chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Grand mal convulsion, Hypersensitivity, Intensive care
Clinical narrative: Patient suffered afebrile tonic-clinic seizures. He was admitted to ICU and must take medication daily to control seizures. If off medication, he has 12-20 seizures per day, each lasting over 4 minutes. Occasionally he has breakthrough seizures when sick, which only stop after medication is increased. Medical records states allergic reaction. msv Per follow up report-Patient is still taking medication daily to control seizures. When he is sick, he has seizures that are uncontrollable with meds and has to be hospitalized. Patient is still speech delayed and gross motor skill delayed. He is currently receiving speech theapy and has 5 words.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Laboratory test abnormal, Motor dysfunction, Nuclear magnetic resonance imaging normal, Speech disorder developmental
Clinical narrative: Patient suffered afebrile tonic-clinic seizures. He was admitted to ICU and must take medication daily to control seizures. If off medication, he has 12-20 seizures per day, each lasting over 4 minutes. Occasionally he has breakthrough seizures when sick, which only stop after medication is increased. Medical records states allergic reaction. msv Per follow up report-Patient is still taking medication daily to control seizures. When he is sick, he has seizures that are uncontrollable with meds and has to be hospitalized. Patient is still speech delayed and gross motor skill delayed. He is currently receiving speech theapy and has 5 words.
Age: 32.0
Sex: F
Vaccine: FLUX, HEP, HEPA, IPV, MEN, TD, YF
Symptoms: Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: There are no seriousness criteria reported in the case described below. Based upon appropriate medical judgement this case is considered non serious. From initial information received on 28DEC2003 through an enhanced surveillance program conducted by the CDC and Prevention, regarding an adverse event occurring in an unknown country, it was reported that a 32 year old female pt received Yellow Fever Vaccine, DT toxoids , Meningococcal Vaccine, Influenza Vaccine, Poliomyelitis Vaccine Activated, Hepatitis A Vaccine and Hepatitis B vaccine on 15dEC2003 in preparation for a trip around the world. Seven days later, on 22DEC2003, the pt was seen in the ER for a severe headache, stiff neck and a low grade fever of less than 100 degrees F. No lumbar puncture was done and the pt was released. No other information was provided.  From additional information received on 05FEB2004 through an enhanced surveillance program conducted by the CDC and Prevention, it was reported that this pt was form Atlanta. it is unknown whether the pt was tested for influenza. Because this event occurred in the USA, the product coding for Yellow Fever Vaccine, DT toxoids, Meningococcal Vaccine have been updated to YF VaX, TD ADS Adult and Menomune A/C/Y/W-135. No new medical information has been provided. Corrective version: The product information has been updated as follow. TD ADS ADULT updated to DT toxoids, manufacturer unknown. Inactivated Polio Vaccine, manufacturer unknown, updated to IPOL.
Age: 68.0
Sex: F
Vaccine: HEPAB, TD, TYP, YF, IPV, TD, YF
Symptoms: Aphasia, Asthenia, Balance disorder, Difficulty in walking, Encephalitis
Clinical narrative: From initial information received on 03/04/04 from an enhanced surveillance program conducted regarding an adverse event that occurred; it was reported that a 67 year old female pt received YF-Vax (lot # not reported); TD ADS ADULT (lot # not reported); and Poliomyelitis vaccine inactivated (lot # not reported) administered on 02/02/04 in preparation for a trip overseas. The next day, on 02/03/04, the pt developed weakness in her legs and difficulty walking.  On 02/11/04 the pt had fever, mild headaches and difficulty speaking. On 02/18/04, the pt was hospitalized for aphasia, difficulty walking, weakness and poor balance. The pt was still hospitalized on 02/23/04.  The pt's past medical history includes Hepatitis C. From additional information received on 22Nov04: from an enchanced surveillance program conducted it was reported that the pt was discharged from the hospital with a diagnosis of aseptic meningitis and encephalitis. Per the reporter, it appeared that the pt was sent to a rehabilitation facility after discharge from the hospital. The reporter was unsure of the pt's recovery status.
Age: 68.0
Sex: F
Vaccine: HEPAB, TD, TYP, YF, IPV, TD, YF
Symptoms: Headache, Meningitis, Pyrexia, Speech disorder
Clinical narrative: From initial information received on 03/04/04 from an enhanced surveillance program conducted regarding an adverse event that occurred; it was reported that a 67 year old female pt received YF-Vax (lot # not reported); TD ADS ADULT (lot # not reported); and Poliomyelitis vaccine inactivated (lot # not reported) administered on 02/02/04 in preparation for a trip overseas. The next day, on 02/03/04, the pt developed weakness in her legs and difficulty walking.  On 02/11/04 the pt had fever, mild headaches and difficulty speaking. On 02/18/04, the pt was hospitalized for aphasia, difficulty walking, weakness and poor balance. The pt was still hospitalized on 02/23/04.  The pt's past medical history includes Hepatitis C. From additional information received on 22Nov04: from an enchanced surveillance program conducted it was reported that the pt was discharged from the hospital with a diagnosis of aseptic meningitis and encephalitis. Per the reporter, it appeared that the pt was sent to a rehabilitation facility after discharge from the hospital. The reporter was unsure of the pt's recovery status.
Age: 68.0
Sex: F
Vaccine: HEPAB, TD, TYP, YF, IPV, TD, YF
Symptoms: Aphasia, Difficulty in walking, Encephalitis, Gait disturbance, Headache
Clinical narrative: From initial information received on 03/04/04 from an enhanced surveillance program conducted regarding an adverse event that occurred; it was reported that a 67 year old female pt received YF-Vax (lot # not reported); TD ADS ADULT (lot # not reported); and Poliomyelitis vaccine inactivated (lot # not reported) administered on 02/02/04 in preparation for a trip overseas. The next day, on 02/03/04, the pt developed weakness in her legs and difficulty walking.  On 02/11/04 the pt had fever, mild headaches and difficulty speaking. On 02/18/04, the pt was hospitalized for aphasia, difficulty walking, weakness and poor balance. The pt was still hospitalized on 02/23/04.  The pt's past medical history includes Hepatitis C. From additional information received on 22Nov04: from an enchanced surveillance program conducted it was reported that the pt was discharged from the hospital with a diagnosis of aseptic meningitis and encephalitis. Per the reporter, it appeared that the pt was sent to a rehabilitation facility after discharge from the hospital. The reporter was unsure of the pt's recovery status.
Age: 68.0
Sex: F
Vaccine: HEPAB, TD, TYP, YF, IPV, TD, YF
Symptoms: Laboratory test abnormal, Meningitis aseptic, Muscular weakness, Pyrexia, Speech disorder
Clinical narrative: From initial information received on 03/04/04 from an enhanced surveillance program conducted regarding an adverse event that occurred; it was reported that a 67 year old female pt received YF-Vax (lot # not reported); TD ADS ADULT (lot # not reported); and Poliomyelitis vaccine inactivated (lot # not reported) administered on 02/02/04 in preparation for a trip overseas. The next day, on 02/03/04, the pt developed weakness in her legs and difficulty walking.  On 02/11/04 the pt had fever, mild headaches and difficulty speaking. On 02/18/04, the pt was hospitalized for aphasia, difficulty walking, weakness and poor balance. The pt was still hospitalized on 02/23/04.  The pt's past medical history includes Hepatitis C. From additional information received on 22Nov04: from an enchanced surveillance program conducted it was reported that the pt was discharged from the hospital with a diagnosis of aseptic meningitis and encephalitis. Per the reporter, it appeared that the pt was sent to a rehabilitation facility after discharge from the hospital. The reporter was unsure of the pt's recovery status.
Age: 80.0
Sex: M
Vaccine: YF, YF
Symptoms: Constipation, Flatulence
Clinical narrative: From initial information received on 19MAR2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that an 80 year old male pt received a dose of YFVAX on 02MAR2004. Ten days later, on 12MAR2004, the pt developed constipation, gas and lack of appetite. The pt felt that this was an adverse reaction to the yellow fever vaccine. The pt denied any fever or diarrhea. He had previously received the yellow fever vaccine in 1965 without an event. Reportedly, the patient recovered form these events.
Age: 80.0
Sex: M
Vaccine: YF, YF
Symptoms: Anorexia, Constipation, Flatulence
Clinical narrative: From initial information received on 19MAR2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that an 80 year old male pt received a dose of YFVAX on 02MAR2004. Ten days later, on 12MAR2004, the pt developed constipation, gas and lack of appetite. The pt felt that this was an adverse reaction to the yellow fever vaccine. The pt denied any fever or diarrhea. He had previously received the yellow fever vaccine in 1965 without an event. Reportedly, the patient recovered form these events.
Age: 60.0
Sex: F
Vaccine: HEPAB, YF, HEPAB, YF
Symptoms: Chest pain, Dyspnoea, Electrocardiogram abnormal, Hypertension, Laboratory test abnormal
Clinical narrative: From initial information received on 06May04 through an enhanced surveillance program conducted by the CDC regarding an adverse event occurring. It was reported that a 60 year old female pt received her first dose of YF VAX and a first dose of TWINRIX on 25Mar04 in preparation for a trip. The sites and routes of administration were not reported. Approximately four hours after receiving the vaccines, the pt experienced chest pain and pain with breathing. It became so severe that about 12 hours after the vaccinations she went to the ER and spent one day in the hospital. The final diagnosis was chest pain with a probable musculoskeletal etiology. Her recovery status was not provided, but it was reported that she was able to go abroad as planned in late April.
Age: 60.0
Sex: F
Vaccine: HEPAB, YF, HEPAB, YF
Symptoms: Chest pain, Dyspnoea
Clinical narrative: From initial information received on 06May04 through an enhanced surveillance program conducted by the CDC regarding an adverse event occurring. It was reported that a 60 year old female pt received her first dose of YF VAX and a first dose of TWINRIX on 25Mar04 in preparation for a trip. The sites and routes of administration were not reported. Approximately four hours after receiving the vaccines, the pt experienced chest pain and pain with breathing. It became so severe that about 12 hours after the vaccinations she went to the ER and spent one day in the hospital. The final diagnosis was chest pain with a probable musculoskeletal etiology. Her recovery status was not provided, but it was reported that she was able to go abroad as planned in late April.
Age: 34.0
Sex: M
Vaccine: YF, YF, YF
Symptoms: Anaphylactic reaction, Heart rate increased, Insomnia, Pharyngeal oedema, Pyrexia
Clinical narrative: From initial information received on 28APR2004 form an RN, regarding an adverse event occurring in the USA, it was reported that a 34 year old male pt received a first dose of YFVAX, lot UB422AA, administered SC in the LA on 27APR2004 at 2.15 PM. Later in the evening on the same day, the patient reported that he developed hives, itching and mouth swelling. He was evaluated and treated by his own physician, who administered an injection of steroids. The patient recovered form these events.
Age: 34.0
Sex: M
Vaccine: YF, YF, YF
Symptoms: Urticaria
Clinical narrative: From initial information received on 28APR2004 form an RN, regarding an adverse event occurring in the USA, it was reported that a 34 year old male pt received a first dose of YFVAX, lot UB422AA, administered SC in the LA on 27APR2004 at 2.15 PM. Later in the evening on the same day, the patient reported that he developed hives, itching and mouth swelling. He was evaluated and treated by his own physician, who administered an injection of steroids. The patient recovered form these events.
Age: 34.0
Sex: M
Vaccine: YF, YF, YF
Symptoms: Pharyngeal oedema, Pruritus, Swelling face, Urticaria
Clinical narrative: From initial information received on 28APR2004 form an RN, regarding an adverse event occurring in the USA, it was reported that a 34 year old male pt received a first dose of YFVAX, lot UB422AA, administered SC in the LA on 27APR2004 at 2.15 PM. Later in the evening on the same day, the patient reported that he developed hives, itching and mouth swelling. He was evaluated and treated by his own physician, who administered an injection of steroids. The patient recovered form these events.
Age: 34.0
Sex: M
Vaccine: YF, YF, YF
Symptoms: Pruritus, Swelling face, Urticaria
Clinical narrative: From initial information received on 28APR2004 form an RN, regarding an adverse event occurring in the USA, it was reported that a 34 year old male pt received a first dose of YFVAX, lot UB422AA, administered SC in the LA on 27APR2004 at 2.15 PM. Later in the evening on the same day, the patient reported that he developed hives, itching and mouth swelling. He was evaluated and treated by his own physician, who administered an injection of steroids. The patient recovered form these events.
Age: 28.0
Sex: F
Vaccine: RAB, YF, RAB, YF
Symptoms: Difficulty in walking, Dizziness
Clinical narrative: From initial information received on 14MAy2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 28 year old female patient received her first dose of IMOVAC Rabies, lot number W1419, administered IM in the left deltoid and her first dose of YFVAX, administered SC in the RA on 21JAN2004. On the morning of 24JAN2004, the patient experienced an episode of dizziness and difficulty walking. Dizziness episodes occurred once or twice daily over the next ten days. Reportedly, the patient recovered from these events. From a telephone message received 19MAY2004 from the reporter, it was reported that this patient probably had some postural hypotension that would be responsible for the difficulty walking. Patient is now doing fine.
Age: 28.0
Sex: F
Vaccine: RAB, YF, RAB, YF
Symptoms: Difficulty in walking, Dizziness, Hypotension
Clinical narrative: From initial information received on 14MAy2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 28 year old female patient received her first dose of IMOVAC Rabies, lot number W1419, administered IM in the left deltoid and her first dose of YFVAX, administered SC in the RA on 21JAN2004. On the morning of 24JAN2004, the patient experienced an episode of dizziness and difficulty walking. Dizziness episodes occurred once or twice daily over the next ten days. Reportedly, the patient recovered from these events. From a telephone message received 19MAY2004 from the reporter, it was reported that this patient probably had some postural hypotension that would be responsible for the difficulty walking. Patient is now doing fine.
Age: 33.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Blister, Skin ulcer
Clinical narrative: This 33-year-old received Anthrax vaccination #6 on 7 February 2004.  Approximately 12 April 2004 (1½-2 months later), his wife noticed several large circular red raised spots "as if he has scraped himself or like lesions similar to being stung by a bee" about ¼ inch diameter all over his back that were non-pruritic.   The rash began to spread to his chest and he sought medical care on 22 April 2004 (records not available).  He states he was placed on two creams and given an unknown pill that did dull the rash.  However, the rash returned once medical treatment was completed.    By May 2004, this service member described his rash as flesh-colored to bright red spots that itched and were centered primarily on his chest and back with scattering spots  to both arms and legs.   He was subsequently referred to a dermatologist with a questionable diagnosis of "Dermatosis of unknown etiology versus Pityriasis".  The rash was documented as a "diffuse annular erythematous macular rash, well marginated with central clearing and satellite papule's." A skin punch biopsy was performed on 22 April 2004 reporting "spongiotic dermatitis with eosinophils suggesting allergic contact dermatitis with differentials to include drug reaction and arthropod bite reaction."  His exam on 10 July 2004 reports the questionable presence of a "Herald spot" to the left groin. Again, he was treated with hydrocortisone-based cream and some pill with diminishment of his rash but never complete resolution.  No anti-histamines were reported to be administered.  As of this interview, he reports the rash to be nonpruritic with the rash less prominent than last April.  He has been off medications since 9 July 2004 with further dermatological appointments scheduled this August.  He reports no aggravating factors, new foods, new stressors, cologne, clothing, deodorants, detergents, or chemical exposure.  He reports a similar rash April 1-7, 2003 while in Basra, Iraq that lasted 1-2 weeks where he was told he was having a "stress reaction verses sand flea bites" and that it would go away. He was placed on Doxycycline after a skin biopsy was taken with unknown report results.
Age: 33.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Dermatitis allergic, Dermatitis contact, Hypersensitivity, Laboratory test abnormal, Pityriasis rosea
Clinical narrative: This 33-year-old received Anthrax vaccination #6 on 7 February 2004.  Approximately 12 April 2004 (1½-2 months later), his wife noticed several large circular red raised spots "as if he has scraped himself or like lesions similar to being stung by a bee" about ¼ inch diameter all over his back that were non-pruritic.   The rash began to spread to his chest and he sought medical care on 22 April 2004 (records not available).  He states he was placed on two creams and given an unknown pill that did dull the rash.  However, the rash returned once medical treatment was completed.    By May 2004, this service member described his rash as flesh-colored to bright red spots that itched and were centered primarily on his chest and back with scattering spots  to both arms and legs.   He was subsequently referred to a dermatologist with a questionable diagnosis of "Dermatosis of unknown etiology versus Pityriasis".  The rash was documented as a "diffuse annular erythematous macular rash, well marginated with central clearing and satellite papule's." A skin punch biopsy was performed on 22 April 2004 reporting "spongiotic dermatitis with eosinophils suggesting allergic contact dermatitis with differentials to include drug reaction and arthropod bite reaction."  His exam on 10 July 2004 reports the questionable presence of a "Herald spot" to the left groin. Again, he was treated with hydrocortisone-based cream and some pill with diminishment of his rash but never complete resolution.  No anti-histamines were reported to be administered.  As of this interview, he reports the rash to be nonpruritic with the rash less prominent than last April.  He has been off medications since 9 July 2004 with further dermatological appointments scheduled this August.  He reports no aggravating factors, new foods, new stressors, cologne, clothing, deodorants, detergents, or chemical exposure.  He reports a similar rash April 1-7, 2003 while in Basra, Iraq that lasted 1-2 weeks where he was told he was having a "stress reaction verses sand flea bites" and that it would go away. He was placed on Doxycycline after a skin biopsy was taken with unknown report results.
Age: 33.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Pruritus, Rash erythematous, Rash macular
Clinical narrative: This 33-year-old received Anthrax vaccination #6 on 7 February 2004.  Approximately 12 April 2004 (1½-2 months later), his wife noticed several large circular red raised spots "as if he has scraped himself or like lesions similar to being stung by a bee" about ¼ inch diameter all over his back that were non-pruritic.   The rash began to spread to his chest and he sought medical care on 22 April 2004 (records not available).  He states he was placed on two creams and given an unknown pill that did dull the rash.  However, the rash returned once medical treatment was completed.    By May 2004, this service member described his rash as flesh-colored to bright red spots that itched and were centered primarily on his chest and back with scattering spots  to both arms and legs.   He was subsequently referred to a dermatologist with a questionable diagnosis of "Dermatosis of unknown etiology versus Pityriasis".  The rash was documented as a "diffuse annular erythematous macular rash, well marginated with central clearing and satellite papule's." A skin punch biopsy was performed on 22 April 2004 reporting "spongiotic dermatitis with eosinophils suggesting allergic contact dermatitis with differentials to include drug reaction and arthropod bite reaction."  His exam on 10 July 2004 reports the questionable presence of a "Herald spot" to the left groin. Again, he was treated with hydrocortisone-based cream and some pill with diminishment of his rash but never complete resolution.  No anti-histamines were reported to be administered.  As of this interview, he reports the rash to be nonpruritic with the rash less prominent than last April.  He has been off medications since 9 July 2004 with further dermatological appointments scheduled this August.  He reports no aggravating factors, new foods, new stressors, cologne, clothing, deodorants, detergents, or chemical exposure.  He reports a similar rash April 1-7, 2003 while in Basra, Iraq that lasted 1-2 weeks where he was told he was having a "stress reaction verses sand flea bites" and that it would go away. He was placed on Doxycycline after a skin biopsy was taken with unknown report results.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Cow pox
Clinical narrative: Rashes; red spots and bumps, itchiness.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Rashes; red spots and bumps, itchiness.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning a friend's child who was vaccinated with a dose of MMR and became autistic. Unspecified medical attention was sought. There was no product quality complaint involved. Upon internal review autistic was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Petechiae, Platelet count decreased, Thrombocytopenic purpura
Clinical narrative: Petechial rash, platelets decreased 30,000. Diagnosed with ITP and given Helmet.
Age: 0.44
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Dyspnoea, Pyrexia, Rhinitis, Vomiting
Clinical narrative: Seizure activity, low grade fever, starting approximately 24 hours after administration of immunizations. Approximately 25-30 minutes of seizure activity; 6-7 discrete episodes, all generalized. No treatment; patient evaluated and observed.  Nurse follow up on 09/28/04 states: "Final diagnosis was fever, possible seizure.  Additional symptoms noted were vomiting described as spitting up after feeds, runny nose, and dyspnea."
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site vesicles
Clinical narrative: Left buttock; large area of erythema and induration around DTaP site. Also had blistering of skin and a small ulcerative type area at site of injection. Erythema spread rapidly despite oral antibiotics. CBC, Sed Rate, wound culture all negative. Thus, suspicion of localized reaction rather than cellulitis. Nonetheless, was treated with 2 days of IV antibiotics and sent home on oral course.  Nurse follow up on 09/13/04 states: "No new information."
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Anaphylactic reaction, Convulsion, Hypotonia, Laboratory test abnormal, Loss of consciousness
Clinical narrative: Limp/pale within a couple of minutes after injection. Then lost consciousness and experienced general seizure for 30-40 minutes. Epinephrine adjusted.  Nurse follow up on 09/09/04 states: "No new information."  Nurse follow up on 09/14/04 states: "Anaphylaxis."
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pallor
Clinical narrative: Limp/pale within a couple of minutes after injection. Then lost consciousness and experienced general seizure for 30-40 minutes. Epinephrine adjusted.  Nurse follow up on 09/09/04 states: "No new information."  Nurse follow up on 09/14/04 states: "Anaphylaxis."
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Chest pain, Dyspnoea, Headache, Hypoventilation
Clinical narrative: Reproducible shortness of breath with AVA #1 and #2. 02/03/03: The day of injection he developed a painful knot in the vaccinated arm the size of a quarter. Within 2 days his entire upper arm and left axilla was exquisitely painful and prevented exercising for 2 weeks.  Within 2 days he developed chest pain that increased in severity with taking a deep breath. He felt he could only do "shallow breathing" otherwise the pain would worsen. The pain did not worsen with lying down but he cannot remember the exact location of the pain. He was not involved in any physical training during this time. He had no other systemic symptoms and is unsure as to the specific onset and duration of symptoms.  All symptoms resolved. 02/27/03: Developed more severe local reaction than from previous AVA to include painful swelling. Remembers being unable to exercise for 4 weeks due to arm pain. Within 2 days of shot (but not within the 1st few hours), he experienced chest pain that interfered with his ability to take a deep breath and some shortness of breath significantly greater intensity that with AVA #1; "It scared me". He had shortness of breath at rest as well as during activity. He also developed headache, fever, nasal congestion and some generalized muscle aches but stated this was "different from a cold."  He sought medical attention by the 4th day. He and his crew were grounded for 4 days due to his symptoms.  Systemic symptoms lasted about 1 week, then resolved without sequelae. Others in his unit had some symptoms but not like his and there was no indication of upper respiratory viral infection among his unit.  A medical visit 03/27/03 details service member's concerns about receiving his 3rd AVA due to "localized swelling of the soft tissue in the deltoid areas with significant tenderness...body malaise, generalized weakness, especially of the upper extremities...he also had difficulty of breathing." Following #1 and #2.  He was issued a "deferment of the 3rd shot of AVA."
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site mass, Injection site oedema, Injection site pain, Malaise, Myalgia
Clinical narrative: Reproducible shortness of breath with AVA #1 and #2. 02/03/03: The day of injection he developed a painful knot in the vaccinated arm the size of a quarter. Within 2 days his entire upper arm and left axilla was exquisitely painful and prevented exercising for 2 weeks.  Within 2 days he developed chest pain that increased in severity with taking a deep breath. He felt he could only do "shallow breathing" otherwise the pain would worsen. The pain did not worsen with lying down but he cannot remember the exact location of the pain. He was not involved in any physical training during this time. He had no other systemic symptoms and is unsure as to the specific onset and duration of symptoms.  All symptoms resolved. 02/27/03: Developed more severe local reaction than from previous AVA to include painful swelling. Remembers being unable to exercise for 4 weeks due to arm pain. Within 2 days of shot (but not within the 1st few hours), he experienced chest pain that interfered with his ability to take a deep breath and some shortness of breath significantly greater intensity that with AVA #1; "It scared me". He had shortness of breath at rest as well as during activity. He also developed headache, fever, nasal congestion and some generalized muscle aches but stated this was "different from a cold."  He sought medical attention by the 4th day. He and his crew were grounded for 4 days due to his symptoms.  Systemic symptoms lasted about 1 week, then resolved without sequelae. Others in his unit had some symptoms but not like his and there was no indication of upper respiratory viral infection among his unit.  A medical visit 03/27/03 details service member's concerns about receiving his 3rd AVA due to "localized swelling of the soft tissue in the deltoid areas with significant tenderness...body malaise, generalized weakness, especially of the upper extremities...he also had difficulty of breathing." Following #1 and #2.  He was issued a "deferment of the 3rd shot of AVA."
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Nasal congestion, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Reproducible shortness of breath with AVA #1 and #2. 02/03/03: The day of injection he developed a painful knot in the vaccinated arm the size of a quarter. Within 2 days his entire upper arm and left axilla was exquisitely painful and prevented exercising for 2 weeks.  Within 2 days he developed chest pain that increased in severity with taking a deep breath. He felt he could only do "shallow breathing" otherwise the pain would worsen. The pain did not worsen with lying down but he cannot remember the exact location of the pain. He was not involved in any physical training during this time. He had no other systemic symptoms and is unsure as to the specific onset and duration of symptoms.  All symptoms resolved. 02/27/03: Developed more severe local reaction than from previous AVA to include painful swelling. Remembers being unable to exercise for 4 weeks due to arm pain. Within 2 days of shot (but not within the 1st few hours), he experienced chest pain that interfered with his ability to take a deep breath and some shortness of breath significantly greater intensity that with AVA #1; "It scared me". He had shortness of breath at rest as well as during activity. He also developed headache, fever, nasal congestion and some generalized muscle aches but stated this was "different from a cold."  He sought medical attention by the 4th day. He and his crew were grounded for 4 days due to his symptoms.  Systemic symptoms lasted about 1 week, then resolved without sequelae. Others in his unit had some symptoms but not like his and there was no indication of upper respiratory viral infection among his unit.  A medical visit 03/27/03 details service member's concerns about receiving his 3rd AVA due to "localized swelling of the soft tissue in the deltoid areas with significant tenderness...body malaise, generalized weakness, especially of the upper extremities...he also had difficulty of breathing." Following #1 and #2.  He was issued a "deferment of the 3rd shot of AVA."
Age: 3.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Right thigh red, swollen, hot. Treated with Orapred and Keflex and signs and symptoms resolved.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Immunization site of right arm red, swollen and warm to touch. Warm compress to right arm and Tylenol every 4 hours given.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Hypoaesthesia, Pyrexia
Clinical narrative: Numbness in neck and arms. Temperature of 101 at home, 99.7 at ER.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema, Pyrexia
Clinical narrative: Grapefruit size swelling on left thigh. Treatment: take Benadryl, call for more swelling/fever.
Age: 9.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt brought back to clinic about 2.5 hours after below named vaccines given. Pt with pruritic hives to left side of face, left upper arm. No shortness of breath. Refused any treatment. Parents advised to give child Benadryl and start Prelone syrup at home. To return in 24 hours or sooner to ER if symptoms progress.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis
Clinical narrative: Cellulitis right forearm (deltoid area) about 3-4x2.5inches.
Age: 54.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Right arm where MMR was given was swollen and red-almost 2-3 inch diameter. Tylenol and Benadryl was given.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Left shoulder is red, swollen and arm. Induration measured 8.5x10cm. Redness extended beyond these measurements 16.5x16cm. Pt advised by MD to watch swelling and redness. If inflammation increases in size and/or becomes painful, pt is to return to clinic. Pt advised to use Motrin or Tylenol for pain and swelling.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness and swelling at injection site, erythemic area 8x7.5cm, Keflex for 10 days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Entire left thigh red, swollen, hot to touch. Localized reaction.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Left deltoid reaction, reddened, raised, local reaction. Complained of itching, soreness 1.5x1.5 inch reaction.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Local reaction to arm injection site, warm, red, swollen around injection site 2x3 inches.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Rash compatible with Varicella 08/21/04
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying
Clinical narrative: High pitched cry x 1.5-2 hours with resolved with Tylenol.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Convulsion, Eye movement disorder, Eyelid oedema, Mydriasis
Clinical narrative: Pt seizured. Eyes rolled back, eyelids became puffy, pupils became dilated.
Age: 1.4
Sex: U
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 7x8cm erythema and induration at site of DTaP.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Left thigh swollen, erythema, feels warm to touch and tender to touch.
Age: 1.3
Sex: F
Vaccine: DTAP
Symptoms: Convulsion
Clinical narrative: Had generalized seizure approximately 12 hours after receiving DTaP with no other risk factors for seizures.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Swelling
Clinical narrative: DTaP given on 8/20/04, by that evening, pt had large area of left upper arm hot and swollen.
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Local erythema/ swollen: left thigh 24-48 hours after Hep A/ IPV/ MMR/ DPT (2 sites: 3cm x 6 cm D 24 - 48 hours)
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: Left leg 2.5 2.5 cm, red painful. Cellulitis.
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Feeling abnormal, Hyperhidrosis, Palpitations, Stomatitis, Tremor
Clinical narrative: According to pt: ER doctor states pt had adverse reaction, not allergic reaction. Pt was driving home around 20 min after injection developed "weird" feeling around mouth, moved to jaw. Started having palpitations. 30 min became shaky. Palms sweating. Sxs began to come in waves, until they eventually disappeared. Pt went to ER: was observed for 1 hours. Discharged about 1300. No treatment. Hx of allergies to peanuts and mustard.
Age: 47.0
Sex: M
Vaccine: TD
Symptoms: Discomfort, Joint range of motion decreased, Pain
Clinical narrative: 2 weeks after injection, pt states he noted discomfort in muscle just above elbow. Pain with reaching backward and lifting, when reading vaccine. Info sheet given. He decided to call. States he is improving, recovering.
Sex: M
Vaccine: MMR
Symptoms: Irritability, Pyrexia, Rash, Rash macular
Clinical narrative: Around 30 hours after MMR = 101 degrees fever, very cranky (lasted 3 days); 5 days after MMR = measles like rash all over chest and back of neck (lasted 24 hours); 13 days after MMR. Severe rash all over neck and chest, very irritable (lasted 5 days). Tested for measles. Came back negative.
Age: 3.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Erythema, Feeling hot, Injection site induration
Clinical narrative: 2 days after immunization, pt developed 10 x 9 cm patch of induration/ warmth/ redness over right anterior thigh
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Right deltoid red and swollen
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site induration
Clinical narrative: Right arm feels hard to touch, above the elbow, below shoulder. Treatment: ice to site, referred urgent care prn.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Erythema, Feeling hot, Pruritus
Clinical narrative: Received DTaP and IPV to right arm on 8/25/04. Complained of itches. DTaP site with bruising. Redness/ heat to site IPV x 24 hour increase in redness. No prior reaction. Redness appeared 26AUG.
Age: 2.0
Sex: F
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local swelling and redness at injection sites. Both sites (both legs).
Age: 0.08
Sex: F
Vaccine: HEP, HIBV
Symptoms: Crying, Feeling hot, Haematoma, Injection site induration, Somnolence
Clinical narrative: Started as persistent crying and swollen right thigh 4 hours after administration, as well as drowsiness. PE: right thigh moderate swelling, warm, slight hematoma, indurated.
Age: 0.08
Sex: F
Vaccine: HEP, HIBV
Symptoms: Swelling
Clinical narrative: Started as persistent crying and swollen right thigh 4 hours after administration, as well as drowsiness. PE: right thigh moderate swelling, warm, slight hematoma, indurated.
Age: 1.25
Sex: F
Vaccine: DTAPH, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Area around shot site became red and swollen as soon as shot. Left arm SQ
Age: 1.23
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: Pt started with redness and swollen upper arm on 7/22/04. Advised to use ice compress and Motrin at home.
Age: 27.0
Sex: M
Vaccine: MMR, TD
Symptoms: Dizziness, Headache
Clinical narrative: Pt complained dizziness, headache, double vision 1 day after receiving MMR and Td. Pt was seen in ER and MRI was done. Pt was seen by neurology and was treated for migraine. Not related to immunizations.
Age: 5.5
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Pain, Pyrexia, Swelling, Tenderness
Clinical narrative: Per telephone call from mom child's left arm is red, swollen today. No fever. Complained of soreness. Instructed to use cold compresses, Tylenol for pain, to see provider if other symptoms develop, fever elevated temperature. No call back with other concerns.
Age: 4.0
Sex: F
Vaccine: HEP, HEPA, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Right deltoid noted with 3 inch diameter area of redness and mild swelling around injection site. Area warm to touch. Instructed mother to apply cold/ ice pack to area (20 min on + 20 min off next 48 hours while child awake). RTC if no improvement after 48 hours.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Injection site induration, Musculoskeletal stiffness, Oedema, Swelling
Clinical narrative: 8/24/04: Arm puffy, red. 8/25/04 shoulder to elbow and around arm, red, swollen, hard spot where shots given, arm is stiff.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Right shoulder is pink, hot, swollen and hard.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Dry skin, Rash
Clinical narrative: Dry, rough skin resulted from rash within 12-24 hours after vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Discomfort, Erythema, Swelling
Clinical narrative: Arm red, swollen, uncomfortable. Advice: cool packs, Tylenol.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Dyspnoea, Flushing, Hypoxia, Wheezing
Clinical narrative: 8/11/04 2:30 PM, coughing started and by 2:39 PM, child flushed, wheezing, and having trouble breathing. Mother contacted health department per phone and was instructed to seek emergency care immediately. 2:45 PM, approximate arrival at ER; oxygen, Orapred, and nebulizer treatment. Discharged home around 4:45 PM. Orapred continued through 8/14/04.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Injection site erythema
Clinical narrative: Red site on right thigh area; no fever 8/11/04.
Age: 36.0
Sex: M
Vaccine: YF
Symptoms: Myalgia, Paraesthesia, Pharyngolaryngeal pain, Viral infection
Clinical narrative: From initial information received on 21APR2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 36 year old male patient received a first dose of YFVAX, administered SC in the left arm on 08MAR2004 at 8:30Am. Approximately two weeks later, about 22MAR2004, the patient experienced polymyalgias and paresthesias following a sore throat. It was reported that the patient could have experienced a possible viral syndrome. The patient had partially recovered from these events at the time of this report.
Age: 17.0
Sex: F
Vaccine: YF
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: From initial information received on 26MAY2004 from a physician regarding an adverse event occurring in the USA, it was reported that a 17 year old female pt receiving first of of YF Vax, administered IM in the distal right posterior deltoid on an unspecified date. Several hours after receiving the vaccination, the pt noted numbness and paresthesias involving the right medial scapula and entire right arm. No systemic sxs were reported. The pat was seen in the ER on 24MAR2004 with weakness and numbness of her right hand. The pt's recovery status was reported as unknown. The pt also received a Hepatitis A vaccine on 17MAR2004, in the right posterior deltoid. It was not reported whether the Hepatitis A vaccine was administered post or prior to the YF VAX.
Age: 22.0
Sex: M
Vaccine: YF
Symptoms: Dyspnoea, Rash
Clinical narrative: From initial information received on 14Jun03 from physician regarding an adverse event occurring. It was reported that a 22 year old male pt received a YF VAX vaccination on 13Jun03, route, site were not reported. Reportedly sometime after the vaccination that same day, the pt developed a rash on both arms and on trunk of body, as well as subjective dyspnea, resp 18. The recovery status of this pt is currently unknown.
Age: 53.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: From initial information received on 27May04 from a RN regarding an adverse event occurring in the USA it was reported that a 53 year old male pt received his first dose of YF VAX, lot number UE128AA, administered SC in the left arm and his first dose of Hep A vaccine, lot number UHA 798A6, administered IM in the right deltoid on 22Apr04. Thirty two days later, the pt experienced numbness of toes of both feet up to the ball area before both arches. Concomitant medications at the time of vaccination included daily ASA (81mg). At the time of initial report the event had not resolved. Pt's pre-existing medical conditions include penicillin allergy. From additional information received on 23Aug04 from a health care professional, it was reported that the pt received a dose of Diphtheria and Tetanus toxoids administered by the local health department on 24May04, the same day as the onset of the adverse event. The lot number, manufacturer, route and site of administration were not reported. The responsible physician's name was also provided. From additional information received on 26Aug04 through a telephone call from a health care professional, the pt reported that he had experienced numbness in his toes, which progressed to his legs and hands. He was subsequently diagnosed with Guillain Barre syndrome, which his physician felt to be related to the tetanus and diphtheria vaccine administered 24May04. The pt stated that he did not require hospitalization, but was in a wheelchair, then used a walker. He is currently on disability and using a cane. He had no information on the manufacturer or lot number for the tetanus and diphtheria vaccine. Due to medical judgement, this case was upgraded to serious (OMIC). From additional information received on 01/Nov/2004 from the reporting facility, it was reported that the Diphtheria and Tetansu Toxoids was not administered by the reporting facility, but by the local health department on 14/May/2004. The patient visit to the reporting facility was on 22/Apr/2004 where he received YR-VAX, Hepatitis A vaccine and Typhim VI (vaccination not mentioned in the previous vaccine, lot number X0482-2, administered intramuscularly in the deltoid. The physician noted as the patient's responsible physician in the medical director at the reporting facility and not the physician employed by the local health department. The patient recovery status is unknown.  20Jan05: Despite additional attempts at obtaining follow up for this case, no more information has been received. The pt's recovery status remains unk. Further information is not anticipated, this case is considered closed.
Age: 36.0
Sex: M
Vaccine: TD
Symptoms: Anorexia, Chills, Injection site oedema, Muscle spasms, Pyrexia
Clinical narrative: Large Local swelling @ injection site, fever later that day lasting 3 days, chills, muscle spasms 30 hours after injection, lasting 24 hours and no appetite.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Pain, Pyrexia, Syncope
Clinical narrative: fever,body aches,loc for about 20 min.
Age: 38.0
Sex: M
Vaccine: LYME
Symptoms: Arthritis, Joint swelling
Clinical narrative: Periodic (approx 5 - 7 weeks) swelling and inflammation of joints. The areas most commonly effected are fingers, toes, wrists, ankles, back of hands, tops and bottom of feet. Outbreaks last approximately 2 weeks
Age: 28.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Arthralgia, Erythema, Fatigue, Joint stiffness, Myalgia
Clinical narrative: Pt presented in less than 24 hours of vaccination with a severe reaction to the 6/6 Anthrax Vaccine.  The patient complained of localized, significant swelling, erythema, tenderness and multi-joint pain/stiffness (particularly fingers & hands), along with fatigue, myalgias, and tongue sensitivity.  Symptoms resolved spontaneously.
Age: 28.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Oedema, Tenderness, Tongue disorder
Clinical narrative: Pt presented in less than 24 hours of vaccination with a severe reaction to the 6/6 Anthrax Vaccine.  The patient complained of localized, significant swelling, erythema, tenderness and multi-joint pain/stiffness (particularly fingers & hands), along with fatigue, myalgias, and tongue sensitivity.  Symptoms resolved spontaneously.
Age: 28.0
Sex: U
Vaccine: HEP
Symptoms: Agitation, Dizziness, Hot flush, Hyperhidrosis, Nausea
Clinical narrative: dizziness, vertigo, nausea, blurred vision, agitation, sleepiness, hot flashes, sweats. Treatment: 1st day-emergency doctor prescribed Antivert. 3rd day-doctor prescribed Compazine and Zofran. 7th day-doctor prescribed Methylprednisolone.