took my self to the Emergency room.  They said that they did not treat pain and referred me to another Dr.  I have been to 5 different doctors and no one can determine what is causing the pain or problems.  All autoimmune tests have come back negative as do the Rheumatoid Arthritis tests.  I have been tested for Tick Borne diseases, diabetes, and all are negative.  My sed. rate is normal and no tests can point to any one cause of the continued pain and swelling.  One Dr. thought I had polymyalgia rheumatica and started me on prednisone.  When they try to wean me off of it, my symptoms return: severe pain, swelling of the hands, unable to make a fist with my right hand, no strength in either hand.  My Rheumatologist treated me for RA even though I tested negative for it.  The Arave that I took for 2+ months had no benefit, only the prednisone works to diminish the symptoms.  I am currently taking 10 mg. prednisone and have for the past year.
Age: 1.1
Sex: M
Vaccine: HEPA, PNC, VARCEL, HEPA, PNC, VARCEL
Symptoms: Blood culture positive, Cerebral infarction, Convulsion, Muscular weakness, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Less than 12 hours after receiving Hep A, prevnar and varicella vaccines, patient had fever, seizures and stroke affecting right side of brain (temporal and parietal lobes specifically)
Age: 1.1
Sex: M
Vaccine: HEPA, PNC, VARCEL, HEPA, PNC, VARCEL
Symptoms: Pyrexia, Staphylococcal bacteraemia
Clinical narrative: Less than 12 hours after receiving Hep A, prevnar and varicella vaccines, patient had fever, seizures and stroke affecting right side of brain (temporal and parietal lobes specifically)
Age: 1.1
Sex: M
Vaccine: HEPA, PNC, VARCEL, HEPA, PNC, VARCEL
Symptoms: Cerebral infarction, Cerebrovascular accident, Convulsion, Nuclear magnetic resonance imaging brain abnormal, Pyrexia
Clinical narrative: Less than 12 hours after receiving Hep A, prevnar and varicella vaccines, patient had fever, seizures and stroke affecting right side of brain (temporal and parietal lobes specifically)
Age: 11.0
Sex: F
Vaccine: DTAP, HEPA, MEN
Symptoms: Crying, Injection site erythema, Injection site pain, Injection site warmth, Nausea
Clinical narrative: Severe pain at injection sight in left arm. Arm red hot to the touch. This occured after 36 + hours after initial injection of vaccine(s). Nausea and continual crying from pain. Advil given for pain but pain returns after Advil wears off. Ice pack was used 2
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Blood test, Endotracheal intubation, Fall, Grip strength decreased
Clinical narrative: I had a flu vaccine on 10-18-26 on the advise of my Doctor.  I noticed no adverse effects until 01-17-2007, when my wife discovered me down on the bedroom floor moaning she woke me and dressed me. I couldn't walk or hold things.  Sh managed to get me to the Hospital where I was incubated and admitted to the hospital.  I do not remember what occurred the next week or two I did end up having advanced physical therepy.  I could not walk or get up or out of bed on my own after about 40 days I was released to home therapy
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test, Moaning, Urine analysis, X-ray
Clinical narrative: I had a flu vaccine on 10-18-26 on the advise of my Doctor.  I noticed no adverse effects until 01-17-2007, when my wife discovered me down on the bedroom floor moaning she woke me and dressed me. I couldn't walk or hold things.  Sh managed to get me to the Hospital where I was incubated and admitted to the hospital.  I do not remember what occurred the next week or two I did end up having advanced physical therepy.  I could not walk or get up or out of bed on my own after about 40 days I was released to home therapy
Age: 0.92
Sex: F
Vaccine: HEP
Symptoms: Injection site rash, Rash
Clinical narrative: Red un-raised splotches appeared on babie's chest and abdomen exactly one hour or so after the vaccine injection on babie's left front thigh. The splotches appeared subcutaneous. Additionally, an hour or two after this transpired, the baby then developed small bumps on the chest and abdomen once the splotches began disappearing.  Upon calling the doctor, age appropriate dose of Children's Benadryl was administered orally to help with the reaction. Thirty six hours after the administration of the Heb B vaccine by Merk, the bumps have resolved on the chest and abdomen but are still present at the injection site on the left thigh.
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: no fever, but pain from the shoulder joint to wrist of the arm the inj. was given. difficult to lift coffee cup the next morning. pain is a 7 on a scale of 1-10 when moved a 2 when at rest. have never had this pain before from other td inj. will rest it, due to no ins, and i know it will pass.
Age: 57.0
Sex: F
Vaccine: HEPA, IPV, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site irritation, Injection site pruritus, Injection site warmth
Clinical narrative: LEFT DELTOID 6 X 8 CM OF ERYTHEMA, WARMTH, IRRITATION (PRURITIC), AND INDURATION SURROUNDING TDAP INJECTION SITE. PT EXAMINED BY FNP.
Age: 36.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Received Varicella vaccine on June 22, 2009. Was diagnosed with Shingles on August 7, 2009.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Pruritus generalised, Rash
Clinical narrative: 15-20 minutes after injection client experienced itching at injection site.  After about 2 hours had itching all over and had rash on cheeks.  Took bath in epsom salts and took benadryl at bedtime.  In a.m. - no further symptoms
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Reading disorder
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no pertinent medical history and no known drug allergies (NKDA) who on 04-NOV-2008 was vaccinated with the first dose of GARDASIL (lot# 660518/0572X, dose and route not reported) and a dose of VARIVAX (Merck) (661668/1194X, dose and route not reported). Concomitant vaccination on 04-NOV-2008 included hepatitis A virus vaccine (unspecified) (lot# AHAVB264AA) and FLUMIST (LOT# 500570P). The patient was vaccinated with the second dose of GARDASIL (lot# 660616/0570X, dose and route not reported) on 10-JAN-2009 and the third 0.5ml dose of GARDASIL (lot# 661846/1312X, injection) on 14-MAY-2009. The patient's first seizure was on 04-MAY-2009 (prior to the third dose of GARDASIL). A computed axial tomography (CT) scan done that day was negative. The patient was not admitted. The patient's next seizure (gran mal) was on 19-MAY-2009. An electroencephalography (EEG) done on that day was abnormal, showing spikes in the left anterior region supportive of seizure disorder. The patient was not admitted again. The patient went on to have additional seizures in the latter part of July 2009, for which she was admitted to hospital and was diagnosed as epileptic syndrome. On unspecified day, a magnetic resonance imaging (MRI) was performed but the results came back clear. Length of hospital stay was unknown. At the time of reporting, the patient was recovering. The patient was being treated with DILANTIN and TOPAMAX and being followed by neurology. It was reported that the condition was not considered life threatening. The physician could only say that the patient found it was hard to read regarding disability. Upon internal review, seizure and gran mal seizure were determined to be other important medical events. Additional information has been requested.  8/14/09 PCP and ER records received DOS 3/28/05 to 7/30/09. Assessment: Localization related epilepsy of left frontal origin. Breakthough Seizures. Subtherapeutic antiseizure levels. 5/04/09 - Patient was sitting at computer, fell sideways to the floor, eyes deviated, foam from mouth, shaking,  "blank in face", tired and unsteady afterwards. Patient was seen at ER and diagnosed with seizure disorder. 6/11/09 - Neurology consult, migraine, epilepsy, patient placed on Topamax. Stopped Topamax against medical advice. 7/21/09 - Seizure and seen again at ER. 7/22/09 - Seen at ER for subsequent grand mal seizure, additional seizure at ER, post-ictal state, ataxia, toxicity from Ativan/Fosphenytoin. 7/28/09 - Neurology consult attributes recurrent seizures to stopping Topmax. 7/30/09 - Felt tired, layed on floor. Falther saw patient sitting on edge of bed, slumped over, upper extremities rigid and some twitiching, ER visit for seizure. Unsteadiness on feet. 8/24/09 Received ICD9 codes: 34590; V1581; 7813. 9/9/09 Hospital records received DOS 7/22/09 to 7/23/09. Additional information abstracted. Assessment: Recurrent Seizure, Post-Ictal. Seizure earlier this evening. Patient complains of headache. Vomited. Unsteady while walking.
Sex: U
Vaccine: DTAP, VARCEL
Symptoms: Immediate post-injection reaction, Wheezing
Clinical narrative: Information has been received from a nurse concerning a child with asthma who on 06-AUG-2009 was vaccinated with a dose of VARIVAX (Merck) (lot#, route and site of administration not reported) and a dose of DTaP (manufacturer unknown). On 06-AUG-2009 the patient experienced wheezing immediately after vaccination. The patient was administered oxygen and Benadryl as treatment. At the time of reporting the patient's outcome was unknown. Wheezing immediately after vaccination was considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Dizziness, Nausea, Pyrexia
Clinical narrative: Fever 102, dizzy, nausea weak next day.
Age: 1.06
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Blister, Pyrexia, Rash, Rash vesicular, Varicella post vaccine
Clinical narrative: Pt. presented to clinic on 8/11/09 with history of blisters X 2 d.  Fever 100 - 101 AX.  Exam revealed approx. 80 - 100 vesicles primarily on the torso.  Dx: Cpox Rx AVEENO, BENADRYL.  No ASA.  Isolate.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt had diffuse swelling/redness of (L) arm within 24-48 h after vaccines. Seen in ED for evaluation.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Headache
Clinical narrative: Severe headache and low grade temp lasted approximately 24 hours. Sx started about 12 -15 h after shot
Age: 0.9
Sex: M
Vaccine: DTAPIPVHIB, HEP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site urticaria, Pyrexia
Clinical narrative: 1) Approximately 2.5 + 2.0 erythematous indurated area around injection site from evening of injection at site of PREVNAR administration.  2)  48 hours after injection sudden onset of urticaria scattered over arms, legs, buttocks with many lesions around injection site + itching + fever.
Age: 0.9
Sex: M
Vaccine: DTAPIPVHIB, HEP
Symptoms: Urticaria
Clinical narrative: 1) Approximately 2.5 + 2.0 erythematous indurated area around injection site from evening of injection at site of PREVNAR administration.  2)  48 hours after injection sudden onset of urticaria scattered over arms, legs, buttocks with many lesions around injection site + itching + fever.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Tdap given before realizing patient had one on 8-18-08.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient given 4 go shots (DTAP, IPV, MMR, VZV KINREX) 2 days ago L arm developed redness and induration with elevated warming with mild tenderness. No fever.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Body temperature increased, Injection site swelling
Clinical narrative: Swelling to injection sites 2 1/2 cm.  Increased T.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Went to eye doctor = pt thought she had another stye, but eye doctor told her he thought it was shingles because it was past the crease in her eye for another stye. Resolved now.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Skin tightness, Skin warm
Clinical narrative: Arm red, swollen, warm to touch. Skin very tight.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site swelling
Clinical narrative: Increase swelling thigh - 10 cm swelling to (L) thigh - 20 cm swelling to (R) thigh - BENADRYL susp. 3/4 tsp PO - SOLUMEDROL 0.38cc IM
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: A cluster of four patients (patient identifiers were not provided) received ADACEL (lot number UF452AA) on an unspecified date.  All patients developed injection site warmth and redness 24 hours post vaccination.  The recovery status was unknown.  No further information was provided.  List of Documents held by Sender: none.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: A cluster of four patients (patient identifiers were not provided) received ADACEL (lot number UP452AA) on an unspecified date. All patients developed site warmth and redness 24 hours post vaccination. The recovery status was unknown. No further information was provided. List of Documents held by sender: none.
Age: 82.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This non serious case was received on 30 April 2009 from a health care professional.  A cluster of four patients (patient identifiers were not provided) received ADACEL (lot number UF452AA) on an unspecified date.  All patients developed injection site warmth and redness 24 hours post vaccination.  The recovery status was unknown.  No further information was provided.  List of Documents held by Sender:  none.
Age: 76.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This non serious case was received on 30 April 2009 from a health care professional.  A cluster of four patients (patients identifiers were not provided) received ADACEL (lot number UF452AA) on an unspecified date.  All patients developed injection site warmth and redness 24 hours post vaccination.  The recovery status was unknown.  No further information was provided.  List of Documents held by Sender: none.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Fungal infection, Laboratory test, Vaccine positive rechallenge
Clinical narrative: Patient developed severe and longlasting yeast infections after first and second dose of Gardasil. Doses were given 2 months apart.  Gardasil #1 08/11/2008. Gardasil #2 10/10/2008
Age: 0.25
Sex: M
Vaccine: DTAP, IPV
Symptoms: Convulsion
Clinical narrative: Day after vaccines were given, pt was taken to hospital for seizures.  Hospital states that they do not believe that the seizures are related to the vaccines.   Pt has other health conditions.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pt received Zostavax on 08/10/09 at 9:30am. She noticed area of injection site was red and itchy on 08/11/09 in AM. Today (08/12/09) she has erythematous patch measuring 6cm x 3 cm in right posterior upper arm, near posterior region of deltoid. Patch is warm and TTP. Not indurated. No lymphangitis. No right axillary lymphandenopathy.
Age: 4.0
Sex: F
Vaccine: DTPPHIB, HEPA, MMR, PPV, VARCEL
Symptoms: Haemorrhage, Pyrexia, Vomiting
Clinical narrative: Parent states the child had "vomiting, slight fever, and alot of bleeding". Grandmother called in on 8/11/09 to report.  Grandmother not sure if she will be taking the grandaughter to the hospital.
Age: 0.17
Sex: F
Vaccine: PNC
Symptoms: Speech disorder
Clinical narrative: According to parents child had decreased babbling after admin of PCV7 vaccine. Resolved on its own. Not witnessed by anyone in this office
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood prolactin normal, Full blood count normal, Gaze palsy, Hypokinesia, Hypotonic-hyporesponsive episode
Clinical narrative: Patient with symptoms c/w partial seizure vs. hypotonia, hyporesponsiveness.  Almost immediately after recieving her 6 mo immunizations, episode where patient with head hyperextended, arms extended to side, left lateral fixed gaze with twitch of orbital muscles, as well as hyporesponsiveness lasting approximately 3-5 minutes followed by a more somnolent state for another 5-10 minutes  10/8/09 ICD-9 Codes service dates 8/7/09 to 8/8/09: 780.32 Atypical febrile sezure poss due to vaccination, 999.0 Generalized vaccinia as complication of medical care, 112.0 Candidiasis of the mouth, E948.4 Pertussis vaccine/pertussis component causing adverse effects in therapeutic use, E849.7 Injury of poisoning occurring at/in residential institution.