chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 06-NOV-2012 at 12:48, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 03-NOV-2012 09:29, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67 year old female patient. The patient's current condition included fibromyalgia and formaldehyde allergy. On 16-NOV-2012, the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX, (lot number reported as 0566ae, expiration date of April-2013, route- subcutaneous). Concomitant medications reported included WELCHOL and oxycodone. On 18-NOV-2012, the patient developed a hard swollen lump at injection site two days after she received ZOSTAVAX injection. The patient reported to the pharmacy, that the swelling had spread down to her elbow. There were no lab diagnostics performed. The patient did not seek medical attention for swelling. There was no treatment rendered for the events. The outcome of the reported events were unknown at the time of this report. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse regarding a 6 months old infant. On 26-NOV-2012, the patient was inadvertently vaccinated intramuscularly with, 0.5 ml VAQTA (lot #, expiry not reported)instead of RECOMBIVAX HB. No concomitant medications were reported. No adverse effects were reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 52 years old female patient. The patient was vaccinated with dose 1 PNEUMOVAX23 on AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 16Nov2012 after getting the PNEUMOVAX23, the patient called her physician to find out if she had ever had one before and he told her she was administered a PNEUMOVAX23 3 months ago in August 2012. She was not experiencing any adverse reactions. It was unknown if there was any relevant laboratory data. On 16Nov2012, it was unknown if she will ever have a PNEUMOVAX23 again, and she was not experiencing any adverse reactions from having 2 PNEUMOVAX23injections in 3 months. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 20-OCT-2012 13:13, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding a male patient of unknown age. On 14-DEC-2011, the patient was vaccinated with a dose of ZOSTAVAX (lot # 671451/1193AA, expiry: 25-OCT-2012). No concomitant medications were reported. The ZOSTAVAX was not kept at the required temperature as it was exposed to 28 degrees Fahrenheit from 17-NOV-2011 to 14-DEC-2011. The physician had confirmed that the ZOSTAVAX was stored improperly. No adverse reactions was reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 14-NOV-2012 at 13:46, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning an adult patient of unknown age and gender. On an unknown date, approximately in May 2012 (approximately 6 months ago), the patient was vaccinated with a first dose of (Merck) VARIVAX (dose, route and lot number unspecified) from an unspecified provider. No concomitant medications were reported. On 20-NOV-2012 (reported as now), the patient was in the pharmacy to receive the second dose of (Merck) VARIVAX (dose, route and lot number unspecified) which was late. Additional information is not expected.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema multiforme, Local reaction, Pruritus, Urticaria
Clinical narrative: Erythema multiform, urticaria, pruritus & large local reaction.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 04-NOV-2012 at 05:43, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 59 years old patient. The patient was vaccinated with a dose of VARIVAX (Merck) on 02-NOV-2012 (lot number, dose and route not provided). No other co-suspects were reported. No concomitant mediations were reported. On 02-NOV-2012 the patient received VARIVAX (Merck) instead of ZOSTAVAX due to human error. No adverse event was reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a 3 months old female patient. The patient had no drug allergy or pertinent medical history. Nurse reported that the patient had a negative titer after receiving a series of hepatitis B vaccine (name and manufacturer unknown) on 09-JUN-1993, 13-SEP-1993 and 22-MAR-1994. On 12-NOV-2012, the patient was vaccinated with a dose of RECOMBIVAX HB (Lot # reported as 008AA/Exp date: 13-OCT-2013) (dose and route not reported). No other co-suspects were reported. Concomitant medications included: AVIANE. No adverse effect reported. The patient had sought medical attention by seeing a nurse. The outcome of event was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 03 NOV-2012 at 17:36, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 05-NOV-2012 at 08:44, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 04-NOV-2012 at 21:12, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0365AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 20-OCT-2012 21:04, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 20-OCT-2012 22:12, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 20-OCT-2012 20:41, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Anti-SS-A antibody positive, CD4 lymphocytes decreased, Immunoglobulin therapy, Lymphopenia, No therapeutic response
Clinical narrative: Information has been received from a healthcare professional, author of the published article, describing a patient with cystic fibrosis (CF), concomitant humoral and cellular immune dysfunction, transplant tolerance, and autoimmune disease. The authors presented as 23 year old female with a history of CF (delta 508 mutation), complicated by cirrhosis requiring transplant at the age of 18 followed by standard immunosuppressive therapy with steroids, Mycophenolate mofetil (MMF), and tacrolimus. Over the course of the next 3 months, she had reactivation of Epstein-Barr Virus (EBV) and Varicella zoster virus (VZV) with recurrent disseminations; work-up for Post-transplant lymphoproliferative disorder (PTLD) was negative. All immunosuppressants were discontinued 7 months after transplant, with the exception of Prednisone (manufacturer unknown), which was discontinued 2 years post-transplant. She developed an Exophiala dermatitidis pulmonary infection, anti-SS-A positive Sjogren's, and seronegative arthritis. A complete immunodeficiency evaluation was initiated. The patient was diagnosed with humoral and cellular mediated immunodeficiencies characterized by hypogammaglobulinemia, specific antibody deficiency with absent response to PNEUMOVAX 23 (dose #, lot # and route of administration not reported), significant CD4 lymphopenia, and markedly diminished response to phytohemaggutinin, pokeweed, and Candida. Antiviral therapy was continued, PCP prophylaxis was initiated, and she was started on replacement IVIg. She has done remarkably well, with decreased severity and frequency of infections and resolution of the arthritis. To date, she has no evidence of liver transplant rejection despite being off immunosuppressants. Additional information is not expected.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Information has been received from a pharmacist and a 68 year old male consumer, who on 12-NOV-2012 was administered ZOSTAVAX, 1 injection, "in the shoulder" (lot # H016766). On 17-NOV-2012, the patient called the pharmacist to report he had a rash around the injection site. The pharmacist instructed the patient to call his primary care physician. (No information provided). On 26-NOV-2012, the patient called the pharmacist again and the patient reported, his rash had initially went away, and now it has returned and it was spreading across one side of his back. The pharmacist instructed the patient to call his physician and seek medical attention, however the patient has not called his physician to this date. The pharmacist stated that he was reaching out to the physician to take make him aware of the consumer's adverse experience. No further information was provided. The patient's present status was unspecified by the reported. Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Erythema, Herpes zoster, Paraesthesia, Rash papular
Clinical narrative: Initial information was received from consumer refers herself, an approximately 38 years old female patient (weight 145 unit not specified, height 61 inches) with allergy to all narcotics, codeine allergy and valium allergy, who in November 2009, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not reported). No other co-suspects were reported. Concomitant medications included tramadol hydrochloride and steroids (unspecified). It was reported that the patient had a case of shingles on 14-NOV-2011, had a tingling sensation on her back and had "little reddish pimples" the size if the hand. Treatment was given for the event. No laboratory test was performed. It was reported that the patient sought medical attention. The patient's outcome was unknown. Additional information is not expected.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 2 months old patient. The patient was inadvertently vaccinated with single dose, live, oral ROTATEQ (1659Z) on 19-NOV-2012, that had expired on 29-AUG-2012 No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. No treatment information was reported. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 13-NOV-2012 at 23:50, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 17-OCT-2012 14:50, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 05-NOV-2012 at 10:27, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Drug eruption, Rash, Rash erythematous, Rash pruritic
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pruritic raised red rash in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent vaccination included TYPHIM VI (non-gsk) ;Sanofi Pasteur MSD given in August 2011. On an unknown date in August 2011 the subject received 1st dose of TWINRIX (1 ml, unknown route, left arm). The healthcare professional reported that the vaccination date was around 19 August 2011, but could not be sure of the exact date. On the same date in August 2011, 2 hours after vaccination with TWINRIX, the subject experienced pruritic raised red rash on both forearms. The rash was greater than 50 mm. The subject's physician considered the rash to be a fixed drug eruption. At the time of reporting the events were resolved. The vaccination course with TWINRIX was discontinued. The subject was referred to an allergist who recommended no further doses of TWINRIX. The healthcare professional considered the events were possibly related to vaccination with TWINRIX.
Sex: F
Vaccine: HEPAB
Symptoms: Dermatitis acneiform, Nasopharyngitis
Clinical narrative: This case was reported by a physician, via a GSK representative, and described the occurrence of acne type rash in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose of TWINRIX (details unknown). Seven days after vaccination with TWINRIX, the subject experienced acne type rash and cold. At the time of reporting the acne type rash was resolved and the outcome of the cold was unknown. The physician reported that the acne type rash took 1 month to go away.
Sex: U
Vaccine: HEPAB
Symptoms: Chest discomfort
Clinical narrative: This case was reported by a physician and described the occurrence of chest tightness in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received 2nd dose of TWINRIX (details unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced chest tightness. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: HEPAB
Symptoms: Rash maculo-papular
Clinical narrative: This case was reported by a physician and described the occurrence of maculopapular rash in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX (unknown). Less than one day after vaccination with TWINRIX, the subject experienced maculopapular rash. At the time of reporting the event was unresolved. The physician considered the event was probably related to vaccination with TWINRIX.
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis B antibody negative
Clinical narrative: This case was reported by a healthcare professional (medical assistant), via another manufacturer (Merck), and described the occurrence of hepatitis B antibody negative in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (details unknown) and experienced hepatitis B antibody negative. The subject received three doses of TWINRIX on unspecified dates and "failed to seroconvert for Hepatitis B". No further information was available.
Sex: U
Vaccine: HEPAB
Symptoms: Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in an adult subject of unspecified gender who was vaccinated with TWINRIX adult (GlaxoSmithKline). On an unspecified date in 2012 the subject received 1st or booster dose of TWINRIX adult (unknown, unknown arm). At an unspecified time within two months of vaccination with TWINRIX adult, the subject experienced decreased therapeutic response. Subject had a viral syndrome either flu or cold (upper respiratory infection) at the time of vaccination and was receiving the TWINRIX for travel and experienced not having the appropriate titer response.
Age: 41.0
Sex: F
Vaccine: HEPAB
Symptoms: Faeces pale, Feeling abnormal, Gastrointestinal disorder, Myalgia
Clinical narrative: This case was reported by a healthcare professional (also the mother of the subject) and described the occurrence of gastrointestinal symptoms in a 41-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included asthma. On the afternoon of 22 February 2012 the subject received 1st dose of TWINRIX in an unknown arm. On the evening of 25 February 2012, 3 days after vaccination with TWINRIX, the subject experienced systemic events of gastrointestinal symptom, feces pale, muscle pain and feeling physically bad. At the time of the reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with TWINRIX. The nurse/mother was trying to determine if her daughter should receive the second dose of TWINRIX in the vaccination series. She noted that it was not known who administered the vaccine, but stated that she believed probably a nurse or a medical assistant and not a physician.
Sex: U
Vaccine: HEPAB
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a pharmacist, via Merck, and described the occurrence of anaphylactic reaction in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX (details unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced anaphylactic reaction. The pharmacist reported that an unspecified patient experienced an anaphylactic reaction after receiving TWINRIX at an unspecified time. No further information was available. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Age: 45.0
Sex: F
Vaccine: HEPAB
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of numbness in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unknown date the subject received unspecified dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced numbness on one side and tingling on one side. At the time of reporting the outcome of the events of numbness and tingling was unspecified. Follow-up information was received on 13 July 2012. It was reported that the subject was a 45 year old female. The subject received 1st dose of TWINRIX on 13 June 2012. Seven days later, on 20 June 2012 at 12:10 (according to the accelerated dosing schedule for TWINRIX), the subject received a 2nd dose of TWINRIX at 1.0 ml, intramuscularly, in the left deltoid. At an unspecified time following administration of the 2nd dose of TWINRIX, the subject experienced an "injection side effect" with numbness and tingling on the left side of the neck, ear, jaw and tongue. The events were not considered to be serious. The outcome of the events was unknown at the time of reporting as well as attribution to vaccination with TWINRIX. The immunization series was said to be discontinued.
Age: 42.0
Sex: F
Vaccine: HEPAB
Symptoms: Dysgeusia, Hypoaesthesia, Hypoaesthesia oral, Immediate post-injection reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of medicine-like taste in mouth in a 42-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). There were no concurrent medications. On 23 August 2012 the subject received 1st dose of TWINRIX (1 ml, unknown, right arm). On 23 August 2012, immediately after vaccination with TWINRIX, the subject experienced medicine-like taste in mouth. Within one minute of vaccination with TWINRIX, the subject experienced feeling of numbness of the nose and lip felt numb. The healthcare professional reported the subject experienced a medication taste in her mouth immediately after TWINRIX was administered on 23 August 2012. Within one minute, the subject complained of nose and lip numbness. The subject was monitored and symptoms resolved without sequalae within 15 to 20 minutes on 23 August 2012. No additional information was known at the time of the report.
Age: 54.0
Sex: M
Vaccine: HEPAB
Symptoms: Rash
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of rash in a  54-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included sulfa allergy. Concurrent vaccination included seasonal influenza vaccine (non-gsk); non-GSK manufacturer; intradermal; unknown given in January 2012. On February 2012 and January 2012 the subject received 2nd dose and 1st dose of TWINRIX (1 ml, unknown route, right arm). Less than one month after vaccination with dose 1 of TWINRIX, less than one year after vaccination with dose 2 of TWINRIX, the subject experienced rash. According to the nurse, the subject reported that he experienced a rash after his first two doses of TWINRIX. At the time of reporting the outcome of the events was unspecified.
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis A antibody negative, Hepatitis B antibody positive
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hepatitis A antibody negative in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On 7 December 2011, 12 January 2012 and 12 June 2012 the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (unknown). On 25 July 2012, 43 days after vaccination with 3rd dose of TWINRIX, 6 months after vaccination with 2nd of TWINRIX, 8 months after vaccination with 1st of dose TWINRIX, the subject experienced hepatitis A antibody negative. The subject had a titer performed on 25 July 2012 Hepatitis A was non reactive and Hepatitis B was reactive. The healthcare professional reported several subjects did not respond to Hepatitis A vaccine; seven with HAVRIX and three with TWINRIX. For the other subjects please see cases A0994236A, A0994238A- A0994244A, A0994245A - A0994246A.
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis A antibody negative, Hepatitis B antibody positive
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hepatitis A antibody negative in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On 21 October 2011, 21 November 2011 and 26 April 2012 the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (unknown). On 26 April 2012, 47 days after vaccination with 3rd dose of TWINRIX, 7 months after vaccination with 2nd dose of TWINRIX, 8 months after vaccination with 1st dose of TWINRIX, the subject experienced hepatitis A antibody negative. The subject had a titer performed on 12 June 2012 Hepatitis A was non reactive and Hepatitis B was reactive. The healthcare professional reported several subjects did not respond to Hepatitis A vaccine; seven with HAVRIX and three with TWINRIX. For the other subjects please see OCEANS cases 0994236A, A0994238A- A0994244A, A0994246A.
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis A antibody negative, Hepatitis B antibody positive
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hepatitis A antibody negative in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On 18 November 2011, 22 December 2011 and 29 May 2012 the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (unknown). On 24 July 2012, 56 days after vaccination with 3rd dose of TWINRIX, 7 months after vaccination with 2nd dose of TWINRIX, 8 months after vaccination with 1st dose of TWINRIX, the subject experienced hepatitis A antibody negative. The subject had a titer performed on 24 July 2012 Hepatitis A was non reactive and Hepatitis B was reactive. The healthcare professional reported several subjects did not respond to Hepatitis A vaccine; seven with HAVRIX and three with TWINRIX. For the other subjects please see cases A0994236A, A0994238A - A0994245A.
Sex: F
Vaccine: HEPAB
Symptoms: Nasopharyngitis, Rhinitis, Rhinorrhoea, Upper respiratory tract infection
Clinical narrative: This case was reported by the boyfriend of a consumer and described the occurrence of upper respiratory symptoms in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. In the late morning on 9 June 2010 the subject received 1st dose of TWINRIX at 1.0 ml. About 3 to 5 days after vaccination (around 12 June 2010) the subject experienced a bad upper respiratory infection with profuse nasal discharge and other symptoms typical of upper respiratory infection. Profuse rhinitis was also reported with onset of 13 June 2010. All symptoms reported to have cleared within 7 to 10 days. The subject received a 2nd dose of TWINRIX on 14 July 2010 and within 3 to 5 days (around 17 July 2010) experienced the exact same upper respiratory symptoms that followed the 1st dose including upper respiratory infection with profuse nasal discharge and other respiratory symptoms of upper respiratory infection. These events went away after 7 to 10 days. In late October 2010 and early November 2010, the subject caught a bad cold after a long plane ride. It was reported to be the subject's worst cold since childhood. At the time of reporting the outcome of the events was unspecified. Similar events occurred with the subject's boyfriend (the reporter) following administration of TWINRIX. For details regarding this case, refer to case number A0985300A.
Age: 65.0
Sex: F
Vaccine: HEPAB
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain
Clinical narrative: This case was reported by a healthcare professional (nurse), via a sales representative, and described the occurrence of injection site reaction in a 65-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included erythema with latex allergy and sulfa allergy. On 19 July 2012 the subject received 1st dose of TWINRIX (unknown route, right deltoid). In 2012, less than one year after vaccination with TWINRIX (sometime before or on 21 August 2011), the subject experienced injection site reaction described as right shoulder weakness and right shoulder limited range of motion in the injection arm. The subject went to the office for her second dose of TWINRIX on 21 August 2012 and reported that "she has weakness in her right shoulder with limited range of motion". According to the nurse, the subject still wanted the second injection of the series and received in on 21 August 2012. The nurse reported that the physician did not feel the weakness and limited range of motion were related to the vaccination. The physician noted that the subject had been to the office between the first and second dose and had not mentioned the weakness or limited range of motion. At the time of reporting the events were unresolved. The healthcare professional considered the event was unrelated to vaccination with TWINRIX. Follow-up information was received on 17 September 2012 via healthcare professional who reported additional events of shoulder pain and soreness. The onset of the injection site pain, shoulder pain and soreness was 19 July 2012. The healthcare professional noted the subject received the 2nd dose of TWINRIX and reported no adverse events. At the time of the report the injection site reaction, shoulder pain and soreness had improved.
Sex: U
Vaccine: HEPAB
Symptoms: Urticaria
Clinical narrative: This case was reported by a healthcare professional (pharmacy student) and described the occurrence of hive in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medications included REGLAN. On an unspecified date the subject received 1st dose of TWINRIX (details unknown). Less than one month after vaccination with TWINRIX, the subject experienced hive. The subject experienced hives for a month after receiving the injection. At the time of reporting the outcome of the event was unspecified.
Age: 65.0
Sex: M
Vaccine: HEPAB
Symptoms: Hypoaesthesia, Neuropathy peripheral
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm numbness in an adult male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose (unknown, right arm0, 2nd dose (unknown, left arm) and 3rd dose of TWINRIX (unknown, right arm). At an unspecified time after vaccination with TWINRIX, the subject experienced bilateral arm numbness and neuropathy arms. At the time of reporting the outcome of bilateral arm numbness and neuropathy were unspecified. A subject reported "he and his wife had the TWINRIX series last year on the traditional schedule, 0, 1 and 6 months. The subject states both he and his wife have had problems with numbness and neuropathy in their arms. Both arms were alternated for the series and it was right, left, right; he reported that both arms are bothering them. She (the wife) went to the clinic and the doctor told her they are seeing this with the hepatitis vaccines (subject was not sure if the doctor meant all hepatitis vaccines or just the TWINRIX). He also said another friend of theirs is experiencing the same thing." This is one of three cases reported; for the second case (wife) see case A0977598A; for the third case (friend) see case A0977599A. Follow-up information was received on 15 June 2012 via healthcare professional who reported the 67-year old male subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (1ml) on 20 October 2010, 23 November 2010 and 2 May 2011 respectively. Concurrent medication included VALTREX. At the time of the report the events were unresolved.
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Hypoaesthesia, Neuropathy peripheral
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm numbness in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (unknown, right arm). At an unspecified time after vaccination with TWINRIX, the subject experienced arm numbness and neuropathy arms. At the time of reporting the outcome of the arm numbness and neuropathy arms were unspecified. The spouse of the subject reported "he and his wife had the TWINRIX series last year on the traditional schedule 0, 1 and 6 months. The spouse of the subject states both he and his wife have had problems with numbness and neuropathy in their arms. Both arms were alternated for the series and it was right, left, right; he reported that both arms are bothering them. She (the wife) went to the clinic and the doctor told her they are seeing this with the hepatitis vaccines (subject was not sure if the doctor meant all hepatitis vaccines or just the TWINRIX). He also said another friend of theirs is experiencing the same thing." This is second of three cases reported; for the first case (husband) see case A0977548A; for the third case (friend) see case A0977599A. Follow-up information was received on 15 June 2012 via healthcare professional who reported the 62-year old female subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (1ml) on 20 October 2010, 23 November 2010 and 02 May 2011 respectively. Concurrent medication included Synthroid. At the time of the report the events were unresolved.
Sex: U
Vaccine: HEPAB
Symptoms: Hypoaesthesia, Neuropathy peripheral
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm numbness in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced arm numbness and neuropathy arms. At the time of reporting the outcome of the arm numbness and neuropathy arms were unspecified. A friend of the subject reported problems with numbness and neuropathy in their arms after receiving the TWINRIX series. He also said another friend of theirs (the subject) is experiencing the same thing. This is third of three cases reported; for the first case see A0977548A and for the second case see case A0977598A.
Age: 35.0
Sex: M
Vaccine: HEPAB
Symptoms: Abdominal discomfort, Abdominal pain upper, Diarrhoea, Dizziness, Fatigue
Clinical narrative: This case was reported by a consumer and described the occurrence of vomiting in a 35-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications conditions included hay fever. There were no concurrent medications. On 13 June 2012 at 17:45 the subject received 2nd dose of TWINRIX in the left arm. On 13 June 2012, 285 minutes after vaccination with TWINRIX (at the time the subject went to bed at 22:30), the subject experienced discomfort in his stomach (gastric discomfort). Later, at midnight on 14 June 2012 (375 minutes after vaccination with 2nd dose of TWINRIX), the subject experienced vomiting, fever (99.3 degrees), malaise, stomach pain and diarrhea. At the time of reporting, the subject reported that he had not vomited in 7 hours and considered the symptom resolved; however, he reported still suffering from the other symptoms, although they were improved. The subject also reported that he had a little dizziness and tiredness about an hour following his 1st vaccination with TWINRIX on an unspecified date. Outcome was not reported.
Age: 35.0
Sex: M
Vaccine: HEPAB
Symptoms: Malaise, Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer and described the occurrence of vomiting in a 35-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications conditions included hay fever. There were no concurrent medications. On 13 June 2012 at 17:45 the subject received 2nd dose of TWINRIX in the left arm. On 13 June 2012, 285 minutes after vaccination with TWINRIX (at the time the subject went to bed at 22:30), the subject experienced discomfort in his stomach (gastric discomfort). Later, at midnight on 14 June 2012 (375 minutes after vaccination with 2nd dose of TWINRIX), the subject experienced vomiting, fever (99.3 degrees), malaise, stomach pain and diarrhea. At the time of reporting, the subject reported that he had not vomited in 7 hours and considered the symptom resolved; however, he reported still suffering from the other symptoms, although they were improved. The subject also reported that he had a little dizziness and tiredness about an hour following his 1st vaccination with TWINRIX on an unspecified date. Outcome was not reported.
Age: 56.0
Sex: F
Vaccine: HEPAB, TTOX
Symptoms: Fatigue, Headache
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of headache in a 56-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline), Tetanus vaccine (non-GSK). A physician or other health care professional has not verified this report. On 27 February 2012 the subject received 1st dose of TWINRIX (unknown route, unknown arm), and an unspecified dose of Tetanus vaccine (non-GSK) (details unknown). On 27 February 2012, less than one day after vaccination with Tetanus vaccine (non-GSK) and TWINRIX, the subject experienced headache and on 28 February 2012, one day after vaccination with Tetanus vaccine (non-GSK) and TWINRIX, the subject experienced fatigue. The subject wanted to take the second TWINRIX dose according to the accelerated dosing schedule.
Age: 49.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Lichen planus, Rash erythematous, Rash pruritic
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of lichen planus in a 50-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent vaccination included BOOSTRIX (GlaxoSmithKline) given on 4 May 2011. There were no concurrent medications. On 4 May 2011 at 14:10 the subject received 1st dose of TWINRIX at 1.0 ml in the right arm. Less than one year after vaccination with TWINRIX, the subject experienced lichen planus. The nurse reported that the subject reported that she developed lichen planus after administration of the 1st dose of TWINRIX. No further details were reported. At the time of reporting the outcome of the event was unspecified. Follow up information received 02 May 2012 via consumer. Additional information included concomitant medication of PERCOCET and concurrent medical condition of neck pain. The subject reported receiving the second dose of TWINRIX on 08 June 2011. The subject stated the Lichen planus started at the end of July 2011, described as broke out in raised itchy, red rash on wrist and ankle. The subject indicated that she initially went to her dermatologist's office and was diagnosed with Lichen planus. She then was referred to a blood doctor who did a number of tests which ruled out any other diseases. The subject indicated that she cannot wear shorts, she has rash on arms and hands and won't be able to go on vacation this year. The immunization series was discontinued. Follow-up information was received on 25 May 2012 via healthcare professional who reported the side effect of lichen planus, pruritic raised red rash outcome was unknown. The events were not considered serious.
Age: 37.0
Sex: M
Vaccine: HEPAB
Symptoms: Dizziness, Dyspnoea
Clinical narrative: This case was reported by a healthcare professional (also a GSK representative) and described the occurrence of shortness of breath in a 37-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included asthma and LEVAQUIN allergy. Concurrent medications included Metoprolol (slow release), VENTOLIN HFA, ZYRTEC and PRILOSEC. On 19 January 2011 the subject received 2nd dose of TWINRIX (1 ml, intramuscularly, left arm). On 19 January 2011, less than one day after vaccination with TWINRIX, the subject experienced shortness of breath and dizziness. On 22 January  2011, the events were resolved. It was reported the symptoms resolved 3 days post-injection. The vaccination course with TWINRIX was discontinued. The healthcare professional considered the events were possibly related to vaccination with TWINRIX. Follow-up information was received on 07 February 2012. It was reported that the events of shortness of breath and dizziness resolved on 21 January 2011 after a three day duration;. No additional details were provided.