chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: F
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Somnolence, Stupor, Subarachnoid haemorrhage, Thrombocythaemia
Clinical narrative: Information has been received on 8/2/01 regarding a 4 month old female who received her 2nd dose of Tetramune, haemophilus influenza type b and Orimune vaccines. Four days, post vax, she presented with low-grade fever, lethargy and decreased oral intake. Her urine leukocyte esterase test was positive. The pt was treated with ceftriaxone, trimethoprim/sulfamethoxazole and acetaminophen. A dx of possible urinary tract infection was made; the result of the urine culture was neg. Three days later, she was admitted to the hospital with severe anemia. The pt was unresponsive, ventilator-dependent and showed evidence of disseminated intravascular coagulation. A warm auto antibody was identified in both her serum and red cell eluate. The pt was transfused with 2 units of red blood cells, 1 unit of cryoprecipitate and 2 units of fresh frozen plasma. She was also administered IV immune globulin, ampicillin and methylprednisolone sodium succinate. Her red cell antibody to ceftriaxone, Ham test, blood cultures, viral serologies and latex agglutination tests for haemophilus influenza, streptococcus pneumonia and Neisseria meningitides were all negative or noncontributory. Severe hemolysis continued and the pt expired 41 hours following hospital admission. An autopsy showed cerebral edema and diffuse subarachnoid hemorrhage but was was otherwise noncontributory. The authors indicated that the development of warm autoimmune hemolytic anemia in this pt suggested a causal relationship to the 2nd DTP (Tetramune) vaccination.
Age: 0.3
Sex: F
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Anaemia, Anorexia, Blood lactate dehydrogenase increased, Brain oedema, Disseminated intravascular coagulation
Clinical narrative: Information has been received on 8/2/01 regarding a 4 month old female who received her 2nd dose of Tetramune, haemophilus influenza type b and Orimune vaccines. Four days, post vax, she presented with low-grade fever, lethargy and decreased oral intake. Her urine leukocyte esterase test was positive. The pt was treated with ceftriaxone, trimethoprim/sulfamethoxazole and acetaminophen. A dx of possible urinary tract infection was made; the result of the urine culture was neg. Three days later, she was admitted to the hospital with severe anemia. The pt was unresponsive, ventilator-dependent and showed evidence of disseminated intravascular coagulation. A warm auto antibody was identified in both her serum and red cell eluate. The pt was transfused with 2 units of red blood cells, 1 unit of cryoprecipitate and 2 units of fresh frozen plasma. She was also administered IV immune globulin, ampicillin and methylprednisolone sodium succinate. Her red cell antibody to ceftriaxone, Ham test, blood cultures, viral serologies and latex agglutination tests for haemophilus influenza, streptococcus pneumonia and Neisseria meningitides were all negative or noncontributory. Severe hemolysis continued and the pt expired 41 hours following hospital admission. An autopsy showed cerebral edema and diffuse subarachnoid hemorrhage but was was otherwise noncontributory. The authors indicated that the development of warm autoimmune hemolytic anemia in this pt suggested a causal relationship to the 2nd DTP (Tetramune) vaccination.
Age: 0.3
Sex: F
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Haemolysis, Haemolytic anaemia, Leukocytosis, Pyrexia, Somnolence
Clinical narrative: Information has been received on 8/2/01 regarding a 4 month old female who received her 2nd dose of Tetramune, haemophilus influenza type b and Orimune vaccines. Four days, post vax, she presented with low-grade fever, lethargy and decreased oral intake. Her urine leukocyte esterase test was positive. The pt was treated with ceftriaxone, trimethoprim/sulfamethoxazole and acetaminophen. A dx of possible urinary tract infection was made; the result of the urine culture was neg. Three days later, she was admitted to the hospital with severe anemia. The pt was unresponsive, ventilator-dependent and showed evidence of disseminated intravascular coagulation. A warm auto antibody was identified in both her serum and red cell eluate. The pt was transfused with 2 units of red blood cells, 1 unit of cryoprecipitate and 2 units of fresh frozen plasma. She was also administered IV immune globulin, ampicillin and methylprednisolone sodium succinate. Her red cell antibody to ceftriaxone, Ham test, blood cultures, viral serologies and latex agglutination tests for haemophilus influenza, streptococcus pneumonia and Neisseria meningitides were all negative or noncontributory. Severe hemolysis continued and the pt expired 41 hours following hospital admission. An autopsy showed cerebral edema and diffuse subarachnoid hemorrhage but was was otherwise noncontributory. The authors indicated that the development of warm autoimmune hemolytic anemia in this pt suggested a causal relationship to the 2nd DTP (Tetramune) vaccination.
Age: 0.3
Sex: F
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Stupor, Subarachnoid haemorrhage, Thrombocytopenia, Urinary tract infection, Urine analysis abnormal
Clinical narrative: Information has been received on 8/2/01 regarding a 4 month old female who received her 2nd dose of Tetramune, haemophilus influenza type b and Orimune vaccines. Four days, post vax, she presented with low-grade fever, lethargy and decreased oral intake. Her urine leukocyte esterase test was positive. The pt was treated with ceftriaxone, trimethoprim/sulfamethoxazole and acetaminophen. A dx of possible urinary tract infection was made; the result of the urine culture was neg. Three days later, she was admitted to the hospital with severe anemia. The pt was unresponsive, ventilator-dependent and showed evidence of disseminated intravascular coagulation. A warm auto antibody was identified in both her serum and red cell eluate. The pt was transfused with 2 units of red blood cells, 1 unit of cryoprecipitate and 2 units of fresh frozen plasma. She was also administered IV immune globulin, ampicillin and methylprednisolone sodium succinate. Her red cell antibody to ceftriaxone, Ham test, blood cultures, viral serologies and latex agglutination tests for haemophilus influenza, streptococcus pneumonia and Neisseria meningitides were all negative or noncontributory. Severe hemolysis continued and the pt expired 41 hours following hospital admission. An autopsy showed cerebral edema and diffuse subarachnoid hemorrhage but was was otherwise noncontributory. The authors indicated that the development of warm autoimmune hemolytic anemia in this pt suggested a causal relationship to the 2nd DTP (Tetramune) vaccination.
Age: 0.3
Sex: F
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Anaemia, Anorexia, Brain oedema, Disseminated intravascular coagulation, Haemolysis
Clinical narrative: Information has been received on 8/2/01 regarding a 4 month old female who received her 2nd dose of Tetramune, haemophilus influenza type b and Orimune vaccines. Four days, post vax, she presented with low-grade fever, lethargy and decreased oral intake. Her urine leukocyte esterase test was positive. The pt was treated with ceftriaxone, trimethoprim/sulfamethoxazole and acetaminophen. A dx of possible urinary tract infection was made; the result of the urine culture was neg. Three days later, she was admitted to the hospital with severe anemia. The pt was unresponsive, ventilator-dependent and showed evidence of disseminated intravascular coagulation. A warm auto antibody was identified in both her serum and red cell eluate. The pt was transfused with 2 units of red blood cells, 1 unit of cryoprecipitate and 2 units of fresh frozen plasma. She was also administered IV immune globulin, ampicillin and methylprednisolone sodium succinate. Her red cell antibody to ceftriaxone, Ham test, blood cultures, viral serologies and latex agglutination tests for haemophilus influenza, streptococcus pneumonia and Neisseria meningitides were all negative or noncontributory. Severe hemolysis continued and the pt expired 41 hours following hospital admission. An autopsy showed cerebral edema and diffuse subarachnoid hemorrhage but was was otherwise noncontributory. The authors indicated that the development of warm autoimmune hemolytic anemia in this pt suggested a causal relationship to the 2nd DTP (Tetramune) vaccination.
Age: 0.3
Sex: F
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Leukocytosis, Pyrexia, Somnolence, Stupor, Subarachnoid haemorrhage
Clinical narrative: Information has been received on 8/2/01 regarding a 4 month old female who received her 2nd dose of Tetramune, haemophilus influenza type b and Orimune vaccines. Four days, post vax, she presented with low-grade fever, lethargy and decreased oral intake. Her urine leukocyte esterase test was positive. The pt was treated with ceftriaxone, trimethoprim/sulfamethoxazole and acetaminophen. A dx of possible urinary tract infection was made; the result of the urine culture was neg. Three days later, she was admitted to the hospital with severe anemia. The pt was unresponsive, ventilator-dependent and showed evidence of disseminated intravascular coagulation. A warm auto antibody was identified in both her serum and red cell eluate. The pt was transfused with 2 units of red blood cells, 1 unit of cryoprecipitate and 2 units of fresh frozen plasma. She was also administered IV immune globulin, ampicillin and methylprednisolone sodium succinate. Her red cell antibody to ceftriaxone, Ham test, blood cultures, viral serologies and latex agglutination tests for haemophilus influenza, streptococcus pneumonia and Neisseria meningitides were all negative or noncontributory. Severe hemolysis continued and the pt expired 41 hours following hospital admission. An autopsy showed cerebral edema and diffuse subarachnoid hemorrhage but was was otherwise noncontributory. The authors indicated that the development of warm autoimmune hemolytic anemia in this pt suggested a causal relationship to the 2nd DTP (Tetramune) vaccination.
Age: 0.3
Sex: F
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Urinary tract infection
Clinical narrative: Information has been received on 8/2/01 regarding a 4 month old female who received her 2nd dose of Tetramune, haemophilus influenza type b and Orimune vaccines. Four days, post vax, she presented with low-grade fever, lethargy and decreased oral intake. Her urine leukocyte esterase test was positive. The pt was treated with ceftriaxone, trimethoprim/sulfamethoxazole and acetaminophen. A dx of possible urinary tract infection was made; the result of the urine culture was neg. Three days later, she was admitted to the hospital with severe anemia. The pt was unresponsive, ventilator-dependent and showed evidence of disseminated intravascular coagulation. A warm auto antibody was identified in both her serum and red cell eluate. The pt was transfused with 2 units of red blood cells, 1 unit of cryoprecipitate and 2 units of fresh frozen plasma. She was also administered IV immune globulin, ampicillin and methylprednisolone sodium succinate. Her red cell antibody to ceftriaxone, Ham test, blood cultures, viral serologies and latex agglutination tests for haemophilus influenza, streptococcus pneumonia and Neisseria meningitides were all negative or noncontributory. Severe hemolysis continued and the pt expired 41 hours following hospital admission. An autopsy showed cerebral edema and diffuse subarachnoid hemorrhage but was was otherwise noncontributory. The authors indicated that the development of warm autoimmune hemolytic anemia in this pt suggested a causal relationship to the 2nd DTP (Tetramune) vaccination.
Age: 0.3
Sex: F
Vaccine: DTPHIB, HIBV, OPV, DTPHIB, OPV, DTPHIB, HEP, OPV, DTPHIB, HIBV, OPV, HEP
Symptoms: Irritability, Otitis media
Clinical narrative: Information has been received on 8/2/01 regarding a 4 month old female who received her 2nd dose of Tetramune, haemophilus influenza type b and Orimune vaccines. Four days, post vax, she presented with low-grade fever, lethargy and decreased oral intake. Her urine leukocyte esterase test was positive. The pt was treated with ceftriaxone, trimethoprim/sulfamethoxazole and acetaminophen. A dx of possible urinary tract infection was made; the result of the urine culture was neg. Three days later, she was admitted to the hospital with severe anemia. The pt was unresponsive, ventilator-dependent and showed evidence of disseminated intravascular coagulation. A warm auto antibody was identified in both her serum and red cell eluate. The pt was transfused with 2 units of red blood cells, 1 unit of cryoprecipitate and 2 units of fresh frozen plasma. She was also administered IV immune globulin, ampicillin and methylprednisolone sodium succinate. Her red cell antibody to ceftriaxone, Ham test, blood cultures, viral serologies and latex agglutination tests for haemophilus influenza, streptococcus pneumonia and Neisseria meningitides were all negative or noncontributory. Severe hemolysis continued and the pt expired 41 hours following hospital admission. An autopsy showed cerebral edema and diffuse subarachnoid hemorrhage but was was otherwise noncontributory. The authors indicated that the development of warm autoimmune hemolytic anemia in this pt suggested a causal relationship to the 2nd DTP (Tetramune) vaccination.
Age: 0.5
Sex: F
Vaccine: PNC, PNC, PNC
Symptoms: Blister
Clinical narrative: A 6 month old female received her 3rd injection of Prevnar on 7/2/01. On 7/4/01, the infant developed blisters and bulla on her legs and body. She was seen in an ER and subsequently, hospitalized for 3 days.
Age: 0.5
Sex: F
Vaccine: PNC, PNC, PNC
Symptoms: Dermatitis bullous
Clinical narrative: A 6 month old female received her 3rd injection of Prevnar on 7/2/01. On 7/4/01, the infant developed blisters and bulla on her legs and body. She was seen in an ER and subsequently, hospitalized for 3 days.
Age: 0.5
Sex: F
Vaccine: PNC, PNC, PNC
Symptoms: Crying, Erythema, Injection site erythema, Injection site pain, Skin exfoliation
Clinical narrative: A 6 month old female received her 3rd injection of Prevnar on 7/2/01. On 7/4/01, the infant developed blisters and bulla on her legs and body. She was seen in an ER and subsequently, hospitalized for 3 days.
Age: 14.0
Sex: F
Vaccine: DTP, HEP, HEP, TD
Symptoms: Convulsion
Clinical narrative: Pt had a muscular seizure, approx. 5-10 minutes. EMS came and took her to the ER.
Age: 14.0
Sex: F
Vaccine: DTP, HEP, HEP, TD
Symptoms: Coma, Hyperhidrosis, Syncope vasovagal
Clinical narrative: Pt had a muscular seizure, approx. 5-10 minutes. EMS came and took her to the ER.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Agitation, Arthralgia, Depression, Gastrointestinal disorder, Insomnia
Clinical narrative: 48 hours, post vax, pt awoke crying, inconsolable crying which lasted 2 months. No kidding. Then off and on for months at a time, around the clock. for another year. Now, episodic, lasting weeks. Irritable, depressed. Complete personality change overnight and was a good sleeper, never cried, but now is a depressed child with developed gross motor delays and complaint of fingers hurting her. The annual folow-up states pt "still has bouts of depression and inconsolable crying. Has bouts of easily triggered tantrums. Still has severe gross motor delays. Bouts of insomnia. Gastrointestinal problems i.e. severe bloating. I want to emphasize that none of the above symptoms existed prior to that DTaP vaccine. Approx. 36 hrs after the vaccine, pt awoke crying inconsolably and has never been the same since. This last "bout" of depression and crying lasted 2 months. The G.I. problems and gross motor delays are a constant. The mood issues are episodic."
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Neurodevelopmental disorder, Personality disorder, Screaming, Sleep disorder
Clinical narrative: 48 hours, post vax, pt awoke crying, inconsolable crying which lasted 2 months. No kidding. Then off and on for months at a time, around the clock. for another year. Now, episodic, lasting weeks. Irritable, depressed. Complete personality change overnight and was a good sleeper, never cried, but now is a depressed child with developed gross motor delays and complaint of fingers hurting her. The annual folow-up states pt "still has bouts of depression and inconsolable crying. Has bouts of easily triggered tantrums. Still has severe gross motor delays. Bouts of insomnia. Gastrointestinal problems i.e. severe bloating. I want to emphasize that none of the above symptoms existed prior to that DTaP vaccine. Approx. 36 hrs after the vaccine, pt awoke crying inconsolably and has never been the same since. This last "bout" of depression and crying lasted 2 months. The G.I. problems and gross motor delays are a constant. The mood issues are episodic."
Age: 2.0
Sex: F
Vaccine: HIBV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Post vax the patient experienced redness, pain and induration of the injection site.
Age: 0.15
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient's father stated that at 17:00 hours on 07/23/2001 the patient's left thigh was pinkish, swollen and hard to the touch. When the patient's legs were lifted to change a diaper, the patient cried uncontrollably. The patient was treated with Tylenol. On 07/24/2001 at 14:00 hours the patient saw Dr who advised treatment with Motrin. On 07/30/2001 the patient's mother called and stated the patient's left thigh is still reddened, swollen and warm to the touch. The mother was advised to apply cold compresses to the thigh. Follow up on 08/01/2001 the father states the patient is still the same and they have not tried cold compresses, as they feel they will not help.
Age: 0.15
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pain
Clinical narrative: Patient's father stated that at 17:00 hours on 07/23/2001 the patient's left thigh was pinkish, swollen and hard to the touch. When the patient's legs were lifted to change a diaper, the patient cried uncontrollably. The patient was treated with Tylenol. On 07/24/2001 at 14:00 hours the patient saw Dr who advised treatment with Motrin. On 07/30/2001 the patient's mother called and stated the patient's left thigh is still reddened, swollen and warm to the touch. The mother was advised to apply cold compresses to the thigh. Follow up on 08/01/2001 the father states the patient is still the same and they have not tried cold compresses, as they feel they will not help.
Age: 1.6
Sex: M
Vaccine: PNC
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: The patient experienced a high fever (102-103F) with nausea and vomiting within 12 hours of vaccine administration. The patient was treated with antipyretics and fluids.
Age: 2.0
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Blister, Erythema, Injection site swelling, Oedema peripheral, Pyrexia
Clinical narrative: Post vax the patient experienced a fever and swelling of the right leg from the injection site to the ankle, and also redness and the development of blisters on that leg. The patient was seen at the ER. Doctors at ER were concerned about possible bug bite.
Age: 1.2
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Injection site erythema
Clinical narrative: In the PM on the day of the vaccination, the patient developed an area of redness around the injection site on the left thigh. On 12/19/2000 the patient was seen in the office, with redness at the site, approximately 3 cm area. Doctor believes reaction is from DTaP
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling, Irritability, Pyrexia
Clinical narrative: Post vax the patient was fussy, a fever of 102F, and redness and swelling on the right proximal thigh.
Age: 53.0
Sex: M
Vaccine: LYME
Symptoms: Bundle branch block, Cardiac failure
Clinical narrative: The pt received his 1st injection of Lymerix in 5/00. Approx. 1 day, post vax, he experienced general malaise. The malaise resolved after an unspecified period of time. The pt received the 2nd injection of Lymerix in 6/00. In 11/00, approx. 5 months, post vax, left bundle branch block was discovered. The pt was referred to a cardiologist, who confirmed the presence of left bundle branch block of unknown origin. The cardiologist reportedly told the pt that the vaccinee "probably had a virus which settled in (his) heart." However, the pt reported that he "was never sick". The pt underwent an unspecified stress test and angiography in 1/01. The angiogram reportedly "was excellent"; however, the pt stated that a "15 to 20% loss of output" was noted. The cardiologist discontinued pravastatin therapy. As of 7/26/01, the left bundle branch block and reduced cardiac output were ongoing. Left bundle branch block and reduced cardiac output are considered GSK "medically serious".
Age: 36.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Oedema peripheral, Pain in extremity
Clinical narrative: Post vax, the patient experienced bilateral knee pain, bilateral foot pain and right prepatella effusion.
Age: 5.0
Sex: M
Vaccine: HEP, HEPA, MMR
Symptoms: Hepatitis A
Clinical narrative: Child dx'd with Hep-A on 8/8/01 by doctor.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt developed red, swelling in leg, 1 week, post vax, lasting about a week.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: Pt developed shoulder and arm pain requiring X-rays and treatment with 800mg ibuprofen.
Age: 1.5
Sex: F
Vaccine: IPV
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Pt received IPV only on 7/25/01 and broke out in a rash on 7/26/01. In for appt on 7/27/01, because no improvement; had urticaria rash. Probable reaction to IPV.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Pt had a fever of 103.8F and a flat, red "tiny" rash around her neck for 2-3 days, post vax. Rash spread to abdomen and back but fever disappeared after 2 days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site inflammation, Injection site reaction, Injection site swelling
Clinical narrative: The following morning, post vax, the pt had swelling and inflammation in right arm. Pt was taken to ER and Rx'd with ice packs to affected arm, Erythometh 200/5mg. Dx'd with local reaction to injection.
Age: 5.0
Sex: M
Vaccine: DT
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Injection site was red and swollen the size of an orange and hot and tender to touch. It also itches and "bothers him".
Age: 45.0
Sex: M
Vaccine: HEPAB
Symptoms: Chest pain, Flank pain
Clinical narrative: The pt stated that on 6/22/01 he had right side pain, under collar bone and across chest. Saw PMD on 7/1/01 with Rx of anti-inflammatory meds. Saw a chiropractor on 7/5/01 who thought he had a rib out of place. Saw this doctor on 7/11/01 and had a CXR with was normal. Pt states pain has been moving moving around since then, according to his wife on 7/22/01.
Age: 1.2
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Pruritus, Rash vesicular
Clinical narrative: Pt had a varicella type rash. Will do home care of Tylenol/Advil and Benadryl as needed for itching.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: On 7/13/01, mom called concerning a temperature of 100.3F and spots like pimples, on back (4) and has been exposed to chickenpox. On 7/17/01, mom called and the pt had no further spots and temperature stayed the same (100.3F-100.7F) all weekend but is OK now.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm with generalized edema, redness and warmth.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Injection site mass, Injection site swelling
Clinical narrative: Area swelled up 3"-4" in diameter around injection site with red bump also at injection site. Pt had joint discomfort, bilateral. Symptoms persisted for 4 days with swelling still evident.
Age: 13.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Abdominal pain, Hypoaesthesia, Injection site pain, Pain, Rash
Clinical narrative: Pt developed a rash and hives on face, arms, chest, back and legs. He had numbness and soreness in right arm and right hand, abdominal pain and vomiting. Symptoms developed within 6 hours, post vax. Pt returned to office and received Benadryl 25mg, IM and observed for 1 hour. Symptoms resolved in office.
Age: 13.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Urticaria, Vomiting
Clinical narrative: Pt developed a rash and hives on face, arms, chest, back and legs. He had numbness and soreness in right arm and right hand, abdominal pain and vomiting. Symptoms developed within 6 hours, post vax. Pt returned to office and received Benadryl 25mg, IM and observed for 1 hour. Symptoms resolved in office.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Pt developed swelling, erythema and warmth at the site of injection. Reported fever to 104F (orally) with increased diameter of left arm of 1" more than right arm.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Epistaxis, Erythema, Headache, Pain in extremity
Clinical narrative: The last week of 12/99, had Christmas family day dinner and afterwards was very ill; headache; fever and blew blood through nose for 2 weeks. Feet were very red and burning for a week. Hot water also turned them very red. Also had a cough and restlessness for 2 weeks. Sore left arm. Prayed to God a lot.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Restlessness
Clinical narrative: The last week of 12/99, had Christmas family day dinner and afterwards was very ill; headache; fever and blew blood through nose for 2 weeks. Feet were very red and burning for a week. Hot water also turned them very red. Also had a cough and restlessness for 2 weeks. Sore left arm. Prayed to God a lot.
Age: 12.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Chest pain, Dyspnoea, Swelling
Clinical narrative: Approx. 1 hour and 45 minutes, post vax, mom called to pick child up from school. Child stated that it was "hard to breathe" and he felt "puffed up inside". Felt as if he had just come back in from running. Felt like someone was "sitting on his chest". Mom states, she took child home and called pediatricians office. They advised to give child Benadryl. Repeated Benadryl dose 4 hours after his 1st dose and he recovered by evening.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Chills, Convulsion, Pyrexia
Clinical narrative: Per mom, shots given at 09:30 and pt had chills by 10:30 and was given Tylenol. Pt's temperature was 102F at 13:00 and was given Tylenol. Temperature increased at 16:30, not taken but felt hot, so was given Tylenol. Pt slept until 18:30 and then he awoke and wanted only to be held. He had a seizure at 19:00 and went to ER. Watched at ER and given antipyretics and sent home. Tylenol and ibuprofen at 02:00. He is doing fine today on 12/5/00.
Age: 0.75
Sex: F
Vaccine: HBHEPB, PNC, HBHEPB, PNC
Symptoms: Hearing impaired, Meningitis, Platelet count increased, Sepsis
Clinical narrative: Information was received from a nurse concerning a 9 month old female who on 3/27/01 was vaccinated, IM, in the left leg, with a 2nd dose of Hib (+) Hep-B (lot 637874/1524K). Concomitant therapy included a 3rd dose, IM, in the right leg, of Prevnar (474726). There was no illness at the time of vaccination. On 5/5/01, the pt developed meningitis and bacteremia and was hospitalized. It was reported that a blood culture was done and was positive. It was noted that on 11/22/00 and 1/16/00, the pt received a 1st dose, IM, in the right leg (lot 473342) and a 2nd dose, IM, in the left leg (lot 473450) respectively, of Prevnar. It was also noted that on 11/22/01, the pt received a 2nd dose, IM, in the right leg of Hib-Titer (lot 560903A). Additional information has been requested.
Age: 0.75
Sex: F
Vaccine: HBHEPB, PNC, HBHEPB, PNC
Symptoms: Bacterial infection, Meningitis
Clinical narrative: Information was received from a nurse concerning a 9 month old female who on 3/27/01 was vaccinated, IM, in the left leg, with a 2nd dose of Hib (+) Hep-B (lot 637874/1524K). Concomitant therapy included a 3rd dose, IM, in the right leg, of Prevnar (474726). There was no illness at the time of vaccination. On 5/5/01, the pt developed meningitis and bacteremia and was hospitalized. It was reported that a blood culture was done and was positive. It was noted that on 11/22/00 and 1/16/00, the pt received a 1st dose, IM, in the right leg (lot 473342) and a 2nd dose, IM, in the left leg (lot 473450) respectively, of Prevnar. It was also noted that on 11/22/01, the pt received a 2nd dose, IM, in the right leg of Hib-Titer (lot 560903A). Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL, MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Convulsion, Dyskinesia, Muscle twitching, Sleep disorder, Torticollis
Clinical narrative: The information was received from a consumer concerning her 12 month old son who on 1/10/01 was vaccinated with a 1st dose of varicella virus vaccine live. Concomitant therapy included a 3rd dose of Prevnar and a 1st dose of MMRII. On 7/12/01, the pt experienced a seizure described by the mother as "his eyes shut, his head jerks to the right side and his right shoulder pulls up". There was no fever associated with the seizure. It was reported at the time of the report, that the child has had at least 75 seizures since 1/12/01 which lasted less than 5 seconds. On 1/23/01 the mother reported to the pediatrician that the pt "had stopped sleeping, was not napping and had a twitch of his right arm that had been occurring for the past week and a half." The pt was seen by a pediatric neurologist on 1/30/01 and a dx of "benign seizure disorder" was made. It was noted that the neurologist could not find a cause and that the child would "probably outgrow" the seizures. The pt was not prescribed medications and is to return to the doctor if the seizures continued for 6 months. On 2/4/01 pt's mother reported that the seizures were occurring less frequently. On 7/5/01 it was noted that no seizures had been noted in the past month. The reporter felt that benign seizure disorder was not related to the therapy with varicella virus vaccine live, Prevnar or MMRII. Upon internal review, the pt's experience was considered to be an "Other Important Medical Event". Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL, MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Convulsion, Dyskinesia
Clinical narrative: The information was received from a consumer concerning her 12 month old son who on 1/10/01 was vaccinated with a 1st dose of varicella virus vaccine live. Concomitant therapy included a 3rd dose of Prevnar and a 1st dose of MMRII. On 7/12/01, the pt experienced a seizure described by the mother as "his eyes shut, his head jerks to the right side and his right shoulder pulls up". There was no fever associated with the seizure. It was reported at the time of the report, that the child has had at least 75 seizures since 1/12/01 which lasted less than 5 seconds. On 1/23/01 the mother reported to the pediatrician that the pt "had stopped sleeping, was not napping and had a twitch of his right arm that had been occurring for the past week and a half." The pt was seen by a pediatric neurologist on 1/30/01 and a dx of "benign seizure disorder" was made. It was noted that the neurologist could not find a cause and that the child would "probably outgrow" the seizures. The pt was not prescribed medications and is to return to the doctor if the seizures continued for 6 months. On 2/4/01 pt's mother reported that the seizures were occurring less frequently. On 7/5/01 it was noted that no seizures had been noted in the past month. The reporter felt that benign seizure disorder was not related to the therapy with varicella virus vaccine live, Prevnar or MMRII. Upon internal review, the pt's experience was considered to be an "Other Important Medical Event". Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL, MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Convulsion, Dyskinesia, Eye disorder, Sleep disorder
Clinical narrative: The information was received from a consumer concerning her 12 month old son who on 1/10/01 was vaccinated with a 1st dose of varicella virus vaccine live. Concomitant therapy included a 3rd dose of Prevnar and a 1st dose of MMRII. On 7/12/01, the pt experienced a seizure described by the mother as "his eyes shut, his head jerks to the right side and his right shoulder pulls up". There was no fever associated with the seizure. It was reported at the time of the report, that the child has had at least 75 seizures since 1/12/01 which lasted less than 5 seconds. On 1/23/01 the mother reported to the pediatrician that the pt "had stopped sleeping, was not napping and had a twitch of his right arm that had been occurring for the past week and a half." The pt was seen by a pediatric neurologist on 1/30/01 and a dx of "benign seizure disorder" was made. It was noted that the neurologist could not find a cause and that the child would "probably outgrow" the seizures. The pt was not prescribed medications and is to return to the doctor if the seizures continued for 6 months. On 2/4/01 pt's mother reported that the seizures were occurring less frequently. On 7/5/01 it was noted that no seizures had been noted in the past month. The reporter felt that benign seizure disorder was not related to the therapy with varicella virus vaccine live, Prevnar or MMRII. Upon internal review, the pt's experience was considered to be an "Other Important Medical Event". Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, DTP, HEP, HIBV, IPV, DTP, HEP, HIBV, IPV
Symptoms: Atelectasis, Coma, Hypotonia, Lymphadenitis, Pneumonitis
Clinical narrative: Information has been received from a health professional concerning an 11 week old pt with no known allergies and a history of swollen lymph nodes in the groin who on 7/20/01 was vaccinated with a dose of haemophilus b conjugate vaccine, a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid, Hep-B vaccine and a poliovirus vaccine (IPOL). Concomitant medication included amoxicillin trihydrate (+) clavulante potassium (Augmentin). Early morning of 07/21/2001, the pt's mother called 911 and performed mouth to mouth on the child. The pt was then rushed by EMS to the hospital. The child died at 02:30 on 7/21/00. It was reported that the cause of death "may be SIDS, but not confirmed at this time". Additional information has been received from a physician who reports the child received a dose of Hep-B vaccine on 6/8/01 and tolerated it well. Four days prior to this vaccination, the child had lymph node enlargement of unknown etiology for which he saw a hematologist/oncologist. This physician did not order any tests and felt the amoxicillin trihydrate(-) clavulance potassium (Augmentin) the child was being treated with was the appropriate course of treatment. It was noted that the pt died, 1 day, post vax, of "presumably SIDS on 7/21/01". Follow-up information from a physician indicated that the diagnosis from the autopsy was interstitaial pneumonitis. From follow-up correspondence received on 11/19/2001 from the director of Autopsy, it was stated, " I have reviewed the autopsy report and six microscopic M & K stained slides of the above mentioned pt. and it my opinion that this infant had a telectasis, a desquamative interstitial pneumonitis and acute and chronic trachsitis." " The inguinal lymph node has a subacute lymphadentitis with peripheral fibrosis and the spleen is slighty lymphocyte depleted. However, malpighian corpuscles are still perserved. Other examined organs were with in normal limits." " I showed the lymph nodes, spleen and bone marrow to another physician and he believes it  is a reactive process. Probably the port of entry was one of scratches found in both lower extremities." "Based on the above-mentioned findings. I can exclude SID possibility of a primary immunodefiency could not be ruled out by this autopsy There are some x-linked forms, like Wiscott aldrich and x-Linked immunodefiecny but in the absence of skin lesions likew eczema (chronic dermatitis) and thrombocytopenia, it is not possible to stongly suspect diagnosis." This case is closed.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, DTP, HEP, HIBV, IPV, DTP, HEP, HIBV, IPV
Symptoms: Tracheitis
Clinical narrative: Information has been received from a health professional concerning an 11 week old pt with no known allergies and a history of swollen lymph nodes in the groin who on 7/20/01 was vaccinated with a dose of haemophilus b conjugate vaccine, a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid, Hep-B vaccine and a poliovirus vaccine (IPOL). Concomitant medication included amoxicillin trihydrate (+) clavulante potassium (Augmentin). Early morning of 07/21/2001, the pt's mother called 911 and performed mouth to mouth on the child. The pt was then rushed by EMS to the hospital. The child died at 02:30 on 7/21/00. It was reported that the cause of death "may be SIDS, but not confirmed at this time". Additional information has been received from a physician who reports the child received a dose of Hep-B vaccine on 6/8/01 and tolerated it well. Four days prior to this vaccination, the child had lymph node enlargement of unknown etiology for which he saw a hematologist/oncologist. This physician did not order any tests and felt the amoxicillin trihydrate(-) clavulance potassium (Augmentin) the child was being treated with was the appropriate course of treatment. It was noted that the pt died, 1 day, post vax, of "presumably SIDS on 7/21/01". Follow-up information from a physician indicated that the diagnosis from the autopsy was interstitaial pneumonitis. From follow-up correspondence received on 11/19/2001 from the director of Autopsy, it was stated, " I have reviewed the autopsy report and six microscopic M & K stained slides of the above mentioned pt. and it my opinion that this infant had a telectasis, a desquamative interstitial pneumonitis and acute and chronic trachsitis." " The inguinal lymph node has a subacute lymphadentitis with peripheral fibrosis and the spleen is slighty lymphocyte depleted. However, malpighian corpuscles are still perserved. Other examined organs were with in normal limits." " I showed the lymph nodes, spleen and bone marrow to another physician and he believes it  is a reactive process. Probably the port of entry was one of scratches found in both lower extremities." "Based on the above-mentioned findings. I can exclude SID possibility of a primary immunodefiency could not be ruled out by this autopsy There are some x-linked forms, like Wiscott aldrich and x-Linked immunodefiecny but in the absence of skin lesions likew eczema (chronic dermatitis) and thrombocytopenia, it is not possible to stongly suspect diagnosis." This case is closed.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, DTP, HEP, HIBV, IPV, DTP, HEP, HIBV, IPV
Symptoms: Laboratory test abnormal, Pneumonitis, Tracheitis
Clinical narrative: Information has been received from a health professional concerning an 11 week old pt with no known allergies and a history of swollen lymph nodes in the groin who on 7/20/01 was vaccinated with a dose of haemophilus b conjugate vaccine, a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid, Hep-B vaccine and a poliovirus vaccine (IPOL). Concomitant medication included amoxicillin trihydrate (+) clavulante potassium (Augmentin). Early morning of 07/21/2001, the pt's mother called 911 and performed mouth to mouth on the child. The pt was then rushed by EMS to the hospital. The child died at 02:30 on 7/21/00. It was reported that the cause of death "may be SIDS, but not confirmed at this time". Additional information has been received from a physician who reports the child received a dose of Hep-B vaccine on 6/8/01 and tolerated it well. Four days prior to this vaccination, the child had lymph node enlargement of unknown etiology for which he saw a hematologist/oncologist. This physician did not order any tests and felt the amoxicillin trihydrate(-) clavulance potassium (Augmentin) the child was being treated with was the appropriate course of treatment. It was noted that the pt died, 1 day, post vax, of "presumably SIDS on 7/21/01". Follow-up information from a physician indicated that the diagnosis from the autopsy was interstitaial pneumonitis. From follow-up correspondence received on 11/19/2001 from the director of Autopsy, it was stated, " I have reviewed the autopsy report and six microscopic M & K stained slides of the above mentioned pt. and it my opinion that this infant had a telectasis, a desquamative interstitial pneumonitis and acute and chronic trachsitis." " The inguinal lymph node has a subacute lymphadentitis with peripheral fibrosis and the spleen is slighty lymphocyte depleted. However, malpighian corpuscles are still perserved. Other examined organs were with in normal limits." " I showed the lymph nodes, spleen and bone marrow to another physician and he believes it  is a reactive process. Probably the port of entry was one of scratches found in both lower extremities." "Based on the above-mentioned findings. I can exclude SID possibility of a primary immunodefiency could not be ruled out by this autopsy There are some x-linked forms, like Wiscott aldrich and x-Linked immunodefiecny but in the absence of skin lesions likew eczema (chronic dermatitis) and thrombocytopenia, it is not possible to stongly suspect diagnosis." This case is closed.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, DTP, HEP, HIBV, IPV, DTP, HEP, HIBV, IPV
Symptoms: Sudden infant death syndrome
Clinical narrative: Information has been received from a health professional concerning an 11 week old pt with no known allergies and a history of swollen lymph nodes in the groin who on 7/20/01 was vaccinated with a dose of haemophilus b conjugate vaccine, a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid, Hep-B vaccine and a poliovirus vaccine (IPOL). Concomitant medication included amoxicillin trihydrate (+) clavulante potassium (Augmentin). Early morning of 07/21/2001, the pt's mother called 911 and performed mouth to mouth on the child. The pt was then rushed by EMS to the hospital. The child died at 02:30 on 7/21/00. It was reported that the cause of death "may be SIDS, but not confirmed at this time". Additional information has been received from a physician who reports the child received a dose of Hep-B vaccine on 6/8/01 and tolerated it well. Four days prior to this vaccination, the child had lymph node enlargement of unknown etiology for which he saw a hematologist/oncologist. This physician did not order any tests and felt the amoxicillin trihydrate(-) clavulance potassium (Augmentin) the child was being treated with was the appropriate course of treatment. It was noted that the pt died, 1 day, post vax, of "presumably SIDS on 7/21/01". Follow-up information from a physician indicated that the diagnosis from the autopsy was interstitaial pneumonitis. From follow-up correspondence received on 11/19/2001 from the director of Autopsy, it was stated, " I have reviewed the autopsy report and six microscopic M & K stained slides of the above mentioned pt. and it my opinion that this infant had a telectasis, a desquamative interstitial pneumonitis and acute and chronic trachsitis." " The inguinal lymph node has a subacute lymphadentitis with peripheral fibrosis and the spleen is slighty lymphocyte depleted. However, malpighian corpuscles are still perserved. Other examined organs were with in normal limits." " I showed the lymph nodes, spleen and bone marrow to another physician and he believes it  is a reactive process. Probably the port of entry was one of scratches found in both lower extremities." "Based on the above-mentioned findings. I can exclude SID possibility of a primary immunodefiency could not be ruled out by this autopsy There are some x-linked forms, like Wiscott aldrich and x-Linked immunodefiecny but in the absence of skin lesions likew eczema (chronic dermatitis) and thrombocytopenia, it is not possible to stongly suspect diagnosis." This case is closed.
Age: 0.7
Sex: F
Vaccine: PNC, PNC, PNC
Symptoms: Blister
Clinical narrative: My baby started crying so much, 2 days later, her neck started getting red and also her leg got red especially where she got her shot and her skin started to come off. She lost about 80% of her skin. I couldn't carry her; she was in a lot of pain. She has suffered a lot.
Age: 0.7
Sex: F
Vaccine: PNC, PNC, PNC
Symptoms: Dermatitis bullous
Clinical narrative: My baby started crying so much, 2 days later, her neck started getting red and also her leg got red especially where she got her shot and her skin started to come off. She lost about 80% of her skin. I couldn't carry her; she was in a lot of pain. She has suffered a lot.
Age: 0.7
Sex: F
Vaccine: PNC, PNC, PNC
Symptoms: Crying, Erythema, Injection site erythema, Injection site pain, Skin exfoliation
Clinical narrative: My baby started crying so much, 2 days later, her neck started getting red and also her leg got red especially where she got her shot and her skin started to come off. She lost about 80% of her skin. I couldn't carry her; she was in a lot of pain. She has suffered a lot.
Age: 1.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Bacterial infection, Cough, Nasal congestion, Pyrexia
Clinical narrative: Information has been received concerning an 18 month old male who on 5/29/01 was vaccinated with haemophilus b conjugate vaccine (+) Hep-B vaccine recombinant (yeast), IM, in the right thigh (lot 637875/1525K) Concomitant therapy included a 3rd injection of Prevnar, IM, left thigh (lot 473351); 1st injection 4/11/00, 2nd on 6/6/00 (lot 471215 and 471209), poliovirus vaccine (IPOL), IM, left thigh (lot T0485) and alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Tripedia), IM, right thigh (lot U0357AA). At the time of the vaccination, the pt was noted to have an ear infection. On 6/6/01, the pt developed a fever of 99.6F, cough, and congestion, but was not treated at that time. On 6/9/01, the pt presented to an ER with a fever and cough and was subsequently, hospitalized. The pt's temperature rose to a maximum of 104F. The pt was subsequently, dx'd with Streptococcal pneumonia. A medical assistant reported in follow-up that on 6/12/01 the pt had been discharged from the hospital with a diagnosis of streptococcal pneumonia. The MA stated that the child had been well at the time of vaccination (conflicts with previously reported info) and had returned to the MD's office on 7/20/01 for an ear infection. At the time of this follow-up, pt was reported to be "doing better." This was originally reported by an MD.