chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: HEPA, HIBV, IPV, PNC, HEPA, HIBV, IPV, PNC
Symptoms: Melaena, Petechiae, Platelet count decreased, Pyrexia, Sneezing
Clinical narrative: It was reported that a 2 month old male received a 1st dose of Prevnar vaccine on 8/23/01. Additional suspect medication included Havrix, Act-Hib and Polio vaccines. On 8/25/01 to 8/26/01, the infant developed bleeding symptoms (nose bleeds). It was noticed that he had increased bruising spots and petechia on palate. The pt had decreased stools but increased quantity. Color change in stools today to darker, minimally sticky. He has been coughing for 1 week with sneezing. Temperature is 38.1C. He has slight jaundice. On 8/27/01, he was given a dx of idiopathic thrombocytopenic purpura. On 8/27/01, lab data revealed a platelet count of 3,000 and other blood work parameters were within normal limits. The infant was hospitalized for 3 days. Dx'd with idiopathic thrombocytopenic purpura. He was treated with IVIG. He is to follow-up with Oncology. The reporter noted that this event was considered to be life threatening. No additional information was available as of the date of this report.
Age: 0.2
Sex: M
Vaccine: HEPA, HIBV, IPV, PNC, HEPA, HIBV, IPV, PNC
Symptoms: Thrombocytopenic purpura, White blood cell count decreased
Clinical narrative: It was reported that a 2 month old male received a 1st dose of Prevnar vaccine on 8/23/01. Additional suspect medication included Havrix, Act-Hib and Polio vaccines. On 8/25/01 to 8/26/01, the infant developed bleeding symptoms (nose bleeds). It was noticed that he had increased bruising spots and petechia on palate. The pt had decreased stools but increased quantity. Color change in stools today to darker, minimally sticky. He has been coughing for 1 week with sneezing. Temperature is 38.1C. He has slight jaundice. On 8/27/01, he was given a dx of idiopathic thrombocytopenic purpura. On 8/27/01, lab data revealed a platelet count of 3,000 and other blood work parameters were within normal limits. The infant was hospitalized for 3 days. Dx'd with idiopathic thrombocytopenic purpura. He was treated with IVIG. He is to follow-up with Oncology. The reporter noted that this event was considered to be life threatening. No additional information was available as of the date of this report.
Age: 99.0
Sex: M
Vaccine: FLU3
Symptoms: Nephritis, Pyrexia, Urinary retention, Urine analysis abnormal, White blood cell disorder
Clinical narrative: High fever 1 AM on 11/23/2001. Taken to hospital. Diagnosis of Urosepsis.
Age: 25.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning a 25 year old male with no known allergies or psychiatric history and a history of varicella who on 02-NOV-2001, at 11:00 AM, was vaccinated with a dose of MMR (second generation). Concomitant therapy included Recombivax HB. There was no other concomitant medication. It was noted that the pt was seen later that day in the early evening, at 6:00 PM, then disappeared. On 19-NOV-2001 the pt's dead body was recovered in the river. It was reported that it was an assumed suicide. The physician reported that she only saw the client for immunizations. Unspecified medical attention was sought. Additional information has been requested. Follow-up info from the reporter indicated that "in her mind there is no connection between the vaccination and the death." Additional info has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous, Laboratory test abnormal
Clinical narrative: Information has been received from a medical assistant and a physician concerning a 31 year old female with no known drug allergies and a recent chicken pox exposure who, on 10/21/00, was vaccinated with varicella virus vaccine live. There was no concomitant medication. It was noted that the pt was vaccinated because she had been exposed to chicken pox. A urine pregnancy test was obtained before vaccination which was negative and her last menstrual period was 10/4/00. On 11/7/00, a serum pregnancy test was done and showed positive results. It was noted that there was no report of rash at this time. Follow-up information from the medical assistant, indicated that the pt had a spontaneous abortion early in her pregnancy.
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Convulsion
Clinical narrative: The child received his first injection of Havrix on 22-AUG-2000. In December 2000, approximately four months post immunization, the child reportedly began to experience seizures. He was seen by a physician and treated with unspecified medication. The child received his second injection of Havrix in April 2001. As of 26-NOV-2001, the child's mother reported that he was receiving an unspecified medication, which was controlling the seizures. Seizures are considered GSK medically serious.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Dyspnoea, Rash pruritic, Vasodilation procedure
Clinical narrative: A 5 year old male was vaccinated on27-AUG-2001 at 9:20 AM with MMR (second generation) SC in the LA. Concomitant vaccinations that same day and time included the first dose of Varivax SC in the LA, the seventh dose of Tripedia IM in the LA and the sixth dose of IPV SC in the LA. There was no illness at the time of vaccination. On 27-AUG-2001 at 10:15 AM the pt's mother called the physician's office and informed them that the pt experienced difficulty breathing, a red "slap like" rash all over with extreme itching. The mother was instructed to go to the doctor or ER. The pt's mother called later in the afternoon to report an ER visit. the pt received prednisone, Prelone times 3 days and Benadryl. It was unknown if the pt recovered. This was originally reported by a nurse. Upon internal review, the pt's difficulty breathing was determined to be an other important medical event. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Drug toxicity, Mental retardation severity unspecified
Clinical narrative: Information has been rec'd regarding a case in litigation which concerns an approximately 5 yr old male pt who on 7/25/96 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). It was reported that less than a year form the date of 11/01/01 the pt was first diagnosed and discovered to have mercury poisoning and related severe mental and physical injuries. Upon internal review, mercury poisoning, severe mental and physical injuries were determined to be other medical events. No further information is available.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Breath odour, Diabetes mellitus, Eye disorder, Hyperglycaemia, Pollakiuria
Clinical narrative: Excessive thirst within 24 hours. Frequent urination, sunken eyes, fruity breath. Injections Wednesday. ER on Sunday. Diagnosed with new onset diabetes. per 1 year follow: Pt ahs not recovered. Pt has Type 1 Diabetes now. These symptoms developed within 24 hours of vaccination. There should be warning on public information that this could happen to children where diabetes runs in the family.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Thirst
Clinical narrative: Excessive thirst within 24 hours. Frequent urination, sunken eyes, fruity breath. Injections Wednesday. ER on Sunday. Diagnosed with new onset diabetes. per 1 year follow: Pt ahs not recovered. Pt has Type 1 Diabetes now. These symptoms developed within 24 hours of vaccination. There should be warning on public information that this could happen to children where diabetes runs in the family.
Age: 0.55
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Convulsion, Dyskinesia, Laboratory test abnormal, Oculogyration, Somnolence
Clinical narrative: Almost 7 month old, previously healthy male with 2 minute episode of altered level of consciousness in which eyes were rolled back and trunk was flexed. Infant staring straight ahead and not responsive. No tonic donic movements. Admitted to hospital 12/02/2001 for work up of new onset seizures. Pt not febrile. Positive 11 year old brother with history of febrile seizures. Hospitalized.
Age: 56.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Infection
Clinical narrative: Joint pain, continuos and throughout the body. No treatment has been effective. Per 1 year follow up: Pt did not recover. No change in symptoms.
Age: 1.56
Sex: M
Vaccine: FLU3
Symptoms: CSF test abnormal, Guillain-Barre syndrome, Muscular weakness, Paralysis
Clinical narrative: Seen 11/18/01 with progressive lower extremity weakness. By 11/30/01 could not move lower extremities: had loss of reflexes. Sent to ED where diagnostic work up began. Diagnosis of Guillain-Barre Syndrome ultimately made. Per 1 year follow up: Pt recovered. Done well with therapy time.
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Atrial fibrillation, Dizziness, Dyspnoea, Electrocardiogram abnormal, Tachycardia
Clinical narrative: Hives within 5 minutes after flu injection, tachycardia and became short of breath and thought he was going to pass out. Sent to ER and was hospitalized for atrial fibrillation.
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Urticaria
Clinical narrative: Hives within 5 minutes after flu injection, tachycardia and became short of breath and thought he was going to pass out. Sent to ER and was hospitalized for atrial fibrillation.
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Atrial fibrillation, Dyspnoea, Electroencephalogram abnormal, Tachycardia, Urticaria
Clinical narrative: Hives within 5 minutes after flu injection, tachycardia and became short of breath and thought he was going to pass out. Sent to ER and was hospitalized for atrial fibrillation.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Pt right leg swelled up to knee to hip and became hard and red. Pt was admitted to hospital for concern of cellulitis.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Muscle spasms
Clinical narrative: Anthrax vaccine developed cramps and joint pains. Joints hurt from time to time, comes and goes to include hip, knees, and elbows.
Age: 50.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain, Arthralgia, Balance disorder, Diarrhoea, Dizziness
Clinical narrative: Approx. 1 month after the 3rd shot, he experienced numbness in his calves. The numbness is accompanied by tingling and occurs with prolonged sitting and driving. The numbness and tingling extends distally to the toes but does not radiate above the knee. The symptoms are relieved with movement for a few minutes. These symptoms persist today. During this time his lab work showed a CBC with a slightly low HCT, but normal indices. No anemia studies were performed and he was not put on iron replacement therapy. He also had increased pain in his left knee. He was evaluated locally and told his symptoms were the result of normal wear and tear. He states that the joint pain is manageable but annoying. He currently takes Glucosamine Chondroitin once a day, which he states helps his joint pain but does not fully resolve it. In 8/01, he began experiencing left-sided abdominal pain and an increased number of loose stools. He attributes these symptoms to starting after swallowing contrast for a radiologic study on 7/30/01. These symptoms have persisted and increased in severity. Currently he is experiencing constant left-sided abdominal pain as well as loose stools following every meal. He tried over the counter remedies, such as Imodium, with only minimal and temporary relief. He also tried over the counter fiber tablets, which he states made the pain worse. He has noticed some weight loss during this time. In 9/01, he began experiencing increased episodes of dizziness and light-headedness. He denies any ringing in his ears. This dizziness has impacted his balance; however, he has not had any episodes of falling. He has not experienced headache with the episodes of dizziness. At this time he has not yet been evaluated for the dizziness. He was referred to oncology for evaluation. It was determined he did not have cancer; however, the oncology service will continue to monitor him for any changes. He has vertigo without tinnitus.
Age: 50.0
Sex: M
Vaccine: ANTH
Symptoms: Haematocrit decreased, Hypoaesthesia, Lung disorder, Skin ulcer, Spleen disorder
Clinical narrative: Approx. 1 month after the 3rd shot, he experienced numbness in his calves. The numbness is accompanied by tingling and occurs with prolonged sitting and driving. The numbness and tingling extends distally to the toes but does not radiate above the knee. The symptoms are relieved with movement for a few minutes. These symptoms persist today. During this time his lab work showed a CBC with a slightly low HCT, but normal indices. No anemia studies were performed and he was not put on iron replacement therapy. He also had increased pain in his left knee. He was evaluated locally and told his symptoms were the result of normal wear and tear. He states that the joint pain is manageable but annoying. He currently takes Glucosamine Chondroitin once a day, which he states helps his joint pain but does not fully resolve it. In 8/01, he began experiencing left-sided abdominal pain and an increased number of loose stools. He attributes these symptoms to starting after swallowing contrast for a radiologic study on 7/30/01. These symptoms have persisted and increased in severity. Currently he is experiencing constant left-sided abdominal pain as well as loose stools following every meal. He tried over the counter remedies, such as Imodium, with only minimal and temporary relief. He also tried over the counter fiber tablets, which he states made the pain worse. He has noticed some weight loss during this time. In 9/01, he began experiencing increased episodes of dizziness and light-headedness. He denies any ringing in his ears. This dizziness has impacted his balance; however, he has not had any episodes of falling. He has not experienced headache with the episodes of dizziness. At this time he has not yet been evaluated for the dizziness. He was referred to oncology for evaluation. It was determined he did not have cancer; however, the oncology service will continue to monitor him for any changes. He has vertigo without tinnitus.
Age: 50.0
Sex: M
Vaccine: ANTH
Symptoms: Vertigo, Weight decreased
Clinical narrative: Approx. 1 month after the 3rd shot, he experienced numbness in his calves. The numbness is accompanied by tingling and occurs with prolonged sitting and driving. The numbness and tingling extends distally to the toes but does not radiate above the knee. The symptoms are relieved with movement for a few minutes. These symptoms persist today. During this time his lab work showed a CBC with a slightly low HCT, but normal indices. No anemia studies were performed and he was not put on iron replacement therapy. He also had increased pain in his left knee. He was evaluated locally and told his symptoms were the result of normal wear and tear. He states that the joint pain is manageable but annoying. He currently takes Glucosamine Chondroitin once a day, which he states helps his joint pain but does not fully resolve it. In 8/01, he began experiencing left-sided abdominal pain and an increased number of loose stools. He attributes these symptoms to starting after swallowing contrast for a radiologic study on 7/30/01. These symptoms have persisted and increased in severity. Currently he is experiencing constant left-sided abdominal pain as well as loose stools following every meal. He tried over the counter remedies, such as Imodium, with only minimal and temporary relief. He also tried over the counter fiber tablets, which he states made the pain worse. He has noticed some weight loss during this time. In 9/01, he began experiencing increased episodes of dizziness and light-headedness. He denies any ringing in his ears. This dizziness has impacted his balance; however, he has not had any episodes of falling. He has not experienced headache with the episodes of dizziness. At this time he has not yet been evaluated for the dizziness. He was referred to oncology for evaluation. It was determined he did not have cancer; however, the oncology service will continue to monitor him for any changes. He has vertigo without tinnitus.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: The pt's right upper arm was red, itchy and warm to touch, immediately after flu injection, 9" X 13". Temperature was 98.8F.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Pruritus
Clinical narrative: Pt developed a gross generalized pruritic rash, myalgia, headaches, dizziness and fatigue. All symptoms improved with exception of the rash. Treatments: Symptomatic treatment with Benadryl, Tylenol, several types of ointments/creams, oral steroids and antihistamines.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Pt developed a gross generalized pruritic rash, myalgia, headaches, dizziness and fatigue. All symptoms improved with exception of the rash. Treatments: Symptomatic treatment with Benadryl, Tylenol, several types of ointments/creams, oral steroids and antihistamines.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt states she developed redness and swelling at the site of the pneumococcal vaccine, 24 hours, post vax. She was seen at Urgent Care 72 hours, post vax, and treated with steroids and antibiotics. She states that her husband, who received the vaccine on 11/2/01, had a similar reaction and was treated for the same.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Oedema, Vasodilation procedure
Clinical narrative: Wife presented to HD stating she saw physician for redness, swelling at pneumococcal vaccine. States husband had same reaction. States husband was treated with steroids and antibiotics just as she was.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Injection site mass
Clinical narrative: Severe headache lasting over 24 hours. Very large hard bump on arm from shot.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site hypersensitivity, Oedema, Pruritus, Vasodilation procedure
Clinical narrative: Injection site red, a little swollen and warm (very) to touch, itchy. Taking Benadryl and ibuprofen.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Drug ineffective, Influenza, Injection site hypersensitivity
Clinical narrative: Flu shot, pt noted area of redness over major portion of upper arm including injection site. Described as "flat pink, non-tender but itchy", warm. Cleared up by 1 week later. On 11/22/2001 pt diagnosed with flu and noticed that red spot on arm had returned, then disappeared.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Face oedema, Pruritus
Clinical narrative: 11:50 Am vaccine given, stated that at 12:30 PM eyes itchy, 2:15 PM presented with face swollen and itchy. No acute distress. Pt's physician uncooperative. given 0.2 epi per MD at 2:30 PM and at 2:40 better and at 4 PM much better. Fine the next day.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Neck pain, Pain, Rash
Clinical narrative: Severe headache, neck ache, rash upper arms and legs, fever, body aches, erythema at injection site. Starting to recover 11/30 after Benadryl and Vicodin.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Paraesthesia
Clinical narrative: The patient reported progressive numbness from the fingertips on her left hand, to the fingertips on her right hand, to the toes on both feet. The patient experienced a feeling of heaviness in both forearms. These symptoms began 15 minutes after the injection.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Joint range of motion decreased, Pain, Paraesthesia
Clinical narrative: 11/13/2001 in the PM, the patient had discomfort in her right arm and hand and felt numb by midnight. The patient awakened in extreme pain and called her MD. The pain is constant down the patient's right arm and she is unable to bend her elbow. The patient was treated with Vicodin and an anti-inflammatory. The patient has pain in the right axillary region, near the anterior scapula.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Face oedema, Urticaria
Clinical narrative: The patient developed hives on both arms and behind his knees and near the joints. The patient's lip was swollen in the A.M., but the shot may not be related.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site pain, Pruritus, Rash maculo-papular
Clinical narrative: 11/22/2001 post vax, the patient developed fiery erythema, hot to touch, palpable hardness and extreme pruritus of the lateral aspect of the upper arm from the acromiun process to the elbow. On 11/23/2001 the patient experienced body wide pruritus with diffuse, reddened blotchy areas body wide. The patient self-medicated with oral Benadryl. On 11/28/2001 the injection site had a 6cm area of diffuse redness. The patient complained of mild to moderate pain at the injection site. The other symptoms were resolved.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Vasodilation procedure
Clinical narrative: 11/22/2001 post vax, the patient developed fiery erythema, hot to touch, palpable hardness and extreme pruritus of the lateral aspect of the upper arm from the acromiun process to the elbow. On 11/23/2001 the patient experienced body wide pruritus with diffuse, reddened blotchy areas body wide. The patient self-medicated with oral Benadryl. On 11/28/2001 the injection site had a 6cm area of diffuse redness. The patient complained of mild to moderate pain at the injection site. The other symptoms were resolved.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Somnolence, Tremor
Clinical narrative: The patient experienced tremors and chills approximately 4 hours after the vaccination. These symptoms lasted 4 hours. The patient experienced lethargy the following day.
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: The patient developed hives/rash over her entire body. This began approximately 1 hour following the injection. The patient was treated with Medrol dose pack, oral Benadryl and Benadryl cream.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: The patient stated she developed a rash which spread over her entire body in one weeks time. This started 24 hours after the vaccine was given.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Injection site oedema, Pyrexia
Clinical narrative: The patient was seen for swelling and redness at the injection site 24 hours after the injection. The area of redness was 5cm in diameter. The patient's temperature was 99.6F. The patient was treated with Tylenol and ice.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Oedema, Pain
Clinical narrative: The patient developed swelling, fluid build-up and soreness under his left arm. The soreness went away after 48 hours. The swelling lasted for approximately 5 days. The patient took Advil for the first 48 hours.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Shoulder pain
Clinical narrative: Three days post vax, the patient developed left arm and shoulder pain that occasionally radiates to the left hand. The patient was seen on 11/23/2001 by the physician for these symptoms.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site hypersensitivity, Injection site oedema, Pyrexia
Clinical narrative: The night after the vaccination the patient had swelling and redness in the left thigh and a temperature of 106F which subsequently resolved with ibuprofen. No other serious problems occurred.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: The patient's left arm was red and swollen. The Dr advised warm soaks. On 11/29/2001 the patient's mother states the patient's arm is improved.
Age: 1.25
Sex: F
Vaccine: DTP, HBHEPB, OPV, PNC
Symptoms: Urticaria
Clinical narrative: Information has been received from a HCP concerning 1 15 month old white "well" female who on 23-AUG-2001 was vaccinated with the third dose of Comvax administered IM in the left leg. Concomitant therapy included Prevnar administered in the right leg, DTP administere in the left leg and IPV administered in the right leg. the following morning, on 24-AUG-2001, the pt woke up with hives from head to toe on the left side of her body. The pt's mother called the Pediatrician's office and reported starting Benadryl. Subsequently, the pt recovered. It was noted that the pt received the  three doses of Comvax at 2 months, 4 months and 12 months of age. No further information is available.
Age: 0.4
Sex: F
Vaccine: DTP, HBHEPB, IPV, PNC
Symptoms: Dyspnoea, Injection site reaction, Rash macular, Urticaria
Clinical narrative: Information has been received from the pt's mother concerning her 20 week old white daughter who on 06-SEP-2000 at 1:20 PM was vaccinated in the left arm with a second dose of Comvax. Concomitant therapy included a second dose in the left arm of DTP, a first dose in the left arm of Prevnar and a second dose in the left arm of IPOL. The pt's other reported that she then developed hives and difficulty breathing. She was given Benadryl for the hives and the symptoms went away. Follow up information has been received from a physician who reported that on 06-SEP-2000, the pt experienced a mild local reaction with a spreading red macular rash around the Comvax injection site. The rash spread from the face the the abdomen. It was noted that the pt had no distress and no respiratory difficulties. It was also noted that the pt was treated with 1/4 teaspoonful of Benadryl and the rash decreased significantly in ten minutes. No lab tests were done and the pt recovered. no further information is available.
Age: 0.08
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Injection site mass, Injection site reaction, Oedema, Pyrexia
Clinical narrative: Information has been received from a LPN concerning a 28 day old female who on 09-MAR-2001 at 10:45 AM, the pt received a first dose in the right thigh of Comvax. Concomitant vaccine therapy that day included a first dose in the right thigh of Prevnar and a first dose in the left thigh of ACEL-IMMUNE. At the time of this report, the pt had no adverse symptoms. Unspecified medical attention was sought. Follow up information received from the physician's office indicated that the pt's mother reported the pt ran a temperature and had local reactions (swelling, limp) following the vaccinations. No further details provided. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a RN concerning a 6 month old female who was vaccinated with Comvax. The pt was also vaccinated with the second dose of Prevnar and ACEL-IMUNE on the same day. Four days post immunization, the pt developed a fever greater than 102.2 F and rash. No further details were provided. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: LYME
Symptoms: Anxiety, Nausea, Vomiting
Clinical narrative: After receiving 3rd dose of Lymerix, developed nausea, vomiting and anxiety. Went to ED, was given IV Benadryl. returned to feeling normal over next hour. Was released to go home.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Arthralgia, Oedema, Pruritus
Clinical narrative: 08/21/2001 MMR vaccine. Day 8 arthralgia, skin itching, knees, fist, hands intermittently. Swelling in arm, basically afebrile. Faint rash. Questionable spots.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema, Vasodilation procedure
Clinical narrative: Pt arm red and swollen 3" by 6". Mother noticed at 1600 11/07/2001. Child playing as usual without complaint.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site hypersensitivity
Clinical narrative: Approx 1 inch in diameter pink raised area noted back of right upper arm where student states chicken pox vaccine was injected. both student and mom state noticed last night, deny other problems. Student states it itches now that he noticed it.
Age: 2.0
Sex: U
Vaccine: HBHEPB
Symptoms: Injection site mass, Injection site reaction, Tenderness
Clinical narrative: Information has been received from a LPN concerning seven pts who were vaccinated with Comvax. The reporter noted that seven out of ten infants had experienced a reaction at the injection site described as hard, size of golf ball, tender to touch and slightly red. The experiences last 6-8 weeks. The pts were "mostly two months and a couple were four months old". The pts sought unspecified medical attention. No further details were provided. Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Crying, Urticaria
Clinical narrative: Information has been received from a LPN concerning a 15 week old Caucasian female who on 14-JUL-2000 was vaccinated wih the first dose of Comvax. Concomitant vaccinations that same day included the first dose of Tripedia and the first dose of IPOL. Following vaccination the child cried for four hours. In follow up it was reported that the continuous crying lasted for 3 hours. On 05-DEC-2000 at 3:30 PM, the child was vaccinated with the second dose of Comvax in the left leg. Concomitant vaccination that same day included the second dose of Tripedia and IPOL in the left leg. On 05-DEC-2000 the child developed a rash that resolved in 20-30 minutes. Later the same evening, the facial rash returned and was also seen on the child's arms and legs. The pt's rash resolved within 30 minutes. In follow up, the LPN reported that 15 minutes after vaccination the pt developed hives on her face that disappeared after 20 minutes and later that night the pt developed hives allover her body (previously reported as a rash). It was noted that the pt had hives 3 times. in follow up, the nurse reported that the pt's mother was instructed to give Benadryl. Twenty minutes later, the pt's hives disappeared. There were no other problems. No other information is available.
Age: 1.0
Sex: M
Vaccine: HBHEPB
Symptoms: Injection site erythema, Injection site mass, Pyrexia
Clinical narrative: On 15-DEC-2000, (at approximately 2 PM), the pt was vaccinated with the third dose of Comvax IM in the thigh. On the morning of 16-DEC-2000 at approximately 10 AM the pt developed a fever that was noted to be a very toxic febrile reaction. In the evening of 16-DEC-2000, the pt's fever went to 103 to 104 degrees and he was treated with Tylenol liquid. The pt was actually ill with fever, irritability and a decreased appetite. the pt also had erythema at the thigh injection site (dime-size) which subsided over 72 hours. On 17-DEC-2000 the pt was seen by his pediatrician. At this time the pt has a fever of 101 degrees and the child had a bump on his outer thigh at the injection site. A blood count was normal. The pediatrician felt the pt's experience was viral and not related to Comvax. It was reported that the pt recovered on 17-DEC-2000 PM. Follow up information received from the physician indicated that no further adverse sequelae were noted since the third Comvax vaccination. At the time of this report on 29-JAN-2001 the pt had not received any additional vaccines. No further information is available.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, RV
Symptoms: Diarrhoea, Gastroenteritis, Irritability, Pyrexia, Vomiting
Clinical narrative: An 18 week old female was vaccinated with a second dose of Comvax IM on 24-JUN-1999 at 10 AM. Concomitant vaccinations that same day included the second dose of Rotasheild PO, the second dose of ACEL-IMUNE IM and the second dose of IPOL SQ. On 28-JUN-1999, the pt developed projectile vomiting, diarrhea and was inconsolable. It was noted that four and five days post vaccination, the pt developed a fever 101 F, vomiting, diarrhea and fussiness. The diarrhea was described as "foul, explosive mucoid green".The pt was reported to have gastroenteritis. The fussiness resolved after 3 weeks. Four weeks post-vaccination, the pt continued to have "green/mucous" stools. The diarrhea resolved after6 weeks. The pt was reported as recovered. Additional information ha been requested. This was originally reported by a physician. Upon follow up, the physician stated "I have had no adverse event." No further info is available.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site mass
Clinical narrative: Information has been received from a HCP concerning a 6 month old white male who on 05-JAN-2001 was vaccinated with a first dose of Comvax. Concomitant therapy included IPOL and Tripedia. On 05-JAN-2001 the pt developed a hard red lump in his thigh where Comvax was administered. Subsequently the pt recovered after 2 months. The reporter also reported that 6 other infants developed injection site pain, redness and swelling while vaccinated with Comvax. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: HBHEPB
Symptoms: Injection site induration, Injection site mass, Pyrexia
Clinical narrative: Information has been received from a RN concerning a 14 month old Hispanic female who was vaccinated in the right thigh with a third dose of Comvax on 05-DEC-2000. It was reported that the adverse reactions started 2 days after the injections, the pt's mother noticed a lump. On 07-DEC-2000, the reaction was 1.5 inches long induration by 1/2 inch wide. It was reported that the mother contacted the doctor one week after vaccination. On 08-JAN-2001 the pt was vaccinated with a fourth dose of Comvax in the left thigh. On 10-JAN-2001 the pt developed an induration 1/2 inch by 1/2 inch and fever of 100.8. It was reported that no pain at the site of injection was noted for either episode at the time of examination. the pt's outcome was reported as unknown. It was reported that 4 other pts had a similar reaction after exposure to Comvax. Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: HBHEPB
Symptoms: Injection site mass
Clinical narrative: Information has been received from a physician concerning a 13 week old white male who on 09-NOV-2000 was vaccinated IM with a dose of Comvax. On 09-NOV-2000, the pt developed a knot which appeared on injection site several hours after it was administered with no redness and no fever, Subsequently,  the pt recovered from the event. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Pain
Clinical narrative: This report concerns a 24 month old male who on 01-DEC-2000 was vaccinated with a dose of Comvax. Concomitant therapy included a dose of Infanrix. On 01-DEC-2001 the pt experienced moderately severe pain at an unspecified site and fever. The next day, he recovered, with out treatment. the reporter considered the pt's experiences to be related to Infanrix administration. No further information is available.
Age: 1.0
Sex: M
Vaccine: HBHEPB
Symptoms: Injection site mass
Clinical narrative: Information has been received from a HCP concerning a 12 month old male who on 27-OCT-2000 was vaccinated with Comvax IM in the right thigh. On 27-OCT-2000 the pt experienced small knot at the injection site. He developed no other symptoms, however the knot remained for five weeks. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: HBHEPB
Symptoms: Injection site mass
Clinical narrative: Information has been received from a certified MA concerning an 8 week old female who was vaccinated IM in the right thigh with a first dose of Comvax on 09-NOV-2000. On 09-NOV-2000, soon after receiving the vaccination, the pt experienced a knot at the injection site. The pt developed no other symptoms. The knot was still present when 4 month exam was performed on 10-JAN-2001. Subsequently, the pt recovered. No further information is available.
Age: 0.3
Sex: M
Vaccine: HBHEPB
Symptoms: Contusion, Injection site mass
Clinical narrative: Information has been received from a RN concerning a 4 month old male pt who on 19-DEC-2000 was vaccinated in the left thigh with a second dose of Comvax. Subsequently, the pt developed a small knot under the injection site. it was reported that 4 other pts had a similar experience following exposure to Comvax. Follow up information has been received from a RN which states the parents did not report the lump and bruise at the injection site until the child's next visit to the doctor in approximately February 2001. The onset of the reaction is unknown. The pt has recovered.
Age: 0.3
Sex: F
Vaccine: HBHEPB
Symptoms: Injection site mass
Clinical narrative: Information has been received from a RN concerning a 19 week old Hispanic female who on 03-FEB-2001 was vaccinated with a second dose in the right thigh of Comvax. On 04-FEB-2001, the pt developed a lump at the injection site. It was reported that the lump was still observable 3 weeks later. On an unknown date the pt recovered. it was noted that the pt had no prior adverse reactions. It was reported that 4 other pts had similar experiences following exposure to Comvax.
Sex: U
Vaccine: HBHEPB
Symptoms: Injection site mass
Clinical narrative: Information has been received from a RN concerning and unidentifiable pt who in approximately February 2001, was vaccinated with a dose of Comvax. Subsequently the pt developed a small knot under the injection site. It was reported that the knot has not resolved yet. Unspecified medical attention was sought. it was reported that 4 other pts had a similar experience following exposure to Comvax. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HBHEPB
Symptoms: Contusion, Injection site mass
Clinical narrative: Information has been received from a RN concerning a 12 month old Hispanic and Black female who was vaccinated on 15-JAN-2001 IM in the right leg with a third dose of Comvax. Subsequently the pt developed a small knot under the injection site. It was reported that the knot has not resolved yet. Unspecified medical attention was sought. it was reported that 4 other pts had a similar experience following exposure to Comvax. Follow up information has been received from a RN which stated that the child developed a lump and bruise at the site which was still present 12 days later. The lump was "the size of a pea". No intervention was needed and pt recovered.
Age: 0.25
Sex: M
Vaccine: DT, HBHEPB, IPV, UNK
Symptoms: Crying, Influenza like illness, Vomiting
Clinical narrative: Information has been received from a male consumer concerning his 3 month old son with no past medical history and no known allergies who, in approx. 2001, was vaccinated with a dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast). Concomitant vaccine therapy included diphtheria, poliovirus vaccine and other "required vaccinations". The child's parent was not certain as to what vaccines were given. According to the parent, within hours of receiving the vaccinations, the child started crying much more than usual and was also "spitting up more". The baby also seemed to be experiencing flu-like symptoms which were not subsiding. Additional information has been requested.
Age: 1.4
Sex: F
Vaccine: HBHEPB
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 17 month old white female with no known allergies who on 4/25/01, at 14:40, was vaccinated, IM, in the left arm with a 1st dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast) (lot 639075/1826K). There was no concomitant medication. There was no illness at the time of vaccination. On 4/26/01, the pt developed a 2" by 3" red, firm and somewhat tender lump surrounded by 1" of redness. On an unknown date the pt recovered. No further information is expected.
Age: 0.8
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Information has been received from a physician concerning a 10 month old female who was vaccinated with haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast) (site not reported). Concomitantly, the pt was vaccinated with diphtheria toxoid/pertussis vaccine/teta (Infanrix) and poliovirus vaccine inactivated (mfr unknown). Subsequently, the pt experienced hives and difficulty in breathing. The pt was treated at the ER and released. No further details were provided. Additional information has been requested. The follow up states an allergy evaluation was performed on the pt, and upon workup, the physician was able to narrow down the pt's problems to be possibly due to the Tetanus component of the vaccine Infanrix. It was noted that hospital records have not been received from the hospital that treated the pt. Additional info has been requested.
Age: 0.75
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Injection site mass
Clinical narrative: Information has been received from an RN concerning a 9 month old white female with no known medical history or allergies who was vaccinated, IM, with a 1st dose, given in the left thigh, and a 2nd dose, given in the right thigh, of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast) on 10/25/00 and 1/3/01 (lot 637201/1036K), respectively. Concomitant vaccination on the same days included a 1st dose, in the right thigh and a 2nd dose (lot 434301), in the left thigh of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Acel-Immune), given IM. There was no illness noted at the time of vaccination. On 4/9/01, the pt developed a lump with purulent discharge at the injection site in the left leg. The lump was 1.5cm by 2.0cm in size. On 5/16/01, the pt developed a lump in the right leg that was 0.5cm. Neither lump had redness or tenderness. It was reported that the pt's lumps were still present. No further information is available. Follow up info indicated that the pt takes "NaFl gtts .25 qd." It was reported that the pt subsequently recovered. No further info is available.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Petechiae
Clinical narrative: Information has been received from a physician concerning a 4 month old female with no past medical history and no known drug allergies who on 8/22/01 was vaccinated with haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast). Concomitant medications included 4 other vaccines from other pharmaceutical companies. Within 24 hours, the pt had petechiae on her extremities. Unspecified medical attention was sought. No further information was provided. Additional information has been requested. The follow up states within 24 hrs the pt had petechiae on her lower extremities, away from the site of the injection, on both legs. The site of the injections was without swelling, petechia or erythema. The pt was considered recovered. Unspecified medical attention was sought. No other info is expected.
Age: 1.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Dyspnoea, Face oedema, Periorbital oedema, Urticaria
Clinical narrative: MMR, Varivax and IPV given 10/08/2001. Pt developed urticaria, facial swelling and trouble breathing at home several hours later. EMS called. EMS brought Pt to ER. Pt give epinephrine, prednisone and Benadryl. In ER pt breathing "fine", still had periorbital swelling and urticaria.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Anorexia, Colitis, Thrombosis
Clinical narrative: Four days after receiving MMR pt complained of "colitis", unable to eat, no vomiting, no diarrhea but states passed bloody mucus per rectum. Seen in ER
Age: 1.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: Immunizations were given on 10/26/01 at 14:00. On 10/27/01 at 14:30, the child experienced a seizure while in the grocery store with his grandmother. The child had a temperature of 102F that Tylenol was Tylenol was being given for. The child was seen by ER and released home.
Age: 1.8
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Hypersensitivity, Injection site hypersensitivity, Oedema, Rash maculo-papular, Vasodilation procedure
Clinical narrative: On 09/02/2001 Morning after immunization right upper arm red and swollen, redness and swelling steadily increasing during the day and not hot to touch. Woke up 09/05/2001 with a few widespread maculopapular areas. No temp but mom has been alternating between Tylenol and Advil since day of immunization. On 09/06/2001 AM right arm now swollen to fingers and mom took child to MD who started pt on Zyrtec and though that possibly was allergic type reaction to DTaP.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Hypertension, Ventricular extrasystoles
Clinical narrative: The patient experienced elevated blood pressure (150/98) lasting several days and multiple and ongoing occurrences of heartbeat irregularity (PVC's) per day.
Age: 1.08
Sex: M
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Convulsion, Oculogyration, Pyrexia
Clinical narrative: The day following the vax the patient's temperature was 101F. The patient was treated with Tylenol. When taken to day care taker, it was noted the patient's eyes were rolling back in his head. 911 was called an arrived within 2 minutes. The seizure lasted less than 30 seconds. There was no seizure activity when the ambulance arrived. Upon examination at the ER the patient was alert and had no further seizures. On 11/27/2001 the patient had a temperature of 102.5-103F. There was no seizure activity. The patient was given a dose of amoxicillin and discharged.
Age: 56.0
Sex: M
Vaccine: RAB
Symptoms: Diarrhoea, Dizziness
Clinical narrative: The patient experienced diarrhea 2 hours after the immunization and dizziness 2 days later.
Age: 5.0
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Rash papular
Clinical narrative: On 11/27/2001 the patient developed several papules, firm vesicles, scattered over his body, on his face, back and groin area. The patient was exposed to chicken pox 2 weeks ago.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Agitation, Crying, Screaming
Clinical narrative: The patient experienced prolonged crying and screaming 3-4 hours. The patient was partially consolable.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: The patient experienced a large local allergic reaction from the injection site in the left deltoid to mid forearm with erythema and swelling. The symptoms were similar to bee sting reaction.
Age: 1.2
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Pt was given Varivax on 9/28/01. Pt seen at clinic 11/27/01 with rash that appeared to be chicken pox.
Sex: M
Vaccine: HIBV, IPV, MMR, VARCEL
Symptoms: Infection
Clinical narrative: Pt developed a rash of varicella lesions.
Age: 0.75
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt had no problems until redness began at vaccine site on the morning of 11/26/01. Initially it was one red spot about 1 cm in diameter, but by the end of the day, there were 5-7 separate red spots close together. By the morning of 11/27, spots had merged into one lesion, red, slightly raised and warm, 5.3 x 2.8 cm. Pt's physical was otherwise nml. No Rx was prescribed at that time.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Dyskinesia, Injection site reaction, Pyrexia
Clinical narrative: Pt developed a localized reaction at site of injection about 2 cm in size. Pt had fever and minimal tongue thrusting. She was treated with Children's Tylenol and Benadryl. Pt to follow-up in 24 hrs.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Almost 2/3 of pt's right upper arm became edematous and indurated with erythema, warmth to the touch and pain. She had a severe localized reaction to DaPT. She was treated with Prelone, ice and elevation.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dysphagia, Nasal congestion, Pharyngeal oedema
Clinical narrative: About 45 minutes post vax, pt developed swelling of the throat and difficulty swallowing. She became lightheaded and had nasal stuffiness. This lasted about 1 hour. She waited it out, and it went away.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Pt had 20+ lesions on trunk and top of head.