chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Medication error, Pruritus, Rash papular
Clinical narrative: From initial information received on 09/29/2004 and 10/05/2004 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 43 year old female patient received a dose of Tetanus Toxoid, lot number U1048CA, administered intra-dermally in error instead of Tuberculin PPD on 08/24/2004.  The site of administration was not reported.  Two days later, on 08/26/2004, the patient developed redness, itching and papular lesions at the site of administration.  She was treated with an unspecified topical cream for the itching and recovered from these events.  Further information is not anticipated, this case is considered closed.
Age: 56.0
Sex: F
Vaccine: TTOX
Symptoms: Blister, Hypersensitivity, Injection site induration, Medication error, Rash papular
Clinical narrative: From initial information received on 09/29/2004 and follow up information received on 10/05/2004 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 55 year old female patient received a dose of Tetanus Toxoid, lot number U1048CA, administered intra-dermally in error instead of Tuberculin PPD on 09/15/2004.  The site of administration was not reported.  Two days later, on 09/17/2004, the patient developed an allergic reaction with blisters, papular lesions and induration at the site of injection.  The patient was not seen by a physician and reportedly recovered from these events.
Age: 42.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site mass, Medication error, Rash papular, Skin ulcer
Clinical narrative: From initial information received on 29Sep04 and additional information received on 05Oct04 from a RN regarding an adverse event occurring, it was reported that a 42 year old female pt received a dose of Tetanus toxoid, lot U1048CA, admin ID instead of Tuberculin PPD on 15Sep04. The site of admin was not reported. On 17Sep04, the pt developed papular lesions at the injection site and a 0.5mm red area with induration. She was treated with antibiotics and topical cream and was seen by her family physician. The pt recovered from these events. The reporter of this case is the same reporter as cases 200403093, 200403240, 200403241, 200403242, and 200403243.
Age: 33.0
Sex: F
Vaccine: TTOX
Symptoms: Arthralgia, Hypoaesthesia, Paraesthesia, Syncope vasovagal
Clinical narrative: From initial information received on 19Jan05 from a physician regarding an adverse event occurring, it was reported that a 32 yr old female pt received a dose of Tet tox Ads USP lot U1367AA, admin IM in the left deltoid on 14Jan05. Two to three minutes later, the pt developed numbness and tingling in her left hand. One hour later, she also developed left shoulder pain. The pt was treated with oral Benadryl and the symptoms resolved after five hours. The symptoms were considered to be a possible vasovagal episode as per the reporter. The pt recovered from these events. From additional information received on 14Mar05 from the responsible physician, it was reported that the pt's vasovagal symptoms were not known. At the time of this report, the pt has completely recovered from these events. No further information is anticipated, this case is considered closed.
Sex: F
Vaccine: TTOX
Symptoms: Fatigue, Headache
Clinical narrative: From initial information received on 08Apr05 from a health care professional regarding an adverse event occurring, it was reported that a female pt (no specific identification provided) received a dose of Tet tox ADS USP, lot unk, admin in her gluteal muscle on 06Apr05. One day later, on 07Apr05, the pt complained of generalized fatigue with local reaction. She also experienced a headache. The pt has not recovered from these events.
Sex: F
Vaccine: TTOX
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site reaction, Medication error
Clinical narrative: From initial information received on 04May05 from a health care professional regarding an adverse event occurring, it was reported that a female pt (age and date of birth not reported) inadvertently received a 0.1 millimeter dose of Tet Tox ADS USP, lot number unk, admin ID in the left forearm on 29Apr05 instead of Tuberculin PPD. An unspecified amount of time later, the pt developed large local redness with warmth over most of her forearm. She was seen in the ER on 01May05 and was diagnosed with cellulitis. The pt was seen for a re-check visit the following day. At that time, the symptoms were less severe. The pt has not recovered from these events.
Age: 41.0
Sex: F
Vaccine: TTOX
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: From initial information received on 05/23/2005 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 40 year old female patient received a dose of Tetanus Toxoid, lot number U1298AA, administered intra-muscularly in the left deltoid on 05/09/2005.  Seven days later, on 05/16/2005, the patient developed nausea and vomiting.  She also reported that her skin hurts all over.  The patient reported the events to the physician's office on 05/23/2005 and at that time she had not recovered from the events.
Age: 30.0
Sex: F
Vaccine: HEPAB, MMR, TTOX
Symptoms: Alopecia, Pruritus
Clinical narrative: From initial information received on 09/16/2004 from information received from another manufacturer regarding an adverse event occurring in the USA, it was initially reported by the 30 year old female patient that she received a Tetanus Toxoid vaccination, an MMR vaccination, and a first dose of Twinrix on 06/21/2004.  The lot numbers, routes and sites of administration were not reported for any of the products.  Approximately seven days later, on 06/28/2004, the patient experienced hair loss and itching.  She was seen in a physician's office and was treated with corticosteroids and desloratadine.  The hair loss continued, but the itching improved.  On 07/23/2004, the patient received a second dose of Twinrix and reported that the hair loss continued following this dose.  The patient has not recovered from this event.  It was reported that the patient declined to grant authority to contact her physician for additional information, therefore none will be available.  Further information is not anticipated, this case is considered closed.
Age: 50.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema nodosum, Pain, Subcutaneous nodule, Swelling
Clinical narrative: From the initial information received on 11/06/2004 from the patient regarding an adverse event occurring in the USA, it was reported that this 49 year old female received a dose of Tetanus Toxoid ADS on 06/19/2004.  The lot number and site of administration were not reported.  During the week of 07/04/2004, the patient noticed some nodules which progressively developed into very painful, purplish nodules under the skin on her shins and lower legs.  This was accompanied by swollen legs and ankles.  In August 2004, she was diagnosed with erythema nodosum.  At the time of this report, the symptoms were persisting and the patient had not recovered from the events.
Age: 71.0
Sex: F
Vaccine: TTOX
Symptoms: Arthralgia, Body temperature increased, Erythema, Feeling hot, Injection site induration
Clinical narrative: From initial information received on 04/22/2005 from the patient regarding an adverse event occurring in the USA, it was reported that a 71 year old female patient received a dose of Tetanus Toxoid, lot number U1298AA, administered in the left arm on 04/05/2005 at 11:30AM.  The route of administration was not reported.  Three and half hours later, at 3:00pm on 04/05/2005, the patient developed redness, warmth, itching, and induration at the site of injection.  She also had a subjective temperature of 99 degrees.  The patient called the physician and was prescribed Benadryl.  The redness still persist and measured the size of a quarter.  Reportedly, the patient also complained of muscle and joint aches on 04/16/2005.  She has not recovered from these events and will be scheduled for follow up visit by the responsible physician on 05/05/2005.
Age: 71.0
Sex: F
Vaccine: TTOX
Symptoms: Myalgia, Pruritus
Clinical narrative: From initial information received on 04/22/2005 from the patient regarding an adverse event occurring in the USA, it was reported that a 71 year old female patient received a dose of Tetanus Toxoid, lot number U1298AA, administered in the left arm on 04/05/2005 at 11:30AM.  The route of administration was not reported.  Three and half hours later, at 3:00pm on 04/05/2005, the patient developed redness, warmth, itching, and induration at the site of injection.  She also had a subjective temperature of 99 degrees.  The patient called the physician and was prescribed Benadryl.  The redness still persist and measured the size of a quarter.  Reportedly, the patient also complained of muscle and joint aches on 04/16/2005.  She has not recovered from these events and will be scheduled for follow up visit by the responsible physician on 05/05/2005.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Eye disorder, Irritability, Laboratory test abnormal, Muscle rigidity
Clinical narrative: Crying a lot, fussy, not eating well, diaper rash. Rigidity and posturing, eye movement irregularities.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Oral intake reduced, Posturing, Rash
Clinical narrative: Crying a lot, fussy, not eating well, diaper rash. Rigidity and posturing, eye movement irregularities.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Lymphadenopathy, Pyrexia
Clinical narrative: Developed right arm swelling and tenderness at site of vaccination, progressive, clearly Cellulitic / right axillary adenopathy.  Given Keflex with resolution. Temp increase to 103 degrees.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Vomiting
Clinical narrative: Mother reports that child had several bouts of vomiting and dizziness within 24 hours.  No fever or diarrhea.  Symptoms resolved spontaneously thereafter.
Age: 1.1
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Drug ineffective, Herpes zoster
Clinical narrative: Child given routine MMR, Varivax, Prevnar on 03/23/2005.  Varivax in left thigh.  Child presented to urgent care 06/07/2005, crash left leg, prescription with calamine lotion and benadryl.  Seen by MD on 06/11/2005 with classis Herpes Zoster in left leg in dermatoma pattern, child in no distress, put on Acyclovir by mouth.
Age: 0.54
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: child presented in the ER with tEmp of 105.3 rectally. MD reports no signs of infection were evident at that time. 06/23/05 5:00PM/
Age: 18.0
Sex: F
Vaccine: HEPA, TYP, VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Pt called physician on 6/24/05 and stated that she had completed the last dose of the typhoid vaccine (oral)tablets and she c/o of "little red rash @face. Denies sob,increased heartrate.  No pain noted.  Only sx/sx is a rash @ face/red patch.  Instructed pt to take benadryl po prn. Continue to moniter.  Report any changes to our office. Pt agreed
Age: 46.0
Sex: M
Vaccine: DTPHEP
Symptoms: Fatigue, Headache, Pyrexia, Serum sickness
Clinical narrative: ON 14 JUN 05, PT RECEIVED A 2nd DOSE OF TWINRIX LOT # AHABA015BA. ON 20 JUN, HE EXPERIENCED FEVER, HEADACHE, FATIGUE, NO SOB, NO DIARRHEA, NO NAUSEA OR VOMITING. WENT TO ER ON 23 JUN 05. DIAGNOSED WITH FEBRILE ILLNESS AND ACUTE SERUM SICKNESS. TREATED WITH BENADRYL 25MG ONE EVERY 6 HOURS WHILE AWAKE, PREDNISONE FOR THE NEXT 3 DAYS. HE WAS ADVISED BY ER DOCTOR TO AVOID THIS IMMUNIZATION IN THE FUTURE. PT STATES THAT HE WAS FINE AND RETURNED TO WORK ON 24 JUN 05. HE WAS SEEN BY A MILITARY PHYSICIAN TODAY 27 JUN. MD CONCLUDED THAT THIS EPISODE HAS RESOLVED, PT RETURNED TO NORMAL.
Age: 20.0
Sex: M
Vaccine: FLU3, HEPAB, IPV, MEN, VARCEL
Symptoms: Dyspnoea, Erythema, Feeling hot, Pyrexia, Rash
Clinical narrative: HIGH FEVER, RASHES (HIVES) UPPER AND LOWER EXTREMETIES WARM TO THE TOUCH AND DEEP RED COLOR, UNUSUAL SHORTNESS OF BREATH DURING LIGHT EXERCISES SUCH AS SIT UPS AND PUSH UPS-PATIENT DENIES.
Age: 20.0
Sex: M
Vaccine: FLU3, HEPAB, IPV, MEN, VARCEL
Symptoms: Urticaria
Clinical narrative: HIGH FEVER, RASHES (HIVES) UPPER AND LOWER EXTREMETIES WARM TO THE TOUCH AND DEEP RED COLOR, UNUSUAL SHORTNESS OF BREATH DURING LIGHT EXERCISES SUCH AS SIT UPS AND PUSH UPS-PATIENT DENIES.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Back pain, Decreased appetite, Headache, Malaise
Clinical narrative: RECIEVED INJECTION ON 06-21-05. NEXT DAY, PATIENT C/O MALAISE, HEADACHES, FEVER (100.4F). PATIENT USED TYLENOL, MOTRIN AND INCREASED FLUIDS INSTRUCTED TO FOLLOW UP WITH DOCTOR IF NO BETTER. SEEN BY PHYSICIAN ON 06-24-05 WITH PERSISTANT ACHES AND PAIN IN JOINTS AND BACK. C/O DECREASED APPETITE. PATIENT DENIES N/V/D/C, ALSO DENIES VISUAL PROBLEMS, WEAKNESS AND PARASTHESIAS.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: RECIEVED INJECTION ON 06-21-05. NEXT DAY, PATIENT C/O MALAISE, HEADACHES, FEVER (100.4F). PATIENT USED TYLENOL, MOTRIN AND INCREASED FLUIDS INSTRUCTED TO FOLLOW UP WITH DOCTOR IF NO BETTER. SEEN BY PHYSICIAN ON 06-24-05 WITH PERSISTANT ACHES AND PAIN IN JOINTS AND BACK. C/O DECREASED APPETITE. PATIENT DENIES N/V/D/C, ALSO DENIES VISUAL PROBLEMS, WEAKNESS AND PARASTHESIAS.
Age: 4.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Arthralgia, Oedema
Clinical narrative: Twelve hours after vaccination of DTaP on the left leg he developed significant pain and swelling in to his knee and initially refused to walk.  Since then he has had ambulation.  He has not had fever but the pain and the swelling has continued. It was palpated and it is going down to his knee. It is 31 cm in diameter.
Age: 1.53
Sex: M
Vaccine: IPV
Symptoms: Cough, Injection site oedema, Injection site warmth, Pharyngitis, Pyrexia
Clinical narrative: The patient received his vaccine just today.  DTaP in right leg and now has a swollen right leg, which is warm and nontender.  He has fever and cough and cold symptoms, which have started last night.
Age: 1.53
Sex: M
Vaccine: IPV
Symptoms: Rhinitis
Clinical narrative: The patient received his vaccine just today.  DTaP in right leg and now has a swollen right leg, which is warm and nontender.  He has fever and cough and cold symptoms, which have started last night.
Age: 5.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Pruritus
Clinical narrative: The patient had vaccines in the last 36 hours and had a DTaP on his left leg.  Mother has noted progressive swelling and redness and somewhat itching around that area.  He also had a scratch over that same area.
Age: 1.45
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Anaphylactic reaction, Face oedema, Hypersensitivity, Respiratory distress, Urticaria
Clinical narrative: This is a case of an 18 month old boy who during a routine 18-month well visit developed facial swelling, generalized hives, and respiratory distress, within 5 minutes following vaccination with DTaP #4, IPV #3, and Prevnar #4 at the doctors office. All of these vaccines had been given previously without any reaction.  The child was said to have had a resolving URI and otitis media which started 6 days prior to episode and had been on amoxicillin, which he had not yet taken on the day of episode. He also had mild eczema controlled with occasional over-the-counter hydrocortisone as an infant and but now Aquaphor alone seems to be helping. He had some mild wheezing with a bout of croup last fall and required a course of Orapred. He has no known food allergies, but has avoided peanut butter and shellfish. He does not appear to be allergic to animals. He has been exposed to cats at daycare without any problems. He does not have chronic nasal problems and is not prone to recurrent infections. Both parents have allergic rhinitis and father has had sinus surgery. The family has two pet Labrador retrievers. They live in a single-family home and there is no obvious exposure to mold.  At the doctors office he was given subcutaneous epinephrine 0.1cc, Benadryl 1½ teaspoon p.o. Within 45 minutes his rash resolved but he had wheezing. Therefore he received albuterol 0.5cc which improved the wheezing. He was subsequently taken to ER.  On admission he was found to be alert, playful and in no respiratory distress. Respiratory exam revealed scattered wheezing but no flaring, grunting or retraction.  The impression was that of anaphylaxis to one of three vaccines. A likely culprit was said to be the adjuvant protein contained in the Prevnar. It was also possible he could be allergic to one of the other vaccines. He was placed on I.V Benadryl 12 mg q.4h, Solumedrol 24 mg stat, and albuterol 0.5 q 1h as needed.  On a follow-up visit 3 weeks after the onset of symptoms an Allergen skin test was performed. It was positive to egg 2+, soy 2+, cashew 2+, and walnut 1+. Negative responses to fish, peanut milk, casein, beef, chicken, wheat, oats, shellfish, and almond were obtained.   Skin testing to vaccines performed 6 weeks post episode showed mild positive reaction to DTaP at 1:100 dilution and significantly positive reaction at the 1:10 dilutions. DTaP gave a 2+ reaction with a 5-mm wheal and 27-mm flare at full strength. Prevnar gave a 2+ reaction with a 5-mm wheal and a 30-mm flare to the 1:10 dilution. There was negative reaction to IPV.
Age: 1.45
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Wheezing
Clinical narrative: This is a case of an 18 month old boy who during a routine 18-month well visit developed facial swelling, generalized hives, and respiratory distress, within 5 minutes following vaccination with DTaP #4, IPV #3, and Prevnar #4 at the doctors office. All of these vaccines had been given previously without any reaction.  The child was said to have had a resolving URI and otitis media which started 6 days prior to episode and had been on amoxicillin, which he had not yet taken on the day of episode. He also had mild eczema controlled with occasional over-the-counter hydrocortisone as an infant and but now Aquaphor alone seems to be helping. He had some mild wheezing with a bout of croup last fall and required a course of Orapred. He has no known food allergies, but has avoided peanut butter and shellfish. He does not appear to be allergic to animals. He has been exposed to cats at daycare without any problems. He does not have chronic nasal problems and is not prone to recurrent infections. Both parents have allergic rhinitis and father has had sinus surgery. The family has two pet Labrador retrievers. They live in a single-family home and there is no obvious exposure to mold.  At the doctors office he was given subcutaneous epinephrine 0.1cc, Benadryl 1½ teaspoon p.o. Within 45 minutes his rash resolved but he had wheezing. Therefore he received albuterol 0.5cc which improved the wheezing. He was subsequently taken to ER.  On admission he was found to be alert, playful and in no respiratory distress. Respiratory exam revealed scattered wheezing but no flaring, grunting or retraction.  The impression was that of anaphylaxis to one of three vaccines. A likely culprit was said to be the adjuvant protein contained in the Prevnar. It was also possible he could be allergic to one of the other vaccines. He was placed on I.V Benadryl 12 mg q.4h, Solumedrol 24 mg stat, and albuterol 0.5 q 1h as needed.  On a follow-up visit 3 weeks after the onset of symptoms an Allergen skin test was performed. It was positive to egg 2+, soy 2+, cashew 2+, and walnut 1+. Negative responses to fish, peanut milk, casein, beef, chicken, wheat, oats, shellfish, and almond were obtained.   Skin testing to vaccines performed 6 weeks post episode showed mild positive reaction to DTaP at 1:100 dilution and significantly positive reaction at the 1:10 dilutions. DTaP gave a 2+ reaction with a 5-mm wheal and 27-mm flare at full strength. Prevnar gave a 2+ reaction with a 5-mm wheal and a 30-mm flare to the 1:10 dilution. There was negative reaction to IPV.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Sinusitis
Clinical narrative: Flu Vaccine administered on 11/12/2002 at place of employment. Chronic Daily Headaches started 11/16/2002. Chronic Pansinusitus. Per follow up 9/20/05 Chronic daily headaches.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, CSF test abnormal, Condition aggravated, Laboratory test abnormal, Pain
Clinical narrative: Pt developed a spontaneous spinal leak of CSF at the upper thoracic area approximately 19 months ago. Although she has not been headache free since April 2003, and she has had multiple exacerbations and moderations of symptoms, she has recently been able to function in her professional role. She notes that frequently if she gets a cough or a cold she will find that the illness aggravates and irritates her spinal symptoms. In an effort to protect herself from the thoracic strain that would result if she were to contract influenza, and because she is an active pediatrician with probable exposure, she received an influenza immunization with Fluzone on November 5, 2004. Seven days later she awoke in her usual state of health, and then at 9am experienced a sudden worsening of squeezing facial pain, much more severe than in months, with reappearance in cervical and thoracic areas of bone pain, as well as a deeper pain between her shoulder blades. She had not coughed or done any activities that might have caused a new leak.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Injection site with large tender, indurated,pink area,  15 by 12 cm.  Seen in office on 6/22/05.  Resolution by 6/24/05 pm
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR
Symptoms: Injection site swelling
Clinical narrative: Swelling of arm in area of injection site (left arm, over deltoid).
Age: 1.08
Sex: M
Vaccine: DTAPH, MMR, PNC, VARCEL
Symptoms: Blister, Rash
Clinical narrative: Aunt called health department stating that Friday 6/3/05 the child's neck had 2 bumps then he had rash on bottom and than 2 days later blisters appear red on hands - aunt not aware of any fever - stated child acts like he feels fine.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site inflammation, Injection site warmth
Clinical narrative: 3 inch inflammation, warm to touch.
Age: 29.0
Sex: F
Vaccine: MMR, TD
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pt had MMR and ATD on 06/02/05, RTC 06/09/05 Left upper arm (bicep) was swollen, hardened, and red. Pt stated she didn't remember which nurse gave injection. site approx quarter size, warm, hard, and reddened.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Cold sweat, Cyanosis, Disorientation, Hypotonia, Pallor
Clinical narrative: Child went limp within 10 minutes of receiving vaccine, skin turned gray and had circumoral cyanosis.  The Child's skin was clammy and he appeared disoriented.  He would not respond to mother or nurse.  His eyes remained open but his eyelids kept fluttering.  Child was transported by ambulance to emergency room.
Age: 21.0
Sex: F
Vaccine: JEV
Symptoms: Rash, Rash erythematous
Clinical narrative: Phone call from client, states she has a red, raised rash at the site of a Japanese Encephalitis injection received on 06/20/05.  Stated started as red,raised area then developed a rash on her arm.  Denied head aches, fever, systemic rash or resp difficulty.  Declined to come to clinic for check.  Encouraged to try otc Benadryl for relief of symptoms.  Seek care if s/s worsen.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: PT. HAD SWELLING IN THE LEFT THIGH AND KNEE THAT IS RED AND HOT TO THE TOUCH.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia
Clinical narrative: States she had tingling in her hand RT the day of receiving a Hep B injection 03/30/2005 On 04/13/05 she presented to the ER for TX. Ultracet RX.
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Td given on 06/24/05 following day, sore on 06/26/05 " turned red and swollen" better today pt applied cold compresses.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site warmth
Clinical narrative: Redness, heat, pain at RL day after vaccination. Extending aroung entire upper leg with induration. Better with cold.
Age: 3.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Vaccination failure
Clinical narrative: none reported
Age: 43.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Arthralgia, Dyspnoea, Haemoptysis, Myalgia, Vasculitis
Clinical narrative: This case was reported by a medical assistant to a sales representative and described the occurrence of Wegner's disease in a 43 year old male subject who was vaccinated with Engerix B for prophylaxis. On an unspecified dates, the subject received hepatitis B vaccine for the first two doses in the hepatitis B vaccination series. On 23 March 2004 the subject received a dose of Engerix B in an unspecified arm as the third dose in the hepatitis B vaccination series (lot ENG537194 - incorrect lot number). On 04 April 2004, 12 days after vaccination with Engerix B, the subject "presented to his physician's office with pulmonary symptoms and fever." The subject was initially diagnosed with pulmonary vasculitis and was hospitalized on 17 April 2004. On 19 April 2004, an echocardiogram showed dilation of the right ventricle. On 20 April 2004, a skin biopsy showed septic vasculitis of an ulcer. On 24 April 2004 a kidney biopsy revealed acute tubular necrosis and osmotic nephrosis, but no evidence of renal vasculitis. On an unspecified dates, unspecified tests for HIV, fungi, bacteria and virus were negative. On 25 April 2004, the subject was diagnosed with "presumed Wegner's Disease, based on symptoms and test results." The subject was placed on hemodialysis for acute tubular necrosis. On 12 May 2004, the subject underwent a tracheostomy. On 12 may 2004, the subject received a "permacath" and wasplaced on intermittent dialysis. At that time, the subject was unable to move his legs. The subject completed a "14 day course of vancomycin on 27 May 2004." The subject was also treated with "several antibiotics, including Bactrim and acyclovir." The duration of the hospitalization was not provided. The outcome of the events was not provided. The medical assistant considered the events to be unrelated to vaccination with Engerix B.
Age: 43.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Cardiovascular disorder, Lung disorder, Myasthenic syndrome, Necrosis, Nephrotic syndrome
Clinical narrative: This case was reported by a medical assistant to a sales representative and described the occurrence of Wegner's disease in a 43 year old male subject who was vaccinated with Engerix B for prophylaxis. On an unspecified dates, the subject received hepatitis B vaccine for the first two doses in the hepatitis B vaccination series. On 23 March 2004 the subject received a dose of Engerix B in an unspecified arm as the third dose in the hepatitis B vaccination series (lot ENG537194 - incorrect lot number). On 04 April 2004, 12 days after vaccination with Engerix B, the subject "presented to his physician's office with pulmonary symptoms and fever." The subject was initially diagnosed with pulmonary vasculitis and was hospitalized on 17 April 2004. On 19 April 2004, an echocardiogram showed dilation of the right ventricle. On 20 April 2004, a skin biopsy showed septic vasculitis of an ulcer. On 24 April 2004 a kidney biopsy revealed acute tubular necrosis and osmotic nephrosis, but no evidence of renal vasculitis. On an unspecified dates, unspecified tests for HIV, fungi, bacteria and virus were negative. On 25 April 2004, the subject was diagnosed with "presumed Wegner's Disease, based on symptoms and test results." The subject was placed on hemodialysis for acute tubular necrosis. On 12 May 2004, the subject underwent a tracheostomy. On 12 may 2004, the subject received a "permacath" and wasplaced on intermittent dialysis. At that time, the subject was unable to move his legs. The subject completed a "14 day course of vancomycin on 27 May 2004." The subject was also treated with "several antibiotics, including Bactrim and acyclovir." The duration of the hospitalization was not provided. The outcome of the events was not provided. The medical assistant considered the events to be unrelated to vaccination with Engerix B.
Age: 43.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Pyrexia, Renal tubular disorder, Renal tubular necrosis, Sepsis, Skin ulcer
Clinical narrative: This case was reported by a medical assistant to a sales representative and described the occurrence of Wegner's disease in a 43 year old male subject who was vaccinated with Engerix B for prophylaxis. On an unspecified dates, the subject received hepatitis B vaccine for the first two doses in the hepatitis B vaccination series. On 23 March 2004 the subject received a dose of Engerix B in an unspecified arm as the third dose in the hepatitis B vaccination series (lot ENG537194 - incorrect lot number). On 04 April 2004, 12 days after vaccination with Engerix B, the subject "presented to his physician's office with pulmonary symptoms and fever." The subject was initially diagnosed with pulmonary vasculitis and was hospitalized on 17 April 2004. On 19 April 2004, an echocardiogram showed dilation of the right ventricle. On 20 April 2004, a skin biopsy showed septic vasculitis of an ulcer. On 24 April 2004 a kidney biopsy revealed acute tubular necrosis and osmotic nephrosis, but no evidence of renal vasculitis. On an unspecified dates, unspecified tests for HIV, fungi, bacteria and virus were negative. On 25 April 2004, the subject was diagnosed with "presumed Wegner's Disease, based on symptoms and test results." The subject was placed on hemodialysis for acute tubular necrosis. On 12 May 2004, the subject underwent a tracheostomy. On 12 may 2004, the subject received a "permacath" and wasplaced on intermittent dialysis. At that time, the subject was unable to move his legs. The subject completed a "14 day course of vancomycin on 27 May 2004." The subject was also treated with "several antibiotics, including Bactrim and acyclovir." The duration of the hospitalization was not provided. The outcome of the events was not provided. The medical assistant considered the events to be unrelated to vaccination with Engerix B.
Age: 43.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Vasculitis
Clinical narrative: This case was reported by a medical assistant to a sales representative and described the occurrence of Wegner's disease in a 43 year old male subject who was vaccinated with Engerix B for prophylaxis. On an unspecified dates, the subject received hepatitis B vaccine for the first two doses in the hepatitis B vaccination series. On 23 March 2004 the subject received a dose of Engerix B in an unspecified arm as the third dose in the hepatitis B vaccination series (lot ENG537194 - incorrect lot number). On 04 April 2004, 12 days after vaccination with Engerix B, the subject "presented to his physician's office with pulmonary symptoms and fever." The subject was initially diagnosed with pulmonary vasculitis and was hospitalized on 17 April 2004. On 19 April 2004, an echocardiogram showed dilation of the right ventricle. On 20 April 2004, a skin biopsy showed septic vasculitis of an ulcer. On 24 April 2004 a kidney biopsy revealed acute tubular necrosis and osmotic nephrosis, but no evidence of renal vasculitis. On an unspecified dates, unspecified tests for HIV, fungi, bacteria and virus were negative. On 25 April 2004, the subject was diagnosed with "presumed Wegner's Disease, based on symptoms and test results." The subject was placed on hemodialysis for acute tubular necrosis. On 12 May 2004, the subject underwent a tracheostomy. On 12 may 2004, the subject received a "permacath" and wasplaced on intermittent dialysis. At that time, the subject was unable to move his legs. The subject completed a "14 day course of vancomycin on 27 May 2004." The subject was also treated with "several antibiotics, including Bactrim and acyclovir." The duration of the hospitalization was not provided. The outcome of the events was not provided. The medical assistant considered the events to be unrelated to vaccination with Engerix B.
Age: 21.0
Sex: F
Vaccine: HEPA, JEV, YF
Symptoms: Back pain, Pyelonephritis, Pyrexia, Urticaria
Clinical narrative: Back paint, fever, and urinary tract infections symptoms.  Urticaria over trunk of body and left arm.  Sought medical attention at emergency room.  Topical lotion to rash.  Levaquin for pyelonephritis.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Chills, Headache, Influenza like illness, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 71 year old male who on the afternoon of 6/13/05 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot # 649914/0578P). The patient had previously been vaccinated with pneumococcal 23v polysaccharide vaccine about 5.5 years ago. On the evening of 6/13/05, the patient experienced pain in the injection arm, cellulitis from his triceps to his forearm. He had a fever of 100.5 F, aches, chills, headache and continuing arm pain. On 6/14/05, he was seen by his physician and was prescribed ibuprofen and dicloxacillin. On 6/16/05, the patient still had a swollen arm which was less painful and flu-like symptoms. The physician further indicated that as of 6/22/05, the patient was improving. The final diagnosis was cellulitis with fever, aches, chills, headache and pain being signs and symptoms. However, the physician reported that the reported flu-like symptoms were possibly not part of the cellulitis. The physician was unsure if the cellulitis or the flu-like symptoms were caused by the vaccination with pneumococcal 23v polysaccharide vaccine. It was confirmed that had the patient not been treated a more serious outcome could have occurred. There was no further information available. Additional information has been requested. (OMIC)
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 71 year old male who on the afternoon of 6/13/05 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot # 649914/0578P). The patient had previously been vaccinated with pneumococcal 23v polysaccharide vaccine about 5.5 years ago. On the evening of 6/13/05, the patient experienced pain in the injection arm, cellulitis from his triceps to his forearm. He had a fever of 100.5 F, aches, chills, headache and continuing arm pain. On 6/14/05, he was seen by his physician and was prescribed ibuprofen and dicloxacillin. On 6/16/05, the patient still had a swollen arm which was less painful and flu-like symptoms. The physician further indicated that as of 6/22/05, the patient was improving. The final diagnosis was cellulitis with fever, aches, chills, headache and pain being signs and symptoms. However, the physician reported that the reported flu-like symptoms were possibly not part of the cellulitis. The physician was unsure if the cellulitis or the flu-like symptoms were caused by the vaccination with pneumococcal 23v polysaccharide vaccine. It was confirmed that had the patient not been treated a more serious outcome could have occurred. There was no further information available. Additional information has been requested. (OMIC)
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Bacterial infection, Dermatitis bullous, Fungal infection, Rash, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 12 month old female who on 5/10/05 was vaccinated with a 0.5ml SC dose of varicella virus vaccine live. It was reported that on 5/23/05 the patient was seen in the office for diaper rash. The patient came back to the office on 5/26/05 because the rash did not go away. The rash was cultured and found to have staph and yeast. The reporter noticed that a varicella type rash had spread to the right inner thigh, back, torso, and left lower leg. The doctor described the case as moderate breakthrough. The patient was given an IM injection of ceftriaxone sodium in the office. She was then prescribed oral cephalexin and fluconazole. It was noted that the doctor felt that the diaper area infection caused the varicella breakthrough. NO product quality complaint was involved. The reporter felt that diaper rash and varicella type rash were other important medical events (OMIC). Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: HBHEPB
Symptoms: Autism, Convulsion
Clinical narrative: Information has been received from a grandmother and a stepfather concerning a 9 week old male who on 3/20/02 was vaccinated with his first dose of hepatitis B virus vaccine (+) HIB conjugate vaccine (lot # 640163/0775L). Concomitant suspect therapy included SC vaccination on an unspecified date with varicella virus vaccine live (lot # 643094/0568M). On 3/20/02 the patient developed seizures. Unspecified medical attention was sought. On 5/24/02, the patient received his second dose of hepatitis B virus vaccine (+) HIB conjugate vaccine (lot # 638581/1668K). On an unspecified date, the patient received his third vaccination with hepatitis B virus vaccine (+) HIB conjugate vaccine (lot # 644276/0914M). In approximately 2004, the patient developed signs of autism and was diagnosed by a psychologist with low grade autism. The signs of autism improved, however it was reported that the patient still had trouble paying attention. As of 6/17/05, the patient's seizures persisted. Upon internal review, seizures and autism were considered to be other important medical events (OMIC). Additional information has been requested.
Age: 0.13
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Grand mal convulsion, Neurodevelopmental disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib-Titer Vaccine was received from a consumer regarding a 4 year old male pt who experienced grand mal seizures and developmental delay. At 2 months of age, the pt received a dose in May 2001. The pt also received a dose of Prevnar and a dose of DTaP in May 2001. Caller reported that her son experienced a seizure at 18 months of age. The child had grand mal seizures all throughout the day, every couple of hours. Caller additionally stated that her son was diagnosed with developmental delay prior to having the seizures. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: HIBV, PNC
Symptoms: Autism, Medication error
Clinical narrative: From initial information received on 06/15/2005 from another manufacturer regarding an adverse event occurring in the USA, it was reported that on an unspecified date after 08/21/2002 and before 10/2002, received a dose of diphtheria, tetanus and acellular pertussis vaccine as the first dose in the diphtheria, tetanus and acellular pertussis vaccination series. On an unspecified date in October 2002, the patient received a dose of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed, as the second dose in the diphtheria, tetanus and acellular pertussis vaccination series. On an unspecified date in February 2002, the patient received a dose of Infanrix as the third dose in the diphtheria, tetanus and acellular pertussis vaccination series. Per the reporter, this was longer than the recommended interval of four to eight weeks between the second and third doses of Infanrix. On an unspecified date in February 2003, the patient received a doses of Infanrix as the fourth dose in the diphtheria, tetanus and acellular pertussis vaccination series. On 09/22/2003, the patient received the first dose of Engerix-B. On 03/01/2004, the patient received the second dose of Engerix B. Per the reporter, this was longer than the recommended interval of one month between the first and second doses of Engerix B. On unspecified date before 05/26/2005, the patient also received injections of 7 valen pneumococcal conjugate vaccine and Haemophilus influenzae. On an unspecified date in 2005 on or before 05/26/2005, the subject was diagnosed with autism. The outcome of the autism was not reported.
Age: 11.0
Sex: M
Vaccine: DT, MNQ
Symptoms: Gastrointestinal disorder, Myalgia, Pyrexia
Clinical narrative: Vaccines 06/15/2005 - c/o right deltoid site pain, 06/15/2005 pm.  06/16/ - seen in office with positive gastroemesis, hamstring tenderness.  Blood work done to rule out myositis.  06/17 - pain improving, fever 101.7 in am, 97.4 at time of visit, lyme and EBV titers normal was well.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Arthritis, Urticaria
Clinical narrative: Urticaria, swollen joints 72 hours post immunizations.
Age: 74.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Injection site vesicles, Rash, Rash erythematous
Clinical narrative: pt  received Havrix and 1st oral Typhoid pill on 06/07/05, 2nd typhoid on 06/09/05 rash started on  06/09/05 3rd typhoid on 06/11/05 4th typhoid on 06/13/2005. Rash is on RL inner and back aspect of thigh. Affected area is 10"x 10". Area has patches that are  red and raised with blister like areas. Size and appearance has not changed since its apppearance Rash is tender, not itchy. Pt applied "ooli cream" This info is from a phone call after 10 days rash is present but only slightly better.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Tenderness
Clinical narrative: Swelling, Redness, Tenderness, warmth for shoulder to elbow. Full ROM. Afebrile
Age: 26.0
Sex: M
Vaccine: TYP
Symptoms: Lymphadenopathy
Clinical narrative: unilateral L cervical lymphadenopathy x 6 weeks, also includes ? in L submandibular, L post auricular areas. Now receiveiving more extensive work up to rule out other cause.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site hypersensitivity, Rash
Clinical narrative: pt co rxn before so we scheduled so we scheduled to give only .01 i beginning then wait. 15 mins to admin second half. 10 minutes with .01 admin pt co rash at injection site extending down arm with lethargy. Benadryl administered. Second dose with held.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Dermatitis bullous, Pyrexia
Clinical narrative: 4-5  Flat red macular lesions. Mom reports one was a clear vesicle. High fever 48 hours.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Contusion, Injection site erythema, Injection site hypersensitivity, Injection site oedema, Nasopharyngitis
Clinical narrative: Large very red swollen arm at injection site day after shot. Also heavily bruised at inject site. Developed very bad cold, sinus infection 2 days after shot. recovery is TBD. Pt still on antibiotics.,
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Sinusitis
Clinical narrative: Large very red swollen arm at injection site day after shot. Also heavily bruised at inject site. Developed very bad cold, sinus infection 2 days after shot. recovery is TBD. Pt still on antibiotics.,
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Abdominal pain, Chills, Dysmenorrhoea, Paraesthesia, Pelvic pain
Clinical narrative: Pt co cramping ( menstrual sx like) tingling sensation on L fingers, severe pelvic pain. Felt like going to the bathroom, chills, severe menstrual cramping. 3:45 Sx resolved within one hour.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Pain
Clinical narrative: Pt had a red swollen area on RA after receiving DTaP and IPV. Pt co no pain. Shot received 06/20/2005, redness and swelling noted on 06/21/2005. Instructed mom to mark area with pen and come in to be evaluated it the redness and swelling spread outside the marked area. Try cool compresses and Tylenol for Pain if any PRN. No temp.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Nausea, Oedema peripheral
Clinical narrative: Pain, redness, and swelling entire upper arm- Day 1. Day 2- Nausea and red and swollen. Day 3-5 Just arm sx improving
Age: 1.04
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Rash
Clinical narrative: Onset of red bumps that evolved into vesicles 06/21/05. Fever. Vesicles itchy.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Injection site oedema, Oedema peripheral, Screaming
Clinical narrative: Persistant crying starting 4-5 hours after vaccine. Mild swelling of Right thigh.
Age: 54.0
Sex: F
Vaccine: HEPAB, PPV, TD
Symptoms: Injection site erythema, Injection site oedema, Injection site vesicles
Clinical narrative: Noted pain and erythema and edema. size of a  coaster with blister formation at inject site RUA approx 5-6 hours after receiving  injections. These Sx lasted approximately 3-4 days with gradual decrease in swelling. No respiratory px noted with episode.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: varicella vaccine breakthrough. Had vaccine on 11/16/2004. Seen in office 06/16/05 by MD and DX with Varicella. 20 vesicles on trunk, arms, and face. No fever. Rash broke out 06/16/05 and crusted by 06/21/2005
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Varicella breakthrough, had vaccine 08/11/1997. Seen in our office 06/16/2005 by MD and DX with varicella. Had about 60 vesicles on trunk, legs, face, no fever. Rash broke out 06/16/2005 and crusted by 06/21/2005.
Age: 1.65
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: RL developed area of 5x5.5 cm which was swollen, erythema and warm to touch. DX of cellulitis of Right thigh, Keflex given for 7 days 125mg QID. Conditon Resolved.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis
Clinical narrative: Comes with RA swollen, red, and warm to touch on 06/16/05. DX secondary to DTaP (Cellulitis) TX with Keflex 250mg/5ml 1 tsp Q 6H x 7 Days. warm compresses.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, MMR, DTAP, IPV, MMR
Symptoms: Cough, Dyspnoea, Urticaria, Vomiting, Wheezing
Clinical narrative: wheezing, Difficult breathing, coughing, hives, vomited. gave epinephrine 0.5mg Im. 2 tsp Benadryl and O2 via mask.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, MMR, DTAP, IPV, MMR
Symptoms: Dyspnoea, Face oedema, Rash
Clinical narrative: wheezing, Difficult breathing, coughing, hives, vomited. gave epinephrine 0.5mg Im. 2 tsp Benadryl and O2 via mask.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, MMR, DTAP, IPV, MMR
Symptoms: Cough, Dyspnoea, Face oedema, Rash, Urticaria
Clinical narrative: wheezing, Difficult breathing, coughing, hives, vomited. gave epinephrine 0.5mg Im. 2 tsp Benadryl and O2 via mask.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, MMR, DTAP, IPV, MMR
Symptoms: Vomiting, Wheezing
Clinical narrative: wheezing, Difficult breathing, coughing, hives, vomited. gave epinephrine 0.5mg Im. 2 tsp Benadryl and O2 via mask.
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Agitation, Crying, Irritability, Pyrexia, Restlessness
Clinical narrative: 9 hours after administration of vaccine ( high pitched cry began). It lasted on and off for 4 days. Accompanied by moderate fever 100.5-101 F, Excessive sleepiness. Next day, agitated, irritable, and restless. Excessive spitting up. Tylenol given seemed better on 5th day.
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Screaming, Somnolence, Vomiting
Clinical narrative: 9 hours after administration of vaccine ( high pitched cry began). It lasted on and off for 4 days. Accompanied by moderate fever 100.5-101 F, Excessive sleepiness. Next day, agitated, irritable, and restless. Excessive spitting up. Tylenol given seemed better on 5th day.
Age: 1.12
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Cough, Eye discharge, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: On 6/15/05 rash began, temp 101f . on 06/16/05 more rash, velvety, temp 102.3 cough, runny nose, matted eyes in the am.
Age: 47.0
Sex: F
Vaccine: RUB
Symptoms: Arthralgia, Hypokinesia, Lymphadenopathy, Musculoskeletal stiffness, Pharyngolaryngeal pain
Clinical narrative: 8d p vaccine stiff neck, sore throat; 9d p vaccine hard to get up; swollen glands cervical and in mandibular area, hips hurt; 10d p rash to face, chest/trunk, fever, took Tylenol.