chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: Left thigh swelling since 5/25/04 PM. Seen in follow up 5/26/04 4:00 PM. treated with cool compresses, Tylenol.
Age: 1.8
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Left thigh red, hot and swollen.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Blister, Erythema, Swelling, Tenderness
Clinical narrative: Left thigh red, tender and swollen. 3.5cm larger than right leg. Large vesicle/bulba on top of left thigh the size of a quarter.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site vesicles
Clinical narrative: Left thigh red, tender and swollen. 3.5cm larger than right leg. Large vesicle/bulba on top of left thigh the size of a quarter.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: Left leg swollen, hot, red and tender to touch. Left thigh measured 34cm compared to right leg at 30cm.
Age: 38.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: Member informed MDG via telephone with complaints of swelling, redness to posterior upper extremity arm, hot to touch, area growing larger.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Convulsion, Pyrexia
Clinical narrative: Temperature up to 106; then had a seizure. Seen at ER.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Urticaria face with localized reaction erythema around injection site.
Age: 22.0
Sex: U
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: red rash both arms back of neck
Age: 17.0
Sex: F
Vaccine: SMALL
Symptoms: Arthralgia, Arthritis, Cerebrovascular accident, Condition aggravated, Pain
Clinical narrative: A consumer reported that she received a dose of Dryvax in August 1968. Medical history included rheumatoid arthritis dizzy spells, removal of joints from her toes in both feet, and a mini stroke/transient ischemic attack confirmed on nuclear magnetic resonance imaging two years ago. Concomitant therapy included Methotrexate, Coumadin, Maxzide, and folic acid. In October 1968, the patient indicated she had a huge flare-up of the rheumatoid arthritis. She stated that every joint of her body was affected and she was subsequently hospitalized for three days. She was treated with prednisone. In October 1969, the patient was hospitalized for rheumatoid arthritis and received steroids. The reporter indicated that the reaction abated and the minor aches and pains were controlled with aspirin. In 1980, the symptoms reappeared and the patient experienced painful, inflamed joints. A definitive diagnosis of rheumatoid arthritis was made. In the summer of 2003, the patient is scheduled to have tendons repaired in her hands and to begin Remicade infusions.
Age: 17.0
Sex: F
Vaccine: SMALL
Symptoms: Rheumatoid arthritis, Transient ischaemic attack
Clinical narrative: A consumer reported that she received a dose of Dryvax in August 1968. Medical history included rheumatoid arthritis dizzy spells, removal of joints from her toes in both feet, and a mini stroke/transient ischemic attack confirmed on nuclear magnetic resonance imaging two years ago. Concomitant therapy included Methotrexate, Coumadin, Maxzide, and folic acid. In October 1968, the patient indicated she had a huge flare-up of the rheumatoid arthritis. She stated that every joint of her body was affected and she was subsequently hospitalized for three days. She was treated with prednisone. In October 1969, the patient was hospitalized for rheumatoid arthritis and received steroids. The reporter indicated that the reaction abated and the minor aches and pains were controlled with aspirin. In 1980, the symptoms reappeared and the patient experienced painful, inflamed joints. A definitive diagnosis of rheumatoid arthritis was made. In the summer of 2003, the patient is scheduled to have tendons repaired in her hands and to begin Remicade infusions.
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chills
Clinical narrative: Information regarding Dryvax was received from a healthcare professional regarding a male patient who experienced chills. The patient received a dose in 2003. Relevant medical history was not provided. Indication for Dryvax was immunization. Product was administered in 2003. Dose regimen was 1 dose 1 time per day (IM). Additional suspect medication included Anthrax Vaccine. Concomitant medications were not reported. The patient experienced chills (rigors). No additional information was available at the time of this report.
Sex: F
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a female patient who in approximately April 2002, was vaccinated with a dose of hepatitis A virus vaccine inactivated. The reporter indicated that about a year ago the patient had a reaction within 24 hours following the vaccination. She developed a non-vesicular rash on the face, cheek, ear, and eye (on both sides of face). The treatment included hydroxyzine embonate, prednisone, and hydrocortisone cream. It was not known how long it took for the reaction to resolve. Unspecified medical attention was sought. It was indicated that the patient recovered. A product quality complaint was not involved. Follow up was received from the registered nurse which indicated that no further medical information was available. No further information is expected.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain, Abdominal pain upper, Diarrhoea, Injection site mass, Nausea
Clinical narrative: Information has been received from a certified medical assistant concerning a 13 year old female who on 5/7/02 and on 6/19/03 was vaccinated with a first (lot # 642671/0103M) and a second dose (lot # 645482/0153N) of hepatitis A virus vaccine inactivated (0.5ml), respectively. There was no concomitant medication. The patient had some stomach pain and nausea after the first dose, which reportedly subsided. Following the second dose, the patient had a local reaction with a goose egg size bump, nausea, vomiting, abdominal pain, diarrhea and a generalized rash. The patient was taken to the emergency room and required treatment was noted. She was not admitted. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Rash, Vomiting
Clinical narrative: Information has been received from a certified medical assistant concerning a 13 year old female who on 5/7/02 and on 6/19/03 was vaccinated with a first (lot # 642671/0103M) and a second dose (lot # 645482/0153N) of hepatitis A virus vaccine inactivated (0.5ml), respectively. There was no concomitant medication. The patient had some stomach pain and nausea after the first dose, which reportedly subsided. Following the second dose, the patient had a local reaction with a goose egg size bump, nausea, vomiting, abdominal pain, diarrhea and a generalized rash. The patient was taken to the emergency room and required treatment was noted. She was not admitted. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a male patient with a history of drug addiction who on 6/25/03 was vaccinated with a dose of hepatitis A virus vaccine inactivated. Three days post vaccination on 6/28/03, the patient developed a generalized rash. Unspecified medical attention was sought, but the patient was not hospitalized. At the time of the report, the patient was fine and it was noted that he recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Asthma, Condition aggravated, Tremor, Wheezing
Clinical narrative: Information has been received from a licensed practical nurse concerning a 7 year old female student with asthma and an allergy to penicillin who on 8/18/03 at 10:00 was vaccinated IM in the left arm with a second dose of hepatitis A virus vaccine inactivated (lot # 646368/0498N). Concomitant therapy included pirbuterol acetate inhalent. The patient was ill with asthma at the time of vaccination. On 8/18/03, the patient's mother called the medical office from home stating that the patient's opposite (unvaccinated) arm began shaking and the patient began to wheeze. The physician stated that the patient's right had and arm had tremors after leaving the immunization clinic. The reporting nurse directed the mother to take the patient to her physician. Unspecified medical attention was sought and no treatment was required. The reporter noted that the therapy was discontinued on 8/18/03. A product quality complaint was not involved. On 9/2/03, it was reported that the physician was called the following day and stated that the child was fine. The patient was having an asthma attack. The patient went to school with no problem. She did not have to go to a doctor, she just took medicine from her pirbuterol acetate inhalant. No further information is expected.
Age: 47.0
Sex: F
Vaccine: HEPA
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning an approximately 47 year old female patient who was vaccinated with three doses of hepatitis A virus vaccine inactivated. The registered nurse reported the patient has not responded. The reporter indicated she did not have the patient's chart in front of her since they are opening a new practice, and they have yet relocated all the old charts. The registered nurse also reported that there were no dates of immunization available at this time, and no additional information was provided. There was no product quality complaint reported. Unspecified medical attention was sought. The reporter also mentioned that the same patient had a similar experience following vaccination with hepatitis B virus vaccine. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Drug ineffective, Hepatitis A
Clinical narrative: Information has been received from a consumer concerning his son who was vaccinated with two doses of hepatitis A virus vaccine inactivated. The father indicated that some blood work recently came back indicating his son may have hepatitis A. He reported they still were not sure if he had it or not. Lot numbers were not available and it was unknown if treatment was required. No product quality complaint was involved. Unspecified medical attention was sought. Follow up information from the patient's mother indicated that there were no problems with the vaccines. She indicated that turns out it was an other related problem. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Irritability, Lethargy, Pallor, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 24 month old female with no past medical history and no concurrent conditions who on 4/10/03, also reported as 4/10/02, was vaccinated IM in the left arm with a first 25u 0.5mL dose of hepatitis A virus vaccine inactivated (lot # 639847/0909L). There was no illness at the time of vaccination. There was no concomitant medication. On 4/12/03, two days later, the patient developed a fever. On 4/20/03, ten days later, the patient looked pale and lethargic. Unspecified medical attention was sought. There was no product quality complaint. No other information was available. There were no adverse events following prior vaccinations of the patient or her siblings. Follow up information received from a physician indicated that on 4/12/03, 2 days after vaccination, the patient developed a fever. On 4/19/03, the child was pale and not herself. This was reported as still intermittent. Additional follow up information received from a physician indicated that on 4/12/03 the child started with the onset of the fever. The mother called on 4/19/02 to indicate that her child was very pale, looked sick, was fussy, her body was warm and her hands were cold, and she was not herself. The mother indicated that this had all occurred since shot last week. The mother called again on 5/19/02 and indicated that the child still appeared very pale to the mother, otherwise she was acting fine, indicating that she was playful, sleeping well, and had a good appetite. Laboratory data is listed below. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 20 year old male with rhinitis allergic and atopic dermatitis who was vaccinated with one dose of hepatitis A virus vaccine inactivated. Within a few hours of vaccination, the patient experienced urticaria. The physician reported that the patient now develops urticaria upon exertion/exercise. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 57 year old white female with no known drug allergies or medical history who on 10/15/03 at 10:00 Am was vaccinated in the right deltoid with a second dose of hepatitis A virus vaccine inactivated (lot # 643456/0701M). There was no illness at the time of vaccination. The reporter indicated that the patient has since developed pain and redness at the injection site. No other symptoms were reported. Unspecified medical attention was sought and on treatment was required. A product quality complaint was not involved. Follow up information was received from the physician which indicated that on 10/16/03 the patient developed local swelling and induration. No diagnostic tests were performed. The patient recovered on 10/23/03. It was also noted that the patient had no adverse events following prior vaccination. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from registered nurse concerning her 16 year old daughter who had no significant medical history or allergies who on 7/31/01 was vaccinated with the first dose of hepatitis A virus vaccine inactivated. There was no concomitant therapy. The patient's mother indicated that her daughter was vaccinated with a dose of hepatitis A virus vaccine inactivated from a recalled lot (lot # not provided(. The patient's mother reported that on 10/10/03, her daughter's hepatitis A titer was negative. Unspecified medical attention was sought. A repeat hepatitis A titer was again negative. At that time, a two shot series of hepatitis A virus vaccine inactivated was restarted. At the time of this report, the outcome is unknown. The RN also reported that she and her other daughter were also vaccinated with a dose of Hepatitis A virus vaccine inactivated from the same recalled lot, but have not had titers drawn. No further information is available.
Age: 4.0
Sex: M
Vaccine: HEPA, IPV, MMR
Symptoms: Feeling hot, Rash, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male with no allergies who on 9/4/03 was vaccinated with a dose of hepatitis A virus vaccine inactivated (lot # 646423/0500N). On approximately 9/4/03 the patient developed 5 generalized small raised bumps which were1/2 inch diameter and felt warm. The patient recovered in a few days. Unspecified medical attention was sought. There was no product quality complaint. The nurse also reported that the patient was vaccinated on 11/3/03 with a first dose of MMR vaccine (lot # 644843/1229M) administered SC in the left and a fourth dose of poliovirus vaccine inactivated (batch # W1156) and the patient had a similar reaction. No further information is expected.
Age: 4.0
Sex: M
Vaccine: HEPA, IPV, MMR
Symptoms: Feeling hot, Rash maculo-papular
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male with no allergies who on 9/4/03 was vaccinated with a dose of hepatitis A virus vaccine inactivated (lot # 646423/0500N). On approximately 9/4/03 the patient developed 5 generalized small raised bumps which were1/2 inch diameter and felt warm. The patient recovered in a few days. Unspecified medical attention was sought. There was no product quality complaint. The nurse also reported that the patient was vaccinated on 11/3/03 with a first dose of MMR vaccine (lot # 644843/1229M) administered SC in the left and a fourth dose of poliovirus vaccine inactivated (batch # W1156) and the patient had a similar reaction. No further information is expected.
Age: 43.0
Sex: F
Vaccine: HEPA
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 43 year old female who on 9/10/03 was vaccinated with hepatitis A virus vaccine inactivated (lot # 644169/0981M). Subsequently, hepatitis A titers at 2 and 4 weeks were negative. The patient sought unspecified medical attention. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: HEPA
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 43 year old African American female with no allergies or medical history who on 9/10/03 was vaccinated with a dose of hepatitis A virus vaccine inactivated. There was no illness at the time of vaccination. On 11/1/03, the patient had a lab drawn, which was negative for HAV AB. The patient was noted to be otherwise healthy and was manifesting no other signs or symptoms. Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information was received from the registered nurse which indicated that the lab report was supplied by the patient through her primary care provider. The nurse indicated that she did not administer the vaccine and that it was given at another location, possibly her primary care physician. One month after vaccination, the patient had routine blood work done for an annual examination. The patient requested the hepatitis A antibody titer because she was traveling overseas and wanted to be sure she was protected. The patient called the reporters office to receive immune globulin because she was told her lab work came back negative. The patient brought the lab report to the reporter's office. The nurse indicated that the lab report was read to the advising physician and verified that it was a negative result. It was decided that the patient would benefit from both immune globulin and hepatitis A vaccination. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 42 year old female employee with no allergies and no past medical history who on 11/12/03 was vaccinated IM in her right arm with a dose of hepatitis A virus vaccine inactivated (lot # 646663/0652N). There was no concomitant medication. Exactly 23 hours later on approximately 11/13/03, the patient developed large welts all over her body, which was also described as a rash. Unspecified medical attention was sought, but laboratory tests were not performed. The patient took diphenhydramine hydrochloride, Subsequently, the rash completely resolved and the patient recovered. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Injection site pain, Skin discolouration
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated in 2002 with a dose of hepatitis A virus vaccine inactivated. The patient recently came back for a visit to the physician's office. The reporter stated the patient still complains of some pain at injection site as well as discoloration. It was noted that the physician could not remember what hepatitis A vaccine was given because the patient went to a different clinic for the vaccination. Unspecified medical attention was sought. There was no product quality complaint involved. It was also noted that the physician refused to provide additional information, and does not want to be contacted. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: HEPA
Symptoms: Drug ineffective, Medication error
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old female with anemia, colitis and Crohn's disease who on 13-Dec-2001 was vaccinated with a dose of hepatitis A virus vaccine inactivated. Concomitant therapy included cyanocobalamin (B12) injections. It was reported that the patient never returned for the booster dose. On 17-Dec-2003 a hepatitis A titer was taken and was negative. No prescription drug was required. A product quality complaint was involved. Unspecified medical attention was sought. No additional information is expected.
Sex: F
Vaccine: HEPA
Symptoms: Injury
Clinical narrative: Information has been received from a physician indicating that the office received 10 packs of hepatitis A virus vaccine inactivated (Lot #647587/0966N), and 2 bottles were broken. One vial neck was broken and the vial completely shattered, and a second vial neck/top was broken off. A nurse in the office cut her finger on the broken bottle, and it bled. Unspecified medical attention was sought. A product quality complaint was filed. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Drug ineffective, Injection site mass, Injection site reaction, Oedema, Pain
Clinical narrative: Information has been received from a physician concerning a 10 year old African American female with no past medical history who on 22-Aug-2001 was vaccinated with a second dose of hepatitis A virus vaccine inactivated (lot #644075/0736M) (IM). There was no illness at the time of vaccination. The patient developed a "knot" in her upper arm and complained of pain. The patient had little bumps around the injection site. The patient's left upper arm showed mild edema. There was no heat. The patient had approximately "2 cm fullness and induration in deltoid muscle". There were fine papules scattered around site. The patient also had a temperature of 99.2 F. The patient was given diphenhydramine HCl (Benadryl) (2 tsps every 6-8 hours) and acetaminophen (Tylenol) (PRN). It was also reported that the patient had "developed hepatitis A". The patient sought unspecified medical attention. There were no relevant diagnostic tests or laboratory data performed. The patient did not experience any adverse events following prior vaccinations. It was reported that the patient recovered. No further information is expected.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, Rash papular, Skin nodule
Clinical narrative: Information has been received from a physician concerning a 10 year old African American female with no past medical history who on 22-Aug-2001 was vaccinated with a second dose of hepatitis A virus vaccine inactivated (lot #644075/0736M) (IM). There was no illness at the time of vaccination. The patient developed a "knot" in her upper arm and complained of pain. The patient had little bumps around the injection site. The patient's left upper arm showed mild edema. There was no heat. The patient had approximately "2 cm fullness and induration in deltoid muscle". There were fine papules scattered around site. The patient also had a temperature of 99.2 F. The patient was given diphenhydramine HCl (Benadryl) (2 tsps every 6-8 hours) and acetaminophen (Tylenol) (PRN). It was also reported that the patient had "developed hepatitis A". The patient sought unspecified medical attention. There were no relevant diagnostic tests or laboratory data performed. The patient did not experience any adverse events following prior vaccinations. It was reported that the patient recovered. No further information is expected.
Sex: U
Vaccine: HEPA
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a licensed practical nurse concerning a dialysis patient who in the past, was vaccinated with a series of hepatitis A virus vaccine inactivated (manufacturer unknown). It is reported that the patient failed to develop immunity. The licensed practical nurse reported that it is not known whether the patient received the vaccination before or after initiation of dialysis treatment. The licensed practical nurse also reported the dose and lot numbers are not known. It was noted that at the time of this report the patient is scheduled to receive another series of hepatitis A virus vaccine inactivated. There was no specific patient information available at the time of this report. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested. The licensed practical nurse also mentioned the same patient failed to develop immunity following vaccination with the dialysis formulation series of hepatitis B virus vaccine RHBsAg (yeast) (manufacturer unknown) (0403USA00320).
Sex: F
Vaccine: HEPA
Symptoms: Injury
Clinical narrative: Information has been received from a registered nurse, who is a public health nurse concerning a female nurse colleague, who in January 2004, was vaccinated with a second dose of hepatitis A virus vaccine inactivated (lot #645022/0065N). The registered nurse reported the female colleague had a needle stick injury. On 04-Mar-204 the nurse colleague had blood drawn for a laboratory study of hepatitis A immunoglobulin M antibody and now she is IGM positive for hepatitis A. The registered nurse reporter stated it was unknown if the needle stick mishap was with a patient who had hepatitis A or not. It was unknown whether treatment was required for the adverse event. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEPAB, TYP, YF
Symptoms: Crohn's disease
Clinical narrative: Given yellow fever on 6 mp- for Crohn's (mercaptopurine). Patient has remained healthy.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Asthenia, Convulsion, Loss of consciousness, Salivary hypersecretion
Clinical narrative: After Vaccination, dressed and walked to front desk to check out, where he became weak and passed out.  He foamed at mouth and lost bladder control.  BP dropped and he stopped breathing. Dr. brought him to consciousness in less than 60 seconds.  Estimated time from vaccination to mild seizure was 3 minutes.  Ambulance was called, but cancelled due to prompt revival.
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Fatigue, Pruritus, Vaccination complication, Viral infection
Clinical narrative: Patient reports getting smallpox vaccination 9 days ago.  He complains of an area on his chest that came up at about the same time period as the vaccination site.  He complains that the site on his chest is itchy and that it seems like it might be the vaccine spreading.  He complains of the typical symptoms of fatigue and feeling like he has a viral infection.  He wears a long sleeve shirt but complains that he has trouble not picking at sores.  He also notices three more spots.  One on his right chin, upper abdomen, and one on his back.
Age: 28.0
Sex: F
Vaccine: DT
Symptoms: Erythema, Feeling hot
Clinical narrative: GIVEN A DT SHOT LEFT DELTOID. COMPLAINED OF RED-HOT ARM. PAIN RADIATION DOWN ARM. SHOT GIVEN 5-24-04, AT 1230 PM. REPORTED SXS ON 5-26. SAID NOTED SHORTLY AFTER SHOT. HAD EVAL BY MD ON  5-26-04. TOLD TO USE BENADRYL AND ICE. TO GET TETANUS ONLY, IN FUTURE, INSTEAD OF DIP/TET.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Pyrexia, Swelling
Clinical narrative: WITHIN 24 HOURS HAD SOME REDNESS, SWELLING, AND LOW GRADE FEVER.   AFTER 24 HOURS, REDNESS SPREAD TO LARGER AREA.   WAS SEEN BY PROVIDER AND DX WITH CELLULITIS.  PRESCRIBED KEFLEX.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: red rash/swelling at injection site (MMr). Resolved with antihistamines (oral).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: Patient with onset of erythema and slight swelling of Left deltoid area 1 day after vaccine adminstration.  Patient with full use of left arm/hand, no limitation of activities.  Patient without fever, vomiting, diarrhea, or other systemic symptoms.  Patient had a 4.5 inch x 5.25 inch area of blanching erythema on left deltoid.  No evidence of pustule or discharge.
Age: 64.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Cough, Dyspnoea, Heart rate increased, Hypoaesthesia, Peripheral coldness
Clinical narrative: Client was seen in Travel clinic.  Was given Hepatitis A and oral Typhoid Fever vaccine (to take at home).  Client took first of 4 capsules on Tuesday afternoon on an empty stomach.   She started coughing sometime in the afternoon, and went to work.  At 5 pm, she was sent home from work.  On Wednesday afternoon, she went to Urgent Care at 3:50 pm, for Rapid heart beat, SOB, shaking all over, and cold and numbness to all extremities. Uncertain when symptoms started on 5/26/04.
Age: 64.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Tremor
Clinical narrative: Client was seen in Travel clinic.  Was given Hepatitis A and oral Typhoid Fever vaccine (to take at home).  Client took first of 4 capsules on Tuesday afternoon on an empty stomach.   She started coughing sometime in the afternoon, and went to work.  At 5 pm, she was sent home from work.  On Wednesday afternoon, she went to Urgent Care at 3:50 pm, for Rapid heart beat, SOB, shaking all over, and cold and numbness to all extremities. Uncertain when symptoms started on 5/26/04.
Age: 1.3
Sex: F
Vaccine: DTAP
Symptoms: Injection site induration, Injection site pain, Injection site vesicles, Pyrexia
Clinical narrative: Induration, pain,  fine vesicles  at site of injection  system  fever
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Erythema, Nausea, Oedema peripheral, Pruritus
Clinical narrative: Client called and had gone to the doctor the next day.  States the doctor determined it probably was the vaccine as there were not any other different factors identified.  symptoms included: puffy legs and feet, skin red all over like a sunburn, blotchy, itchy type rash. Some nausea and diarrhea. She was put on prednisone for about a week.  Client states it took about two weeks before she completely returned to normal.  She had two prior hepatitis b vaccinations, october and november 2003 without any problems.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Rash macular
Clinical narrative: Client called and had gone to the doctor the next day.  States the doctor determined it probably was the vaccine as there were not any other different factors identified.  symptoms included: puffy legs and feet, skin red all over like a sunburn, blotchy, itchy type rash. Some nausea and diarrhea. She was put on prednisone for about a week.  Client states it took about two weeks before she completely returned to normal.  She had two prior hepatitis b vaccinations, october and november 2003 without any problems.
Age: 0.1
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Cough, Fatigue, Hypersensitivity, Hyperventilation, Hypoxia
Clinical narrative: Patient's mom stated the approximately one hour after he received the (Dtap) shot, he had heavy breathing, appeared tired and pale.  She took him to hospital and during a nebulizer treatment, he coughed once and then stopped breathing.  He was intubated and transferred to another hospital by helicopter.  There he was treated and was in the ICU for 2 days.  He was then transferred to the children's floor for 2 days and then released on 5-22-2004.  Mom states that he recovered except that he continues to have mild cold symptoms. He has an appointment to see an allergist on 6-3-2004.    Nurse follow up on 07/27/04 states: "tachycardia; Rash; Consolidation RUL."  Nurse follow up on 07/27/04 states: "allergic reaction."
Age: 0.1
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Laboratory test abnormal, Pallor, Pharyngitis, Pulmonary oedema, Respiratory disorder
Clinical narrative: Patient's mom stated the approximately one hour after he received the (Dtap) shot, he had heavy breathing, appeared tired and pale.  She took him to hospital and during a nebulizer treatment, he coughed once and then stopped breathing.  He was intubated and transferred to another hospital by helicopter.  There he was treated and was in the ICU for 2 days.  He was then transferred to the children's floor for 2 days and then released on 5-22-2004.  Mom states that he recovered except that he continues to have mild cold symptoms. He has an appointment to see an allergist on 6-3-2004.    Nurse follow up on 07/27/04 states: "tachycardia; Rash; Consolidation RUL."  Nurse follow up on 07/27/04 states: "allergic reaction."
Age: 0.1
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Rhinitis, Tachycardia
Clinical narrative: Patient's mom stated the approximately one hour after he received the (Dtap) shot, he had heavy breathing, appeared tired and pale.  She took him to hospital and during a nebulizer treatment, he coughed once and then stopped breathing.  He was intubated and transferred to another hospital by helicopter.  There he was treated and was in the ICU for 2 days.  He was then transferred to the children's floor for 2 days and then released on 5-22-2004.  Mom states that he recovered except that he continues to have mild cold symptoms. He has an appointment to see an allergist on 6-3-2004.    Nurse follow up on 07/27/04 states: "tachycardia; Rash; Consolidation RUL."  Nurse follow up on 07/27/04 states: "allergic reaction."
Age: 0.1
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Hypoxia, Laboratory test abnormal, Respiratory distress
Clinical narrative: Patient's mom stated the approximately one hour after he received the (Dtap) shot, he had heavy breathing, appeared tired and pale.  She took him to hospital and during a nebulizer treatment, he coughed once and then stopped breathing.  He was intubated and transferred to another hospital by helicopter.  There he was treated and was in the ICU for 2 days.  He was then transferred to the children's floor for 2 days and then released on 5-22-2004.  Mom states that he recovered except that he continues to have mild cold symptoms. He has an appointment to see an allergist on 6-3-2004.    Nurse follow up on 07/27/04 states: "tachycardia; Rash; Consolidation RUL."  Nurse follow up on 07/27/04 states: "allergic reaction."
Age: 1.2
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site swelling
Clinical narrative: Swollen area, left thigh (at immunization site)
Age: 9.0
Sex: F
Vaccine: LYME
Symptoms: Laboratory test abnormal, Oedema peripheral, Pain, Skin discolouration, Tendonitis
Clinical narrative: Started with swelling in hand on 9/01 and developed into inflammed tendons in elbow, shoulder and hand.  Also joint achiness in all areas(feet, knee, hips). In April 2004, developed swelling in hands and feet with discoloration on top of hands and feet (especially on right side). Have taken over the counter anti-inflammatory's continuously for the past 3-4 years but most recently started to take Celebrex.
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Diarrhoea, Pyrexia, Skin nodule
Clinical narrative: Diarrhea, fever. right deltoid (3) small bumps pt was given Benadryl before shots because of previous reactions.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Autism
Clinical narrative: From initial information received on 5/17/04 from another manufacturer regarding a case in litigation concerning an adverse event occurring in the USA, a male patient (born on 1/4/00) received, at the age of 18 months, a third dose of IPV, a dose of MMR and a fourth dose of DTaP on 7/25/01. On 10/02/2002, the patient was diagnosed with severe autism when aged of 32 months. It was reported that thimerosal used in the vaccines and the MMR vaccine, individually and /or jointly combined caused the child's autism spectrum disorder. Additional information is expected. it was not reported whether the patient recovered from this event. Upon medical review, this case was assessed as serious/other medical event (OMIC).
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Brain oedema, Fracture, Murder, Neurological symptom, Subarachnoid haemorrhage
Clinical narrative: This subject is a ten month old who died due to child abuse/homicide while enrolled in a Comparative post-marketing study of DAPTACEL administered with other recommended vaccines according to the US standard of care, at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received one dose of the study vaccine on 12/30/02. The subject received a DAPTACEL vaccination, lot number C0812AA (route and site not reported) on 12/30/02. On 9/7/03, the subject suffered acute neurologic deterioration association with occipital skull fracture, cerebral edema and subarachnoid hemorrhage. On 1/26/04, the patient died from injuries secondary to child abuse. Per the coroner's office the cause of death was blunt force trauma. This case is considered a homicide and is still under investigation. An autopsy was performed but not obtained. The death was reported by the investigator as unrelated to the study vaccine.
Age: 0.6
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Cardiac failure, Respiratory arrest
Clinical narrative: This subject is a seven month old female, who died while enrolled in Comparative post-marketing safety study of DAPTACEL administered with other recommended vaccines according to the US standard of care, at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received two doses of the study vaccine. The last dose prior to the event was given on 1/22/04. On 2/4/04 the subject died. The subject suffered from Walker-Warburg Syndrome and expired due to respiratory arrest and cardiac failure. No autopsy was performed. The death was reported by the investigator as unrelated to the study vaccine.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Agitation, Crying, Irritability, Oral intake reduced, Screaming
Clinical narrative: Screaming, inconsolable crying for 2 days, fussy, wasn't feeding or sleeping as usual.  Nurse follow up on 07/28/04 states: "SIDS."
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Sleep disorder, Sudden infant death syndrome
Clinical narrative: Screaming, inconsolable crying for 2 days, fussy, wasn't feeding or sleeping as usual.  Nurse follow up on 07/28/04 states: "SIDS."
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Hypertension, Joint range of motion decreased, Pain
Clinical narrative: Pain to LVE, difficult ROM with slight pain, high blood pressure.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Infection
Clinical narrative: Patient developed chicken pox ca 5/13/2004, this being after vaccinated with varicella vaccine on 08/09/2000.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Chills, Erythema, Hyperhidrosis, Injection site erythema, Pyrexia
Clinical narrative: Signs= pt. had redness, tenderness & low grade fever with chills for 2 days (shots given Fri)- signs/symptoms sweat started fri night. Seen here mon am. Laboratory= vitals: afebrile P-68 BP 12/76. Left arm- 6-7 cm erythema tender to palpation around injection site. Prescription Medrol dose pt-7 day Dictoxallin 2 days qid, allergra 180 mg po for 6 days qd.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Tenderness
Clinical narrative: Signs= pt. had redness, tenderness & low grade fever with chills for 2 days (shots given Fri)- signs/symptoms sweat started fri night. Seen here mon am. Laboratory= vitals: afebrile P-68 BP 12/76. Left arm- 6-7 cm erythema tender to palpation around injection site. Prescription Medrol dose pt-7 day Dictoxallin 2 days qid, allergra 180 mg po for 6 days qd.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema, Tenderness
Clinical narrative: Right upper arm-red, swelling & tender.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Feeling hot, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Dizziness, nausea 5/19/04. Swelling erythema at site 5 cm x 3 cm with induration warm to touch. Patient complains of feeling shaky and she passing out.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Loss of consciousness, Nausea, Tremor
Clinical narrative: Dizziness, nausea 5/19/04. Swelling erythema at site 5 cm x 3 cm with induration warm to touch. Patient complains of feeling shaky and she passing out.
Age: 15.0
Sex: F
Vaccine: HEP, TD
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: She complains of tingling left arm immediately after injection- numbness. neuro neck of arm was ok.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Cough, Fatigue, Feeling abnormal, Rash, Rhinorrhoea
Clinical narrative: 3 days after vaccine she developed a slight cough very slight runny nose. 2 days later she had a whistling cough and on the 3rd and 3th day after she broke out in a rash on her stomach & upper legs which quickly went away after cool bath and dose of Dipenhist however 18 days later she is still whiny a little grumpy and extremely tired and says she doesn't feel good. Teacher commented on her tiredness and says there's been a big change. I took her to a pediatrician who gave her something for cough but did no blood work even though I ask for it.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Myalgia
Clinical narrative: Redness L- 12 cm W-10cm warm to touch. Soreness of upper right arm.
Age: 7.0
Sex: M
Vaccine: DTPHIB, MMR
Symptoms: Infection, Rash
Clinical narrative: Rash on torso consistent with varicella.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Eye movement disorder, Hyperhidrosis, Musculoskeletal stiffness, Pallor, Staring
Clinical narrative: Immediately following mennigococcal immunization, the client became pale diaphoretic, eyes rolled upward then he stiffened and had a blank stare for approx 15 seconds, then became alert. BP at this point 70/40, HR 48, RR 16. vital signs 2 min after episode BP 120/70 HR 60, alert and oriented.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Dysphagia, Erythema, Injection site swelling, Pain, Skin ulcer
Clinical narrative: 24 hours later- red raised area left thigh 3 3/8" x 2 3/8" around vaccination site. Hydratisone 1 criad 25 mg, Benadryl. 47 hours later red raised red area is 4 3/4 x 7 250 mg/5ml 3 tsp Cephenxin bid for 7 days. 72 hours-difficulty swallowing aphthous ulcer increase 1 oz Lidocaine/Manlox ulcer pain.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 48 hours later red & swollen 3 1/4 x 2 1/2 inches around DTaP injection site. Treatment Motrin & Benadryl left thigh.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Agitation, Oedema, Screaming, Skin discolouration
Clinical narrative: 2 months old male who developed purple discoloration with swelling from the umbilical downward involving both extremties. Pt. was examined at hosp. ER it was determined Rx was 2 hours to DTaP uncomfortable crying for more than 3 hours.
Age: 40.0
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy, Ocular hyperaemia, Pruritus
Clinical narrative: 2 weeks after receiving MMR, symptoms swollen neck gland, red eyes, itching left arm.
Age: 18.0
Sex: F
Vaccine: MER
Symptoms: Dyspnoea, Pallor
Clinical narrative: MMR # 2given at 8:30, student returned no sllc approx 09:30 pale & complains of S03/dyspnea. Epi-pen adm. x 2, parents called her. EMS called. Student initially improved talking po repeated. Parents notified students PCP noticed. Student transported to PCP per mother.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Erythema, Feeling hot
Clinical narrative: Large area 6 1/2 inches in diameter red and slightly warm, non tender. Child can walk, even walk without difficulty.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Insomnia, Oral intake reduced, Rash, Screaming
Clinical narrative: Crying non-stop rash on check, ear & neck, spitting up food. No sleeping.
Age: 0.3
Sex: M
Vaccine: PNC
Symptoms: Erythema, Injection site induration, Oedema
Clinical narrative: Child had prevnar with increasing erythema, edema over 24 hours. 4 cm induration.
Age: 68.0
Sex: F
Vaccine: PPV, TD
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: After 3 days of vaccinations of TD and Pneumo, pt stopped by clinic showing right arm redness, soreness and swelling with warm to touch. Pt states was painful for 3 days already. States with temp, but didn't bother to check temp and didn't know how much temp she had.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site induration, Swelling
Clinical narrative: Left deltoid arm, with swelling, redness, both extending shoulder to above elbow, 2.5 inch induration from injection site, hard and warm to touch. Explain to parent cold compress and tylenol or motrin prn for pain. No fever.
Age: 24.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema, Injection site hypersensitivity, Lymphadenopathy, Pruritus, Rash
Clinical narrative: This 24-year-old female presents with concerns over a spreading rash to her face and left arm that began 2 days after receiving her Smallpox vaccination on 21 May 2004 to her right deltoid.  She indicates the rash by pointing to multiple individual raised white-tan-skin toned papules to her left upper lip.  There is a fine erythematous hue with scattered macularpapules visible to her left cheek, jawline, across her forehead just above the eyebrows and one to top of her left hand.  Dry pink tinged spots to her left forearm were identified as resolved rash site. She complains of facial itching.    The smallpox injection site itched 24-48 hours after inoculation with minimal swelling, no redness or fevers.  Associated symptoms with her Typhoid in the right deltoid toms included slight cervical lymph node swelling for 1-1 ½ days.  It is day 5-6-post smallpox vaccination showing the site with a depressing centered vesicle-pustule with surrounding erythema.  Patient noticed the facial rash begin to her left upper lip as if it were acne breaking out.  She treated with facial scrubs and rubbing alcohol with no relief.  The rash continued to progress over the next few days over her upper lip, cheek, and forehead with increased itching.  Concern over a possible reaction made her consult medical friends and family who suggested she contact the Vaccine Healthcare Center and seek medical care.  She denies any dysphasia, speech difficulty, myalgias, weakness, fatigue, facial pain, tingling, chest pain, breathing problems or persistent lymph node swelling.  She reports receiving her first Anthrax vaccination to the left deltoid and Typhoid in the right deltoid on 18 May 2004 without incident.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Rash on R ear lobe down cervical neck on R side per school nurse. Nurse talked to doctor and was diagnosed with shingles.  Rash had been wet, is now dry & child returned to school per RN.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Muscle spasms, Pruritus, Rash macular
Clinical narrative: Cramps in joints; red patches/spots at joints. Blotches on feet, legs and thighs. Itching on back.