chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: The morning following vax, the pt developed an injection site reaction characterized by an area of redness, swelling, and warmth, "the size of a quarter". The reaction became larger that evening. They physician instructed the mother to  administer acetaminophen and apply warm compresses to the injection site. The vaccine provider confirmed the event.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Somnolence
Clinical narrative: Following the vax, the pt became very sleepy. She was still sleepy on the following day. Additional information received from the vaccine provider indicated that the infant also received Infanrix, Pedvaxhib, and IPV.
Sex: U
Vaccine: PNC
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: The pt cried during the injection. Later the pt developed an injection site reaction characterized by redness and induration. No further information was available at the date of this report.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Rash, Urticaria
Clinical narrative: Within 48 hours post vax, she developed a rash and hives. She recovered.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Irritability
Clinical narrative: Within 24 hours, the pt developed an excessive irritability and inconsolable crying. The physician prescribed acetaminophen. She was seen by the physician on 7/10/00.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Rash
Clinical narrative: On 7/16/00, the infant developed a rash described as "diffuse fine sandpaper". The infant recovered.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Within a few hours post vax, the infant developed a fever of 103, which went as high as 103.4. The following day her temp was still 103.3. The infant was treated with Tylenol and the fever resolved in approximately 40 hours.
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: A physician reports that she gave herself an injection of Prevnar on 7/25/00 and subsequently developed an injection site reaction characterized by redness and swelling. This is 1 of 2 pt's from this facility who developed an injection site reaction following receipt of Prevnar, the pt's are husband and wife.
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: A physician reported that her husband received an injection of Prevnar on 7/25/00 and subsequently developed an injection site reaction characterized by redness and swelling.
Sex: F
Vaccine: PNC
Symptoms: Rash
Clinical narrative: A company representative reported that a female child received an injection of Prevnar and subsequently developed a rash. No further information is available.
Age: 1.25
Sex: M
Vaccine: DTPHIB, PNC
Symptoms: Injection site rash
Clinical narrative: One day post vax, the pt developed a rash at the Prevnar injection site and in the diaper area. The child recovered.
Age: 1.3
Sex: F
Vaccine: DTP, PNC
Symptoms: Erythema, Pyrexia, Urticaria, Vomiting
Clinical narrative: One day post vax, the child developed a fever of 101 degrees. Two days post vax the pt vomited. Three days post vax, the pt developed generalized, red, raised welts. The welts persisted as of 8/8/00.
Age: 1.7
Sex: F
Vaccine: PNC
Symptoms: Febrile convulsion
Clinical narrative: The morning following the vax, the child had a fever of 101. By that night, the fever had risen to 105. The fever was treated with alternating doses of acetaminophen and ibuprofen.
Sex: U
Vaccine: PNC
Symptoms: Muscle twitching
Clinical narrative: Pt experienced muscle twitching.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Urticaria
Clinical narrative: Red wheel, hot area about 4 cm around injection site. The reaction lasted for 2 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Post vax pt developed redness, swelling and severe pain from the injection site to the elbow. She was seen by the physician, who diagnosed cellulitis and prescribed an antibiotic. This is 1 of 2 patients from this facility to develop cellulitis at the injection site following receipt of vax lot #454-380 the patients are husband and wife. Follow-up information received from vax provider indicated that the final diagnosis was "severe immediate hypersensitivity". The patient was treated with diphenhydramine and recovered.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Joint swelling, Oedema, Polyarthritis, Rheumatoid factor
Clinical narrative: The pt developed swelling of an arm and pain in his joints, hand, wrist and fingers. The pt was seen by a rheumatologist who measured the pt's rheumatoid factor. An x-ray revealed swollen joints. A diagnosis of polyarthritis was made and the pt was treated with Naprosyn and prednisone.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Breast pain, Injection site oedema, Injection site pain, Oedema peripheral
Clinical narrative: Within 1 hour the patient developed swelling in one arm and foot. The next day she developed swelling in the other foot and soreness in her shoulder blades and genital area. As of Feb. 22, 1999, the swelling had not resolved. Follow-up information was received from the patient on June 1, 2000. She provided her past medical history beginning with events in 1991 through the present sciatic nerve involvement of right hip, groin and leg; gout in the big toe of her left foot, hypertension, cramping in her left calf. She stated that subsequent to the receipt of PNU-Immune-23 on Jan, 20, 1999, which was a booster to a previous vax, she developed an injection site reaction characterized by swelling and pain, followed by recurring bouts of swollen painful feet, enlarged big toe, sores on her lips and genitals, breast tenderness, pain beneath the shoulder blades, right hip pain extending down the leg into her circulatory blockage. In early 1999, her physician ordered blood work and a Doppler.  The results of the Doppler and blood work reportedly revealed nothing. Her physician later prescribed Naproxen for continuing pain and swelling in her right foot, In mid 2000, revealed hip degeneration. As of the date reported the patient continued to have ongoing pain, swelling and mobility problems. She supplied the name and address of her recent treating physician. The patient has directly submitted a report.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pelvic pain
Clinical narrative: Within 1 hour the patient developed swelling in one arm and foot. The next day she developed swelling in the other foot and soreness in her shoulder blades and genital area. As of Feb. 22, 1999, the swelling had not resolved. Follow-up information was received from the patient on June 1, 2000. She provided her past medical history beginning with events in 1991 through the present sciatic nerve involvement of right hip, groin and leg; gout in the big toe of her left foot, hypertension, cramping in her left calf. She stated that subsequent to the receipt of PNU-Immune-23 on Jan, 20, 1999, which was a booster to a previous vax, she developed an injection site reaction characterized by swelling and pain, followed by recurring bouts of swollen painful feet, enlarged big toe, sores on her lips and genitals, breast tenderness, pain beneath the shoulder blades, right hip pain extending down the leg into her circulatory blockage. In early 1999, her physician ordered blood work and a Doppler.  The results of the Doppler and blood work reportedly revealed nothing. Her physician later prescribed Naproxen for continuing pain and swelling in her right foot, In mid 2000, revealed hip degeneration. As of the date reported the patient continued to have ongoing pain, swelling and mobility problems. She supplied the name and address of her recent treating physician. The patient has directly submitted a report.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Vasodilatation
Clinical narrative: Injection site reaction. A 60-year-old female reported that she received a booster dose of Pnu-Imune 23 on 06-23-1999. The next day, the pt developed an injection site reaction characterized by swelling, redness, pain and warmth which extended to the wrist. The pt considered this to be an allergic reaction. She was treated with hydrocortisone cream and doxycycline. On 06-28-1999, slight redness persisted. Additional information received from the vax provider on 10/01/1999 did not confirm the diagnosis of allergic reaction. The pt recovered.
Age: 30.0
Sex: M
Vaccine: PPV, TD, PPV, TD
Symptoms: Injection site hypersensitivity, Pruritus, Vasodilatation
Clinical narrative: Within 24 hours, pt developed redness and itching on his right hand and then, his left hand. The pt also developed redness, then itching across his chest and redness on his anterior thighs, pubic area and slight redness on both deltoids. On September 29, 1999, he developed increased redness on deltoid area and increased skin temperature. That day the patient was seen by the physician and prescribed Benadryl 25mg, 1 to 2 capsules every 6 hours and a topical steroid cream, 3 times a day. This report was received from Merck (Ref. No. U1999007920). Additional information received 12/30/1999 from the physician indicated the patient recovered. The physician also indicated that the patient was a volunteer for a pharmaceutical study ( not at time of vaccination) and it is unknown whether he may have been exposed to substances which may have sensitized him to some component of the vaccine over time.
Age: 30.0
Sex: M
Vaccine: PPV, TD, PPV, TD
Symptoms: Body temperature increased, Erythema, Pruritus
Clinical narrative: Within 24 hours, pt developed redness and itching on his right hand and then, his left hand. The pt also developed redness, then itching across his chest and redness on his anterior thighs, pubic area and slight redness on both deltoids. On September 29, 1999, he developed increased redness on deltoid area and increased skin temperature. That day the patient was seen by the physician and prescribed Benadryl 25mg, 1 to 2 capsules every 6 hours and a topical steroid cream, 3 times a day. This report was received from Merck (Ref. No. U1999007920). Additional information received 12/30/1999 from the physician indicated the patient recovered. The physician also indicated that the patient was a volunteer for a pharmaceutical study ( not at time of vaccination) and it is unknown whether he may have been exposed to substances which may have sensitized him to some component of the vaccine over time.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A nurse reported that a 70 year old female received Pnu-Imune 23 and Flu Shield (1999-2000) on 10/20/99. Later that evening, she developed an injection site reaction at the site of the Pnu-Imune 23 site, characterized by erythema and swelling which extended to the elbow. Cellulitis was ruled out and the pt was treated with Benadryl. She recovered.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A nurse reported that a pt received an injection of Pnu-Imune 23 and Fluogen (Park-Davis) vaccines on 10/5/99 and subsequently, developed on injection site reaction, at the site of the Pnu-Imune 23 administration, characterized by "more" redness and swelling than usual. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune 23. Additional information received from the physician on 11/5/99, indicated that this pt is a 42 year old female who is allergic to generic Synthroid.
Age: 19.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypokinesia, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: A physician reported that a 19 year old female received Pnu-Imune 23 and 1999-2000 formula influenza virus vaccines on 10/25/99. Approx. 6 hours, post vax, she developed an injection site reaction characterized by warmth and swelling at the site of Pnu-Imune 23 administration; the reaction resulted in a decrease in range of motion. The pt recovered.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site mass
Clinical narrative: On Nov 6, 1999 pt developed urticaria, erythema and induration at the injection site. She was treated with Benadryl and recovered. This is 1 of 10 residents from this facility who had adverse experience following receipt of 2 different lots of vax.
Age: 88.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site mass
Clinical narrative: On Nov. 6, 1999, she developed an injection site reaction characterized by urticaria, erythema, and induration. She was treated with Benadryl 25 mg orally, every 4 hours and recovered. This is 1 of 10 residents from this facility who had an adverse experience following receipt of 2 different lots of PNU-Immune. This report was received from PMC U1999009800
Age: 88.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Urticaria
Clinical narrative: On Nov. 6, 1999, she developed an injection site reaction characterized by urticaria, erythema, and induration. She was treated with Benadryl 25 mg orally, every 4 hours and recovered. This is 1 of 10 residents from this facility who had an adverse experience following receipt of 2 different lots of PNU-Immune. This report was received from PMC U1999009800
Age: 78.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site mass, Pyrexia
Clinical narrative: On November 5, 1999, she developed an injection site reaction characterized by an 8 cm by 10 cm area of redness, urticaria, and induration and a fever. She was treated with Benadryl 25 mg orally, every 4 hours. She recovered on Nov. 09,1999. This is 1 of 10 residents from this facility who had an adverse experience following receipt of 2 different lots of Pnu-Imune. This report was received from PMC U1999-009630.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site induration, Pyrexia, Urticaria
Clinical narrative: On November 5, 1999, she developed an injection site reaction characterized by an 8 cm by 10 cm area of redness, urticaria, and induration and a fever. She was treated with Benadryl 25 mg orally, every 4 hours. She recovered on Nov. 09,1999. This is 1 of 10 residents from this facility who had an adverse experience following receipt of 2 different lots of Pnu-Imune. This report was received from PMC U1999-009630.
Age: 88.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site mass, Urticaria
Clinical narrative: A nurse reported that an 88 year old female received Pnu-Imune 23, as well as, Fluzone SV (PMC USA) vaccines mixed in a single syringe on 11/4/99. On 11/6/99, the pt developed urticaria, erythema and induration. The pt was treated with Benadryl; she recovered. Additional information received from the physician on 1/26/00, indicated that the pt remained recovered.
Age: 88.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Urticaria
Clinical narrative: A nurse reported that an 88 year old female received Pnu-Imune 23, as well as, Fluzone SV (PMC USA) vaccines mixed in a single syringe on 11/4/99. On 11/6/99, the pt developed urticaria, erythema and induration. The pt was treated with Benadryl; she recovered. Additional information received from the physician on 1/26/00, indicated that the pt remained recovered.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site mass
Clinical narrative: The pt received Pnu-Imune and Fluzone mixed in the same syringe. Two days later she developed an injection site reaction characterized by erythema, urticaria, and induration. She was treated with Benadryl every four hours and recovered.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Urticaria
Clinical narrative: The pt received Pnu-Imune and Fluzone mixed in the same syringe. Two days later she developed an injection site reaction characterized by erythema, urticaria, and induration. She was treated with Benadryl every four hours and recovered.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site mass, Urticaria
Clinical narrative: A nurse reported that a female resident of a nursing center received Pnu-Imune 23 and Fluzone '99-'00 vaccines mixed in the same syringe on 11/4/99. On 11/6/99, she developed urticaria, erythema and an induration at the injection site. She was treated with oral Benadryl 25mg every 4 hours. She recovered on 11/9/99. This is 1 of 10 residents from this facility who had an adverse experience following receipt of 2 different lots of Pnu-Imune.
Age: 93.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site mass, Urticaria
Clinical narrative: A nurse reported that a 93 year old female received Pnu-Imune 23 and Fluzone '99-'00 vaccines mixed in the same syringe on 11/4/99. On 11/6/99, she developed an injection site reaction characterized by erythema, urticaria and an induration. She was treated with Benadryl 25mg orally, every 4 hours. She recovered on 11/7/99. This is 1 of 10 residents from this facility who had an adverse experience following receipt of 2 different lots of Pnu-Imune.
Age: 93.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Urticaria
Clinical narrative: A nurse reported that a 93 year old female received Pnu-Imune 23 and Fluzone '99-'00 vaccines mixed in the same syringe on 11/4/99. On 11/6/99, she developed an injection site reaction characterized by erythema, urticaria and an induration. She was treated with Benadryl 25mg orally, every 4 hours. She recovered on 11/7/99. This is 1 of 10 residents from this facility who had an adverse experience following receipt of 2 different lots of Pnu-Imune.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site mass, Pruritus, Urticaria
Clinical narrative: A nurse reported that a 72 year old female received Pnu-Imune 23 and Fluzone '99-'00 vaccines mixed in the same syringe on 11/4/99. On 11/6/99, she developed an injection site reaction characterized by a 6cm X 8cm area of redness, itching, urticaria and induration. She was treated with Benadryl 25mg orally every 4 hours. She recovered on 11/9/99. This is 1 of 10 residents from this facility who had an adverse experience following receipt of 2 different lots of Pnu-Imune.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site induration, Pruritus, Urticaria
Clinical narrative: A nurse reported that a 72 year old female received Pnu-Imune 23 and Fluzone '99-'00 vaccines mixed in the same syringe on 11/4/99. On 11/6/99, she developed an injection site reaction characterized by a 6cm X 8cm area of redness, itching, urticaria and induration. She was treated with Benadryl 25mg orally every 4 hours. She recovered on 11/9/99. This is 1 of 10 residents from this facility who had an adverse experience following receipt of 2 different lots of Pnu-Imune.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site hypersensitivity, Injection site inflammation, Injection site mass, Injection site oedema, Pain
Clinical narrative: A 62 year old female received Pnu-Imune 23 on 10/27/99 and that afternoon, developed an injection site mass and an injection site reaction characterized by redness and swelling. That evening, the swelling extended to her elbow. On 10/28/99, the pt was seen by the physician. The next day, she experienced muscle pain in her neck which extended to her shoulder. The pt recovered.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Stupor
Clinical narrative: A 62 year old female received Pnu-Imune 23 on 10/27/99 and that afternoon, developed an injection site mass and an injection site reaction characterized by redness and swelling. That evening, the swelling extended to her elbow. On 10/28/99, the pt was seen by the physician. The next day, she experienced muscle pain in her neck which extended to her shoulder. The pt recovered.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site oedema, Myalgia, Neck pain
Clinical narrative: A 62 year old female received Pnu-Imune 23 on 10/27/99 and that afternoon, developed an injection site mass and an injection site reaction characterized by redness and swelling. That evening, the swelling extended to her elbow. On 10/28/99, the pt was seen by the physician. The next day, she experienced muscle pain in her neck which extended to her shoulder. The pt recovered.
Age: 60.0
Sex: M
Vaccine: HIBV, MEN, PPV, HIBV, MEN, PPV
Symptoms: Cerebrovascular accident
Clinical narrative: This male pt, the same day post vax, experienced 'stroke-like symptoms' and was brought to an ER. 'After extensive testing, it was determined that he had an embolic stroke and the reporter did not feel it was related to the vaxs.' The pt died 'either on 02/15/2000 or 02/16/2000.'
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV, IPV, DTAP, HIBV, IPV, DTAP, HIBV, IPV, DTAP, HIBV, IPV
Symptoms: Apnoea, Cardiac arrest, Sudden infant death syndrome
Clinical narrative: "A nurse reported that a 2 month old male pt received Hib-Titer, Tripedia and IPV vaccines on 5/2/00. In the morning of 5/3/00, the infant was found dead in his crib by his parents. No further information was available at the date of this report." A 15-day follow up report received 03/14/2003 adds: Reportedly on 05/03/2000, the pt was 'found apneic and asystolic, tied up in blankets less than 24 hours after visit'. Pt was pronounced dead and autopsy pending at state Medical Examiners office. From follow-up correspondence received on 05/18/2000, amendments in the route/site that the IPOL and the Hibtiter vaccinations were given were provided. Upon review of 10/13/2000, it was determined that there is a duplicate of this report. Report #U2000-00705 is a duplicate of this report. This report (U2000-00308) will be referred to as the report of reference. No further information has been obtained for this report. The case is closed. Follow-up #2 (latest received date 01/07/2003): During internal review of this case, it was confirmed to be a duplicate of case U2000-00705. Report U2000-00308 will continue to be the report of reference. Information obtained from case U2000-00705 included the route of administration for IPOL and HBPV-HIBTITER. An autopsy was performed by the State Medical Examiner's office. A report from Lederle Labs (HW536460MAY2000) stated that 'a nurse reported that a 2-month-old male received Hib-Titer, Tripedia (Aventis Pasteur Inc.) and IPV (Aventis Pasteur SA) vaccine on 05/02/2000. In the morning of 05/03/2000, the infant was found dead in his crib by his parents. No further information was available at the date of this report'. A 15-day follow up report received 6/23/2003 adds: No further info has been obtained for this report. The case is closed.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV, IPV, DTAP, HIBV, IPV, DTAP, HIBV, IPV, DTAP, HIBV, IPV
Symptoms: Sudden infant death syndrome
Clinical narrative: "A nurse reported that a 2 month old male pt received Hib-Titer, Tripedia and IPV vaccines on 5/2/00. In the morning of 5/3/00, the infant was found dead in his crib by his parents. No further information was available at the date of this report." A 15-day follow up report received 03/14/2003 adds: Reportedly on 05/03/2000, the pt was 'found apneic and asystolic, tied up in blankets less than 24 hours after visit'. Pt was pronounced dead and autopsy pending at state Medical Examiners office. From follow-up correspondence received on 05/18/2000, amendments in the route/site that the IPOL and the Hibtiter vaccinations were given were provided. Upon review of 10/13/2000, it was determined that there is a duplicate of this report. Report #U2000-00705 is a duplicate of this report. This report (U2000-00308) will be referred to as the report of reference. No further information has been obtained for this report. The case is closed. Follow-up #2 (latest received date 01/07/2003): During internal review of this case, it was confirmed to be a duplicate of case U2000-00705. Report U2000-00308 will continue to be the report of reference. Information obtained from case U2000-00705 included the route of administration for IPOL and HBPV-HIBTITER. An autopsy was performed by the State Medical Examiner's office. A report from Lederle Labs (HW536460MAY2000) stated that 'a nurse reported that a 2-month-old male received Hib-Titer, Tripedia (Aventis Pasteur Inc.) and IPV (Aventis Pasteur SA) vaccine on 05/02/2000. In the morning of 05/03/2000, the infant was found dead in his crib by his parents. No further information was available at the date of this report'. A 15-day follow up report received 6/23/2003 adds: No further info has been obtained for this report. The case is closed.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV, IPV, DTAP, HIBV, IPV, DTAP, HIBV, IPV, DTAP, HIBV, IPV
Symptoms: Apnoea, Cardiac arrest
Clinical narrative: "A nurse reported that a 2 month old male pt received Hib-Titer, Tripedia and IPV vaccines on 5/2/00. In the morning of 5/3/00, the infant was found dead in his crib by his parents. No further information was available at the date of this report." A 15-day follow up report received 03/14/2003 adds: Reportedly on 05/03/2000, the pt was 'found apneic and asystolic, tied up in blankets less than 24 hours after visit'. Pt was pronounced dead and autopsy pending at state Medical Examiners office. From follow-up correspondence received on 05/18/2000, amendments in the route/site that the IPOL and the Hibtiter vaccinations were given were provided. Upon review of 10/13/2000, it was determined that there is a duplicate of this report. Report #U2000-00705 is a duplicate of this report. This report (U2000-00308) will be referred to as the report of reference. No further information has been obtained for this report. The case is closed. Follow-up #2 (latest received date 01/07/2003): During internal review of this case, it was confirmed to be a duplicate of case U2000-00705. Report U2000-00308 will continue to be the report of reference. Information obtained from case U2000-00705 included the route of administration for IPOL and HBPV-HIBTITER. An autopsy was performed by the State Medical Examiner's office. A report from Lederle Labs (HW536460MAY2000) stated that 'a nurse reported that a 2-month-old male received Hib-Titer, Tripedia (Aventis Pasteur Inc.) and IPV (Aventis Pasteur SA) vaccine on 05/02/2000. In the morning of 05/03/2000, the infant was found dead in his crib by his parents. No further information was available at the date of this report'. A 15-day follow up report received 6/23/2003 adds: No further info has been obtained for this report. The case is closed.
Age: 0.08
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Apnoea, Haemoglobin decreased, Hypotonia, Stupor
Clinical narrative: The pt received the vaccines on 5/25/00 and subsequently developed a hypotonic reaction. The pt was hospitalized and placed on a ventilator. Follow up information received on 7/18/00 indicated that one day post vax, the pt became restless, very quiet and did not breathe well. He required assisted ventilation. The reporter indicated that the pt recovered, however, the reporter also indicated that there may be problems later and that permanent disability is "to be determined."
Age: 0.08
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Dyspnoea, Hypotonia, Mental impairment, Restlessness
Clinical narrative: The pt received the vaccines on 5/25/00 and subsequently developed a hypotonic reaction. The pt was hospitalized and placed on a ventilator. Follow up information received on 7/18/00 indicated that one day post vax, the pt became restless, very quiet and did not breathe well. He required assisted ventilation. The reporter indicated that the pt recovered, however, the reporter also indicated that there may be problems later and that permanent disability is "to be determined."
Age: 0.08
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Depersonalisation, Dyspnoea, Hypotonia, Hypoxia, Restlessness
Clinical narrative: The pt received the vaccines on 5/25/00 and subsequently developed a hypotonic reaction. The pt was hospitalized and placed on a ventilator. Follow up information received on 7/18/00 indicated that one day post vax, the pt became restless, very quiet and did not breathe well. He required assisted ventilation. The reporter indicated that the pt recovered, however, the reporter also indicated that there may be problems later and that permanent disability is "to be determined."
Age: 33.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Asthenia, Feeling hot, Pain, Pyrexia, Rash
Clinical narrative: A nurse reported that a 33 year old female received her 2nd dose of Pnu-Imune 23 on 4/18/00. Her 1st dose of Pnu-Imune 23 was administered in 1997. At 12:00 on 4/18/00, the pt felt warm. That evening, she developed chills, aches, and generalized weakness. She also developed pain at the injection site and a rash just below the injection site. The next morning, she took her temperature; it was 100F. The fever, chills and aches persisted throughout that day. She recovered on 4/20/00.
Age: 33.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Asthenia, Injection site pain, Injection site rash, Pain, Pyrexia
Clinical narrative: A nurse reported that a 33 year old female received her 2nd dose of Pnu-Imune 23 on 4/18/00. Her 1st dose of Pnu-Imune 23 was administered in 1997. At 12:00 on 4/18/00, the pt felt warm. That evening, she developed chills, aches, and generalized weakness. She also developed pain at the injection site and a rash just below the injection site. The next morning, she took her temperature; it was 100F. The fever, chills and aches persisted throughout that day. She recovered on 4/20/00.
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV
Symptoms: Ascites, Blood bilirubin increased
Clinical narrative: The same day of vax, the pt had routine lab tests and her bilirubin was elevated to 34.2 and that evening she was hospitalized. On 5/25/00, inpatient labs were performed and the pt underwent a Kasal procedure. Post surgery she developed ascites. The pt was transferred to a tertiary care facility on 5/21/00 and a liver transplant was performed. She developed complications and expired on 6/8/00. The pt had a concurrent medical history of biliary atresia and neonatal hepatitis. The reporter indicated that the pt's death was "clearly unrelated to vaccination." From follow up correspondence received on 10/23/00, it was reported the no additional information is available at this time.
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV
Symptoms: Ascites, Blood bilirubin increased, Liver disorder
Clinical narrative: The same day of vax, the pt had routine lab tests and her bilirubin was elevated to 34.2 and that evening she was hospitalized. On 5/25/00, inpatient labs were performed and the pt underwent a Kasal procedure. Post surgery she developed ascites. The pt was transferred to a tertiary care facility on 5/21/00 and a liver transplant was performed. She developed complications and expired on 6/8/00. The pt had a concurrent medical history of biliary atresia and neonatal hepatitis. The reporter indicated that the pt's death was "clearly unrelated to vaccination." From follow up correspondence received on 10/23/00, it was reported the no additional information is available at this time.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection, Scar
Clinical narrative: Zoster developed on 7/3/00 on right thigh (same location of Vaccine given on 3/8/00), with multiple deep lesions, resulting in scarring. Confirmed by Dermatology
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Nausea
Clinical narrative: Erythema, pain at injection site (right deltoid), and nausea on and off with chills.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Asthma, Cold sweat, Dizziness, Feeling cold, Hyperhidrosis
Clinical narrative: Within 5 minutes, post vax, pt became diaphoretic, cold and pale with no evidence of seizure activity. Within a few minutes, pt was complaining of being sleepy and slept for 2 hours but was still clammy and he was faint when standing up. He was fed and seemed to improve. He vomited on the way home from office and was clammy again. Admitted to hospital for observation. Seemed totally recovered by 12 hours, post vax.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Hyperventilation, Hypotension, Pallor, Somnolence, Tachycardia
Clinical narrative: Within 5 minutes, post vax, pt became diaphoretic, cold and pale with no evidence of seizure activity. Within a few minutes, pt was complaining of being sleepy and slept for 2 hours but was still clammy and he was faint when standing up. He was fed and seemed to improve. He vomited on the way home from office and was clammy again. Admitted to hospital for observation. Seemed totally recovered by 12 hours, post vax.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Vomiting
Clinical narrative: Within 5 minutes, post vax, pt became diaphoretic, cold and pale with no evidence of seizure activity. Within a few minutes, pt was complaining of being sleepy and slept for 2 hours but was still clammy and he was faint when standing up. He was fed and seemed to improve. He vomited on the way home from office and was clammy again. Admitted to hospital for observation. Seemed totally recovered by 12 hours, post vax.
Age: 10.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Pt developed apparent shingles of the central compartment of the dermatome on the right.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt's arm became sore, swollen and red on 9/28/00. Pt did not develope fever. Encouraged to come to office to be examined. Pt unable to get transportation. Called pt on 9/29/00 and arm was less swollen and red and the pain was completely gone. Condition is improving on date this form was filled out.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Pain
Clinical narrative: Pt was given vaccine on 9/25/00. Received call from Rehabilitation program on 9/28/00. Stated pt called and was unable to come to class because her arm was too sore to move. Attempted to call pt on 9/28/00 and 9/29/00 and was unable to reach. Reviewed message on 10/2/00 from pt that stated her arm was not as swollen and the soreness was almost diminished completely.
Age: 1.25
Sex: F
Vaccine: DTAP, HEP, HIBV
Symptoms: Cellulitis, Dry throat, Ear pain, Injection site hypersensitivity, Injection site vesicles
Clinical narrative: The pt experienced ear pain, throat dryness and was diagnosed in the ER with cellulitis of the left thigh. 2 blisters at the site were aspirated and a culture was sent out. IV antibiotics started and told to start antibiotics by mouth later that day. Thigh was very swollen.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Asthma, Condition aggravated, Eczema, Lethargy, Pyrexia
Clinical narrative: The pt experienced lethargy, high fever, asthma, and eczema flared up for 4-5 days after received the 1st dose of Hepatitis A.
Age: 1.5
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Blister, Dermatitis
Clinical narrative: The pt experienced vesicular dermatitis on the left side of the face and neck.
Age: 1.3
Sex: M
Vaccine: HIBV, MMR
Symptoms: Agitation, Pyrexia, Rash
Clinical narrative: The pt experienced a pale pink rash on his trunk, frequent and long lasting temper tantrums, crying over an hour, low grade fever, high fever of 103 with an onset of 8 days post vax, dark pink uneven rash on whole body with a duration of 4 days. Treated with Benadryl and Tylenol.
Age: 0.75
Sex: U
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: The pt experienced redness and induration that measured 10 x 5cm on left thigh.
Age: 1.9
Sex: M
Vaccine: MMR
Symptoms: Convulsion, Pyrexia, Rash
Clinical narrative: The vaccine was given on 9/14/00, By Saturday evening on 9/18/00 the pt developed a fever of 99. His temp rose to 102 and then to 105 in one ear and 104.3 in the other. The pt was given Motrin. The pt then suffered a seizure. After being cooled down in the Ambulance, his fever was 104.3. His fever fluctuated in the 99 - 100 range. He also experienced a rash on his torso.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Oedema
Clinical narrative: The pt experienced swelling at site and from elbow to shoulder on side opposite injection site. The pt had a fevered red hot elbow and forearm. Does not hurt. Injection site not sore.
Sex: U
Vaccine: DTAP
Symptoms: Arthralgia, Fatigue, Hyperhidrosis
Clinical narrative: On 8/28/00, an adult pt was inadvertently administered a dose of Acel-Imune instead of Tetanus Diphtheria toxoid. The pt reported feeling "tired", with achy joints, and sweating profusely. Symptoms started on the day of the injection and continues as of day reported.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Gait disturbance, Injection site erythema, Injection site haemorrhage, Injection site oedema
Clinical narrative: Grandmother brought child in and the right thigh was red and swollen at the site of injection. It is red all over the thigh with a quarter sized bruise at injection site. The pt experienced limping. Use Benadryl and cold compresses if needed. By the next day, the child was doing much better. After a few days the child was ok.
Age: 4.75
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Chills, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: The parent related a high temperature (never taken) headache, chilling and then sweating. Treatment of bath and Tylenol. This was reported by Dad.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Abortion spontaneous
Clinical narrative: 48 hours post vax, the pt had a miscarriage.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema
Clinical narrative: Within 1 minute of vax, the pt experienced a localized red 7 x 7cm area on outer right thigh. The pt was given Benadryl and the redness lasted approximately 45 minutes.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain
Clinical narrative: The pt complained of continued soreness post vax. Pt denies redness, swelling, fever or hot to the touch areas of the arm. Pt does report she had not had a TD booster in more than 30 years. Pt reports she had used Tylenol or ibuprofen without much improvement and quit using them.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site warmth, Oedema, Pruritus
Clinical narrative: 6 hours post vax, the pt experienced itching in the right deltoid area. The following morning on 8/30/00 the pt experienced swelling, redness, and the area was hot to the touch. On 9/1/00 a bruise developed on lower deltoid inside a 2mm area.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Feeling cold, Multiple sclerosis, Paraesthesia
Clinical narrative: On 9/16/99, the pt experienced tingling, the feet were "asleep" to the knees, cold and numbness to the side going to the vaginal area. 9/99 saw an MD for blood work, and 2 MRI's. The pt was referred to a neurologist. Diagnosis of MS.
Age: 18.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Unevaluable event
Clinical narrative: The pt received the vaccine on 8/15/00. The pt notified the health department on 8/29/00 that she just learned that she is pregnant. She is concerned about possible side effects to the baby. She has no adverse events at this time.
Age: 6.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: The pt experienced a fever, right arm swelling, redness and warmth to the touch. On 9/22/00, the pt's fever has decreased and the pt is much better.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Screaming
Clinical narrative: The pt experienced screaming for 6 hours after receiving vax. The screaming started 1 hour post injections. The MD has stated that the Pertussis vax should not be given.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pain, Rash
Clinical narrative: Post vax, the pt developed weeping, red, sore skin on buttocks. A small diffuse sandpaper rash along inside length of arms, along upper torso and on left forearm. Treated with Fluocinonide cream. Scaly lesions on buttocks, persistent.  Follow up 10/25/2000: "Patient partially recovered from adverse event.  Flaking, psoriatic lesions on lower termini of both buttocks.  More lesions on left buttock, recurrent sandpaper rash on left forearm.  continued yellow discoloration of bedsheets and t-shirts from upper torso.  Patient received further anthrax shots since reported event.  The event from that was localized sandpaper rash inside of tricep on shot arm, snuggling."
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Urticaria
Clinical narrative: 15 minutes post vax, the pt developed 4 tiny hives on feet. Hives were about 3 mm in diameter. No other symptoms.
Age: 1.5
Sex: F
Vaccine: PNC
Symptoms: Hyperpyrexia, Lethargy
Clinical narrative: The pt developed hyperpyrexia of over 105 within 12 hours of vaccine and lethargy.
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Coordination abnormal, Irritability, Pyrexia
Clinical narrative: Post vax, the pt developed a temperature of 102. Two days later became ataxic and hyperirritable. Hospitalized overnight. Back to normal within 48 hours.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Conjunctival discolouration, Eyelid oedema, Injection site rash, Sneezing, Urticaria
Clinical narrative: The pt developed a rash around the injection site and swollen eyelids, red conjunctivitis, sneezing, hive on body. The pt has autism. Treated with Benadryl.
Age: 4.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema
Clinical narrative: Post vax, the pt developed a large circular area of erythema around injection on left upper arm. Treated with Benadryl.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Bacterial infection, Febrile convulsion, Upper respiratory tract infection, Urinary tract infection
Clinical narrative: On 4/29/00, the infant was seen in the ER, due to febrile seizures and probable UTI. The infant was hospitalized. The infant was discharged from the hospital with a dx of UTI. The infant was seen in the clinic on 5/20/00. The clinic physician made dx of UTI and URI. The infant recovered fully. Both the investigator and the medical monitor agree that the febrile seizure and UTI are not reasonably related to Prevnar administration.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, OPV
Symptoms: Autism, Cough, Dyspnoea, Laryngitis, Pyrexia
Clinical narrative: On 8/25/93, the infant developed a fever of 104 and viral croup. He was hospitalized. Subsequently, he developed a bleeding rash on his cheeks and was reportedly dx with autism. The mother attributed these events to the vaccines he received since the age of 4 months. She also believes that the preservative thimerosal is related to the development of autism.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, OPV
Symptoms: Rash, Similar reaction on previous exposure to drug
Clinical narrative: On 8/25/93, the infant developed a fever of 104 and viral croup. He was hospitalized. Subsequently, he developed a bleeding rash on his cheeks and was reportedly dx with autism. The mother attributed these events to the vaccines he received since the age of 4 months. She also believes that the preservative thimerosal is related to the development of autism.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A pharmacy student reported that a patient inadvertently received an intradermal injection of Pnu-Imune and subsequently developed and injection site reaction characterized by redness and swelling. This reporter indicated that 2 patients experienced this event; however they are presently not identifiable.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Rhinitis
Clinical narrative: Immediately post injection, she developed swelling at the injection site. Within 10 hours, her arm was huge and red and she could not use it. After the reaction she developed chronic rhinitis. She was treated with unspecified prescription medicine.
Age: 13.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Pyrexia, Vomiting
Clinical narrative: Post vax, pt developed a low-grade fever, vomiting, and an injection site reaction characterized by redness and pain. The pt was treated with Tylenol and warm baths; he recovered within 36 hours.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Post vax, pt developed an injection site reaction characterized by redness and swelling, and muscle pain radiating down the arm. Additional information received from the MD on May 17, 2000 indicated that the pt recovered. This is 1 of 2 pts from this facility who experienced this event following injection.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Pt was prescribed Flagyl, Tessalon Pearls and Guaiffen LA at same time of vax. Four days post vax, pt developed low grade fever, nausea and headache. Pt stated she cannot tell if these symptoms were medicine related or vax related.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cough, Guillain-Barre syndrome, Inflammation, Neuropathy peripheral, Pain
Clinical narrative: At the time of vax, the pt had a chronic cough which persisted following immunization. The pt was prescribed AUGMENTIN and a decongestant and subsequently developed inflammation and neuropathy of the legs. Additional information was received from the vaccine provider on Nov. 4, 1999 and Nov 15, 1999. The vaccine provider indicated that a diagnosis of GUILLIAN-BARRE syndrome had been made. He indicated that the pt had not recovered and was permanently disabled.  Additional information was received from pts neurologist on 01-05-2000.  One week post vax, she experienced pain in her legs, however she could pick up her legs. Neurologists made diagnosis of inflammation and neuropathy of the legs. The pt was treated with a course of oral prednisone therapy and a course of IV immune globulin. The neurologist stated that the pt was not hospitalized; she did not recover, but was not permanently disabled. THis event is considered medically inportant.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Drug ineffective, Pain, Pyrexia, Sepsis
Clinical narrative: a physician reported that his 33 year old asplenic daughter received an injection of Pnu-immune 23 in 01/99 following a case of pneumoccal sepsis with disseminated intravascular coagulation. On 10/23/99, she felt achy anf developed shakes and a fever of 103 degrees F.  She was hospitalized with a diagnosis of pneumococcal sepsis (serotype not provided). Upon internal review on 01/29/02, this case will be redistributed to reflect change in code from vaccination failure to drug ineffective.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: a physician reported that his 33 year old asplenic daughter received an injection of Pnu-immune 23 in 01/99 following a case of pneumoccal sepsis with disseminated intravascular coagulation. On 10/23/99, she felt achy anf developed shakes and a fever of 103 degrees F.  She was hospitalized with a diagnosis of pneumococcal sepsis (serotype not provided). Upon internal review on 01/29/02, this case will be redistributed to reflect change in code from vaccination failure to drug ineffective.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Post vax, the pt experienced an adverse reaction. No further information is available.