chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood cholesterol increased
Clinical narrative: A pharmacist reported the occurrence of elevated aspartate aminotransferase (AST) and alanine aminotransferase (ALT) concentrations in a 41 y.o. male who was vaccinated with Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject of this report was the reporting pharmacist. There was not relevant medical history, concurrent condition, or concurrent medication. On 8/16/02, the subject received his first injection of Engerix-B. On 8/19/02, three days post-immunization, he was found to have elevated concentrations of AST (105), ALT (58), and cholesterol (237). The most recent info. was received on 12/10/02. The elevated concentrations of AST, ALT, and cholesterol resolved on 10/30/02. The subject considered the events to be possibly related to Engerix-B administration.
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: A nurse reported the occurrence of hives in a female subject of unspecified age who received an injection of Hep B vaccine recombinant (Engerix-B). Medical history, concurrent conditions, and concurrent medications were not provided. On an unspecified date, the subject received an injection of Engerix-B. Following the injection, the subject "broke out in hives." Treatment was not specified. The outcome of the event was reported to be resolved.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Anorexia, Immunoglobulins increased, Lethargy
Clinical narrative: A nurse practitioner reported the occurrence of elevated immunoglobulin G (IgG) in a 31 y.o. female who was vaccinated w/Hep B vaccine recombinant (Engerix-B). Medical history or concurrent conditions were not specified. Concomitant medications included a daily multivitamin and oral contraceptive. On 7/8/02, the subject received her 3rd injection of Hep B vaccine recombinant (Engerix B). On an unspecified date in July 02, the subject experienced loss of appetite, lethargy, and had an elevated immunoglobulin G. As of 9/11/02, the events persisted.
Sex: U
Vaccine: HEP
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: A GlaxoSmithKline sales rep reported that she received info. from "some" physicians who reported that "some" of their subjects experienced burning at the inject site after receiving Hep B vaccine recombinant (Engerix-B). The subjects' medical histories, concurrent medical conditions, and concurrent medications were not specified. On unspecified dates, "some" subjects received Hep B vaccine recombinant in unspecified sites and dosages. At some point after receiving the vaccine, the subjects complained of burning at the inject site. The outcome of these events was not specified. Comments: The physicians indicated that "some" subjects experienced burning at the inject site; however,, the subjects are not presently identifiable. Additional reports will be generated when identifiers are provided.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: A physician reported that occurrence of a subject testing positive for "Hep B" after being vaccinated with Hep B vaccine recombinant (Engerix-B). The medical history noted that the subject was a dialysis PT. Concurrent medical conditions and concurrent medications were not specified. On an unknown date, the subject received an injection of Hep B vaccine recombinant (Engerix-B). The physician reported that the "subject tested positive for Hep B after receiving the vaccination." The outcome of this event was not specified.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Back pain, Diarrhoea, Dyspepsia, Influenza like illness
Clinical narrative: A pharmacist reported the occurrence of flu-like symptoms in a 37 y.o. female who was vaccinated with Hep B vaccine recombinant (Engerix-B). The subject's medical history, concurrent medications were not specified. On 9/11/02 or 9/12/02, the subject received her first injection of Hep B vaccine recombinant (Engerix-B). The subject experienced flu-like symptoms, muscle aches, backaches, diarrhea, upset stomach with gas or abdominal cramps, and possibly a low grade fever. The outcome for these events was reported as unresolved.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Pyrexia
Clinical narrative: A pharmacist reported the occurrence of flu-like symptoms in a 37 y.o. female who was vaccinated with Hep B vaccine recombinant (Engerix-B). The subject's medical history, concurrent medications were not specified. On 9/11/02 or 9/12/02, the subject received her first injection of Hep B vaccine recombinant (Engerix-B). The subject experienced flu-like symptoms, muscle aches, backaches, diarrhea, upset stomach with gas or abdominal cramps, and possibly a low grade fever. The outcome for these events was reported as unresolved.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Chest pain, Palpitations
Clinical narrative: This report described the occurrence of chest pain in a 30 y.o. female who was vaccinated with Hep B vaccine recombinant (Engerix-B). This report was received from a PT and has not been verified by a physician or other health care professional. The subject's medical history, concurrent medical conditions, and concurrent medications were not specified. On 9/13/02, the subject received her first injection of Hep B vaccine recombinant (Engerix-B). On the same date, the subject reported heart palpitations, chest pain, and back pain, which she described as thought she was "being punched from both sides." The outcome for this event was reported to be unresolved.
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Herpes zoster
Clinical narrative: A nurse reported the occurrence of shingles in a 28 y.o. male who was vaccinated with Hep B vaccine recombinant (Engerix-B). Medical history, concurrent medical conditions, and concomitant medications were not specified. On 8/19/02, the subject received the first injection of Hep B vaccine recombinant in the left arm. One day later, on 8/20/02, the subject developed shingles. The subject was seen by a physician and treated with famciclovir (Famvir) for two weeks at his doctor's office. The subject is reportedly feeling much better after treatment. As of 9/19/02, the shingles reportedly persisted, however have improved. Follow up on 01/16/02: "The pt received the second and third injections of Engerix-B on an unspecified date and on 06/26/03, respectively, without adverse event."
Sex: U
Vaccine: HEP
Symptoms: Injection site inflammation, Injection site pain, Paraesthesia
Clinical narrative: A physician via a GlaxoSmithKline sales rep. reported the occurrence of inject site pain in a subject who was vaccinated with Hep B vaccine recombinant (Engerix-B). Medical history, concurrent medical conditions, and concomitant medications were not specified. On an unspecified date, the subject received Hep B vaccine recombinant (Engerix-B prefilled tip-lok syringes) and experienced pain, burning, and stinging upon injection. The physician believed the pain, burning and stringing upon injection was due to the prefilled syringes being cold upon injection. Comment: The reporter indicated that there were an unspecified # of subjects who experienced these adverse effects. However, they are not presently identifiable. Additional reports will be generated when identifiers are provided.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: A nurse reported the occurrence of non-response to Hep B vaccine in a 41 y.o. female who was vaccinated w/Hep B vaccine recombinant (Engerix-B). Medical history, concurrent medical conditions, and concomitant medications were not specified. On unspecified dates, the subject received a complete series of Hep B vaccine recombinant (Engerix-B). In August 02, the subject was tested for antibody response and was found to have no antibodies to the Hep B virus. The reporter considered the lack of response to be probably related to the Hep B vaccine recombinant.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: A physician reported the occurrence of a positive test for Hep B surface antigen following vaccination with Hep B vaccine recombinant (Engerix-B). The subject's medical history included hemodialysis. Concurrent medical conditions or concomitant medications were not specified. On an unspecified date, the subject received an injection of Engerix-B. At an unspecified date post-vaccination, the subject tested positive for Hep B surface antigen. Comment: The reporter indicated that two subjects experienced this event. However, they are not presently identifiable.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: A physician reported the occurrence of non-response in a 50 to 55 y.o. female who was vaccinated w/Hep B vaccine recombinant (Engerix-B). Medical history, concurrent medical conditions, and concomitant medications were not known. On unspecified dates, the subject received two series of Hep B vaccine recombinant (Engerix-B) totaling 6 doses of vaccine. The subject reportedly had no response to the vaccinations. The physician considered the non-response to be probably related to vaccination with Hep B vaccine recombinant.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: A nurse reported the inability of several subjects to respond to the Hep B vaccine recombinant (Engerix-B) immunization series. The subjects were males and females in their 50's and 60's. The # of injections varied. The nurse stated that seroconversion was increasingly difficult to obtain with increasing age of the subject. A specific subject has not been identified; therefore this report is considered non-reportable. Comment: This case has been linked to case #A0384251A due to the same reporter.
Sex: M
Vaccine: HEP
Symptoms: Anorexia
Clinical narrative: A physician reported the occurrence of decreased appetite in a neonate of unspecified gender who was vaccinated with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date, the subject received his first injection of Engerix B. Two to three hours later, the infant did not want to eat. The infant was admitted to the hospital where he was given unspecified tests, including a spinal work up. All of the unspecified tests were reportedly negative, and the symptoms resolved in approximately 24 hours.
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Chills, Headache, Malaise, Pyrexia
Clinical narrative: A nurse reported the occurrence of joint pain in an adult male of unspec'd age who was vaccinated w/Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the subject received his first injection of Engerix-B. At an unspecified time post-immunization, he experienced joint pain, headache, fever, malaise, and chills. As of 10/10/02, the outcomes of the events were unknown. Comment: This report has been linked to report #A0383040A due to same reporter.
Sex: M
Vaccine: HEP
Symptoms: Headache, Nausea
Clinical narrative: A nurse reported the occurrence of headache in an adult male of unspecified age who was vaccinated with Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the subject received his first injection of Engerix-B. At an unspecified time post-immunization, he experienced headache and nausea. As of 10/10/02, the outcomes of the events were unknown. Comment: This report has been linked to report A0383039A due to same reporter.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Injection site oedema
Clinical narrative: This report describes the occurrence of headache in a 30 y.o. female who was vaccinated w/Hep B vaccine (brand unknown) for prophylaxis. This report was received from a subject and has not been verified by a physician or other health care professional. Medical history, concurrent conditions, and concurrent medications were not reported. The subject experienced no adverse events following previous immunizations. On 10/9/02, the subject reportedly received her 3rd injection of Hep B vaccine (brand unknown). The injection was reportedly administered intradermally. The prescribing info. for Engerix-B recommends that injections of Engerix-B be administered via the intramuscular route. The subject reported that on 10/10/02 she experienced a headache and inject site swelling. She stated that she consulted a health care prof'l regarding the events.
Sex: M
Vaccine: HEP
Symptoms: Malaise
Clinical narrative: A nurse reported the occurrence of "feeling blah" in an adult male of unspecified age who was vaccinated with Hep B vaccine recombinant (Engerix-B). Medical history included an allergy to penicillin and hypertension. Concurrent medications included an unspecified medication for high blood pressure. On 10/8/02 the subject received his first injection of Engerix-B. Approximately two days later, on 10/10/02 the subject reported "feeling blah". The subject informed the reporter that he did not have a fever, chills or inject site reaction, he just was not feeling well. As of 10/11/02 the outcome of the event was unknown.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Blister, Rash
Clinical narrative: A nurse reported the occurrence of Zoster type rash in an 11 y.o. male who was vaccinated with Hep B vaccine Recombinant (Engerix-B) for prophylaxis. The reporter submitted this report directly to VAERS. There were no relevant past medical history or concurrent medications. On 10/9/02, the subject received his first injection of Engerix-B (10 mcg) in the left deltoid (lot # ENG5286A). Approximately 24 hrs later on 10/10/02 the subject developed a rash on both arms along a dermatome, which was characterized by 9 or 10 eruptions varying from blisters to crusting. The child had no fever or rash on the chest or abdomen or any other part of the body. As of 10/11/02, the event persisted.
Age: 1.5
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: A nurse reports the occurrence of an 18 month old female who did not respond to the Hep B vaccine recombinant (Engerix-B) immunization series. The subject was born to a mother, who at the time of the subject's birth, tested positive for Hep B surface antigen. Concurrent conditions and concurrent medications were not specified. The subject received her first and 2nd injections of Hep B vaccine (mnft'r unknown) on 4/13/01 and 6/20/01, respectively. "Titers (NOS)" were obtained on 2/26/02 and results revealed a level of less than 2 (> 10 normal range). On 3/9/02 and 6/27/02, the subject received injections of Engerix-B subcutaneously (lot ENG5253C9). On 6/15/02 and 10/11/02, "Titers (NOS)" were obtained and results revealed a level of less than 2 (>10 normal range).
Sex: F
Vaccine: HEP
Symptoms: Laboratory test abnormal, Unevaluable event
Clinical narrative: A physician reported the occurrence of a positive antibody to Hep B core antigen in an adult female of unspecified age who received Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date approximately 4 or 5 yrs ago, the vaccinee received her first injection of Engerix-B. The subject did not complete the immunization series. In Oct. 02, a Hep B panel was performed. Serology revealed that antibodies to Hep B surface antigen were greater than 140, while antibodies to Hep B core antigen were reactive. No Hep B infection was reported.  Follow up on 01/16/02: "The reporter stated the events were unrelated to the Engerix-B vaccine."
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Lacrimal disorder, Laryngospasm, Pruritus, Rhinitis
Clinical narrative: This report describes a 48 y.o. female who experienced swelling of the throat after receiving Hep B vaccine recombinant (Engerix-B) for prophylaxis. Medical history, concurrent conditions, and concurrent medications were not specified. On 8/29/02, the vaccinee received her 1st injection of Engerix-B (lot ENG5346A2). A "few days" later, the subject experienced watery eyes, itching of the ears, swelling of the throat, and congestion. Initial treatment included diphenhydramine (Benadryl), however her physician later prescribed fexofenadine hydrochloride (Allegra) for her symptoms. Events resolved after approximately 3 weeks.
Sex: F
Vaccine: HEP
Symptoms: Flushing, Pruritus
Clinical narrative: A physician's assistant reported the occurrence of pruritus in a female in her 30's who was vaccinated w/Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject received her first and 2nd injections of Engerix-B in '95. At an unspecified time following her 2nd immunization, she experienced "itching and flushing of her whole body." She sought medical attention for her adverse events. She did not complete the Engerix-B immunization series. As of 10/18/02, the outcomes of the events were unknown.
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: A pharmacist reported that an adult male of unspecified age was a non-responder following completion of Hep B vaccine recombinant (Engerix-B) series. The subject's medical history, concurrent medical condition, and concurrent medication were not provided. Over a year ago, in 2001, the subject received three injections of Hep B vaccine recombinant (Engerix-B). Serological tests were performed and revealed that the subject was a non-responder. The subject was administered a booster injection of Hep Engerix-B (20 mcg.). Approximately 1 to 2 months later (date unspec'd), titers were performed again and revealed that the subject still was a non-responder.
Age: 50.0
Sex: F
Vaccine: HEP, TD
Symptoms: Eye disorder, Urticaria
Clinical narrative: This report described the occurrence of hives in a 58 y.o. female who was vaccinated w/the Hep B vaccine recombinant (Engerix-B). This report was received by the subject and has not been verified by a physician or health care professional. The subject's medical history included allergies specifically to penicillin, sulfa drugs, and strawberries. There were no concurrent medications. The subject stated she received a smallpox vaccine (unknown mnft'r) approximately 30 yrs ago which caused her "tear ducts to dry up". On 12/5/94, the subject received her 2nd injection of Engerix-B. On this same date, the subject also received a tetanus + diphtheria injection (unknown mnft'r). At an unspecified time post vaccination, the subject developed hives and "something to do with her eyes". The events were reported to have resolved. On 8/5/95, the subject received the 3rd injection of Engerix-B and did not experience any adverse reaction.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: A nurse reported that a 27 y.o. female did not respond to the Hep B vaccine recombinant (Engerix-B) immunization series. The subject's medical history, concurrent conditions, and concurrent medications were unknown. The subject experienced no adverse events following previous immunizations. The subject received Engerix-B on 1/3/02 (lot ENG5214A2), 2/9/02 (lot ENG5214A2), and 7/23/02 (lot ENG5313A2; expiry, Dec. 03). An unspecified titer, measured on 9/17/02, 52 days after the 3rd injection of Engerix-B, was "negative for antibodies". The reporter considered the event to be probably related to Engerix-B administration.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Dermatitis bullous, Vasodilation procedure
Clinical narrative: A physician reported the occurrence of a blister in a 15 y.o. female who was vaccinated w/Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject had no medical history, or concurrent conditions. She received no concurrent medications. The subject received her first injection of Hep B vaccine (brand unknown) in 1998 without any known adverse events occurring. On 10/16/02, the subject received her 2nd injection of Engerix-B (lot 5353B; expiry, 2/11/04). Three days later, on 10/19/02, the subject stated that she developed a blister above the elbow which was not at the inject site but in the same arm. The PT described the blister "as containing fluid and being surrounded by a ring of red." Reportedly, the blister broke open and released tannish-yellowish fluid. The physician stated that the affected area was 1.5 X 0.5 cm. As of 10/24/02, the events had "improved". Comment: The reporter stated that the Engerix-B lot # was 5353B; however, this is an invalid Engerix-B lot #.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Fatigue, Myalgia, Mydriasis
Clinical narrative: A nurse reported the occurrence of shortness of breath in a 43 y.o. female who received Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject had a history of blood clots while receiving unspecified birth control pills. She was allergic to penicillin, codeine, and ciprofloxacin hydrochloride (Cipro). She received no concurrent medications. She experienced no adverse events following 3 previous injections of Engerix-B and one injection of Hep A vaccine (brand unknown). In March 02, June 02, and Sept. 02, the subject received Engerix-B without adverse event. On 10/22/02, the subject received her 4th injection of Engerix-B (lot ENG5290A4; expiry, 9/19/03). 5 mins later, she started having dizziness. 1/2 hour later, she experienced pupil dilation, shortness of breath, fatigue, and muscle aches. The PT had to call the EMS to her house after she returned home from the physician's office. No add'l details were provided related to this home visit. The reporting nurse spoke with the subject on 10/23/02 and at that time, the dizziness, pupil dilation, and shortness of breath had resolved while the fatigue and muscle aches were "worse." The Engerix-B immunization series was discontinued.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: A nurse reported the occurrence of bumps at the inject site in a subject of unspecified age and gender who received an intradermal injection of Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On unspecified dates, the subject received injections of Engerix-B. The subject did not respond to the injections and was subsequently administered the vaccine intradermally. At an unspecified time post-immunization of the intradermal injection, the subject experienced bumps at the inject site. As of 9/25/02, the outcomes of the events were unknown. Comment: This report has been linked to report #A0381698A due to the same reporter. Multiple subjects in their 50's and 60's did not respond to the Engerix-B immunization series and were subsequently administered intradermal injections. Follow up on 01/16/02: "On unspecified dates, the subject received six injections of Engerix B.  The subject did not seroconvert and was subsequently administered an unspecified number of 0.1mL Engerix B "boosters". These "boosters" were administered intradermally.  At an unspecified time after the "boosters", the subject developed bumps at the injection site that did not hurt or itch.  Subsequently, the subject seroconverted.  The injection site bumps resolved after an unspecified period of time."
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: A nurse described the inability of a 37 y.o. female to respond to the Hep B vaccine recombinant (Engerix-B) immunization series. The subject's medical history included no known diagnosed allergies. No concurrent medications were reported. She received no concurrent vaccines. The subject experienced no adverse events following previous immunizations. On 3/27/97, 4/29/97, and 10/1/97,the subject received injections of Engerix-B. Each injection consisted of 2 pediatric doses of 10 mcg to provide the recommended adult dose of 20 mcg. An unspecified titer was performed on an unspecified date after the 3rd Engerix-B injection and the result was "negative." On 10/23/02, the subject received her 4th injection of Engerix-B (lot ENG5156A2; expiry, May 02) approximately 5 months past the expiry date. On 11/14/02, the subject's Hep B surface antibodies tested positive.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: A physician described the inability of an adult female of an unspecified age to respond to 2 series of Hep B vaccine (brand unknown). The subject's medical history, concurrent conditions, and concurrent medications was unknown. On unspecified dates, the subject received 2 series of Hep B vaccine injections. At an unspecified time following her 6th immunization, she was found to be a nonresponder.
Sex: F
Vaccine: HEP
Symptoms: Influenza, Rash, Vomiting
Clinical narrative: A nurse reported the occurrence of vomiting in a female subject of unspecified age who was vaccinated w/Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unknown. On 10/14/02, the subject received her first injection of Engerix-B (lot ENG5294B6; expiry, 10/19/03). On 10/24/02, 10 days later, she experienced a subcutaneous rash, vomiting, and flu-like symptoms. Medical attention was required at the physician's office. The subcutaneous rash and vomiting resolved on 10/26/02. The outcome of the flu-like symptoms was unknown. The reporter considered the flu-like symptoms to be possibly related to Engerix-B administration. The relationship of the subcutaneous rash and vomiting to Engerix-B administration was not specified.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis, Laboratory test abnormal
Clinical narrative: A pharmacist reported that a subject of unspecified age and gender became hepatitis B positive prior to completing the hepatitis B vaccine recombinant (Engerix B) immunization series. The subject's medical history, concurrent conditions, and concurrent medications were unknown. On an unspecified date, the subject received an injection of Engerix-B; the number of previous injections of Engerix B was not reported. Prior to completing the immunization series, the subject became hepatitis B positive. The subject was hospitalized. As of 11/7/02, the event persisted.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: A nurse described the occurrence of rash in a 33 y.o. female who was vaccinated w/Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject had no medical history, concurrent conditions, or concurrent medications. The subject received her 1st injection of Engerix-B in 1998. She received her 2nd injection on 10/02/02. "A few days" after the 2nd injection, she developed a "mild" rash that resolved after an unspecified period of time. On 11/4/02, the subject received her 3rd injection of Engerix-B (lot ENG5291A4). Two days later, she developed a rash on both forearms. She was seen by a physician. The reporting nurse considered the rash to be possibly related to Engerix-B administration. As of 12/5/02, the rash had "improved".
Sex: U
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: This report describes the occurrence of inject site pain in an adult of unspecified age and gender who was vaccinated w/Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unknown. On an unspecified date, the subject received an injection of Engerix-B (lot ENG5285D6); it was not known if the subject had received previous injections of Engerix-B. Subsequently, the subject experienced pain at the inject site. The pain resolved after an unspecified period of time.
Sex: U
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: This report described the occurrence of inject site pain in an adult of unspecified age and gender who was vaccinated with Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unknown. On an unspecified date, the subject received an injection of Engerix-B (lot ENG5320D6); it was not known if the subject had received previous injections of Engerix-B. During the injection, the subject experienced pain at the inject site and "actually drew away from the syringe." The pain resolved after an unspecified period of time.
Age: 26.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Dizziness, Headache, Nausea, Pain, Vomiting
Clinical narrative: Dizziness, light-headedness, body aches, nausea, vomiting, and headache
Age: 26.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Dizziness, Headache, Influenza like illness, Myalgia, Oedema
Clinical narrative: Dizziness, light-headedness, body aches, nausea, vomiting, and headache
Age: 26.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Vertigo
Clinical narrative: Dizziness, light-headedness, body aches, nausea, vomiting, and headache
Age: 29.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Eosinophilia, Erythema, Lymphocytosis, Pyrexia, Rash pruritic
Clinical narrative: Pt received anthrax left arm at 1030 and flu-vaccine at 1300. By 1900 hours he developed pruritic red rash, initially beginning on his arm, and then progressing overnight to also iclude face, trunk, back, palms. Also asscoiated with mild fever, but no other systemic symptoms. On exam the next day he had multiple 1-2cm red, indurated lesions on his upper arms, forehead, palms, trunck, back. The remainder of his exam was normal. Pt was treated with course of prednisone and antihistamines and rash eventually resolved several days later.
Age: 29.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Skin ulcer
Clinical narrative: Pt received anthrax left arm at 1030 and flu-vaccine at 1300. By 1900 hours he developed pruritic red rash, initially beginning on his arm, and then progressing overnight to also iclude face, trunk, back, palms. Also asscoiated with mild fever, but no other systemic symptoms. On exam the next day he had multiple 1-2cm red, indurated lesions on his upper arms, forehead, palms, trunck, back. The remainder of his exam was normal. Pt was treated with course of prednisone and antihistamines and rash eventually resolved several days later.
Age: 30.0
Sex: M
Vaccine: MEN
Symptoms: Cough, Headache, Myalgia, Petechiae, Pyrexia
Clinical narrative: Follow-up report on 2/4/03: History of Present Illness: The PT became ill with a nonspecific illness just before Christmas (appears to be of 2002). This illness is characterized by myalgias, fevers, headaches, and a somewhat productive cough. The PT has taken a variety of nonsteroidal pyretic agents including Advil, also Tylenol and his symptoms persisted. He came to the Emer. dept this morning and was found to have a temp of 103 deg's w/headache and painful neck that was uncomfortable in all directions of motion. While the PT's spinal fluid was being evaluated an add'l dose of dexamethasone 38 mg and vancomycin and Rocephin were administered. Spinal tap turned out to have no elevations of his white cells and a normal glucose and protein. The PT had given a history of a possible small pox immunization as well as possible Anthrax immunization.  Infectious diseases was consulted because of the possibility of a vaccine reaction as well as the consideration of an acute infectious process. The PT has a remarkably negative past medical history. He was once treated for tonsillitis. He has been treated for Helicobacter pylori in the past. He has had a tonsillectomy as a youngster. The PT has some diffuse myalgias w/out localization of any particular joints.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Fatigue, Injection site hypersensitivity, Oedema, Pain
Clinical narrative: On the day following vaccine administration I developed a temperature of 103 F coupled with body aches, weakness, and extreme fatigue. My arm was in severe pain and I also experienced a complete loss of range of motion. I could not even lift it high enough to brush my teeth. The upper arm also developed swelling the size of a golf ball under the skin. There was also a 4x4 area around the injection site that was red and very hot to the touch. It is now a week later and I continue to have pain, weakness, and swelling in the arm.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: On the day following vaccine administration I developed a temperature of 103 F coupled with body aches, weakness, and extreme fatigue. My arm was in severe pain and I also experienced a complete loss of range of motion. I could not even lift it high enough to brush my teeth. The upper arm also developed swelling the size of a golf ball under the skin. There was also a 4x4 area around the injection site that was red and very hot to the touch. It is now a week later and I continue to have pain, weakness, and swelling in the arm.
Age: 24.0
Sex: F
Vaccine: SMALL
Symptoms: Pruritus, Rash
Clinical narrative: Thirty minutes after small pox vaccination, patient developed a body rash and said she felt itchy all over
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Disorientation, Irritability, Pyrexia, Rash, Screaming
Clinical narrative: fever 7 days after vaccine administered.  The fever lasted 2 days, going as high as 104.  Patient developed a rash over most of her body.  She won,t eat or drink much.  Patient has episodes of uncontrolable screaming.  She is very uncomfortable and irritable.  She hasn't slept mor than 4 hours at a time for the past 4 days. Patient had been sleeping through the night since she was an infant.  When she wakes up she is very disoriented and seems to be dilarious or halusinating.  She points at things and asks for them when there is nothing there.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: 1/14/03 Hives--2 p.m.--bedtime. 1/14/03 Fever--in a.m. when awake 101 degrees F axillary.  Tylenol (3 tabs q. 4 hours while awake--children's dosage).  Benadryl x 1 for hives--resolved 1/15/03.
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Oedema
Clinical narrative: Pt with 12cm by 16 cm erthematous, edematous swelling of lateral upper arm. This was the same arm that had received the Anthrax immunization 3 days prior.
Age: 29.0
Sex: M
Vaccine: RAB
Symptoms: Diarrhoea, Headache, Hypertension, Nausea, Pyrexia
Clinical narrative: From telephone contact with reporting health prof'l it was stated that a 29 y.o. male PT received an Imovax Rabies vaccination on 5/30/01. 30 mins after vaccination the PT developed headache, nausea and vomiting. Several hours later the PT developed a fever (103 deg F) and his blood pressure was elevated. A physician saw the PT. These symptoms completely resolved w/in 2 days. From add'l correspondence received on 9/11/01, it was reported that the PT also experienced diarrhea through the night. The PT received Rabavert for 3rd dose on 6/13/01. Follow-up telephone call on 6/20/01, PT stated he had "no problems".
Age: 29.0
Sex: M
Vaccine: RAB
Symptoms: Vomiting
Clinical narrative: From telephone contact with reporting health prof'l it was stated that a 29 y.o. male PT received an Imovax Rabies vaccination on 5/30/01. 30 mins after vaccination the PT developed headache, nausea and vomiting. Several hours later the PT developed a fever (103 deg F) and his blood pressure was elevated. A physician saw the PT. These symptoms completely resolved w/in 2 days. From add'l correspondence received on 9/11/01, it was reported that the PT also experienced diarrhea through the night. The PT received Rabavert for 3rd dose on 6/13/01. Follow-up telephone call on 6/20/01, PT stated he had "no problems".
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Dysphagia, Urticaria
Clinical narrative: From telephone contact w/reporting nurse practitioner it was stated that a 26 y.o. female PT received an Imovax Rabies vaccination on 7/9/01 (dose 1) and 7/12/01 (dose 2). 24 hrs after 2nd dose the PT developed systemic hives and difficulty swallowing. She was seen in the physician's office.
Age: 31.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Injection site erythema, 1cm-5cm (dia) or mild tenderness within 24 hours. DX: Cellulitis right shoulder.
Age: 0.08
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: Baby received first set of immunizations (hep B #1 at birth) on 12/17/02 at a clinic at 1330. Mom took baby to visit grandma. Baby slept from about 1400-1730. After that, mom wrapped up baby in typical fashion to carry under her coat and travelled by snow-machine across town (about two miles) to home and within a few minutes at home, mom heard baby grunt and not breathing, foam at nose. Health aid and PAC called to home around 1845-1900 and baby pronounced dead.
Age: 0.08
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Grunting
Clinical narrative: Baby received first set of immunizations (hep B #1 at birth) on 12/17/02 at a clinic at 1330. Mom took baby to visit grandma. Baby slept from about 1400-1730. After that, mom wrapped up baby in typical fashion to carry under her coat and travelled by snow-machine across town (about two miles) to home and within a few minutes at home, mom heard baby grunt and not breathing, foam at nose. Health aid and PAC called to home around 1845-1900 and baby pronounced dead.
Age: 0.75
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Cardiac arrest
Clinical narrative: Child died 1/2/03. Enclosed is copy of obituary. No cause of death given. Discharge summary received on 4/30/2003 indicates Acute Cardiac Arrest.
Age: 0.4
Sex: M
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Anaemia, Blood bilirubin increased, Haemoglobin decreased, Influenza like illness, Jaundice
Clinical narrative: Information has been received from a literature source. A 6 month old male presented with jaundice and anemia 2 days after developing cold/flu symptoms, and one month post Prevnar, DTaP, IPV, and hepatitis B vaccines. Autoimmune hemolytic anemia was suspected but the standard DAT and antibody detection tests were negative. The author noted no significant environmental or infectious exposures, bacterial and viral studies were negative, and Hb electrophoresis and glucose-6 phosphate dehydrogenase studies were normal. See lab section for full lab results. He responded to a combination of whole blood exchange, simple transfusion, and immunosuppresive therapy. Six months after presentation his hemoglobin returned to normal and steroid therapy was being slowly tapered. It was the author's conclusion that rare DAT negative AIHA due to low affinity anti-PR presented in this infant following viral infection and vaccinations. This event was considered medically important (OMIC). See copy of attached literature article for additional details.
Age: 0.4
Sex: M
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Laboratory test abnormal, Pharyngitis, Rhinitis, Viral infection
Clinical narrative: Information has been received from a literature source. A 6 month old male presented with jaundice and anemia 2 days after developing cold/flu symptoms, and one month post Prevnar, DTaP, IPV, and hepatitis B vaccines. Autoimmune hemolytic anemia was suspected but the standard DAT and antibody detection tests were negative. The author noted no significant environmental or infectious exposures, bacterial and viral studies were negative, and Hb electrophoresis and glucose-6 phosphate dehydrogenase studies were normal. See lab section for full lab results. He responded to a combination of whole blood exchange, simple transfusion, and immunosuppresive therapy. Six months after presentation his hemoglobin returned to normal and steroid therapy was being slowly tapered. It was the author's conclusion that rare DAT negative AIHA due to low affinity anti-PR presented in this infant following viral infection and vaccinations. This event was considered medically important (OMIC). See copy of attached literature article for additional details.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Thrombocytopenia
Clinical narrative: Thrombocytopenia
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: 1/14/02 approx. 7pm, mother stated child indicated to her that his arm is growing. On 1/15/03 when she checked his left arm she noted that it was swollen, hard and red. 1/15/03 731pm child was seen in the ER. Dx ? allergic reaction vs cellulitis L deltoid. Tx: Benadryl 12.5mg and EES 200mg PO. CBC drawn. Child was admitted with diagnosis cellulitis left arm. No fever. Medication: Cefotaxine 500mg IV q 6 hrs.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Dizziness, Headache, Nausea
Clinical narrative: Pt received vaccine at approx. 16:00-17:00 on Thursday, 1/2/03. At 12:01 AM, Saturday, 1/4/03, she developed nausea, dizziness and vomiting every hour. She also developed headache, back ache and blurred vision and chest pressure.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred, Vomiting
Clinical narrative: Pt received vaccine at approx. 16:00-17:00 on Thursday, 1/2/03. At 12:01 AM, Saturday, 1/4/03, she developed nausea, dizziness and vomiting every hour. She also developed headache, back ache and blurred vision and chest pressure.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Eye irritation, Eye pain, Injection site erythema, Injection site pain, Pruritus
Clinical narrative: Itching all over, arm red and burning where vaccine was injected. Burning and itchy eyes. Hives on arm that was injected.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Urticaria
Clinical narrative: Itching all over, arm red and burning where vaccine was injected. Burning and itchy eyes. Hives on arm that was injected.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Arthritis, Dizziness, Dyspnoea, Hypoaesthesia, Migraine
Clinical narrative: Numbness of left arm and hand, weakness in left forearm, arthritic pains in both arms and hands, burning sensation in left arm, migraine headaches, shortness of breath (last night), a dizzy spell (last week), blurry vision lasting about 5 minutes (once), left hand colder than normal to touch.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Muscular weakness, Pain, Peripheral coldness, Vision blurred
Clinical narrative: Numbness of left arm and hand, weakness in left forearm, arthritic pains in both arms and hands, burning sensation in left arm, migraine headaches, shortness of breath (last night), a dizzy spell (last week), blurry vision lasting about 5 minutes (once), left hand colder than normal to touch.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Injection site pain, Oedema peripheral, Pain
Clinical narrative: On 1/14/03, reported symptoms over the phone: Right arm is weak, can't lift items like pots and pans. Arm is sore and has pain when lifts arm above ear level. Also, pain if she lays on it. Complained of soreness at site and swollen right hand. No swelling noted.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Pruritus, Rash maculo-papular
Clinical narrative: About 1 week after flu shot, pt noted pruritus in left deltoid area. Pruritus has spread to dorsal trunk. Shortly after the pruritus started, he developed erythematous macular-papular rash which continues to spread. Seen on 12/19/02 at clinic with rash/itching on dorsal trunk and LUE. No SOB or fever.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Pruritus
Clinical narrative: Moderate to intense itching and fatigue.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Numbness and tingling of left pinky and ring finger and extending to left wrist. TX: Physical Therapy.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Anaphylactic reaction, Fatigue, Injection site pain, Pyrexia, Tremor
Clinical narrative: Noon shot; went back to work. Arm was sore and I was tired. Went home and went to bed. Had fever and shakes the next morning at 09:00. Went to doctor's office and fever was 104F but shakes had stopped. Benadryl, Celebrex and Bextra given by doctor. Pt improved. DX: Anaphylactic/allergy to either Pneumonia or Infanrix.
Age: 1.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Oral intake reduced, Pruritus, Pyrexia, Rash
Clinical narrative: 1/8/03 in the evening, pt experienced a fever of 102F-103F. Tylenol was given at 04:00. Fever increased to 105F and repeated Tylenol brought temperature down to 102F. Mild rash on face and trunk noted. Thursday 1/9/03, temperature "down" and rash has increased on face and trunk with increased itching. Saw MD and he Rx'd Benadryl. On 1/10/03, itching continues. No fever and improved appetite.
Age: 12.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Injection site swelling, Lymphadenopathy, Rash morbilliform
Clinical narrative: Swelling at site on right arm and swelling of her neck. Measle-type rash, onset of symptoms Friday 1/10/03. Pt's mother contacted MD. He prescribed Zyrtec 10mg 1 daily, Benadryl and Tagamet. Pt's mother called back on Monday 1/13/03 and MD ordered a 6 day DS of Steripred dose-pack.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Headache, Nasal congestion, Nausea, Pharyngolaryngeal pain
Clinical narrative: Headache, sore throat, nausea, emesis, abdominal pain and head congestion.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Headache, sore throat, nausea, emesis, abdominal pain and head congestion.
Age: 2.08
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Mild and brief 4 day course of chickenpox (less than 20 spots) after past history of receiving vaccine.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Pt received MMR vaccine on 12/31/02 and ran a fever of 103.5F from 1/8/03 to 1/11/03. Explained that this was a normal reaction to MMR, but mother insisted we report to Vaers.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pruritus, Rash
Clinical narrative: The arm where the vaccine was applied was broken out with itchy rash that spread over entire arm. It took about 3 weeks to clear up. I used Benadryl and it helped a little with the itch and discomfort.
Age: 7.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Pt developed fever and was seen with 15 lesions and dx'd with chickenpox.
Age: 57.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pruritus, Rash
Clinical narrative: Pt had TD on 1/13/03. Noticed itching on 1/14/03 through 1/16/03. Rash noted on 1/17/03. Evaluated in clinic on 1/17/03 and had local redness, swelling and induration 1 1/4" X 1/2" around injection site with rash under arm (mild).
Age: 2.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Feeling hot, Hypokinesia, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: About 12 hours, post vax (DTAP), pt complained of leg pain, felt hot (no documented temperatures). Leg was noticed to be swollen and tender. Fever of 101-102F, the next day with swelling and soreness in leg and limping. Swelling persists after 48 hours.
Age: 28.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: From telephone correspondence received at Aventis Pasteur, Inc. on 8/28/02, it was reported that a 28 y.o. male PT was vaccinated on 8/21/02 with TD. Vaccination was given intramuscularly as a booster with a dosage of 0.5 ml. On 8/28/02, the PT developed a local site reaction of redness, swelling and tenderness 7 days post-vaccination. No treatment was prescribed by the physician. The lot number initially reported on the PT was U0394AB, which is DT ADS PED USP for pediatric use, not TD for adult. A follow-up phone call to the physician was made and she was advised of the same. The physician later called back and stated that "the nurse said she charted the lot # from a paper, not what was on the vial" and provided another lot # (U0382AA), which is TD for adult use. It was not reported whether the PT recovered.