chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: BCG
Symptoms: Rash
Clinical narrative: A 72 year old man has received several series of Tice BCG bladder installations over the past 2-3 years, for treatment of bladder cancer.  Most recently, he had been receiving "booster" installations once every 3 months.  Following the most recent installation on 12/31/2002, within less than 48 hours, he developed a rash, present "all over his body", which has persisted and actually worsened, per the patient's wife, over the following 3 weeks (as of 01/22/2003).  The patient has reportedly "tried everything" (non-prescription) for the rash, including Benadryl and topical solutions, all without relief.  He has not started taking any new medication during the time period involved.  Per the reporter, there is no evidence of  a systemic BCG infection.
Sex: M
Vaccine: BCG
Symptoms: Chills, Dysuria, Micturition urgency
Clinical narrative: A male patient in his mid-50's, diagnosed with Transitional Cell Carcinoma of the Bladder in late December 2002, with transurethral resection of bladder tumor, received an initial treatment of Tice BCG on approximately 01/20/2003.  It was the first of a planned series of a 6 weekly instillations.  Following this one, the patient began experiencing chills intermittently, lasting 1-2 days, and also "severe burning with urination" and "suprapubic bladder pressure all the time", both of which continued to persist severely 10-11 days later, at the time of the report.  Due to the severity of the patient's symptoms, he did not receive any further BCG therapy.  No further treatment.
Age: 77.0
Sex: M
Vaccine: BCG
Symptoms: Anorexia, Asthenia, Micturition urgency, Pyrexia, Urinary incontinence
Clinical narrative: On 12/21/2002, a cystoscopy was done with "clear" results, and a weekly series of 3 planned instillations of maintenance BCG was started on 01/21/2003, at 10 am (only one instillation was given).  On the following morning, the patient's wife called to report, since 5 pm of 01/21/2003 (7 hours after instillation), the patient had been experiencing chills, fever of 102.5 degrees F, and was so weak, when he arose from sitting, he fell and hit his head, sustaining a bruise.  He went to bed, where his symptoms persisted, and also urinary urgency and "leakage" (urinary incontinence), and difficulty eating.  Two days later, the fever was beginning to resolve; the patient was able to eat a normal breakfast, and was beginning to feel better.
Age: 76.0
Sex: M
Vaccine: BCG
Symptoms: Cough, Fatigue, Influenza like illness, Pyrexia
Clinical narrative: A 76 year old male patient received 4 instillations of Tice BCG for bladder cancer, administered at weekly (and occasionally longer) intervals, with the first instillation given on 12/20/2002.  Since almost immediately after receiving the first instillation, he began experiencing a "productive cough, low-grade fever, fatigue, and flu-like symptoms", which continue to persist approximately 7 weeks later.  He was hospitalized for the continuing symptoms on 02/02/2003, and remains hospitalized.
Age: 71.0
Sex: M
Vaccine: BCG
Symptoms: Chills, Cough, Influenza like illness, Pain, Pharyngolaryngeal pain
Clinical narrative: A 71 year old male patient received 2 intravesical instillations of Tice BCG.  Within the first 48 hours after, the second instillation, he had developed "flu-like symptoms", including a fever, initially 100 degrees F, which progressed to 103 degrees F and persisted up to 103 degrees through 02/16/2003. He also experienced chills, achiness and a sore throat.  Prior to receiving the BCG, he had already been experiencing a cough, which continued intermittently after the BCG, and for which the patient reported he had taken Penicillin for approximately 2-3 days, but discontinued before receiving any BCG.
Age: 71.0
Sex: M
Vaccine: BCG
Symptoms: Pyrexia
Clinical narrative: A 71 year old male patient received 2 intravesical instillations of Tice BCG.  Within the first 48 hours after, the second instillation, he had developed "flu-like symptoms", including a fever, initially 100 degrees F, which progressed to 103 degrees F and persisted up to 103 degrees through 02/16/2003. He also experienced chills, achiness and a sore throat.  Prior to receiving the BCG, he had already been experiencing a cough, which continued intermittently after the BCG, and for which the patient reported he had taken Penicillin for approximately 2-3 days, but discontinued before receiving any BCG.
Sex: M
Vaccine: BCG
Symptoms: Arthralgia
Clinical narrative: A male patient approximately 70 years old, has been receiving Tice BCG for treatment of T1 Bladder Cancer.  In February 2003, a second maintenance series of 3 instillations was given.  Very shortly after the third instillation the patient began to experience "very severe arthralgias", which still persisted through the time of this report.
Age: 22.0
Sex: F
Vaccine: BCG
Symptoms: Drug administration error, Laboratory test abnormal
Clinical narrative: A nurse, who handled Tice BCG from 1996 or 1997 until 1999, both mixing it and administering it to patients reported she "PPD Converted" (positive response to PPD test), approximately 6 months after she had stopped working with Tice BCG.  She always wore a "special mask", and gown and gloves when working with BCG, and had never had any events of "spills" nor any other known potential exposure incidents.  After the positive PPD a chest x-ray one by the "CDC" (Center for Disease Control), was negative/normal; she had no other symptoms of possible TB infection.  A consulted Infectious Disease Specialist prescribed prophylactic INH therapy and pyridoxine/Vit  B-6.  However, due to the adverse effects from the INH she self-discontinued the INH after 1 month.  She has not had any further follow up chest x-rays or PPD tests.  She has remained asymptomatic but thinks Tice BCG caused the conversion.  Prophylactic INH therapy and pyridoxine/Vit B-6 which she self-discontinued after 1 month.
Age: 70.0
Sex: U
Vaccine: BCG
Symptoms: Blister, Skin ulcer
Clinical narrative: A 70 year old female patient has been receiving OncoTICE a "maintenance" series of one instillation per month for 3 months, intermittently.  When seen on 05/27/2003, 20 days after her last instillation, her labia were very blistered, with open lesions near the labia, on the external skin.  Her treating physician has diagnosed her condition as a "delayed hypersensitivity reaction".  Patient is being treated with Levaquin, Diflucan, and a third (unnamed) medication; the lesions are now resolving.
Age: 54.0
Sex: F
Vaccine: BCG
Symptoms: Dysuria, Pyrexia
Clinical narrative: A 54 year old female patient received a second maintenance instillation on 06/05/2003, and shortly after, developed a fever of 39.1 degrees C, which was treated with Tylenol and was down to 38.1 degrees C the next day.  Prior to the second recent instillation, she was also complaining of dysuria.  A urine exam at that time was negative and the reporting physician does not believe she had a urinary tract infection.  Since the second instillation, the patient began taking Macrodantin independently (not prescribed by reporting physician).
Age: 82.0
Sex: M
Vaccine: BCG
Symptoms: Haematuria, Micturition urgency, Neoplasm malignant, Pain, Urinary incontinence
Clinical narrative: An 82 year old male patient had bladder cancer diagnosed early 2002, which treated with OncoTice from a different physician.  The patient experienced subsequent, persistent haematuria, which was stopped twice in May 2002 after treatment.  His present physician diagnosed a Grade II carcinoma of the bladder, and he has had ongoing problems with hematuria, for which hyperbaric oxygen therapy was offered, but declined by the patient was "too painful".  A single instillation was given in April 2003, followed again by hematuria for 4-5 weeks.  After the hamaturia had stopped for 1-2 weeks, a second instillation was given on 06/04/2003. The patient experienced difficulty with urgency and incontinence, and has had hematuria during the week following the most recent instillation.  It is unknown if any further OncoTice has since been given.
Age: 56.0
Sex: M
Vaccine: BCG
Symptoms: Fatigue, Influenza like illness, Malaise, Pyrexia
Clinical narrative: A 56 year old male patient received OncoTice weekly instillations.  Within 2 hours after the 5th instillation the patient developed a fever, ranging 37.7-38.3 degrees Celsius.  The 6th instillation has been withheld.  The patient is also experiencing malaise, fatigue, and flu-like symptoms.  Tylenol or Motrin occasionally for the symptoms.
Age: 60.0
Sex: M
Vaccine: BCG
Symptoms: Malignant hypertension
Clinical narrative: A 60 year old male received six weekly instillations of Tice BCG for bladder cancer. On 06/24/2003 the patient informed the healthcare professional that his internist started his on Norvasc treatment for "malignant hypertension" that day.
Sex: U
Vaccine: BCG
Symptoms: Arthralgia, Nausea
Clinical narrative: The patient (age and sex unknown) received Tice BCG (indication and therapy dates unknown), and has subsequently experienced joint pain and nausea for approximately 1 week.  The patient is afebrile.
Sex: F
Vaccine: BCG
Symptoms: Drug administration error
Clinical narrative: A registered nurse reports that while another RN was preparing Oncotice, she was squirted on her hand by some of the medication.  She immediately washed her hands with soap and water, then with bleach.  One day later she developed some blisters and sores on her finger around her ring.
Age: 56.0
Sex: M
Vaccine: BCG
Symptoms: Back pain, Chills, Neck pain, Pyrexia
Clinical narrative: A male patient of about 56 years old, received Tice BCG series of 6 weekly instillations, from approximately 05/02/2002 until 06/06/2002.  On 06/13/2002, he reported he had been experiencing a fever up to 103 degrees F (39.4 degrees C), chills, and back and neck pain for the past few days.  He was being seen by his urologist on 06/13/2002.  FU: On 01/15/2003 information was received that the patient had the flu; there were no signs of a BCG reaction.
Age: 82.0
Sex: M
Vaccine: BCG
Symptoms: Bacterial infection, Laboratory test abnormal
Clinical narrative: Initial information received 06/10/2002: A male patient, previously treated with Tice BCG bladder irrigations, for an unspecified indication, currently has a disseminated BCG infection, and is being monitored by the reporter, an infectious disease specialist.  Follow up information received 01/16/2003: A male patient with past history of Transitional Cell Carcinoma (TCC), Grade II, of Bladder (1969) and recurrence of Grade II TCC in 1998, at which time he received 6 weeks of BCG therapy, was diagnosed with a recurrence of TCC Grade I in January 2002.  A cystoscopy in November 2002 showed another recurrent bladder tumor.  The patient, with a history of bilateral hip replacements prior to his current symptoms, had been hospitalized on 05/31/2002 for evaluation of a right hip abscess and had undergone removal of his right hip prosthesis the same day.  The hip infection was identified as "mycobacterium and bovis".  Per the evaluation of an infectious disease physician on 06/04/2002, while the patient was still hospitalized, it is noted that a left upper lobe mass had been found prior to hip surgery, and a bronchoscopy had been done, with negative findings; a subsequent culture positive for "myobacterium tuberculosis complex, resistatn to PEA."  On 03/27/2002, a bronchial brush had been "positive for an organism consistent with MTBC complex, pyrasinamide resistant."  As of 06/04/2002, while still hospitalized since 05/31/2002), the patient "denies any fevers, chills, or sweats, and admits to only a modest weight loss around the present hospitalization."  As of 06/04/2002, he had been "given twice-weekly directly-observed therapy by the health department", for the lung conditions, and as of 06/04/2002, "his chest x-ray has substantially improved and is said to have cleared."  The infectious disease physician assessed the patient as "Pulmonary bacillus Calmetta-Guerin infection, probably disseminated bacillus Calmetta-Guerin infection, with infection of the right hip."  On 07/24/2002, the right hip prosthesis was replaced.  On 10/17/2002, when reassessed by the infectious disease physician, it was noted that the patient "has been continuously on antimicrobacterial therapy," including Azithromycin while hospitalized, and continuing, since in the hosptial "INH, Ethambutal, and Rifampin."  The infectious disease physican's impression on 10/17/2002: "BCG infection with dissemination following intravesical BCG therapy of bladder cancer."  The plan of treatment was to continue the patient on Rifampin, Myambutal, and INH for 12-24 months.
Sex: U
Vaccine: BCG
Symptoms: Drug ineffective
Clinical narrative: A patient of unknown age and gender recently received Tice BCG (dosage and dates unknown) for treatment of bladder cancer.  Approximately May 2002, the patient had a recurrence of the bladder cancer.  The treating physician is very familiar with correct procedures and expected outcome.
Age: 67.0
Sex: M
Vaccine: BCG
Symptoms: Chills, Dysuria, Nocturia, Pollakiuria, Pyrexia
Clinical narrative: A 67 year old male patient, diagnosed with bladder cancer 04/2001, had received a six week series of Tice BCG 3 months earlier, with no problems.  The first dose of the second series was given on 10/16/2001.  Later that day, the patient experienced a fever of 102.5-103 degrees F, with dysuria, frequency and urgency, and nocturia.  He contacted his internist physician, who prescribed Cipro, and he gradually improved over the next 5 days.  On 10/23/2001, he advised the reporting physician of his symptoms following the previous Tice BCG treatment, and the physician administered half of the standard dose (25 cc's) of Lot @# 451B211.  The patient tolerated the procedure well and was given INH to take for 2 days preventively.  The reporter called the patient at 7pm on 10/23/2001: the patient was in bed, with a fever of 102 degrees F and chills, and with urinary urgency and frequency again; he was taking Tylenol for his symptoms.  The reporter advised the patient to go to the ER, but the patient did not want to.  The patient's outcome is unknown, and it is unknown if any further Tice BCG has been given.  Follow up information received 05/20/2002: The patient did well, but received no further BCG.  Prescribed Cipro/Tylenol.
Age: 42.0
Sex: M
Vaccine: SMALL
Symptoms: Headache
Clinical narrative: Client developed severe headaches 2 days after vaccination.  Headaches not relieved with Tylenol.  Headaches ceased for a few minutes then returned.  Headaches reoccurred with physical activity.  headaches gone after 2 weeks MRI negative.  Neurological exam was negative.  Requested written report-not received.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Blood pressure increased, Dyspnoea, Heart rate increased, Injection site swelling, Injection site warmth
Clinical narrative: very large swelling and high temperature at site of injection. Difficult Breathing, wheezing, fast heart beat. Blood preasure 130 over 87  Patient refused to seek medical attention. "I had a reaction like this seven years ago and should not have gotten the shot. I will live."
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Wheezing
Clinical narrative: very large swelling and high temperature at site of injection. Difficult Breathing, wheezing, fast heart beat. Blood preasure 130 over 87  Patient refused to seek medical attention. "I had a reaction like this seven years ago and should not have gotten the shot. I will live."
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: Very sore arm, lymph node tenderness in armpit area and on rib cage area adjacent to injected arm site.
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Dizziness, Dyspnoea, Nausea, Vomiting
Clinical narrative: 10/01/03 (11:00)- received her anthrax #5- "right after" she received the injection, she started to feel dizzy- dizziness worsened and she started to experience nausea and vomiting. 10/01/03 (13:30)- went to clinic- at the clinic, she started to develop shortness of breath- because of her history of "heart condition" she was then transferred to the ER. 10/01/03 (15:30)- by the time she arrived at the ER, all her sxs have dissipated on their own- patient was discharged home in stable condition.    According to the patient, she experienced a similar reaction (dizziness and nausea) after she received her first anthrax vaccine (28 March 01)- those sxs lasted few minutes and they resolved on their own.  No adverse reactions experienced with her anthrax #2, #3, and #4.  A copy of the patient's clinical summary sent to VAERS via FedEX on 10/31/03
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Cyanosis, Hypotonia, Pupils unequal
Clinical narrative: several hours after the pt received the vaccine, he woke up from a nap, cried vigorously while in his mother's arms and then turned teal blue, as described by the mother, and limp. his parents called 911 for the paramedics and stimulated him so that when the paramedics arrived he was no longer dusky looking. he was brought to er where he had an ekg and a cxr done, both of which were normal. he was transferred to hospital on october 30, where he is presently admitted. in the er he had anisecoria and an intermittent murmur on exam, the rest of the exam was normal. The hospital discharge summary received on 1/16/04 confirms diagnosis of anisocoria. It also mentions ALTE (acute life-threatening event) due to DTaP.
Age: 33.0
Sex: U
Vaccine: FLU3
Symptoms: Asthma, Chest discomfort, Dyspnoea, Hypersensitivity, Urticaria
Clinical narrative: 24 hours after the administration of the vaccine 10/14/03 the employee complained of asthma type symptoms including shortness of breath and chest tightness. He was seen in the ER on 10/15/03, oxygen was administered and he was released. Employee reported on 10/28/03 that following the ER visit he developed hives on chest, back, arms and hands. States he has been taking benedryl prn for symptoms. Employee denied egg allergy at the time of vaccination but stated on 10/28/03 that he did have a sensitivity to chicken feathers. Employee states that he is still experiencing mild asthma type symptoms. He was advised to follow up with his MD.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Neck pain, Syncope
Clinical narrative: Took Hep. B this morning.  Felt faint, light-headed, laid 20 min an went back to work.  1-1.5 hours later experienced throbbing headache and heavy neck.  Post Hep B injection questionable reaction.
Age: 6.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Diarrhoea, Pyrexia, Rash vesicular, Vomiting
Clinical narrative: Extrememly high fever 104.5 was the highest recorded.  Broke out in "chicken pox" like marks...approximately 12-15.  Vomiting, diarrhea.
Age: 36.0
Sex: F
Vaccine: FLUX, TD
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site warmth, Myalgia, Pain
Clinical narrative: Flu Vaccine recieved on 28Oct2003-no immediate reaction. 24h later, arm bright read 1 inch around injection site, itching, cutaneous skin pain, minimal muscle pain. Progressed to 2 inch bright red area around injection site. Hot to touch severe itch resolves with Benadryl.
Age: 36.0
Sex: F
Vaccine: FLUX, TD
Symptoms: Pruritus
Clinical narrative: Flu Vaccine recieved on 28Oct2003-no immediate reaction. 24h later, arm bright read 1 inch around injection site, itching, cutaneous skin pain, minimal muscle pain. Progressed to 2 inch bright red area around injection site. Hot to touch severe itch resolves with Benadryl.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Fatigue, Incoherent, Somnolence
Clinical narrative: DIZZINESS, WEAKNESS ,OUT OF SORTS ,SLEEPY ,  WENT TO HOSPITAL     CHECK ME FOR HEART, ANEMIA AND SUGAR, ALL OK, STILL FEEL SYMPTONS FEEL OUT OF SORTS WEAK VERY TIRED
Age: 14.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Grand mal convulsion, Somnolence
Clinical narrative: Appx 30 mins after recieving flu shot (Aventis LOT#U1075AA Exp 6/30/04) and Hepatitis A (Merck  LOT# 1411L Exp 3/14/2004) patient had appx 30 second grand mal seizure. This was observed by mother only who wheeled pt back to dept for appx 90 min observation. No further seizure activity was noted by medical personel or mother. Patient has severe CP, non-verbal, seizure disorder. Has been on Lamictal daily for several years. The medical record received on 2/3/04 states postictal. sleepy.
Age: 44.0
Sex: M
Vaccine: SMALL
Symptoms: Lymphadenopathy
Clinical narrative: PT PRESENTED TO EMERGENCY DEPARTMENT C/O 7 DAYS OF SWOLLEN GLANDS.  ANTIBOTICS KEFLEX PRESCRIBED
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Chills, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Approx. 12 hrs after vaccine I suffered chills which lasted several hours but no fever. Following day was weak and stiff and developed fever about 9 PM day after vaccine. After a good night's sleep I returned to normal and remain well.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Hypokinesia, Joint stiffness, Pain, Pain in extremity
Clinical narrative: I have experienced moderate to very severe joint inflamation and pain every single day and night since the evening of 12/24/2002.  Immediately following the 12/24/02 immunization I experienced painful feet which quickly became severe pain that lasted about 5 months (gradually got better), and inflammation of my index fingers.  Following the third immunization on 5/23/03 I have experienced inflamation and pain in numerous joints.  It has been so severe that there have been times I literally have had to fall into bed at night and roll out in the morning.  Several mornings I was so stiff and achy that I was like a zombie.  I could not click a pen, comb my hair, turn a doorknob or butter my toast.  The doctor tried numerous medications (vioxx, bextra, etc.) without results.  Started prednisone on 6/17 and plaquenil on 7/9.  I still have ongoing daily pain and/or inflamation in my left knee, left shoulder, left pinkie and left thumb ...... right wrist and right shoulder.  I have had 2 steroid shots in my wrist which has helped some.  I am also on voltaren 4 times per day. I do not know which hep b vaccine I had ...... I only have the 'ENG' number.  I also do not know the route ...... I am assuming 'intramuscular'.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Injection site hypersensitivity, Injection site swelling, Pruritus, Thermal burn
Clinical narrative: When I recieved the injection there was a slight sting. My arm swelled at the injection site. I had a whelp 1.5 by 2.5 with burning,itching at sight for 5 days now. It is starting to clear. I had recieved a flu vacination last December for the first time, this is my second flu shot. I did have some tightness in my chest for 1-2 days. Since I have asthma, I just used my inhaler and was not overly concerned, I did call the wellness center and also my allergy specialist just to have it documented.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Immediate left arm soreness, traveling into left arm and into neck.  Now, after over 9 hrs. pain exists;  General tiredness occured about 2 hrs. later;  Approx. 4 hrs. after injection, severe nausea, dizziness, headache, paleness and clamminess, profuse sweating, extreme muscle weakness.  Patient sat on edge of bed for about 5 minutes with fan directly on.  Then laid down in bed and slept for 3 hrs.  After awakering, nausea, tiredness and weakness still present.  Next morning, nausea (though not severe), muscle tiredness, and fatigue continues.  Soreness in arm, shoulder and neck continues.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Nausea, Neck pain, Pain, Pallor
Clinical narrative: Immediate left arm soreness, traveling into left arm and into neck.  Now, after over 9 hrs. pain exists;  General tiredness occured about 2 hrs. later;  Approx. 4 hrs. after injection, severe nausea, dizziness, headache, paleness and clamminess, profuse sweating, extreme muscle weakness.  Patient sat on edge of bed for about 5 minutes with fan directly on.  Then laid down in bed and slept for 3 hrs.  After awakering, nausea, tiredness and weakness still present.  Next morning, nausea (though not severe), muscle tiredness, and fatigue continues.  Soreness in arm, shoulder and neck continues.
Age: 0.2
Sex: F
Vaccine: PNC
Symptoms: Agitation, Cough, Croup infectious, Diarrhoea, Dysphonia
Clinical narrative: The evening after receiving Prevnar, developed fevers to 102, hoarse voice, barky cough, and loose stools. Seen in office next day: afebrile, hoarse voice, stridorous with agitation. Treated as croup. Prescribed PO Decadron x 1 dose. 2 days after Prevnar dose, also noted to have periorbital petechiae but otherwise, no other new symptoms.
Age: 0.2
Sex: F
Vaccine: PNC
Symptoms: Petechiae, Pyrexia, Stridor
Clinical narrative: The evening after receiving Prevnar, developed fevers to 102, hoarse voice, barky cough, and loose stools. Seen in office next day: afebrile, hoarse voice, stridorous with agitation. Treated as croup. Prescribed PO Decadron x 1 dose. 2 days after Prevnar dose, also noted to have periorbital petechiae but otherwise, no other new symptoms.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Myalgia, Neck pain
Clinical narrative: Muscle aches around the neck area dizziness starting the next morning after shot administered. Muscle aches gone 4 days later but dizziness persists. I have not goe in for any treatment.
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Cough, Crying, Diarrhoea, Eye discharge, Pyrexia
Clinical narrative: About a week after receiving shots, my daughter developed a fever (102 degrees) severe coughing, vomiting, diarahhea, runny nose, and sticky yellow stuff in her eyes that glued them shut during the night, she would also pull at her ears.  She was constantly crying and you could tell she was hurting.
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Rhinorrhoea, Vomiting
Clinical narrative: About a week after receiving shots, my daughter developed a fever (102 degrees) severe coughing, vomiting, diarahhea, runny nose, and sticky yellow stuff in her eyes that glued them shut during the night, she would also pull at her ears.  She was constantly crying and you could tell she was hurting.
Age: 0.9
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: My right arm became very swollen, red and painful from the injection site down to below the elbow. Clinic does mention whether or not vaccine contains thimersol when they ask about allergic reactios.
Age: 43.0
Sex: M
Vaccine: ANTH, FLU3
Symptoms: Dizziness, Eye irritation, Respiratory distress
Clinical narrative: Patient felt dizzy, eyes were burning, and he had mild respiratory distress.  Patient was seen 2 hours later, and was feeling much better.  His blood pressure was normal.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Myalgia
Clinical narrative: 10 hours after vaccination at place of employment, patient experienced rigors, fever of 101 degrees, dizziness, fatigue, myalgias, and shortness of breath. Patient's symptoms resolved two days after vaccination, self-administration of acetaminophen, and plenty of sleep.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: 10 hours after vaccination at place of employment, patient experienced rigors, fever of 101 degrees, dizziness, fatigue, myalgias, and shortness of breath. Patient's symptoms resolved two days after vaccination, self-administration of acetaminophen, and plenty of sleep.
Age: 10.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain, Myalgia, Pain, Pyrexia
Clinical narrative: The evening of the shot, extreme pain in arm.  Received pneumonia innoculation in other arm and it was a dull ache for comparison.  The pain moved to the underarm, side of the breast and down the side.  That night a fever of 104.0 degree F oral. Not 100.4 but 104.0.  Severe chills, muscle ache. Arm was NOT paralysed but from the pain could not be used.  Two days later, the same fever, same pain and same chills.  Called physician he called in Tylenol 3 for the pain and recommended putting ice on the innoculation site.
Age: 1.73
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin ulcer
Clinical narrative: On 11/11/03 he developed a vesicular rash which was seen by doctor on 10/12/03.  The lesion were on his posterior and anterior trunk form the neck to the waistline. On 10/28/03 Patient's 4 month old brother was seen by doctor. He has a rash with with red papules and a yellow raised center. There were no vesicles. All the lesions were in the same stage and were located on the trunk, scalp, and neck. Neither boy was ill. The mother reports that she had a positive varicella titer drawn during her pregnancy.
Age: 13.0
Sex: F
Vaccine: MMR
Symptoms: Laboratory test abnormal, Lung disorder
Clinical narrative: Annual PPD (PMC C1262AA) done, read @ hospital at a 10mm and positive to some of questions on screening. Radiologist noted a questionable node on Lung. MD started pt. on INH 300mg for 90 days. Pt. is compliant with taking medication. RN checked bottle and questioned pt. No s/sx's of problems today.Just received report and approached by pt. today.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Acidosis, Cardiac arrest, Coma, Dyspnoea, Encephalopathy
Clinical narrative: The pt went to hospital earlier that day and received a Pneumovax. During lunch time she complained of shortness of breath, became unresponsive and 911 was called. ACLS performed, pt brought to hospital and intubated. Dx: cardiac arrest-shock. The hospital discharge states end stage renal dx, encephalopathy, acidosis, and aspiration pneumona.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Pneumonia, Renal failure acute, Shock
Clinical narrative: The pt went to hospital earlier that day and received a Pneumovax. During lunch time she complained of shortness of breath, became unresponsive and 911 was called. ACLS performed, pt brought to hospital and intubated. Dx: cardiac arrest-shock. The hospital discharge states end stage renal dx, encephalopathy, acidosis, and aspiration pneumona.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Atrial fibrillation, Pain
Clinical narrative: This case was initially reported by a pharmacist with additional info subsequently provided by a registered nurse and described the occurrence of atrial fibrillation in a female of approximately 40 years of age who received Engerix B. Concurrent vaccines/medications and concurrent medical conditions were not reported. The patient had no adverse events following receipt of previous doses of the hepatitis B vaccine. The patient did not have a history of cardiac problems. On 10 October 2003 at approximately 15:00, the patient received the third dose of Engerix B in a deltoid muscle. Three days post-immunization, on 13 October 2003 at approximately 4:00, the patient was awoken from sleep with a heart rate of 160 beats per minute. She was taken via ambulance to the local emergency room, where a diagnosis of atrial fibrillation was made. The reporting nurse did not believe that the patient was cardioverted electrically, but rather that cardioversion was achieved through treatment with IV CARDIZEM. The atrial fibrillation resolved while the patient was in the emergency room. CARDIZEM therapy was initiated. The patient also began to experience sciatica on 13 October 2003. The outcome of the sciatica was unknown. The pharmacist, considered the atrial fibrillation to be life threatening and clinically significant (OMIC) (or requiring intervention). The nurse considered that the events were possibly related to vaccination with Engerix B.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Apnoea, Face oedema, Hyperhidrosis, Laboratory test abnormal, Paraesthesia
Clinical narrative: Within 15 minutes of injection, rash, tingling of tongue/ lips and wheezing developed. Pt has asthma and was on a medrol dose pak. Given po Benadryl total of 50mg with improvement within 30 minutes got worse take to ER intubated and on ventilator x 2 da. Now home and OK. Throat remains sore due to respirator. Discharge summary states vomiting, sweat, apnea, facial edema. msv
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Vomiting, Wheezing
Clinical narrative: Within 15 minutes of injection, rash, tingling of tongue/ lips and wheezing developed. Pt has asthma and was on a medrol dose pak. Given po Benadryl total of 50mg with improvement within 30 minutes got worse take to ER intubated and on ventilator x 2 da. Now home and OK. Throat remains sore due to respirator. Discharge summary states vomiting, sweat, apnea, facial edema. msv
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain
Clinical narrative: L arm-sore next morning. Induration 15mm x 20mm, erythema 25-30mm
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Onset red mark on arm (noted by husband). Induration 36x38mm, erythema 50x50mm L arm.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: L arm induration 15x18mm, erythema 30x40mm.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Itching and pain on evening of shot L arm. Induration 20x25mm, erythema 40x40mm.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Myalgia, Tenderness
Clinical narrative: Soreness of muscle noted same evening. Warm and tenderness in L biceps 70x70mm (skin above not red or erythematous).
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain
Clinical narrative: Onset pain approximately 39 hours after shot R arm induration 16x18mm, erythema 25x45mm.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain
Clinical narrative: Began as sore arm L arm induration 20x25mm, erythema 30x50mm.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Noticed severe itching an dpain. Hot feeling L arm indurated 30x34mm, erythema 50x55mm.
Age: 54.0
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Rash
Clinical narrative: Severe skin rash L arm induration 53x65mm, erythema 90x110mm.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: L arm induration 34x36, erythema 60x70mm.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Itching began same evening. Red and swollen 24 hrs L arm induration 10x12mm, erythema 25x30mm not measured until 96 hrs after (10/31/03).
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Onset itching approximately 24 hrs. Then developed swelling and redness L arm induration 20x22mm, erythema 30x36mm.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: Noted pain and swelling in arm next morning L arm 60x65mm swelling in muscle (skin above minor erythema only).
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Skin ulcer
Clinical narrative: Noted arm lesion only after asked ? L arm induration 18x18mm, erythema 25x25mm.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain
Clinical narrative: Onset soreness at 18 hrs l arm induration 27x29mm, erythema 40x55mm.
Age: 2.08
Sex: M
Vaccine: FLU3, PNC
Symptoms: Oedema peripheral
Clinical narrative: Pt had swelling of the L thigh which has increased over 24 hrs.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Macular papular erhthemic rash over creases in skin, started evening after pt got the flu shot. Pt given medrol dose pack.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hyperhidrosis, Pyrexia, Vomiting
Clinical narrative: Sweats, fever, emesis treated by personal physician with Benadryl and Cipro x 3 days.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Pt c/o Rt arm started hurting later that evening. The pain radiates from Rt shoulder down to hand. Pain is intermittent. No redness or swelling at site or arm was noted by pt and family members. Pain intermittent x 1 week. Spoke to pt several times during week but did not mention during those times.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives occurred about one hour after flu vaccine administered. No shortness of breath. Treated with Benadryl.
Age: 26.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Oedema, Urticaria
Clinical narrative: Reports ? swelling, hives palms, legs evening of 10/29.  Resolving when seen 10/30 by provider.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Nausea
Clinical narrative: Nausea, metallic taste in throat, lasted 5 minutes.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Pain
Clinical narrative: Patient complained of severe achy arm left and left shoulder for 5 days. Concerned regarding 3mm pink area with clear dried serous droplet at puncture site.  No signs of swelling, nodular area, redness.  Denies any pain today denies fever at any time.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Erythema
Clinical narrative: Right thigh 6-7 inch area with irregular edges sup erythema.
Age: 1.4
Sex: M
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site induration
Clinical narrative: Right thigh 6 x 5 cm erythema, increasing 3.5 cm induration.  Warm to touch.  Treatment: Amox 250mg susp, 1 tsp three times a day.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Began 07/01/2003 evening with warmth and redness. No complaints of pain or itching. Worsened during night. Swollen 07/02/2003 morning with warmth. Mother applied warm compress and administered Tylenol.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pruritus
Clinical narrative: Complained of pain, redness and swelling at injection site; some itching at site also.  Redness and swelling size of silver dollar.  Is taking Tylenol and Benadryl.  To put ice on site also.
Age: 12.0
Sex: M
Vaccine: HEP, TD
Symptoms: Paraesthesia, Pharyngolaryngeal pain, Skin burning sensation
Clinical narrative: Mother states took child to hospital ER due to complaints of throat sore and scratchy feeling and complaints of burning/tingling feeling in extremities.  Was told in ER, allergic reaction to vaccines and was given prescription for steroid and told to give him Benadryl.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Headache, Injection site oedema
Clinical narrative: 10/07/2003: Client reported severe headache during the night.  Did not take any medication.  Headache this AM is moderate.  Injection site swollen with bruising noted at site.  Swelling approximately 3 inches in diameter.  Instructed to take Tylenol and use ice packs on area.  To consult with MD about Benadryl since has glaucoma.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 2.5 to 2 3/4 inch area of redness and swelling at injection site.  To take Tylenol, Benadryl and apply ice to site.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Feeling hot, Injection site oedema
Clinical narrative: 10/17/2003: Mother reported swelling of left arm.  Stated she had not given her Tylenol or tried ice to site.  Nurse recommended Tylenol or Motrin every 4-6 hours with ice to site.  10/20/2003: Mother in clinic-states she took child to ER 10/17/2003 PM-is on antibiotic and Motrin.  States arm was swollen from her shoulder to wrist left arm was slightly warm to touch with moderate swelling at injection site.
Age: 88.0
Sex: F
Vaccine: RAB
Symptoms: Confusional state, Diarrhoea, Night sweats, Vertigo
Clinical narrative: Patient started Rabies post exposure vaccine on 09/01/2003.  Patient started with diarrhea, vertigo, nightsweats, and confusion after her 4th vaccine on 09/15/2003.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysgeusia, Dyspnoea, Pain
Clinical narrative: Shot given on Friday 10/17/2003.  Immediately following shot had metallic taste in mouth that lasted all day, dizziness on and off and shortness of breath on and off all day.  By evening had back ache, on saturday, back, legs and hips; sunday whole body ache that continued until wednesday.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Dizziness
Clinical narrative: Dizziness/lightheadedness
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Had a localized red, painful, hot to touch about 2 inches below injection site.  No fever.  No treatment given (patient notified us after had resolved).  Reported to us 10/15.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Dry throat, Feeling hot, Pruritus, Pyrexia, Rash erythematous
Clinical narrative: Patient had a about 3 inch red, raised area, warm to touch, slight temperature elevation to 100.0 F/per mouth, slight scratchy throat with some itching.  Benadryl given for itching, cool compress applied to area and Tylenol given for fever, follow up 3 days then resolved.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Called our office 10/15, had had a localized reaction started 2 inches below injection site down arm about 9 inches red, very painful, hot to touch, no fever.  Wife gave Tylenol, resolved after 3 days.
Age: 0.1
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Pyrexia, Urticaria
Clinical narrative: Mother examined baby's temperature was 104 with hives on face, several hours after receiving vaccines.  Mother took baby to ER.  Received vaccines on 10/23 AM to ER 10/23 PM.
Age: 17.0
Sex: M
Vaccine: HEP, TD
Symptoms: Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: Student received Td imm right deltoid. 10/30/03 in AM came to clinic 10/31/03 AM at 9 AM with 99 degrees oral temp. C/o muscle stiffness, soreness. 12:30 temp above 101. Parents notified and student sent home. Encouraged to push fluids with Tylenol. Then after shot and Friday AM no Tylenol. Student also received Hep B #2 vaccine in left deltoid. Had c/o of pain in right deltoid.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Skin irritation
Clinical narrative: Irritation, swelling, redness interior to administration site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Confusional state, Crying, Disorientation, Pyrexia, Staring
Clinical narrative: Patient, 2-3 hours after DTAP had increase ? , excessive crying, very disoriented and confused.  As per mother, patient's eyes were glassy and glazed.  Patient refused to sit still for 6 hours.  He also had an elevated body temperature of 101.103 degrees F.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Fatigue, headache, slight dizziness, fever 2 days of 103, pain, myalgia.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Fatigue, headache, slight dizziness, fever 2 days of 103, pain, myalgia.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Dyskinesia
Clinical narrative: Jerking motions bilateral hands and arms and had lasting approximately 5 seconds but was repeated 6-10 times over 1 1/2 hours, 2 days after immunizations.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Coronary artery disease, Myocardial infarction
Clinical narrative: This subject is a 76 year old male who died while enrolled in the RSV11 study. The subject received RSV vaccine or Placebo and influenza vaccine on 11/13/02. The investigator was informed by one of the family members that the subject had died in July, 2003. Specific dates not reported. Causality was not reported. Further info from the investigator has been requested. The death certificate received on 11/20/03 states myocardial infarction and CAD. Follow up on 11/26/03: "Efforts are being made to contact next of kin and to obtain a death certificate through the State.  No details are known at this time. Additional info received 11/18/03.  The subject died on 07/08/03, 237 days post immunization.  Death Cert: Cause of Death: Acute MI due to CAD.  The acute MI was reported by the investigator as not related to the study vaccine." Follow up on 12/16/2003: "Additional information received 12/01/2003: Complementary Information Form: Diagnoses at Enrollment: COPD, Bronchiectasis, Ischemic heart disease.  Medication: Psyllium oral power, Ranitidine, Furosemide, Nitroglycerin, Albuterol, Beclomethasone NS, Hydrocodone/Acetaminophen, Tamazepam, Ipratropium bromide inhaler, Lisinopril, Salmeterol inhaler, Prednisone, Theophyline."
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Arthritis, Ear pain, Headache, Influenza like illness, Nausea
Clinical narrative: 10/01 - ear and jaw pain, nausea, flu-like symptoms with headache arthritis pain. 10/07 Rash Appears.  Adverse reaction confirmed by doctor on 10/7.  Stayed home from work 10/07-10/11. Coworker now says she was "confirmed" with a case of measles from my vaccination, although no blood work was done by her physician, just a visual exam.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pain in jaw
Clinical narrative: 10/01 - ear and jaw pain, nausea, flu-like symptoms with headache arthritis pain. 10/07 Rash Appears.  Adverse reaction confirmed by doctor on 10/7.  Stayed home from work 10/07-10/11. Coworker now says she was "confirmed" with a case of measles from my vaccination, although no blood work was done by her physician, just a visual exam.
Age: 33.0
Sex: M
Vaccine: FLUX, SMALL
Symptoms: Asthenia, Chest discomfort, Dizziness, Dyspnoea, Pruritus
Clinical narrative: Within 1 hour of vaccination with both smallpox and flu vaccine, he began to feel shortness of breath and then progressed to throat and chest tightness.  Mild dizziness and weakness.  No syncope or hives noted.  some pruritus
Age: 33.0
Sex: M
Vaccine: FLUX, SMALL
Symptoms: Throat tightness
Clinical narrative: Within 1 hour of vaccination with both smallpox and flu vaccine, he began to feel shortness of breath and then progressed to throat and chest tightness.  Mild dizziness and weakness.  No syncope or hives noted.  some pruritus
Age: 43.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Anaphylactic reaction, Apnoea, Chest discomfort, Convulsion, Dyspnoea
Clinical narrative: Within a period of an hour or so after receiving the immunization, the vaccinee developed itching, flushing, chest discomfort, and breathing difficulty.  She was at work as an RN in a hospital so, as she collapsed and began to seize, a code was called.  She was intubated and taken to the ICU where she remains at this time.  She has been extubated. Nurse follow up on 06/28/04 states: "ADD: Anaphylactic reaction, respiratory failure, pseudo seizure, gastritis, left sided weakness."
Age: 43.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Flushing, Gastritis, Loss of consciousness, Pruritus
Clinical narrative: Within a period of an hour or so after receiving the immunization, the vaccinee developed itching, flushing, chest discomfort, and breathing difficulty.  She was at work as an RN in a hospital so, as she collapsed and began to seize, a code was called.  She was intubated and taken to the ICU where she remains at this time.  She has been extubated. Nurse follow up on 06/28/04 states: "ADD: Anaphylactic reaction, respiratory failure, pseudo seizure, gastritis, left sided weakness."
Age: 43.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Anaphylactic reaction, Convulsion, Gastritis, Hemiparesis, Rash
Clinical narrative: Within a period of an hour or so after receiving the immunization, the vaccinee developed itching, flushing, chest discomfort, and breathing difficulty.  She was at work as an RN in a hospital so, as she collapsed and began to seize, a code was called.  She was intubated and taken to the ICU where she remains at this time.  She has been extubated. Nurse follow up on 06/28/04 states: "ADD: Anaphylactic reaction, respiratory failure, pseudo seizure, gastritis, left sided weakness."
Age: 43.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Respiratory arrest
Clinical narrative: Within a period of an hour or so after receiving the immunization, the vaccinee developed itching, flushing, chest discomfort, and breathing difficulty.  She was at work as an RN in a hospital so, as she collapsed and began to seize, a code was called.  She was intubated and taken to the ICU where she remains at this time.  She has been extubated. Nurse follow up on 06/28/04 states: "ADD: Anaphylactic reaction, respiratory failure, pseudo seizure, gastritis, left sided weakness."