chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: The pt experienced chest tightness and shortness of breath. Use Albuterol inhaler 2 times for relief. Shortness of breath and chest tightness continued for awhile but did not seek physicians treatment. Ok the following day.
Age: 8.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: The pt experienced upper arm redness, warmth to the touch, swollen, painful per pt report after the vaccine was administered.
Age: 16.0
Sex: F
Vaccine: HEP, TD
Symptoms: Dyspnoea, Face oedema, Pruritus, Urticaria
Clinical narrative: The pt started itching, had welts all over body, then the face began to swell and she had problems with breathing. Mom and sister took her to the ER.
Age: 1.0
Sex: F
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: The pt experienced a 1 x 2 cm are of redness with 5cm area of firm edema under injection site. No lymphangitis. No fever. Localized Cellulitis.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: The pt experienced redness, swelling and increased warmth at the site. The pt was seen by her MD and prescribed an antibiotic. The pt used warm alternated with cool intermittent compresses to the site.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Blister, Injection site vesicles
Clinical narrative: The pt experienced a small blister noted at the site of injection and a small blister on anterior abdominal wall.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: The pt received the vaccines on 7/30/1996 and was then diagnosed with Varicella on 2/23/01. The pt was exposed 10 days prior to eruption.
Age: 1.08
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Pyrexia, Rash maculo-papular
Clinical narrative: The pt experienced a high fever, cough, maculo-papular full body rash, starting on face and developing distally.
Age: 1.2
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Pyrexia, Rash macular, Rash papular
Clinical narrative: The pt experienced a fever, then a rash developed which was non-pruritic. Mostly macular and some slightly papular pink lesions to the trunk and extremities. Rash persists upon exam.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Injection site haemorrhage, Injection site induration
Clinical narrative: The child returned one week after vax with a 25 cent piece sized hardened area and with slight bruising evident.
Age: 32.0
Sex: M
Vaccine: HEPA
Symptoms: Headache, Malaise, Myalgia
Clinical narrative: The pt experienced a headache, myalgia to the neck and malaise.
Age: 48.0
Sex: M
Vaccine: HEPA
Symptoms: Headache, Musculoskeletal stiffness
Clinical narrative: The pt experienced a stiff neck and headache.
Age: 33.0
Sex: M
Vaccine: HEPA
Symptoms: Headache, Malaise, Musculoskeletal stiffness
Clinical narrative: The pt experienced a headache, neck stiffness, and malaise.
Age: 43.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Headache, Malaise, Myalgia
Clinical narrative: The pt experienced malaise, myalgia and headache.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: The pt developed a lump at the injection site with redness and tenderness. Now painless but same size.
Age: 7.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Infection
Clinical narrative: The pt received the vaccines on 4/7/99. Was exposed and contracted chicken pox on 2/7/01. Very mild case.
Age: 1.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Rash erythematous, Urticaria
Clinical narrative: The pt experienced red raised areas, brought to MD's office and diagnosed with urticaria.
Age: 1.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Rash erythematous, Rash papular
Clinical narrative: 10 days post vax, the pt came in with red raised papules with central yellow area.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, OPV, RV
Symptoms: Injection site hypersensitivity, Mouth ulceration, Mucous membrane disorder
Clinical narrative: Information has been received from a health professional concerning an 18 week old female who on 04/15/99 was vaccinated with the 2nd dose of Haemophilus B conjugate vaccine. Concomitant therapy included the 1st dose of Rotavirus vaccine, 2nd dose of Diphtheria Toxoid + Pertussis vaccine + Tetanus Toxoid (Tripedia), and the 2nd dose of Poliovirus vaccine (IPOL). On 04/15/99 the patient experienced white blisters in the mouth, and redness on the outside of the cheek on the side of the mouth into which rotavirus vaccine (Rotashield) was administered. This was reported as ulcerative stomatitis. On 04/20/99, the patient recovered from ulcerative stomatitis. No further info is available.
Age: 34.0
Sex: M
Vaccine: TYP
Symptoms: Hypersensitivity, Immune system disorder, Laryngospasm, Rash maculo-papular, Skin discolouration
Clinical narrative: A 34 year old male reported that he received a booster dose of Typhoid vaccine, USP, Heat Phenol In activated in 08/99. Within 15 minutes, he developed blotchy redness, then "turned white as a ghost", and could feel his throat closing. He lost consciousness. He was taken to the ER by ambulance and treated with Epinephrine and steroids. He was seen by an allergist, who reportedly diagnosed "delayed cellular immunity". The patient reported that he now "has a hard time doing anything" and that he develops hives whenever he over exerts himself. The initial allergic reaction treated with Epinephrine and steroids is considered medically important. The vaccine provider confirmed this report on 09/15/2000. The vaccine provider indicated that the patient received Typhoid vaccine, USP, heat Phenol Inactivated and Tuberculin PPD on 08/27/99. The patient is a chronic smoker.
Age: 34.0
Sex: M
Vaccine: TYP
Symptoms: Syncope, Urticaria, Vasodilatation
Clinical narrative: A 34 year old male reported that he received a booster dose of Typhoid vaccine, USP, Heat Phenol In activated in 08/99. Within 15 minutes, he developed blotchy redness, then "turned white as a ghost", and could feel his throat closing. He lost consciousness. He was taken to the ER by ambulance and treated with Epinephrine and steroids. He was seen by an allergist, who reportedly diagnosed "delayed cellular immunity". The patient reported that he now "has a hard time doing anything" and that he develops hives whenever he over exerts himself. The initial allergic reaction treated with Epinephrine and steroids is considered medically important. The vaccine provider confirmed this report on 09/15/2000. The vaccine provider indicated that the patient received Typhoid vaccine, USP, heat Phenol Inactivated and Tuberculin PPD on 08/27/99. The patient is a chronic smoker.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Headache, Hypoaesthesia, Muscle twitching, Paraesthesia
Clinical narrative: Pt reports post vaccine in December 1999 she developed redness and swelling to injection site, injection site filled with pus and purulent exudate. She was treated with antibiotics and recovered within a few days. She then experienced fatigue and felt rubbery all over. She experienced tingling, numbness, and twitching in her feet, legs, hands and arms which moved up to her neck and head. She reports headaches and decreased ability to concentrate.
Age: 27.0
Sex: F
Vaccine: HEP, HEPA, TYP
Symptoms: Arthralgia, Hypokinesia, Myalgia, Oedema peripheral
Clinical narrative: A 27 year old female reported that she received Typhoid vaccine, USP, Heat Phenol Inactivated, Hepatitis A and Hepatitis B vaccines on 12/28/99. Within 2 to 3 days, the patient reportedly developed muscle and joint pain and swelling of her knees and ankles. She was unable to walk. She also stated that she felt as if she "was hit by a truck". The patient was prescribed Celebrex and Prednisone. Her symptoms have persisted for 2 months. Additional info received 04/21/00 from the physician indicated that the patient was seen in the office on 03/20/00 and had recovered.
Age: 42.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: A nurse reported a pt received vaccine. On 4/14/200 pt was seen by physician who noted injection site reaction, characterized by induration, warmth, redness and pain.
Age: 38.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site induration, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: A nurse reported a pt received vaccine on 3/20/2000, pt was seen on 3/22/2000 by physician with injection site reaction characterized by  8cm induration, warmth, and pain.
Age: 25.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: A nurse reported that a 25 year old male received an injection of Tetanus and Diphtheria Adsorbed, Ultrafined on 03/03/00. The next day, he developed and injection site reaction characterized by a "baseball size" area of swelling and redness. He was treated with Acetaminophen and Benadryl and recovered. The patient's last injection of Tetanus Toxoid was administered in 1994. This is 1 of 4 patients from this facility who had an adverse experience following receipt of Tetanus Toxoid Adsorbed, Ultrafined. This report was  received from Medeva.
Age: 25.0
Sex: F
Vaccine: TD
Symptoms: Headache, Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: A nurse reported that a 25 year old female received an injection of Tetanus and Diphtheria Toxoids Adsorbed for Adult Use, Ultrafined on 03/15/00 and developed an injection site reaction characterized by a 6 cm area of redness and swelling described as the "size of a baseball". She also experienced a headache. The patient was seen by the physician who prescribed applications of ice, oral Benadryl, and Acetaminophen.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: A nurse reported that a 27 year old female received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Ultrafined on 02/29/00. On 03/01/00, the developed an injection site reaction characterized by a "baseball size" area of redness and swelling. On 03/02/00, the patient was seen by the physician and treated with Benadryl and Acetaminophen. She recovered that day.
Age: 24.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: A nurse reported that a 24 year old male received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Ultrafined. On 03/15/00, he developed an injection site reaction characterized by redness and swelling described as the "size of a baseball".
Age: 24.0
Sex: F
Vaccine: TD, TD
Symptoms: Muscle spasms, Nausea, Pyrexia, Vomiting
Clinical narrative: A nurse reported that a 24 year old female received the first dose of the primary immunization series of Tetanus and Diphtheria Toxoids Adsorbed, Ultrafined on 06/09/00. Later that afternoon, she developed a fever of 102F, nausea, vomiting, "severe" cramping of the lower back, legs, and feet. The fever, nausea, and vomiting resolved within 2 days. The cramping persisted, but was less severe. One week post-immunization, she developed "severe" cramping of the soles of her feet and her lower legs. She was seen by a physician and treated with diphenhydramine, hydrocodone / acetaminophen, and NSAID. The cramping of the feet persisted as of 06/30/00.
Age: 24.0
Sex: F
Vaccine: TD, TD
Symptoms: Muscle spasms, Pain, Pyrexia
Clinical narrative: A nurse reported that a 24 year old female received the first dose of the primary immunization series of Tetanus and Diphtheria Toxoids Adsorbed, Ultrafined on 06/09/00. Later that afternoon, she developed a fever of 102F, nausea, vomiting, "severe" cramping of the lower back, legs, and feet. The fever, nausea, and vomiting resolved within 2 days. The cramping persisted, but was less severe. One week post-immunization, she developed "severe" cramping of the soles of her feet and her lower legs. She was seen by a physician and treated with diphenhydramine, hydrocodone / acetaminophen, and NSAID. The cramping of the feet persisted as of 06/30/00.
Age: 24.0
Sex: F
Vaccine: TD, TD
Symptoms: Muscle spasms, Nausea, Pyrexia, Vomiting
Clinical narrative: A nurse reported pt received vaccine on 6/9/2000 and 2 hours later developed a fever greater than 102 deg F,and muscle cramps and pain.
Age: 24.0
Sex: F
Vaccine: TD, TD
Symptoms: Muscle spasms, Pain, Pyrexia
Clinical narrative: A nurse reported pt received vaccine on 6/9/2000 and 2 hours later developed a fever greater than 102 deg F,and muscle cramps and pain.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth
Clinical narrative: A 43 year old female received a booster dose of Tetanus and Diphtheria Toxoids Adsorbed,  Ultrafined on 06/29/00 and the next morning, developed an injection site reaction characterized by a large area (greater than 15 cm) of redness, swelling and warmth. She was treated with applications of ice to the affected area and Acetaminophen and recovered with 4 days.
Age: 55.0
Sex: M
Vaccine: TD
Symptoms: Injection site induration, Injection site pain, Pyrexia
Clinical narrative: A nurse reported that a 55 year old male received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Ultrafined on 07/28/00. The next day, he developed a fever of 101 F and general malaise. He recovered. The patient's last dose of Tetanus Toxoid was administered on 10/05/88. The patient also experienced pain and firmness at the injection site. Treatment included one dose of Advil and an ice pack to the site.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site rash, Pruritus
Clinical narrative: A HCP reported that a pt received a vaccine on 7/7/2000, post vaccine she developed an injection site rash characterized by redness, erythema, itching, and tenderness. Pt was treated and recovered.
Age: 11.0
Sex: M
Vaccine: DT
Symptoms: Injection site reaction
Clinical narrative: A healthcare professional reported that an 11 year old male received an injection of Tetanus and Diphtheria Toxoids Adsorbed, Ultrafined on 07/08/00. Two days later, on 07/10/00, he developed an injection site reaction. The event was treated with Augmentin. He recovered.
Age: 10.0
Sex: M
Vaccine: DT
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: A healthcare professional reported that a 10 year old male received an injection of Tetanus Diphtheria Toxoids Adsorbed, Ultrafined (Wyeth) on 07/10/00. Two days later, on 07/12/00, he developed a 3 cm circular red, erythematous injection site reaction with 2-plus tenderness. The event was treated with Keflex. He recovered.
Age: 0.6
Sex: F
Vaccine: DTAP
Symptoms: Injection site abscess, Injection site mass, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: A nurse reported that a pt received vaccine on 9/18/00 and 3 weeks later developed a marble sized lump at the injection site. Over the next several weeks the lump became large, (golf ball size) the pt developed a fever and her leg became swollen. An ultrasound of the lump was performed; results were not provided. Pt skin at the injection site became taut and broke open, green purulent like fluid drained from the abscess.
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV, IPV, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site swelling, and erythema at injection site, after 48 hours swelling subsided but redness persisted.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: A physician reported that a 73 year old female received Flu Shield and Pneumovax vaccines on 12/13/00. On 12/18/00, the patient experienced ascending paralysis and was diagnosed with Guillain Barre' syndrome. She was hospitalized where she was put on a ventilator. On 01/12/01, the patient had a tracheotomy. The reporter considered this event to be life threatening. This report of a serious, labeled event is being submitted in a 15 day time frame, as requested by FDA. A copy of this report has been forwarded to Merck, manufacturer of Pneumovax.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: CSF test abnormal, Guillain-Barre syndrome, Hypoxia, Laboratory test abnormal, Paralysis
Clinical narrative: A physician reported that a 73 year old female received Flu Shield and Pneumovax vaccines on 12/13/00. On 12/18/00, the patient experienced ascending paralysis and was diagnosed with Guillain Barre' syndrome. She was hospitalized where she was put on a ventilator. On 01/12/01, the patient had a tracheotomy. The reporter considered this event to be life threatening. This report of a serious, labeled event is being submitted in a 15 day time frame, as requested by FDA. A copy of this report has been forwarded to Merck, manufacturer of Pneumovax.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Antidiuretic hormone abnormality, CSF test abnormal, Guillain-Barre syndrome, Laboratory test abnormal, Paralysis
Clinical narrative: A physician reported that a 73 year old female received Flu Shield and Pneumovax vaccines on 12/13/00. On 12/18/00, the patient experienced ascending paralysis and was diagnosed with Guillain Barre' syndrome. She was hospitalized where she was put on a ventilator. On 01/12/01, the patient had a tracheotomy. The reporter considered this event to be life threatening. This report of a serious, labeled event is being submitted in a 15 day time frame, as requested by FDA. A copy of this report has been forwarded to Merck, manufacturer of Pneumovax.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Paralysis flaccid, Pneumonia, Urinary tract infection
Clinical narrative: A physician reported that a 73 year old female received Flu Shield and Pneumovax vaccines on 12/13/00. On 12/18/00, the patient experienced ascending paralysis and was diagnosed with Guillain Barre' syndrome. She was hospitalized where she was put on a ventilator. On 01/12/01, the patient had a tracheotomy. The reporter considered this event to be life threatening. This report of a serious, labeled event is being submitted in a 15 day time frame, as requested by FDA. A copy of this report has been forwarded to Merck, manufacturer of Pneumovax.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, DTAP, HIBV, MMR, PNC
Symptoms: Convulsion, Hypotonia, Pyrexia, Vomiting
Clinical narrative: A 1 year old female received vaccines on 1/17/01 and that evening, she awoke with a fever of 103.4F. She was given ibuprofen. At 02:15 on 1/18/01, she developed seizures and was taken to the ER. She was treated with rectal diazepam. She vomited. The seizures resolved, but she was lying limp on the left side of her body and unable to hold up her head. She was transferred to a pediatric ICU at another facility. She was unable to use the left side of her body. She was released from the hospital.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, DTAP, HIBV, MMR, PNC
Symptoms: Convulsion, Hemiplegia, Hypotonia, Pyrexia, Vomiting
Clinical narrative: A 1 year old female received vaccines on 1/17/01 and that evening, she awoke with a fever of 103.4F. She was given ibuprofen. At 02:15 on 1/18/01, she developed seizures and was taken to the ER. She was treated with rectal diazepam. She vomited. The seizures resolved, but she was lying limp on the left side of her body and unable to hold up her head. She was transferred to a pediatric ICU at another facility. She was unable to use the left side of her body. She was released from the hospital.
Age: 34.0
Sex: F
Vaccine: TD, TD
Symptoms: Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: A nurse reported a pt received vaccine 7/12/00 and on 7/13/00 she developed swelling at the injection site, aches and a low grade fever.
Age: 34.0
Sex: F
Vaccine: TD, TD
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: A nurse reported a pt received vaccine 7/12/00 and on 7/13/00 she developed swelling at the injection site, aches and a low grade fever.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Infection, Meningitis
Clinical narrative: Information received concerning a 72 year old female pt who was vaccinated with a dose of pneumococcal vaccine 14 polyvalent. The pt developed meningitis and subsequently died. The cause of death was meningitis.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Infection, Meningitis
Clinical narrative: Information concerning a 9 year old male pt who was vaccinated with a dose of pneumococcal vaccine 14 polyvalent. The pt developed meningitis and subsequently died. The cause of death was meningitis.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Infection, Meningitis
Clinical narrative: Information concerning a 62 year old female who previously underwent a splenectomy was vaccinated with a dose of pneumococcal vaccine 14 polyvalent. The pt developed meningitis and subsequently died. The cause of death was meningitis.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Infection, Sepsis
Clinical narrative: Information concerning an 11 year old male pt who was vaccinated with a dose of pneumococcal vaccine 14 polyvalent. The pt developed sepsis and subsequently died. The case of death was sepsis.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Convulsion
Clinical narrative: Pt had Hep-B shot on 4/29/00 and had 2 seizures on 5/2/00. Sent to another hospital and was put on Phenobarbital for a few months. Is now off of it. Doctors said they did not know why she had the seizures after hearing our medical history. Some have said may have been due to the Hep-B shot and others said they would question this. Was in the hospital from 5/2/00 to 5/4/00.
Age: 0.9
Sex: F
Vaccine: PNC
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Pt developed diarrhea and vomiting and a fever of 101F, within 24 hours. Required hospitalization and IV fluids.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: This child had Left thigh erythema, and swelling surrounding the site of injection. Started the evening after receiving vaccination and worsening over the next 2 days. Admitted for cellulitis, and treated with IV antibiotics, then discharged on PO antibiotics to complete 10 day course.
Age: 13.0
Sex: M
Vaccine: HBHEPB
Symptoms: Platelet count decreased, Thrombocytopenic purpura
Clinical narrative: Purpuric spots, low platelet count picture similar to ITP.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Infection, Oral intake reduced, Pyrexia, Shock, Somnolence
Clinical narrative: Immunized 1/30/01, on 2/1/01 and 02/02/01 slept a lot and had a fever of 102F on 02/02/01 with decrease feeds. Admitted to hospital to rule out sepsis. Dx'd with influenza B. In hospital from 2/1/01 to 2/4/01 and went into shock by the time she was admitted to the hospital.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, PNC
Symptoms: Febrile convulsion
Clinical narrative: Pt is 16 months old and is behind on vaccines. Seen in a clinic within a shelter. Physical exam done then given vaccines in arm. That evening, pt had febrile seizure and was taken to hospital.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Febrile convulsion, Irritability, Pyrexia
Clinical narrative: Fever to 103F X 2 days. Simple febrile seizure and irritability.
Age: 39.0
Sex: M
Vaccine: LYME
Symptoms: Back pain, Feeling hot, Musculoskeletal stiffness, Neck pain
Clinical narrative: Neck and high back soreness (pain), tightness, grinding, cracking, hot spots. Pain is chronic and extends out through muscles in back and neck. Pain began just days after 1st vaccine and intensified after the 2nd Lymerix on 6/30/00 (same lot #). Treatment: Anti-inflammatories not helping. 60 day follow-up states the pt now has arthritic pain in neck, back, and at the shoulders. Has continual grinding, cracking, etc. Medication does not help. Doc 210785, annual follow up states the following: continued extreme spinal, joint and back pain directly related to vaccines given.
Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Antinuclear antibody positive, Arthritis, Infection, Rheumatoid arthritis
Clinical narrative: Arthritis in hands, feet and ankles. (Had second Lymerix on 5/7/99)
Age: 64.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: This patient had joint pain.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Depressed level of consciousness, Hypoxia, Influenza like illness, Loss of consciousness
Clinical narrative: A pharmacist reported that a 40 year old female received an IM injection of Flu Shield on 02/20/01. The patient was noted to have "Flu symptoms" at the time of the vaccination. Two days following vaccination, on 02/22/01, the patient was admitted to an ICU in an unconscious state. The reporter thought that the patient was intubated and she was unarousable. She was treated with Acyclovir and unspecified antibiotics.
Age: 1.25
Sex: M
Vaccine: HIBV, IPV, MMR, PNC, HIBV, IPV, MMR, PNC
Symptoms: Contusion, Otitis media, Platelet count decreased, Thrombocytopenic purpura, Vaccination complication
Clinical narrative: Information has been received from an investigator concerning a 15 month old who received vaccines on 9/2/00 as part of a post-marketing safety surveillance trial. On 9/25/00, he presented for otitis media where the physician noted that the subject had possible bruising on the chest. The physician speculated that this may have been secondary to trauma. On 9/29/00, he had more bruising and was brought in by his parents. He was hospitalized and treated with IV immune globulin. He was discharged on 10/2/00. The next day, he was seen and his platelet count was 295,000 cells/mm3. Both the investigator and the medical monitor agree that idiopathic thrombocytopenic purpura (not expected) was 'possibly related' to either Prevnar or other vaccines administered.
Age: 1.25
Sex: M
Vaccine: HIBV, IPV, MMR, PNC, HIBV, IPV, MMR, PNC
Symptoms: Contusion, Otitis media, Platelet count decreased, Thrombocytopenic purpura
Clinical narrative: Information has been received from an investigator concerning a 15 month old who received vaccines on 9/2/00 as part of a post-marketing safety surveillance trial. On 9/25/00, he presented for otitis media where the physician noted that the subject had possible bruising on the chest. The physician speculated that this may have been secondary to trauma. On 9/29/00, he had more bruising and was brought in by his parents. He was hospitalized and treated with IV immune globulin. He was discharged on 10/2/00. The next day, he was seen and his platelet count was 295,000 cells/mm3. Both the investigator and the medical monitor agree that idiopathic thrombocytopenic purpura (not expected) was 'possibly related' to either Prevnar or other vaccines administered.
Age: 0.2
Sex: M
Vaccine: DTP, HEP, IPV, DTP, HEP, IPV
Symptoms: Blindness, Child maltreatment syndrome, Contusion, Convulsion, Deafness
Clinical narrative: The pt's grandmother reported that a 2 month old male pt received vaccines on 10/23/00. Reportedly, the next day, the pt developed continuous crying, seen in physician's office. The pt was hospitalized on 11/22/00 due to respiratory failure, bruising around the mouth, petechia and swollen tongue. Pt was discharged on 12/20/00 with a dx of Shaken Baby Syndrome with brain damage, blind and deaf. Pt is on feeding tube and Phenobarbital for seizures. No further info is available. Upon internal review, seizures were considered an other medical event. this is an amended report. The pt's age has been changed to 7 wks old. This is corrected report as amended. Mailed follow-up correspondence received on 06/12/2001 stated: the vaccine administered physician did not report this adverse event. F/U mail follow up correspondence rec'd from (WAES01061938) on 7/9/01 specified that the Hepatitis B vaccine given to the patient was Recombivax HB. F/U other business numbers include F200100677,F2001006771 and U200100437. F/U faxed correspondence received on 9/4/01 reports, "This is an amended report. The pt's age has been changed from a 12 to a 7 week old". F/U info rec'd on 11/26/01 from a physician indicated that  this was not a reaction to vaccine and that it was whaken baby syndrome as previously reported. The physician noted that he did not report the event as a possible vaccine reaction. No further information was available because the physician was not at the practice where the child was seen. The physician felt that continous crying, respiratory failure, bruising around mouth, petechiae, swollen tongue, brain damage, blind, deaf and seizures were not related to the therapy with hepatitis B vaccine. Upon internal review, seizures were considered to be an other important medical event. From faxed correspondence received on 09/04/2001 states that "this is an amended report. The pt's age has been changed from a 12 to a 7 week old. From follow-up correspondence received on 11/26/2001 it was reported,"This was not a reaction to vaccine, it was Shaken Baby syndrome as I previously reported. I did not report it as a possible vaccine reaction. I do not have any other information, as I'm not at the practice where this child was seen." The pt's grandmother was the initial reporter per the physician.
Age: 0.2
Sex: M
Vaccine: DTP, HEP, IPV, DTP, HEP, IPV
Symptoms: Delirium, Petechiae, Respiratory failure, Screaming, Tongue oedema
Clinical narrative: The pt's grandmother reported that a 2 month old male pt received vaccines on 10/23/00. Reportedly, the next day, the pt developed continuous crying, seen in physician's office. The pt was hospitalized on 11/22/00 due to respiratory failure, bruising around the mouth, petechia and swollen tongue. Pt was discharged on 12/20/00 with a dx of Shaken Baby Syndrome with brain damage, blind and deaf. Pt is on feeding tube and Phenobarbital for seizures. No further info is available. Upon internal review, seizures were considered an other medical event. this is an amended report. The pt's age has been changed to 7 wks old. This is corrected report as amended. Mailed follow-up correspondence received on 06/12/2001 stated: the vaccine administered physician did not report this adverse event. F/U mail follow up correspondence rec'd from (WAES01061938) on 7/9/01 specified that the Hepatitis B vaccine given to the patient was Recombivax HB. F/U other business numbers include F200100677,F2001006771 and U200100437. F/U faxed correspondence received on 9/4/01 reports, "This is an amended report. The pt's age has been changed from a 12 to a 7 week old". F/U info rec'd on 11/26/01 from a physician indicated that  this was not a reaction to vaccine and that it was whaken baby syndrome as previously reported. The physician noted that he did not report the event as a possible vaccine reaction. No further information was available because the physician was not at the practice where the child was seen. The physician felt that continous crying, respiratory failure, bruising around mouth, petechiae, swollen tongue, brain damage, blind, deaf and seizures were not related to the therapy with hepatitis B vaccine. Upon internal review, seizures were considered to be an other important medical event. From faxed correspondence received on 09/04/2001 states that "this is an amended report. The pt's age has been changed from a 12 to a 7 week old. From follow-up correspondence received on 11/26/2001 it was reported,"This was not a reaction to vaccine, it was Shaken Baby syndrome as I previously reported. I did not report it as a possible vaccine reaction. I do not have any other information, as I'm not at the practice where this child was seen." The pt's grandmother was the initial reporter per the physician.
Age: 0.2
Sex: M
Vaccine: DTP, HEP, IPV, DTP, HEP, IPV
Symptoms: Blindness, Child maltreatment syndrome, Contusion, Convulsion, Crying
Clinical narrative: The pt's grandmother reported that a 2 month old male pt received vaccines on 10/23/00. Reportedly, the next day, the pt developed continuous crying, seen in physician's office. The pt was hospitalized on 11/22/00 due to respiratory failure, bruising around the mouth, petechia and swollen tongue. Pt was discharged on 12/20/00 with a dx of Shaken Baby Syndrome with brain damage, blind and deaf. Pt is on feeding tube and Phenobarbital for seizures. No further info is available. Upon internal review, seizures were considered an other medical event. this is an amended report. The pt's age has been changed to 7 wks old. This is corrected report as amended. Mailed follow-up correspondence received on 06/12/2001 stated: the vaccine administered physician did not report this adverse event. F/U mail follow up correspondence rec'd from (WAES01061938) on 7/9/01 specified that the Hepatitis B vaccine given to the patient was Recombivax HB. F/U other business numbers include F200100677,F2001006771 and U200100437. F/U faxed correspondence received on 9/4/01 reports, "This is an amended report. The pt's age has been changed from a 12 to a 7 week old". F/U info rec'd on 11/26/01 from a physician indicated that  this was not a reaction to vaccine and that it was whaken baby syndrome as previously reported. The physician noted that he did not report the event as a possible vaccine reaction. No further information was available because the physician was not at the practice where the child was seen. The physician felt that continous crying, respiratory failure, bruising around mouth, petechiae, swollen tongue, brain damage, blind, deaf and seizures were not related to the therapy with hepatitis B vaccine. Upon internal review, seizures were considered to be an other important medical event. From faxed correspondence received on 09/04/2001 states that "this is an amended report. The pt's age has been changed from a 12 to a 7 week old. From follow-up correspondence received on 11/26/2001 it was reported,"This was not a reaction to vaccine, it was Shaken Baby syndrome as I previously reported. I did not report it as a possible vaccine reaction. I do not have any other information, as I'm not at the practice where this child was seen." The pt's grandmother was the initial reporter per the physician.
Age: 0.2
Sex: M
Vaccine: DTP, HEP, IPV, DTP, HEP, IPV
Symptoms: Deafness, Injury, Nervous system disorder, Petechiae, Respiratory failure
Clinical narrative: The pt's grandmother reported that a 2 month old male pt received vaccines on 10/23/00. Reportedly, the next day, the pt developed continuous crying, seen in physician's office. The pt was hospitalized on 11/22/00 due to respiratory failure, bruising around the mouth, petechia and swollen tongue. Pt was discharged on 12/20/00 with a dx of Shaken Baby Syndrome with brain damage, blind and deaf. Pt is on feeding tube and Phenobarbital for seizures. No further info is available. Upon internal review, seizures were considered an other medical event. this is an amended report. The pt's age has been changed to 7 wks old. This is corrected report as amended. Mailed follow-up correspondence received on 06/12/2001 stated: the vaccine administered physician did not report this adverse event. F/U mail follow up correspondence rec'd from (WAES01061938) on 7/9/01 specified that the Hepatitis B vaccine given to the patient was Recombivax HB. F/U other business numbers include F200100677,F2001006771 and U200100437. F/U faxed correspondence received on 9/4/01 reports, "This is an amended report. The pt's age has been changed from a 12 to a 7 week old". F/U info rec'd on 11/26/01 from a physician indicated that  this was not a reaction to vaccine and that it was whaken baby syndrome as previously reported. The physician noted that he did not report the event as a possible vaccine reaction. No further information was available because the physician was not at the practice where the child was seen. The physician felt that continous crying, respiratory failure, bruising around mouth, petechiae, swollen tongue, brain damage, blind, deaf and seizures were not related to the therapy with hepatitis B vaccine. Upon internal review, seizures were considered to be an other important medical event. From faxed correspondence received on 09/04/2001 states that "this is an amended report. The pt's age has been changed from a 12 to a 7 week old. From follow-up correspondence received on 11/26/2001 it was reported,"This was not a reaction to vaccine, it was Shaken Baby syndrome as I previously reported. I did not report it as a possible vaccine reaction. I do not have any other information, as I'm not at the practice where this child was seen." The pt's grandmother was the initial reporter per the physician.
Age: 0.2
Sex: M
Vaccine: DTP, HEP, IPV, DTP, HEP, IPV
Symptoms: Tongue oedema
Clinical narrative: The pt's grandmother reported that a 2 month old male pt received vaccines on 10/23/00. Reportedly, the next day, the pt developed continuous crying, seen in physician's office. The pt was hospitalized on 11/22/00 due to respiratory failure, bruising around the mouth, petechia and swollen tongue. Pt was discharged on 12/20/00 with a dx of Shaken Baby Syndrome with brain damage, blind and deaf. Pt is on feeding tube and Phenobarbital for seizures. No further info is available. Upon internal review, seizures were considered an other medical event. this is an amended report. The pt's age has been changed to 7 wks old. This is corrected report as amended. Mailed follow-up correspondence received on 06/12/2001 stated: the vaccine administered physician did not report this adverse event. F/U mail follow up correspondence rec'd from (WAES01061938) on 7/9/01 specified that the Hepatitis B vaccine given to the patient was Recombivax HB. F/U other business numbers include F200100677,F2001006771 and U200100437. F/U faxed correspondence received on 9/4/01 reports, "This is an amended report. The pt's age has been changed from a 12 to a 7 week old". F/U info rec'd on 11/26/01 from a physician indicated that  this was not a reaction to vaccine and that it was whaken baby syndrome as previously reported. The physician noted that he did not report the event as a possible vaccine reaction. No further information was available because the physician was not at the practice where the child was seen. The physician felt that continous crying, respiratory failure, bruising around mouth, petechiae, swollen tongue, brain damage, blind, deaf and seizures were not related to the therapy with hepatitis B vaccine. Upon internal review, seizures were considered to be an other important medical event. From faxed correspondence received on 09/04/2001 states that "this is an amended report. The pt's age has been changed from a 12 to a 7 week old. From follow-up correspondence received on 11/26/2001 it was reported,"This was not a reaction to vaccine, it was Shaken Baby syndrome as I previously reported. I did not report it as a possible vaccine reaction. I do not have any other information, as I'm not at the practice where this child was seen." The pt's grandmother was the initial reporter per the physician.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Drug interaction, Hypoaesthesia, Paraesthesia
Clinical narrative: Report received 2/13/00, from a physician, regarding adverse events possibly associated with Fluvirin. A 47 year old female pt received the vaccination at the end of October, 2000 and within 2 weeks, she developed severe arthritic symptoms; took ibuprofen, with relief; stopped the ibuprofen and relapsed. In mid-December, she developed ascending numbness, from feet to neckline and the sensation of "stocking/glove"; not complete loss of sensation. On 1/01/01, she noticed electrical-shocking spasms. She has been prescribed a 21 day course of Ceftin for Lyme Disease-like symptoms; is also being treated with Pamelor some compound (carisoprodol and aspirin preparation), and Motrin. The pt had received her 3rd and final dose of Lymerix vaccine in June of 2000. The reporting MD questions interaction between Lymerix and Fluvirin or the possibly that Fluvirin stimulated on autoimmune reaction to trigger Lyme-like reaction. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Asthma, Heart rate increased, Hypoxia, Pyrexia, Respiratory distress
Clinical narrative: The pt experienced respiratory distress and fever. Onset from 8-12 hours post vax. The pt was hospitalized for 24 hours. Treated with albuterol. Diagnosed with Viral Respiratory Infection with RAD
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Respiratory rate increased, Viral infection
Clinical narrative: The pt experienced respiratory distress and fever. Onset from 8-12 hours post vax. The pt was hospitalized for 24 hours. Treated with albuterol. Diagnosed with Viral Respiratory Infection with RAD
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Dyspnoea, Urticaria
Clinical narrative: On 01/03/01, this patient developed hives approximately 6 PM, tightness in the upper chest, and difficulty breathing. The patient saw the doctor on 01/04/2001, said his lungs "sounded like a 70 year old smoker" in stead of a 42 year old non-smoker. Given breathing treatment on 01/04/01 and 01/05/01. Medications: Prednisone, Combivent inhaler, Atarax, and Zantac.
Age: 42.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Pruritus, Throat tightness, Urticaria
Clinical narrative: On 01/03/01, this patient developed hives approximately 6 PM, tightness in the upper chest, and difficulty breathing. The patient saw the doctor on 01/04/2001, said his lungs "sounded like a 70 year old smoker" in stead of a 42 year old non-smoker. Given breathing treatment on 01/04/01 and 01/05/01. Medications: Prednisone, Combivent inhaler, Atarax, and Zantac.
Age: 1.25
Sex: F
Vaccine: DTAP, IPV
Symptoms: Acidosis, Convulsion, Encephalopathy, Rash, Respiratory disorder
Clinical narrative: Seizure activity: stopped breathing and was given CPR by mother until EMS arrived. Transported to hospital for evaluation and admitted for observation. Diagnosis includes probable encephalopathy secondary to DTaP, Metabolic Acidosis, Dermatitis
Age: 0.2
Sex: M
Vaccine: DTPHIB, OPV
Symptoms: Autism, Coma, Convulsion, Encephalopathy, Hyperexplexia
Clinical narrative: He was limp, unresponsive (as if he wasn't there) when you waved your hands in front of his open eyes. He also kept startling at the slightest noise. Seizure type reaction; duration at least 1/2 hour. Was later dx'd with "Autistic Encephalopathy".
Age: 0.2
Sex: M
Vaccine: DTPHIB, OPV
Symptoms: Hypotonia
Clinical narrative: He was limp, unresponsive (as if he wasn't there) when you waved your hands in front of his open eyes. He also kept startling at the slightest noise. Seizure type reaction; duration at least 1/2 hour. Was later dx'd with "Autistic Encephalopathy".
Age: 1.4
Sex: M
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: A physician reported that a 17 month old male received his 2nd injection of Prevnar on 9/25/00. One day, post vax, the child was seen in the clinic after developing angioedema and urticaria. The child recovered. Both the investigator and the medical monitor considered the events to be "possibly" related to Prevnar administration.
Age: 1.25
Sex: F
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: A physician reported that a 14 month old female received her 2nd injection of Prevnar on 11/10/00. One day, post vax, the child was seen in the clinic after developing angioedema and urticaria. The child recovered. Angioedema was considered to be "Medically Important". Both the investigator and the medical monitor considered the events to be "possibly" related to Prevnar administration. Follow up information received 03/09/2001 clarified that the patient did not experience angioedema as originally reported. The patient experienced hives/urticaria only. Therefore, this report has been downgraded to non-serious.
Age: 1.4
Sex: M
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: Information has been received from an investigator concerning a 17 month old male child who received Prevnar on 12/8/00. The next day, post vax, the child was taken to a local clinic with urticaria and angioedema. The child has since recovered. Angioedema was considered a "Medically Important Event". Both the investigator and the medical monitor agree that this event was 'possibly' related to vaccine administration. Follow up information was received on 03/09/2001 that clarified that the patient did not experience angioedema as originally reported. the patient experienced hives/urticaria only. Therefore, this report has been downgraded to non-serious.
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: A physician reported that a 12 month old male received his 2nd Prevnar on 9/27/00. Two days, post vax, the child was seen in the clinic after developing angioedema and hives/urticaria. The child recovered. Both the investigator and the medical monitor considered the events to be 'possibly' related to Prevnar administration. Follow up information received 03/09/2001 clarified that the  patient did not experience angioedema as originally reported. The patient experienced hives/urticaria only. Therefore, this report has been downgraded to non-serious.
Age: 1.08
Sex: F
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: A physician reported that a 13 month old female received her 2nd Prevnar and the next day, experienced angioedema and hives/urticaria. The child recovered. Angioedema was considered to be "Medically Important". Both the investigator and the medical monitor considered the events to be 'possibly' related to Prevnar administration. Follow up information received 03/09/2001 clarified that the patient did not experience angioedema as originally reported. The patient experienced hives/urticaria only. Therefore, this report has been downgraded to non-serious.
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: Information has been received from an investigator concerning a 12 month old male child who received Prevnar on 9/26/00 and on the next day, the child was taken to a local clinic for urticaria and angioedema. The child has since recovered. Angioedema was considered a "Medically Important Event". Both the investigator and the medical monitor agree that this event was 'possibly' related to vaccine administration. Follow up information received on 03/09/2001 clarified that the patient did not experience angioedema as previously reported. The patient experienced urticaria only. Therefore, this report has been downgraded to non-serious.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: Information has been received from an investigator concerning a 26 month old female child who received Prevnar on 8/25/00 and the next day, the child was taken to a local clinic for urticaria and angioedema. The child has since recovered. Angioedema was considered a "Medically Important Event". Both the investigator and the medical monitor agree that this event was 'possibly' related to vaccine administration. Follow up information received 03/09/2001 clarified that the patient did not experience angioedema as previously reported. The patient experienced urticaria only. Therefore, this report has been downgraded to non-serious.
Age: 1.08
Sex: F
Vaccine: PNC
Symptoms: Angioneurotic oedema, Urticaria
Clinical narrative: Information has been received from an investigator concerning a 13 month old female child who received Prevnar on 5/1/00 and later that day, the child was taken to a local clinic for urticaria and angioedema. The child has since recovered. Angioedema was considered a "Medically Important Event". Both the investigator and the medical monitor agree that this event was 'possibly' related to vaccine administration.