chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Skin burning sensation, Urticaria
Clinical narrative: Hives on 1 hand (palm) and both feet hives and burning (evening of #3 HBV). History per pt: Had hives beginning in July but could not remember if before or after 1st Hep-B or 2nd Hep-B; has had "hives" at all intervals since 8/00; resolved 1 week prior to #3 Hep-B. Has been seen by dermatologist but did not relate that she had had 2 HBV's. Was advised to take Benadryl but chose to use Claritin.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Ecchymosis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 5 1/2cm X 4 1/2cm area of redness, induration and bruising and increased warmth.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Screaming
Clinical narrative: Mother phoned stating baby was fine yesterday. He woke up at 04:00 and is screaming (not crying) until 11:00, napped for 1/2 hour and woke up screaming. Advised MD visit. On Tylenol.
Age: 3.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Rash
Clinical narrative: This child broke out with just a few rashes on arms and back. She had a small amount that were disappearing fast.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Urticaria
Clinical narrative: 5 minutes, post vax, the child broke out in something that appeared to be small welt-like and in about 5 minutes, they began to disappear all over.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Injection site swelling
Clinical narrative: Redness and swelling on area.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Arthritis, Erythema, Pruritus, Rash
Clinical narrative: Rash in joints (knees, elbows, ankles) red, inflammed and itchy.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm very swollen, red and hot the day after Hep-A.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Pt complained of tenderness noted at left deltoid arm. Noted mild induration at the injection site. No erythema or soft tissue swelling and no heat.
Age: 16.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Convulsion, Injection site erythema, Injection site mass, Otitis media, Pyrexia
Clinical narrative: "Pt developed a knot and redness at injection site on right leg (larger than a 50 cent piece) that lasted through 2/4/01". "Pt had seizure and was taken by rescue squad to hospital ER on 2/5/01. Fever was 101F and was dx'd with ear infections at ER". Per mom, she is to see PMD on 2/8/01.
Age: 23.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 6cm X 7 1/2cm erythematous and warm to touch area at left shoulder. Given E-Mycin and Hydrocortisone cream and Benadryl. Use ice prn. This event happened 24 hours, later. Treated on 2/1/00 at 12:55.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, HEP, IPV
Symptoms: Agitation, Rash macular
Clinical narrative: Parent stated a mild macular rash began on her neck and trunk, 24 hours, post vax, then in 48 hours, child began to cry inconsolably. Follow-up on 1/30/01 by phone, rash lasted 2-3 days; more started behind ears.
Sex: F
Vaccine: TD
Symptoms: Injection site erythema
Clinical narrative: A physician reported that a female inadvertently received an ID injection of TD and subsequently, developed a "large" area of redness at the injection site. She was treated with hot soaks and recovered.
Age: 75.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Pruritus
Clinical narrative: A 75 year old female reported that, post vax, 2 days later, she developed a 2" red area at the injection site. On 1/16/00, the site became very red, warm, itchy and inflammed; the inflammation extended from the upper arm to below the elbow. The pt was seen by the physician on 1/17/00 and treated with Benadryl, prednisone and applications of ice to the affected area. The pt's previous dose of TD was given in 1967.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: A 35 year old female received TD on 1/11/00. On 1/13/00, she developed an injection site reaction characterized by a 3cm area of redness and warmth. She recovered without treatment. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of either TD adsorbed or Diphtheria and Tetanus Toxoid Adsorbed.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: A nurse reported that a 43 year old female received TD Adsorbed, Ultrafined on 1/24/00. She returned to the physician's office on 1/27/00, after she developed a 3cm to 4cm area of redness and warmth at the injection site. She was treated with hydrocortisone cream. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of either Tetanus Toxoid Adsorbed or Diphtheria and Tetanus Toxoid Adsorbed.
Sex: F
Vaccine: TD
Symptoms: Injection site pain
Clinical narrative: A pharmacist reported that a female may have inadvertently received 1 ml of Tetanus Toxoid Adsorbed, Ultrafined. She developed a "little" pain at the injection site. No further information was available at the date of this report.
Sex: F
Vaccine: TTOX
Symptoms: Swelling
Clinical narrative: A nurse reported that a female pt received an injection of tetanus toxoid absorbed and subsequently developed "swelling". This report was received on 2/29/00, no further information was available at that time.
Age: 59.0
Sex: U
Vaccine: TD
Symptoms: Parotid gland enlargement
Clinical narrative: A physician reported that a 59 year old pt received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 10/3/00. The next day, the pt developed left parotid gland swelling.
Sex: F
Vaccine: TD
Symptoms: Vision blurred
Clinical narrative: A nurse reported that a pt inadvertently received an expired dose of Tetanus Toxoid Adsorbed, Ultrafined or Tetanus Toxoid Fluid on 11/8/00. The vaccine expired in 1998. On 11/8/00, she experienced blurriness which resolved within 2 hours. As of 11/8/00, no further information was available.
Sex: F
Vaccine: TD
Symptoms: Injection site reaction, Pruritus, Urticaria
Clinical narrative: A physician reported that a female received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 4/18/00. On 4/24/00, she developed an injection site reaction characterized by right shoulder hives with pruritus. The pt was treated with Benadryl and cool compresses. She recovered.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: A physician reported that a 40 year old female sustained an injury with a foreign body. As part of wound management, the physician administered a SC injection of Tetanus Toxoid Adsorbed, Ultrafined at 10:00 on 5/2/00. Later that day, the pt became concerned that the injury site appeared infected; she went to the ER. The infected injury was treated with cephalexin. A second dose of Tetanus Toxoid Adsorbed (manufacturer unknown) was administered by the ER staff at 15:00 on 5/2/00. On 5/4/00, the pt developed a fever of 100.4F and she also developed redness, inflammation, warmth and pain at each TD administration site.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Injury, Pyrexia
Clinical narrative: A physician reported that a 40 year old female sustained an injury with a foreign body. As part of wound management, the physician administered a SC injection of Tetanus Toxoid Adsorbed, Ultrafined at 10:00 on 5/2/00. Later that day, the pt became concerned that the injury site appeared infected; she went to the ER. The infected injury was treated with cephalexin. A second dose of Tetanus Toxoid Adsorbed (manufacturer unknown) was administered by the ER staff at 15:00 on 5/2/00. On 5/4/00, the pt developed a fever of 100.4F and she also developed redness, inflammation, warmth and pain at each TD administration site.
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: A physician reported that a 26 year old female received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 6/20/00. The next day, she developed an injection site reaction characterized by redness, swelling, warmth and induration. This is 1 of 2 pts from this facility who had an adverse experience following receipt of this vaccine, lot 4998103.
Age: 25.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: A physician reported that a 25 year old female received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 6/17/00. The next day, she developed an injection site reaction characterized by redness, swelling, warmth and induration. This is 1 of 2 pts from this facility who had an adverse experience following receipt of this vaccine, lot 4998103.
Sex: F
Vaccine: TD
Symptoms: Injection site erythema
Clinical narrative: A nurse reported that an adult female inadvertently received an ID injection of Tetanus Toxoid Adsorbed on 7/14/00. On 7/15/00, she developed redness at the injection site. She recovered within 3 days. The reporter indicated that 2 pts experienced this event; however, only 1 person has been identified.
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: A nurse reported that an adult female inadvertently received an ID injection of Tetanus Toxoid Adsorbed, Ultrafined on 7/3/00. Some of the injection may also have been given SC. That day, she developed "slight" induration at the injection site. She then developed redness at the injection site. She reported to the ER but no treatment was given. She applied cold compresses to the site. As of 7/5/00, a "large" red area at the injection site persisted.
Sex: F
Vaccine: TD
Symptoms: Erythema, Hypersensitivity, Injection site pain, Injection site swelling, Injury
Clinical narrative: A pharmacist reported that a female received an injection of Tetanus Toxoid Adsorbed, Ultrafined and subsequently developed an area of redness that surrounded her leg wound. She also developed an injection site reaction characterized by swelling and tenderness. The reporter considered these events to represent an allergic reaction to Tetanus Toxoid Adsorbed, Ultrafined.
Sex: M
Vaccine: TD
Symptoms: Pruritus, Urticaria
Clinical narrative: A nurse reported that an adult male received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 12/29/99. The pt subsequently, developed welts with itching on his chest and his hands extending to his elbows. He was treated with prednisone and diphenhydramine. The welts and itching persisted as of 3/13/00.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: A nurse reported that a 12 year old male received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 10/23/00 and 8 days later, he developed an injection site reaction characterized by a 3" red, firm, swollen area. According to the reporter, the pt's mother refused to allow her child to be seen by the physician and instead, treated her son with "ginger gel". The reporter indicated that the mother called to report that her son's symptoms gradually resolved.
Sex: U
Vaccine: DT
Symptoms: Hypersensitivity
Clinical narrative: A pharmacist reported that a pt received Tetanus Toxoid as a child and subsequently developed an allergy. As of 10/12/00, no further information was available.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A medical technician reported that a 62 year old female received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 11/13/00. On 11/15/00, the pt developed an injection site reaction characterized by redness and swelling.
Age: 34.0
Sex: F
Vaccine: TD, TD
Symptoms: Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: A nurse reported that a 34 year old female received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 6/12/00. On 6/14/00, the pt developed a "low-grade" fever and generalized aches. She also developed an injection site reaction characterized by pain and swelling extending to her armpit. The pt recovered. Follow-up info received on 02/26/2001 from the physician indicated that the pt recovered by 06/16/2000 with "no lasting affects."
Age: 34.0
Sex: F
Vaccine: TD, TD
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: A nurse reported that a 34 year old female received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 6/12/00. On 6/14/00, the pt developed a "low-grade" fever and generalized aches. She also developed an injection site reaction characterized by pain and swelling extending to her armpit. The pt recovered. Follow-up info received on 02/26/2001 from the physician indicated that the pt recovered by 06/16/2000 with "no lasting affects."
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: A male who wishes to remain anonymous, reported that he received an injection of Tetanus Toxoid Adsorbed, Ultrafined and subsequently developed an injection site reaction characterized by redness, swelling and induration.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: A 33 year old female reported that she received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 5/26/00. On 6/7/00, she developed hives. She was seen by her physician who prescribed Claritin and Benadryl. Allergy testing was reportedly positive for tetanus. The hives persisted and she was treated with prednisone on 7/5/00. On 8/10/00, the physician prescribed Tagamet and an unspecified antihistamine along with the Claritin previously prescribed.
Age: 19.0
Sex: F
Vaccine: ANTH, ANTH, ANTH, ANTH
Symptoms: Abnormal behaviour
Clinical narrative: On 07/28/98, the Anthrax vaccine was administered to the patient about what was considered to be the time of her conception. The vaccine was administered again on 09/03/98, about 6-10 weeks post conception. The child is the one reported with all of the adverse effects, also reported to have received usual childhood vaccinations. Possible association of PPD and Anthrax vaccine is based on lay media reports of military adverse events resulting from Anthrax immunization. Additional info will be provide, as it becomes available. F/U rec'd 7/25/01; physician stated that he last saw the pt in March. With therapy, she has made some improvements in attempts at communication, however, the physician does not expect full recovery.
Age: 19.0
Sex: F
Vaccine: ANTH, ANTH, ANTH, ANTH
Symptoms: Foetal disorder
Clinical narrative: On 07/28/98, the Anthrax vaccine was administered to the patient about what was considered to be the time of her conception. The vaccine was administered again on 09/03/98, about 6-10 weeks post conception. The child is the one reported with all of the adverse effects, also reported to have received usual childhood vaccinations. Possible association of PPD and Anthrax vaccine is based on lay media reports of military adverse events resulting from Anthrax immunization. Additional info will be provide, as it becomes available. F/U rec'd 7/25/01; physician stated that he last saw the pt in March. With therapy, she has made some improvements in attempts at communication, however, the physician does not expect full recovery.
Age: 19.0
Sex: F
Vaccine: ANTH, ANTH, ANTH, ANTH
Symptoms: Autism, Neurodevelopmental disorder
Clinical narrative: On 07/28/98, the Anthrax vaccine was administered to the patient about what was considered to be the time of her conception. The vaccine was administered again on 09/03/98, about 6-10 weeks post conception. The child is the one reported with all of the adverse effects, also reported to have received usual childhood vaccinations. Possible association of PPD and Anthrax vaccine is based on lay media reports of military adverse events resulting from Anthrax immunization. Additional info will be provide, as it becomes available. F/U rec'd 7/25/01; physician stated that he last saw the pt in March. With therapy, she has made some improvements in attempts at communication, however, the physician does not expect full recovery.
Age: 19.0
Sex: F
Vaccine: ANTH, ANTH, ANTH, ANTH
Symptoms: Abnormal behaviour, Cardiac disorder, Neurodevelopmental disorder, Speech disorder, Ventricular septal defect
Clinical narrative: On 07/28/98, the Anthrax vaccine was administered to the patient about what was considered to be the time of her conception. The vaccine was administered again on 09/03/98, about 6-10 weeks post conception. The child is the one reported with all of the adverse effects, also reported to have received usual childhood vaccinations. Possible association of PPD and Anthrax vaccine is based on lay media reports of military adverse events resulting from Anthrax immunization. Additional info will be provide, as it becomes available. F/U rec'd 7/25/01; physician stated that he last saw the pt in March. With therapy, she has made some improvements in attempts at communication, however, the physician does not expect full recovery.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiovascular disorder, Cough, Depression, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: On 12/25/00, reported 1st symptoms of sinus congestion and uncontrollable coughing. On 1/3/01, seen in ER with numbness and paralysis. Transferred to another hospital where she was told the dx was Guillain-Barre Syndrome. Is recovering. 60 day follow up states patient is experiencing blurred vision in the right eye. Sinus infection starting 12/21/2000
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Paralysis, Sinus congestion
Clinical narrative: On 12/25/00, reported 1st symptoms of sinus congestion and uncontrollable coughing. On 1/3/01, seen in ER with numbness and paralysis. Transferred to another hospital where she was told the dx was Guillain-Barre Syndrome. Is recovering. 60 day follow up states patient is experiencing blurred vision in the right eye. Sinus infection starting 12/21/2000
Age: 4.0
Sex: M
Vaccine: MMR, PNC, MMR, PNC, MMR, PNC
Symptoms: Eyelid oedema, Lacrimation increased, Ocular hyperaemia, Sneezing
Clinical narrative: Both eyelids were puffy with red and watery eyes, sneezing but no signs and symptoms of shortness of breath. Treatment with Epinephrine and Benadryl given.
Age: 4.0
Sex: M
Vaccine: MMR, PNC, MMR, PNC, MMR, PNC
Symptoms: Abdominal pain, Eye swelling, Hypersensitivity, Influenza, Lacrimation increased
Clinical narrative: Both eyelids were puffy with red and watery eyes, sneezing but no signs and symptoms of shortness of breath. Treatment with Epinephrine and Benadryl given.
Age: 4.0
Sex: M
Vaccine: MMR, PNC, MMR, PNC, MMR, PNC
Symptoms: Pharyngeal oedema, Pruritus, Pyrexia, Sneezing, Somnolence
Clinical narrative: Both eyelids were puffy with red and watery eyes, sneezing but no signs and symptoms of shortness of breath. Treatment with Epinephrine and Benadryl given.
Age: 1.0
Sex: M
Vaccine: HEP, PNC
Symptoms: Laboratory test abnormal
Clinical narrative: A routine CBC, done 2 weeks after the Prevnar and HBV were given and showed miniature cells which were referred to a hematologist and prompted an evaluation for leukemia.
Age: 44.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Dizziness, Dyskinesia, Heart rate increased, Immune system disorder, Muscle disorder
Clinical narrative: In May, 1998, two days post vax, the pt experienced dizziness, racing heart, jerking of limbs, "sinking to bottom of bones", pins and needles, from head to tow and a pathology report revealed smudging of elastic fibers in deeper reticular dermis. Elastic fibers have confetti-like appearance in the mid reticular dermis. In deeper dermis, some degeneration of elastic fibers, collagen fibers and diminished elastic fibers suspicious for mucin deposition. It was noted that these events resulted in a persistent or significant disability/capacity. The physician noted that the vaccine was not refrigerated and was not clear. The pt developed a generalized skin involvement and deterioration of the elastic fibers of the skin with a presumed autoimmune component. As of 2/01, the pt's symptoms persisted. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Paraesthesia, Skin disorder
Clinical narrative: In May, 1998, two days post vax, the pt experienced dizziness, racing heart, jerking of limbs, "sinking to bottom of bones", pins and needles, from head to tow and a pathology report revealed smudging of elastic fibers in deeper reticular dermis. Elastic fibers have confetti-like appearance in the mid reticular dermis. In deeper dermis, some degeneration of elastic fibers, collagen fibers and diminished elastic fibers suspicious for mucin deposition. It was noted that these events resulted in a persistent or significant disability/capacity. The physician noted that the vaccine was not refrigerated and was not clear. The pt developed a generalized skin involvement and deterioration of the elastic fibers of the skin with a presumed autoimmune component. As of 2/01, the pt's symptoms persisted. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Asthenia, Convulsion, Dizziness, Movement disorder, Syncope
Clinical narrative: In May, 1998, two days post vax, the pt experienced dizziness, racing heart, jerking of limbs, "sinking to bottom of bones", pins and needles, from head to tow and a pathology report revealed smudging of elastic fibers in deeper reticular dermis. Elastic fibers have confetti-like appearance in the mid reticular dermis. In deeper dermis, some degeneration of elastic fibers, collagen fibers and diminished elastic fibers suspicious for mucin deposition. It was noted that these events resulted in a persistent or significant disability/capacity. The physician noted that the vaccine was not refrigerated and was not clear. The pt developed a generalized skin involvement and deterioration of the elastic fibers of the skin with a presumed autoimmune component. As of 2/01, the pt's symptoms persisted. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Collagen disorder, Dizziness, Dyskinesia, Heart rate increased, Immune system disorder
Clinical narrative: In May, 1998, two days post vax, the pt experienced dizziness, racing heart, jerking of limbs, "sinking to bottom of bones", pins and needles, from head to tow and a pathology report revealed smudging of elastic fibers in deeper reticular dermis. Elastic fibers have confetti-like appearance in the mid reticular dermis. In deeper dermis, some degeneration of elastic fibers, collagen fibers and diminished elastic fibers suspicious for mucin deposition. It was noted that these events resulted in a persistent or significant disability/capacity. The physician noted that the vaccine was not refrigerated and was not clear. The pt developed a generalized skin involvement and deterioration of the elastic fibers of the skin with a presumed autoimmune component. As of 2/01, the pt's symptoms persisted. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: FLU3, PPV, IPV, PPV
Symptoms: Asthenia, Hypoaesthesia, Influenza like illness, Rash maculo-papular, Vasculitis
Clinical narrative: Information has been received from a physician concerning a 89 year old female who was vaccinated. Within 12 hours of vaccination the patient experienced severe fatigue, fever, muscle aches, and developed a skin rash on her lower extremities. The patient was diagnosed with vasculitis. Follow up from the physician indicated that the patient had a hypersensitivity vasculitis following her vaccination and was placed on steroids. Her symptoms are slowly improving. Upon internal review the vasculitis was determined to be an Other Important Medical Event. F/U from the pt's relative indicated that on 10/20/00 the pt had severe flu like symtoms. This lasted several days. In Nov her legs and feet were covered with red splotches. Pt has had swelling in her feet and legs. Pt has had problems with weakness, being jittery and nervous. The events were reported to be disabling. The pt has not totally recovered yet. Follow-up has amended this report to include the times of vaccination and the onset of adverse events as well as labs.
Age: 89.0
Sex: F
Vaccine: FLU3, PPV, IPV, PPV
Symptoms: Asthenia, Fatigue, Feeling jittery, Hypersensitivity, Influenza like illness
Clinical narrative: Information has been received from a physician concerning a 89 year old female who was vaccinated. Within 12 hours of vaccination the patient experienced severe fatigue, fever, muscle aches, and developed a skin rash on her lower extremities. The patient was diagnosed with vasculitis. Follow up from the physician indicated that the patient had a hypersensitivity vasculitis following her vaccination and was placed on steroids. Her symptoms are slowly improving. Upon internal review the vasculitis was determined to be an Other Important Medical Event. F/U from the pt's relative indicated that on 10/20/00 the pt had severe flu like symtoms. This lasted several days. In Nov her legs and feet were covered with red splotches. Pt has had swelling in her feet and legs. Pt has had problems with weakness, being jittery and nervous. The events were reported to be disabling. The pt has not totally recovered yet. Follow-up has amended this report to include the times of vaccination and the onset of adverse events as well as labs.
Age: 89.0
Sex: F
Vaccine: FLU3, PPV, IPV, PPV
Symptoms: Myalgia, Oedema peripheral, Pyrexia, Rash maculo-papular, Red blood cell sedimentation rate increased
Clinical narrative: Information has been received from a physician concerning a 89 year old female who was vaccinated. Within 12 hours of vaccination the patient experienced severe fatigue, fever, muscle aches, and developed a skin rash on her lower extremities. The patient was diagnosed with vasculitis. Follow up from the physician indicated that the patient had a hypersensitivity vasculitis following her vaccination and was placed on steroids. Her symptoms are slowly improving. Upon internal review the vasculitis was determined to be an Other Important Medical Event. F/U from the pt's relative indicated that on 10/20/00 the pt had severe flu like symtoms. This lasted several days. In Nov her legs and feet were covered with red splotches. Pt has had swelling in her feet and legs. Pt has had problems with weakness, being jittery and nervous. The events were reported to be disabling. The pt has not totally recovered yet. Follow-up has amended this report to include the times of vaccination and the onset of adverse events as well as labs.
Age: 89.0
Sex: F
Vaccine: FLU3, PPV, IPV, PPV
Symptoms: Vasculitis
Clinical narrative: Information has been received from a physician concerning a 89 year old female who was vaccinated. Within 12 hours of vaccination the patient experienced severe fatigue, fever, muscle aches, and developed a skin rash on her lower extremities. The patient was diagnosed with vasculitis. Follow up from the physician indicated that the patient had a hypersensitivity vasculitis following her vaccination and was placed on steroids. Her symptoms are slowly improving. Upon internal review the vasculitis was determined to be an Other Important Medical Event. F/U from the pt's relative indicated that on 10/20/00 the pt had severe flu like symtoms. This lasted several days. In Nov her legs and feet were covered with red splotches. Pt has had swelling in her feet and legs. Pt has had problems with weakness, being jittery and nervous. The events were reported to be disabling. The pt has not totally recovered yet. Follow-up has amended this report to include the times of vaccination and the onset of adverse events as well as labs.
Age: 0.25
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Information has been received from an investigator concerning a 3 month old female who received her 1st injection of Prevnar, Hib-Titer, Infanrix and IPV vaccines and her 2nd injection of Recombivax-HB vaccine on 7/19/00, as part of a study trial. On 8/27/00, the child died due to sudden infant death syndrome. Both the investigator and the medical monitor agree that this event was not related to vaccine administration.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Dermatitis, Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome
Clinical narrative: Information was received from an investigator regarding a 2 month old male who received his vaccinations on 04/25/2000. On 06/14/00, at age of 4 months, the patient died. An autopsy revealed the cause of death to be Sudden Infant Death Syndrome. Both the investigator and medical monitor consider this event not related to vaccine administration. This report of a serious, labeled event is being submitted to the FDA in a 15-day time frame, as requested by FDA. Autopsy also stated the infant had dermatitis, pulmonary edema and congestion.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Information was received from an investigator regarding a 2 month old male who received his vaccinations on 04/25/2000. On 06/14/00, at age of 4 months, the patient died. An autopsy revealed the cause of death to be Sudden Infant Death Syndrome. Both the investigator and medical monitor consider this event not related to vaccine administration. This report of a serious, labeled event is being submitted to the FDA in a 15-day time frame, as requested by FDA. Autopsy also stated the infant had dermatitis, pulmonary edema and congestion.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion
Clinical narrative: Information has been received from a consumer, a 34 year old Caucasian female who in June 1999 and on 7/22/99, respectively, was vaccinated with the 1st and 2nd dose of varicella virus vaccine live and subsequently in August, 1999, the pt found out she was pregnant. Follow-up information from an RN at the physician's office reported that the pt had an elective abortion in October, 1999. It was reported that there was no medical indication for the pregnancy termination but was the personal choice of the pt. No further information is available.
Age: 32.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Eye oedema, Face oedema, Infection, Pruritus
Clinical narrative: Information has been received from a 32 year old male and his physician. The patient, noticed that his sister had a Varicella in late December 2000. On 01/12/01 the patient was vaccinated with his first dose of Varicella virus vaccine live, SQ in his left arm. The patient reported there were no vesicles or scabbing noted. On 02/01/01 the patient developed hives on his entire body. On 02/02/01 the patient received Prednisone med pak for 6 days. On 02/04/01 the patient developed edema of the lips, eyes and face, and was seen in the ER. Therapy with intravenous antihistamine was given and the symptoms subsided. Upon internal review it was determined that the hives and edema of the lips, eyes and face were considered to be an Other Important Medical Event. The physician reported that on 02/05/01 or 02/06/01 the patient broke out in chicken pox pustules that disappeared quickly. At the time of this report the rash was better but continued to itch. The physician indicated that the patient did not think he should receive the second dose due to this experience and the physician agreed. Additional follow up from a public health nurse revealed that the patients condition has subsided and the patient was able to return to work.
Age: 32.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a 32 year old male and his physician. The patient, noticed that his sister had a Varicella in late December 2000. On 01/12/01 the patient was vaccinated with his first dose of Varicella virus vaccine live, SQ in his left arm. The patient reported there were no vesicles or scabbing noted. On 02/01/01 the patient developed hives on his entire body. On 02/02/01 the patient received Prednisone med pak for 6 days. On 02/04/01 the patient developed edema of the lips, eyes and face, and was seen in the ER. Therapy with intravenous antihistamine was given and the symptoms subsided. Upon internal review it was determined that the hives and edema of the lips, eyes and face were considered to be an Other Important Medical Event. The physician reported that on 02/05/01 or 02/06/01 the patient broke out in chicken pox pustules that disappeared quickly. At the time of this report the rash was better but continued to itch. The physician indicated that the patient did not think he should receive the second dose due to this experience and the physician agreed. Additional follow up from a public health nurse revealed that the patients condition has subsided and the patient was able to return to work.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Injection site abscess, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 40 year old female who on 1/25/01 was vaccinated with MMR II. On 1/27/01, the pt thought the injection site felt unusual. On 2/4/01, the pt was seen and treated in the ER for a huge boil or abscess that was swollen, red, hot and painful. Upon internal review the furuncle was determined to be an "Other Important Medical Event". The area was lanced and packing placed in the area. Therapy with Ceftin and Tylenol #3 were initiated. On 2/5/01, the pt had a packing changed in the ER. On 2/6/01, the pt saw a surgeon. The nurse reported in follow-up that the site was healing slowly and she is still recovering. Additional information has been requested.F/U additional info from the nurse indicated that the pt's recovery was ongoing ans she was healing. The abscess was considered an other medical event. No further info is available.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia, Hypersensitivity, Oedema peripheral, Pain, Pharyngolaryngeal pain
Clinical narrative: On 2/2/01, approx. 18:00, feet started to itch, then broke out in "hives" on trunk and right hand started to swell then had hoarseness and "sore" throat. Went to ER at 19:00 and was there until 23:59 and went home. Put on Zantac and Benadryl. Was given IV and shot of Benadryl at 2nd time in ER. (Was at hunting camp, Friday, when reaction occurred. Returned home at midnight after being seen in ER. On 2/3/01, Saturday AM, symptoms of itching, hives and pain and swelling in both hands had returned. He then went to local ER and was seen by ER MD and wife states he was given IV and injection and sent home. Told at both visits to the ER's that it was an allergic reaction to the flu vaccine, as this was all that was different or unusual in his routine. He has had previous flu shots in the past years. He was improved after treatments and pain and swelling started to resolve. No breathing problems. No problems Saturday or Sunday. On Monday, 2/5/01, at approx. 07:00, had started to complain of pain and swelling in right hand and left hand and feet starting to itch again. Experienced "sore throat" and hoarseness again. He went to his local MD and was admitted to the hospital and given Benadryl, Zantac IV and other things "pain meds") He was hospitalized from 2/5/01 until 2/8/01. Discharged on 2/9/01 and told by MD that he had Rheumatoid Arthritis and given Vioxx for pain and given "Z-pack" for inflammation. Wife comes to health unit today, 2/13/01, to inform me of pt's adverse reactions to flu vaccine. He is still having problems. Right hand swollen and pain in right arm. Also, feet have started to itch again as of yesterday. He is not convinced that he has Rheumatoid Arthritis and feels that his symptoms are still related to adverse vaccine reaction. Went to see another doctor for a second opinion and further treatment as he is very uncomfortable. It was suggested that he go to another hospital that has an arthritis clinic. Per annual follow up: Patient has had no more complications from the influenza vaccine from last year. He has not taken any more influenza vaccine as per doctor's order.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rheumatoid arthritis, Urticaria
Clinical narrative: On 2/2/01, approx. 18:00, feet started to itch, then broke out in "hives" on trunk and right hand started to swell then had hoarseness and "sore" throat. Went to ER at 19:00 and was there until 23:59 and went home. Put on Zantac and Benadryl. Was given IV and shot of Benadryl at 2nd time in ER. (Was at hunting camp, Friday, when reaction occurred. Returned home at midnight after being seen in ER. On 2/3/01, Saturday AM, symptoms of itching, hives and pain and swelling in both hands had returned. He then went to local ER and was seen by ER MD and wife states he was given IV and injection and sent home. Told at both visits to the ER's that it was an allergic reaction to the flu vaccine, as this was all that was different or unusual in his routine. He has had previous flu shots in the past years. He was improved after treatments and pain and swelling started to resolve. No breathing problems. No problems Saturday or Sunday. On Monday, 2/5/01, at approx. 07:00, had started to complain of pain and swelling in right hand and left hand and feet starting to itch again. Experienced "sore throat" and hoarseness again. He went to his local MD and was admitted to the hospital and given Benadryl, Zantac IV and other things "pain meds") He was hospitalized from 2/5/01 until 2/8/01. Discharged on 2/9/01 and told by MD that he had Rheumatoid Arthritis and given Vioxx for pain and given "Z-pack" for inflammation. Wife comes to health unit today, 2/13/01, to inform me of pt's adverse reactions to flu vaccine. He is still having problems. Right hand swollen and pain in right arm. Also, feet have started to itch again as of yesterday. He is not convinced that he has Rheumatoid Arthritis and feels that his symptoms are still related to adverse vaccine reaction. Went to see another doctor for a second opinion and further treatment as he is very uncomfortable. It was suggested that he go to another hospital that has an arthritis clinic. Per annual follow up: Patient has had no more complications from the influenza vaccine from last year. He has not taken any more influenza vaccine as per doctor's order.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Swelling at injection site, raised, reddened area measuring 70mm X 70mm at injection site of left deltoid. Pt experienced some malaise and fatigue. Seen by our MD. Treated with ibuprofen prn.
Age: 0.9
Sex: M
Vaccine: HEP, PNC, VARCEL
Symptoms: Erythema, Infection, Skin nodule
Clinical narrative: Red, hard bump/infection. Treated with Biaxin.
Age: 0.4
Sex: F
Vaccine: DTAP, HEP, PNC
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Left thigh red, hard bump the size of a quarter.
Age: 1.25
Sex: F
Vaccine: HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Hard lump on right thigh/ red/size of a quarter.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, PNC, VARCEL, HBHEPB, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash and fever for 3 days prior to ER visit. Seen in ER X 1 then by Pediatrician the next day. Treated with acetaminophen for fever control. Pediatrician felt MMR II was the culprit.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL, HBHEPB, MMR, PNC, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: MMR administered to pt with measles signs and symptoms appearing 3 days later. Child's mother noticed a rash on the upper body and neck of child and brought the child to the medical center for check-up by pediatrician.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Pt came to clinic complaining of rash with itching on 1/26/01. States rash developed on 1/24/01. Rash observed by nurse on back, waist and under arm. Pt states she may have run fever. Pt instructed to take OTC Benadryl for itching. Pt called back on 1/29/01. She went to ER on 1/27/01 and was given cortisone injection and sent home on oral pk cortisone. Pt was instructed by ER to found out if she was allergic to component in Flu shot.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Injection site pain, Muscle spasms
Clinical narrative: On 1/16/01, pt in for complain of soreness at injection site on left deltoid and across back, previously between shoulder blades since flu vaccine received on 11/7/00. States pain had been across chest also but that pain has since been relieved. States he saw MD on 12/15/00 for complaints and was treated with anti-inflammatory RX. Pt was advised to return to PMD ASAP. Pt was treated with Voltaren po and Flexeril po; dx was thoracic paraspinous spasm; pt was not recommended for additional follow-up after 12/20/00 appt.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Febrile convulsion, Viral infection
Clinical narrative: On 1/11/01, had well child visit. On 1/16/01, to ER with temperature of 103F with febrile convulsion. Dx'd with viral infection. On 1/17/01 follow-up, fever was down to 99.9F. Throat infected. Mom has history of febrile seizures as a child.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Hives less than 24 hours, post vax.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash maculo-papular
Clinical narrative: Rash on side after vaccine. erythema, macula papule.
Age: 47.0
Sex: U
Vaccine: TTOX
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pt has 1 1/2" diameter hard and painful swelling at injection site.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Approx 48 hours post DPT injection, swelling, induration and erythema at site in right thigh. Max. diameter 11x11cm.Reaction lasted 7 days locally with gradual decrease in size of indurated area to 1cm diameter.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Insomnia, Malaise, Pruritus, Rash
Clinical narrative: Pt reports rash, hive like spots appeared on chest day after receiving #2 Hep B. Spots itch. Friday morning (2 days after, increased spots, stomachache , malaise, insomnia.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Pt reports rash, hive like spots appeared on chest day after receiving #2 Hep B. Spots itch. Friday morning (2 days after, increased spots, stomachache , malaise, insomnia.
Age: 69.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Pruritus, Rash macular
Clinical narrative: Pt reports no immediate problems, shortly after receiving injection, however on following morning she woke up with intense itching and red macular rash on arms, abdomen, back and legs. She went to PMD and Dr thinks it was allergic reaction to Hepatitis vaccine and he gave her a shot of cortisone and a prescription for Prednisone 60mg daily x 7days. Pt also reports that greater than one week ago she had poison sumac which was treated with topical ointment.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Abnormal behaviour, Cold sweat, Flushing, Injection site erythema, Injection site mass
Clinical narrative: 7 days post vax, the pt developed a fever, cheeks were flushed and then became cold and clammy. Behavior was more difficult to control from 7-14 days post vax. 10 days post vax, noticed 1 inch diameter red, hard, knot at the injection site. Small red spot on chest at 2 weeks.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: 7 days post vax, the pt developed a fever, cheeks were flushed and then became cold and clammy. Behavior was more difficult to control from 7-14 days post vax. 10 days post vax, noticed 1 inch diameter red, hard, knot at the injection site. Small red spot on chest at 2 weeks.
Age: 10.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt started to develop itching within 5 min of injections. Small welts developed on LT arm. Large welts developed on Rt arm. one welt developed on side of neck. Vital signs taken at 9:30, BP 102/88, pulse 62, resp 24. Benadryl 25mg given IM RA deltoid. Vital signs re-checked 5-10 min times 30 min. Dr notified. Follow-up Q 4-6 hrs at home if welts re-occur, ER if breathing difficulty. Pt to be at home with Mom. Left at 10:00am BP 100/60, pulse 114.
Age: 10.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Myalgia, Pyrexia, Urticaria
Clinical narrative: Pt received MMR and Hepatitis B on 1/26/01. By evening pt reported fever (?amt), muscle aching - 1/27/01, continues with aches. 1/28/01 whelps reported by mother to face and neck - Treated in ER with Benadryl and antibiotics. Improvement 1/28 now returning.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injury, Rash papular
Clinical narrative: Pt reports excoriated, papular lesions on face, trunk and extremities.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain
Clinical narrative: Upon receiving injection, client developed immediate aching and pain at site. Since that time, has experienced aching at site extending down arm. Also has limited motion. Problem is ongoing. Pt being sent to PMD for evaluation and work-up.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Upon receiving injection, client developed immediate aching and pain at site. Since that time, has experienced aching at site extending down arm. Also has limited motion. Problem is ongoing. Pt being sent to PMD for evaluation and work-up.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, PNC, VARCEL, HBHEPB, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash and fever for 3 days prior to ER visit. Seen in ER X 1 then by Pediatrician the next day. Treated with acetaminophen for fever control. Pediatrician felt MMR was the culprit.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: No data listed.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Cyanosis, Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome
Clinical narrative: This patient died 11/14/00, from possible SIDS. He was taken to the ER 11/14/00, after being found in his crib cyanotic at 8:30 AM. Autopsy also states pulmonary congestion and edema. Final opinion of autopsy is the infant died because of sudden infant death syndrome.
Age: 1.25
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Apnoea, Cardio-respiratory arrest, Coma, Hypoxia, Sepsis
Clinical narrative: Information has been received from an investigator concerning a 15 month old male who received his first injection of Prevnar, his second injection of Recombivax-HB, and his third injection of Hib-Titer and Infanrix vaccines on 08/07/00. The child was found in his crib one morning not breathing and in cardiac arrest. The child was taken to a local emergency room where a heartbeat was re-established following a long code. The child was placed on a ventilator, but was unresponsive to light and painful stimuli. The patient was removed from the ventilator and died due to "SIDS-LIKE SYNDROME" on 01/11/01. Both the investigator and the medical monitor agree that this event was not related to vaccine administration. NOTE: This report is being submitted in a 15-day time frame as requested by FDA. F/U received on 4/25/02 from the study investigator contained autopsy results. The reported cause of death has been changed from "Sids-like syndrome" to "cardiorespiratory failure (cardio-respiratory arrest) secondary to possible sepsis, etiology unknown" as found upon autopsy. The investigator considered the event not related to vaccine administration.