chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Pt began to complain of abdominal pain and nausea the night after receiving the vaccine. The morning after complaint of "feeling bad" with abdominal pain, fever 101.2F for 12 hrs. Night of 1/29/03 complaint of nausea, dizziness, and shortness of breath. morning of 1/30/03 Pt had no complaints. Fever broke after every 4 hrs of tylenol on 1/29/03.
Age: 4.3
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: 2X2 cm red local reaction.
Age: 34.0
Sex: F
Vaccine: SMALL
Symptoms: Headache, Malaise, Pyrexia
Clinical narrative: Patient developed headache on day 5 following vaccination.  This was followed by malaise, and fever to 100.9 degrees F on day 13.  She was placed on medical leave of absence and improved with medication, bedrest and fluids.  All symptoms resolved by 15 days post vaccination.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Right upper arm urticaria-like reaction.  Patient c/o itching.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Malaise, Myalgia, Pyrexia, Rash maculo-papular
Clinical narrative: Primary smallpox vaccination. Maculopapular rash on trunk, and extremities (sparing face, palms and plantar surfaces) erupted 8 days after primary vaccination.  Initially accompanied by fever, malaise, and myalgia.  Rash persisted and fever, body aches resolved within 48 hours of beginning treatment with keflex, benadryl, and naproxen.  Rash progressed to various stages of vesicular, pustular, and crusted pustules.  Some of the rash had appearance of maculopapular erythematous lesions. His lesions on the first day were maculopapular/vesicular.  The lesions that were vesicular evolved to pustular/crusted very quickly - maybe 2 days.  There were very few that were true pustules.  Only one of the lesions looked like a smaller version of the vaccine site. It was on his back and had a central pustule of about 2 mm diameter and a base of erythema that was about 1cm diameter.  I took a photo of it but it didn't turn out well.  Over 2-3 days is crusted and looked like acne.  Now his lesions are very much dissipated to mildly erythematous macular lesions on his dorsal hands.  They look somewhat urticarial.  After the initial day he has had no fever or malaise. He returned to work today (5 Feb 03) and will be flying within 4-5 days.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Rash vesicular, Skin ulcer, Urticaria
Clinical narrative: Primary smallpox vaccination. Maculopapular rash on trunk, and extremities (sparing face, palms and plantar surfaces) erupted 8 days after primary vaccination.  Initially accompanied by fever, malaise, and myalgia.  Rash persisted and fever, body aches resolved within 48 hours of beginning treatment with keflex, benadryl, and naproxen.  Rash progressed to various stages of vesicular, pustular, and crusted pustules.  Some of the rash had appearance of maculopapular erythematous lesions. His lesions on the first day were maculopapular/vesicular.  The lesions that were vesicular evolved to pustular/crusted very quickly - maybe 2 days.  There were very few that were true pustules.  Only one of the lesions looked like a smaller version of the vaccine site. It was on his back and had a central pustule of about 2 mm diameter and a base of erythema that was about 1cm diameter.  I took a photo of it but it didn't turn out well.  Over 2-3 days is crusted and looked like acne.  Now his lesions are very much dissipated to mildly erythematous macular lesions on his dorsal hands.  They look somewhat urticarial.  After the initial day he has had no fever or malaise. He returned to work today (5 Feb 03) and will be flying within 4-5 days.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Cow pox, Injection site erythema, Malaise, Rash maculo-papular, Skin ulcer
Clinical narrative: Primary smallpox vaccination. Has diffuse maculopapular lesions on thorax and upper extremities consistent with generalized vaccinia.  Mild malaise for 2 days.  Vaccination site with 5 cm surrounding erythema. Small pustules in the center of most of his thoracic lesions, so qualifies as "possible generalized vaccinia."
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Cow pox, Malaise, Rash maculo-papular, Skin ulcer
Clinical narrative: Has diffuse maculopapular lesions on thorax and upper extremities consistent with generalized vaccinia.  No systemic symptoms at this time.  No pustules. Had general malaise for 3 days ending yesterday, otherwise feels fine.  Vaccination site normal.
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Developed nausea vomiting and diarrhea on 2 Feb 2003.  Evaluated in clinic on 3 Feb 2003 and received 3 liters of IV fluids for dehydration.  Returned to work on 4 Feb 2003.  Family members were ill with AGE on 1 Feb 2003. BP 140/70, pulse 90
Age: 26.0
Sex: F
Vaccine: SMALL
Symptoms: Diarrhoea, Nausea, Orthostatic hypotension, Pain, Vomiting
Clinical narrative: 3 days after receiving the smallpox vaccination the patient developed nausea and vomiting.  This persisted for 4 days. On the 4th day she was seen in the clinic and rehydrated and given phenergan.  She returned to work for 2 days then developed nausea, vomiting, RLQ pain and diarrhea.  She was seen in the ER and received 4 liters of IV fluids.  She was seen the following am and was still orthostatic so she was admitted to the hospital for IV hydration.  She remained in the hospital for 2.5 days.  At the end of her hospitalization all symptoms had resolved.  Her injection site had a normal appearance for small pox.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Folliculitis, Rash
Clinical narrative: The morning of 1/25/03 Pt noticed small red spots along the upper portion of chest. The quantity of red spots multiplied by the following morning reaching down to the bottom of the sternum. This morning (1/28/03) Pt noticed even more of the spots reaching to the top of his abdomen. Now the spots are forming in more of a cluster formation in some sites. At this time the "rash" does not itch cause discomfort.
Age: 35.0
Sex: M
Vaccine: SMALL
Symptoms: Headache, Lethargy, Myalgia
Clinical narrative: Pt rec'd smallpox vaccination 1/9/03. On day 15 C/O muscle aches, generalized lethargy, and headache, mental acuity. Placed on ? guerfent  for 7 hrs. (even the week-end). Felt better within 48 hrs, no additional treatment.
Age: 24.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Erythema, Fatigue, Headache, Injection site induration, Injection site mass
Clinical narrative: Vesicle 8X8mm, erythema 30mm X 30mm with outside light erythema 75mm X 75mm with slight rash at edges, hard tissue and bump from site to L axilla 153mm X 150mm. Pt C/O itching all over, headache, muscle ache, fatigue, sore lymph nodes ??, night sweats. Referred to infections disorder MD.
Age: 24.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Injection site rash, Injection site vesicles, Lymph node pain, Muscle spasms, Night sweats
Clinical narrative: Vesicle 8X8mm, erythema 30mm X 30mm with outside light erythema 75mm X 75mm with slight rash at edges, hard tissue and bump from site to L axilla 153mm X 150mm. Pt C/O itching all over, headache, muscle ache, fatigue, sore lymph nodes ??, night sweats. Referred to infections disorder MD.
Age: 24.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Pruritus
Clinical narrative: Vesicle 8X8mm, erythema 30mm X 30mm with outside light erythema 75mm X 75mm with slight rash at edges, hard tissue and bump from site to L axilla 153mm X 150mm. Pt C/O itching all over, headache, muscle ache, fatigue, sore lymph nodes ??, night sweats. Referred to infections disorder MD.
Age: 24.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Rash
Clinical narrative: Vesicle 8X8mm, erythema 30mm X 30mm with outside light erythema 75mm X 75mm with slight rash at edges, hard tissue and bump from site to L axilla 153mm X 150mm. Pt C/O itching all over, headache, muscle ache, fatigue, sore lymph nodes ??, night sweats. Referred to infections disorder MD.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Dehydration, Difficulty in walking, Diplopia, Encephalitis, Vertigo
Clinical narrative: My mother received the flu shot on October 4, 2002 and two days later was having problems walking.  This progressed until the end of Dec. when she became sick and dehydrated and had double vision. The 60 day follow up states pt is in intensive care with encephalitis and as of today is not responding well.
Age: 20.0
Sex: F
Vaccine: ANTH
Symptoms: Unevaluable event
Clinical narrative: No adverse events or reactions have been reported to this date.  Patient was pregnant at the time she received the second anthrax vaccine.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Skin ulcer, Tenderness
Clinical narrative: PATIENT DEVELOPED A LESION AT SITE OF. TENDER TO TOUCH
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Arthritis, Arthropathy, Pain
Clinical narrative: Shot was given up high on my right shoulder. Soreness from shot continued. 3/14/00: I discussed pain in shoulder with Dr.  while in the office for other purpose-he thought immunization might have hit the bursas in my right shoulder. Tried 3 ibuprophin twice daily in Sept/Oct 2001.  10/29/01: Dr. referred me to physical therapy for right should pain.  11/16/01-12/27/01: went to physical therapy.  The therapist suggested that there might be other problems beyond what therapy could do for me.  1/21/02: x-ray of right shoulder. 2/4/02: Dr.  diagnosed osteoartritis in my right shoulder and gave me my 1st cortisone shot.  11/11/02: Returned to Dr. and received a 2nd cortosone shot.  Shoulder is still painful from the arthitis in the same location as I had received the flu shot. The follow up states the date of the flu immunization is incorrect in the letter and on the authorizations for release of info. It should be 10/8/99, not 10/8/02. I changed the date. I didn't provide the following info when I filed the original report. I was taking a prescription medication for cyclobenzaprine 10mg after seeing physician's assistant. This was also for the right shoulder (muscle strain). I received physical therapy from 11/16/01-12/27/01. I didn't give you the name of the provider in the original report. I'm mailing the authorizations for release of info today. Degenerate AC joint change.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis
Clinical narrative: Cellulitis to the left arm.  IV antibiotics given for 48 hours.  Patient recovered with no problems.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Inflammation, Vasodilation procedure
Clinical narrative: From info. received via fax at a manufacturer on 9/23/02, it was reported that a 4 y.o. female PT was vaccinated with Tripedia, IPOL, MMR and Varicella on 9/17/02. Tripedia's lot # is U0582DA, was given IM in the right thigh as dose #5. IPOL's lot # is U1275, was given IM in the left thigh as dose #4. MMR's lot # is 0235M, was given SC in the right thigh as dose #2. Varicella's lot # is 0547M, was given SC in the left thigh as dose #1. On 9/18/02, the PT's right thigh was red, swollen and hot to touch. Redness was measured to be 11 x 19.5 cm. PT was given Benadryl in doctor's office for reaction, and given a prescription of Atarax & Orapred to take for 5 days. PT was seen in MD's office and recovered. The case is closed.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: It was reported that a pt rec'd a 4th dose of Tripedia, lot #U054803, on 9/6/02 at 4pm. The pt's father called the reporter on 9/7/02 to tell them that the pt's thigh had a 4 X 3" red area at vaccination site LL. No further information is provided. Reportedly the pt recovered.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction, Vasodilation procedure
Clinical narrative: From info. received via mail at a manufacturer on 9/19/02, it was reported that a 5 y.o. female PT was vaccinated on 8/21/02 at 2 p.m. with Tripedia, IPOL, and MMR. Tripedia's lot # is U0544BA, was given IM in the left leg as dose #5. IPOL's lot # is U1428, was given IM in the right upper leg as dose #4. MMR's lot # is 0180M, was given IM in the right leg as dose #2. PT started to have reaction of redness and warm to the touch on left leg about 8cm size on 8/22/02, at the Tripedia site. PT was given a 10 day course Keflex for the reaction versus cellulitis. Symptoms resolved and PT recovered. Case is closed.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: It was reported that apt was given a 5th dose of Tripedia, lot #U05448A, IM in th LL. 4th dose of IOPL was given lot #U0907 IM in RL. the pt also rec'd a 2nd dose of MMR lot #0128M IM in the RL. All vaccinations were given on 8/14/02 at 6pm. 41 hrs after injection, the pt developed a 6 X 4cm, area of erythema over the L thigh at the site of the Tripedia injection. It was reported that the pt has recovered.
Age: 1.6
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: It was reported that a pt was vaccinated with Tripedia lot #U0549BA, on 9/17/02. Pt developed fever and swelling post vaccination and was prescribed orapred 10mg BID for 3 to 5 days. Pt recovered.
Age: 1.6
Sex: F
Vaccine: DTAP
Symptoms: Pain, Vasodilation procedure
Clinical narrative: From faxed correspondence received at Aventis Pasteur, Inc. on 9/26/02, it was reported that a 1.5 y.o. female child was vaccinated with Tripedia, lot #U0549BA on 9/17/02. PT developed a swollen, red and painful area and received cold compresses and Tylenol for pain. It was reported that the PT recovered. The case is closed. See case #U200200967, U200200968, and U200200969 w/same reporter.
Age: 1.6
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Oedema, Vasodilation procedure
Clinical narrative: From info. received via fax at a manufacturer on 11/18/02, it was reported that a 1.5 y.o. male child was vaccinated w/Tripedia (lot #&a698AA/A0547AA, given IM in the right thigh as dose #4) and Varivax (lot #0422M, given SC in the left thigh as dose #1) on 11/11/02. On 11/12/02, PT's right thigh was red, swollen and warm to touch. It is unknown whether the PT recovered.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Aortic valve stenosis, Bradycardia, Hypotension, Respiratory distress, Respiratory failure
Clinical narrative: Pt developed severe respiratory distress that led to respiratory failure. Subsequently, despite mechanical ventilation, develped hypotension, bradycardia.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Electrocardiogram abnormal, Pneumonia
Clinical narrative: Shortness of breath; 7 days in hospital; 2 days in intensive care.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Chest pain, Influenza like illness
Clinical narrative: Flu-like symptoms X 2-3 days No headache. Pt has had 6 severe episodes of chest pain from 7/99 - 5/02. Both problems continue to the present.
Sex: M
Vaccine: ANTH
Symptoms: Hypersensitivity
Clinical narrative: Pt had large local reaction approximately 2-3 days after receiving Anthrax #2 (120mm X 140mm) Tx with allegra 60mg and changed to Prednisone taper (6mg for 2 days 50mg X 2 days, with resolution of symptoms. Rec'd Anthrax #3 SQ 2/1/03 w/o any  reaction.
Age: 43.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Cyst, Fatigue, Headache, Myalgia
Clinical narrative: Pt reported after 2nd Anthrax vaccine she reported significant side effects. The day of the vaccine pt experienced fever, arthralgia, nausea, headache, generalized muscle aches and increased nasal congestion. These symptoms worsened over the next 2-3 days. pt developed abrupt onset of L side paresthesia on day 2 involving her scalp/face and shoulder. This paresthesia was present continuously X 24 hrs then occurred intermittently with lessening frequency thereafter. Pt also developed a circular blur defect in her L visual field which interfered  with her ability to focus within either near or far visual fields.This visual impairment has impacted her civilian job responsibilities and is creating eye strain and fatigue. The eye doctor diagnosed macular cyst not of genetic origin, with recommendation of no further Anthrax vaccines. finally resolving on 12/25/01
Age: 43.0
Sex: F
Vaccine: ANTH
Symptoms: Nasal congestion, Nausea, Paraesthesia, Pyrexia, Vision blurred
Clinical narrative: Pt reported after 2nd Anthrax vaccine she reported significant side effects. The day of the vaccine pt experienced fever, arthralgia, nausea, headache, generalized muscle aches and increased nasal congestion. These symptoms worsened over the next 2-3 days. pt developed abrupt onset of L side paresthesia on day 2 involving her scalp/face and shoulder. This paresthesia was present continuously X 24 hrs then occurred intermittently with lessening frequency thereafter. Pt also developed a circular blur defect in her L visual field which interfered  with her ability to focus within either near or far visual fields.This visual impairment has impacted her civilian job responsibilities and is creating eye strain and fatigue. The eye doctor diagnosed macular cyst not of genetic origin, with recommendation of no further Anthrax vaccines. finally resolving on 12/25/01
Age: 2.2
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: It was reported that a child had a rash, redness, swelling in L leg that was quite significant. He did not state what treatment was administered.
Age: 11.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Cellulitis, Contusion, Injection site pain, Joint range of motion decreased, Skin striae
Clinical narrative: Right arm very tender to the touch from shoulder to finger tips. 01/24/2003 Pt has strai radial apparent and loss of ROM or strength. No redness or induration at injection site. Small 1cm bruise.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Erythema, swollen area around injection site- seen in ER. 01/16/2003 and treated with Augmentin- heat at area.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Left shoulder swollen, red, very tender 3in x 2in. Started last night after DTAP.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Rash macular
Clinical narrative: Rash over neck area which mother insists appeared right after the immunizations. Has macular appearance.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion, Rash
Clinical narrative: Vaccine 01/21/2003. Febrile seizure 01/29/2003. Measles like rash on torso.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Cellulitis, Erythema, Injection site induration, Oedema
Clinical narrative: Red, hard, swollen area- Dx with cellulitis.
Age: 23.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Dyspnoea, Headache, Pain, Pyrexia
Clinical narrative: Fever, shortness of breath, body aches, weakness, headaches.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Apnoea, Convulsion, Pyrexia, Skin discolouration
Clinical narrative: Had DTaP shot about 10am. Had seizure at 6:30pm called paramedics. Has another seizure 11:30pm, stopped breathing turned blue had to do CPR fever 103.9 at hospital. Had Tylenol every 4 hours since 10am.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Anorexia, Face oedema
Clinical narrative: Right side of gum and lip all swelled up. Didn't want to drink or eat anything. Was acting up a little bit.
Sex: F
Vaccine: TYP
Symptoms: Head discomfort, Injection site pain
Clinical narrative: Right shoulder sore, pain, radiated up to neck unable to turn head to do normal activities.
Age: 43.0
Sex: M
Vaccine: SMALL
Symptoms: Arthralgia, Diarrhoea, Nausea, Pyrexia
Clinical narrative: FEVER, NAUSEA, DIARRHEA, JOINT ACHES.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Dysphonia, Fatigue, Hallucination, Pain, Wheezing
Clinical narrative: Approximately 12 hours after vaccine was administered: body aches, hallucinations, hoarseness, slight wheezing lasting for about 2 hours, followed by exhaustion.  Aspirin
Age: 0.8
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Erythema, Irritability, Lethargy, Oedema, Pyrexia
Clinical narrative: Pt. received Comvax in right leg and DTaP and IPV in left leg on 02/04/2003.  On 02/06/2003 the pt's mother came in with a note from a MD. The note stated that the pt. had a temp of 100.4, erythema and swelling on right leg about 2.5 cm in diameter and was lethargic and irritable.
Age: 24.0
Sex: M
Vaccine: ANTH, YF
Symptoms: Rash
Clinical narrative: Anthrax, yellow fever and Typhoid immunization on 1/17/03. PT presents today with rash on trunk.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Headache, Pain, Rash
Clinical narrative: Headaches, neck pain, chills, rash on upper body, L under arm pain
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Face oedema, Urticaria
Clinical narrative: It was reported that a 5 1/2 year-old male vaccinated with DTaP and MMR on 9/12/02. Within 30-45 minutes after vaccination, patient developed generalized urticaria and swelling of the periorbital area and lips. Patient treated with Benadryl, Epinephrine, and Decadron. Patient's oxygen saturation was 98%. Patient recovered. Follow up on 01/21/04: "It was reported that: 'reviewed, no additional information at this time.' Case is closed."
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site hypersensitivity, Pyrexia
Clinical narrative: It was reported that a 5-year-old male received his fifth dose of DTAP on 1/8/02 administered in the left anterior thigh. The next day, his thigh was red, swollen and hot to the touch in a 17x18cm area. The patient had a 104F fever which came down to 103F after medicated with Motrin. He was seen by a physician on 1/9/02 and 1/10/02.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site oedema
Clinical narrative: It was reported by the patient's parents that DTAP(lot# U0537AB) was administered about one year ago to their 4-year-old daughter. Immediately after vaccination, the patient developed a large red and swollen area at the injection site. The patient was seen and treated in the emergency room. the events were fully resolved.
Age: 1.5
Sex: U
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: It was reported that an infant rec'd a vaccine of TriHIBit (Tripedia (lot #U0542E) and ActHIB (lot # UA687AA) on 8/26/2002. the pt was seen in the Dr's office on 8/27/02 at which time exhibited a 6 X7cm area, which was red and swollen with slight induration at the injection site.
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: It was reported that 4 children who rec'd a dose of Tripedia vaccine (lot U0583AA) All 4 pt's experienced local reactions of redness and swelling. No additional information was provided. see cases U2002-00803 to U202-00805, same reporter.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Syncope
Clinical narrative: It was reported that a pt was vaccinated with Tripedia on 9/5/02. On 9/6/02, the pt was presented to the Dr's office with a fever of 99.4F, which later went to 101.0F. The pt complained of feeling faint so the doctor sent him to the ER and was discharged when they could not find anything wrong with him. The administering nurse discovered that the vaccine was expired by 12 days when given (expiration date 24/Aug/2002).
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: It was reported that a child had been vaccinated with Tripedia on 8/23/02. The site was warm to the touch following administration of the vaccine. On /26/02, the pt's mother ret'd to the Dr's office with the pt, who was exhibiting a red, swollen area on her L arm, approx 3-4 inches in diameter. It was not reported whether the pt recovered.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site haemorrhage, Injection site induration
Clinical narrative: From telephone correspondence rec'd on 9/13/02, it was reported that a child was vaccinated with Tripedia, Lot # U0549SA, in the L deltoid on 9/4/02. On 9/6/02 the child was evaluated and treated by the physician with motrin, benadryl, and compresses for a local reaction of ecchymosis and an area of induration measuring 10X10cm. Follow-up visit was 9/16/02. It was not reported whether the pt recovered.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: From telephone correspondence rec'd on 9/17/02, it was reported that a pt (L.B.) rec'd her 4th dose of Tripedia on 9/12/2002 in the thigh. On 9/14/02, the child's mother brought her to the doctor's office with a swollen and red thigh (area measured 14X13cm). Ice and warm soaks were recommended, as well as children's tylenol. A date of birth was not reported for this child and the initial source document notes 2 different ages (4 yrs and 10 mo). No additional info was provided and it was not reported whether the child recovered.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Eye oedema, Injection site swelling
Clinical narrative: A report rec'd on 8/30/02, reported: medical technician called to report AE of child. The pt rec'd her 5th and final dose of Infanrix (Tripedia) the day before at approx 3pm. Beginning today at approx 1pm EST, she began to experience swelling a the injection site and swelling of her L eye. Parent's took her back to Dr's office, where she was given a shot of epinephrine. Pt has never had any previous reactions with vaccine, and she is not taking any medicines. Medical info has no letters concerning eye swelling.
Age: 1.4
Sex: M
Vaccine: DTAP
Symptoms: Pharyngitis, Pyrexia, Rhinitis
Clinical narrative: From telephone correspondence rec'd on 10/4/02, it was reported that a child rec'd a dose of Tripedia on 10/3/02. Later that evening the pt had a 101F temperature and symptoms of a cold were present. The pt's mother brought the child to the Dr's office on 10/4/02. The pt's temperature was then 103.5F and the Dr referred the pt to the hospital for assessment. It was not reported whether the child was admitted to the hospital or whether the pt recovered.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been rec'd from a Dr's office. It was reported that 4 children who received a dose of Tripedia vaccine (Lot #U0583AA). All 4 of the pt's experienced local reactions of redness and swelling. No additional info was provided. A phone call was made to the reporter on 9/12/02, to obtain additional info on pt's. Reporter stated that she does not have any specific information to identify each pt at this time. she agreed to inform the manufacturer when the info becomes available. See cases U2002-0067, U2002-0084, U2002-00805, same reporter.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Info has been rec'd from Dr's office. It was reported that 4 children who received a dose of Tripedia vaccine (lot # U0583AA) All 4 of the pt's experienced local reactions of redness and swelling. No additional info was provided. A phone call was made to the reporter on 9/12/02, to obtain additional info on pt's. Reporter stated that she does not have any specific information to identify each pt at this time. She agreed to inform the Mfr when the info becomes available. See cases U2002-00697, U2002-00803, and U2002-00805, same reporter.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a pediatrician's office. It was reported that four children who received a dose of Tripedia vaccine (U0583AA). All four of the pts experienced local reactions of redness and swelling. No additional info was provided. A telephone call was made to the reporter on 9/12/02, to obtain additional info on pts. Reporter stated that she does not have any specific info to identify each pt at this time. She agreed to inform manufacture when the info becomes available. See cases U2002-00697, U2002-00803, and U2002-00804, same reporter.
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: It was reported that a pt experienced a red, swollen arm around the injection site after receiving a Tripedia vaccination. The vaccine was identified as Infanrix however the lot number provided is that for Tripedia. it was reported this AE and was not provided with complete details. Reportedly, the Dr is using a smaller gauge needle (smaller than 5/8 needle). No further information was reported. It was not reported whether the pt recovered.
Age: 0.2
Sex: U
Vaccine: DTAP
Symptoms: Lethargy, Movement disorder
Clinical narrative: It was reported that on 10/21/02 a pt was administered with Tripedia Lot # U0583BA, expiration date 9/8/02 on 10/16/02, Once the vaccine was administered the baby lost his ability to move and became lethargic for about a minute or two. Oxygen was administered through a facemask. The infant reportedly recovered.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site inflammation, Rash
Clinical narrative: From initial correspondence received at a manufacturer on 11/21/02, it was reported that a 3 y.o. child received 0.5 ml dosage of Tripedia lot #U0581AA, in the right leg on 8/14/02. Nurse thinks the dose # in series is #5. PT experienced large areas of erythema and a warm, swollen patch around the inject site (2x3 inches). Onset date is unknown. The site of the erythema was not reported. The PT recovered.
Age: 38.0
Sex: M
Vaccine: SMALL
Symptoms: Conjunctivitis, Erythema, Eye irritation, Eye oedema, Nasal congestion
Clinical narrative: Developed red, irritated left eye 6 d post-vaccination.  Associated SS include viral prodrome of pharyngitis, nasal congestion. No fever, constitutional systems.  Excellent site care (reviewed) and no sick contacts.  PMHx of HTN, Hyperlipidemia, GERD, no eye surgerys, medications. Seen in ED yesterday evening and dx'ed (ID consulted) with conjunctivitis.  This morning developed redness around eye, some swelling. No photophobia, H/A, purulent d/c, but copious clear d/c.  PE shows him to be afebrile, no LN, looks well, conjunctival erythema w/ clear mucoid d/c.  PERRLA, normal fundus, no corneal lesions.  Exam by Ophthalmologist pending. Cultures taken.  Patient placed on medical restrictions. Take check for 1/7 pending.
Age: 38.0
Sex: M
Vaccine: SMALL
Symptoms: Pharyngitis
Clinical narrative: Developed red, irritated left eye 6 d post-vaccination.  Associated SS include viral prodrome of pharyngitis, nasal congestion. No fever, constitutional systems.  Excellent site care (reviewed) and no sick contacts.  PMHx of HTN, Hyperlipidemia, GERD, no eye surgerys, medications. Seen in ED yesterday evening and dx'ed (ID consulted) with conjunctivitis.  This morning developed redness around eye, some swelling. No photophobia, H/A, purulent d/c, but copious clear d/c.  PE shows him to be afebrile, no LN, looks well, conjunctival erythema w/ clear mucoid d/c.  PERRLA, normal fundus, no corneal lesions.  Exam by Ophthalmologist pending. Cultures taken.  Patient placed on medical restrictions. Take check for 1/7 pending.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Cow pox, Pruritus, Rash, Skin ulcer
Clinical narrative: Patient presented to the clinic with a generalized vaccinia rash.  He is currently day 19 from vaccination.  The lesions are the classic vesicular type with a central divit (ulceration and eschar formation).  Each lesion is pruritic.  He also has three satellite lesions.  No treatment given at this time, other that supportive care.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Chest pain, Headache, Lymphadenopathy, Myocarditis
Clinical narrative: 25 JAN 03 patient  RECEIVED A DIRECTED SMALLPOX IMMUNIZATION.  ON 2 FEB 03 HE EXPERIENCED SWOLLEN GLANDS IN HIS NECK AND SEVERE HEADACHE.  ON 5 fEB 03 AT 5:30 A.M. patient TRANSPORTED HIMSELF TO THE EMERGENCY ROOM  WITH A COMPLAINT OF CHEST PAIN.  HOSPITALIZATION THRU 7 FEB 03 FOLLOWED.  INDIVIDUAL WAS Dx WITH PRESUMPTIVE VACCINIA MYOCARDITIS.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Chest pain, Influenza like illness, Myocarditis
Clinical narrative: 25 JAN 03 patient  RECEIVED A DIRECTED SMALLPOX IMMUNIZATION.  ON 2 FEB 03 HE EXPERIENCED SWOLLEN GLANDS IN HIS NECK AND SEVERE HEADACHE.  ON 5 fEB 03 AT 5:30 A.M. patient TRANSPORTED HIMSELF TO THE EMERGENCY ROOM  WITH A COMPLAINT OF CHEST PAIN.  HOSPITALIZATION THRU 7 FEB 03 FOLLOWED.  INDIVIDUAL WAS Dx WITH PRESUMPTIVE VACCINIA MYOCARDITIS.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Chest pain, Influenza like illness
Clinical narrative: 25 JAN 03 patient  RECEIVED A DIRECTED SMALLPOX IMMUNIZATION.  ON 2 FEB 03 HE EXPERIENCED SWOLLEN GLANDS IN HIS NECK AND SEVERE HEADACHE.  ON 5 fEB 03 AT 5:30 A.M. patient TRANSPORTED HIMSELF TO THE EMERGENCY ROOM  WITH A COMPLAINT OF CHEST PAIN.  HOSPITALIZATION THRU 7 FEB 03 FOLLOWED.  INDIVIDUAL WAS Dx WITH PRESUMPTIVE VACCINIA MYOCARDITIS.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Rash
Clinical narrative: Red patches or bumps on the skin all over body.  Contacted pt on 6Feb03, pt states seeing Derm for problem and has more bumps, but not as red.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Received third dose of Hepatitis B vaccine 1/21/03 given in rt. deltoid.  No reactions to previous doses. Returned to clinic next day with pain and erythema at injection site.  Returned following day with worsening symptoms - 5cm circular induration.  No evidence of cellulitis. Evaluated by MD in clinic.  Returned following day with improvement in symptoms, which appear to be resolving.
Age: 34.0
Sex: M
Vaccine: ANTH, FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: SORENESS AND REDNESS (APPROX 5 IN DIAMETER AROUND INJECTION SITE) CONTINUING AFTER 3 1/2 DAYS SINCE ADMINISTRATION.
Age: 18.0
Sex: M
Vaccine: HEP, IPV, MMR, TD, HEP, IPV, MMR, TD
Symptoms: Blood pressure decreased, Dizziness, Dry skin, Hyperhidrosis, Pallor
Clinical narrative: Approximately 3 mins. post vaccination, PHN heard thud outside door of IMM. PT found hives on left side. Alert and oriented x3 but complained of dizziness. Recovered w/in 10 mins and discharged home w/parents in stable condition, previously vaccinated with same vaccines on 12/18/02 with same response recorded. Follow up states: Have not received forms back from reviewing mediacl authority.
Age: 18.0
Sex: M
Vaccine: HEP, IPV, MMR, TD, HEP, IPV, MMR, TD
Symptoms: Skin warm
Clinical narrative: Approximately 3 mins. post vaccination, PHN heard thud outside door of IMM. PT found hives on left side. Alert and oriented x3 but complained of dizziness. Recovered w/in 10 mins and discharged home w/parents in stable condition, previously vaccinated with same vaccines on 12/18/02 with same response recorded. Follow up states: Have not received forms back from reviewing mediacl authority.
Age: 18.0
Sex: M
Vaccine: HEP, IPV, MMR, TD, HEP, IPV, MMR, TD
Symptoms: Dizziness, Urticaria
Clinical narrative: Approximately 3 mins. post vaccination, PHN heard thud outside door of IMM. PT found hives on left side. Alert and oriented x3 but complained of dizziness. Recovered w/in 10 mins and discharged home w/parents in stable condition, previously vaccinated with same vaccines on 12/18/02 with same response recorded. Follow up states: Have not received forms back from reviewing mediacl authority.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Diarrhoea, Fatigue, Lymphadenopathy, Nausea, Pain
Clinical narrative: Intense pain under left arm (in armpit).  Lymph node swollen and continuously painful from day 3 through present.  (Pain is a 5-6 on a 1-10 scale where 10 is immobilizing and 1 is hardly noticeable.)  Motrin (800 mg) eliminates pain for a few hours.   Patient feeling continually exhausted since a couple of days after administration of vaccine.   Patient experiencing short, sporadic bouts of nausea (NO vomitting--nausea typically in evening/night) beginning 5 days after vaccination and lasting up to 10 minutes each time.  Also experienced diarrhea one time in conjuntion with nausea.
Age: 45.0
Sex: M
Vaccine: SMALL
Symptoms: Rash erythematous
Clinical narrative: Erythmatous rash on upper trunk on day 10
Age: 39.0
Sex: M
Vaccine: SMALL
Symptoms: Back pain, Influenza like illness, Renal pain
Clinical narrative: FLU LIKE SX, LOWER BACK PAIN AND KIDNEY PAIN
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Anorexia, Cardiac failure, Chills, Lethargy
Clinical narrative: Pt received influenza vaccine on Tuesday and complained of chills and lethargy the following afternoon. Family was instructed to take him to a doctor as he had a terminal illness, but pt refused to go as he feared he would be placed in a nursing home. Nurse contacted family today and again encouraged he go to hospital as he was not eating, bed-bound and less responsive. He died when he got to hospital 1/17/03. Death certificate received on 3/5/2003 indicates CHF as the cause of death.
Sex: F
Vaccine: MU
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning an adult female pt who was vaccinated with a dose of mumps virus vaccine live. The reporter indicated that a doctor told her that the pt died after being vaccinated. The cause of death was not reported. Unspecified medical attention was sought. Additional info has been requested.
Age: 1.25
Sex: M
Vaccine: PNC
Symptoms: Condition aggravated, Strabismus
Clinical narrative: A company representative reported that a 20 month old male received a 4th dose of Prevnar vaccine in August 2002, at the age of 15 months. Medical history included "developmentally slow" and surgery for 6th nerve paralysis in March 2002, which occurred 2 days after he received his 3rd dose of Prevnar (see related report IDHQWYE029327JAN03). On 12/18/02, he received diphtheria and tetanus toxoids and acellular pertussis vaccine (manuf unk), polio vaccine and haemophilus B conjugate vaccine (manuf unk). In January 2003, at the age of 20 months, he experienced a 2nd episode of 6th nerve paralysis in the optic nerve. It was reported that "the pt's eyes are crossed again." No further info was available at the date of this report. Additional info received by telephone message on 1/30/03, from the company representative, revealed a vaccine that began with a "P," possibly Prevnar. The physician did not think the paralysis was vaccine-related, but perhaps due to a "virus." It was felt that the Prevnar had "nothing to do with the child's 6th nerve paralysis." The physician, his staff, and the mother of the child "do not wish to pursue this speculation, nor be called on or contacted."
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Hives began night/morning after injection, appearing all over body.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills, Hyperhidrosis
Clinical narrative: Extremely sore joints, chills/sweats
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Muscle twitching, Pyrexia
Clinical narrative: Shot given on 1/29/03. By the evening, she started having rhythmic uncontrollable jerking of the left arm. 5-8 jerks per episode. No loss of consciousness. No other symptoms other than mild fever on 1/30/03.
Age: 32.9
Sex: M
Vaccine: ANTH
Symptoms: Chills, Pyrexia
Clinical narrative: Fever of 103.4 deg F, uncontrollable shivers
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Autism, Gastrointestinal disorder, Muscle twitching
Clinical narrative: A nurse reported the occurrence of autistic symptoms in a 6 month old male who was vaccinated with Infanrix for prophylaxis. The subject had no relevant medical history. On an unspecified date in June 2001, the subject received his first injection of Infanrix (505A2). He received another injection of Infanrix (505A2) on an unspecified date in September 2001. In June 2001, he also received injections of haemophilus influenzae type B conjugate vaccine (manuf unk), IPOL, and Prevnar. Later in June 2001, an unspecified time post-immunization, he began "experiencing autistic symptoms such as twitching and digestive problems." These symptoms "have been displaying on and off." The events persisted as of 1/28/03. The autistic symptoms in this report are considered medically serious (OMIC).
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Autism, Dyspepsia, Muscle twitching
Clinical narrative: A nurse reported the occurrence of autistic symptoms in a 6 month old male who was vaccinated with Infanrix for prophylaxis. The subject had no relevant medical history. On an unspecified date in June 2001, the subject received his first injection of Infanrix (505A2). He received another injection of Infanrix (505A2) on an unspecified date in September 2001. In June 2001, he also received injections of haemophilus influenzae type B conjugate vaccine (manuf unk), IPOL, and Prevnar. Later in June 2001, an unspecified time post-immunization, he began "experiencing autistic symptoms such as twitching and digestive problems." These symptoms "have been displaying on and off." The events persisted as of 1/28/03. The autistic symptoms in this report are considered medically serious (OMIC).
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Arthropathy, Asthenia, Bacterial infection, Cerebral ischaemia
Clinical narrative: Complained of left arm pain after flu shot; was admitted to hospital due to questionable stroke. Received cardiac/pacemaker work-up (negative). Then saw doctor in pain clinic and was referred to neurologist. Rx for PT, Trileptol and Darvocet. Still having pain. Thinks shot was given too high. The 60 day follow up residual weakness, numbness with occasional flare-ups of pain related to certain positions. Pt feels that flu shot was given "too high" in her deltoid muscle. Neurology report shows encapsulitis.  Follow up 9/10/04: Pt doing so well, just had battery replaced on pacemaker. No longer a volunteer at this hospital. Discharge summary states TIA, facial paralysis, urinary tract infection, degenerative joint disease, abdomenial pain. msv
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Cerebrovascular accident, Facial palsy, Hypoaesthesia, Injection site pain, Laboratory test abnormal
Clinical narrative: Complained of left arm pain after flu shot; was admitted to hospital due to questionable stroke. Received cardiac/pacemaker work-up (negative). Then saw doctor in pain clinic and was referred to neurologist. Rx for PT, Trileptol and Darvocet. Still having pain. Thinks shot was given too high. The 60 day follow up residual weakness, numbness with occasional flare-ups of pain related to certain positions. Pt feels that flu shot was given "too high" in her deltoid muscle. Neurology report shows encapsulitis.  Follow up 9/10/04: Pt doing so well, just had battery replaced on pacemaker. No longer a volunteer at this hospital. Discharge summary states TIA, facial paralysis, urinary tract infection, degenerative joint disease, abdomenial pain. msv
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Urinary tract infection
Clinical narrative: Complained of left arm pain after flu shot; was admitted to hospital due to questionable stroke. Received cardiac/pacemaker work-up (negative). Then saw doctor in pain clinic and was referred to neurologist. Rx for PT, Trileptol and Darvocet. Still having pain. Thinks shot was given too high. The 60 day follow up residual weakness, numbness with occasional flare-ups of pain related to certain positions. Pt feels that flu shot was given "too high" in her deltoid muscle. Neurology report shows encapsulitis.  Follow up 9/10/04: Pt doing so well, just had battery replaced on pacemaker. No longer a volunteer at this hospital. Discharge summary states TIA, facial paralysis, urinary tract infection, degenerative joint disease, abdomenial pain. msv
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Impaired work ability, Migraine, Myalgia, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Myalgias/arthralgias - resolved. Migraine headache - unresolved at this time. On 60-day follow up report received 04/24/2003, reporter states, "Was improving but after returning to strenous heavy labor job, migraines have returned and is needing to be off work frequently. Needs to change jobs in order to remain employed. May need to be medically separated from service." Annual follow up on 03/05/04: "It is unknown if pt recovered.  Still had 2-3 migraines a month and takes amerge for headache abortment.  Member seen this as an improvement. Continues on Pamelor 150mg every day for headache prevention. Remains in with the same job. Follow-up: Persistent migraines headaches after AVA. Symptom: Headache, Migraine Comment: Severe, persistent, new-onset. Migraines have persisted and pt is now being separated from the Military due to non-deployability status.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Abasia, Cough, Diarrhoea, Dizziness, Dysarthria
Clinical narrative: Patient was first seen on 1/14/03 while hospitalized in the ICU. He was unable to communicate verbally and therefore the following history was obtained from his spouse, mother and his medical records. Patient was healthy with no medical problems and taking no medication prior to 12/3/02. He has received 3 anthrax vaccinations in November and December 2002. The following is an account of their sequellae. Patient went to the emergency room on 1/4/03. His records indicate he was amb with assist secondary to unsteady gait.....and verbalized complaints of dizzy, blurred vision, cough, nausea, vomiting and diarrhea 4x/day....which started 1 week ago. Vital signs were 101.4--101--20--132/30. He received IV fluids, lab work, a CXR and was discharged from the ER with the diagnosis of atypical pneumonia and gastroenteritis. Medications included azithromycin and ibuprofen with directions to follow up on 1/6/03. Records from the remaining outpatient visit(s) and admission are not available. Patient was transferred on 1/10/03 and admitted to the ICU. Diagnosis included Probable viral vs. immune mediated encephalitis. On 1/15/03 neurology consultation reports meningoencephalitis most consistent with bickerstaff (brain stem) encephalitis. Findings included oculomotor paresis, dysarthric speech, hiccups , autonomic instability and R>L LE>UE quadriparesis. The remains the current diagnosis. Elevated amylase and lipase suggest pancreatitis with unknown ideology. He has received IVIG and antiviral therapy with little improvement. Currently is relieving IV steroid therapy with minimal improvements. He also is receiving respiratory, occupational and physical therapy. On 60-day follow up report received 04/24/2003, reporter states, "Currently in rehab unit of V.A. hospital. Has debilitating sx remaining, but is now able to talk." 9/9/2003 six months after contracting encephalomyelitis post anthrax vaccine, pt remains in the hospital. Family memebers states he has made light improvement. Cannot move his right extremities, and is not walking. Can speak words but not form sentences. He still has a T-tube in place but is eating some things by mouth and feeding self. Cognitively he appears to be in tact. Annual follow up on 02/24/04: "Pt has not recovered from adverse events.  In hospital, he is speaking clearly, eating well (although gipeg still in place), has full use of left side but right side non-functional in continuous tremor. Cannot walk. Severe myostatic constructual right wrist, right foot. Continuously in tact, memory 100%, depressed. Awaiting transfer to another rehab hospital.