chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: Report 20010071841 described sore shoulder (injection site) in a male of unspecified age who received hepatitis B vaccine recombinant (Engerix-B) for the prophylaxis of hepatitis B. The vaccinee had no known drug allergies. Medical history and concomitant medications were unspecified. On 02/16/2001, the vaccinee received his 1st left deltoid "adult" dose of Engerix-B. On 02/17/2001, the vaccinee complained of soreness in his left shoulder and unspecified "problems with rotation." As of 03/19/2001, the outcome event is unresolved.
Sex: F
Vaccine: HEP
Symptoms: Laboratory test abnormal
Clinical narrative: Report 20010072721 described antigenemia in a female vaccinee of unspecified age who received hepatitis B vaccine recombinant (engerix-B). Allergies, medical history, and concomitant medications were unspecified. The reporter stated that the vaccinee was presumed to have a negative hepatitis B surface antigen prior to immunization with Engerix-B. On 02/22/2001, the vaccinee received her first "adult" dose of Engerix-B. Labs done on 02/27/2001 showed positive for hepatitis B surface antigent. As of 03/19/2001, the outcome of the event is unknown.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Report 20010077051 describes a 47 year old female who did not seroconvert following receipt of an injection of hepatitis B vaccine (Engerix-B). Concurrent medical conditions were not specified. Concurrent medications included fluoxetine (Prozac), conjugated estrogens (Premarin), and phenylephrine/phenylpropanolamine/guaifenesin (Entex). The vaccinee received hepatitis B vaccine (lot 1382J) on 04/14/2000 and a second injection lot 0510J on 05/16/2000. On 10/17/2000, she received 1.0ml of Engerix B pediatric, rather than 0.5ml of engerix B adult. On 11/22/2000, 36 days following receipt of Engerix-B, antibodies against hepatitis B surface antigen were < 2 (positive, >10).
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Report 20010077221 describes a 31 year old female who did not seroconvert following receipt of an injection of hepatitis B vaccine. Concurrent medical conditions included a positive response to tuberculin purified protein derivative, depression and environmental allergies to dust, pollen, and leaves. The vaccinee is a smoker. Concurrent medications included isoniazid and sertraline. The vaccinee received hepatitis B vaccine on 07/07/2000. On 08/07/2000 and 01/11/2001, she received Engerix B pediatric rather than Engerix-B adult. The vaccinee received Engerix-B from lot ENG3221A2 on 08/07/2000, and lot ENG3223A2 on 01/11/2001. On 02/14/2001, 34 day sfollowing receipt of the second injection of Engerix-B, antibodies against hep B surface antigen were <2 (positive, >10). Failure to seroconvert persisted as of 05/18/2001. The reporter indicated that the failure to seroconvert following receipt of the second dose of Engerix-B ped. could be associated with lack of efficacy, or could be associated with the pre-existing depression or positive response to tuberculin purified protein derivative, or to therapy with isoniazid or Zoloft.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Report 20010078551 describes a 47 year old male who did not seroconvert following recipt of an injection of hep B vaccine. Conucrrent medical conditions included asthma. Concurrent medications included zafirlukast (Accolate). The vaccinee received hep B vaccine on 05/15/2000 and a second injection  on 06/16/2000. On 11/17/2000, he received Engerix B ped., rather than of Engerix B adult. On 01/08/2001, 52 days following receipt of the second injection of Engerix B, antibodies against hep B surface antigen were < 2 (positive, >10). Outcome of this event was not provided. The reporter indicated that the failure to seroconvert following receipt of Engerix B ped. could be associated with lack of efficacy, or could be associated with the pre-existing asthma, or to therapy with Accolate.
Sex: U
Vaccine: HEP
Symptoms: Myalgia
Clinical narrative: Report 20010085541 described muscle pains in a vaccinee of unspecified age and gender who received hep B vaccine (brand unknown). Allergies, medical history, and concomitant medications were not specified. On an unspecified date "a couple of years ago," the vaccinee received the unspecified dose of hep B vaccine. Subsequently, the vaccinee experienced muscle pains for about six months. As of 03/30/2001, the outcome of the event is unknown.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Reprot 20010086071 described whole body rash in a 30 year old female who received hep B vaccine (brand unknown) for prophylaxis of hep B. The vaccinee denied allergies, medical history and concomitant medications. On 01/16/2001, the vaccinee received her first dose of hep B vaccine. Twelve to twenty-four hours post vaccination, she experienced a whole body rash. The vaccinee self-treated and was not give the second hep B vaccine dose. As of 04/03/2001, the outcome of the event is resolved.
Age: 8.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Report 20010087151 described hives in an 8 year old male who received hep B vaccine. Allergies, medical history, and concomitant medicaitons were not specified. On an unspecified date, the vaccinee received his first dose of Engerix B. Subsequently, he experienced "hives on trunk." As of 04/04/2001, the outcome of the event is unknown.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Dysgeusia, Neck pain
Clinical narrative: On 7 March 2001 (right deltoid) and 4 April 2001 (left deltoid), the vaccinee received her first and second doses of Engerix-B, respectively. Following the second Engerix-B dose, she experienced metallic taste in her mouth, and neck and arm soreness. As of 5 April 2001, the outcome of the event is recovered.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Dysgeusia
Clinical narrative: Report 20010092281 described bitter taste in mouth in a femal in her "thirties" who received hep B vaccine. The vaccinee had no known drug allergies or medical history. She took no concomitant medications. On 03/05/2001, the vaccinee received her first "adult" right deltoid dose of Engerix-b. Six to 12 hours following vaccination, she experienced "bitter taste in moutn." As of 04/06/2001, the event resolved.
Age: 6.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Dysphonia, Injection site erythema, Injection site mass, Wheezing
Clinical narrative: Report 20010094981 described coughing in a 6 year old female who received hep b vaccine. The reporter denied allergies, medical history and concomitant medications. On 04/10/2001, the vaccinee received her 3rd dose of Engerix-B. Four hours post vaccination, she experienced wheezing, hoarseness, and a cough which produced phlegm. On 04/11/2001, the injection site was red and hard from shoulder to elbow, and the vaccinee ahd a "lump about size of tennis ball (at the injection site)." The vaccinee was seen by a physician. As of 04/12/2001, the outcome of the events was unknown.
Sex: F
Vaccine: HEP
Symptoms: Herpes zoster
Clinical narrative: Report 20010099331 described herpes zoster in a female of unspecified age who received hep B. Reportedly, the vaccinee had no allergies and took no concomitant medications. Her medical history included arthritis. On 04/13/2001, the vaccinee received her first dose of Engerix-B. three days later, on 04/16/2001, she was diagnosed with herpes zoster. As of 04/18/2001, the event was unresolved.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Report 20010099371 described rash with itch in a 35 year old male who received hep B vaccine(Engerix-B). Reportedly, the vaccinee had no known drug allergies or medical history. He took no concomitant medications. On 04/18/2001, the vaccinee received his first "adult" left deltoid dose of Engerix-B. 17 hours later, he experiened a red rash with welts on the waist and bilateral lower extremities which itched. A physician visit was required. As of 04/19/2001, the events had not resolved.
Sex: U
Vaccine: HEP
Symptoms: Eye swelling, Throat tightness, Vomiting
Clinical narrative: Report 2001011532 described throat constriction in a vaccinee of unspecified gender and age who received hep B vaccine (Engerix-B). The vaccinee's allergies, medical history, and concomitant medications were not specified. On an unspecified date, the vaccinee received the first dose of Engerix-B. Subsequently, the vaccinee experienced throat constriction, vomiting, and swollen eyes. As of 05/08/2001, the adverse events resolved.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Injection site hypersensitivity, Pruritus, Urine glucose false positive
Clinical narrative: Report 2010116501 described injection site warmth in a 41 year old female who received hep B vaccine(Engerix-B). Allergies, medical history, and concomitant medications were not specified. On 05/03/2001, the vaccinee received a 1cc subcutaneous dose of Engerix-B. It was not specified whether or not she had received previous doses of Engerix-B. On 05/04/2001, she began having redness, warmth, and itching at the injection site on her left arm. As of 05/07/2001, the redness is a red circular area around the injection site.
Age: 57.0
Sex: U
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: Report 2010116591 described itching in a 57 year old female who received hep B vaccine (Engerix-B). This report was received from a consumer and has not been verified by a physician or other healthcare professional. The vaccinee's allergies were unspecified. Her medical histor included cervical cancer. She took estrogen. On 10/06/2000, the vaccinee received her 1st left deltoid dose of Engerix-B. Within 1-2 days post vaccination she experienced itching which did not resolve.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia
Clinical narrative: Report 20010119521 described weakness in a 30 year old male who received hep B vaccine (Engerix-B). The vaccinee's allergies, medical history, and concomitant medications wer enot specified. On 04/11/2001, the vaccinee received his first "adult" dose of Engerix-B. Three to four hours post vaccination, he experienced weakness, which resolved within 24 hours. As of 05/14/2001, the event resolved.
Age: 41.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Arthralgia, Chills, Dysuria, Flushing, Malaise
Clinical narrative: Report 20010119991 described erectile dysfunction in a 41 year old male who received hep B vaccine (Engerix-B). The patient was allergic to penicillin. He reportedly had no pre-existing medical conditions and was taking no concomitant medications. On 04/25/2001, the vaccinee received his first doses of Engerix-B and hep A vaccine (Havrix). The vaccinating physician reported that the pt experienced chills and "did not feel well" the evening of 04/25/2001. Three days after on 04/28/2001, the pt reported general achiness, numbness and tingling of his genitals, urethral burning and impotence. He was seen by the physician, who obtained urine and urethral cultures; these cultures did not reveal any pathogens. The physician prescribed Medrol Dosepak. On 05/16/2001, the pt was seen by an associate of the vaccinating physician. At that time, the pt reported a recurrence of chills, tingling sensation of the face, rash, and a small perioral ulcer. viral and bacterial cultures of the ulcer were obtained, and complete blood count, erythrocyte sedimentation rate, and assay for C-reactive protein were performed. (results of all evaluations performed were not provided). The physician prescribed acyclover and referred the pt to an infectious disease specialist. On 05/16/2001, the pt's fathe rreported that his son developed a generalized, red, raised rash; itching; flushed face; nausea; fever; and mouth blisters within four hours of immunization on 04/25/2001. "Several days later," the pt experienced numbness and tingling of the lower extremities and penis. He was reportedly seen by an urologist. The pt's father stated that the urologist's diagnosis was urinary tract infection and "possible nerve damage" (NOS). The urologist reportedly prescribed phenazopyridine 200mg and levofloxacin (Levaquin). On 05/18/2001, the pt's father reported that his son's "condition has worsened." He stated that his son had "sexual dysfunction due to numbness in his penis." He also reported that the pt's facial hives were worse. He stated that the pt's work trip was cancelled, and that the pt "now will suffer with a loss of income, too."  On 05/18/2001, the pt stated, "I'm having a reaction to one or both of your vaccines. I'm having erectile dysfunction." No other symptoms were reported. On 05/18/2001, the infectious disease specialist stated that the pt reported tingling of the face,"vague malaise," a macular rash on the face and anterior chest, arthralgias, and inability to have an erection. As of 05/18/2001, all adverse events were unresolved, and the pt's condition had "worsened," per the pt's father. On 05/31/2001, the internist found the condition of the pt to be "normal" other than the subjective complaint of erectile impotence. The physician recommended prednisone as treatment. The pt was previously seen by a urologist who prescribed Medrol DosePak; the pt subsequently felt better "for awhile." When he stopped taking Medrol DosePak, his symptoms returned
Age: 41.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Nausea, Nerve injury, Pain, Paraesthesia, Pruritus
Clinical narrative: Report 20010119991 described erectile dysfunction in a 41 year old male who received hep B vaccine (Engerix-B). The patient was allergic to penicillin. He reportedly had no pre-existing medical conditions and was taking no concomitant medications. On 04/25/2001, the vaccinee received his first doses of Engerix-B and hep A vaccine (Havrix). The vaccinating physician reported that the pt experienced chills and "did not feel well" the evening of 04/25/2001. Three days after on 04/28/2001, the pt reported general achiness, numbness and tingling of his genitals, urethral burning and impotence. He was seen by the physician, who obtained urine and urethral cultures; these cultures did not reveal any pathogens. The physician prescribed Medrol Dosepak. On 05/16/2001, the pt was seen by an associate of the vaccinating physician. At that time, the pt reported a recurrence of chills, tingling sensation of the face, rash, and a small perioral ulcer. viral and bacterial cultures of the ulcer were obtained, and complete blood count, erythrocyte sedimentation rate, and assay for C-reactive protein were performed. (results of all evaluations performed were not provided). The physician prescribed acyclover and referred the pt to an infectious disease specialist. On 05/16/2001, the pt's fathe rreported that his son developed a generalized, red, raised rash; itching; flushed face; nausea; fever; and mouth blisters within four hours of immunization on 04/25/2001. "Several days later," the pt experienced numbness and tingling of the lower extremities and penis. He was reportedly seen by an urologist. The pt's father stated that the urologist's diagnosis was urinary tract infection and "possible nerve damage" (NOS). The urologist reportedly prescribed phenazopyridine 200mg and levofloxacin (Levaquin). On 05/18/2001, the pt's father reported that his son's "condition has worsened." He stated that his son had "sexual dysfunction due to numbness in his penis." He also reported that the pt's facial hives were worse. He stated that the pt's work trip was cancelled, and that the pt "now will suffer with a loss of income, too."  On 05/18/2001, the pt stated, "I'm having a reaction to one or both of your vaccines. I'm having erectile dysfunction." No other symptoms were reported. On 05/18/2001, the infectious disease specialist stated that the pt reported tingling of the face,"vague malaise," a macular rash on the face and anterior chest, arthralgias, and inability to have an erection. As of 05/18/2001, all adverse events were unresolved, and the pt's condition had "worsened," per the pt's father. On 05/31/2001, the internist found the condition of the pt to be "normal" other than the subjective complaint of erectile impotence. The physician recommended prednisone as treatment. The pt was previously seen by a urologist who prescribed Medrol DosePak; the pt subsequently felt better "for awhile." When he stopped taking Medrol DosePak, his symptoms returned
Age: 41.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Pyrexia, Rash, Testicular disorder, Urinary tract infection, Urticaria
Clinical narrative: Report 20010119991 described erectile dysfunction in a 41 year old male who received hep B vaccine (Engerix-B). The patient was allergic to penicillin. He reportedly had no pre-existing medical conditions and was taking no concomitant medications. On 04/25/2001, the vaccinee received his first doses of Engerix-B and hep A vaccine (Havrix). The vaccinating physician reported that the pt experienced chills and "did not feel well" the evening of 04/25/2001. Three days after on 04/28/2001, the pt reported general achiness, numbness and tingling of his genitals, urethral burning and impotence. He was seen by the physician, who obtained urine and urethral cultures; these cultures did not reveal any pathogens. The physician prescribed Medrol Dosepak. On 05/16/2001, the pt was seen by an associate of the vaccinating physician. At that time, the pt reported a recurrence of chills, tingling sensation of the face, rash, and a small perioral ulcer. viral and bacterial cultures of the ulcer were obtained, and complete blood count, erythrocyte sedimentation rate, and assay for C-reactive protein were performed. (results of all evaluations performed were not provided). The physician prescribed acyclover and referred the pt to an infectious disease specialist. On 05/16/2001, the pt's fathe rreported that his son developed a generalized, red, raised rash; itching; flushed face; nausea; fever; and mouth blisters within four hours of immunization on 04/25/2001. "Several days later," the pt experienced numbness and tingling of the lower extremities and penis. He was reportedly seen by an urologist. The pt's father stated that the urologist's diagnosis was urinary tract infection and "possible nerve damage" (NOS). The urologist reportedly prescribed phenazopyridine 200mg and levofloxacin (Levaquin). On 05/18/2001, the pt's father reported that his son's "condition has worsened." He stated that his son had "sexual dysfunction due to numbness in his penis." He also reported that the pt's facial hives were worse. He stated that the pt's work trip was cancelled, and that the pt "now will suffer with a loss of income, too."  On 05/18/2001, the pt stated, "I'm having a reaction to one or both of your vaccines. I'm having erectile dysfunction." No other symptoms were reported. On 05/18/2001, the infectious disease specialist stated that the pt reported tingling of the face,"vague malaise," a macular rash on the face and anterior chest, arthralgias, and inability to have an erection. As of 05/18/2001, all adverse events were unresolved, and the pt's condition had "worsened," per the pt's father. On 05/31/2001, the internist found the condition of the pt to be "normal" other than the subjective complaint of erectile impotence. The physician recommended prednisone as treatment. The pt was previously seen by a urologist who prescribed Medrol DosePak; the pt subsequently felt better "for awhile." When he stopped taking Medrol DosePak, his symptoms returned
Age: 13.0
Sex: M
Vaccine: HEP, TTOX
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: On 4/9/01, the pt rec'd a dose of hepatitis B vaccine (manufacturer unknown), as well as, tetanus and diphtheria Toxoids (manufacturer unknown). It was not known whether the pt had rec'd previous doses of either vaccine. Exactly one week later on 4/16/01 the pt developed dizziness (NOS), nausea, vomiting and headache. As of 5/16/01, the reported symptoms persisted, and had prevented the pt from attending school or reading for one month. No information about diagnostic testing or therapy was available. The pt was reportedly scheduled to be evaluated by a neurologist on 5/18/01. Since the pt missed one month of school, the events are considered incapacitating and this report is considered serious.
Sex: U
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Report 2001012946-1 describes rash in a pt of unspecified age and gender who rec'd hepatitis B vaccine recombinant (Engerix-B). Allergies, medical history, and concomitant medications are unspecified. On an unspecified date, the pt rec'd a dose of Engerix-B, it was not known whether the pt had rec'd previous doses of Engerix-B. Subsequently, the pt experienced a rash. as of 5/22/01, the outcome of the event was unknown.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Report 2001013015-1 describes lack of therapeutic effect in a pt who rec'd hepatitis B vaccine recombinant (Engerix-B). In 1992, the pt rec'd her first, second and third doses of Engerix-B respectively. Recent serological testing revealed that the pt was anti-Hbs A negative. The pt was subsequently administered a dose of hepatitis B vaccine recombinant (Recombivax HB). As of 5/24/01 the outcome of the event was unknown.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia
Clinical narrative: Report 200101354-1 described pulled muscle in a pt who rec'd hepatitis B vaccine recombinant (Engerix-B) for prophylaxis of hepatitis B. This report was rec'd from the pt's mother and has not been verified by a physician or other HCP. Reportedly, the pt had no known allergies or medical history. Reportedly she rec'd no  concomitant medications. reportedly, the pt had never previously experienced a pulled or painful muscle. On 5/29/01, the pt rec'd her first R deltoid dose of Engerix-B. On 5/31/01, while running in the gym, the pt reportedly experienced a pulled muscle or pain (unknown if R or L leg). Reportedly, the pt's symptoms resolved in 24 hrs.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Report 2001013626-1 describes therapeutic lack of effect in a pt of unspecified gender and age who rec'd hepatitis B vaccine (Engerix-B). The rec'd dialysis. Allergies and concomitant medications were not specified. Prior to coming to the dialysis facility 2 yrs ago, the pt rec'd a series of Engerix-B on unspecified dates. The pt's titer is "0". As of 6/5/01, the outcome of the event is unknown.
Age: 51.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Abdominal pain
Clinical narrative: Report 2001013714-1 described abdominal pain in a pt who rec'd hepatitis Be vaccine (recombinant)(Engerix-B). Allergies and concomitant medications were not specified. Per the pt's daughter the pt was having problems before in this area (liver). There was no illness at the tie of vaccination. Per the reporter, the pt denied any problems prior to the administration of Engerix-B and hepatitis A vaccine inactivated (Havrix). This report has been submitted by the reporter also to the center for disease control. On 3/25/01 at 15:30 the pt rec'd his first 20 mcg intra-muscular dose of Engerix-B, his first intra-muscular dose of Havrix, and a 0.5 cc intra-muscular dose of tetanus - diphtheria vaccine. 48 hrs following vaccination ,on 3/29/01, the pt complained of moderate pain in liver. This symptom was subsequently reported as abdominal pain right side under rib. 2 weeks later, the pt was seen by a physician. The pt had discomfort at this time. A CT scan, and a liver enzymes study on approx 4/13/01 were normal. No drugs were used to treat the adverse event. The abdominal pain resolved in 9 days, on 4/23/01. the reporting nurse stated that the abdominal pain was moderate in intensity and possibly related to Engerix-B. The physician recommended that the pt no continue with the follow-up vaccines. As of 6/20/01, the event resolved.
Age: 3.0
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Convulsion, Dehydration, Gastrointestinal disorder
Clinical narrative: Report 2001013861-2 describes a seizure in a pt who rec'd hepatitis B vaccine (brand unspecified). The pt provider submitted this report directly to VAERS. Allergies were unknown. The pt presented to the vaccine provider with no medical records, no possibility of obtaining medical records, and no known immunization history. Therefore, the vaccine provider began a complete immunization series. On follow-up, the reporter stated that the pt had rec'd an initial dose of tetanus and diphtheria Toxoids and acellular pertussis vaccine (different manufacturer) on 10/12/00. Reportedly, the family stated that the pt had a gastrointestinal illness (NOS) the day prior to vaccination, although he had no symptoms the day of the immunization.  On 5/1/01, the pt rec'd the second 0.5 ml intra-muscular dose of hepatitis B vaccine (brand unspecified) the second 0.5 ml intra-muscular dose of tetanus, diphtheria, and acellular pertussis vaccine (Infanrix), the second 0.5 ml intra-muscular dose of inactivated poliovirus vaccine (IPOL, Aventis Pasteur), the second 0.5 ml intra-muscular dose of Haemophilus influenzae type B vaccine (brand unspecified), a 0.1 ml intra-dermal dose of purified protein derivative and the second dose of T-valent pneumococcal conjugate vaccine (Prevnar. Lederle labs), a few hrs later the pt experienced a seizure and was taken to the local ER. All tests (NOS) performed at the ER were negative. Seizure is considered GSK medically serious. The reporter indicated that the seizure was possibly related to Infanrix. The reporter also indicated that the seizure could be associated with possible mild dehydration. As of 8/7/01, the seizure had resolved.
Age: 0.7
Sex: M
Vaccine: HEP, PNC
Symptoms: Cold sweat, Lethargy, Pallor, Vomiting
Clinical narrative: On 6/5/01 at 13:00, the pt received his 3rd left thigh dose of Engerix-B and a left thigh dose of Prevnar. One hour, post vax, at 14:00, the mother called and stated that the vaccinee was vomiting "uncontrollably" and was very lethargic, clammy and pale. The pt was seen in the doctor's office at 15:00 and kept for observation until 20:00. During this 5 hour period, the pt continued to vomit until approx. 19:30. Small amounts of fluid (NOS) were given to the child and tolerated by him. The pt remained lethargic, clammy and pale for approx. the 1st 4 hours of observation. No limb edema, redness or fever was noted. As of 6/7/01, symptoms had completely resolved.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Dizziness, Fatigue, Headache, Musculoskeletal stiffness
Clinical narrative: On 6/6/01, the pt received her 3rd left deltoid adult dose of Engerix-B. On 6/7/01, the vaccinee experienced headache, stiff neck, dizziness, vomiting, chills and fatigue. All symptoms resolved except for fatigue and stiff neck. As of 6/8/01, the adverse events were resolving "slowly".
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: On 6/6/01, the pt received her 3rd left deltoid adult dose of Engerix-B. On 6/7/01, the vaccinee experienced headache, stiff neck, dizziness, vomiting, chills and fatigue. All symptoms resolved except for fatigue and stiff neck. As of 6/8/01, the adverse events were resolving "slowly".
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Eye irritation, Eye swelling, Pruritus
Clinical narrative: Report 20010141421 described swelling and itching (eyes) in a 33 year old female who received hep B vaccine (Engerix-B) for the prophylaxis of hep B. This report was received from the vaccinee and has not been verified by a physician or other health care professional. The vaccinee is allergic to penicillin. Her medical history was not specified. She received the tuberculin tine test on 04/30/2001. On 04/30/2001, the vaccinee received her first left arm dose of Engerix-B. That evening, she experienced itching of the eyes. On 05/01/2001, she woke up with "marked" swelling of the eyes. She "consulted" with the physician and was told to call back if the situation worsened, or alternatively to seek emergency medical attention. On 05/02/2001, the swelling was "the same"; she went to see the physician. The physician consulted with an immunologist who reportedly said that swelling occur as a side effect of the vaccine; he advised that she receive no more immunizations with this vaccine. As of 06/11/2001, the outcome of the events was unknown.
Sex: U
Vaccine: HEP
Symptoms: Anaphylactic reaction
Clinical narrative: Report 20010143451 described anaphylactic reaction in an employee of unspecified age and gender who received hep B vaccine for the prevention of hep B. Allergies, medical history, and concomitant medications were not specified. On an unspecified date, the vaccinee received a dose of hep B vaccine; it was known whether the vaccine had received previous doses of hep B vaccine. Subsequently, the vaccinee experienced an anaphylactic reaction. As of 06/11/2001, the outcome of the event was unknown.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia
Clinical narrative: On 4/11/01, the pt received his 1st IM dose of Engerix-B. Post vax, on 4/11/01, the pt experienced weakness and fatigue. The reporter stated that these adverse events were moderate in severity and possibly related to Engerix-B. No drugs were used to treat the adverse events. They resolved on 4/12/01. Engerix-B was stopped. As of 6/12/01, the adverse events had resolved.
Age: 15.0
Sex: F
Vaccine: HEP, TTOX
Symptoms: Injection site erythema
Clinical narrative: On 6/5/01, the pt received her 1st 0.5cc IM dose of Engerix-B and a 0.5cc IM dose of diphtheria-tetanus vaccine. On 6/8/01, the pt developed a "minor" red spot at the injection site. No drugs were used to treat the adverse event. The reporting physician stated that the adverse event was mild in intensity and was possibly related to Engerix-B. The adverse event resolved on 6/10/01. As of 7/2/01, the adverse event had resolved.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Injection site atrophy
Clinical narrative: On an unspecified date, the pt received his 1st pediatric dose of Engerix-B. One month later, he was observed to have a "big dimple" in his leg (injection site). As of 6/20/01, the outcome of the event was unresolved.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor, Palpitations
Clinical narrative: On 4/6/01 and 5/18/01, the pt received her 1st and 2nd doses of Engerix-B, respectively. Post vax, on 5/10/01, she experienced nausea, dizziness, palpitation, cold sweats and pallor. As of 6/20/01, the events had resolved.
Age: 18.0
Sex: U
Vaccine: HEP
Symptoms: Lymphadenopathy, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: On 6/19/00, the pt received her 2nd IM 0.5cc dose of Engerix-B. Following dose 2, the pt experienced flu-like symptoms consisting of body aches, gland edema, fever, and runny nose. The reporter stated that these events were moderate in intensity and possibly related to Engerix-B. They resolved on 7/2/01. On an unspecified date, the vaccinee received the 3rd dose of Engerix-B and post vax, the pt experienced unspecified flu-like symptoms. As of 7/24/01, the outcome of the 2nd episode of flu-like symptoms was unknown.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Blood glucose decreased, Chills, Dizziness, Injection site pain, Nausea
Clinical narrative: On an unspecified date, the pt received her 1st dose of Engerix-B without adverse event. On 7/13/01, at 08:00, the pt received her 2nd right deltoid dose of Engerix-B. Two hours later, the pt reported severe dizziness, injection site pain, nausea and chills. She was brought to the clinic where her blood sugar was found to be 55mg/dl at 08:00 and 51mg/dl at 10:00. She was treated with Benadryl and 5% dextrose and 1/2 normal saline. The pt did eat prior to receiving her 2nd dose of Engerix-B. The pt was now sleeping. As of 7/13/01, the adverse events were resolving.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: On 6/11/99, 7/12/99 and 12/9/99, the pt received her 1st, 2nd and 3rd doses of Engerix-B, respectively. A titer drawn on 4/22/01, indicated that the pt had not seroconverted. The pt received her 4th dose Engerix-B and again failed to seroconvert. As of 7/17/01, the outcome of the event was unknown.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Angioneurotic oedema, Dry throat, Pruritus, Urticaria
Clinical narrative: On an unspecified date, the child received an injection of Engerix-B at school; number of previous injections of Engerix-B was not reported. On 9/26/00, an unspecified amount of time, post vax, the child developed angioedema, throat itch, pruritus and urticaria. He was taken to the local ER and treated with unspecified steroids. He remained symptom-free for the next 2 weeks. The urticaria then returned. He was seen by an Allergist and was treated with Zyrtec 10mg daily, cimetidine 75mg daily and Benadryl. As of 4/01, the urticaria persisted. The reporting Allergist considered the angioedema, throat itch, pruritus and urticaria to be of moderate intensity and possibly related to Engerix-B administration.
Sex: U
Vaccine: HEP, HIBV
Symptoms: Injection site swelling
Clinical narrative: On an unspecified date, the pt received a right arm dose of Engerix-B (it was not known whether the pt had received previous doses of Engerix-B) and a left arm dose of Haemophilus influenza type b vaccine. Subsequently, the pt developed a "large" swelling at the right arm injection site. As of 7/17/01, the outcome of the event was unknown.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Rash maculo-papular
Clinical narrative: On 6/6/01, the pt received a 0.5cc left deltoid dose of Engerix-B for an IZ update; it was not known how many previous doses of Engerix-B the pt had received. Within 24 hours, post vax, the pt developed a rash that was "all over her body". The rash was "splotchy" and lasted for 3-4 days before resolving. It was not pruritic and there was no fever involved. As of 7/20/01, the adverse event had resolved.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Headache, Hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: Report 2001018011-1 describes pain at the injection site in a pt who rec'd hepatitis B vaccine (Engerix-B). Medical history, concurrent conditions, and concurrent medications were not specified. The pt had no illness at time of immunization. On 11/1/99, 02/02/01 (R deltoid), and 7/13/01 (IM, L deltoid) , the pt rec'd her first, second, and third 20mcq dose of Engerix-B, respectively. Within hrs after receiving her third injection of Engerix-B, the pt experienced pain at the injection site, and numbness and tingling of her left ring and fifth fingers. These events persisted on 7/16/01, and she reported them to her manager. At that time, she also complained of swelling and warmth at the injection site, headaches, and pain in her neck and back. The pt was sent to the ER for evaluation on 7/20/01. The ER physician prescribed a rapidly-tapering course of methylprednisolone (Medro DosePak). On 8/2/01, the injection site warmth had resolved. The pt continued to complain of cramping in the fingers and neck pain. She was referred to an orthopedic surgeon. The most recent information was rec'd  on11/8/01. The pt was under care of 2 physicians. She was initially treated with dexropropoxphene acetaminophen (Darvocet N) and an unspecified muscle relaxant. The pain persisted, and she was treated with gabapentin (Neurontin) the dosage was initially 100mg daily and was increased to the current dosage of 400 mg 3 times daily. The pt does not feel she is improving and states she has pain all the time at the injection site. The pain radiated underneath the mid arm and on down to the little and ring finger. The outcome of the other events were not specified. The pt was cleared for light duty, but could not lift anything heavier than 5 pounds. As a result, she worked part-time and her job duties were changed. Because it resulted in job restrictions, the pain at the injection site is considered to be incapacitating. Therefore, this report has been reclassified as serious.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Injection site warmth, Neck pain, Paraesthesia
Clinical narrative: Report 2001018011-1 describes pain at the injection site in a pt who rec'd hepatitis B vaccine (Engerix-B). Medical history, concurrent conditions, and concurrent medications were not specified. The pt had no illness at time of immunization. On 11/1/99, 02/02/01 (R deltoid), and 7/13/01 (IM, L deltoid) , the pt rec'd her first, second, and third 20mcq dose of Engerix-B, respectively. Within hrs after receiving her third injection of Engerix-B, the pt experienced pain at the injection site, and numbness and tingling of her left ring and fifth fingers. These events persisted on 7/16/01, and she reported them to her manager. At that time, she also complained of swelling and warmth at the injection site, headaches, and pain in her neck and back. The pt was sent to the ER for evaluation on 7/20/01. The ER physician prescribed a rapidly-tapering course of methylprednisolone (Medro DosePak). On 8/2/01, the injection site warmth had resolved. The pt continued to complain of cramping in the fingers and neck pain. She was referred to an orthopedic surgeon. The most recent information was rec'd  on11/8/01. The pt was under care of 2 physicians. She was initially treated with dexropropoxphene acetaminophen (Darvocet N) and an unspecified muscle relaxant. The pain persisted, and she was treated with gabapentin (Neurontin) the dosage was initially 100mg daily and was increased to the current dosage of 400 mg 3 times daily. The pt does not feel she is improving and states she has pain all the time at the injection site. The pain radiated underneath the mid arm and on down to the little and ring finger. The outcome of the other events were not specified. The pt was cleared for light duty, but could not lift anything heavier than 5 pounds. As a result, she worked part-time and her job duties were changed. Because it resulted in job restrictions, the pain at the injection site is considered to be incapacitating. Therefore, this report has been reclassified as serious.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Flushing, Influenza like illness, Nausea
Clinical narrative: Report 2001018374-1 describes lightheadedness in a pt who rec'd hepatitis B vaccine recombinant (Engerix-B). This report was rec'd from a person of unspecified professional identity and had not been verified by a physician or other HCP. Allergies, medical history, and concomitant medications were unknown. On 7/23/01, the pt rec'd her first L deltoid dose of Engerix-B, 20 minutes later, she was lightheaded, flushed, and nauseous. She experienced flu-like symptoms and was not feeling with it. As of 7/25/01, the pt's symptoms were resolving.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Nausea, Neck pain
Clinical narrative: Report 2001018593-1 describes head pain in a pt who rec'd hepatitis B vaccine recombinant (Engerix-B). Allergies and medical history were not specified. The pt rec'd medoxyprogesterone acetate (Depo-Provera). On unspecified dates, the pt rec'd her first and second doses of Engerix-B without adverse event. On 7/31/01 she rec'd her third L deltoid dose of Engerix-B, immediately upon vaccination, she experienced nausea, and shooting head and neck pain. She was treated  with ice. As of 7/31/01, the adverse events had resolved.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea
Clinical narrative: Report 2001018598-1 describes faint feeling in a pt who rec'd hepatitis B vaccine recombinant (Engerix-B). Allergies, medical history, and concomitant medications were not specified. On 7/31/01, the pt rec'd her third dose of Engerix-B, ten minutes later, she experienced nausea and faint feeling. She was treated with ice. As of 7/31/01, the adverse events were resolving.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Hot flush, Hyperhidrosis, Retching
Clinical narrative: Report 2001018603-1 describes dry heaves in a pt who rec'd hepatitis B vaccine recombinant (Engerix-B). Allergies, medical history, and concomitant medications were unspecified. On 7/31/01, the pt rec'd her first L deltoid dose of Engerix-B, ten minutes after receiving Engerix-B, the pt experienced stomach pain, dry heaves and was hot and sweaty. She was treated with ice applied to the injection site. As of 7/31/01, the adverse events had not resolved.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Report 2001018607-1 describes pressure, burning and tightness in the sternal area in a pt who rec'd hepatitis B vaccine recombinant (Engerix-B). This report was rec'd from a pharmaceutical intern and has not been verified by a physician or a HCP. Allergies, medical history, and concomitant medications were unspecified. In 6/01, the pt rec'd her first dose of Engerix-B, immediately upon receiving Engerix-B, she experienced pressure, burning and tightness in the sternal area. The adverse events resolved in 15 minutes. As of 7/31/01, the adverse events had resolved.
Age: 68.0
Sex: M
Vaccine: HEP
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: Report 2001018872-1 describes injection site swelling in a pt who rec'd hepatitis B vaccine recombinant (Engerix-B). Allergies were not specified. The pt's medical history included liver transplant in 1986 and hemodialysis since 4/01. She rec'd carvedilol (Coreg), azathioprine (Imuran), acetylsalicylic acid, alprazolam (Xanax), iron, allopurinol, and Prednisone.  On 7/2/01, the pt rec'd her first 40 mcg dose of Engerix-B. The pt rec'd one 20 mcg dose in the L deltoid. No adverse events were experienced. On 8/3/01, the pt rec'd her second 40 mcg dose of Engerix-B. Again, the pt rec'd one 20 mcg dose in the R deltoid and one 20 mcg dose in the L deltoid. Ninety minutes post vaccination, she experienced baseball-sized swelling of the L deltoid with dime-sized hematoma at the injection site. Sixty minutes later, she experienced golf ball sized swelling of he R deltoid. Ice was applied to the site and the pt was evaluated in the ER. As of 8/3/01, the outcome of the adverse events was unknown.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Body temperature decreased, Decreased appetite, Depressed level of consciousness, Irritability, Laboratory test abnormal
Clinical narrative: Report 2001019092-1 describes difficult to arouse in an 11 day old infant who rec'd hepatitis B vaccine recombinant (Engerix-B). This report was rec'd from the pt's mother with follow-up medical records. Medical history, allergies, and review of systems were non-contributory. On 2/21/96, the pt rec'd her first L leg dose of Engerix-B. The pt became irritable that day and night. she was difficult to arouse. Her body temperature was decreased to 96.6F and she fed poorly. Her parents noted that she was not right for 18 hrs following immunization. An exam in her physician's office the following day was normal and she was considered to have recovered. A recent titer showed no immunity. 1/23/01; physician stated that the pt had an episode of prolonged fussiness and lethargy following her hepatitis B vaccination at 11 days of age. total, her parents felt that for 18 hrs after the vaccination, the pt displayed abnormal levels of irritability, drowsiness and temperature drop to 96.6F. Her physical exam was completely within normal limits. The physician explained to the mother that the reaction they described was totally inconsistent with an immediate hypersensitivity reaction. As of 8/7/01, the outcome of the adverse events was resolved.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Lethargy
Clinical narrative: Report 2001019092-1 describes difficult to arouse in an 11 day old infant who rec'd hepatitis B vaccine recombinant (Engerix-B). This report was rec'd from the pt's mother with follow-up medical records. Medical history, allergies, and review of systems were non-contributory. On 2/21/96, the pt rec'd her first L leg dose of Engerix-B. The pt became irritable that day and night. she was difficult to arouse. Her body temperature was decreased to 96.6F and she fed poorly. Her parents noted that she was not right for 18 hrs following immunization. An exam in her physician's office the following day was normal and she was considered to have recovered. A recent titer showed no immunity. 1/23/01; physician stated that the pt had an episode of prolonged fussiness and lethargy following her hepatitis B vaccination at 11 days of age. total, her parents felt that for 18 hrs after the vaccination, the pt displayed abnormal levels of irritability, drowsiness and temperature drop to 96.6F. Her physical exam was completely within normal limits. The physician explained to the mother that the reaction they described was totally inconsistent with an immediate hypersensitivity reaction. As of 8/7/01, the outcome of the adverse events was resolved.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper
Clinical narrative: Report 2001019101-1 describes stomach pains in a pt who rec'd hepatitis Be vaccine recombinant (Engerix-B). Allergies, medical history, and concomitant medications were not specified. On 7/23/01, the pt rec'd a dose of Engerix-B, it was not known whether she had rec'd previous doses of Engerix-B. Subsequently, the pt experienced stomach pains and sought medical attention. As of 8/3/01, the outcome of the adverse event was unknown.
Sex: F
Vaccine: HEP
Symptoms: Oedema
Clinical narrative: Report 2001019244-1 describes edema in a pt who rec'd hepatitis B vaccine recombinant (Engerix-B). Medical History included allergy to diphenhydramine (Benadryl). Concurrent medications include bupropion HC1 (Zyban), which was initiated by the pt's primary care physician on approx 2/6/01. the pt rec'd her first injection of Engerix-B on 1/19/01. she had no adverse experience following receipt of this injection. She rec'd her second injection of Engerix-B on 2/20/01, within 24 hrs of receiving the second injection, she developed edema all over. She went to the local ER on 2/21/01 and was treated with unspecified steroids. The vaccine provider reported that the pt's primary care physician considered the edema to be a possible adverse event to either Engerix vaccine or Zyban. Therefore, the primary care physician discontinued Zyban therapy on 2/21/01. The edema resolved after an unspecified period of time.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Eye movement disorder, Tic
Clinical narrative: His mother reported that he began to have tics in his arm in 1998. He has reportedly been seen "numerous" times by physicians. A neurologist performed an unspecified magnetic resonance imaging MRI study; results of this study were not provided. The mother reported that the neurologist made a diagnosis of Tourette's syndrome. The vaccinee "now has severe tics all over his body, and his eyes roll back into his head." Treatment of the Tourette's syndrome was not specified.
Age: 33.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Blood bilirubin increased
Clinical narrative: Report 20010203732 described elevated bilirubin in a 33 year old male who received hep B vaccine (brand unspecified). This report was received from the vaccinee's wife and has not been verified by a physician or other health care professional. The vaccinee's allergies, and medical history were not specified. In August 2000, the vaccinee reportedly received an injection of hep b vaccine and a subcutaneous injection of hep a vaccine inactivated. Reportedly, the vaccinee subsequently developed an elevated bilirubin level, which he was currently. The consumer consulted a health care professional regarding the adverse event. Hep B vaccine was discontinued. As of 08/17/2001, the outcome of the adverse event was ongoing.
Sex: U
Vaccine: HEP
Symptoms: Lymphadenopathy
Clinical narrative: Report 20010207481 described lymphadenopathy in a vaccinee of unspecified age and gender who received hep B vaccine recombinant. The vaccinee's allergies, medical history, and concomitant medications were not specified. On an unspecified date, the vaccinee received a dose of Engerix-B; it was not known whether the vaccinee had received previous doses of Engerix-B. subsequently, the vaccinee experienced lymphadenopathy. As of 08/24/2001, the outcome of the adverse event was unknown.