chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, IPV, RV5
Symptoms: Flushing, Hypotonia, Injection site erythema
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of floppy in a 6-month-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline), ENGERIX B, IPV and Rotavirus vaccine (Non-GSK). On 13 October 2008 the subject received 3rd dose of INFANRIX (.5 ml, unknown, left thigh), unspecified dose of ENGERIX B (unknown, left thigh), unspecified dose of IPV (unknown), unspecified dose of Rotavirus vaccine (unknown). On 13 October 2008, five minutes after vaccination with ENGERIX B, INFANRIX, IPV and Rotavirus vaccine, the subject experienced floppy, flushing and injection site redness. The physician is an allergist and is seeking components for testing of an infant subject that received INFANRIX and ENGERIX B vaccine on 13 October 2008. The subject became floppy and flushed about five minutes after the vaccinations. The subject also experienced redness around the IPV injection site. The subject was observed for a period of time in the physician's office and symptoms were completely resolved after 20 minutes. The physician was not certain if the subject reacted to the INFANRIX, IPV or ENGERIX B vaccination. The brands of the two previous DTaP vaccinations were unknown, but the subject did not have a reaction to them. On 13 October 2008, after 20 minutes the events were resolved. The healthcare professional considered the events were possibly related to vaccination with INFANRIX, ENGERIX B, IPV and Rotavirus vaccine.
Sex: F
Vaccine: DTAP
Symptoms: Convulsion, Electroencephalogram normal, Staring, Vomiting projectile
Clinical narrative: This case was reported by a consumer, the subject's grandmother, and described the occurrence of seizure in an infant female subject who was vaccinated with INFANRIX (GlaxoSmithKline). The subject had no concurrent medications or relevant medical history. On an unspecified date in 2008 and 20 January 2009 at 16:30 the subject received 1st dose and 2nd dose of INFANRIX (unknown). She received the second dose when she was four months old. On an unspecified date in November 2008, around the time the subject received her two month INFANRIX dose (but the grandmother does not recall very well), the subject experienced projectile vomiting which resolved on an unspecified date. On 22 January 2009, two days after vaccination with the second dose of INFANRIX, the subject experienced seizure accompanied by projectile vomiting while she was sleeping. The subject was not febrile when the seizure occurred. The subject's mother called a physician, but did not take the subject to be seen because the physician stated it was not necessary. The subject has not been seen since this seizure occurred. The seizure resolved on an unspecified date. Outcome of the projectile vomiting was unspecified. This case was assessed as medically serious by GSK. Follow-up information was received from a physician on 30 March 2009. The subject had no relevant medical history or allergies. On 11 March 2009, electroencephalogram (EEG) was normal. The physician reported that no further DTaP vaccine would be administered for now. The physician reported that the events resolved. The physician considered that the events were unlikely related to vaccination with INFANRIX. The physician reported that the events could have been associated with the following: The subject's mother reported a ten minute staring spell which occurred one to two days after DTaP administration. No spontaneous movement was noted. There was no vomiting per the physician's records.
Age: 0.3
Sex: F
Vaccine: DTAP
Symptoms: Adverse event, Injection site swelling, Vomiting
Clinical narrative: This case was reported by the grandmother of a consumer and described the occurrence of hyporesponsive reaction (unspecified) in a 4-month-old female subject who was vaccinated with (INFANRIX, GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced hyporesponsive reaction (unspecified), vomiting and lump injection site that lasted over two weeks. At the time of reporting the outcome of the events was unspecified.
Sex: U
Vaccine: DTAP
Symptoms: Adverse drug reaction, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of an unspecified adverse event in a subject of unspecified age and gender who was vaccinated with (INFANRIX, GlaxoSmithKline). On an unspecified date the subject received 4th dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced an unspecified adverse event. The reporter believed that there might be a quality assurance problem that caused the adverse event. This was considered to be a product complaint. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were probably related to vaccination with INFNARIX. The representative was not sure it the INFANRIX was in prefilled syringes or vials. Follow-up information from Quality Assurance was received on 23 June 2009. The INFANRIX vaccine lot AC14B088AA met the requirements of our specifications and batch was suitable for vaccination purposes. Linked cases include A0772416A and A0772420A.
Sex: U
Vaccine: DTAP
Symptoms: Adverse event, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of an unspecified adverse event in a subject of unspecified age and gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received 4th dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced an unspecified adverse event. The reporter believes that there might be a quality assurance problem that caused the adverse event. This was considered to be a product complaint. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the event s were probably related to vaccination with INFANRIX. The representative was not sure if the INFANRIX was in prefilled syringes or vials. Follow-up information from Quality Assurance was received on 23 June 2009. The INFANRIX vaccine lot AC14B088AA met the requirements of our specifications and the batch suitable for vaccination purposes. Linked cases include A0772416A and A0772419A.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 4-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline).  Concurrent vaccination included IPOL (Aventis Pasteur) given in the left thigh given and VARIVAX (Merck) also given in the left thigh on 16 March 2009.  There were no concurrent medications.  On 16 March 2009 at 10:40 the subject received 5th dose of INFANRIX at 0.5 ml in the left arm.  On 16 March 2009, less than one day after vaccination with INFANRIX, immediately after the subject left the office, she experienced swelling and redness at the injection site.  The swelling was 3 and 3/4 by 3 inches at the time of reporting and was spreading from the injection site to above the elbow (swelling of arm following injection).  The redness was also spreading from the initial injection site toward the elbow and changed in darkness.  At the time of reporting the events were considered to be worsening and they were just monitoring and documenting the reaction.  No treatment was required at the time of report.  The healthcare professional considered the events were probably related to vaccination with INFANRIX.  The concomitant vaccines were not suspected as they were given in the thigh which is away from the site of the swelling and redness.  Follow-up information was received on 17 April 2009 from the healthcare professional who administered the vaccine.  Diagnosis was reported as topical reaction. Onset date of the events was reported as 18 March 2009.  The events resolved on 19 March 2009.  The healthcare professional considered the events were related to vaccination with INFANRIX.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: redness and swelling in a 6x6 are to Right thigh where MMR vaccine was administered, swollen area was hot to touch and painful
Age: 37.0
Sex: M
Vaccine: DTAP
Symptoms: Activities of daily living impaired, Arthralgia, Disorientation, Dizziness, Fatigue
Clinical narrative: - Received shot Tues afternoon; minor discomfort at injection site.  - Started to feel extreme fatigue Weds. afternoon (approx 1300hrs) quickly followed by increasing muscle cramps and joint pain/joint aches.  - Finished workshift (1630hrs), drove home, took TheraFlu and went to sleep (approx. 1730).  Woke (approx 2330hrs, Weds night) in profuse sweat and dizzy/disoriented.  Got some water; went back to sleep; joints still hurt; still extremely tired.   Woke Thurs. morning (approx 0400) still sweating and itchy; upon waking noted large distinct hives on torso, chest and arms; very itchy.  Joints still ached/hurt to move; had extremely painful migrane/headache (very sensitive to light/sound, "pain in the center of skull" which varied between different quadrants of head; eventually migrane nausea).  - Called in to work sick, took Tylenol went back to bed.  Could not sleep due to migrane.  - Migrane and muscle/joint pain began to ease approx. Thurs evening (approx 1700hrs) followed by deep sleep Thurs. night.  Woke Friday morning with 'residual' headache; reported for duty.
Age: 37.0
Sex: M
Vaccine: DTAP
Symptoms: Headache, Hyperacusis, Hyperhidrosis, Injection site discomfort, Insomnia
Clinical narrative: - Received shot Tues afternoon; minor discomfort at injection site.  - Started to feel extreme fatigue Weds. afternoon (approx 1300hrs) quickly followed by increasing muscle cramps and joint pain/joint aches.  - Finished workshift (1630hrs), drove home, took TheraFlu and went to sleep (approx. 1730).  Woke (approx 2330hrs, Weds night) in profuse sweat and dizzy/disoriented.  Got some water; went back to sleep; joints still hurt; still extremely tired.   Woke Thurs. morning (approx 0400) still sweating and itchy; upon waking noted large distinct hives on torso, chest and arms; very itchy.  Joints still ached/hurt to move; had extremely painful migrane/headache (very sensitive to light/sound, "pain in the center of skull" which varied between different quadrants of head; eventually migrane nausea).  - Called in to work sick, took Tylenol went back to bed.  Could not sleep due to migrane.  - Migrane and muscle/joint pain began to ease approx. Thurs evening (approx 1700hrs) followed by deep sleep Thurs. night.  Woke Friday morning with 'residual' headache; reported for duty.
Age: 37.0
Sex: M
Vaccine: DTAP
Symptoms: Migraine, Muscle spasms, Photophobia, Pruritus, Urticaria
Clinical narrative: - Received shot Tues afternoon; minor discomfort at injection site.  - Started to feel extreme fatigue Weds. afternoon (approx 1300hrs) quickly followed by increasing muscle cramps and joint pain/joint aches.  - Finished workshift (1630hrs), drove home, took TheraFlu and went to sleep (approx. 1730).  Woke (approx 2330hrs, Weds night) in profuse sweat and dizzy/disoriented.  Got some water; went back to sleep; joints still hurt; still extremely tired.   Woke Thurs. morning (approx 0400) still sweating and itchy; upon waking noted large distinct hives on torso, chest and arms; very itchy.  Joints still ached/hurt to move; had extremely painful migrane/headache (very sensitive to light/sound, "pain in the center of skull" which varied between different quadrants of head; eventually migrane nausea).  - Called in to work sick, took Tylenol went back to bed.  Could not sleep due to migrane.  - Migrane and muscle/joint pain began to ease approx. Thurs evening (approx 1700hrs) followed by deep sleep Thurs. night.  Woke Friday morning with 'residual' headache; reported for duty.
Age: 11.0
Sex: F
Vaccine: RAB
Symptoms: Injection site rash
Clinical narrative: rash began 2 days following the injections. It began as a ring about an inch from every injection and on the next day had covered her whole body except the face. she began zyrtec on the 4th day of the injections
Age: 61.0
Sex: M
Vaccine: HEPAB
Symptoms: Arthralgia, Bone pain, Malaise, Myalgia, Oedema peripheral
Clinical narrative: A feeling of malaize approximately 12 hours after injection.  36 hours later, muscle pain in the upper inside of calf of lower left leg.  Pain in upper body joints and upper arm bones gradually increasing through first week after injection.  Almost exactly one week from injection, lower left leg and foot swell to approximately one and half normal size.  Doctor visit on eighth day and subsequent ultrasound to rule out blood clots.  Ceased all other meds and applied warm compresses to leg, elevated at night above heart...swelling reduced to approximately 10 to 20 percent above normal size.  Pain gradually reducing over time.  Still have swelling in late AM through PM, OK in early AM upon arising.  Still have joint and bone pain in upper body.  Intermittant feelings of malaize.
Age: 61.0
Sex: M
Vaccine: HEPAB
Symptoms: Ultrasound scan
Clinical narrative: A feeling of malaize approximately 12 hours after injection.  36 hours later, muscle pain in the upper inside of calf of lower left leg.  Pain in upper body joints and upper arm bones gradually increasing through first week after injection.  Almost exactly one week from injection, lower left leg and foot swell to approximately one and half normal size.  Doctor visit on eighth day and subsequent ultrasound to rule out blood clots.  Ceased all other meds and applied warm compresses to leg, elevated at night above heart...swelling reduced to approximately 10 to 20 percent above normal size.  Pain gradually reducing over time.  Still have swelling in late AM through PM, OK in early AM upon arising.  Still have joint and bone pain in upper body.  Intermittant feelings of malaize.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Sleep terror
Clinical narrative: Mom reports child developed night terrors and feels it is due to DtaP. Had first night terror night vaccine given, has had one again 2 other times when I spoke to mom again
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Fall, Headache, Hypotension, No reaction on previous exposure to drug
Clinical narrative: 06052009@9:16am MOC t.c. c/o mild dizziness 1 hours post vaccinations then severed ha, lbp and dizziness with falling this morning on ambulation.  had previous HPV vaccinations w/o issue, suspect menactra but referred to pmd for evaluation of any possible underlying medical conditions prior to this conclusion for patient safety and care.  MOC stated verbal understanding of instruction and will call pmd immediately.  per MOC pt is not suffering any breathing or chest pain currently but is aware to take to ER immediately if it occurs, MOC stated verbal understanding.
Age: 1.5
Sex: M
Vaccine: DTAP, MMR, PNC
Symptoms: Urticaria
Clinical narrative: Developed urticaria all over body 3 days after receiving vaccinations.  Also on a new med - flonase, and has tried a new food - cherries, so etiology unclear.  No breathing distress, fever, or difficulty swallowing.  Given benadryl.
Age: 19.0
Sex: F
Vaccine: IPV, TYP, YF
Symptoms: Dyspnoea, Vaccination complication
Clinical narrative: Above client had 3 vaccines administered on 5/26/09 @ approximately 12:00 pm. Client called @ approx 1:25 and stated "I'm having trouble breathing."  She was instructed by a nurse to go to the closest ER. If unable to drive, call 911. I received the message and try to call client (left message on phone) I called her Mom's cell phone and she said that she told client to use her asthma inhaler and see if she felt better.  I advised that patient should go to closest ER.  At approx 4.45 pm mother called to let me know that patient was in the ER and that she was told that this was probably a reaction from the vaccines she received earlier.  I followed up with client the next and she said that she doing well.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest X-ray, Erythema, Pyrexia, White blood cell count increased
Clinical narrative: Erythema, Swelling, Tenderness, fevers, Elevated white blood cell count. 6/26/2009 MR received for DOS 6/4-7/2009 with D/C DX: Cellulitis.  Pt presented with fever of 104"F, redness, induration, warm and tenderness at injection site, chills and malaise.  Seen by surgery-nothing to drain.  Tx IV abx. D/C on abx.   ICD9 780.6.
Age: 1.19
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PPV, VARCEL
Symptoms: Crying, Irritability, Pyrexia, White blood cell count increased
Clinical narrative: TC FROM MOTHER REQUESTING LIST OF IMMUNIZATIONS GIVEN AT LAST VISIT ON 05.27.2009 (MOTHER WAS GIVEN RECORD THE DAY OF IMMUNIZATIONS) STATES CHILD SAW MD YESTERDAY AS WAS FUSSY, AND HAD A FEVER OF 101 DEGREEES AND CRYING.  HAS HAD MANY EAR INFECTIONS IN PAST, EARS WERE OK BUT WBC WAS HIGH.  WAS GIVEN INJECTABLE ANTIBIOTIC AND IS GOING BACK TO THE CLINIC TODAY FOR ANOTHER INJECTION.  PARENT STATES CHILD IS DOING BETTER TODAY.
Age: 0.45
Sex: F
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Child received rotateq on 4/3/09 and was admitted to the hospital for intussusception on 4/9/09.  7/24/09 Hospital records received DOS 4/9/09 to 4/27/09 (Inpatient 4/9/09 to 4/13/09). Discharge Diagnosis: Status post exploratory laparotomy with manual reduction of intussusception and appendectomy. Parent reports child has bloody stools, projectile vomiting, and fever, 'grape jelly' stools. Unwilling to lay flat on her stomach. Abdominal pain. Has not been urinating as much as usual. Operative reduction of intussusception with appendectomy performed. 7/28/09-Diagnosis, 560.0; Abdominal Procedure, 46082; Surgery, 47.19  7/31/31 Hospital records received DOS 12/15/08 to 6/17/09. Additional information abstracted. ASSESSMENT: URI, wheezing, bronchospasm. Several months post surgery (exploratory laparotomy with manual reduction of intussusception and appendectomy) patient presents with wheezing, runny nose, and cough. A few episodes of posttussive emesis. Slight decreased by mouth intake.
Age: 23.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: swelling in left arm wth mild erythema on the site not likely cellulitis.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Chills, Headache, Lethargy, Pyrexia
Clinical narrative: Patient's mother calls to report that about 3 hours after immunizations received client began feeling "lethargic" and then later in the evening developed "low-grade fever, headache,and chills".  Mother does not know highest temp. because said temperature was not taken with a thermometer.  Client having symptoms at time of report but are not worsened.  Instructed mother to have patient rest, push fluids, and give tylenol and/or ibuprofen as directed and to call if any additional symptoms.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Crying, Injection site pain, Tenderness
Clinical narrative: He received Hib and DTP/DTap vaccinations on 04/Jun/2009 and developed pain and sore at the injection site.  He cried when I was holding him up, especially touching his arms.  He was difficult to hold his bottle and picked up things.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: VARICELLA FROM VACCINE
Age: 1.3
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Body temperature increased, Chest X-ray normal, Computerised tomogram normal, Convulsion, Electroencephalogram normal
Clinical narrative: Mom reports child had 1st seizure 6-3-09 at 2030 lasting approx. 1 min. taken directly to hospital ER. CT of head and CXR done.  Ativan and Tylenol supp. given.  Temp 101.7 CT and CXR WNL. Sent to Hosp per parents request.  Had 3 min. seizure in ambulance to hosp.  EEG done, normal.  Child is allegic to PCN.  Was given Omnicef by PCP on 5-27 for ear infection.  Mom stopped giving medication on 6-3. Discharged child with RX of Cefdinir 125mg 2.8ml bid x 10d. Child was afebrile at time of vaccine administration.  Parent agreed no temp prior to.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Abnormal faeces, Culture stool positive, Diarrhoea, Rotavirus test positive
Clinical narrative: 2 WEEKS OF DIARRHEA (5 TIMES DAILY), VERY ODOROUS
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Affective disorder, Arthralgia, Back pain, Dizziness, Headache
Clinical narrative: Dizziness, vomiting, headaches, pain in joints, backache, aches in the arm that was injected.  Bad mood and sleepnessness.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain, Insomnia, Vomiting
Clinical narrative: Dizziness, vomiting, headaches, pain in joints, backache, aches in the arm that was injected.  Bad mood and sleepnessness.
Age: 1.33
Sex: M
Vaccine: DTAP, FLUX, HEPA, MMR, PNC, VARCEL
Symptoms: Rash maculo-papular, Strawberry tongue
Clinical narrative: child experienced generalized macular papular rash over body with "strawberry toungue" beginning 06/03/09 afebrile
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: pt received vaccine on 6-2-09. on 6-5-09 patient still complains of injection site redness, warmth and itch. i advised pt to take some ibuprofen for the redness and swelling and benadryl for the itch. patient is to notify us if the symptoms stay the same or get worse within the next 24 hrs.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site swelling, Oxygen saturation normal, Urticaria
Clinical narrative: Child break out in hive after MMR and Varirex, the right thigh swell up and swollen where MMR was administered. Gave Benadryl 2.5 ml po x1 , no respiratory distress, Pul O2 100 %,  Observe for 30 minutes in office. Child is stable will start him on 3 days course of predinsone and RTC follow up on Sunday.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Intense pain in deltoid area, swelling and  slight fever. Pain for 3 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 6/3: Injection site became itchy within 1 hour & became very red that evening. 6/4: Site became painful, swollen, tneder, redness spread, and she became itchy all over her body. That night she began to experience severe itching where she previously had singles. Per PCP, patient can return to work if blisters to not appear by Tuesday am.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: 6/3: Injection site became itchy within 1 hour & became very red that evening. 6/4: Site became painful, swollen, tneder, redness spread, and she became itchy all over her body. That night she began to experience severe itching where she previously had singles. Per PCP, patient can return to work if blisters to not appear by Tuesday am.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: GAVE 2ND TdAP
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Lymphadenitis, Oedema peripheral
Clinical narrative: During the evening on the day of injection the patient developed a egg sized lump on the back of the right arm.  When the arm was reassessed in the morning the upper right arm was swollen rea and warm to the touch from the mid upper arm down to the mid forearm.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Pt. described itching during the night and small red dots over her body. She took Benadryl during the am and now (6-5-09,1:00pm) reports no S/S.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Stomatitis
Clinical narrative: MOTHER NOTICED ON 06/04/2009 2 SMALL WHITE SPOTS ON ROOF OF MOUTH.  NO FEVER, DID HAVE DAY OF IMMUNIZATIONS. ANOTHER SPOT A DEVOLOPED THIS AM.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: The injection site was found to be swollen, firm, red, and hot to touch. Patient temp of 99.00 in the afteroon after the injection resolved by 2300 that same night.
Age: 1.67
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt comes for evaluation of red swollen right thigh. Warm to touch. Sore. Treatment advised: supportive measures. Cool compresses and Tylenol.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: An hour later of administration of the vaccine Pt called the pharmacy complaining of numbness and tingling sensation.  From the talk to Doctor at office to report her S.E
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Skin swelling, erythema (10 x 10 cm area) itching, mild induration directly under injection site (2 x 2 cm area).
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 4.0cm x 6.5 cm erythema around injection site. Warm non tender.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Severe swelling, tenderness, redness and warmth over right deltoid appeared 2 days after injection. Mild erythema without warmth left upper arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Lower 2/3 of left arm with edema and erythema.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Localized reaction. Sore and swelling.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: Patient had severe localized reaction to this immunization.
Age: 45.0
Sex: F
Vaccine: HEPA
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Neck pain
Clinical narrative: This case was reported by a healthcare professional (also the subject) and described the occurrence of injection site pain in a 45-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). The subject had not experienced adverse events following previous vaccinations. Concurrent medications included TRIAMTERENE, MAXIDE and MULTIVITAMINS. On 12 May 2009 the subject received 1st dose of HAVRIX (unknown route, right arm). On 12 May 2009, immediately after vaccination with HAVRIX, the subject experienced injection site pain. On 22 May 2009, the pain had spread from her right shoulder/scapula down her arm and in her hand. On 28 May 2009, 16 days after vaccination with HAVRIX, the subject experienced neck pain and numbness in her right hand. The subject intended to seek medical attention. The healthcare professional considered the events were disabling. The subject was treated with MOTRIN. At the time of reporting the events had worsened. The healthcare professional considered the events were probably related to vaccination with HAVRIX.
Age: 1.3
Sex: U
Vaccine: DTAP, HEPA
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: Child presented to clinic 6-4-09 w. cc "crying a lot", 7 cm reddened swollen LAT at site of 4th INFANRIX. Mom advised to warm packs, return to clinic 3-4 days.
Age: 81.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pneumonia, Rhinorrhoea
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of pneumonia in a 81-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline) and received ADVAIR  250/50 multi dose powder inhaler over a period of 18 months for chronic obstructive pulmonary disease. A physician or other health care professional has not verified this report. The subject's medical history included allergy to CEFPODOXIME, CIPRO, SEPTRA, CODEINE, ENDOCET, MEGACE, TRIMADOL and SULFA. The subject had previously received unknown number of influenza vaccinations (manufacturer unknown), with no adverse events. The subject had not experienced adverse events following other previous vaccinations. Concurrent medical conditions included chronic obstructive pulmonary disease. Concurrent vaccination included pneumonia vaccine (non-GSK) (manufacturer unspecified). Concurrent medications included LISINOPRIL, WARFARIN, and DILTIAZEM. On an unknown date in 2007 the subject started Fluticasone propionate+salmeterol xinafoate (inhaled) twice per day. In the Fall of 2008 the subject received unspecified dose of FLUARIX (details unknown). On 24 February 2009, less than one year after vaccination with FLUARIX, the subject experienced pneumonia and runny nose. The subject noted that the pneumonia started out as a runny nose which would not stop. The subject was hospitalised for 6 days. Treatment with Fluticasone propionate+salmeterol xinafoate was continued. At the time of reporting the events were resolved.
Age: 22.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Shortness of breath and dizziness
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash, Skin infection
Clinical narrative: Pt was admitted to clinic with warm red areas on bilateral upper extremities.  Pt rec'd vaccines on 6/3/09. MENACTRA in (R) arm and Tdap in (L) arm IM.  Pt warm, red swollen area on (R) arm measured 5.5x3.5 inches; warm red, swollen area on (L) are measured 3x1.5 inches.  Pt treated by Dr., Dx- Rash + non specific skin infection, started septra 05x10 days.
Age: 12.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site induration, Injection site urticaria
Clinical narrative: 1 inch diameter induration with 2 in wheal on LA surrounding VARIVAX adm site. Normal pulses. bilat.
Age: 1.6
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Balance disorder, Blood culture, Body temperature increased, Chest X-ray normal, Crying
Clinical narrative: Pt started 2 days after vaccine T. 102 + more jerky movements  after 3 days  of vaccination as per mom less of balance and frequent falling lethargy, sleepiness, crying/inj Rocephin x1 Normal CBC - CXR- Pending u/cx - b/cx- no source of lab found in Pt 6am.
Age: 1.6
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Culture urine, Dyskinesia, Fall, Full blood count normal, Lethargy
Clinical narrative: Pt started 2 days after vaccine T. 102 + more jerky movements  after 3 days  of vaccination as per mom less of balance and frequent falling lethargy, sleepiness, crying/inj Rocephin x1 Normal CBC - CXR- Pending u/cx - b/cx- no source of lab found in Pt 6am.
Age: 1.6
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Somnolence, Urine analysis
Clinical narrative: Pt started 2 days after vaccine T. 102 + more jerky movements  after 3 days  of vaccination as per mom less of balance and frequent falling lethargy, sleepiness, crying/inj Rocephin x1 Normal CBC - CXR- Pending u/cx - b/cx- no source of lab found in Pt 6am.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Skin lesion
Clinical narrative: Redness, pain, swelling left arm onset day after rec'd VARICELLA vaccine in left arm.  Low grade fe.  T 99.2.  10 X 6 cm red tender lesion below inj site 6/5/09, had been 6 X 6 on 6/4/09 in ER.  Extends around upper arm.
Age: 24.0
Sex: M
Vaccine: FLU3, HEPA, TYP, YF
Symptoms: Influenza like illness, Malaise, Pruritus, Rash, Rash erythematous
Clinical narrative: 5/23/09 - chest & back rash red, bumps mild itching x 1 1/2 hrs without fever, general malaise saw MD 5/23/09. 6/1/09 Blood work showed low white blood cell count. Rash resolved now have flu like symptoms with partial recovery.
Age: 24.0
Sex: M
Vaccine: FLU3, HEPA, TYP, YF
Symptoms: White blood cell count decreased
Clinical narrative: 5/23/09 - chest & back rash red, bumps mild itching x 1 1/2 hrs without fever, general malaise saw MD 5/23/09. 6/1/09 Blood work showed low white blood cell count. Rash resolved now have flu like symptoms with partial recovery.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site irritation, Rash
Clinical narrative: Red, irritated skin under bandage around vaccination site. Individual, isolated rash clusters under arm & across chest and abdomen.
Age: 0.6
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Enema administration, Intussusception, Surgery
Clinical narrative: Pt developed intussusception requiring surgical reduction. Also had symptoms of resolving virus + viral exanthem c/w parvovirus (fifth's disease) on the day of when vaccines given.   6/15/09 Received hospital medical records of 5/31-6/3/2009. FINAL DX: Intussusception, s/p laparotomy w/manual reduction & appendectomy Records reveal patient experienced bilious emesis & bloody stools x 1 day.  Surgical consult done.  To OR when BE failed to reduce.  Progressed well & d/c to home.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: Low grade fever, overall "joint aching" + head "feels too big for her body"
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site discolouration, Muscle spasms, Pain
Clinical narrative: Acute muscle spasms to arm x 24hrs. Nickel sized area "bullseyes" at injection site. Unable to do prom because pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right deltoid with erythema and swelling.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Oedema peripheral, Pharyngeal oedema
Clinical narrative: Swelling, excessive of arm, shoulder & neck involving throat.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Rash, Skin warm, Swelling
Clinical narrative: Redness and swelling after 6 hours on date of vaccine. Then rash that became larger the next day. The next she mad an observation, was on 6/3/09 due to itching and noted large are of raise rash that was red, swollen and warm to touch.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Wheezing
Clinical narrative: Acute onset of wheezing approx 10 minutes post vaccine administered nebulized albuterol given.
Age: 18.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Blood test, Body temperature, Disorientation, Dyskinesia, Heart rate
Clinical narrative: Patient had received the Typhoid vaccine first. Then she was administered the Hep. A. As soon as the Hep, A was removed the nurse, patient slumped over as of she fainted, then stiffened as if in a mild seizure, shaking head and kicking, then came out of it. She was very pale, pulse was racing and disoriented for a few minutes.
Age: 18.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Musculoskeletal stiffness, Pallor, Syncope
Clinical narrative: Patient had received the Typhoid vaccine first. Then she was administered the Hep. A. As soon as the Hep, A was removed the nurse, patient slumped over as of she fainted, then stiffened as if in a mild seizure, shaking head and kicking, then came out of it. She was very pale, pulse was racing and disoriented for a few minutes.
Age: 34.0
Sex: M
Vaccine: HEP, TD
Symptoms: Dizziness
Clinical narrative: Received Tetanus booster and Hep B shot at 4:30pm on Thursday June 4th.  Woke up at 5:30 June 5th very dizzy.  Called Dr.  He said to wait it out and if it got worst to come in.  He recommended a Benadryl.  I took a Benadryl around 8am.  With 2 hours symptoms disappeared.I don't know the manufacturer...maybe the Dr. would know.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Bradycardia, Presyncope, Syncope
Clinical narrative: PT CAME IN TO RECIEVE ANTHRAX AND SMALLPOX  VACCINES AT 141 MDG WA ANG. PT RECIEVED INITIAL ANTHRAX VACCINE. HE WAS ASKED TO HAVE A SEAT IN WAITING AREA UNTIL TECHNICIAN WAS AVAILABLE TO GIVE SMALLPOX VACCINE. AFTER 15+MIN PT WAS ASKED TO COME INSIDE FOR SMALLPOX, BRIEFED ON VACCINE AND THEN HE HAD A SYNCOPE EPISODE. PT WAS LAYED ON THE GROUND, FEET ELEVATED, VITALS TAKEN OF INITIAL 98/72 FOR BP,AND IV STARTED W/18G R ARM AC 1000 CC FLUIDS OPEN BOLUS, AS WELL AS O2 GIVEN.  911 WAS CALLED AND AMR ARRIVED. PT HEART RHYTHME WAS EVALUATED AND WAS NOTED HAVING BRADYCARDIA BY PARAMEDIC.  PT WAS TAKEN TO DOWN TOWN SPOKANE HOSPITAL SACRED HEART.  PT WAS TREATED FOR A VASOVAGAL REACTION.  PT RETURNED A FEW HOURS LATER TO 141 MDG NOTING HE WAS FINE.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Activated partial thromboplastin time, Full blood count normal, Oedema, Petechiae, Prothrombin time normal
Clinical narrative: Pedal pecechiae & edema - transient & self resolving.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Colonoscopy normal, Fatigue, Myalgia, Rectal haemorrhage
Clinical narrative: Soreness in all muscle groups, Fatigue, rectal bleeding. (On initial series 6 doses bleeding remained for several months) Concurrent doses 1-2 weeks
Age: 1.04
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Regressive behaviour
Clinical narrative: Child went from a typically developing boy, to full regression in to Autism within one week of his MMR shots. He also recieved the Varicella vaccine on the same day. He has never received the 2nd dose of the MMR.
Age: 1.0
Sex: M
Vaccine: FLUX, VARCEL
Symptoms: Autism spectrum disorder, Food allergy, Urticaria
Clinical narrative: Broke out in hives (10/19/07).  Developed a allergy to peanuts which had not been present prior to the immunization.   Long term adverse affect PDDnos.  8/7/09 MR rec'd from PCP.  Infor WCC 10/9/07 with normal exam, no concerns. 10/19/09 hives 2' to eating peanut butter.  DX:  urticaria.  Parental concern 10/14/08 re: not talking yet and rxn to PB.  Assess:  Speech and  Language delay. Failure to thrive dx on 1/22/09. Neurodevelopmental eval 5/2009 with dx:  PDD-Autism spectrum disorder.  .
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, MMRV
Symptoms: Activities of daily living impaired, Bronchitis, Cough, Dyspnoea, Injection site erythema
Clinical narrative: Left upper thigh was red, warm, swollen & itchy shortly after the injections.  He was in pain & wanted to be carried because his legs were weak.  Around 8pm on 6/1, he was having difficulty breathing.  He was wheezing & coughting.  By 6AM on 6/2, he sounded like he had a whooping cough.  Breathing became progressively worse.  Around 8pm he vomited.  Wend to MD on 6/3 (AM) & was Dx with bronchitus & given a breathing treatment in the office.  He was also given scripts for Zithromax, Predisone, & Albutrol.  Began meds on 6/3, but continued to get worse & vomited again the night of 6/3 in the middle of the night while sleeping.  On 6/4 he was still coughing & having some breathing problems.  He was out of daycare/school from 6/2-6/4 & was picked up early on 6/5.  He was still & is still having breathing problems & coughing.  They are getting better, but the breathing problem are still there.  We will return to MD on 6/8 at 4PM.  6/9/09 Medical records received DOS 6/1//09 6/3/09. Assessment: Acute bronchospasm, bronchitis. Post vaccination: Coughing, wheezing and difficulty in breathing. Chest pain. Nasal congestion with post nasal drip. Scattered rales.  Follow-up: He has had continued complaints of leg pains and continued breathing problems with wheezing and coughing. On 3/8/10 he was again dx with bronchitis. We had to get a nebulizer w/ compressor. He was given steroids again, an antibiotic and albuterol for treatment. On 6/10/10 he was again dx w/ bronchitis. This time he is taking Amoxicillin, Albuterol and MUCINEX. We have an apt w/ an allergy specialist on 6/29/10. Prior to the vaccine he had no breathing problems. Now it seems like we go in for breathing problems frequently. The medications used to treat the breathing problems change his behavior and he complains that they make him "crazy", which I would interpret from a 5 yr old that it makes it difficulty for him to focus and think.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, MMRV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Muscular weakness
Clinical narrative: Left upper thigh was red, warm, swollen & itchy shortly after the injections.  He was in pain & wanted to be carried because his legs were weak.  Around 8pm on 6/1, he was having difficulty breathing.  He was wheezing & coughting.  By 6AM on 6/2, he sounded like he had a whooping cough.  Breathing became progressively worse.  Around 8pm he vomited.  Wend to MD on 6/3 (AM) & was Dx with bronchitus & given a breathing treatment in the office.  He was also given scripts for Zithromax, Predisone, & Albutrol.  Began meds on 6/3, but continued to get worse & vomited again the night of 6/3 in the middle of the night while sleeping.  On 6/4 he was still coughing & having some breathing problems.  He was out of daycare/school from 6/2-6/4 & was picked up early on 6/5.  He was still & is still having breathing problems & coughing.  They are getting better, but the breathing problem are still there.  We will return to MD on 6/8 at 4PM.  6/9/09 Medical records received DOS 6/1//09 6/3/09. Assessment: Acute bronchospasm, bronchitis. Post vaccination: Coughing, wheezing and difficulty in breathing. Chest pain. Nasal congestion with post nasal drip. Scattered rales.  Follow-up: He has had continued complaints of leg pains and continued breathing problems with wheezing and coughing. On 3/8/10 he was again dx with bronchitis. We had to get a nebulizer w/ compressor. He was given steroids again, an antibiotic and albuterol for treatment. On 6/10/10 he was again dx w/ bronchitis. This time he is taking Amoxicillin, Albuterol and MUCINEX. We have an apt w/ an allergy specialist on 6/29/10. Prior to the vaccine he had no breathing problems. Now it seems like we go in for breathing problems frequently. The medications used to treat the breathing problems change his behavior and he complains that they make him "crazy", which I would interpret from a 5 yr old that it makes it difficulty for him to focus and think.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, MMRV
Symptoms: Vomiting, Wheezing
Clinical narrative: Left upper thigh was red, warm, swollen & itchy shortly after the injections.  He was in pain & wanted to be carried because his legs were weak.  Around 8pm on 6/1, he was having difficulty breathing.  He was wheezing & coughting.  By 6AM on 6/2, he sounded like he had a whooping cough.  Breathing became progressively worse.  Around 8pm he vomited.  Wend to MD on 6/3 (AM) & was Dx with bronchitus & given a breathing treatment in the office.  He was also given scripts for Zithromax, Predisone, & Albutrol.  Began meds on 6/3, but continued to get worse & vomited again the night of 6/3 in the middle of the night while sleeping.  On 6/4 he was still coughing & having some breathing problems.  He was out of daycare/school from 6/2-6/4 & was picked up early on 6/5.  He was still & is still having breathing problems & coughing.  They are getting better, but the breathing problem are still there.  We will return to MD on 6/8 at 4PM.  6/9/09 Medical records received DOS 6/1//09 6/3/09. Assessment: Acute bronchospasm, bronchitis. Post vaccination: Coughing, wheezing and difficulty in breathing. Chest pain. Nasal congestion with post nasal drip. Scattered rales.  Follow-up: He has had continued complaints of leg pains and continued breathing problems with wheezing and coughing. On 3/8/10 he was again dx with bronchitis. We had to get a nebulizer w/ compressor. He was given steroids again, an antibiotic and albuterol for treatment. On 6/10/10 he was again dx w/ bronchitis. This time he is taking Amoxicillin, Albuterol and MUCINEX. We have an apt w/ an allergy specialist on 6/29/10. Prior to the vaccine he had no breathing problems. Now it seems like we go in for breathing problems frequently. The medications used to treat the breathing problems change his behavior and he complains that they make him "crazy", which I would interpret from a 5 yr old that it makes it difficulty for him to focus and think.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Headache, Malaise, Product contamination
Clinical narrative: Patient felt ill 11 days after ANTHRAX vaccination in 1998 & hospitalized at the end of work in service.  Pt has had headaches (daily) & joint pain since that time 11 years ago.  Pt found vaccine he was given was contaminated.  Pt seen for 1st time in our VA clinic on 5/6/09 where he reported the above.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Abdominal pain, Biopsy bone marrow, Blood bilirubin increased, Fatigue, Hepatic enzyme abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old female on 19-DEC-2008 was vaccinated intramuscularly into right arm with a first dose of GARDASIL (lot # 661531/1311X). Concomitant therapy included ADACEL and  HAVRIX. At time and the months up to March the patient was no local or systemic reaction to any of the Immunizations. On 03-March-2009 the patient came to the office with s/sx of fatigue, abdominal pain and jaundice. UA was done and showed 3 plus Bilirubin and 2 plus urobilirubin. She had hepatomegaly and splenomegaly and pharyngitis. Labs revealed Epstein Barr Positive IgG antibody which may indicate a past infection-mono. The patient returned to the clinic with severe jaundice. The patient had negative Hepatitis panel with abnormal Hepatic levels. The patient consulted Pediatric Infectious Disease Specialist, and repeat labs showed increases in liver enzymes and bilirubin level and US showed enlarged grossly thickened gallbladder wall, mild hepatomegaly and mod splenomegaly. There was no evidence of bilary duct obstruction or pancreatic abnormality noted. Hospital was consulted and patient was admitted where her hepatic levels continued to rise as well as her INR. She was at hospital for almost three weeks and a bone marrow was done. She was discharged 05-APR-2009 and her hepatic functions and INR are continuing to be monitored. This form is filled out at the request of physicians in the event the vaccines contributed to the illness. Doctor called this "seronegative hepatitis". On 16-APR-2009, records was received-for DOS from 17-MAR-2009 to 05-APR-2009: DC DX: DC DX: Liver failure, rash. The patient's Transaminases elevated. Needle biopsy showed acute hepatitis without necrosis. Hepatitis differential diagnosis is infectious versus autoimmune. Skin biopsy showed slig. The patient was presented with sudden onset of emesis, abdominal pain, diarrhea and jaundice 3 weeks prior to admission. The patient developed erythematous pruritic papular rash. Abdominal pain, jaundice, fatigue, hepatomegaly, splenomegaly, pharyngitis, urine analysis abnormal, urine bilirubin increased, urobilin urine present, hepatic failure, hepatitis, hepatitis viral test, hepatic enzyme abnormal, blood bilirubin increased, diarrhoea, vomiting, erythematous rash, rash pruritic, rash papular and biopsy bone marrow were considered to be immediately life-threatening and other important medical events. A standard lot check investigation was performed. All in-process quality checks for the lot number 661531/1311X in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Agency and was released. The VAERS # is 343764.