chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a healthcare professional via Merck and described the occurrence of hepatitis b surface antigen positive in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified time after vaccination with ENGERIX B, the subject experienced hepatitis b surface antigen positive. The nurse reported the subject was given one dose of ENGERIX B, two weeks later went to donate plasma and found to be positive for hepatitis b surface antigen. At the time of the report no other information was available. At the time of reporting the outcome of the hepatitis b surface antigen positive was unspecified.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: This spontaneous report was received from a 59 years old female consumer reporting on herself with allergy to penicillin and who on 11-JAN-2012, was vaccinated in her left arm with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. Concomitant medications included CRESTOR and LUNESTA. The consumer reported that on 11-JAN-2012, she experienced an injection site reaction after receiving ZOSTAVAX. The consumer stated the injection site on her left arm was red, hot, itchy and painful and she had a rash from her elbow to her under arm. BENADRYL was given as a treatment for the experience. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for injection site on her left arm was red, patient had a rash from her elbow to her under arm, injection site on her left arm was painful, itchy and injection site on her left arm was hot was unknown for ZOSTAVAX. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a 59 years old female consumer reporting on herself with allergy to penicillin and who on 11-JAN-2012, was vaccinated in her left arm with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. Concomitant medications included CRESTOR and LUNESTA. The consumer reported that on 11-JAN-2012, she experienced an injection site reaction after receiving ZOSTAVAX. The consumer stated the injection site on her left arm was red, hot, itchy and painful and she had a rash from her elbow to her under arm. BENADRYL was given as a treatment for the experience. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for injection site on her left arm was red, patient had a rash from her elbow to her under arm, injection site on her left arm was painful, itchy and injection site on her left arm was hot was unknown for ZOSTAVAX. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site rash, Oedema peripheral
Clinical narrative: This report refers to a 26 years old female patient enrolled in a not blinded other studies. The patient's current condition includes Crohns disease, drug allergy ALEVE, PNEUMOVAX allergy manifests as swelling, non-smoker and alcohol use:socially. The patient's medical history included spinal fusion. The patient was vaccinated (route not provided) with PNEUMOVAX23 (lotnumber and expiry date not provided) on AUG-2012. Other suspect therapies included HUMIRA with dosage information as (40 mg, 1 in 2 wk) on SEP-2011. Concomitant medications included: PENTASA. On AUG-2012 the patient experienced swollen arm. On SEP-2012 the patient experienced pain with injections and red circle at injection site. On an unknown date the patient experienced bumps with injection, the solution dispensed with HUMIRA, pulled pen off to soon, feels like knife when needle goes in, sore to touch after injection, red rash with injection and bruising with injection. No treatment information was reported. The outcome of bumps with injection, the solution dispensed with HUMIRA, pulled pen off to soon, swollen arm, feels like knife when needle goes in, sore to touch after injection, red rash with injection, bruising with injection, red circle at injection site and pain with injection is unknown. The relatedness for bumps with injection, the solution dispensed with HUMIRA, pulled pen off to soon, swollen arm, feels like knife when needle goes in, sore to touch after injection, red rash with injection, bruising with injection, red circle at injection site and pain with injections is unknown for PNEUMOVAX23. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 79 years old female with hypercholesterolemia and hypertension and no drugs reactions or allergies, who on 24-DEC-2012, was vaccinated subcutaneously with 0.65 ml dose of live ZOSTAVAX (lot number H012523, Exp. Date:09-OCT-2013. No other co-suspects were reported, No concomitant medications were reported. It was reported that on 24-DEC-2012, the patient developed a red area around injection site about a size of quarter, 1 day after onset of therapy and patient developed a red area around injection site about a size of quarter which was mildly itchy. No treatment was given for the experience. No lab diagnostics studies were performed. At the time of the report, the itching has subsided, but the redness was still present. The patient sought unspecified medical attention. The relatedness for patient developed a red area around injection site about a size of quarter which was mild itchy was unknown for live ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (details unknown). On an unspecified date, more than 1 month after the 3rd dose of ENGERIX B, the subject experienced not responding to therapy. It was reported that a titre level was drawn more than 1 month after the 3rd dose in the hepatitis series and those titres were zero. The healthcare professional reported that 4 subject experienced not responding to therapy (please see case numbers A0962820-22A for the other 3 subjects).
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative, No therapeutic response, Tinnitus
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in a 55-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included anxiety, hypercholesterolemia and OCD. Concurrent medications included flucoxamine and Niacin. On 15 June 2011, 1 August 2011 and 4 January 2012, the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown, left deltoid), respectively. On 15 August 2011, 14 days after vaccination with the 2nd dose of ENGERIX B, the subject experienced tinnitus. The tinnitus resolved approximately two weeks later. On an unspecified date in 2012, less that one after receiving the 1st, 2nd and 3rd doses of ENGERIX B, the subject experienced not responding to therapy. The subject stated titers were drawn at approximately "four months" showed no seroconversion. The immunizations series was noted to be delayed. The pharmacist considered the tinnitus were possibly related to vaccination with ENGERIX B.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Dysarthria, Tinnitus, Vertigo, Visual field defect
Clinical narrative: Told by male nurse frozen vaccine. Vertigo, tinnitus, field of vision lowered, speech slurred.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Nervousness, Pharyngeal oedema, Throat irritation, Tongue disorder
Clinical narrative: About 2 hours after received PPD and TDAP, employee returns to Employee Health Clinic c/o 20 minute hx of feeling nervous, coughing, throat irritations, swollen throat & bumpy tongue. B/P 106/64, HR 68. Tongue is red and bumpy. States had anaphylactic episode at age 18 after admin of ROCEPHIN. States 1 yr ago ate something - unknown - that made her face swell. Within 20 minutes states is less nervous, tongue less bumpy. Went home.
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Expired drug administered, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of the use of expired vaccine in a 15-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline), Hepatitis B vaccine. There were no concurrent medications. On 6 July 2012 the subject inadvertently received an expired 1st dose of ENGERIX B at 0.5 ml in the left arm. This was technically the 4th dose of hepatitis B vaccine for this subject as she previously completed a hepatitis B vaccination series (manufacturer unspecified) on unspecified dates and did not respond to therapy. Follow-up information was received on 07 August 2012 via healthcare professional who reported the subject did not experience any adverse reactions due to the administration of ENGERIX B.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Anti-cyclic citrullinated peptide antibody positive, Antinuclear antibody increased, Antinuclear antibody positive, Arthralgia, Chemotherapy
Clinical narrative: Sudden onset. No injury, right hand/right ankle, swelling, pain, limited range of motion, difficulty ambulating. Symptoms have continued to this date including various joints of all extremities, requiring steroid, anti-inflammatory and chemo-therapy medication.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Gait disturbance, Joint range of motion decreased, Joint swelling, Oedema peripheral, Pain in extremity
Clinical narrative: Sudden onset. No injury, right hand/right ankle, swelling, pain, limited range of motion, difficulty ambulating. Symptoms have continued to this date including various joints of all extremities, requiring steroid, anti-inflammatory and chemo-therapy medication.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: Sudden onset. No injury, right hand/right ankle, swelling, pain, limited range of motion, difficulty ambulating. Symptoms have continued to this date including various joints of all extremities, requiring steroid, anti-inflammatory and chemo-therapy medication.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of not responding to therapy in a 57-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent vaccination included hepatitis B vaccine recombinant;GlaxoSmithKline;unknown;unknown given on 5 July 2012. On an unspecified date the subject received 1st dose, 2nd dose, 3rd dose of ENGERIX B (details unknown) and within weeks of vaccination with ENGERIX B, the subject experienced not responding to therapy. The nurse explained that the subject was administered 3 dose series of ENGERIX B and a "few weeks later upon testing did not have antibody titers to show a response to the vaccine". Therefore, on an unspecified date the subject received 4th dose of ENGERIX B (details unknown) and this time experienced decreased therapeutic response. The nurse stated the subject was tested after the 4th dose and the results showed low titer level and on 05 July 2012, the subject was administered a 5th dose of ENGERIX B.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response, Therapeutic response decreased
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (1 ml, unknown) and experienced decreased therapeutic response. The pharmacist reported that four subjects in a row were non-reactive with a count less than 2.89. At the time of the report no additional information was provided. This is the third of four cases reported by the pharmacist, please see cases A0975396A, A0975397A and A0975399A. Follow-up information was received on 23 May 2012 via healthcare professional who reported on 13 March 2012, 4 October 2011 and 19 August 2011 in a 60-year old female subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B (1 ml, unknown, right deltoid) respectively. On 24 April 2012, 42 days after vaccination with 3rd dose of ENGERIX B, 7 months after vaccination with 2nd dose of ENGERIX B, 8 months after vaccination with 1st dose of ENGERIX B, the subject experienced not responding to therapy. On 24 April 2102 Hepatitis B titer result was 2.89. The subject received a booster dose of ENGERIX B on 07 May 2012.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Listless, Pallor
Clinical narrative: Approximately 4 hrs. after receiving vaccine HPV GARDASIL 2nd dose, he became pale and listless. Laid in bed for about 4 hrs., then was fine, I would call this a mild reaction, no headache, no fever, just weakness.
Age: 0.21
Sex: M
Vaccine: HEP, PNC
Symptoms: Infantile spitting up
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of spitting up in a 2-month-old male subject who was vaccinated with HEPATITIS B vaccine (manufacturer unspecified), PREVNAR (non-gsk). Concurrent medical conditions included anemia, gastroesophageal reflux disease, heart murmur and prematurity. Concurrent vaccination included combined diphtheria, tetanus acellular pertussis and inactivated poliomyelitis vaccine; GlaxoSmithKline; unknown; right thigh given on 8 June 2012 at 17:00; haemophilus influenzae type b vaccine (non-gsk); Sanofi; unknown; unknown given on 8 June 2012. Concurrent medications included POLY-VI-SOL w/ iron and Ranitidine hydrochloride. On 15 June 2012 the subject received unspecified dose of HEPATITIS B VACCINE (details unknown), unspecified dose of PREVNAR (details unknown). On 15 June 2012, less than one day after vaccination with HEPATITIS B VACCINE and PREVNAR, the subject experienced spitting up. On 16 June 2012, the subject was evaluated in the emergency room (ER). At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was unrelated to vaccination with HEPATITIS B VACCINE and PREVNAR. According to the healthcare professional, the "spitting up in the ER was not considered an adverse event associated with the vaccines". The subject had a case involving KINRIX. See A0982926A for details for KINRIX case. The healthcare professional reported a second case with another subject for KINRIX. See case A0982921A for details.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Malaise, Muscle tightness, Musculoskeletal discomfort, Pain in jaw
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of jaw pain in a 36-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. On 24 July 2012, the subject received 1st dose of ENGERIX B (details unknown, left arm). On 24 July 2012, 2 hours after vaccination with ENGERIX B, the subject experienced severe jaw pain, jaw tightness, neck discomfort, headache and general malaise. The healthcare professional reported that the subject came to their clinic about two hours after receiving an ENGERIX B vaccination, complaining of severe jaw pain, jaw tightness, neck discomfort, headache, and general malaise. She did not receive any other vaccinations at that time. At the time of reporting, the symptoms seem to be improving. The healthcare professional considered the events were probably related to vaccination with ENGERIX B.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Paraesthesia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site reaction in a 51-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included allergic to compazine, allergy to LORTAB, allergy to oxycodone, allergy to sulfa drugs, depression, diabetes, emphysema, hepatic encephalopathy, hypertension, nausea, non alcoholic steatohepatitis, penicillin allergy and vomiting. Concurrent medications included Aspirin, Glipizide, Hyoscyamine, IRON, KLONOPIN, Lactose, ONDANSETRON, PHENERGAN, PREMARIN, PROBIOTIC, PROTONIX, PROVENTIL, PROZAC, SINGULAIR, Stool softener, Vitamin E and XIFAXAN. On 23 July 2012 at 16:00 the subject received 3rd dose of ENGERIX B (20 mcg, intramuscular, right deltoid). On 24 July 2012, 1 day after vaccination with ENGERIX B, the subject experienced a larger than expected injection site reaction, injection site redness, swelling injection site and injection site tingling. The subject was recommended an unknown (Over counter medicines) for treatment by the healthcare professional. At the time of reporting the larger than expected injection site reaction, injection site redness, swelling injection site and injection site tingling were unresolved. The healthcare professional considered the events were probably related to vaccinations with ENGERIX B.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy, Musculoskeletal discomfort, Pyrexia
Clinical narrative: This prospective pregnancy case was reported by a consumer (subject's father) and described the occurrence of fever in a 17-year-old female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified), seasonal influenza vaccine (non-gsk), MMR vaccine (non-gsk), meningitis vaccine and strain not specified (Meningococcal vaccine) for prophylaxis during pregnancy. A physician or other health care professional has not verified this report. The subject had no previous pregnancies. The subject was not using contraception. The conception was by normal method. On 10 October 2012 the subject received 2nd dose of Hepatitis B vaccine (unknown details) during approximately the 2nd trimester of pregnancy. In June 2012 the subject received the first dose of Hepatitis B vaccine (unknown details), a dose of Meningococcal vaccine (unknown details) and experienced vaccine exposure during approximately the first trimester of pregnancy. The gestational age at the times of vaccination exposures were not reported. The date of the last menstrual period was reported as May 2012. The estimated date of delivery was reported as February or March of 2013. The reporter stated that he "did not know the brand of the vaccines the patient received." The reporter stated that "he received [GSK's] number from a leaflet that he received at the clinic. [GSK's] number was listed along with other numbers and he did not know where to call to ask questions about receiving vaccines while being pregnant." In 2012, less than one year after vaccination with Hepatitis B vaccine, MMR vaccine (Non-GSK), Meningococcal vaccine and Seasonal influenza vaccine (Non-GSK), the subject experienced fever and muscle discomfort. In 2012, the events of fever and muscle soreness were resolved. At the time of reporting, the pregnancy was ongoing.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a consumer and described the occurrence of not responding to therapy in a 32-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included Birth control. In 1989 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown details). In 1989, less than one year after vaccination with ENGERIX B, the subject experienced not responding to therapy. The reporter described herself as "a nonresponder". The reporter did not consult a healthcare provider regarding the event.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site soreness in a roughly 34-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included psoriasis. There were no concurrent medications. On 19 July 2012 the subject received 1st dose of ENGERIX B at 1 ml in the left deltoid. On 19 July 2012, immediately after vaccination with ENGERIX B, the subject experienced injection site soreness (soreness around the injection site). At the time of reporting, the injection site soreness was continuing (unresolved). The intensity was not known. It was not determined if the series would be discontinued or delayed. Attribution of the event to vaccination with ENGERIX B was not reported. It was noted that the subject was an employee at the clinic and the vaccine responsible physician was the medical director for the clinic. The lot number was reported as AHBVC047AA from the reporter; however, based on GlaxoSmithKline batch numbering the lot number was updated to AHBVC047AA.
Sex: U
Vaccine: HEP
Symptoms: Serum sickness-like reaction, Urticaria
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of serum sickness like symptoms in a 7-day-old subject of unspecified gender who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). On an unspecified date the subjects received 1st dose of Hepatitis B vaccine (unknown). At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced serum sickness like symptoms and hive. The sales representative stated the physician reported a 7-day old subject received Hepatitis B vaccine (unknown manufacturer) and developed hives and serum like sickness after the dose. The subject has also seen an allergist regarding these issues. At the time of the report no additional information was available. At the time of reporting the serum sickness like symptoms and hive were resolved.
Sex: F
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in an adult female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). Concurrent medical conditions included sjogren's syndrome. Concurrent vaccination included hepatitis A vaccine inactivated; manufacturer unspecified; unknown; unknown given on an unspecified date. On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (unknown). At an unspecified time, after vaccination with Hepatitis B vaccine series, the subject experienced not responding to therapy. The healthcare professional reported the adult subject was diagnosed with Sjogren's disease by a previous providers office (unknown name and place) within the last five years (estimated) received a vaccine series of a hepatitis B vaccine (unknown if ENGERIX B) along with hepatitis A vaccine (unknown if HAVRIX). Titer testing at unknown interval after series showed seroconversion to Hepatitis A but no seroprotection to hepatitis B; lack of expected effect. The subject is going to travel and inquired if she should receive another dose of hepatitis B vaccine or series. Follow-up information was received on 15 October 2012 via healthcare professional who reported the subject "called the office for travel vaccines and has not been in". The subject has a history of Sjogren's syndrome and was not responding to therapy with Hepatitis b vaccine. At the time of the report, the event was unresolved, no other information was provided.
Sex: U
Vaccine: HEP
Symptoms: Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of ENGERIX B (1 ml, unknown). At an unspecified time after vaccination with ENGERIX B, the subject experienced pain. It was reported that the Hepatitis B for adults comes in a 1 ml vial and is more painful compared to other vaccines. At the time of reporting the outcome of the pain was unspecified.
Sex: F
Vaccine: HEP
Symptoms: Injection site discolouration
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of discolored area at injection site in a female subject aged 18 or 19 years old who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). On an unspecified date the subject received 2nd dose of Hepatitis B vaccine in an unknown arm (unknown if ENGERIX B or RECOMBIVAX). Within years of vaccination with Hepatitis B vaccine, the subject experienced discolored area at injection site (purplish stain on arm). At the time of reporting the event was resolved (the event went away in less than a week).
Sex: U
Vaccine: HEP
Symptoms: Pruritus generalised
Clinical narrative: This case was reported by a consumer and described the occurrence of whole body itching in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 7 June 2012 the subject received 2nd dose of ENGERIX B (unknown). Within a day after vaccination with ENGERIX B, the subject experienced severe, uncontrollable itching over her entire body. The itching continued despite taking multiple antihistamines, prednisone and applications of various topical agents. "Pruritus is my only symptom. Nothing else changed or was added to my system." At the time of reporting the whole body itching and itching were unresolved.
Sex: F
Vaccine: HEP
Symptoms: Abnormal sensation in eye, Asthenia, Vision blurred
Clinical narrative: This case was reported by a physician and described the occurrence of body weakness in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown). At an unspecified time after vaccination with ENGERIX B, the subject experienced body weakness (weakness on one side of the body), eye pressure (pressure in the left eye) and blurred vision. At the time of reporting the outcome of the events was unspecified.
Sex: M
Vaccine: HEP, HEPA
Symptoms: Fatigue, Headache, Urticaria
Clinical narrative: This case was reported by consumer (subject's mother) and described the occurrence of hive in a child male subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received 1st dose of Hepatitis B vaccine (details unknown). On 18 June 2012, at an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced hive. At the time of reporting the outcome of the event was unspecified. The vaccination course with Hepatitis B vaccine was discontinued. The subject's mother called because her now 18-year-old son had headache and tiredness lasting 4 days and still ongoing at the time of the report after receiving HAVRIX. See case A0982384A for details. She reported the hives with Hepatitis B vaccine when asked about previous vaccinations. Denied permission to contact physician.
Sex: M
Vaccine: HEP, HEPA
Symptoms: Fatigue, Headache
Clinical narrative: This case was reported by consumer (subject's mother) and described the occurrence of hive in a child male subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received 1st dose of Hepatitis B vaccine (details unknown). On 18 June 2012, at an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced hive. At the time of reporting the outcome of the event was unspecified. The vaccination course with Hepatitis B vaccine was discontinued. The subject's mother called because her now 18-year-old son had headache and tiredness lasting 4 days and still ongoing at the time of the report after receiving HAVRIX. See case A0982384A for details. She reported the hives with Hepatitis B vaccine when asked about previous vaccinations. Denied permission to contact physician.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Nausea, Performance status decreased
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of headache in a 31-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On unspecified dates, the subjects received 1st and 2nd dose of ENGERIX B (20 mcg, unknown). At an unspecified time after vaccination with 1st and 2nd doses of ENGERIX B (20 mcg), the subjects experienced headache, dizziness, nausea and could not function. The healthcare professional reported that the subjects received two doses of 20 mcg of ENGERIX B and experienced a headache, dizziness, nausea and the subject said she "couldn't function". All events resolved without intervention on an unspecified date. No additional information was known at the time of reporting.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 54 years old female patient with no relevant medical history or past drug history. The patient was vaccinated with left deltoid with a dose of ZOSTAVAX (dose and lot number was not reported) on 03-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. On 04-DEC-2012 (reported also as on "an unknown date in December 2012") after having ZOSTAVAX the patient experienced redness the size of a nickel and itching at the injection site. No treatment information was reported. No lab diagnostic studies were performed. It was also reported that as of 17-DEC-2012, the patient did not plan on having a ZOSTAVAX again. It was unknown if the patient sought medical attention. The redness lasted about 3 days and the itching lasted about 5 days and then resolved. The relatedness for the events was unknown for ZOSTAVAX. This is one of several reports received from the same source. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: 09/04/2012 at 5:37 pm MENACTRA vaccine was administered by physician.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse refers to a patient of unknown age who on 02-JAN-2013, was vaccinated with a dose of ROTATEQ, oral (lot number 0777AA) (dose not reported) that was expired. The vaccine expired on 14-NOV-2012. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.37
Sex: M
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse refers to a patient of unknown age who on 31-DEC-2012, was vaccinated with a dose of ROTATEQ, oral (lot number 0777AA) (dose not reported) that was expired. The vaccine expired on 14-NOV-2012. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.06
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Slightly red area on right thigh afterwards, now getting bigger approx. 1.5cm right outer thigh.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Noted to have 4" x 5" raised red, tender area at injection site.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, PNC13, VARCEL, DTAP, HEPA, HIBV, PNC13, VARCEL
Symptoms: Convulsion, Cough, Dysphonia, Hypotonia, Malaise
Clinical narrative: Around 7:00 pm on November 20th my son had a 103 temp. His voice was hoarse and couldn't talk very well. The next day the 21st my husband called the health dept. where he received his shots and was told to give him Tylenol and that was it.  We continued to monitor him. Gave him Tylenol and Ibuprofen, luke warm baths and let him sleep because he could barely move he was sooo sick.  That evening he was sleeping and I checked on him and he was flopping everywhere and shaking.  My husband rushed him to the ER and we were told he had a seizure. My son was sick for 3 days after that with a fever and cough and a hard time talking.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, PNC13, VARCEL, DTAP, HEPA, HIBV, PNC13, VARCEL
Symptoms: Mobility decreased, Speech disorder, Tremor
Clinical narrative: Around 7:00 pm on November 20th my son had a 103 temp. His voice was hoarse and couldn't talk very well. The next day the 21st my husband called the health dept. where he received his shots and was told to give him Tylenol and that was it.  We continued to monitor him. Gave him Tylenol and Ibuprofen, luke warm baths and let him sleep because he could barely move he was sooo sick.  That evening he was sleeping and I checked on him and he was flopping everywhere and shaking.  My husband rushed him to the ER and we were told he had a seizure. My son was sick for 3 days after that with a fever and cough and a hard time talking.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, PNC13, VARCEL, DTAP, HEPA, HIBV, PNC13, VARCEL
Symptoms: Injection site swelling, Pyrexia, Staring, Tonic clonic movements
Clinical narrative: Around 7:00 pm on November 20th my son had a 103 temp. His voice was hoarse and couldn't talk very well. The next day the 21st my husband called the health dept. where he received his shots and was told to give him Tylenol and that was it.  We continued to monitor him. Gave him Tylenol and Ibuprofen, luke warm baths and let him sleep because he could barely move he was sooo sick.  That evening he was sleeping and I checked on him and he was flopping everywhere and shaking.  My husband rushed him to the ER and we were told he had a seizure. My son was sick for 3 days after that with a fever and cough and a hard time talking.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered at inappropriate site, Inflammation, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain
Clinical narrative: Vaccination was improperly administered into shoulder rather than in upper arm. Injection administered one finger width below shoulder joint. At the time of administration, pain at site of injection. Worsening pain in left shoulder at vaccination site, radiating down outside of arm to wrist. Inflammation causing limited mobility in arm. Was seen at primary care physician's office for pain on 01/16/2013, was prescribed Motrin 600 mg 4 times/day and ice area.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Pain in extremity
Clinical narrative: Vaccination was improperly administered into shoulder rather than in upper arm. Injection administered one finger width below shoulder joint. At the time of administration, pain at site of injection. Worsening pain in left shoulder at vaccination site, radiating down outside of arm to wrist. Inflammation causing limited mobility in arm. Was seen at primary care physician's office for pain on 01/16/2013, was prescribed Motrin 600 mg 4 times/day and ice area.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Rash, Skin ulcer
Clinical narrative: Patient reported to the clinic c/o rash and sores that had not healed since vaccination.  Patient stated that he was trying to allow self healing and did not want to report to clinic since he felt he was always at the clinic and thought they would self heal.
Age: 32.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Dizziness, Erythema, Nausea, Pain, Pruritus
Clinical narrative: Swelling, redness, itching, pain, tenderness, dizziness, nausea.
Age: 32.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Swelling, Tenderness
Clinical narrative: Swelling, redness, itching, pain, tenderness, dizziness, nausea.
Age: 19.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient's mother informed office staff on 1/16/13 that patient experienced redness, warmth, and pain at injection site, extending across his upper arm after injection. She reported that his symptoms have resolved.
Age: 31.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Hepatitis B surface antigen negative
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen negative in a 39-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included gastroesophageal reflux disease and tachycardia. Concurrent vaccination included influenza virus vaccine; manufacturer unspecified; unknown; unknown given on an unspecified date; MMR (non-gsk); non-GSK manufacturer; unknown; unknown given in October 2004; varicella virus vaccine (non-gsk); non-GSK manufacturer; unknown; unknown given on 10 September 2004. Concurrent medications included TAMBOCOR, metoprolol, XANAX and DEXILANT. In October 2004, September 2004 and August 2004 the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B (unknown) respectively. At an unspecified time after vaccination with ENGERIX B, the subject experienced hepatitis B surface antigen negative. The healthcare professional reported no antibodies to hepatitis B surface antigen after three of four injections on an accelerated dosing schedule that was not completed from 2004. It was noted that the subject had poorly documented immunization details. Immunization series was discontinued/delayed. At the time of the report the outcome of no antibodies to hepatitis B surface antigen was unspecified. Follow-up information was received via the reporting nurse practitioner. It was reported that as the subject was vaccinated 10 years ago, she has no further information to provide.
Age: 84.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: This case was reported by a pharmacist and described the occurrence of decreased therapeutic response in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (1 ml, unknown) and experienced decreased therapeutic response. The pharmacist reported that four subjects in a row were non-reactive with a count less than 2.89. At the time of the report no additional information was provided. This is the fourth of four cases reported by the pharmacist, please see cases A0975396A, A0975397A and A0975398A. Follow-up information was received on 23 May 2012 via healthcare professional who reported on 16 February 2012, 16 September 2011 and 19 August 2011 the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B (1 ml, unknown right deltoid) respectively. On 19 April 2012, 63 days after vaccination with 3rd dose ENGERIX B, 7 months after vaccination with 2nd dose ENGERIX B, 8 months after vaccination with 1st dose ENGERIX B, the subject experienced decreased therapeutic response. On 19 April 2012 Hepatitis B titer result was less than 2.80(9.99 or less is negative, greater than 10 positive). The subject received a booster dose of ENGERIX B on 26 April 2012.
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: This case was reported by a pharmacist and described the occurrence of decreased therapeutic response in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (1 ml, unknown) and experienced decreased therapeutic response. The pharmacist reported that four subjects in a row were non-reactive with a count less than 2.89. At the time of the report no additional information was provided. This is one of four cases reported by the pharmacist, please see cases A0975396A, A0975398A and A09755399A. Follow-up information was received on 23 May 2012 via healthcare professional who reported on 27 January 2012, 26 August 2011 and 29 July 2011 the subject received 3rd doe, 2nd dose and 1st dose of ENGERIX B (1 ml, unknown, right deltoid). The lot number for the last dose of ENGERIX B was noted to be "AHBV94BB". On 12 April 2012, 76 days after vaccination with 3rd dose of ENGERIX B, 8 months after vaccination with 2nd dose of ENGERIX B, 9 months after vaccination with 1st dose of ENGERIX B, the subject experienced decreased therapeutic response. On 12 April 2012 Hepatitis B titer results were less than 2.80 (9.99 or less is negative 10 or more is positive). The subject received a booster dose of ENGERIX B on 16 April 2012. The lot number was reported as AHBV94BB from the reporter; however, based on a safety lot number review, the lot number was updated to AHBVB944BB.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Dizziness, Headache, Lacrimation increased, Nausea
Clinical narrative: Approx 10 minutes after getting HPV #2, pt's eyes began to water severely. Approx 5 minutes after that, pt had severe headache, nausea, dizziness, clammy hands, blurry vision. After a larger dose of BENADRYL at the ER, pt started to feel better. Pt does have a lingering headache but the other symptoms have resolved.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred
Clinical narrative: Approx 10 minutes after getting HPV #2, pt's eyes began to water severely. Approx 5 minutes after that, pt had severe headache, nausea, dizziness, clammy hands, blurry vision. After a larger dose of BENADRYL at the ER, pt started to feel better. Pt does have a lingering headache but the other symptoms have resolved.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Feeling hot, Head banging, Headache
Clinical narrative: 1 1/2" deep red & blistered center 5 1/2" x 10" outer lighter red area arm swelled from shoulder to elbow red-heat full of hear-itching achy, unable to sleep, headache, felt unwell. The swelling & redness continued for 5 days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Oedema peripheral, Pain, Pruritus
Clinical narrative: 1 1/2" deep red & blistered center 5 1/2" x 10" outer lighter red area arm swelled from shoulder to elbow red-heat full of hear-itching achy, unable to sleep, headache, felt unwell. The swelling & redness continued for 5 days.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: This case was reported by a pharmacist and described the occurrence of decreased therapeutic response in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (1 ml, unknown) and experienced decreased therapeutic response. The pharmacist reported that four subjects in a row were non-reactive with a count less than 2.89. At the time of the report no additional information was provided. This is the fourth of four cases reported by the pharmacist, please see cases A0975397A, A0975398A and A0975399A. Follow-up information was received on 23 May 2012 via healthcare professional who reported who reported on 16 February 2012, 26 September 2011 and 23 August 2011 the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B (1 ml, unknown, left deltoid) respectively. On 31 March 2012, 44 days after vaccination with 3rd dose ENGERIX B, 6 months after vaccination with 2nd dose ENGERIX B, 7 months after 1st dose vaccination with ENGERIX B, the subject experienced decreased therapeutic response. On 31 March 2012 Hepatitis B titer result was less than 2.80 (9.99 or less is negative, greater than 10 positive). The subject received a booster dose of ENGERIX B on 12 April 2012. The lot number was reported as AHABVC018BA from the reporter; however, based on a safety lot number review, the lot number was updated to AHBVC018BA.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: 8-11-12 Received shingles vaccine. 8-18-12 Developed shingles. Healthy adult male.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Skin warm
Clinical narrative: Pt's arm is red and warm to touch. Pt's mother stated that he has not complained of any discomfort.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Pt reported throat felt tight approx. 45 min. after admin of shot. Advised pt to go to ER - pt was not in apparent distress. At ER pt was given an Epi shot & BENADRYL & was sent home. Pt recovered well - spoke to her approximately 2 hours later.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of low seroconversion to hepatitis b vaccine in a 29-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. On 1 August 1996, 29 August 1996 and 6 February 1997 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown, unknown deltoid). On 16 April 2012, 15 years after vaccination with ENGERIX B, 16 years after vaccination with ENGERIX B, the subject experienced not responding to therapy. Laboratory results on 16 April 2012 showed "no immunity to hep B. Result was less than 5mIU/mL". At the time of the report no additional information was available.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Back pain, Headache, Influenza like illness, Nausea, Neck pain
Clinical narrative: Pt reports that his whole body feels sore, with headache described as an aching in temple areas, going to back of head, neck and back. Rates headache as a # 4-5 on scale of 1-10 and stated this is not the worse headache he has had. He reports nausea, but no emesis and is keeping fluids down. He denies fever, cough and sneezing, and stated he feels like he has the flu. He reported that he was feeling a little under the weather prior to the administration of AVA. He reported that he usually feels bad following immunizations including his flu shot he received in Sep. Stated he has not taken anything for his symptoms. He denied any significant medical history.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Pain
Clinical narrative: Pt reports that his whole body feels sore, with headache described as an aching in temple areas, going to back of head, neck and back. Rates headache as a # 4-5 on scale of 1-10 and stated this is not the worse headache he has had. He reports nausea, but no emesis and is keeping fluids down. He denies fever, cough and sneezing, and stated he feels like he has the flu. He reported that he was feeling a little under the weather prior to the administration of AVA. He reported that he usually feels bad following immunizations including his flu shot he received in Sep. Stated he has not taken anything for his symptoms. He denied any significant medical history.