chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Crying, Hypersensitivity, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Mom called approx 1530 on 6/3/09 stating "my son got shots there yesterday now he is having an allergic reaction." Mom questioned as to what kind of allergic reaction child was having she stated "his leg where he got the shot is swollen and has a lump.  This never happened before. The lady that was there before told me this would be his last shot in the series."  I explained to mom that this is normal.  The child received a tetanus shot in the left leg, which was the one that was swollen.  I recalled the conversation I had with mom and dad about tetanus forming a lump in the muscle and the need to gently massage, cool compress today (6/2/09) and warm compress tomorrow (6/3/09).  Mom stated " I tried that it didn't work." I assured mom it may take more than one try to work the lump down. Mom said, " he cried last night, he never cries."  I asked if she gave Tylenol for comfort, she said "no he didn't have a fever".  I assured mom that Tylenol is also a pain reliever, and that his leg was probably sore from the shots.  Mom states, "no fever, no vomiting, no diarrhea. Child continues to eat and drink.  Mom told if continues to be concerned about childs condition by all means please seek medical attention at a doctor's office or nearest ER.  Mom encouraged to reread her VIS form.
Age: 67.0
Sex: M
Vaccine: VARCEL
Symptoms: Abdominal discomfort, Arthralgia, Flatulence, Headache, Injection site pain
Clinical narrative: 1. discomfort in abdomen, like cramping or feeling of gas. began approx 8 hours after injection ( 4:30 PM ) and lasted through the night. 2. aching in arm and leg joints. began upon rising in morning ---16 hours after injection. 3. soreness at sight continues after 20 hours 4. slight headache at 20 hours                                             Upon rising on 6/3 (40 hours after injection ) most of discomfort in joints has gone.
Age: 67.0
Sex: M
Vaccine: VARCEL
Symptoms: Muscle spasms
Clinical narrative: 1. discomfort in abdomen, like cramping or feeling of gas. began approx 8 hours after injection ( 4:30 PM ) and lasted through the night. 2. aching in arm and leg joints. began upon rising in morning ---16 hours after injection. 3. soreness at sight continues after 20 hours 4. slight headache at 20 hours                                             Upon rising on 6/3 (40 hours after injection ) most of discomfort in joints has gone.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site mass, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: A LARGE RED BUMP FIRST SHOWED ON WEDNESDAY, 27 MAY, THEN AS THE DAYS PROGRESSED THE BUMP STAYED BUT THE REDNESS MOVED TO THE OUTSIDE OF THE BUMP.  THE REDNESS AND SWELLING ALSO BEGAN TO GROW FROM THE OUTSIDE AND FORMED MORE BUMPS SURROUNDING IT.  THE INJECTION SITE IS HOT TO THE TOUCH AND ITCHES.  WAS SEEN BY CLINIC YESTERDAY, 2 JUN, AND WAS DIRECTED TO RETURN TO IMMUNIZATIONS TO COMPLETE FORM.  WAS GIVEN ANTIBIOTIC AND ITCHING MEDICINE FROM CLINIC.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of right arm where vaccine was given. Antibiotics and antihistamines given.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Headache, Syncope
Clinical narrative: I felt intense headaches and fainted and had a seizure.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Headache, Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: About 5 hours after receiving the third of three injections of  GARDASIL, I began to experience intense muscular pain and headache which continued for about 24 hours. After that time the majority of muscle pain subsided, although my lower back and neck - particularly the levator scapulae- were still sore and stiff. I did not experience any adverse side effects after the first two injections of GARDASIL
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug
Clinical narrative: About 5 hours after receiving the third of three injections of  GARDASIL, I began to experience intense muscular pain and headache which continued for about 24 hours. After that time the majority of muscle pain subsided, although my lower back and neck - particularly the levator scapulae- were still sore and stiff. I did not experience any adverse side effects after the first two injections of GARDASIL
Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Hodgkin's disease, Lymphadenopathy
Clinical narrative: Close to 9 months after being given the GARDASIL vaccine. I had a ct scan done, which showed that my lymph nodes were enlarged. A little over a year later. I was diagnosed with Hodgkin's Lymphoma -HL-. I am now undergoing chemotherapy treatment for this illness. This vaccine needs to be researched properly. I am convinced there is an increased risk for Lymphoma in women who were vaccinated. How many people have to die or get seriously sick for this vaccine to be investigated? I known of several women who became sick with Lymphoma months following vaccination with GARDASIL. I do not believe this is a mere coincidence. Statistical data would prove a connection, I'm certain. No oncologist or other doctor has ever asked me whether I was vaccinated with GARDASIL.  6/15/09 Oncology records received DOS 12/23/08 to 5/5/09. FINAL DIAGNOSIS: Hodgkin's Disease Lymphocytic Depletion, Unspec Site. Presented with complaints of fever and swollen cervical lymph nodes. Fatigue, pain/discomfort right neck. Night sweats. Decreased appetite. Muscle weakness and soreness in joints. Numbness right hand. Peri-anal itching, diarrhea, rectal fissure pain. Undergoing six cycles of chemotherapy. Has chemotherapy related side effects.  ICD-9 Code: 201.70  6/19/09 PMH records received. PMH:  Appy, ankle fx, ovarian cyst, blocked duct, UTI.  6/24/09 Medical, vaccine records received. DOS 4/23/07 to 5/17/07. Medical records consist of laboratory studies only.
Age: 39.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Arthralgia, Bone pain, Erythema, Headache, Malaise
Clinical narrative: On Tuesday arm (R) became painful - swollen and red. Pt took TYLENOL all day. On Wed 6/309 Pt begins with "spinal pain" body aches, headaches, hip pain, malaise. Given 125 mg SOLUMEDROL.
Age: 39.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Oedema peripheral, Pain, Pain in extremity
Clinical narrative: On Tuesday arm (R) became painful - swollen and red. Pt took TYLENOL all day. On Wed 6/309 Pt begins with "spinal pain" body aches, headaches, hip pain, malaise. Given 125 mg SOLUMEDROL.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Hyperaemia, Injection site oedema
Clinical narrative: R deltoid edema erythema hyperemia measuring 15X12 cm oval.
Age: 29.0
Sex: F
Vaccine: HEPAB
Symptoms: Dyskinesia, Loss of consciousness, Nausea, Syncope
Clinical narrative: 5/29/09 Approx. 10:45 AM - Pt fainted outside clinic in the front passenger side of her car. Revived when her arm was shook by nurse. Ambulance was called by front desk staff. B/P- 98/60 P-62 R- 12 - C/O nausea, nurse cooled her with cool washcloth, Husband was with her he stated he seen her make jerking movements before passing out. Ambulance arrived and transported her to hospital.
Age: 69.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: Td given 5/21/09 LDT - RTC 5/27/09 and large red warm localized reaction to Td.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Itchy, erythematous, macular rash on her back, trunk. No fever.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Lt arm lateral 5 inches x 2 inches tender, erythematous swelling.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Rash erythematous, Urticaria
Clinical narrative: Immediate red rash raised bumps (hive-like) 1 patient sat for 1/2 hr gave Benadryl 12.5 melt tablets (1) + 1 to take home (2prn) = 4 tablets (iced rash immediately)
Age: 27.0
Sex: F
Vaccine: TYP
Symptoms: Flushing, Palpitations
Clinical narrative: Client called Health center on 6/3/09 2:20 PM to report flushing, palpitations. Had 2-3 episodes of palpitations and flushing. Vaccination for Typhoid given a day before. Pt told to follow up with Hospital ER. If it continued. Pt has no physician. Pt called again at 6pm. No report she wasn't feeling any better. Told to call an ambulance.
Age: 11.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Oedema peripheral
Clinical narrative: Pt had a swollen arm.  was seen a ER & followed up with us 5 days after initial shot 3 days after ER vistis.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Bacterial culture, Nausea, Skin lesion, Viral test, Vomiting
Clinical narrative: Patient given Pneumovax on 5-26-09.  He states that he became nauseated within a few minutes, then vomitted.  The following day, he developed blister- like lesions, which later ulcerated.  Lesions located on (R) shoulder, (R) arm, groin area.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Mass, Musculoskeletal pain, Pain in extremity
Clinical narrative: 4-30-09 VARICELLA vaccine given all following info received from clinic 5-6 DEPO PROVERA shot - 5-11 " Lump on arm" - Pain shoulder to elbow" 5-13 AUGMENTIN for cellulitis in left deltoid
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: cellulitis 4cm x 2.5 cm indurated, increased warmth, fever 39.8 C Keflex prescribed
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: cellulitis 4cm x 2.5 cm indurated, increased warmth, fever 39.8 C Keflex prescribed
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Excoriation, Face injury, Fall, Mouth injury
Clinical narrative: After receiving immunizations and walking to office to be checked out he became "light headed" fainted hitting desk. Small abrasion R eye brow + bottom lip.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Syncope
Clinical narrative: After receiving immunizations and walking to office to be checked out he became "light headed" fainted hitting desk. Small abrasion R eye brow + bottom lip.
Age: 1.17
Sex: M
Vaccine: IPV, MU
Symptoms: Anorexia, Irritability, Pyrexia, Respiratory rate increased
Clinical narrative: fever over 103 for 3 days, loss of apetite, body aches, fast breething, fussiness
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Dizziness, Dyspnoea, Immediate post-injection reaction, Pallor
Clinical narrative: w/in 3 minutes of receiving the 1st does of gardisil she was dizzy, pale, light headed, saying that she couldn't breathe. it sounded like she was gasping for air.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Back pain, Chills, Erythema, Nausea, Neck pain
Clinical narrative: FEVER OF 101.8, ACHY ALL OVER WITH SHOOTING PAINS DOWN ARMS AND LEGS OCCASIONALLY.  PATIENT ALSO FELT PAIN IN MIDDLE OF BACK AND NECK WHEN LOOKING DOWN. CHILLS AND SLIGHT NAUSEA.  C/O OF FEET HOT AND BRIGHT RED.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pain, Pyrexia, Skin warm
Clinical narrative: FEVER OF 101.8, ACHY ALL OVER WITH SHOOTING PAINS DOWN ARMS AND LEGS OCCASIONALLY.  PATIENT ALSO FELT PAIN IN MIDDLE OF BACK AND NECK WHEN LOOKING DOWN. CHILLS AND SLIGHT NAUSEA.  C/O OF FEET HOT AND BRIGHT RED.
Age: 1.6
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Swelling face, Urticaria
Clinical narrative: Within 15 minutes cheeks were red and swollen with urticaria
Sex: F
Vaccine: MMR
Symptoms: Haemorrhage intracranial, Idiopathic thrombocytopenic purpura
Clinical narrative: Information has been received from a pharmacist regarding a case in litigation concerning a young female relative (exact age unknown) of a healthcare worker who was vaccinated with a dose of MMR II several years ago. It was reported that the patient developed idiopathic thrombocytopenic purpura shortly after receiving the vaccine. The child subsequently developed an intracranial hemorrhage and "almost died". The patient sought unspecified medical attention. The child did fully recover. The reporter considered the adverse experiences to be life-threatening. Additional information has been requested.
Sex: M
Vaccine: RVX
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a registered nurse concerning a child male patient who on approximately 27-MAY-2009 was vaccinated with the first dose of either ROTATEQ or ROTARIX. On 30-MAY-2009 the patient experienced rotavirus symptoms and was hospitalized. On an unspecified date, the patient had a positive test for rotavirus. In the morning of 01-JUN-2009, the patient had been discharged from the hospital and had recovered. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial information has been received from a nurse and follow up information from a medical assistant who reported that a 49 year old female was on 20-APR-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot #662667/1435X), 0.5 ml. On approximately 20-APR-2009 the patient experienced pain, redness, warmth on the injection site and the injection site was tender to the touch. She sought unspecified medical attention. The medical assistant reported that she did not know the patient's status as she had not kept her appointment. Follow up information received on 01-JUN-2009 from a medical assistant stated that a manager had no illness at the time of vaccination, and on 21-APR-2009 (not 20-APR-2009 as previously reported) at 12:22 was vaccinated with the first dose of PNEUMOVAX 23 (lot 662667/1435X), intramuscularly into the left deltoid. On the same date the patient developed severe swelling, warmth and erythema (patient reported). No laboratories studies performed. In follow up, the medical assistant reported that the severe swelling, warmth and erythema resulted in persistent or significant disability/incapacity. The patient's outcome was unknown. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Information has been received from a pharmacist reported that a patient was believed to received a dose of PNEUMOVAX 23 in April 2009 but no documentation could be produced (immunization status unclear). On approximately 29-MAY-2009 the patient experienced pneumonia and was hospitalized. At the time of reporting, the outcome was unknown. No further information is available.
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site vesicles
Clinical narrative: Pt c/o redness, swelling and itchy @ site 3cm x 2cm raised rash R upper arm with Sl blistering . Benadryl + Ibuprofen PRN, cold compresses to area advised by MD.
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash generalised, Rash papular, Skin nodule
Clinical narrative: Generalized nodular papular rash
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness. swelling, heat @injection site
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness on the area of injection 5x8 cm with 2x3 cm of - induration.
Age: 1.3
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Varicella post vaccine
Clinical narrative: Varicella vaccine break through. Diagnosed with varicella on 5-29-09
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Paralysis
Clinical narrative: Ascending motor paralysis  6/9/09 Hospital ER records received DOS 5/28/09. Post immunization patient c/o shoulder pain, knee pain, generalized aches, weakness, headache. Discharged.  6/11/09 Vax records and ICD-9 codes received. ICD-9 Codes: 786.50 chest pain, 995.3 allergic reaction unspecified, 732.4 Osgood-Slatter, V40.0 Problem learning, 314.01 Attention deficit disorder with hyperactivity, V65.3 Counseling, dietary / Nutritional Assessment, V20.2 Well Adolescent.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Patient came to the clinic 6-1-09.  Stating she had a red area on left thigh.  States the red area started on Sat and has gotten larger.  Band aids are still over inj site  the area of redness is more distal and medial 4 X 4"
Age: 18.0
Sex: U
Vaccine: HEPA, HPV4, TDAP
Symptoms: Chest discomfort, Immediate post-injection reaction
Clinical narrative: Sensation of chest tightness within 5 min after immunization with HEPA, HPV, TDAP. PPD test done also at same time. Symptoms persisted for 3 days until Albuterol was given. Symptoms not reported to office staff there in office - asked to stay in office for 15 minutes after shots were given.
Age: 10.0
Sex: F
Vaccine: HPV4, MMR
Symptoms: Abortion, Drug exposure during pregnancy, Foetal disorder, Ultrasound scan abnormal
Clinical narrative: Pt denied being preg. 12/31/08.  Had US on Feb'2009 and was informed baby had problems and abortion done 3/18/09 at OB.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fatigue
Clinical narrative: 06/04/2009 MILD Other - Fatigue, Some dizziness
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Received vaccine 5/27/2009 and seen 5/29/2009 with red very swollen arm treated with BENADRYL, ice, Hydrocortisone 1% cream for itching.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site rash, Rash pruritic
Clinical narrative: Large red mildly itching rash, 10 cm, over injection site
Age: 38.0
Sex: F
Vaccine: LYME
Symptoms: Neuropathy peripheral
Clinical narrative: Periphral Neuropathy.  3-6mo after vaccine. Tests, pain medication.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: 1 day following vaccination, child developed erythema and edema of lower, lateral aspect of upper right arm, in region of subcutaneous varicella vaccine administration.  Patient seen on 6/3/2009 with same complaint and diagnosed with moderate local vaccine reaction.  Parent advised to administer oral diphenhydramine to patient to reduce local swelling. By phone report on 6/4/2009, swelling has decreased; no new symptoms.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Computerised tomogram, Concussion, Loss of consciousness
Clinical narrative: RECIEVED TDAP, GARDISIL, MENINGOCOCCAL INJECTION, TOLERATED WELL, WALKED OUT OF EXAM ROOM AND PASSED OUT (5 -7 MINUTES AFTER INJECTIONS)  6/10/09 Hospital records received DOS 6/3/09 to 6/4/09. FINAL DIAGNOSIS: Syncope, closed head injury. Post vaccination patient passed out, hit back of head, had brief jerking activity. Emotional, crying, headache, left hand numbness. Nausea, visual changes, lightheaded. Tenderness, swelling over occiput.  7/16/09 ICD-9 Codes: 780.2, 959.01, 784.0, 780.4
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Body temperature increased, Chills, Injection site erythema, Injection site induration, Muscle spasms
Clinical narrative: PATIENT HAD PNEUMOVAX ON RIGHT DELTOID AREA ON 3/30/09 .ON 3/31/09 HE HAD MUSCLE ACHES AND ON 4/1/09 DEVELOPED FEVER , CHILLS AND NOTICED REDNESS IN DELTOID AREA, WHICH HAd INCREASED . HE HAS APPLIED ICE OVER AREA AND TAKEN IBUPROFEN AND TYLENOL FOR PAIN. Patient given CEPHALEXIN 500 MG PO QID X 10 DAYS and was told to follow-up if symptoms persisted. patient did not return in 10 days so symptoms improved.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: PATIENT HAD PNEUMOVAX ON RIGHT DELTOID AREA ON 3/30/09 .ON 3/31/09 HE HAD MUSCLE ACHES AND ON 4/1/09 DEVELOPED FEVER , CHILLS AND NOTICED REDNESS IN DELTOID AREA, WHICH HAd INCREASED . HE HAS APPLIED ICE OVER AREA AND TAKEN IBUPROFEN AND TYLENOL FOR PAIN. Patient given CEPHALEXIN 500 MG PO QID X 10 DAYS and was told to follow-up if symptoms persisted. patient did not return in 10 days so symptoms improved.
Age: 60.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Injection site pain
Clinical narrative: PATIENT STATED THAT SHE EXPERIENCED DEEP THROBBING PAIN AT THE SITE OF INOCULATION ON 5/20/2009. SHE SOUGHT MEDICAL ATTENTION FROM HER PRIMARY CARE PHYSICIAN WHO PRESCRIBED MOTRIN AND WARM COMPRESS. THIS ALLEVIATED THE SYMPTOMS PAIN RETURNED AT INTERVALS.
Age: 60.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Activities of daily living impaired, Injection site pain, Pain
Clinical narrative: PATIENT STATED THAT SHE EXPERIENCED DEEP THROBBING PAIN AT THE SITE OF INOCULATION ON 5/20/2009. SHE SOUGHT MEDICAL ATTENTION FROM HER PRIMARY CARE PHYSICIAN WHO PRESCRIBED MOTRIN AND WARM COMPRESS. THIS ALLEVIATED THE SYMPTOMS PAIN RETURNED AT INTERVALS.
Age: 31.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Body temperature increased, Headache, Nausea, Vomiting
Clinical narrative: Called Immunization clinic 6/04/09 at 12:30 PM, C/O headache on 6/03/09 (the evening of taking the vaccines.)  Headache worse 6/04/09 with Nausea/Vomiting and "Temperture" (no thermometer)nurse advised client to go to ER for evaluation (over the phone)
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash pruritic, Rash vesicular, Varicella post vaccine
Clinical narrative: Pt started with rash and fever of 102 on 05/30/2009 and continued with pruritic rash that developed into red oval shaped areas with vesicular lesion on each (like dew drop on rose petal) as seen upon exam by physician on 06/01/2009. Pt was given dx of Chicken Pox/Varicella.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site haematoma, Injection site induration, Injection site pain
Clinical narrative: Pt received vaccines on 6/2/09.  On 6/3/09 after pt got home from school, mom called office stating arms were now both red at injection sites and sore.  Advised at that time to apply cool compresses and take tylenol.  No fever, pt feeling okay, no respiratory problems.  On 6/4/09, spoke with pt's mom again and redness was spreading down his arms  - half-way to elbow on left, starting to spread down right as well. (left was worse than right arm).  Mom stating still no fever and no respiratory problems.  pt's arms red, swollen, and very sore.  Skin warm to the touch and skin feeling hard.  No blisters or open areas.  Pt unable to sleep due to this.  Per Dr. - pt with localized skin reactions on both arms.  Dr. prescribed CEFDINIR 300 MG PO CAPS 1 capsule daily for 10 days and listed diagnosis code as CELLULITIS OF ARM [682.3] as well.  Also on left arm, pt had diamond shaped bruise at injection site.  Otherwise, pt feeling fine.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: Pt received vaccines on 6/2/09.  On 6/3/09 after pt got home from school, mom called office stating arms were now both red at injection sites and sore.  Advised at that time to apply cool compresses and take tylenol.  No fever, pt feeling okay, no respiratory problems.  On 6/4/09, spoke with pt's mom again and redness was spreading down his arms  - half-way to elbow on left, starting to spread down right as well. (left was worse than right arm).  Mom stating still no fever and no respiratory problems.  pt's arms red, swollen, and very sore.  Skin warm to the touch and skin feeling hard.  No blisters or open areas.  Pt unable to sleep due to this.  Per Dr. - pt with localized skin reactions on both arms.  Dr. prescribed CEFDINIR 300 MG PO CAPS 1 capsule daily for 10 days and listed diagnosis code as CELLULITIS OF ARM [682.3] as well.  Also on left arm, pt had diamond shaped bruise at injection site.  Otherwise, pt feeling fine.
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: rash, redness, swelling at site, started 2 days after injection.
Age: 1.42
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Swelling face
Clinical narrative: facial swelling morning after vaccine, no fever, no treatment needed
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles symptoms appears one week after receiving vaccine.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Convulsion, Dyskinesia, Loss of consciousness, Pallor, Urinary incontinence
Clinical narrative: Approx 5 min after receiving immz, pt appeared to have a seizure; loss of consciousness <45 seconds, jerky movements, urinated on self.  Ammonia inhalant used, pt. conscious, pale color, O2 givenapprox after 1 minute pt AOX3.  However, approx in the next 3 minutes pt again appears to have another seizure in the same manner as above, lasting approx <45 seconds.  911 called, pt stabilized and transported to ER.  I spoke with the parent the next day and she advises that they discharged her and diagnosed her as having a seizure and the follow up; the parent advised she will follow up.  6/10/09 Received ER medical records of 6/1/2009. FINAL DX: acute syncopal episode, mild volume depletion Records reveal patient experienced altered mental status x 2 episodes, dizziness, hypotonia & orthostatic collapse w/fall, tonic-clonic seizure-like activity, urinary incontinence.  Was hypotensive in ER.  Tx w/IVF, improved & d/c to home w/PCP f/u.  Returned to ER on 6/2/09.  FINAL DX: Fever, viral syndrome. Experienced low-grade fever.  Tx w/IV antibiotic.  LP performed.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Balance disorder, Computerised tomogram, Convulsion, Electroencephalogram, Headache
Clinical narrative: Approx 5 min after receiving immz, pt appeared to have a seizure; loss of consciousness <45 seconds, jerky movements, urinated on self.  Ammonia inhalant used, pt. conscious, pale color, O2 givenapprox after 1 minute pt AOX3.  However, approx in the next 3 minutes pt again appears to have another seizure in the same manner as above, lasting approx <45 seconds.  911 called, pt stabilized and transported to ER.  I spoke with the parent the next day and she advises that they discharged her and diagnosed her as having a seizure and the follow up; the parent advised she will follow up.  6/10/09 Received ER medical records of 6/1/2009. FINAL DX: acute syncopal episode, mild volume depletion Records reveal patient experienced altered mental status x 2 episodes, dizziness, hypotonia & orthostatic collapse w/fall, tonic-clonic seizure-like activity, urinary incontinence.  Was hypotensive in ER.  Tx w/IVF, improved & d/c to home w/PCP f/u.  Returned to ER on 6/2/09.  FINAL DX: Fever, viral syndrome. Experienced low-grade fever.  Tx w/IV antibiotic.  LP performed.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Lumbar puncture, Pyrexia, Syncope, Vomiting
Clinical narrative: Approx 5 min after receiving immz, pt appeared to have a seizure; loss of consciousness <45 seconds, jerky movements, urinated on self.  Ammonia inhalant used, pt. conscious, pale color, O2 givenapprox after 1 minute pt AOX3.  However, approx in the next 3 minutes pt again appears to have another seizure in the same manner as above, lasting approx <45 seconds.  911 called, pt stabilized and transported to ER.  I spoke with the parent the next day and she advises that they discharged her and diagnosed her as having a seizure and the follow up; the parent advised she will follow up.  6/10/09 Received ER medical records of 6/1/2009. FINAL DX: acute syncopal episode, mild volume depletion Records reveal patient experienced altered mental status x 2 episodes, dizziness, hypotonia & orthostatic collapse w/fall, tonic-clonic seizure-like activity, urinary incontinence.  Was hypotensive in ER.  Tx w/IVF, improved & d/c to home w/PCP f/u.  Returned to ER on 6/2/09.  FINAL DX: Fever, viral syndrome. Experienced low-grade fever.  Tx w/IV antibiotic.  LP performed.
Age: 1.09
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, PNC, VARCEL
Symptoms: Activated partial thromboplastin time, Anaemia, Angiogram, Cerebral infarction, Cerebral ischaemia
Clinical narrative: After well-baby check-up and vaccination on 4-20-09, visited physician on 4-23-09 with N/V and lethargy.  By that evening, she was taken to the ED with seizures.  At Hospital she was still having seizures and now decerebrate posturing.  At that time she was entubated.  On 4-25-09 she was transferred to Hospital where she was diagnosed with rt ICA dissecting aneurysm, s/p hemorrhage, cerebral ischemia/infarct, intracranial hypertension, seizures, lt hemiparesis, rt cranial nerve palsy, s/p decompression craniectomy, anemia and hyponatremia. On 6-4-09 she was transferred for rehabilitation after 41 days hospitalization.  6/19/09 Hospital records DC summary received DOS 4/29/09 to 6/4/09. Assessment: Cerebral infarction, ruptured intracranial hemorrhage, aneurysm of the right internal carotid artery. Patient presented with repeated episodes of vomiting. Appeared tired and sleepy. Later difficulty falling asleep, intermittent extending and flexing of right arm, kicking while asleep. Generalized jerking. Found unresponsive with unequal pupils. Respiratory failure - placed on ventilator. Bruise right thigh. Anemia. Endotracheal tube, gastric tube placed. Decompression craniotomy. Left lung collapse, right lung hyperinflated. Subsequent left hemiparesis, dysphagia, language delay.  7/29/09- ICD-9 codes: 430. 345.90, 518.81, 348.5, 787.29, 599.0, 348.2, 464.10, 0411.0, 342.90, 720.29.
Age: 1.09
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, PNC, VARCEL
Symptoms: Convulsion, Cranial nerve paralysis, Craniectomy, Culture urine, Endotracheal intubation
Clinical narrative: After well-baby check-up and vaccination on 4-20-09, visited physician on 4-23-09 with N/V and lethargy.  By that evening, she was taken to the ED with seizures.  At Hospital she was still having seizures and now decerebrate posturing.  At that time she was entubated.  On 4-25-09 she was transferred to Hospital where she was diagnosed with rt ICA dissecting aneurysm, s/p hemorrhage, cerebral ischemia/infarct, intracranial hypertension, seizures, lt hemiparesis, rt cranial nerve palsy, s/p decompression craniectomy, anemia and hyponatremia. On 6-4-09 she was transferred for rehabilitation after 41 days hospitalization.  6/19/09 Hospital records DC summary received DOS 4/29/09 to 6/4/09. Assessment: Cerebral infarction, ruptured intracranial hemorrhage, aneurysm of the right internal carotid artery. Patient presented with repeated episodes of vomiting. Appeared tired and sleepy. Later difficulty falling asleep, intermittent extending and flexing of right arm, kicking while asleep. Generalized jerking. Found unresponsive with unequal pupils. Respiratory failure - placed on ventilator. Bruise right thigh. Anemia. Endotracheal tube, gastric tube placed. Decompression craniotomy. Left lung collapse, right lung hyperinflated. Subsequent left hemiparesis, dysphagia, language delay.  7/29/09- ICD-9 codes: 430. 345.90, 518.81, 348.5, 787.29, 599.0, 348.2, 464.10, 0411.0, 342.90, 720.29.
Age: 1.09
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, PNC, VARCEL
Symptoms: Haemorrhage, Hemiparesis, Hyponatraemia, International normalised ratio, Intracranial aneurysm
Clinical narrative: After well-baby check-up and vaccination on 4-20-09, visited physician on 4-23-09 with N/V and lethargy.  By that evening, she was taken to the ED with seizures.  At Hospital she was still having seizures and now decerebrate posturing.  At that time she was entubated.  On 4-25-09 she was transferred to Hospital where she was diagnosed with rt ICA dissecting aneurysm, s/p hemorrhage, cerebral ischemia/infarct, intracranial hypertension, seizures, lt hemiparesis, rt cranial nerve palsy, s/p decompression craniectomy, anemia and hyponatremia. On 6-4-09 she was transferred for rehabilitation after 41 days hospitalization.  6/19/09 Hospital records DC summary received DOS 4/29/09 to 6/4/09. Assessment: Cerebral infarction, ruptured intracranial hemorrhage, aneurysm of the right internal carotid artery. Patient presented with repeated episodes of vomiting. Appeared tired and sleepy. Later difficulty falling asleep, intermittent extending and flexing of right arm, kicking while asleep. Generalized jerking. Found unresponsive with unequal pupils. Respiratory failure - placed on ventilator. Bruise right thigh. Anemia. Endotracheal tube, gastric tube placed. Decompression craniotomy. Left lung collapse, right lung hyperinflated. Subsequent left hemiparesis, dysphagia, language delay.  7/29/09- ICD-9 codes: 430. 345.90, 518.81, 348.5, 787.29, 599.0, 348.2, 464.10, 0411.0, 342.90, 720.29.
Age: 1.09
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, PNC, VARCEL
Symptoms: Intracranial pressure increased, Lethargy, Nausea, Posturing, Rehabilitation therapy
Clinical narrative: After well-baby check-up and vaccination on 4-20-09, visited physician on 4-23-09 with N/V and lethargy.  By that evening, she was taken to the ED with seizures.  At Hospital she was still having seizures and now decerebrate posturing.  At that time she was entubated.  On 4-25-09 she was transferred to Hospital where she was diagnosed with rt ICA dissecting aneurysm, s/p hemorrhage, cerebral ischemia/infarct, intracranial hypertension, seizures, lt hemiparesis, rt cranial nerve palsy, s/p decompression craniectomy, anemia and hyponatremia. On 6-4-09 she was transferred for rehabilitation after 41 days hospitalization.  6/19/09 Hospital records DC summary received DOS 4/29/09 to 6/4/09. Assessment: Cerebral infarction, ruptured intracranial hemorrhage, aneurysm of the right internal carotid artery. Patient presented with repeated episodes of vomiting. Appeared tired and sleepy. Later difficulty falling asleep, intermittent extending and flexing of right arm, kicking while asleep. Generalized jerking. Found unresponsive with unequal pupils. Respiratory failure - placed on ventilator. Bruise right thigh. Anemia. Endotracheal tube, gastric tube placed. Decompression craniotomy. Left lung collapse, right lung hyperinflated. Subsequent left hemiparesis, dysphagia, language delay.  7/29/09- ICD-9 codes: 430. 345.90, 518.81, 348.5, 787.29, 599.0, 348.2, 464.10, 0411.0, 342.90, 720.29.
Age: 1.09
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, PNC, VARCEL
Symptoms: Transfusion, Vomiting
Clinical narrative: After well-baby check-up and vaccination on 4-20-09, visited physician on 4-23-09 with N/V and lethargy.  By that evening, she was taken to the ED with seizures.  At Hospital she was still having seizures and now decerebrate posturing.  At that time she was entubated.  On 4-25-09 she was transferred to Hospital where she was diagnosed with rt ICA dissecting aneurysm, s/p hemorrhage, cerebral ischemia/infarct, intracranial hypertension, seizures, lt hemiparesis, rt cranial nerve palsy, s/p decompression craniectomy, anemia and hyponatremia. On 6-4-09 she was transferred for rehabilitation after 41 days hospitalization.  6/19/09 Hospital records DC summary received DOS 4/29/09 to 6/4/09. Assessment: Cerebral infarction, ruptured intracranial hemorrhage, aneurysm of the right internal carotid artery. Patient presented with repeated episodes of vomiting. Appeared tired and sleepy. Later difficulty falling asleep, intermittent extending and flexing of right arm, kicking while asleep. Generalized jerking. Found unresponsive with unequal pupils. Respiratory failure - placed on ventilator. Bruise right thigh. Anemia. Endotracheal tube, gastric tube placed. Decompression craniotomy. Left lung collapse, right lung hyperinflated. Subsequent left hemiparesis, dysphagia, language delay.  7/29/09- ICD-9 codes: 430. 345.90, 518.81, 348.5, 787.29, 599.0, 348.2, 464.10, 0411.0, 342.90, 720.29.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Depressed level of consciousness, Echocardiogram normal, Electroencephalogram normal, Loss of consciousness, Tonic clonic movements
Clinical narrative: Was standing in line 5-10 minutes after the injection making an appointment when she lost conciousness and suffered tonic clonic movements for 30 seconds and then did not respond completely with alertered conciousness.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Amnesia, Contusion, Full blood count normal, Gaze palsy, Grand mal convulsion
Clinical narrative: Was standing in line 5-10 minutes after the injection making an appointment when she lost conciousness and suffered tonic clonic movements for 30 seconds and then did not respond completely with alertered conciousness.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Head injury, Headache, Loss of consciousness, Muscle twitching, Neck pain
Clinical narrative: Was standing in line 5-10 minutes after the injection making an appointment when she lost conciousness and suffered tonic clonic movements for 30 seconds and then did not respond completely with alertered conciousness.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pallor, Ultrasound scan normal
Clinical narrative: Was standing in line 5-10 minutes after the injection making an appointment when she lost conciousness and suffered tonic clonic movements for 30 seconds and then did not respond completely with alertered conciousness.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, No reaction on previous exposure to drug, Swelling
Clinical narrative: Given 3rd GARDASIL on 5/27/2009 - swelling/ redness started within 24 hours - seen 5/29/09 - treated with MOTRIN, BENADRYL. No previous Rxn to GARDASIL
Age: 1.6
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Rash morbilliform
Clinical narrative: 10 days after receiving MMR, patient developed measles like rash.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives all over body.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Fatigue, Feeling abnormal, Nausea, Paraesthesia
Clinical narrative: Felt bad last PM (about 5-6 hours after injection) very fatigued then this AM 6/4/09 dizzy, nauseated. Now slightly better. No rash - No difficulty breathing. No numbness ...tingling in legs.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Rash pruritic
Clinical narrative: Very itchy rash on chest, abdomen, and eyes
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Pt experienced (L) arm pn @ injection site with approximately 1 cm surrounding ecchymosis, arm has erythema/induration heat approximately 115x10 cm total.  Quite warm to touch.  No tx @ this time.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Rash, Rash papular
Clinical narrative: Rash developed one month after the vaccine was given. Rash is red, bumps, painful on arms and legs. Was seen by PCP and given PREDNISONE. Continues to have painful rash as of 6/4/09.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Rash papular
Clinical narrative: Rash - Red, papular to trunk & limbs 3 days after vaccine - lasted one week - No treatment
Age: 1.6
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Vomiting projectile
Clinical narrative: Projectile vomiting approximately 8-9 hours after vaccines given - administered @ ~1500 on 06/03/09 Started vomiting ~ 0100 - 0200 06-/04 /09
Age: 49.0
Sex: M
Vaccine: TTOX
Symptoms: Chest discomfort, Dizziness, Feeling cold, Hyperhidrosis, Tremor
Clinical narrative: Pt received immunization 9:05 AM, pt went out to smoke a cigarette, 15 mins later started feeling dizzy and sweating. Pt went inside to sit, started to feel his chest constrict/tighten, resolved in 5 mins. Pt started to feel chilly, started to shake, feeling cold. Pt did say his teeth were chattering and felt cold during plasma donation previous to immunization. Pt recovered 10:08 AM
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Nausea, Vomiting
Clinical narrative: Employee had c/o nausea with emesis after injection by another nurse earlier that day.  He was told to check with this nurse before leaving his shift.  He did.  feel better, but did state that during his last series, years ago, that he had a "seizure".  Informed mgmt.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 2 doses PEDIARIX given simultaneously
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Paraesthesia oral, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash in a 58-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline).  The subject had consumed tuna fish and wore latex gloves prior to vaccination with BOOSTRIX.  She had previously received flu vaccination (vaccine details unknown) on an unknown date with no known adverse reaction.  The subject's medical history included poison ivy the previous week and used CLARITIN and local application.  Concurrent medications included CLARITIN.  On 27 April 2009 at approximately 09:00 the subject received a dose of BOOSTRIX (0.5 ml, unknown route, left arm).  On 07 May 2009, 10 days after vaccination with BOOSTRIX, the subject experienced rash and tingling of lips.  The healthcare professional considered the events were clinically significant (or requiring intervention).  The subject was treated with PREDNISONE by her dermatologist.  At the time of reporting the outcome of the events were was unspecified.  Follow-up information received on 01 June 2009 indicated that the subject experienced an undetermined sensitivity reaction with rash and tingling of lip.  The outcome of these events was not known at the time of follow-up.  In the reporter's opinion, the events were possibly related to treatment with BOOSTRIX.
Age: 46.0
Sex: F
Vaccine: HEPAB
Symptoms: Erythema multiforme, Pain, Rash
Clinical narrative: This case was reported by a physician via a GSK representative, and described the occurrence of a rash in an adult subject of unspecified gender who was vaccinated with (TWINRIX, GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX (details unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced "significant" rash. At the time of reporting the outcome of the event was unspecified. Follow-up information received on 01 June 2009 indicated that the subject was a 46 year old female with a history of cardiac arrhythmia. She received TWINRIX 1.0 ml in the left deltoid on 30 March 2009. The next day, on 31 March 2009, the subject developed a painful rash and was diagnosed with erythema multiforme. The event reportedly jeopardized the subject or required intervention and resolved by 03 April 2009. In the reporter's opinion, the event was related to vaccination with TWINRIX. Concurrent medication reported was Atenolol.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration
Clinical narrative: 3 X 3 cm induration (R) arm
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Psychomotor hyperactivity
Clinical narrative: Baby given VYANESE doses after vaccines.  A couple of hours later hyperactive behavior had escalated more than normal.  Called pediatrician but did not make recommendations.  Doctor visit on 6/4/09 began treatment to detox body from vaccines.  Currently, hyperactivity on & off; can't focus.
Age: 5.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Pt received shot Fri - Pt brought in Monday to be seen. Noted markedly erythematous area that measures probably 3 x 2 cm. around that faint redness 0 tender 0 warm 0 infection noted. Additional information . Tuesday 6/02/09 mother was asked to bring child in for follow-up. Mother declined states legs reddened and has no further concerns, but will call if necessary.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Hypoaesthesia, Myelitis transverse, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Around 4 days after Hepatitis B vaccine my thumb and pointer finger on right hand were numb and i went to my family doctor and within the next week it spread to the rest of my hand and i lost the ability to control movement in my right hand went to get MRI and lesions were shown in spinal cord and brain was referred Dr. and she said MS type symptoms and called it a rare immunization reaction called Transverse Myelitis
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Crying
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of crying in a 6-month-old male subject who was vaccinated with (INFANRIX, GlaxoSmithKline). Concurrent vaccination included (HIB, Sanofi) and (PREVNAR, Wyeth) both given on 7 November 2007. There were no concurrent medications. On 7 November 2007 the subject received 3rd dose of INFANRIX at 0.5 ml in the left thigh. At an unspecified time after vaccination with INFANRIX, on 7 November 2007, the subject experienced persistent crying. On 9 November 2007, the event was resolved after 36 hours. The healthcare professional considered the event was probably related to vaccination with INFANRIX.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, DTAP
Symptoms: Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of extensive swelling of the vaccinated limb in a 4-year-old male subject who was vaccinated with INFANRIX, AVENTIS. On 12 March 2008 at 12:30 the subject received 5th dose of INFANRIX (unknown, left arm) and the subject received 3rd dose of Polio vaccine (unknown). On 14 March 2008, 2 days after vaccination with INFANRIX and Polio vaccine, the subject experienced severe swelling in left upper arm through elbow. This case was also associated with a pharmaceutical product complaint as the reporter is concerned that something is wrong with these vaccines and that they ar holding on to them to return to GSK if necessary. The lot number for INFANRIX was reported to be AC14606999. The physician considered the events were clinically significant (or requiring intervention). The subject was seen in the physician's office and treated with antibiotics. At the time of reporting the outcome of the severe arm swelling was resolved. The physician considered the extensive swelling of the vaccinated limb was possibly related to vaccination with INFANRIX and Polio vaccine. The physician indicated that she had a second patient with the same issues. See GSK case number A0723483A for details. Follow-up information was received on 09 May 2008 via a physician, who reported that the polio vaccine received was actually the 4th dose in the series, rather than 3rd dose as originally reported. The reporting physician also indicated that the extensive swelling of the vaccinated limb was not related to the Polio vaccine. In addition, the physician stated that the event occurred on 15 March 2008, three days after vaccination with INFANRIX instead of 14 March 2008 as originally reported. The physician stated that the subject was also treated with steroid, in addition to the originally reported antibiotics, and the events resolved. The physician considered the event to be possibly related to the use of INFANRIX, and also listed this particular batch (lot # AC14B069AA) of the vaccine as a possible cause.