chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Blister, Erythema, Hypersensitivity, Oedema peripheral, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm redness in a 4-year-old female subject who was vaccinated with diphtheria an tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) plus a separate injection of inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) for prophylaxis. The healthcare professional reported this case directly to VAERS. The subject had no pre-existing medical conditions and no illness at the time of vaccination, 26 September 2006. Concurrent medications included Multivitamins (Multivitamin). On 26 September 2006 at 6:30 p.m., the subject received 5th dose of Infanrix in the left deltoid and the 4th dose of IPOL in the left arm. On 26 September 2006 at 6:30 p.m., the subject also received an injection of live attenuated measles, mumps (strain not specified), rubella vaccine (MMR II vaccine, Merck) in the right arm. The "evening" of 26 September 2006, less than one day after vaccination with IPOL and Infanrix, the subject experienced left arm redness. The subject was treated with ibuprofen (Motrin). On 27 September 2006, the redness extended from the upper left arm to the elbow. On 28 September 2006, the left arm swelled "to twice the size of the right arm." The left arm was "red, swollen on top of the shoulder, hard, feverish, and the size of a baseball." By the evening of 28 September 2006, the arm redness turned a "brownish reddish color." At 7:30 p.m. on 28 September 2006, the subject experienced arm pain. At 9:00 p.m. on 28 September 2006, "little blisters appeared on th arm in the brownish red area." The subject was seen in an emergency room on 28 September 2006. At this time, the blisters "had grown to pencil eraser size with smaller blisters appearing." The subject was treated with steroid (Steroids). On 29 September 2006, the subject was seen at a physician's office. At the physician's office it was noted that the arm redness and swelling were decreasing, but that the blisters had "increased in size to nickel and quarter sizes." The physician prescribed silver sulfadiazine (Silver sulphadiazine) for the blisters, clindamycin phosphate (Cleocin) for a "possible staphylococcal infection," and prednisolone "for the allergic reaction." On 02 October 2006, the subject was again seen at the physician's office. As of 02 October 2006, the reporter noted that the subject, "improving, arm is now covered, some blisters have broken; no secondary infections, skin on the arm is rough." This case was also reported from the health professional via a sales representative. Additional information included that a sibling of the subject had swelling and a feverish reaction at the injection site following receipt of the 5th dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Adacel). The health professional considered the events to be probably related to vaccination with Infanrix.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm swollen in a 6-year-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix, GlaxoSmithKline) plus a separate injection of inactivated poliomyelitis virus vaccine (IPOL) for prophylaxis. On 03 October 2006 the subject received 5th dose of Infanrix (lot AC14A007BA) in an unspecified arm. The expiration date for this lot of Infanrix is 11 September 2006. On 03 October 2006 the subject also received 4th dose of IPOL in the opposite arm. On 03 October 2006 and on or before 05 October 2006, the father of the subject reported to the healthcare profession that the subject's arm was red and swollen. The healthcare professional reported that she did "not recall if the redness and swelling was in the arm in which Infanrix was given." The outcome of redness and swelling was not reported.
Sex: M
Vaccine: DTAP
Symptoms: Drug ineffective, Laboratory test, Pertussis
Clinical narrative: This case was reported by an consumer and described the occurrence of possible pertussis in a male child who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline for prophylaxis. The reported is the mother of the subject. A physician or other health care professional has not verified this report. On an unspecified date in 2000 the subject received a dose of Infanrix (dose number not reported). On an unspecified date in 2006 on or before 06 October 2006, 6 years after vaccination with Infanrix, the subject experienced a possible pertussis infection and lack of effect. The subject was seen at a physician's office. The mother of the subject reported on 06 October 2006 that she was, "awaiting verification of lab results." The outcome of the event was not reported. Follow-up will not be available.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema
Clinical narrative: This case was reported by a physician and described the occurrence of red raised skin on arms in a 2-year-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix, GlaxoSmithKline) for prophylaxis. The subject's medical history, concurrent conditions and concurrent medications were not reported. On 22 October 1998 the subject received unspecified dose of Infanrix at 0.5 ml, intramuscularly in an unknown thigh. Th lot number and expiration date were not provided. The following day, on 23 October 1998, the subject developed a red, raised area on his arm down to his elbow. The event resolved on 25 October 2006. Further treatment with Infanrix was delayed. The physician was questioning if the subject should receive the next dose of Infanrix in the series. No additional information was provided.
Age: 0.6
Sex: F
Vaccine: DTAP
Symptoms: Tremor
Clinical narrative: This case was reported by a consumer and described the occurrence of tremor in a 7-month-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. Th reported is the mother of the subject. A physician or other health care professional has not verified this report. The subject had no pre-existing medical conditions. There were no concurrent medications. On an unspecified date in July 2006 the subject received 2nd dose of Infanrix. On an unspecified date in either July 2006 or August 2006, 4 days after vaccination with Infanrix, the subject experienced tremor. The consumer reported that the subject, "would have a tremor every two or three days, then went for two weeks without a tremor, then she had a tremor and then none since." The subject was seen at a physician's office. The tremors resolved on an unspecified date in 2006.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth, Swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling of limb in a 6-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The subject's medical history include birth twin. There were no concurrent medications. On 17 October 2006 the subject received 4th dose of Infanrix in the right thigh. On 17 October 2006, the subject was also injected with inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) in the left thigh. On 20 October 2006, 3 days after vaccination with Infanrix, the subject experienced swelling of the right limb, injection site redness and injection site warmth at the site of the Infanrix injection. The subject was seen at a physician's office. At the time of initial reporting, 20 October 2006, the events were ongoing. The healthcare professional considered the events probably related to vaccination with Infanrix.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth, Swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling of limb in a 6-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. The subject's medical history included birth twin. There were no concurrent medications. On 17 October 2006 the subject received 4th dose of Infanrix in the right thigh. On 17 October 2006, the subject was also injected with inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur) in the left thigh. On 20 October 2006, 3 days after vaccination with Infanrix, the subject experienced swelling of the right limb, injection site redness and injection site warmth at the site of Infanrix injection. the subject was seen at a physician's office. At the time of initial reporting, 20 October 2006, the events were ongoing. The healthcare professional considered the events were probably related to vaccination with Infanrix.
Age: 42.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Epistaxis, Headache, Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of headache in a 42-year-old female subject who was inadvertently vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline). The reporter is the subject. A physician or other health care professional has not verified this report. The subject's medical history included allergic bronchopulmonary aspergillosis, allergies, elevated cholesterol, Hashimoto's disease and menopausal. Concurrent medications included Montelukast sodium (Singular), Thyroxine sodium (Levothyroxin), Atorvastatin calcium (Lipitor), Fluticasone propionate (Flonase), Calcitriol (Calcitrol), Calcium carbonate (OsCal 500), Estrogen (Estrogen patch), Fluticasone propionate (Flovent) and Prednisone.  On 06 November 2006 at 10:00 a.m., the subject inadvertently received 1st dose of Infanrix in the left arm. Infanrix is not recommended for immunizing individuals 7 years of age or older. On 06 November 2006, less than one day after vaccination with Infanrix, the subject experienced headache, chills, and injection site tenderness. On 07 November 2006, the subject experienced epistaxis. The subject was seen at physician's office. The chills resolved on 07 November 2006. At the time of initial reporting, 08 November 2006, the headache and injection site tenderness had improved and the epistaxis was ongoing.
Age: 42.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: This case was reported by a consumer and described the occurrence of headache in a 42-year-old female subject who was inadvertently vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline). The reporter is the subject. A physician or other health care professional has not verified this report. The subject's medical history included allergic bronchopulmonary aspergillosis, allergies, elevated cholesterol, Hashimoto's disease and menopausal. Concurrent medications included Montelukast sodium (Singular), Thyroxine sodium (Levothyroxin), Atorvastatin calcium (Lipitor), Fluticasone propionate (Flonase), Calcitriol (Calcitrol), Calcium carbonate (OsCal 500), Estrogen (Estrogen patch), Fluticasone propionate (Flovent) and Prednisone.  On 06 November 2006 at 10:00 a.m., the subject inadvertently received 1st dose of Infanrix in the left arm. Infanrix is not recommended for immunizing individuals 7 years of age or older. On 06 November 2006, less than one day after vaccination with Infanrix, the subject experienced headache, chills, and injection site tenderness. On 07 November 2006, the subject experienced epistaxis. The subject was seen at physician's office. The chills resolved on 07 November 2006. At the time of initial reporting, 08 November 2006, the headache and injection site tenderness had improved and the epistaxis was ongoing.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Decreased appetite, Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 2-year-old male subject who was vaccinated with Infanrix, GlaxoSmithKline. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. The subject had no pre-existing medical conditions. There were no concurrent medications. On 12 August 2005 the subject received 4th dose of Infanrix. On 12 August 2005, 4 hours after vaccination with Infanrix, the subject experienced a "high" fever. "A few days later," on an unspecified date in August 2005, the subject experienced lack of appetite and vomiting. The consumer reported that the subject "was taken to the hospital where blood tests were run." The subject was not admitted to the hospital. The results of the blood tests were not provided. The fever resolved on 17 August 2005 and the lack of appetite and vomiting resolved in "about a week" on an unspecified date in 2005.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Oedema peripheral
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of swelling of limb in a 5-year-old male subject who was vaccinated with Infanrix (GlaxoSmithKline). On an unspecified date in November 2006 the subject received 5th dose of Infanrix at an unspecified site of injection. On an unspecified date in November 2006, less than one week after vaccination with Infanrix, the subject experienced swelling of limb. The event resolved on an unspecified date on or before 01 December 2006. The healthcare professional considered the event was probably related to vaccination with Infanrix.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration, Injection site erythema
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site redness in a 3-year-old male subject who was vaccinated with Infanrix, GlaxoSmithKline or Pediarix. A physician or other health care professional has not verified this report. The reporter was the subject's father. There was not relevant medical history or concurrent medications. On an unspecified date on or prior to 17 January 2007, the subject received 4th dose of Infanrix (unknown) or 4th dose of Pediarix (unknown). The father of the subject was not sure if the subject received Pediarix or Infanrix. The reporter also "believed" it was the 4th dose of the vaccination. At an unspecified time after vaccination with Infanrix or Pediarix, the subject experienced localized redness at injection site. The subject's health care provider was consulted. In addition, the subject received the 4th dose three months after the last dose he had received, which was sooner than is recommended. According to the Infanrix prescribing information, the recommended interval between the 3rd and 4th dose is 6 to 12 months. At the time of reporting the outcome of the events were was unspecified.
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by an other manufacturer and described the occurrence of injection site redness in a male subject of unspecified age who was vaccinated with DTaP, manufacturer unspecified. On an unspecified date the subject received unspecified dose of DTaP (unknown). On or before 24 January 2007, at an unspecified time after vaccination with DTaP, the subject experienced injection site redness and swelling injection site. At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of swelling of the injection site in a female subject of unspecified age who was vaccinated with Infanrix, GlaxoSmithKline. On an unspecified date the subject received unspecified dose of Infanrix in an unknown thigh. At an unspecified time after vaccination with Infanrix, the subject experienced swelling injection site. At the time of reporting the outcome of the event was unspecified.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 5-year-old female subject who was vaccinated with Infanrix, GlaxoSmithKline. The subject's medical history included abdominal pain. The subject had no adverse events following receipt of prior immunizations. Concurrent medications included Paracetamol (Tylenol). On 01 February 2007 at 2:00 p.m., the subject received 5th dose of Infanrix in the left arm. On 01 February 2007, less than one day after vaccination with Infanrix, the subject experienced swelling injection site. The event resolved on an unspecified date on or after 01February2007 and on or before 16 February 2007.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 15-month-old male subject who was vaccinated with Infanrix, GlaxoSmithKline. The subject had no adverse events following receipt of prior immunizations. The subject had no pre-existing medical conditions. The subject's concurrent conditions were not reported. There were no concurrent medications. On 09 March 2007 at 9:00 a.m., the subject received 4th dose of Infanrix in the right arm. On 09 March 2007, the subject also received injections of PedvaxHIB (Merck) and Prevnar (Wyeth Labs) at unspecified sites of administration. Approximately "24 to 48 hours later," on an unspecified date in March 2007, the subject experienced redness and edema at the injection site of the Infanrix administration. The reporter considered the events to be due to potential quality issue for this lot of Infanrix. The events resolved on an unspecified date on or before 14 March 2007. No treatment was required.
Age: 1.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in an 18-month-old male subject who was vaccinated with Infanrix, GlaxoSmithkline. The subject had no adverse events following receipt of prior immunizations. The subject had no pre-existing medical conditions. The subject's concurrent conditions were not reported. There were no concurrent medications. On 06 March 2007 at 9:00 a.m., the subject received 4th dose of Infanrix in the left arm. On 06 March 2007, the subject also received an injection of Prevnar at an unspecified site of administration. On 07 March 2007, 1 day after vaccination with Infanrix, the subject experienced redness and edema at the injection site of Infanrix injection and edema at the site of the Infanrix injection "down to the elbow." The subject was seen at a physician's office and was treated with cool compress, ibuprofen (Advil) and diphenhydramine hydrochloride (Benadryl). The reporter considered the events to be due to potential quality issue for this lot of Infanrix. The events resolved on an unspecified date on or before 14 March 2007.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 5-year-old female subject who was vaccinated with Infanrix, GlaxoSmithKline. Concurrent medical conditions included latex allergy. The subject had no adverse events following receipt of prior immunizations. There were no concurrent medications. On 12 March 2007 at 10:30 a.m., the subject received 5th dose of Infanrix in the right arm. On 12 March 2007, the subject also received injections of IPOL vaccine (Aventis Pasteur), MMR II and a PPD (Parkdale) skin test at unspecified sites of administration. On 13 March 2007, 1 day after vaccination with Infanrix, the subject experienced redness, swelling, and pain at the injection site of Infanrix and "down the subject's arm about 5 cm." The subject was seen at a physician's office and was treated with cephalexin (Keflex). The reporter considered the events to be due to potential quality issue for this lot of Infanrix. The outcome of the events was not reported.
Age: 43.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Acoustic stimulation tests, Deafness, Vertigo
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of unilateral hearing loss in a 43-year-old male subject who was vaccinated with Twinrix for prophylaxis prior to travel. Concurrent vaccination included Td given on 11 May 2007, and inactivated poliomyelitis virus vaccine (unknown) given on 11 May 2007. There were no concurrent medications. On 11 May 2007 the subject received the first dose of Twinrix (unknown, left arm). On 11 May 2007, less than one day after vaccination with Twinrix, the subject experienced unilateral hearing loss. This case was assessed as medically serious by manufacturer. On 12 May 2007, the subject presented for examination due to hearing loss. At the time of reporting the outcome of the event was was unspecified.
Age: 43.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Blood test, Body temperature increased, Nausea, Nuclear magnetic resonance imaging normal, Sudden hearing loss
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of unilateral hearing loss in a 43-year-old male subject who was vaccinated with Twinrix for prophylaxis prior to travel. Concurrent vaccination included Td given on 11 May 2007, and inactivated poliomyelitis virus vaccine (unknown) given on 11 May 2007. There were no concurrent medications. On 11 May 2007 the subject received the first dose of Twinrix (unknown, left arm). On 11 May 2007, less than one day after vaccination with Twinrix, the subject experienced unilateral hearing loss. This case was assessed as medically serious by manufacturer. On 12 May 2007, the subject presented for examination due to hearing loss. At the time of reporting the outcome of the event was was unspecified.
Age: 43.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Vertigo, White blood cell count increased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of unilateral hearing loss in a 43-year-old male subject who was vaccinated with Twinrix for prophylaxis prior to travel. Concurrent vaccination included Td given on 11 May 2007, and inactivated poliomyelitis virus vaccine (unknown) given on 11 May 2007. There were no concurrent medications. On 11 May 2007 the subject received the first dose of Twinrix (unknown, left arm). On 11 May 2007, less than one day after vaccination with Twinrix, the subject experienced unilateral hearing loss. This case was assessed as medically serious by manufacturer. On 12 May 2007, the subject presented for examination due to hearing loss. At the time of reporting the outcome of the event was was unspecified.
Age: 43.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Blood test, Nausea, Nuclear magnetic resonance imaging normal, Pyrexia, Sudden hearing loss
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of unilateral hearing loss in a 43-year-old male subject who was vaccinated with Twinrix for prophylaxis prior to travel. Concurrent vaccination included Td given on 11 May 2007, and inactivated poliomyelitis virus vaccine (unknown) given on 11 May 2007. There were no concurrent medications. On 11 May 2007 the subject received the first dose of Twinrix (unknown, left arm). On 11 May 2007, less than one day after vaccination with Twinrix, the subject experienced unilateral hearing loss. This case was assessed as medically serious by manufacturer. On 12 May 2007, the subject presented for examination due to hearing loss. At the time of reporting the outcome of the event was was unspecified.
Age: 43.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Deafness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of unilateral hearing loss in a 43-year-old male subject who was vaccinated with Twinrix for prophylaxis prior to travel. Concurrent vaccination included Td given on 11 May 2007, and inactivated poliomyelitis virus vaccine (unknown) given on 11 May 2007. There were no concurrent medications. On 11 May 2007 the subject received the first dose of Twinrix (unknown, left arm). On 11 May 2007, less than one day after vaccination with Twinrix, the subject experienced unilateral hearing loss. This case was assessed as medically serious by manufacturer. On 12 May 2007, the subject presented for examination due to hearing loss. At the time of reporting the outcome of the event was was unspecified.
Age: 43.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Blood test, Deafness, Deafness unilateral, Nausea, Nuclear magnetic resonance imaging
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of unilateral hearing loss in a 43-year-old male subject who was vaccinated with Twinrix for prophylaxis prior to travel. Concurrent vaccination included Td given on 11 May 2007, and inactivated poliomyelitis virus vaccine (unknown) given on 11 May 2007. There were no concurrent medications. On 11 May 2007 the subject received the first dose of Twinrix (unknown, left arm). On 11 May 2007, less than one day after vaccination with Twinrix, the subject experienced unilateral hearing loss. This case was assessed as medically serious by manufacturer. On 12 May 2007, the subject presented for examination due to hearing loss. At the time of reporting the outcome of the event was was unspecified.
Age: 43.0
Sex: M
Vaccine: DPP, HEPAB, IPV, HEPAB, IPV, TD, DT, HEPAB, IPV, HEPAB, IPV, TD, HEPAB, IPV, TD
Symptoms: Pyrexia, Sudden hearing loss, Vertigo
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of unilateral hearing loss in a 43-year-old male subject who was vaccinated with Twinrix for prophylaxis prior to travel. Concurrent vaccination included Td given on 11 May 2007, and inactivated poliomyelitis virus vaccine (unknown) given on 11 May 2007. There were no concurrent medications. On 11 May 2007 the subject received the first dose of Twinrix (unknown, left arm). On 11 May 2007, less than one day after vaccination with Twinrix, the subject experienced unilateral hearing loss. This case was assessed as medically serious by manufacturer. On 12 May 2007, the subject presented for examination due to hearing loss. At the time of reporting the outcome of the event was was unspecified.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthma, Pharyngolaryngeal pain, Productive cough, Wheezing
Clinical narrative: Patient had first shot of Gardasil on 5/15, 20 min after patient started wheezing and had sore throat, cervical dyspnea.  02 96%.  On 5/16 had productive cough and weezing.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Oxygen saturation normal, Pharyngolaryngeal pain, Productive cough, Wheezing
Clinical narrative: Patient had first shot of Gardasil on 5/15, 20 min after patient started wheezing and had sore throat, cervical dyspnea.  02 96%.  On 5/16 had productive cough and weezing.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Noted to have hives around hip/lower trunk area, walnut sized, red, raised c/o itching- took Zyrtec 10mg.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Noted to have hives around hip/lower trunk area, walnut sized, red, raised c/o itching- took Zyrtec 10mg.
Age: 3.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Asthenia, Blood pressure decreased, Heart rate decreased, Oxygen saturation decreased, Pallor
Clinical narrative: Information has been received from a registered nurse concerning a 36 month old male with no known medical history or allergies, who on 07-MAY-2007 was vaccinated with a 0.5ml, intramuscular (in the thigh) dose of hepatitis A (lot number 656316/1282F). There was no concomitant medication. On 07-MAY-2007 the patient stood after the injection and developed a loss of color in his face and began to collapse. Diagnostic tests included: a heart rate that was between 60-70, his blood pressure was 82/40 and his oxygen saturation was 87-88%. The patient was treated for an allergic reaction with an epinephrine (EPINEPHRAN) pen, and taken to the emergency room. The patient received methylprednisolone sodium succinate (SOLU-MEDROL) and hydrocortisone sodium succinate (SOLU-CORTEF), and intravenous fluids. Medical attention was sought. It was reported that the patient's status was considered to be immediately life-threatening. The patient's status was unknown. No product quality complaint was involved. The patients adverse experience was considered to be an other important medical event. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Blood pressure decreased, Circulatory collapse, Heart rate decreased, Hypersensitivity, Oxygen saturation
Clinical narrative: Information has been received from a registered nurse concerning a 36 month old male with no known medical history or allergies, who on 07-MAY-2007 was vaccinated with a 0.5ml, intramuscular (in the thigh) dose of hepatitis A (lot number 656316/1282F). There was no concomitant medication. On 07-MAY-2007 the patient stood after the injection and developed a loss of color in his face and began to collapse. Diagnostic tests included: a heart rate that was between 60-70, his blood pressure was 82/40 and his oxygen saturation was 87-88%. The patient was treated for an allergic reaction with an epinephrine (EPINEPHRAN) pen, and taken to the emergency room. The patient received methylprednisolone sodium succinate (SOLU-MEDROL) and hydrocortisone sodium succinate (SOLU-CORTEF), and intravenous fluids. Medical attention was sought. It was reported that the patient's status was considered to be immediately life-threatening. The patient's status was unknown. No product quality complaint was involved. The patients adverse experience was considered to be an other important medical event. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Oxygen saturation decreased, Pallor
Clinical narrative: Information has been received from a registered nurse concerning a 36 month old male with no known medical history or allergies, who on 07-MAY-2007 was vaccinated with a 0.5ml, intramuscular (in the thigh) dose of hepatitis A (lot number 656316/1282F). There was no concomitant medication. On 07-MAY-2007 the patient stood after the injection and developed a loss of color in his face and began to collapse. Diagnostic tests included: a heart rate that was between 60-70, his blood pressure was 82/40 and his oxygen saturation was 87-88%. The patient was treated for an allergic reaction with an epinephrine (EPINEPHRAN) pen, and taken to the emergency room. The patient received methylprednisolone sodium succinate (SOLU-MEDROL) and hydrocortisone sodium succinate (SOLU-CORTEF), and intravenous fluids. Medical attention was sought. It was reported that the patient's status was considered to be immediately life-threatening. The patient's status was unknown. No product quality complaint was involved. The patients adverse experience was considered to be an other important medical event. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Chest pain, Fatigue, Laboratory test, Pain, Pyrexia
Clinical narrative: Arm Pain and Welts per pt report. Chest pain 4-5 days after injection. Unsure if related.
Age: 38.0
Sex: F
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Urticaria
Clinical narrative: Arm Pain and Welts per pt report. Chest pain 4-5 days after injection. Unsure if related.
Age: 38.0
Sex: F
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Cardiac enzymes, Chest pain, Electrocardiogram, Pain in extremity, Urticaria
Clinical narrative: Arm Pain and Welts per pt report. Chest pain 4-5 days after injection. Unsure if related.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Headache, Rash
Clinical narrative: rash on face and body, headache
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Body temperature increased, Erythema, Skin warm
Clinical narrative: Left deltoid erytematous, warm bandlike streaking 3x4cm diameter with T=99F
Sex: U
Vaccine: HEPAB, TDAP
Symptoms: Influenza like illness, Renal pain
Clinical narrative: Flu like symptoms - Aches kidney pain, lost work
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain, Skin warm
Clinical narrative: Information has been received from a physician concerning a female patient who in approximately May 2007, was vaccinated with a dose of Zostavax. It was reported that in approximately May 2007, the patient experienced significant redness, warmth, and pain 48 hours post-injection. The patient was diagnosed with cellulitis and was treated with cephalexin (KEFLEX). At the time of report, the patient was recovering. A product quality complaint was not involved. Cellulitis was considered to be an other important medical event by the reporter. This is one of the several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain, Skin warm
Clinical narrative: Information has been received from a physician concerning a male patient who in approximately May 2007, was vaccinated with a dose of Zostavax. It was reported that in approximately May 2007, the patient experienced significant redness, warmth, and pain 48 hours post-injection. The patient was diagnosed with cellulitis and was treated with cephalexin (KEFLEX). At the time of report, the patient was recovering. A product quality complaint was not involved. Cellulitis was considered to be an other important medical event by the reporter. This is one of the several reports received from the same source. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Excoriation, Herpes zoster disseminated, Pruritus
Clinical narrative: Information has been received from a physician concerning a 20 year old male with drug hypersensitivity to Vancomycin and a medical history of heart transplant, in "June 2004" who on an unknown date, was vaccinated with a dose of Varivax. Concomitant therapy included: prednisone, sirolimus, pantoprazole sodium (PROTONIX), Cyclosporin and diltiazem hydrochloride (CARDIZEM). It was reported that "the first week of May, the patient developed disseminated Zoster". The first signs were scalp discomfort and itching. The patient presented to the physician on 10-MAY-2007 the first day of hospitalization with zoster of the dermatome C-2 distribution that was right sided and several (5-6) ulcercerations on the right side of the tongue. The lesions were described as red, excoriated lesions, 3-4 mm in diameter. On the second day of hospitalization, 11-May-2007, the patient developed vesicles 1-2 mm in diameter described as papules in an erythematous base 1.5 to 2cm in diameter. The vesicles were spread bilaterally through out the anterior and posterior trunk and neck. The patient was treated with intravenous acyclovi (ZOVIRAX) and discharged from the hospital in the morning of 14-MAY-2007. The Flourescent antibody test was positive for varicella and positive culture of varicella. The patient status is recovering. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Tongue ulceration, Vaccination failure, Varicella, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning a 20 year old male with drug hypersensitivity to Vancomycin and a medical history of heart transplant, in "June 2004" who on an unknown date, was vaccinated with a dose of Varivax. Concomitant therapy included: prednisone, sirolimus, pantoprazole sodium (PROTONIX), Cyclosporin and diltiazem hydrochloride (CARDIZEM). It was reported that "the first week of May, the patient developed disseminated Zoster". The first signs were scalp discomfort and itching. The patient presented to the physician on 10-MAY-2007 the first day of hospitalization with zoster of the dermatome C-2 distribution that was right sided and several (5-6) ulcercerations on the right side of the tongue. The lesions were described as red, excoriated lesions, 3-4 mm in diameter. On the second day of hospitalization, 11-May-2007, the patient developed vesicles 1-2 mm in diameter described as papules in an erythematous base 1.5 to 2cm in diameter. The vesicles were spread bilaterally through out the anterior and posterior trunk and neck. The patient was treated with intravenous acyclovi (ZOVIRAX) and discharged from the hospital in the morning of 14-MAY-2007. The Flourescent antibody test was positive for varicella and positive culture of varicella. The patient status is recovering. No product quality complaint was involved. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Chills, Computerised tomogram normal, Myalgia, Nausea
Clinical narrative: Information has been received from a physician concerning a 22 year old female who on an unspecified date was vaccinated with Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). Approximately two and half weeks after the vaccination, the patient experienced abdominal pain, nausea, chills and muscle aches. She was hospitalized for 5-6 days. Multiple unspecified CT-scans, x-rays and blood tests were performed. All the results were negative. She was treated with an unspecified antibiotic. Subsequently, the patient recovered. The physician felt that the abdominal pain, nausea, chills and muscle aches were disabling. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: X-ray normal
Clinical narrative: Information has been received from a physician concerning a 22 year old female who on an unspecified date was vaccinated with Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). Approximately two and half weeks after the vaccination, the patient experienced abdominal pain, nausea, chills and muscle aches. She was hospitalized for 5-6 days. Multiple unspecified CT-scans, x-rays and blood tests were performed. All the results were negative. She was treated with an unspecified antibiotic. Subsequently, the patient recovered. The physician felt that the abdominal pain, nausea, chills and muscle aches were disabling. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, PNC, RV5
Symptoms: Abdominal X-ray, Carbon dioxide abnormal, Intussusception, Lethargy, Vomiting
Clinical narrative: Intussusception with vomiting, lethargy.  6/5/07 Received vax records from PCP which confirms lot & dose # on report. Vax record faxed to CDC.  10/16/07 Received hospital medical records which reveal patient experienced irritability, decreased oral intake, tender abdomen, listlessness, vomiting & nonbloody diarrhea x 1 day.  Had sick contact with viral enteritis.  Saw pcp who palpated mass in RUQ & sent to ER.  Admitted 5/15-5/16/2007 for overnight observation s/p reduction of IS.  Progressed well & d/c to home. FINAL DX: ileocecal intussusception, enema reduced.  Records faxed to CDC.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, PNC, RV5
Symptoms: X-ray abnormal
Clinical narrative: Intussusception with vomiting, lethargy.  6/5/07 Received vax records from PCP which confirms lot & dose # on report. Vax record faxed to CDC.  10/16/07 Received hospital medical records which reveal patient experienced irritability, decreased oral intake, tender abdomen, listlessness, vomiting & nonbloody diarrhea x 1 day.  Had sick contact with viral enteritis.  Saw pcp who palpated mass in RUQ & sent to ER.  Admitted 5/15-5/16/2007 for overnight observation s/p reduction of IS.  Progressed well & d/c to home. FINAL DX: ileocecal intussusception, enema reduced.  Records faxed to CDC.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Nausea / vomiting, chills, fever 101 began 5/18/07 at 600 am. Patient given IV antibiotic and nausea medicine. Injection site swollen and tender. Patient continued to have nausea and was admitted for OBS.  06/11/2007 MR received for o/n observation for c/o fever, nausea, and vomiting after vaccination.  Seen in PCP office and given IVF, Cipro and Zofran without improvement, so admitted.  PE: revealed a weak appearing pt. with Temp of 101.9'F.  Pulse rate 140.  LUE shows induration and swelling at the injection site.  Impression:  Fever, nausea and vomiting. ? Adverse effect to vaccination.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Nausea / vomiting, chills, fever 101 began 5/18/07 at 600 am. Patient given IV antibiotic and nausea medicine. Injection site swollen and tender. Patient continued to have nausea and was admitted for OBS.  06/11/2007 MR received for o/n observation for c/o fever, nausea, and vomiting after vaccination.  Seen in PCP office and given IVF, Cipro and Zofran without improvement, so admitted.  PE: revealed a weak appearing pt. with Temp of 101.9'F.  Pulse rate 140.  LUE shows induration and swelling at the injection site.  Impression:  Fever, nausea and vomiting. ? Adverse effect to vaccination.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Injection site pain, Injection site swelling, Rash macular
Clinical narrative: erythema macule (2x8cm with swelling and tenderness at injection site Treated ->observation.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Patient presents with swelling and redness approximately 10-12cm x 6-8cm area on right thigh. P/C of itching and pain areas of bubling/blistering noted. Patient's mother denies any  swelling/redness with previous immunizations. Redness and minor swelling (smaller than a dime) at injection site for ProQuad. Patient sent to doctor for evaluation.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: No reaction on previous exposure to drug
Clinical narrative: Patient presents with swelling and redness approximately 10-12cm x 6-8cm area on right thigh. P/C of itching and pain areas of bubling/blistering noted. Patient's mother denies any  swelling/redness with previous immunizations. Redness and minor swelling (smaller than a dime) at injection site for ProQuad. Patient sent to doctor for evaluation.
Age: 1.3
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Pyrexia, Varicella
Clinical narrative: Fever 1 week after vaccine administration, Dx with chicken pox 10 days after vaccine administration
Age: 14.0
Sex: U
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling and redness at right arm painful no itching or rash no signs infection. Seen 5/17/07
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Large erythematous area-hot to touch-itchy.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Rash, Urticaria
Clinical narrative: Rash, hives that spread up back and buttock - Has hard knot at injection site.
Age: 1.0
Sex: M
Vaccine: HBHEPB, HEPA, MMRV, PNC
Symptoms: Rash, Rash generalised
Clinical narrative: Patient developed a rash on face and spread to all his body, no fever, 12 days after vaccination.
Age: 5.0
Sex: F
Vaccine: DTAP, MMRV, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Immediately after vaccination patients arm become warm, red, raised and a rash developed from above injection site to elbow 1/1 tsp Benadryl given - (+) effect 20 minutes later.
Age: 5.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: immediately after vaccine given arm became warm, raised, red and rashy from above injection site to below site approx 12 cm across 1 1/2 tsp Benadryl given in office
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: fever after 2 m vaccination and other sx
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Rash macular
Clinical narrative: 9cm x 12cm erythematous, macular, warm rash at site of Varicella vaccine administration (right upper arm) approximately 24 hours after vaccine administration.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Electrocardiogram abnormal, Heart rate increased, Nausea
Clinical narrative: Pt felt nauseated on the first day of injection. Next day patient had shortness of breath and chest pain. Patient reported SOB lasted a couple of days. Pt reported wheezing and Fast heart beat on the second day as well
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Pt felt nauseated on the first day of injection. Next day patient had shortness of breath and chest pain. Patient reported SOB lasted a couple of days. Pt reported wheezing and Fast heart beat on the second day as well
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 5/15/2007 child came for well child examination. Child received Varicella vaccine today. 5/17/07 Doctor's progress notes read as follows: swelling at injection site after varicella vaccine. P.E: 10x4cm area of induration and erythema L arm at injection site. Plans report react -benadryl - rech prn Note: sibling came in same day 5/17/2007 for same findings: reaction to varicella vaccine given 5/15/2007
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Musculoskeletal stiffness, Oedema peripheral, Paraesthesia, Similar reaction on previous exposure to drug
Clinical narrative: Stiffness, edema of hands with paresthesia and radiation to elbow primarily on right side. Symptoms occurred approximately 20 minutes follow anthrax immunization. Previous symptoms occurring for same immunization April 14-15 2007 the day after immunization. Manager reported this and recommended Ibuprofen resolved in 3-4 days.
Age: 8.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: 13 x 11.5cm erythematous, warm, tender area right upper arm after vaccinated with MMR and VZV.
Age: 8.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Child vaccinated at 12 months presented at age 8 years with significant herpes zoster (shingles).
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever up to 105.2 (a) approximately 12 hours after immunization and lasting around 8-10 hours.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Cellulitis, Injection site induration, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: 5/15/07 Child became irritable, right leg became swollen, hard and warm to touch - went to ER - dx with cellulitis - prescribed Clindamycin.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, UNK, VARCEL
Symptoms: Erythema, Gaze palsy, Hypotonia, Musculoskeletal stiffness
Clinical narrative: Body stiffness, eyes rolled back, face turned red, went limp. No longer than 10 seconds.
Age: 59.0
Sex: M
Vaccine: YF
Symptoms: Arthralgia, Back pain, Balance disorder, Dry mouth, Ear infection
Clinical narrative: cluster headaches on left side of head since 1991, joints and muscle pain, balance problems. Dry mouth, ear and sinus infection, lower back pain etc.