chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Speech disorder
Clinical narrative: Pt diagnosed with PDD NOS (mid form of autism) at 3.5 years. Symptoms noticed at 18 months. Treated with behavioral therapy, vitamins and nautral detox for heavy metals. Symptoms included speech delays, tantrusm, no eye contact, abnormal play, not social. Cumulative effect of various vaccines and possibly mercury build up from vaccines. The following are the pt's immunization record: 02/12/96 hep B; 03/25/96 Tetramune, OPV, Hep B; 05/22/96 DPT/Hib, polio; 07/17/96 DPT/Hib, polio; 02/11/97 Tetramune, Hep b. On 06/02/97, fever of 103 deg since 05/30; told it was viral. 18 month visit temperament tantrums. 2 year visit temperament tantrums. 2 8/12 year visit consult to birth to three program after continuing to complain to doctor that all transitions are difficult, speech delays and speaking "own language," obsessive compulsive behavior, abnormal play and social prob. 02/16/99, 3year continues tantrums. Started speech and OT at school. On 06/28/99, got PDD-NOS diagnosis. 10/99 started behavioral therapy with wise early autism project. 03/16/2000, requested labs RE:Immune deficiency-refused immunizations-told not to return. 01/25/2001, started vitamin therapy and natural detox for 6 months. 02/28/2001, titer done for MMR. 05/16/01, IPV given. 08/2001, completed therapy-dropped speech and OT at school. The annual follow up received on 7/17/03 states, "pt was diagnosed with PDD-NOS, a mild form of autism at age 3. Through therapy (speech, occupational, and behavioral) and natural supplements and delox therapy, I would sy pt is 90-95% recovered. Some behavioral problems remain as well as sound hypersensitivity and some learning disabilities and hyperactivity." A 60-day follow report received 9/9/2002 adds: Pt has a mild form of autism including hearing sensitivity; difficulty with social aspects of life, rigid play, some difficulty with transitions and other sensory issues. Pt has made a lot of progress with therapy-behavioral, speech and occupational therapy. These 2 vaccines were given at the county health dept due to switching insurance and jobs. Actual diagnosis was obtained at the neuropsychiatric clinic. Received therapy for 2 years and speech and occupational therapy through another program and then school.
Age: 1.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Coma, Erythema, Listless, Rash maculo-papular, Vomiting
Clinical narrative: Mom states had projectile vomiting approx 4 hrs after rec vaccines, became somewhat listless, somewhat unresponsive at times. Red splotches on face, neck and abd. Seen in ER. No fever, no resp problems.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Contusion, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Approx 3 hrs after vaccine was given the infant developed a red raised linear warm area across the area of the thigh in site where the Hib vaccine was administered. The area remained red and warm for 2 days and then appeared bruised with no other residual effects.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 4cm round reddened area to left upper thigh. Treated with Keflex antibiotic 250/5 1/2 tsp TID x 10 days.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Myocardial infarction
Clinical narrative: An anonymised single pt print was received on 06/17/2002 concerning a 58 year old male pt, who experienced myocardial infarction 4 hrs after receiving FluVirin on 11/20/2001. At the time of reporting, the pt had recovered. There was insufficient info to determine the reporter's causality assessment.
Age: 19.0
Sex: M
Vaccine: ANTH, FLUX, HEPA, TYP, YF
Symptoms: Syncope
Clinical narrative: Subject BIT010006, a 19 year old male with no known previous medical conditions, received the 2nd dose of Anthrax vaccine (Lot FAV044) on 01/11/2000. Other vaccines given on this date included, yellow fever, typhoid, influenza, and hep A. The pt was taking no concomitant medications at the time of the event. No previous reactions to the Anthrax vaccine are known. In March 2000, the pt experienced the first of seven episodes which lasted less than one minute and occurred over an eleven month period. The first episode began with heat exhaustion during a road march in late February or early March 2000. The second episode occurred in April 2000 during a 12-mile road march. The last syncopal episode occurred in June 2001. The pt had evaluations by cardiology, pulmonary, endocrine, and psychology specialists and no etiology has been identified. Treatment for this event and the outcome are unknown at this time.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Headache
Clinical narrative: Subject BIT010018, a 27 year old male with a medical history of headaches, received the 3rd dose of Anthrax vaccine (lot FAV048B) on 06/29/2000. On 07/25/2000, the pt received a tetanus/dipheria vaccine (lot 0994610). The pt was not taking any concomitant medications at the time of the event and did not have any illness at the time of the vaccination. Reactions to previous vaccinations are unknown. In September 2000, the pt began to experience dull, non-pounding, frontal headaches which continued from one to four days and occurred approximately on a weekly basis. Aspirin, Tylenol, no Ibuprofen provided relief. The headaches were more severe than the ones the pt previously experienced, but they did not result in any loss of work time. The outcome of this event is unknown.
Age: 22.0
Sex: F
Vaccine: ANTH, RAB
Symptoms: Acne, Anxiety, Condition aggravated, Erythroleukaemia, Hot flush
Clinical narrative: Subject BIT010019, a 22 year old female with a medical history of hyperthyroidism, received the 1st dose of Anthrax vaccine (lot FAV038) on 06/17/1999. The pt also received the 1st dose of Rabies vaccine (lot PO989) on the same date. The pt's previous reactions to vaccines are unknown. The pt was taking no concomitant medications at the time of the event. On an unknown date in June 1999 after receiving the immunizations, the pt experienced worsening symptoms of hyperthyroidism that included sweating, increased weight loss, acne, diarrhea, hyperreflexes, and increased hot flashes. In the summer of 2000, the pt also experienced insomnia, vision changes, anxiety, and hand tremors. The outcome of these events is unknown at this time.
Age: 22.0
Sex: F
Vaccine: ANTH, RAB
Symptoms: Hyperhidrosis, Hyperreflexia, Insomnia, Tremor, Visual disturbance
Clinical narrative: Subject BIT010019, a 22 year old female with a medical history of hyperthyroidism, received the 1st dose of Anthrax vaccine (lot FAV038) on 06/17/1999. The pt also received the 1st dose of Rabies vaccine (lot PO989) on the same date. The pt's previous reactions to vaccines are unknown. The pt was taking no concomitant medications at the time of the event. On an unknown date in June 1999 after receiving the immunizations, the pt experienced worsening symptoms of hyperthyroidism that included sweating, increased weight loss, acne, diarrhea, hyperreflexes, and increased hot flashes. In the summer of 2000, the pt also experienced insomnia, vision changes, anxiety, and hand tremors. The outcome of these events is unknown at this time.
Age: 22.0
Sex: F
Vaccine: ANTH, RAB
Symptoms: Weight decreased
Clinical narrative: Subject BIT010019, a 22 year old female with a medical history of hyperthyroidism, received the 1st dose of Anthrax vaccine (lot FAV038) on 06/17/1999. The pt also received the 1st dose of Rabies vaccine (lot PO989) on the same date. The pt's previous reactions to vaccines are unknown. The pt was taking no concomitant medications at the time of the event. On an unknown date in June 1999 after receiving the immunizations, the pt experienced worsening symptoms of hyperthyroidism that included sweating, increased weight loss, acne, diarrhea, hyperreflexes, and increased hot flashes. In the summer of 2000, the pt also experienced insomnia, vision changes, anxiety, and hand tremors. The outcome of these events is unknown at this time.
Age: 58.0
Sex: F
Vaccine: ANTH
Symptoms: Dizziness, Headache, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Subject BIT010024, a 58 year old female with a medical history of allergy to sulfa drugs, received the 5th dose of Anthrax vaccine (lot FAV048B) on 02/08/2001. No other vaccines were given on this date. Concomitant medications at the time of the event included Estrogen, Provers, and dailty multiple vitamins. The pt did not have an illness at the time of vaccination and has no history of reactions to previous vaccinations. Two days post vaccination, the pt experienced a red, swollen, hot to touch area on the upper arm, five and one half to six inches in diameter. The redness continued for six days. Dizziness occurred on the third and fourth day post immunization. Ringing in he ears occurred on the third and fourth day, which was the most severe. While the ringing continued as of 02/22/2001, it is improving. The pt also experienced headaches that were treated with Tylenol from 02/11/2001 to 02/17/2001. While mild headaches continued as of 02/22/2001, the pt had discontinued the use of Tylenol to treat them. The pt noted increased sinus secretions associated with the headaches. Additional info received on 03/08/2001 indicated the headaches resolved b 03/02/2001. The outcome of the other events is unknown.
Age: 58.0
Sex: F
Vaccine: ANTH
Symptoms: Tinnitus
Clinical narrative: Subject BIT010024, a 58 year old female with a medical history of allergy to sulfa drugs, received the 5th dose of Anthrax vaccine (lot FAV048B) on 02/08/2001. No other vaccines were given on this date. Concomitant medications at the time of the event included Estrogen, Provers, and dailty multiple vitamins. The pt did not have an illness at the time of vaccination and has no history of reactions to previous vaccinations. Two days post vaccination, the pt experienced a red, swollen, hot to touch area on the upper arm, five and one half to six inches in diameter. The redness continued for six days. Dizziness occurred on the third and fourth day post immunization. Ringing in he ears occurred on the third and fourth day, which was the most severe. While the ringing continued as of 02/22/2001, it is improving. The pt also experienced headaches that were treated with Tylenol from 02/11/2001 to 02/17/2001. While mild headaches continued as of 02/22/2001, the pt had discontinued the use of Tylenol to treat them. The pt noted increased sinus secretions associated with the headaches. Additional info received on 03/08/2001 indicated the headaches resolved b 03/02/2001. The outcome of the other events is unknown.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Oedema peripheral, Pruritus, Rash
Clinical narrative: Subject BIT010035, a 30 year old male with no previous medical conditions, received the 3rd dose of Anthrax vaccine (lot FAV031) on 02/08/2000. No other vaccines were given on this date. Concomitant medications at the time of the event are unknown. The pt did not report any illness at the time of the vaccination, nor did he report any reactions to previous vaccinations. Beginning 05/15/2000, the pt experienced daily swelling of the feet and a recurrent rash, with occasional pruritus, that was localized to the hands and feet. The pt was treated with histamine blockers with relief of symptoms. At the time of this report, the pt's symptoms have not resolved.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Anger, Disturbance in attention, Insomnia
Clinical narrative: A 30 year old male, who denies any previous medical conditions, received the 1st dose of Anthrax vaccine on 27 September 1999. No other vaccines were given on this date. The patient was taking no concomitant medications at the time of the event. The patient denies any illnesses at the time of the vaccination and did not report any reactions to previous vaccinations. The patient stated that sicne the date of the first vaccination, he has been full of rage, anger, and unable to concentrate and sleep. He also has other psychological effects, but denies hospitalization or temperature, redness or pain at the injection site. At the time of this report, the patient had not fully recovered.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Gastrooesophageal reflux disease, Headache, Hernia, Muscular weakness
Clinical narrative: A 25 year old male with no previous medical conditions, received the 2nd dose of anthrax on  04/07/99. In 07/99, the patient began experiencing a weakening of the eye muscle on the left eye. It was harder to focus, his vision worsened and eyeglasses were required. the patient experienced constant head pain in 08/99 while in Egypt, but the severity was sporadic. The patient received the 3rd dose of anthrax vaccine on 12/12/99 and the 4th dose of Anthrax vaccine on 01/16/00. In 02/00, the patient experienced acid reflux that is still ongoing which was treated with Nexium. The patient experienced itchy fluid-filled bumps on the back of his legs behind the knees in 10/00 that lasted  for several weeks and improved with cortisone cream treatment At the same time, the patient experienced generalized itchness and pruitus ani which are still ongoing and being treated with cortisone and antifungal cream which helps. In 08/01, the patient began to experience occasional muscle and joint pain in the legs and shoulder area. The patient was diagnosed with an Ingurial hernia in 09/01 for which he understands surgical repair. At the time of this report, the patient had not fully removed.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus ani, Rash vesicular, Visual acuity reduced
Clinical narrative: A 25 year old male with no previous medical conditions, received the 2nd dose of anthrax on  04/07/99. In 07/99, the patient began experiencing a weakening of the eye muscle on the left eye. It was harder to focus, his vision worsened and eyeglasses were required. the patient experienced constant head pain in 08/99 while in Egypt, but the severity was sporadic. The patient received the 3rd dose of anthrax vaccine on 12/12/99 and the 4th dose of Anthrax vaccine on 01/16/00. In 02/00, the patient experienced acid reflux that is still ongoing which was treated with Nexium. The patient experienced itchy fluid-filled bumps on the back of his legs behind the knees in 10/00 that lasted  for several weeks and improved with cortisone cream treatment At the same time, the patient experienced generalized itchness and pruitus ani which are still ongoing and being treated with cortisone and antifungal cream which helps. In 08/01, the patient began to experience occasional muscle and joint pain in the legs and shoulder area. The patient was diagnosed with an Ingurial hernia in 09/01 for which he understands surgical repair. At the time of this report, the patient had not fully removed.
Age: 56.0
Sex: M
Vaccine: ANTH
Symptoms: Dermatitis, Injection site induration, Pityriasis rosea, Rash erythematous, Rash pruritic
Clinical narrative: A 56 year old male with unknown medical history who denies any allergies, received a 2nd dose of Anthrax vaccine on 18 December 1999. It is unknown if any other vaccines were given on this date. The patient was taking Calan at the time of the event. It is also unknown if the patient had any illness at the time of the vaccination or a history of reactions to previous vaccinations. On an unknown date after the second Anthrax vaccination, the patient developed a poison ivy-like rash over the torso, groin and upper arms that was mildly pruritic. The patient denies any constitutional symptoms. During an examination on 17 January 2000, the rash was described as flat, lichenified with irregulary shaped plaques of approximately 10 mm x 5 mm, An area of induration was noted in the distal right deltoid at the injection site. Additionally, the patient had non tender areas of scabbing with secondary pruritus. The patient applied alcohol to the rash for relief. After examination, the physician suggested using Solarcaine instead of alcohol. On 06 March 2002, the patient was seen by a dermatologist and reported he had a three month history of pruritic patches involving his trunk and extremities. He also reported treated with Gold Bond anti-itch cream which resulted in little improvement. Upon exam, multiple erythematous patches involving the patient's trunk and extremities were described. Some lesions had an annular configuration with a slight raised border, a few vesicles were present on the soles of the patient's feet. A biopsy was taken from a representative lesion on the patient's right arm. The patient was treated wtih Triamcinolone ointment applied once to twice daily to the pruritic patches. On 09 March 2000, the biopsy report returned the diagnosis of pityriasis rosea. On 31 March 2000, at a follow up visit to the dermatologist, the patient stated the rash on his body was clearing somewhat, but occasionally flares on his back. It was recommended that the patient continue using 0.1% Triamcinolone ointment once daily for a few weeks. At the time of this report, the patient's recovery status was unknown.
Age: 56.0
Sex: M
Vaccine: ANTH
Symptoms: Rash vesicular
Clinical narrative: A 56 year old male with unknown medical history who denies any allergies, received a 2nd dose of Anthrax vaccine on 18 December 1999. It is unknown if any other vaccines were given on this date. The patient was taking Calan at the time of the event. It is also unknown if the patient had any illness at the time of the vaccination or a history of reactions to previous vaccinations. On an unknown date after the second Anthrax vaccination, the patient developed a poison ivy-like rash over the torso, groin and upper arms that was mildly pruritic. The patient denies any constitutional symptoms. During an examination on 17 January 2000, the rash was described as flat, lichenified with irregulary shaped plaques of approximately 10 mm x 5 mm, An area of induration was noted in the distal right deltoid at the injection site. Additionally, the patient had non tender areas of scabbing with secondary pruritus. The patient applied alcohol to the rash for relief. After examination, the physician suggested using Solarcaine instead of alcohol. On 06 March 2002, the patient was seen by a dermatologist and reported he had a three month history of pruritic patches involving his trunk and extremities. He also reported treated with Gold Bond anti-itch cream which resulted in little improvement. Upon exam, multiple erythematous patches involving the patient's trunk and extremities were described. Some lesions had an annular configuration with a slight raised border, a few vesicles were present on the soles of the patient's feet. A biopsy was taken from a representative lesion on the patient's right arm. The patient was treated wtih Triamcinolone ointment applied once to twice daily to the pruritic patches. On 09 March 2000, the biopsy report returned the diagnosis of pityriasis rosea. On 31 March 2000, at a follow up visit to the dermatologist, the patient stated the rash on his body was clearing somewhat, but occasionally flares on his back. It was recommended that the patient continue using 0.1% Triamcinolone ointment once daily for a few weeks. At the time of this report, the patient's recovery status was unknown.
Age: 27.0
Sex: F
Vaccine: DT
Symptoms: Injection site erythema, Injection site hypersensitivity, Pruritus
Clinical narrative: Subject BIT010149, a 27 year old female with no previous medical condition, received the 2nd dose of Anthrax vaccine (lot FAV048B) on 10/16/2001. No other vaccinations were given on that date and the pt was taking no concomitant medication. The pt received the 1st dose of Anthrax vaccine (lot FAV048B) on 09/20/2001 with no adverse reaction. At 19:30 on 10/17/2001, the pt noted an erythematous, pruritic area (105mmx 100mm) of the right upper arm which was not painful. The pt took Benadryl 30mg, po at 21:30 on 10/17/2001. At 10:00 on 10/18/2001, the pt was seen by the nurse who applied hydrocortisone cream and ice to the area. On 10/18/2001 at 13:00, the pt was seen by the hospital physician who prescribed Allegra and topical hydrocortisone that the pt took from 10/18/2001. by 17:00 on 10/19/2001, all symptoms had resolved.
Age: 18.0
Sex: F
Vaccine: MMR, TD
Symptoms: Coma, Dyskinesia, Eye movement disorder, Feeling abnormal, Headache
Clinical narrative: Received TD, then MMR #2, within 1-2 mins c/o feeling "funny" became unresponsive, eyes rolled back and fixated, became rigid with head hyper extended, gurgling sounds from throat. BP 120/60, pulse80, continuous respirations. Ammonia inhalant applied under nose; rigidity of limbs and head began subsiding. Then followed random involuntary movement of limbs and pt had to be restrained by nurse to prevent injury; she then began responding. Slowly to name and returned to conscious state. c/o head hurting and eyes stinging. She was ambulatory on leaving with mother who transported her to PMD ofice for further eval of reactions.
Age: 18.0
Sex: F
Vaccine: MMR, TD
Symptoms: Muscle rigidity, Nuchal rigidity, Paraesthesia
Clinical narrative: Received TD, then MMR #2, within 1-2 mins c/o feeling "funny" became unresponsive, eyes rolled back and fixated, became rigid with head hyper extended, gurgling sounds from throat. BP 120/60, pulse80, continuous respirations. Ammonia inhalant applied under nose; rigidity of limbs and head began subsiding. Then followed random involuntary movement of limbs and pt had to be restrained by nurse to prevent injury; she then began responding. Slowly to name and returned to conscious state. c/o head hurting and eyes stinging. She was ambulatory on leaving with mother who transported her to PMD ofice for further eval of reactions.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Injection site oedema, Respiratory distress
Clinical narrative: Lt arm experienced arm edema to tip of hand. Reported some respiratory difficulty. Resolved with Benadryl.
Age: 41.0
Sex: M
Vaccine: RAB
Symptoms: Headache
Clinical narrative: Complained of severe headache.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Left upper arm cellulitus, red, round, hot, tender, swelling on left deltoid 3 1/2 x 4inches. D.O. Keflex 250/5 1 1/2 tsp TID x 10 days. Motrin 100/2 2 1/2 tsp q 6-8 H prn. RTC on AM 06/01/02.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site warmth
Clinical narrative: Left upper arm cellulitus, red, round, hot, tender, swelling on left deltoid 3 1/2 x 4inches. D.O. Keflex 250/5 1 1/2 tsp TID x 10 days. Motrin 100/2 2 1/2 tsp q 6-8 H prn. RTC on AM 06/01/02.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Rash macular
Clinical narrative: DTaP and IPV was administered at left upper arm deltoid area on 05/15/02, presented today with a discrete patchy area of erythema, swelling and heat at affected area approx 8 x 14cm diameter. Recommended cool compresses and Benadryl.
Age: 10.0
Sex: M
Vaccine: TTOX
Symptoms: Nausea, Pallor
Clinical narrative: Immediately after TD given, pt became very pale and nauseated. Assisted to lying position 10:10am BP 88/64, P 76. At 10:13 BP 88/64 P 76. At 10:22 BP 90/58 P 72. 10:32am BP 88/56 P 76 R 24. 10:38 sitting BP 90/64 P 72. 10:43 lying BP 100/74 P 72 R 20 sitting BP 10/84.
Age: 19.0
Sex: F
Vaccine: TD
Symptoms: Injection site oedema
Clinical narrative: TD given at 10:55pm on 05/08/2002. Swelling on left arm at site of injection approximately 4.5cm in size. Pt instructed to use ice on left shoulder for 20 mins three times a day.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest pain, Hypokinesia, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Received varicella vaccine on 06/03/02 local redness, swelling, tenderness at site inj area. Unable to raise arm. Pain axilla, chest hurting day after immunization.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain
Clinical narrative: Received varicella vaccine on 06/03/02 local redness, swelling, tenderness at site inj area. Unable to raise arm. Pain axilla, chest hurting day after immunization.
Age: 21.0
Sex: F
Vaccine: TD
Symptoms: Rash papular, Urticaria
Clinical narrative: Onset papular, urticarial rash approx. 24 hrs after administration of Td booster began on arm booster given in spread to other arm and legs over two day period when seen three days after booster. Urticaria treated wtih Benadryl and steroid cream.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Left upper outer arm 8-10cm longitudinal measurement redness, tenderness.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema
Clinical narrative: Redness 3" x 5" left upper arm.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Red, inflammed area, slightly painful 3x6inch.
Age: 1.5
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Anorexia, Hypokinesia, Laboratory test abnormal, Pyrexia
Clinical narrative: Onset of temp of 103 F for > 24 hours. On 06/05/02 c/o not eating, not drinking, decrease in activity. pt seen in clinic 06/06/02 and 06/07/02. Child treated with Rocephin IM x 2d. CBC showed increased WBC count, and increased granulocytes. Blood culture pending.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 11x14 red, raised, erythematous, painful plaque at injection site.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Abscess
Clinical narrative: Sterile abscess left ant thigh after Convax. I + D done.
Age: 1.4
Sex: M
Vaccine: DTAP, MMR, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left upper leg, red, warm t touch, raised and treated with Tylenol.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site pain, Pruritus
Clinical narrative: 06/05/02, pt was taken to Urgent care, right leg was swollen was given Benadryl and placed ice on area. On 06/06/02, pt in office with moter and sibling had 9 x 10 1/2cm reddened area surrounding a 9x5cm pink/white area c/o itching and tender to touch no fever. 06/10/02 mother states daughter OK.
Age: 5.25
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Convulsion, Dyskinesia, Eye movement disorder, Fall, Muscular weakness
Clinical narrative: Approx. 4-5min after injections child feel to floor. RHN did not see her fall. Was conscious at all time. Mother report child's "eyes rolled back she was jerky" color pale. P 100 reg. resp. got cold compress to head. Child sat up approx. 2 min later. Drank some juice. Child did hit her head on side of chair. Mother and child left approx 10 mins later walking on her own. At 4:30 child "is feeling better." Advised Ibuprofen for 24-40 hrs. Later on Fri evening mother reported she took her to ER as she was having another seizure like episode. ER did BSV it was normal. All vital normal. Mother reported she had three more episodes (total 5). She was back to normal today. Dr in ER dx HHE. During that time she was pale and weakness in legs only sl. fever of 100 deg on Sat..
Age: 5.25
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pallor, Pyrexia
Clinical narrative: Approx. 4-5min after injections child feel to floor. RHN did not see her fall. Was conscious at all time. Mother report child's "eyes rolled back she was jerky" color pale. P 100 reg. resp. got cold compress to head. Child sat up approx. 2 min later. Drank some juice. Child did hit her head on side of chair. Mother and child left approx 10 mins later walking on her own. At 4:30 child "is feeling better." Advised Ibuprofen for 24-40 hrs. Later on Fri evening mother reported she took her to ER as she was having another seizure like episode. ER did BSV it was normal. All vital normal. Mother reported she had three more episodes (total 5). She was back to normal today. Dr in ER dx HHE. During that time she was pale and weakness in legs only sl. fever of 100 deg on Sat..
Age: 3.5
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Right thigh with erythema, induration approx 15cm radius, stable. Left thigh with erythema, induration approx 10cm radius, stable. No fever, no warmth.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Injection site oedema, Injection site pain, Vertigo
Clinical narrative: Pt c/o pain and swelling in left upper arm with vertigo and weakness started evening of the day of the injection lasted throughout next day 06/19/02. Pt feeling much better today 06/20/02.
Age: 1.5
Sex: M
Vaccine: DTAP, OPV
Symptoms: Herpes zoster, Pyrexia
Clinical narrative: 06/18/02 developed a few vesicles on trunk 06/19/02 woke up at 30-40 chicken pox lesions on trunk, face, arms and buttocks. T 99.2.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Swelling, pain with mark in site, swelling and pain above clavicle area. Symptoms stayed for four days. Treated with antihistamines.
Age: 2.08
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site oedema
Clinical narrative: Left entire leg swelling seen at ER.
Age: 27.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Fatigue
Clinical narrative: Report A0370834A describes "arthritis type symptoms" in a 27 year old female vaccinee who received Lyme Disease vaccine recombinant OspA. This report was received form the vaccinee and has not been verified by a physician or other health care professional. There was no relevant medical history reported. Concurrent medications were not specified. The vaccinee did not remember having adverse experiences following receipt of prior immunizations. The dates of the first two injections of LYMErix were not recalled. The third injection was administered "some time in 1999." At an unspecified time post immunization, the vaccinee experienced "arthritis type symptoms" and fatigue. The vaccinee reported that no medical attention was needed. The info received on 06/05/2002 reports the events as ongoing. The adverse event of "arthritis type symptoms" does not meet serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Age: 1.5
Sex: M
Vaccine: DTAP, MMR, PNC
Symptoms: Flushing, Injection site erythema, Injection site induration
Clinical narrative: 7.5 x 7.5cm area of erythema, induration, high temp of skin LLE, vastus lateralis. Follow up: chart indicates Prevnar site.  Treatment: antibiotics.
Age: 17.0
Sex: F
Vaccine: HEP, MEN
Symptoms: Anxiety, Chills, Disorientation, Emotional disorder, Fatigue
Clinical narrative: A few local hives around injection sites within 20 minutes. Hives gone over night. Never seen by MD. Palpitation in chest on 05/2/02, nausea, chills, headache, anxious feeling, emotional dis, decease in energy, feels disoriented.
Age: 17.0
Sex: F
Vaccine: HEP, MEN
Symptoms: Headache, Nausea, Palpitations, Urticaria
Clinical narrative: A few local hives around injection sites within 20 minutes. Hives gone over night. Never seen by MD. Palpitation in chest on 05/2/02, nausea, chills, headache, anxious feeling, emotional dis, decease in energy, feels disoriented.
Age: 36.0
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Injection site abscess, Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Fever, pain in arm, red hot area around arm, puss open hold where vaccine was administered stinging sensation.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Pollakiuria, Urine analysis abnormal
Clinical narrative: PT WAS GIVEN 4 IMMUNIZATIONS: DTaPC DTaP-INFANRIX; IPV POLIO VACCINE, INJECTABLE; MMR, HER 2ND DOSE; AND VAR (VARICELLA).  THEY WERE GIVEN IN HER LEFT AND RIGHT ARMS, BUT I DO NOT KNOW WHICH SHOTS IN WHICH ARM.  I DO NOT HAVE ALL OF THE INFORMATION REQUESTED IN ITEM 13. THE LOT NUMBER IS NOT LISTED ON THE IMMUNIZATION RECORD THAT I RECEIVED 6/19/2002. THAT VERY SAME DAY SHE STARTED URINATING VERY FREQUENTLY.  THE SAME THING HAPPENED ON THURSDAY.  SHE WENT TO STAY WITH HER GRANDMOTHER THURSDAY EVENING UNTIL SATURDAY, AND SHE TOLD ME PT HAS CONTINUOUSLY BEEN WETTING HERSELF ALSO.  I'M CONCERNED BECAUSE THIS IS NOT NORMAL FOR HER.  WE ALSO NOTICED THE URINE HAS A VERY STRONG SMELL. SHE HAS BEEN EATING (EXCEPT SHE'S BEEN DRINKING A LOT OF  MILK) & PLAYING NORMALLY AND TODAY, JUNE 22, SHE'S NOT WETTING HERSELF AS FREQUENTLY BUT THE ODOR IS STILL VERY STRONG. HER LAST VACCINES WERE IN 1998: DTAP; OPV; MMR; AND HIBA.  NO ADVERSE SYMPTOMS WERE NOTICED AT THAT TIME; BUT SHE WAS STILL WEARING A DIAPER THEN.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Myalgia
Clinical narrative: Patient developed systemic arthralgias and myalgia after 3rd and 4th anthrax injection in July 1999 and June 2000. (See summary 22 FEB 2002) Had temporary medical exemption for 6 months that is no longer in effect. Currently patient is in good health without any complaints. Recommend she receive future anthrax vaccine with pre-treatment.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Report 20010111081 describes sudden infant death syndrome in a 3 month old female who received an injection of Infanrix. concurrent medical conditions and medications were not specified. On 01/25/2001, the infant received her second injection of Infanrix. That day, she also received her second injections of Prevnar, ActHib, and IPOL. Four days post-imunization, on the afternoon of 01/29/2001, she was found dead in her crib. Autopsy results were consistent with sudden infant death syndrome.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: Report 20010110271 describes the death of a 2 month old female who received an injection of Infanrix. Medical history included "recent" bronchiolitis. There were no concurrent medications. On 02/07/2001, the infant received her first injection of Infanrix. That day, she also received her first injections of Prevnar, ActHib, and IPOL. Two days post-immunization, on 02/09/2001, she was found dead in her crib.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Report 20010091251 describes possible sudden infant death syndrome in a 3 month old male who received an injection of Infanrix. Concurrent medical conditions were not specified. There were not concurrent medications. On 03/07/2001, the infant received his first injection of Infanrix. That day, he also received his first injections of Prevnar, IPOL and Comvax. Within 24 hrs post-immunization, on 03/08/2001, the infant died. The infant's grandmother indicated that "death was due to possible SIDS."
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Cardiac arrest, Cough, Pyrexia, Respiratory disorder, Respiratory rate decreased
Clinical narrative: Report 20010159521 describes a cardiac arrest in a 15 month old female who received an injection of Infanrix. Medical history included "severe" prematurity, bronchopulmonary dysplasia, reactive airway disease, pulmonary stenosis, gastroesophageal reflux disease, and insertion of a gasrostomy tube. Concurrent medications included Pulmicort, Serevent, Aldactazide, Lasix, Zantac and potassium chloride. On 04/25/2001, the child received her fourth injection of Infanrix. On that date, she also received her second injections of Prevnar, and Comvax. On 04/26/2001, one day post-immunization, the child developed heavy breathing with cough and began pulling at her ears. On 04/27/2001, two days post-immunization, she developed a fever of 40.2 deg C. She was taken to the local ER on 04/27/2001. There, her oxygen saturation was 94%. material removed from the child's gastrostomy tube had a coffee ground appearance and was heme positive. The child was tachycardic, with a heart fate of 190 beats/minute. Following albuterol administration,the child experienced supreventricular tachycardia, diminished respiratory effort and a cardiac arrest. "The child later died." Date and cause of death were not provided. The report from the manufacturer listed Infanrix, Comvax and albuterol as suspects in the events leading to the child's death.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Supraventricular tachycardia
Clinical narrative: Report 20010159521 describes a cardiac arrest in a 15 month old female who received an injection of Infanrix. Medical history included "severe" prematurity, bronchopulmonary dysplasia, reactive airway disease, pulmonary stenosis, gastroesophageal reflux disease, and insertion of a gasrostomy tube. Concurrent medications included Pulmicort, Serevent, Aldactazide, Lasix, Zantac and potassium chloride. On 04/25/2001, the child received her fourth injection of Infanrix. On that date, she also received her second injections of Prevnar, and Comvax. On 04/26/2001, one day post-immunization, the child developed heavy breathing with cough and began pulling at her ears. On 04/27/2001, two days post-immunization, she developed a fever of 40.2 deg C. She was taken to the local ER on 04/27/2001. There, her oxygen saturation was 94%. material removed from the child's gastrostomy tube had a coffee ground appearance and was heme positive. The child was tachycardic, with a heart fate of 190 beats/minute. Following albuterol administration,the child experienced supreventricular tachycardia, diminished respiratory effort and a cardiac arrest. "The child later died." Date and cause of death were not provided. The report from the manufacturer listed Infanrix, Comvax and albuterol as suspects in the events leading to the child's death.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: Report 20010158041 describes the death of a 3 month old male who received an injection of Infanrix. Medical history was not specified. There were no pre-existing illnesses or concurrent medications. On 05/15/2001, the infant received his first injection of Infanrix. On that date, he also received his first injections of Prevnar, HibTiter, hep B (Recombivax), and IPOL. The office visit on 05/15/2001 was the infant's first one since birth. One day post-vaccination, on the morning of 05/16/2001, the infant was found dead in his crib. The cause of death was not specified.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: Report 20010155721 describes the death of a 3 month old male who received an injection of Infanrix. Medical history was not specified. Concurrent medical conditions included otitis media. Concurrent medications included . On 04/04/2001, the infant received an injection of Infanrix; it is not known if he had received previous injections of Infanrix. On that same day, he also received injections of Prevnar, HibTiter and IPOL; it is not known if he had received previous injections of these vaccines. The infant died 24 hrs post-immunization, on 04/05/2001; cause of death was not reported. An autopsy was performed; results were pending at the time the report was submitted to the Food and Drug Adminstration.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: Report 20010154141 describes the death of a 2 month old male who received an injection of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. This report was received from manufacturer. This report has also been forwarded to a medical institution. Medical history and concurrent medical conditions were not specified. There were no concurrent medications. On 13 April 2001, the infant received his first injection of Infanrix. On that same day, he also received his first injecations of 7-valent pneumococcal conjugate vaccine, combination hepatitis B/Haemophilus influenzae type B, and inactivated poliomyelitis virus vaccine. The infant died on 14 Aril 2001; cause of death was not reported. An autopsy was performed; results were pending at the time the report was submitted.
Sex: U
Vaccine: FLUX
Symptoms: Infection, Influenza like illness, Red blood cell count decreased, White blood cell disorder
Clinical narrative: Flu shot first week in October 10/98, by 10/12/98 huge infected mass forms on chest rather got flu symptoms immediately after shot. WBC doubled over night and WBC kept rising, RBC falling until dead 5 months later. March 10, 1999 cortizons injected to knee March 14, 1999 dead.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Circulatory collapse, Difficulty in walking, Fatigue, Muscular weakness
Clinical narrative: 2nd hep B vaccine given 08/24/2001. She began feeling fatigued which led to her collapsing on 08/26/2001. Weakness in lower limbs got progressively worse and resulted in 2 hospitalizations and 7 months in a wheel chair. Correlation between vaccine and symptoms discovered 05/12/2002 by the doctor. Much better.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Dyskinesia, Eye disorder, Gastrointestinal disorder, Pharyngitis
Clinical narrative: On 04/16/02 pt had DTaP, IPV, Comvax and Prevnar vaccines. Pt noted on 04/27/02, had episode of eyes shifting from left to right and slight jerking of arms, decrease ability to focus. Pt seen at ER on 04/27/02.
Age: 40.0
Sex: U
Vaccine: FLUX, FLU3
Symptoms: Dyspnoea, Urticaria
Clinical narrative: The pt experienced shortness of breath and hives formed all over her body.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site reaction, Paraesthesia
Clinical narrative: Large local reaction (45mm x 10mm), tingling hands/feet, left ant thigh.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: The pt had pain and swelling over her RUE starting approx. 6 hrs after the immunization. She had a 5-6cm diameter of erythema reaction (photo taken). She had a low grade fever measured at 99.8 F at the clinic. She went to develop pain and tenderness of ther MTP's right hand took for five days to resolve.
Age: 0.3
Sex: M
Vaccine: HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Pt given Prevnar injection into upper let thigh 06/06/02. Mother states pt has red raised lump in area of injection site on 06/07/02 was seen in office for follow-up by doctor.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Dry skin, Eczema, Pain, Pruritus, Rash
Clinical narrative: Dry, itchy, painful rash appeared on hands approximately 6 months later. During exacerbations pustules appear on the back of hands and fingers. Eczema like lesions on hands, refractory to treatment. Treated with Lamisil for a possible fungal infection. His symptoms improved slightly but never resolved. He returned to sick call for evaluation and was told it was not a fungal infection. He was referred to internal medicine and given Cidex that had minimal impact on his symptoms. In October 2001, a doctor evaluated him and he diagnosed him with dyshydrotic eczema and prescribed Temovate 0.05% cream. He also recommended patch testing and allergy testing to determine if there is an allergic component involved. Currently he is using the Temovate cream twice a day as directed. He still experiences exacerbations that do not seem to be related to increased hand washing, foods, gloves, stress, water intake, etc. The lesions (when flaring) often wake the pt from sleep.
Age: 0.7
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema
Clinical narrative: Local reaction (3 x 3cm erythema) to Prevnar given in left thigh. Followup 05/11/02
Age: 1.6
Sex: F
Vaccine: PNC
Symptoms: Eye disorder, Listless, Musculoskeletal stiffness, Pallor, Tremor
Clinical narrative: Pt received Prevnar 06/11/02. At daycare on 06/12/02 body stiffened like a board with her arms out, fists clenched and shook very hard, whole body very hard for 10 seconds. Eyes appeared dialated (black)and tongue was just hanging on her lip. She appeared pale and listless not even wanting her blanket, or a drink. stayed very quiet for 35 mins.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Ecchymosis
Clinical narrative: Ecchymotic rash to right leg. No significant swelling.
Age: 36.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Erythema, Rash
Clinical narrative: Red rash over body.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Child has had shingles 3 times (02/21/02 approx 4 days, 04/25/02 approx 3 days, 06/18/02 approx 3 days). RT check all three times. Given Acyclovir topical for control every 2 hr appliation. Episodes lasting. Short term recovery.
Age: 1.4
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Temp > 106 F seven days post MMR.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Pallor, Visual disturbance, Vomiting
Clinical narrative: Client became pale, a double vision change, c/o bright spots, vomiting, lips gray. Client very anxious person to injection.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Had cellulitis over left thigh, unresponsive to oral abx. Required IV antibiotics and 2 ED visits. Recovered without complication.
Age: 2.75
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Contracted varicella June 2002-received Varivax July 1995.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site induration, Injection site oedema
Clinical narrative: 10 x 8.5cm area of swelling and induration to right leg at vaccine site. Was given Benadryl 1/4 tsp q 6hrs as necessary and to use cool compresses.
Age: 3.6
Sex: F
Vaccine: VARCEL
Symptoms: Dyspnoea, Urticaria, Wheezing
Clinical narrative: Child was at health dept for appoint after immunization. Developed raspy wheeze and hives on trunk and legs approx 25 mins later. Epinepherine 0.13mg given Benadryl 0.3ml given IM. Breathing improved shortly after EMS arrived transported to local ER for evaluation. Mother stated no allergies prior to shot then after event stated allergic to Lasex.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Breath holding, Crying, Eye movement disorder, Hypotonia, Jaundice
Clinical narrative: Crying after 1st of three vaccines. After 3rd vaccine-turned pale, limp, eyes rolled back, responded quickly to stimulation. Suspect vasovagal reaction/breathholding spell. Tylenol after vaccines.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Pallor, Syncope vasovagal
Clinical narrative: Crying after 1st of three vaccines. After 3rd vaccine-turned pale, limp, eyes rolled back, responded quickly to stimulation. Suspect vasovagal reaction/breathholding spell. Tylenol after vaccines.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Lethargy, Pallor, Pyrexia, Vomiting
Clinical narrative: Mother called nurse practitioner at 9:30pm on 06/11/02 stated child had sudden raise of temp >101.7 vomited X T was pale and lethargic there was no local reaction.
Sex: U
Vaccine: DTAP, HIBV
Symptoms: Coordination abnormal, Difficulty in walking, Fall, Injection site induration, Injection site oedema
Clinical narrative: Ataxia, falling to the right, difficulty walk. Local swelling and induration right thigh.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site induration, Pruritus
Clinical narrative: Vaccine administered within 20 min mm returned with child left arm showed induration with noticeable itching. Prescribed HC 2.5%.
Age: 4.25
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Pruritus
Clinical narrative: .50 cent size local reaction at injection erythema, sl. raised, pruritic.
Age: 1.08
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Cellulitis, Injection site induration, Injection site reaction, Injection site vesicles
Clinical narrative: Pt with cellulitis/blistering on right thigh. Also with induration on right thigh.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Hyperhidrosis, Hypotension, Nausea, Pallor
Clinical narrative: 9:30am 06/17/02 pt received hep B vaccine 2nd dose. Pt became nauseated, pale, diaphoretic, hypotensive and dizzy. Epipen 0.3mg auto-injection given left thigh at 9:35am and rescue was called as "ordered" by doctor. BP returned to WNL; color returned, no nausea or dizziness. ER MD felt it was a vasovagal reaction.