chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.57
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, HEP, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Bacterial infection, Pulmonary embolism, Sepsis
Clinical narrative: From initial information received on 3/10/05 from another manufacturer (HQWYE781121JAN05), regarding an adverse event occurring in the USA, it was initially reported by a health care facility that a seven month old male patient received ACTHIB, a dose of IPOL, and a dose of TRIPEDIA on 9/28/04. The lot numbers, routes and sites of administration were not reported. Six days later, the patient developed pseudomonal sepsis and multiple pulmonary emboli. He expired that same day. It was not reported whether an autopsy was completed. From additional information received on 4/21/05 from a registered nurse, it was reported that an autopsy was performed on this patient and the report has been sent. The reporter was unsure whether the report could be provided to the manufacturer. No other information was provided at this time. From additional information received on 5/13/05 from a registered nurse, it was reported that they must decline the request for copies of the medical records and autopsy report. No further information anticipated, this case is considered closed.
Age: 29.0
Sex: F
Vaccine: IPV, YF, IPV, YF, IPV, YF
Symptoms: Headache, Hyperhidrosis, Laboratory test abnormal, Malaise, Mouth ulceration
Clinical narrative: From initial information received on Feb 04 2005 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 29 year old female patient received a dose of YF-VAX as well as a does of IPOL, administered on Jan  28 2005. The lot numbers, routes and sites of administration were not reported. The following day, the patient developed a fever of 103 degrees Fahrenheit, chills, sweats, nausea, and vomiting as well as swollen gums and mouth ulceration. She was seen in the emergency room and by an infectious disease specialist. Reportedly, the patient received a dose of Typhim VI and hepatitis A vaccine within four weeks prior to immunization on Jan 28 2005, but exact dates were not provided. it was not reported whether she developed any reacytions after receiveing these injections. Per the reporter, the patient has not recovered from these events. Follow-up information received Nov 18, 2005 from a health care professional. The YF-VAX vaccine given on Jan 28, 2005 was given in the right arm and the lot number was UE353AB. The IPOL vaccine given on Jan 28, 2005 was given in the left deltoid and the lot number was X1244. The patient was taking Lamisil, Vicodin and Tylenol at the time of the vaccination. No treatment or therapy was provided for these adverse events. The patient recovered from these events on Feb 7, 2005. No further information is expected.
Age: 29.0
Sex: F
Vaccine: IPV, YF, IPV, YF, IPV, YF
Symptoms: Nausea, Pharyngolaryngeal pain, Pyrexia, Vomiting
Clinical narrative: From initial information received on Feb 04 2005 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 29 year old female patient received a dose of YF-VAX as well as a does of IPOL, administered on Jan  28 2005. The lot numbers, routes and sites of administration were not reported. The following day, the patient developed a fever of 103 degrees Fahrenheit, chills, sweats, nausea, and vomiting as well as swollen gums and mouth ulceration. She was seen in the emergency room and by an infectious disease specialist. Reportedly, the patient received a dose of Typhim VI and hepatitis A vaccine within four weeks prior to immunization on Jan 28 2005, but exact dates were not provided. it was not reported whether she developed any reacytions after receiveing these injections. Per the reporter, the patient has not recovered from these events. Follow-up information received Nov 18, 2005 from a health care professional. The YF-VAX vaccine given on Jan 28, 2005 was given in the right arm and the lot number was UE353AB. The IPOL vaccine given on Jan 28, 2005 was given in the left deltoid and the lot number was X1244. The patient was taking Lamisil, Vicodin and Tylenol at the time of the vaccination. No treatment or therapy was provided for these adverse events. The patient recovered from these events on Feb 7, 2005. No further information is expected.
Age: 29.0
Sex: F
Vaccine: IPV, YF, IPV, YF, IPV, YF
Symptoms: Chills, Face oedema, Hyperhidrosis, Mouth ulceration, Nausea
Clinical narrative: From initial information received on Feb 04 2005 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 29 year old female patient received a dose of YF-VAX as well as a does of IPOL, administered on Jan  28 2005. The lot numbers, routes and sites of administration were not reported. The following day, the patient developed a fever of 103 degrees Fahrenheit, chills, sweats, nausea, and vomiting as well as swollen gums and mouth ulceration. She was seen in the emergency room and by an infectious disease specialist. Reportedly, the patient received a dose of Typhim VI and hepatitis A vaccine within four weeks prior to immunization on Jan 28 2005, but exact dates were not provided. it was not reported whether she developed any reacytions after receiveing these injections. Per the reporter, the patient has not recovered from these events. Follow-up information received Nov 18, 2005 from a health care professional. The YF-VAX vaccine given on Jan 28, 2005 was given in the right arm and the lot number was UE353AB. The IPOL vaccine given on Jan 28, 2005 was given in the left deltoid and the lot number was X1244. The patient was taking Lamisil, Vicodin and Tylenol at the time of the vaccination. No treatment or therapy was provided for these adverse events. The patient recovered from these events on Feb 7, 2005. No further information is expected.
Age: 29.0
Sex: F
Vaccine: IPV, YF, IPV, YF, IPV, YF
Symptoms: Pyrexia, Vomiting
Clinical narrative: From initial information received on Feb 04 2005 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 29 year old female patient received a dose of YF-VAX as well as a does of IPOL, administered on Jan  28 2005. The lot numbers, routes and sites of administration were not reported. The following day, the patient developed a fever of 103 degrees Fahrenheit, chills, sweats, nausea, and vomiting as well as swollen gums and mouth ulceration. She was seen in the emergency room and by an infectious disease specialist. Reportedly, the patient received a dose of Typhim VI and hepatitis A vaccine within four weeks prior to immunization on Jan 28 2005, but exact dates were not provided. it was not reported whether she developed any reacytions after receiveing these injections. Per the reporter, the patient has not recovered from these events. Follow-up information received Nov 18, 2005 from a health care professional. The YF-VAX vaccine given on Jan 28, 2005 was given in the right arm and the lot number was UE353AB. The IPOL vaccine given on Jan 28, 2005 was given in the left deltoid and the lot number was X1244. The patient was taking Lamisil, Vicodin and Tylenol at the time of the vaccination. No treatment or therapy was provided for these adverse events. The patient recovered from these events on Feb 7, 2005. No further information is expected.
Age: 29.0
Sex: F
Vaccine: IPV, YF, IPV, YF, IPV, YF
Symptoms: Chills, Hyperhidrosis, Mouth ulceration, Nausea, Oedema
Clinical narrative: From initial information received on Feb 04 2005 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 29 year old female patient received a dose of YF-VAX as well as a does of IPOL, administered on Jan  28 2005. The lot numbers, routes and sites of administration were not reported. The following day, the patient developed a fever of 103 degrees Fahrenheit, chills, sweats, nausea, and vomiting as well as swollen gums and mouth ulceration. She was seen in the emergency room and by an infectious disease specialist. Reportedly, the patient received a dose of Typhim VI and hepatitis A vaccine within four weeks prior to immunization on Jan 28 2005, but exact dates were not provided. it was not reported whether she developed any reacytions after receiveing these injections. Per the reporter, the patient has not recovered from these events. Follow-up information received Nov 18, 2005 from a health care professional. The YF-VAX vaccine given on Jan 28, 2005 was given in the right arm and the lot number was UE353AB. The IPOL vaccine given on Jan 28, 2005 was given in the left deltoid and the lot number was X1244. The patient was taking Lamisil, Vicodin and Tylenol at the time of the vaccination. No treatment or therapy was provided for these adverse events. The patient recovered from these events on Feb 7, 2005. No further information is expected.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Vomiting
Clinical narrative: From initial information received on 13Apr05 from a healthcare professional regarding an adverse event occurring, it was reported that a four year old male pt received a fourth dose of Ipol, lot number X0771, admin SC in the right arm; a fourth dose of Tripedia, lot number U1301AA, admin IM in the right deltoid and a second dose of MMR, lot number 1185N, admin SC in the left arm on 11Apr05 at 2:00PM. One day later, on 12Apr05 at 2:00PM, the pt experienced two episodes of vomiting. As per the reporter, it is unk if the pt has recovered from this event.
Age: 1.11
Sex: M
Vaccine: IPV, PNC, IPV, PNC, IPV, PNC
Symptoms: Cellulitis, Injection site reaction, Pyrexia
Clinical narrative: From initial information received on 19May05 from a RN regarding an adverse event occurring, it was reported that a 13 month old male pt received his third dose of IPOL, lot number Y0241, admin IM in the left deltoid thigh, as well as a dose of Prevnar, lot number A67185C, admin IM in the left thigh on 13May05. The following day, on 14May05 at 12:55AM, the pt developed fussiness and a fever of 104.5 F. He was seen in the ER and was given IV Rocephin. The pt returned to the ER at 6:26PM with continued fever. He was diagnosed with cellulitis of the left thigh and was treated with oral Clindamycin. He was seen by a physician on 16May05. His medication was changed to oral Cefzil. Reportedly, the pt has fully recovered from these events. The reporter of this case is the same as for case 200500969.
Age: 1.11
Sex: M
Vaccine: IPV, PNC, IPV, PNC, IPV, PNC
Symptoms: Cellulitis, Feeling hot, Hypokinesia, Injection site erythema, Injection site reaction
Clinical narrative: From initial information received on 19May05 from a RN regarding an adverse event occurring, it was reported that a 13 month old male pt received his third dose of IPOL, lot number Y0241, admin IM in the left deltoid thigh, as well as a dose of Prevnar, lot number A67185C, admin IM in the left thigh on 13May05. The following day, on 14May05 at 12:55AM, the pt developed fussiness and a fever of 104.5 F. He was seen in the ER and was given IV Rocephin. The pt returned to the ER at 6:26PM with continued fever. He was diagnosed with cellulitis of the left thigh and was treated with oral Clindamycin. He was seen by a physician on 16May05. His medication was changed to oral Cefzil. Reportedly, the pt has fully recovered from these events. The reporter of this case is the same as for case 200500969.
Age: 1.11
Sex: M
Vaccine: IPV, PNC, IPV, PNC, IPV, PNC
Symptoms: Injection site swelling, Irritability, Pyrexia
Clinical narrative: From initial information received on 19May05 from a RN regarding an adverse event occurring, it was reported that a 13 month old male pt received his third dose of IPOL, lot number Y0241, admin IM in the left deltoid thigh, as well as a dose of Prevnar, lot number A67185C, admin IM in the left thigh on 13May05. The following day, on 14May05 at 12:55AM, the pt developed fussiness and a fever of 104.5 F. He was seen in the ER and was given IV Rocephin. The pt returned to the ER at 6:26PM with continued fever. He was diagnosed with cellulitis of the left thigh and was treated with oral Clindamycin. He was seen by a physician on 16May05. His medication was changed to oral Cefzil. Reportedly, the pt has fully recovered from these events. The reporter of this case is the same as for case 200500969.
Age: 1.11
Sex: M
Vaccine: IPV, PNC, IPV, PNC, IPV, PNC
Symptoms: Cellulitis, Injection site reaction, Irritability, Pyrexia
Clinical narrative: From initial information received on 19May05 from a RN regarding an adverse event occurring, it was reported that a 13 month old male pt received his third dose of IPOL, lot number Y0241, admin IM in the left deltoid thigh, as well as a dose of Prevnar, lot number A67185C, admin IM in the left thigh on 13May05. The following day, on 14May05 at 12:55AM, the pt developed fussiness and a fever of 104.5 F. He was seen in the ER and was given IV Rocephin. The pt returned to the ER at 6:26PM with continued fever. He was diagnosed with cellulitis of the left thigh and was treated with oral Clindamycin. He was seen by a physician on 16May05. His medication was changed to oral Cefzil. Reportedly, the pt has fully recovered from these events. The reporter of this case is the same as for case 200500969.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Haematuria, Rash, Urticaria
Clinical narrative: From initial information received on 24Nov04 from another manufacturer (ref A0534190A), initially reported by a health care professional, regarding an adverse event occurring, it was reported that a four year old male pt received a dose of IPOL, lot number not reported, route and site of administration not reported, a fifth dose of Infanrix, lot number 622A2, administered in the left arm (route of administration not reported) and a dose of measles, mumps and rubella vaccine, lot number not reported, route and site of admin not reported, administered on 10Feb04. Within days of vaccination, on an unspecified date in Feb 2004, the pt developed hives at the site of injection of Infanrix. An unspecified amount of time later, the pt developed hives all over his body. The hives resolved after several months.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: From initial information received on 24Nov04 from another manufacturer (ref A0534190A), initially reported by a health care professional, regarding an adverse event occurring, it was reported that a four year old male pt received a dose of IPOL, lot number not reported, route and site of administration not reported, a fifth dose of Infanrix, lot number 622A2, administered in the left arm (route of administration not reported) and a dose of measles, mumps and rubella vaccine, lot number not reported, route and site of admin not reported, administered on 10Feb04. Within days of vaccination, on an unspecified date in Feb 2004, the pt developed hives at the site of injection of Infanrix. An unspecified amount of time later, the pt developed hives all over his body. The hives resolved after several months.
Age: 47.0
Sex: M
Vaccine: MMR, MMR
Symptoms: CSF test abnormal, Diarrhoea, Guillain-Barre syndrome, Muscle atrophy, Muscular weakness
Clinical narrative: SYMPTOMS STARTED 4/30/05 STARTED FEELING FATIGUED AND WEAK, UNABLE TO SLEEP, DEVELOPED SOME NAUSEA (NO DIARRHEA) WEAKNESS IN ARMS I COULD NOT LIFT MY ARMS ABOVE MY HEAD. MUSCLE SPASMS (LIKE A WATER FALL) I HAD NO SENSATION OF HOT OR COLD IN MY HANDS. SYMPTOMS STARTED GRADUALLY FROM 4/30/05 TO 5/5/05 WITH THE WORST SYMPTOMS ON 5/5/05. I WENT TO THE E.R. ON 5/8/05 AND WAS ADMITTED WITH THE ASSUMPTION THAT I HAD GUILLAIN BARRE SYNDROME. THEY NEEDED TO DO A SPINAL TAP TO CHECK FOR ELEVATED PROTEINS (THE DIAGNOSIS OF GBS WAS CONFIRMED) MRI AND CT SCANS.  TREATMENT - IVIG FOR 2 DAYS, PLASMA EXCHANGE 7 DAYS THAN 5 DAYS MORE OF IVIG. THE EXTREME WORSE SYMTOMS OF PARALYSIS TO ALMOST NEEDING A VENTILATOR WERE DURING MY 1ST WEEKS IN THE HOSPITAL. I STILL HAVE HAVE SOME SYMPTOMS THAT I AM RECOVERING FROM.  I HAVE NO USE OF MY RIGHT ARM AND MY FEET FEEL STIFF W/PINS AND NEEDLES. I STILL HAVE FATIGUE.  I GO TO PHYSICAL THERAPY 3x A WEEK AND OCCUPATIONAL THERAPY 2x A WEEK AND CONTINUE THIS TREATMENT.
Age: 47.0
Sex: M
Vaccine: MMR, MMR
Symptoms: White blood cell count increased
Clinical narrative: SYMPTOMS STARTED 4/30/05 STARTED FEELING FATIGUED AND WEAK, UNABLE TO SLEEP, DEVELOPED SOME NAUSEA (NO DIARRHEA) WEAKNESS IN ARMS I COULD NOT LIFT MY ARMS ABOVE MY HEAD. MUSCLE SPASMS (LIKE A WATER FALL) I HAD NO SENSATION OF HOT OR COLD IN MY HANDS. SYMPTOMS STARTED GRADUALLY FROM 4/30/05 TO 5/5/05 WITH THE WORST SYMPTOMS ON 5/5/05. I WENT TO THE E.R. ON 5/8/05 AND WAS ADMITTED WITH THE ASSUMPTION THAT I HAD GUILLAIN BARRE SYNDROME. THEY NEEDED TO DO A SPINAL TAP TO CHECK FOR ELEVATED PROTEINS (THE DIAGNOSIS OF GBS WAS CONFIRMED) MRI AND CT SCANS.  TREATMENT - IVIG FOR 2 DAYS, PLASMA EXCHANGE 7 DAYS THAN 5 DAYS MORE OF IVIG. THE EXTREME WORSE SYMTOMS OF PARALYSIS TO ALMOST NEEDING A VENTILATOR WERE DURING MY 1ST WEEKS IN THE HOSPITAL. I STILL HAVE HAVE SOME SYMPTOMS THAT I AM RECOVERING FROM.  I HAVE NO USE OF MY RIGHT ARM AND MY FEET FEEL STIFF W/PINS AND NEEDLES. I STILL HAVE FATIGUE.  I GO TO PHYSICAL THERAPY 3x A WEEK AND OCCUPATIONAL THERAPY 2x A WEEK AND CONTINUE THIS TREATMENT.
Age: 47.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Asthenia, Fatigue, Guillain-Barre syndrome, Hypoaesthesia, Muscle spasms
Clinical narrative: SYMPTOMS STARTED 4/30/05 STARTED FEELING FATIGUED AND WEAK, UNABLE TO SLEEP, DEVELOPED SOME NAUSEA (NO DIARRHEA) WEAKNESS IN ARMS I COULD NOT LIFT MY ARMS ABOVE MY HEAD. MUSCLE SPASMS (LIKE A WATER FALL) I HAD NO SENSATION OF HOT OR COLD IN MY HANDS. SYMPTOMS STARTED GRADUALLY FROM 4/30/05 TO 5/5/05 WITH THE WORST SYMPTOMS ON 5/5/05. I WENT TO THE E.R. ON 5/8/05 AND WAS ADMITTED WITH THE ASSUMPTION THAT I HAD GUILLAIN BARRE SYNDROME. THEY NEEDED TO DO A SPINAL TAP TO CHECK FOR ELEVATED PROTEINS (THE DIAGNOSIS OF GBS WAS CONFIRMED) MRI AND CT SCANS.  TREATMENT - IVIG FOR 2 DAYS, PLASMA EXCHANGE 7 DAYS THAN 5 DAYS MORE OF IVIG. THE EXTREME WORSE SYMTOMS OF PARALYSIS TO ALMOST NEEDING A VENTILATOR WERE DURING MY 1ST WEEKS IN THE HOSPITAL. I STILL HAVE HAVE SOME SYMPTOMS THAT I AM RECOVERING FROM.  I HAVE NO USE OF MY RIGHT ARM AND MY FEET FEEL STIFF W/PINS AND NEEDLES. I STILL HAVE FATIGUE.  I GO TO PHYSICAL THERAPY 3x A WEEK AND OCCUPATIONAL THERAPY 2x A WEEK AND CONTINUE THIS TREATMENT.
Age: 47.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Nausea, Paralysis, Peripheral coldness, Sleep disorder
Clinical narrative: SYMPTOMS STARTED 4/30/05 STARTED FEELING FATIGUED AND WEAK, UNABLE TO SLEEP, DEVELOPED SOME NAUSEA (NO DIARRHEA) WEAKNESS IN ARMS I COULD NOT LIFT MY ARMS ABOVE MY HEAD. MUSCLE SPASMS (LIKE A WATER FALL) I HAD NO SENSATION OF HOT OR COLD IN MY HANDS. SYMPTOMS STARTED GRADUALLY FROM 4/30/05 TO 5/5/05 WITH THE WORST SYMPTOMS ON 5/5/05. I WENT TO THE E.R. ON 5/8/05 AND WAS ADMITTED WITH THE ASSUMPTION THAT I HAD GUILLAIN BARRE SYNDROME. THEY NEEDED TO DO A SPINAL TAP TO CHECK FOR ELEVATED PROTEINS (THE DIAGNOSIS OF GBS WAS CONFIRMED) MRI AND CT SCANS.  TREATMENT - IVIG FOR 2 DAYS, PLASMA EXCHANGE 7 DAYS THAN 5 DAYS MORE OF IVIG. THE EXTREME WORSE SYMTOMS OF PARALYSIS TO ALMOST NEEDING A VENTILATOR WERE DURING MY 1ST WEEKS IN THE HOSPITAL. I STILL HAVE HAVE SOME SYMPTOMS THAT I AM RECOVERING FROM.  I HAVE NO USE OF MY RIGHT ARM AND MY FEET FEEL STIFF W/PINS AND NEEDLES. I STILL HAVE FATIGUE.  I GO TO PHYSICAL THERAPY 3x A WEEK AND OCCUPATIONAL THERAPY 2x A WEEK AND CONTINUE THIS TREATMENT.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, MMR, DTAP, IPV, MMR
Symptoms: Cough, Dyspnoea, Urticaria, Vomiting, Wheezing
Clinical narrative: Case received from another on 12Aug05 under the ref number WAES0507USA00134. It was initially reported by a health care professional that a 5 year old male pt with a medical history of rash due to egg allergy, had received an IM injection of IPOL, lot number 02402 (not a valid lot number), an IM injection of Infanrix, lot 649509/0773P, on 21Jul05 at 9:15AM. Fifteen minutes later, at 9:30AM, pt experienced a severe reaction with difficulty breathing, wheezing, swollen face, coughing, vomiting, hives and a rash everywhere. The pt was taken to the ER and was treated with oxygen via a mask, diphenhydramine HC1 (Benadryl) 25mg and epinephrine (Epi-pen) 0.5mg IM. The pt was stable in a couple of hours. On 22Jun05, the pt was seen in the doctor's office and was treated with diphenhydramine HC1 again and was given a prescription for epinephrine (Epi-pen). Subsequently, the pt recovered. As per the company, no product quality complaint was involved. The other company considered severe reaction and difficulty breathing to be other important medical events. It was noted that the nurse did not feel that the pt's experience was an other important medical event (OMIC).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, MMR, DTAP, IPV, MMR
Symptoms: Dyspnoea, Face oedema, Rash
Clinical narrative: Case received from another on 12Aug05 under the ref number WAES0507USA00134. It was initially reported by a health care professional that a 5 year old male pt with a medical history of rash due to egg allergy, had received an IM injection of IPOL, lot number 02402 (not a valid lot number), an IM injection of Infanrix, lot 649509/0773P, on 21Jul05 at 9:15AM. Fifteen minutes later, at 9:30AM, pt experienced a severe reaction with difficulty breathing, wheezing, swollen face, coughing, vomiting, hives and a rash everywhere. The pt was taken to the ER and was treated with oxygen via a mask, diphenhydramine HC1 (Benadryl) 25mg and epinephrine (Epi-pen) 0.5mg IM. The pt was stable in a couple of hours. On 22Jun05, the pt was seen in the doctor's office and was treated with diphenhydramine HC1 again and was given a prescription for epinephrine (Epi-pen). Subsequently, the pt recovered. As per the company, no product quality complaint was involved. The other company considered severe reaction and difficulty breathing to be other important medical events. It was noted that the nurse did not feel that the pt's experience was an other important medical event (OMIC).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, MMR, DTAP, IPV, MMR
Symptoms: Cough, Dyspnoea, Face oedema, Rash, Urticaria
Clinical narrative: Case received from another on 12Aug05 under the ref number WAES0507USA00134. It was initially reported by a health care professional that a 5 year old male pt with a medical history of rash due to egg allergy, had received an IM injection of IPOL, lot number 02402 (not a valid lot number), an IM injection of Infanrix, lot 649509/0773P, on 21Jul05 at 9:15AM. Fifteen minutes later, at 9:30AM, pt experienced a severe reaction with difficulty breathing, wheezing, swollen face, coughing, vomiting, hives and a rash everywhere. The pt was taken to the ER and was treated with oxygen via a mask, diphenhydramine HC1 (Benadryl) 25mg and epinephrine (Epi-pen) 0.5mg IM. The pt was stable in a couple of hours. On 22Jun05, the pt was seen in the doctor's office and was treated with diphenhydramine HC1 again and was given a prescription for epinephrine (Epi-pen). Subsequently, the pt recovered. As per the company, no product quality complaint was involved. The other company considered severe reaction and difficulty breathing to be other important medical events. It was noted that the nurse did not feel that the pt's experience was an other important medical event (OMIC).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, MMR, DTAP, IPV, MMR
Symptoms: Vomiting, Wheezing
Clinical narrative: Case received from another on 12Aug05 under the ref number WAES0507USA00134. It was initially reported by a health care professional that a 5 year old male pt with a medical history of rash due to egg allergy, had received an IM injection of IPOL, lot number 02402 (not a valid lot number), an IM injection of Infanrix, lot 649509/0773P, on 21Jul05 at 9:15AM. Fifteen minutes later, at 9:30AM, pt experienced a severe reaction with difficulty breathing, wheezing, swollen face, coughing, vomiting, hives and a rash everywhere. The pt was taken to the ER and was treated with oxygen via a mask, diphenhydramine HC1 (Benadryl) 25mg and epinephrine (Epi-pen) 0.5mg IM. The pt was stable in a couple of hours. On 22Jun05, the pt was seen in the doctor's office and was treated with diphenhydramine HC1 again and was given a prescription for epinephrine (Epi-pen). Subsequently, the pt recovered. As per the company, no product quality complaint was involved. The other company considered severe reaction and difficulty breathing to be other important medical events. It was noted that the nurse did not feel that the pt's experience was an other important medical event (OMIC).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Cough, Erythema, Sneezing, Urticaria
Clinical narrative: Case received from another company on 12Aug05 under the reference number WAES0507USA014010. It was initially reported by a health care professional that a four year old male pt had received a SC injection of Ipol lot number X1244, an IM dose of Tripedia, lot number U1345DA, and a SC dose of MMR II/Measles, mumps and rubella vaccine, lot number 648294/0782P, on 18Jul05 at 11:00AM. The sites of administration were not reported. Approx three minutes after vaccination (also reported as 11:20AM), the pt began sneezing, coughing and looked woozy. The pt's cheeks were red with no rash at that time. His chest was clear, eyes watery and his pulse oximetry was 95%. After five minutes, teh pt had diffuse hives. His chest was clear and there was no stridor. Epinephrine 0.15cc was given. The pt's pulse was 154, blood pressure 100/54, oximetry 97%. 15 minutes later, diphenhydramine HC1 (Benadryl) 18.75mg per os was given. Ten minutes after that, the pt was sleepy and his face was very red with diffuse hives. His chest remained clear. There was a blanched area over the site of the epinephrine injection. The pt's blood pressure was 80/40, oximetry 99% and his skin remained a diffuse red. The pt was negative for wheeze and stridor. The pt was considered stable, but his symptoms persisted. He was sent to the ER for further monitoring. The pt's mother reported that the ER just monitored the pt. The pt was considered to be recovered on experienced to be immediately life threatening and other medical events (OMIC).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Cough, Dizziness, Injection site discolouration, Injection site erythema, Lacrimation increased
Clinical narrative: Case received from another company on 12Aug05 under the reference number WAES0507USA014010. It was initially reported by a health care professional that a four year old male pt had received a SC injection of Ipol lot number X1244, an IM dose of Tripedia, lot number U1345DA, and a SC dose of MMR II/Measles, mumps and rubella vaccine, lot number 648294/0782P, on 18Jul05 at 11:00AM. The sites of administration were not reported. Approx three minutes after vaccination (also reported as 11:20AM), the pt began sneezing, coughing and looked woozy. The pt's cheeks were red with no rash at that time. His chest was clear, eyes watery and his pulse oximetry was 95%. After five minutes, teh pt had diffuse hives. His chest was clear and there was no stridor. Epinephrine 0.15cc was given. The pt's pulse was 154, blood pressure 100/54, oximetry 97%. 15 minutes later, diphenhydramine HC1 (Benadryl) 18.75mg per os was given. Ten minutes after that, the pt was sleepy and his face was very red with diffuse hives. His chest remained clear. There was a blanched area over the site of the epinephrine injection. The pt's blood pressure was 80/40, oximetry 99% and his skin remained a diffuse red. The pt was negative for wheeze and stridor. The pt was considered stable, but his symptoms persisted. He was sent to the ER for further monitoring. The pt's mother reported that the ER just monitored the pt. The pt was considered to be recovered on experienced to be immediately life threatening and other medical events (OMIC).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Sneezing, Urticaria
Clinical narrative: Case received from another company on 12Aug05 under the reference number WAES0507USA014010. It was initially reported by a health care professional that a four year old male pt had received a SC injection of Ipol lot number X1244, an IM dose of Tripedia, lot number U1345DA, and a SC dose of MMR II/Measles, mumps and rubella vaccine, lot number 648294/0782P, on 18Jul05 at 11:00AM. The sites of administration were not reported. Approx three minutes after vaccination (also reported as 11:20AM), the pt began sneezing, coughing and looked woozy. The pt's cheeks were red with no rash at that time. His chest was clear, eyes watery and his pulse oximetry was 95%. After five minutes, teh pt had diffuse hives. His chest was clear and there was no stridor. Epinephrine 0.15cc was given. The pt's pulse was 154, blood pressure 100/54, oximetry 97%. 15 minutes later, diphenhydramine HC1 (Benadryl) 18.75mg per os was given. Ten minutes after that, the pt was sleepy and his face was very red with diffuse hives. His chest remained clear. There was a blanched area over the site of the epinephrine injection. The pt's blood pressure was 80/40, oximetry 99% and his skin remained a diffuse red. The pt was negative for wheeze and stridor. The pt was considered stable, but his symptoms persisted. He was sent to the ER for further monitoring. The pt's mother reported that the ER just monitored the pt. The pt was considered to be recovered on experienced to be immediately life threatening and other medical events (OMIC).
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness to left deltoid. Amoxicillin 125mg/5cc 1tsp PO TID for 10 days. Benadryl.
Age: 42.0
Sex: M
Vaccine: HEP, HEPA, MEN, SMALL, TYP, YF
Symptoms: Difficulty in walking, Dysuria, Hypersensitivity, Laboratory test abnormal, Multiple sclerosis
Clinical narrative: Patient with a history of burning and burning sensation - felt like I had a scratch under my wrist watch that began on his left wrist 2 days post multiple vaccines. The sensation greatly increased after receiving smallpox vaccine 1 week later now radiating from his lower back, spreading across is abdomen, lower chest and down into his legs. The burning became increasingly painful over several days until by 6/22 it was unbearable (11/10 on pain scale) and he sought medical care for pain medication and was treated with IV steroids. He returned 2-3 days alter complaining of difficulty urinating. "I was drinking lots of fluid" with no urinary output in 12 hours. He was placed on 20 day oral steroid taper with some improvement in his symptoms and deployed. Once there his symptoms again progressed to include lower extremity weakness and difficulty walking. He was subsequently transported to a hospital and from there to another hospital on 8/13/05. Per follow up report- Service member says that he is feeling better, although he still has some burning and tingling in his lower back and legs and to a lesser extent, in his arms and hands.  He is completely self sufficient in giving himself his weekly Avenox injections and says he "feels pretty good" on the medication.  He says he doesn't tire as easily and noticed he can walk farther without having to stop and rest as often as before.  He still works out at the gym daily and continues to coach.  He has an appointment to be seen by Dr on 22 Nov 05 for follow up and review of his labs (CBC and CMP) done the end of October.  It was suggested during the Vaccine Healthcare Center's Neurological Conference, that a serum antibody (NMO-IgG) ordered through the facility might help to differentiate between Devic's disease and MS.  Service member plans to discuss this test with his doctor during his next appointment.
Age: 42.0
Sex: M
Vaccine: HEP, HEPA, MEN, SMALL, TYP, YF
Symptoms: Muscular weakness, Pain, Paraesthesia, Skin ulcer, Thermal burn
Clinical narrative: Patient with a history of burning and burning sensation - felt like I had a scratch under my wrist watch that began on his left wrist 2 days post multiple vaccines. The sensation greatly increased after receiving smallpox vaccine 1 week later now radiating from his lower back, spreading across is abdomen, lower chest and down into his legs. The burning became increasingly painful over several days until by 6/22 it was unbearable (11/10 on pain scale) and he sought medical care for pain medication and was treated with IV steroids. He returned 2-3 days alter complaining of difficulty urinating. "I was drinking lots of fluid" with no urinary output in 12 hours. He was placed on 20 day oral steroid taper with some improvement in his symptoms and deployed. Once there his symptoms again progressed to include lower extremity weakness and difficulty walking. He was subsequently transported to a hospital and from there to another hospital on 8/13/05. Per follow up report- Service member says that he is feeling better, although he still has some burning and tingling in his lower back and legs and to a lesser extent, in his arms and hands.  He is completely self sufficient in giving himself his weekly Avenox injections and says he "feels pretty good" on the medication.  He says he doesn't tire as easily and noticed he can walk farther without having to stop and rest as often as before.  He still works out at the gym daily and continues to coach.  He has an appointment to be seen by Dr on 22 Nov 05 for follow up and review of his labs (CBC and CMP) done the end of October.  It was suggested during the Vaccine Healthcare Center's Neurological Conference, that a serum antibody (NMO-IgG) ordered through the facility might help to differentiate between Devic's disease and MS.  Service member plans to discuss this test with his doctor during his next appointment.
Age: 1.28
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Febrile convulsion
Clinical narrative: Complex febrile seizure (status > 17 minutes) approximately 24 hours after vaccines. No other symptoms. No history of seizures.
Age: 3.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Anaphylactic reaction, Angioneurotic oedema, Chest pain, Erythema, Face oedema
Clinical narrative: Chest pain, hives, edema face, angioedema right leg and throat swelling. Epipen 2 times, dexamathasone, Benadryl given. Transported via ambulance to hospital. This is in follow-up to report(s) previously submitted on 5/19/2006. Information has been received from a health professional concerning a 19 month old male who was vaccinated with a subcutaneous second dose in the right thigh of MMR II (Lot# 649230/0027R0. Concomitant vaccine administered on the same day included a first intramuscular dose in the left thigh of HAVRIX (Lot# AHAVB032AA). Subsequently the patient experienced an anaphylactic reaction from the vaccine. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information from a health professional indicated that on 17-AUG-2005, shortly after vaccination, the patient developed respiratory difficulty and small hives. Also he developed flushing of the skin. Oximetry at that point was 90% and he was having mild respiratory distress. He was given BENADRYL, 1 tsp, oral administration, plus and EPI-PEN, 0.15 mg, intramuscular. The patient responded clinically with increased oxygenation, ease of breathing and the redness decreased. The patient did develop some swelling around his eyes at that point. After about 30-minutes the patient returned to having respiratory distress. The patient was given a second shot of epinephrine plus dexamethasone, 8 mg, oral administration. The assessment was respiratory difficulty. The patient was sent to a medical center. It was noted that the patient was stable at the time of discharge. Follow-up information from a health professional indicated that the patient has recovered and was fine. No other information was provided. Anaphylactic reaction to vaccine was considered to be an other important medical event. Additional information is not expected.
Age: 3.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Pharyngeal oedema, Respiratory disorder, Respiratory distress, Urticaria
Clinical narrative: Chest pain, hives, edema face, angioedema right leg and throat swelling. Epipen 2 times, dexamathasone, Benadryl given. Transported via ambulance to hospital. This is in follow-up to report(s) previously submitted on 5/19/2006. Information has been received from a health professional concerning a 19 month old male who was vaccinated with a subcutaneous second dose in the right thigh of MMR II (Lot# 649230/0027R0. Concomitant vaccine administered on the same day included a first intramuscular dose in the left thigh of HAVRIX (Lot# AHAVB032AA). Subsequently the patient experienced an anaphylactic reaction from the vaccine. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information from a health professional indicated that on 17-AUG-2005, shortly after vaccination, the patient developed respiratory difficulty and small hives. Also he developed flushing of the skin. Oximetry at that point was 90% and he was having mild respiratory distress. He was given BENADRYL, 1 tsp, oral administration, plus and EPI-PEN, 0.15 mg, intramuscular. The patient responded clinically with increased oxygenation, ease of breathing and the redness decreased. The patient did develop some swelling around his eyes at that point. After about 30-minutes the patient returned to having respiratory distress. The patient was given a second shot of epinephrine plus dexamethasone, 8 mg, oral administration. The assessment was respiratory difficulty. The patient was sent to a medical center. It was noted that the patient was stable at the time of discharge. Follow-up information from a health professional indicated that the patient has recovered and was fine. No other information was provided. Anaphylactic reaction to vaccine was considered to be an other important medical event. Additional information is not expected.
Age: 1.91
Sex: F
Vaccine: FLUX
Symptoms: Blindness, Demyelination, Myelitis transverse, Myelopathy, Neurological symptom
Clinical narrative: Acute transverse myelitis, optical neuropathy - loss of vision (impairment), demyelinating disorder (CNS) severe, myelopathy. Per follow up report-Neurological symptoms that has been ongoing for the past three years as of 10-31-05.  Patient didn't have this conditon before the shot was given.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Headache, Pyrexia
Clinical narrative: 7/12/05 Pediarix given. 9 AM 7/13 Mom reports temperature 102.4 and headache. No other signs or symptoms. 10 AM 7/14 Mom reports temperature 101.0 but no headache. No other symptoms. 2 PM 7/15 Mom reports symptoms resolved. Report completed.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pain, Pruritus, Pyrexia, Swelling
Clinical narrative: Fever, swelling, redness, itchy and sore.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Patient with swelling of left arm at vaccine site. Low grade fever.
Age: 1.26
Sex: M
Vaccine: MMR
Symptoms: Rash pruritic, Viral infection
Clinical narrative: 7/19/05 Presented with itchy rash last night. Exposed to varicella 2 weeks ago. History of varicella 7/16/02. Diagnosed with varicella.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 2"x4" red, raised patch surrounding shot site. Treated with Augmentin, Motrin, Benadryl.
Age: 1.01
Sex: F
Vaccine: HEP, MMR, PNC, VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Child received immunization (Varivax) left thigh 5/25/05. On 8/18/05 presented with rash. 8/20/05 Rash diagnosed as varicella zoster on left thigh at site of immunization.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site mass, Swelling
Clinical narrative: Mother called 8/17/05 to report swelling 3-4 times normal left arm from above shoulder to elbow. Called Pediatrician and told alternate Motrin with Tylenol and ice packs. Swelling increased and took child to ER and told same instruction and see pediatrician if needed. Took to MD and said was definite reaction to immunization to immunization. Very sleepy. Follow up 8/18/05: Phone call to parent. Arm back to normal size. Knot present at deltoid injection site. Normal activity level.
Age: 32.0
Sex: M
Vaccine: HEP, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Joint range of motion decreased, Pyrexia
Clinical narrative: 24-36 hours after pneumococcal vaccination, developed erythema/tenderness over pneumococcal injection site, fever, chills. Fevers up to 101. Had difficulty using arm. Treated with Levofloxacin 750 PO for 5 days. Symptoms improved within 24 hours.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Hypersensitivity, Oedema
Clinical narrative: Left leg increasing redness, swelling and warmth over 4 days. Omnicef x 10 days
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pruritus
Clinical narrative: Redness/itching palms and leg. Some redness ears/eye lids. Given Benadryl PO. No wheezing.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Face oedema, Feeling hot, Hypersensitivity, Oedema
Clinical narrative: From initial information received on Aug 18 2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that a five year old female patient received a dose of Daptacel, lot number C1699AA, administered in the right thigh, a dose of Ipol, lot number X0138, administered in the right thigh and a dose of MMR-Measles, Mumps and Rubella vaccine, lot number 1033N, administered in the left thigh on Jul 30 2004. The routes of administration were not reported. 20 minutes later, the patient developed red itchy hives, as well as swelling on one side of her face. The patient also vomited. On Aug 20 2004, the patient also developed an area of redness, warmth and bruising measuring seven inches in diameter on her right thigh, Per the reporter, the hives, swelling of the eyes and hands lasted for two days. The patient was treated with Benadryl. It was not reported whether the patient recovered from the remaining events. From additional information received on Oct 20 2004 from the initial reporter, it was reported that the patient was seen by a physician on Aug 02 2004. She was treated with anitbiotics and has recovered from these events. No further information is anticipated, this case is considered closed. The reporter of this case is the same reporter as for case 200402696.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus, Urticaria, Vomiting
Clinical narrative: From initial information received on Aug 18 2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that a five year old female patient received a dose of Daptacel, lot number C1699AA, administered in the right thigh, a dose of Ipol, lot number X0138, administered in the right thigh and a dose of MMR-Measles, Mumps and Rubella vaccine, lot number 1033N, administered in the left thigh on Jul 30 2004. The routes of administration were not reported. 20 minutes later, the patient developed red itchy hives, as well as swelling on one side of her face. The patient also vomited. On Aug 20 2004, the patient also developed an area of redness, warmth and bruising measuring seven inches in diameter on her right thigh, Per the reporter, the hives, swelling of the eyes and hands lasted for two days. The patient was treated with Benadryl. It was not reported whether the patient recovered from the remaining events. From additional information received on Oct 20 2004 from the initial reporter, it was reported that the patient was seen by a physician on Aug 02 2004. She was treated with anitbiotics and has recovered from these events. No further information is anticipated, this case is considered closed. The reporter of this case is the same reporter as for case 200402696.
Age: 0.38
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Agitation
Clinical narrative: From initial information received on 09/13/2004 from a nurse regarding an adverse event occurring in the USA, it was reported that a 4 month old female patient received a second dose of IPOL, lot number W1582-2, administered in the right thigh, a second dose of Tripedia, lot number U1272DB, administered in the left thigh, and a second dose of Pedvax-Hib (Merck), lot number 0995-N administered in the right thigh on 05/04/2004.  Immediately after the doctor visit during the drive home, the patient experienced inconsolable crying, which lasted for 2 hours.  The patient then took a nap and was perfectly fine when she awoke.  The patient recovered from this event.  From additional information received on 12/27/2004 from a healthcare professional, it was reported that no relevant diagnostic tests or laboratory data were obtained.  No other medical information was provided.  No further information is anticipated, this case is considered closed.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Difficulty in walking, Feeling hot, Gait disturbance, Injection site pain, Skin burning sensation
Clinical narrative: From initial information received on 11Jan05 from a RN regarding an adverse event occurring, it was reported that a five year old male pt received a dose of Daptacel, lot number C1700AA, a dose of Ipol, lot number not reported, and a dose of MMR, lot number not reported, all administered in the right thigh on an unspecified date in Oct of 2004. The routes of admin were not reported. Approx two hrs later, the pt's thigh was burning hot from the top of the thigh to his knee. The pt also developed a 4x8 cm purple area around the site of injection and hives in the 4x8 inch area. In addition, the pt had difficulty walking. He was given Benadryl by his mother. Reportedly, he recovered from these events.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Skin discolouration, Urticaria
Clinical narrative: From initial information received on 11Jan05 from a RN regarding an adverse event occurring, it was reported that a five year old male pt received a dose of Daptacel, lot number C1700AA, a dose of Ipol, lot number not reported, and a dose of MMR, lot number not reported, all administered in the right thigh on an unspecified date in Oct of 2004. The routes of admin were not reported. Approx two hrs later, the pt's thigh was burning hot from the top of the thigh to his knee. The pt also developed a 4x8 cm purple area around the site of injection and hives in the 4x8 inch area. In addition, the pt had difficulty walking. He was given Benadryl by his mother. Reportedly, he recovered from these events.
Age: 0.42
Sex: M
Vaccine: HBHEPB, IPV
Symptoms: Lethargy
Clinical narrative: From initial information received on 14Jan05 from a health care professional regarding an adverse event occurring, it was reported that a five month old male pt received his second dose of IPOL, lot number X1006, as well as his second dose of Comvax (haemophilus b conjugate and hep B), lot number 0223, administered on 15Nov04. The following day, the pt became lethargic. Per the pt's mother, this lasted four to five days. Reportedly, the pt was not evaluated by a physician at that time.  the pt also previously received a dose of Infanrix, as well as a dose of Pneumovax, lot number A57560B, administered on an unspecified date. He recovered from this event. From additional information received on 25Apr05 from a health care professional, it was reported by the pt's parent that no treatment was provided for symptoms. Per the reporter, the pt did not have any illness at the time of vaccination. The site of the other vaccinations given on 14Oct04 were provided. Infanrix, administered in the right thigh, and Prevnar, administered in the left thigh. Reportedly, this adverse event has not been reported previously. Also the name of the vaccine administrator was provided. No further information is anticipated, this case is considered closed.