chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Body temperature increased, Muscular weakness, Urticaria
Clinical narrative: I had an incidental interaction w/patient this AM at approx. 8:30 AM, following the monthly staff meeting where she asked me "if she's supposed to tell me about a "reaction" she got from the flu vaccine" (I confirmed she did receive the vax here on 10/14/14 at approx. 5 AM - as she recalls). I asked her if she reported it thru her PCP and she said she had called to report her symptoms but they did not want to see her - it is unclear to me when she placed this call to her MD office in response to her symptom development. She reports the following symptoms with the approximate time of presentation: - "Itching" - developed 1 hour (6AM) after flu vax given - did not report this to RN on duty - "Hives" - developed 2-3 hours (7-8 AM) after flu vax was given - did not report this to RN on duty - Weakness and Numbness in her Left Arm (site of injection) "by the time she got home" - she could hardly open the door to her vehicle" - did not report to this nurse until 11/12/14 and is resolved. - Temp of 101 (I did not verify w/her that this was not 100.1, but 101) - developed at Midnight the following night after the vaccine was administered, while here at work. She states she reported this to her supervisor, and another staff RN gave her TYLENOL while here at work to treat the fever and she continued to work her shift. - She denies being sick the day of the injection; Denies allergy to eggs, egg products or chicken feathers, gelatin, or thimerosal. - She reports her only allergy as AUGMENTIN. Patient was asked to contact her PCP to assure that they hadn't followed up by completing VAERS reporting (based on her report, it was unsure to me if she actually spoke to the office, was seen by a provider or not) and to let me know if this was not reported, b/c of the need for follow up with VAERS. She agreed to do so and get back to me. She returned to my office approx. 20 minutes later and said she had called her Dr and per her "they have no report in her file of her having called in to report these symptoms". I did verify with her that she did NOT go any urgent care of ED for treatment of anaphylaxis. She states she did not. She does not admit to taking any medication post vaccination (Ex: BENADRYL to treat symptoms, only TYLENOL). She denied any long lasting adverse effects at this time and reports she is back to baseline.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old female patient with diabetes. On 31-OCT-2014, the patient was vaccinated with PNEUMOVAX 23, 25/0.5 Y, intramuscular in the arm (dose and lot number were not reported). Other suspect therapies included influenza virus vaccine (unspecified) (dose, strength, frequency and route were not reported) on the arm, received on 31-OCT-2014. The pharmacist reported on behalf of his patient that she developed an injection site reaction following administration of PNEUMOVAX 23 and influenza virus vaccine (unspecified). Beginning on unspecified date, patient reported to pharmacist that she experienced redness, swelling and tenderness at injection site. Patient stated that she could barely raised her arm. The outcome of the events ws not reported. Treatment included ibuprofen. The patient did not seek medical attention. Additional information has been requested.
Sex: M
Vaccine: HEPAB
Symptoms: Diarrhoea, Hepatitis A antibody positive, Hepatitis B antibody positive, Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of possible hepatitis A in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On March 2005, the subject received the 1st dose of TWINRIX (unknown details). In November 2006 and May 2007 the subject received 2nd dose and 3rd dose of TWINRIX (unknown details) and experienced drug dose administration interval too long. The subject was aware that his 2nd and 3rd doses of TWINRIX were delayed; however, he was told by the nurse at the time of administration that "it was still okay". In 2013, 8 years after vaccination with TWINRIX 1st dose, 7 years after vaccination with TWINRIX 2nd dose, and 6 years after vaccination with TWINRIX 3rd dose, the subject experienced possible hepatitis A, possible vaccination failure, and diarrhea. This case was assessed as medically serious by GSK. Relevant diagnostic tests were as follows: The subject reported that he "had a test in 2009 which showed that he was nonreactive for hepatitis A." In 2013, the subject "had blood work done at his doctor's office" and "the test showed he was immune to hepatitis B as expected and all test results were within range with one exception, his hepatitis A result now displays 'reactive' though there is no actual number included." At the time of reporting the events were unresolved.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Blood culture negative, Crying, Culture urine negative, Febrile convulsion, Full blood count normal
Clinical narrative: Crying, fussy, will sit. He was found to have a rectal temp of 105. He was given TYLENOL and MOTRIN, and had blood and urine cultures sent. An LP was performed because of his fussiness and age, which is negative for infection. His fever has defervesced and he has eaten well here. ED Diagnosis: Febrile seizure; simple. Upper respiratory infection. Additional diagnosis: Prematurity
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Irritability, Lumbar puncture normal, Pyrexia, Upper respiratory tract infection
Clinical narrative: Crying, fussy, will sit. He was found to have a rectal temp of 105. He was given TYLENOL and MOTRIN, and had blood and urine cultures sent. An LP was performed because of his fussiness and age, which is negative for infection. His fever has defervesced and he has eaten well here. ED Diagnosis: Febrile seizure; simple. Upper respiratory infection. Additional diagnosis: Prematurity
Age: 3.0
Sex: M
Vaccine: DTAP, FLUN4, HIBV, PNC13
Symptoms: Erythema, Petechiae, Urticaria
Clinical narrative: Patient received catch up vaccines and FLUMIST today in clinic. After administration patient had red hives and petechiae on face and chest. BENADRYL was given and patient was monitored for 1 hour post vaccines. Evaluated vital sings and MD evaluation was done.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema, Pruritus
Clinical narrative: Localized erythema, edema with pruritis. No airway compromise. Resolved with ice application. No pain. ROM is full. LUE 5/5 strength bilaterally.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Pruritus generalised, Swollen tongue
Clinical narrative: Flushing, generalized itching, swelling of tongue. BENADRYL administered and brought to ED. ED observed and administered additional BENADRYL.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Left arm muscle pain.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient received vaccine Monday, Nov. 10, '14. Received a call at 1 pm Nov. 12, '14 reporting hives on stomach, back and arms.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was given a FLUZONE Intradermal vaccine. The vaccine is to be administered to pt's 18 yrs of age to 64 yrs of age. Pt is 17 yrs old. Spoke to someone - was told that there is no contraindication - to call pt and re-vaccinate pt with appropriate vaccine.
Age: 20.0
Sex: F
Vaccine: FLU3, HEPAB
Symptoms: Injection site pain, Pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm pain at injection site in a 20-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent vaccination included seasonal influenza vaccine (non-gsk); Novartis; unknown right arm given on 10 November 2013. On 10 November 2013 at 16:21 the subject received 3rd dose of TWINRIX (1 ml, unknown route, left arm). In November 2013, within days of vaccination with TWINRIX, the subject experienced arm pain at injection site. The arm pain at injection site was described as "short stabbing pain going down left arm." The subject did consult a healthcare professional regarding the event. At the time of reporting the event was unresolved.
Age: 38.0
Sex: M
Vaccine: FLU3, HEPAB, TYP
Symptoms: Hyperhidrosis, Trance
Clinical narrative: This case was reported by a healthcare professional (office manager) via sales representative and described the occurrence of trance in a 38-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline), FLULAVAL and typhoid (non-gsk). In 2013 the subject received 1st dose of TWINRIX (intramuscular, unknown details), a dose of FLULAVAL (unknown details), unspecified dose of typhoid (non-GSK) (oral). In 2013, within minutes of vaccination with FLULAVAL, oral typhoid vaccine (Non-GSK) and TWINRIX, the subject experienced trance and sweating. Per the reporter, the events occurred "shortly afterwards" when describing the onset of the events. Per the reporter, the subject "went into 2 to 3 minutes of a trance and was a little sweaty." Per the reporter, the subject stated that "he had never had before." The events were not the result of suspected transmission of an infectious agent via a medicinal product. At the time of reporting the events were resolved. Per the reporter, "after resolution he felt fine." The subject "did not come back for the next dose of TWINRIX." It was unclear from the report of the vaccination course with TWINRIX was discontinued. The reporter did not consider this case to be serious.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pt stated had arm pain from vaccine received on 10/20/14. She went to PCP and said deltoid may have been bruised.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Injection site swelling, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. The patient had allergy to Z-PAK. On 01-OCT-2014 the patient was vaccinated with one shot of PNEUMOVAX 23 (strength and route not reported), lot # J013555, expiration date: 02-MAY-2015, in the left deltoid. Concomitant therapies included a flu shot given in the right arm on 01-OCT-2014. On 02-OCT-2014 (also reported as unknown date), the patient experienced plum sized swelling 6 inches down from the injection site, redness and soreness. It was unknown if there was relevant lab data. As of 02-OCT-2014, it was unknown if the patient continued on PNEUMOVAX 23 and the swelling had gone down but the redness and soreness continued. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Computerised tomogram head normal, Paralysis, Vaccination complication, Viral infection
Clinical narrative: A divergence palsy occurred 1 month after FLUMIST given. Uncertain etiology, vaccine vs. viral infection per ophthalmologist.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Paraesthesia
Clinical narrative: Redness at the injection site. The redness faded after 45 minutes gradually. The patient also complained of tingling sensation of the throat but no swelling occurred. Approximately 3:45 pm BP 110/68 HR 86. BP 108/69 (10 min later).
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Flushing, Pruritus
Clinical narrative: Itching of face and neck at 1:20 pm itching of ear at 1:28 pm. Blood pressure 145/88 pulse 67 at 1:30 pm. Itching improved, but felt hot, flushed in face/neck. Took 25mg diphenhydramine, decreased itching. 4:00 pm felt fine and itching stopped.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Myalgia, Pain in extremity
Clinical narrative: Received Influenza vaccine 10/24/14 4:07 pm. Had arm muscle pain after vaccine. Saturday at 10 am had numbness from shoulder to fingers lasting till 10/27/14 at 8AM. No meds, no ice/heat. Numbness went away but still with pain in upper. Takes 400mg Ibuprofen daily for migraines. Applying heat.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age. The unspecified patients medical history was not reported. On an unspecified dates since 05-MAY-2014, an unspecified number of patients received PROQUAD (Merck) (lot # K000710 and expiry date: 16-JUL-2015) which was exposed to temperatures outside of the proper storage range. No adverse effect reported. No product complaint was reported for PROQUAD (Merck). This case is linked to 1411USA001655, 1411USA004432, 1411SUA004433, 1411USA004434, 1411USA004435, 1411USA004436, 1411USA004437, 1411USA004438, 1411USA004440, 1411USA004441 and 1411USA004442 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age (reported as under the age of 50 years old) and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date, dose, route were not reported). No adverse experiences were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unspecified date the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot #, dose, route and frequency were not provided). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age. The unspecified patients medical history was not reported. The physician stated that her refrigerator and freezer units began to have temperature excursions as of 05-MAY-2014. GARDASIL was improperly exposed to 29F for multiple unspecified excursions (many more than 2 cycles into the freezing range) since 05-MAY-2014 and also to 49F for 12 hours. On unspecified dates since 05-MAY-2014, an unspecified number of patients received GARDASIL which was improperly stored. No product complaint was reported for GARDASIL. This case is linked to 1411USA001655, 1411USA004432, 1411USA004433, 1411USA004435, 1411USA004436, 1411USA004437, 1411USA004438, 1411USA004439, 1411USA004440, 1411USA004441 and 1411USA004442 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age. The unspecified patients medical history was not reported. On an unspecified dates since 05-MAY-2014, an unspecified number of patients received PROQUAD (Merck) (lot # K007799 and expiry date: 29-NOV-2015) which was improperly exposed to 22F for 1920 hours. No known adverse effects. No product complaint was reported for PROQUAD (Merck). This case is linked to 1411USA001655, 1411USA004432, 1411USA004433, 1411USA004434, 1411USA004435, 1411USA004436, 1411USA004437, 1411USA004439, 1411USA004440, 1411USA004441 and 1411USA004442 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age. The unspecified patients medical history was not reported. The physician stated that her refrigerator and freezer units began to have temperature excursions as of 05-MAY-2014. ROTATEQ was improperly exposed to 29F for multiple unspecified excursions (many more than 2 cycles into the freezing range) since 05-MAY-2014 and also to 49F for 12 hours. On unspecified dates since 05-MAY-2014, an unspecified number of patients received ROTATEQ which was improperly stored. No product quality was reported for ROTATEQ. This case is linked to 1411USA001655, 1411USA004432, 1411USA004433, 1411USA004434, 1411USA004436, 1411USA004437, 1411USA004438, 1411USA004439, 1411USA004440, 1411USA004441 and 1411USA004442 (same reporter link).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. On 03-NOV-2014, the patient was vaccinated with ZOSTAVAX vaccine vial, with lot number J008528 and expiry date 19-OCT-2014 (dosage information and route not reported). No concomitant medication was reported. On 03-NOV-2014, a nurse vaccinated the patient with expired ZOSTAVAX vaccine. No adverse effects were reported. The outcome of the events were unknown. A product quality complaint (PQC) was not filed. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: The spontaneous report as received from a physician refers to a unspecified number of patients of unknown age. The unspecified patients medical history was not reported. The physician stated that her refrigerator and freezer units began to have temperature excursions as of 05-MAY-2014. VAQTA was improperly exposed to 29F for multiple unspecified excursions (many more than 2 cycles into the freezing range) since 05-MAY-2014 and also to 49F for 12 hours. On unspecified dates since 05-MAY-2014, an unspecified number of patients received VAQTA which was improperly stored. No product complaint was reported for VAQTA.  This case in linked to: 1411USA001655, 1411USA004433, 1411USA004434, 1411USA004435, 1411USA004436, 1411USA004437, 1411USA004438l, 1411 USa004439. 1411USA004440, 1411USA004441 and 1411USA004442 (same reporter link). Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Pyrexia, Rash generalised, Viral test
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 month old male patient with ventricular septal defect and no drug reactions or allergies. On 07-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot # K003423, expiry date 06-MAR-2016, 0.5 ml, subcutaneous. There was no concomitant medication. On 25-OCT-2014, the patient experienced a rash on his entire body that started on his legs and a fever. The patient went to the emergency room on 26-OCT-2014. The patient had a follow up visit with the physician assistant on 28-OCT-2014 and the patient still had a rash on his entire body and fever. The patient has not been seen by the physician assistant since 28-OCT-2014 so the reporting medical assistant did not know if the patient was recovered. The patient was given ZYRTEC, CALAMINE lotion, TYLENOL, MOTRIN as a treatment. There were viral culture, immunoglobulin G (IgG) and immunoglobulin M (IgM) laboratory tests performed (results not provided). The outcome of a rash on his entire by that started on his legs and fever is unknown. Relatedness between the rash on his entire body and fever and (Oka/Merck) VARIVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age. The unspecified patients medical history was not reported. On an unspecified dates since 05-MAY-2014, an unspecified number of patients received PROQUAD (lot # K006219 and expiry date: 29-OCT-2015) which was improperly exposed to 22F for 2000 hours. No known adverse effects. No product complaint was reported for PROQUAD. This case is linked to 1411USA001655, 1411USA004432, 1411USA004433, 1411USA004434, 1411USA004435, 1411USA004436, 1411USA004438, 1411USA004439, 1411USA004440, 1411USA004441 and 14411USA004442 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a physician refers to a unspecified number of patient of unknown age. The unspecified patients medical history was not reported. The physician stated that her refrigerator and freezer units began to have temperature excursions as of 05-MAY-2014. RECOMBIVAX HB was improperly exposed to 29F for multiple unspecified excursions (many more than 2 cycles into the freezing range) since 05-MAY-2014 and also to 49F for 12 hours. ON unspecified dates since 05-MAY-2014, an unspecified number of patients received RECOMBIVAX HB which was improperly stored. No product complaint was reported for RECOMBIVAX HB.   This case is linked to 1411USA004655, 1411USA004432, 1411USA004434, 1411USA004435, 1411USA004436, 1411USA003347, 1411USA004438, 1411USA004439, 1411USA004440, 1411USA004441, and 1411USA004442
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. Since 01-OCT-2014, the unspecified number of patients had been vaccinated with doses of LIQUID PEDVAXHIB (lot #, dose, route and frequency were not provided), which had underwent supported and unsupported temperature excursions (on unspecified dates of 2014). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age. The unspecified patients medical history was not reported. Since 05-MAY-2014, unspecified number of patients received PROQUAD (Merck) which was improperly exposed to temperatures above 5F. No known adverse effects. No product complaint was reported for PROQUAD (Merck). This case is linked to 1411USA001655, 1411USA004432, 1411USA004433, 1411USA004434, 1411USA004435, 1411USA004437, 1411USA004438, 1411USA00439, 1411USA004440, 1411USA004441 and 1411USA004442 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a unspecified number of patient of unknown age. The unspecified patients medical history was not reported. On an unspecified dates since 05-MAY-2014, an unspecified number of patients received (Oka/Merck) VARIVAX (lot# K009727 and expiry date: 07-AUG-2015) which was improperly exposed to 22F for 4224 hours. No known adverse effects reported.  No product quality complaint was reported for (Oka/Merck) VARIVAX.     This case is linked to 1411USA001655, 1411USA004432, 1411USA004433, 1411USA004434, 1411USA004435, 1411USA004436, 1411USA004437, 1411USA004438, 1411USA004439, 1411USA004440, 1411USA004441. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HEPAB
Symptoms: Allergy test, Ear discomfort, Ear pain, Erythema, Hypersensitivity
Clinical narrative: This case was reported by a consumer and described the occurrence of allergic reaction in a 35-year-old female subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to erythromycin, penicilline allergy and sulfa allergy. The subject had sensitivity to formaldehyde. Historic vaccination included hepatitis A or B vaccine; manufacturer unspecified given at last 10 years ago. On 14 April 2014 at 01:00-01:30 pm, the subject received unspecified dose of TWINRIX adult (left arm; unknown route and lot number not provided). On 14 April 2013, about 3 hours after vaccination with TWINRIX adult, the subject experienced an allergic reaction that started with her ears burning, getting red and hurting. About 15 minutes after her ear symptoms, her lips and tongue started to go number. The subject consulted an allergist about the reaction, and she was currently undergoing testing for Galactosealpha-1,3-galactose, or alpha-gal, allergy. The subject was treated with BENADRYL and this helped her symptoms. At the time of reporting the events were resolved. This case was identified as duplicate of A1073512A. Case A1073512A was voided and all the future correspondence will be added in the present case which stands as case of record for this subject.
Age: 35.0
Sex: F
Vaccine: HEPAB
Symptoms: Hypoaesthesia oral
Clinical narrative: This case was reported by a consumer and described the occurrence of allergic reaction in a 35-year-old female subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to erythromycin, penicilline allergy and sulfa allergy. The subject had sensitivity to formaldehyde. Historic vaccination included hepatitis A or B vaccine; manufacturer unspecified given at last 10 years ago. On 14 April 2014 at 01:00-01:30 pm, the subject received unspecified dose of TWINRIX adult (left arm; unknown route and lot number not provided). On 14 April 2013, about 3 hours after vaccination with TWINRIX adult, the subject experienced an allergic reaction that started with her ears burning, getting red and hurting. About 15 minutes after her ear symptoms, her lips and tongue started to go number. The subject consulted an allergist about the reaction, and she was currently undergoing testing for Galactosealpha-1,3-galactose, or alpha-gal, allergy. The subject was treated with BENADRYL and this helped her symptoms. At the time of reporting the events were resolved. This case was identified as duplicate of A1073512A. Case A1073512A was voided and all the future correspondence will be added in the present case which stands as case of record for this subject.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: This spontaneous report as received from a 71 year old female patient with no pertinent medical history and no drug reactions/allergies refers to herself. On 12-AUG-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date, dose, route were not reported). There were no concomitant medications. On 14-AUG-2014, the patient experienced numbness and total complete loss of arm after receiving ZOSTAVAX. No treatment was given for adverse event. No lab diagnostics were performed. On 23-AUG-2014 the patient sought medical attention by visiting the office. The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, Injection site reaction
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified amount of patients of unknown age and gender. On an unknown dates the patients were vaccinated with doses of LIQUID PEDVAXHIB that underwent temperature excursions. On an unknown dates, unspecified amount of patients developed "localized reactions" at the injection site after receiving LIQUID PEDVAXHIB. The patients did not seek medical attention. No treatment was given for the events. The outcome of "localized reactions at the injection site was unknown. Relatedness between "localized reactions" at the injection site and LIQUID PEDVAXHIB was not reported. Thi sis one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: HEPAB
Symptoms: Decreased appetite
Clinical narrative: This case was reproted by a consumer and described the occurrence of loss of appetite in an adult male subject who was vaccinated with TWINRIX, (GlaxoSmithKline) as part of a program to cure Hepatitis C. A physician or health care professional has not verified this report. Concurrent medical conditions included Hepatitis C. On an unspecified date, the subject received an unspecified dose of TWINRIX (unknown route and injection site, batch number not provided) to cure Hepatitis C. At an unspecified time after vaccination with TWINRIX, the subject experienced loss of appetite. At the time of reporting, the outcome of the event was unspecified. The reporter would not provide any additional information about this case. Case was closed. The reporter also reported his own case of appetite loss after vaccination with TWINRIX (see case A1079811A).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, Injection site reaction, Local reaction
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified amount of patients of unknown age and gender. On an unkonwn dates the patient were vaccinated with doses of GARDASIL that underwent temperature excursions. On an unknown dates, unspecified amount of patients developed 'localized reactions' at the injection site after GARDASIL. The patients did not seek medical attention. No treatment was given for the events. The outcome of 'localized reactions' at the injection site was unknown. Relatedness between 'localized reactions' at the injection site and GARDASIL was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis (as told by patient's mom)
Age: 31.0
Sex: M
Vaccine: HEPAB, TYP, YF
Symptoms: Asthenia, Musculoskeletal stiffness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of stiff neck in a 31-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline), typhoid vaccine (non-gsk) and Yellow fever (non-gsk). Concurrent medications included Azithromycin. On 14 March 2014, the subject received 1st dose of TWINRIX (unknown route, left arm), 1st dose of Typhoid vaccine (Non-GSK) (oral), 1st dose of Yellow fever (unknown route and injection site). On 15 March 2014, 1 day after vaccination with TWINRIX, Typhoid vaccine (Non-GSK) and Yellow fever, the subject experienced stiff neck and weakness in neck. At the time of reporting the events were unresolved.
Age: 56.0
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: This case was reported by a healthcare professional (medical assistant) and described the occurrence of expired vaccine used in a 56-year-old subject of unspecified gender who was vaccinated with TWINRIX (GlaxoSmithKline). On 13 December 2013 the subject received a dose of TWINRIX (unknown details) and experienced expired vaccine used. The expiry of TWINRIX was 5 October 2013). Per the reporter, there were "no symptoms reported".
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a pharmacist via a claims benefit management company and described the occurrence of adverse reaction in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline), typhoid vaccine (non-gsk). On 8 November 2013 the subject received unspecified dose of TWINRIX (unknown details), unspecified dose of Typhoid vaccine (Non-GSK) (unknown details). On an unspecified date in 2013, within months of vaccination with TWINRIX and Typhoid vaccine (Non-GSK), the subject experienced adverse reaction. At the time of reporting the outcome of the event was unspecified.
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Hypoaesthesia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hand and feet numbness in a 60-year-old female subject who was vaccinated with TWINRIX, (GlaxoSmithKline). On 13 September 2013 and 6 September 2013 the subject received 2nd dose and 1st dose of TWINRIX (1 ml, unknown route, right arm). In 2013, less than one month after vaccination with TWINRIX, the subject experienced hand and feet numbness. The pharmacist reported that the subject stated that she had "experienced the symptoms for 2 weeks." No additional details were provided. At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: HEPAB
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a pharmacist and described the occurrence of vaccine exposure during pregnancy in a female subject of unspecified age who was possibly vaccinated with TWINRIX (GlaxoSmithKline) for prophylaxis during pregnancy. Historic vaccination included TWINRIX; GlaxoSmithKline; unknown; unknown given on an unspecified date. On an unspecified date the subject possibly received 3rd dose of TWINRIX (unknown details) and possibly experienced vaccine exposure during the 2nd trimester of pregnancy. The gestational at the time of the possible vaccination was 20 weeks per the pharmacist. The date of last menstrual period was not reported. The estimated date of delivery was calculated to be approximately 10 June 2014. The pregnancy was ongoing at the time of reporting. At the time of reporting, administration of the 3rd dos of TWINRIX was not confirmed. The pharmacist stated that the subject was considering getting her 3rd dose of TWINRIX because she will be "traveling outside of the country." The pharmacist reported that the subject "may wait to get the 3rd dose of TWINRIX after she delivers." No further details were provided. Follow up was received from the pharmacist on 17 February 2014. The pharmacist stated that the subject was "not under her care" and the subject "just asked" about administration of TWINRIX during pregnancy. The pharmacist did not administer the vaccine to the subject. The pregnancy case was closed as lost to follow up since it was unclear if the subject received the vaccine from another healthcare professional.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of expired vaccine used 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 (1 ml, unknown details) and expired vaccine used. The expiry of TWINRIX was 3 November 2013. The immunization series was not discontinued or delayed and symptoms did not recur following subsequent administration. No adverse events were reported. The reporter documented another case of expired vaccine used. See case A1059914A for details on the other case.
Age: 55.0
Sex: M
Vaccine: HEPAB
Symptoms: Condition aggravated, Hypertension
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of aggravated hypertension in a 55-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included hypertension. On an unspecified date, the subject received unspecified dose of TWINRIX (unknown route, injection site and batch number). At an unspecified time after vaccination with TWINRIX, the subject experienced aggravated hypertension. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of PROQUAD (Merck) (lot # not reported) that were improperly stored on 04-SEP-2012, 06-NOV-2012, 21-MAR-2013 and 07-AUG-2014. The cumulative excursions were supported and doses were administered to patients since 04-SEP-2012. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Malaise, Peripheral swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a field employee refers to a male patient of unknown age. Medical history and concurrent conditions were not reported. On 20-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 in the arm (dose, route, lot number and expiry date were not reported). Concomitant medications were not reported. On 20-OCT-2014, the patient who also was a co-worker of the pharmacist, developed redness and swelling that extended from the injection site past the elbow and down to the hand after receiving PNEUMOVAX 23. The patient felt "ill" after receiving PNEUMOVAX 23 and also stated that the patient had not returned to work since receiving PNEUMOVAX 23 due to he not being recovered yet. The patient was seen by the physician on 20-OCT-2014 when sought medical attention. At the time of the report, the outcome of developed redness and swelling that extended from the injection site past the elbow and down to the hand, felt "ill", the patient had not returned to work was not recovered. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HEPAB
Symptoms: Aspartate aminotransferase increased, Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of last elevated out of range in a 26-year-old female subject who was vaccinated with TWINRIX adult, (GlaxoSmithKline). Concurrent vaccination included TWINRIX, (GlaxoSmithKline); 1st dose given on 4 June 2014. On 18 June 2014, the subject received 2nd dose of TWINRIX adult (unknown route and injection site) which was administered at only 14 days after the first dose which led to a drug dose administration interval too short. Less than 1 month, after the 2nd vaccination with TWINRIX adult, the subject experienced last elevated out of range, her's level of 52 (normal range 5-35). At the time of reporting, the outcome of the events was unspecified.
Sex: U
Vaccine: HEPAB
Symptoms: Drug interaction
Clinical narrative: This case was reported by a clinician and described the occurrence of possible drug interaction in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date, the subject received an unspecified dose of TWINRIX (unknown route and injection site, batch number not provided). At an unspecified time after vaccination with TWINRIX, the clinician reported a potential drug interaction with TWINRIX. Despite several attempts, no further information could be obtained. At the time of reporting, the outcome of the event was unspecified. Further information was requested.
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Hepatitis B antibody negative, Latent tuberculosis, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional via other manufacturer (Merck) and described the occurrence of antibody nos negative in a female subject of hepatitis b antibody negative in a 43-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). In 2010-2011, the subject completed the TWINRIX series (1st, 2nd and 3rd doses; unknown route and injection site; lot number not provided). At an unspecified time after vaccination with TWINRIX, the subject performed serological testing which showed her titer negative. The subject had not responded to therapy. On 19 June 2014, the subject started a treatment with isoniazid for latent tuberculosis and on the same day she also received the second round of hepatitis B series with ENGERIX-B. At the time of reporting the outcome of the events was unspecified. No additional details were provided. Follow-up information received on 18 August 2014: Subject's details were provided. Subject's previous vaccination went uncomplicated. On 3 September 2010, 1 October 2010 and 9 June 2011, the subject received 1st, 2nd and 3rd doses of TWINRIX (1 cc, unknown injection site) administered per schedule. At an unspecified time after vaccination with TWINRIX, the subject experienced hepatitis b antibody negative. As an incidental finding, latent tuberculosis was diagnosed at the same time as the non-responding to hepatitis B therapy. The subject was traveling to a foreign country due to her work. The hepatitis B series was repeated. At the time of reporting the events were unresolved.
Age: 55.0
Sex: M
Vaccine: HEPAB
Symptoms: Anger, Decreased appetite, Epistaxis, Hypertension, Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a consumer and described the occurrence of loss of appetite in a 55-year-old male subject who was vaccinated with TWINRIX adult (GlaxoSmithKline) and Influenza vaccine (manufacturer unspecified) to cure Hepatitis C as a part of program 8 years ago. A physician or other health care professional has not verified this report. Concurrent medical conditions included Hepatitis C. On unspecified dates, the subject received 4 doses of TWINRIX adult one week apart (unknown routes and injection sites, batch numbers not provided). The approved accelerated dosing for TWINRIX is series of 4 doses given on days 0, 7, and 21 to 30 followed by a booster dose at month 12. The interval between 2nd and 3rd dose as well as the interval between 3rd and 4th doses were too short. On an unspecified date, the subject also received a dose of unspecified influenza virus vaccine. The 1st, 3rd and 4th injections were fine. The next morning after vaccination with 2nd dose of TWINRIX adult, the subject woke up with no appetite. For the next year he had no appetite when he woke up in the morning and since then, his appetite has gotten worse and worse. He used to weight 180 pounds and he weighed 148 pounds at the time of reporting, He ate only 1/2 a sandwich in a day and typically ate only every 3 days. It has been 3 days since he late ate when this report was made. His thyroid was shot too, and his anger issues and hypertension have gotten worse. In the past month he has also been experiencing nose bleeds. He felt this was slowly killing him and he will not last the year. The only benefit he received was that he did not have Hepatitis C any more. The caller felt that all of this happened because TWINRIX was a type of alpha interferon and these are symptoms of alpha interferon. He said the agency will not release his medical records, and he will be taking this up with a lawyer and will be going to News. He said the agency claimed to have given him only 2 of the TWINRIX injections, but he knew he received all 4, one week apart. The agency tried to claim that one of the injections was a flu vaccine he received, but he said that he received a flu vaccine in addition to 4 TWINRIX injections.
Age: 55.0
Sex: M
Vaccine: HEPAB
Symptoms: Thyroid disorder, Weight decreased
Clinical narrative: This case was reported by a consumer and described the occurrence of loss of appetite in a 55-year-old male subject who was vaccinated with TWINRIX adult (GlaxoSmithKline) and Influenza vaccine (manufacturer unspecified) to cure Hepatitis C as a part of program 8 years ago. A physician or other health care professional has not verified this report. Concurrent medical conditions included Hepatitis C. On unspecified dates, the subject received 4 doses of TWINRIX adult one week apart (unknown routes and injection sites, batch numbers not provided). The approved accelerated dosing for TWINRIX is series of 4 doses given on days 0, 7, and 21 to 30 followed by a booster dose at month 12. The interval between 2nd and 3rd dose as well as the interval between 3rd and 4th doses were too short. On an unspecified date, the subject also received a dose of unspecified influenza virus vaccine. The 1st, 3rd and 4th injections were fine. The next morning after vaccination with 2nd dose of TWINRIX adult, the subject woke up with no appetite. For the next year he had no appetite when he woke up in the morning and since then, his appetite has gotten worse and worse. He used to weight 180 pounds and he weighed 148 pounds at the time of reporting, He ate only 1/2 a sandwich in a day and typically ate only every 3 days. It has been 3 days since he late ate when this report was made. His thyroid was shot too, and his anger issues and hypertension have gotten worse. In the past month he has also been experiencing nose bleeds. He felt this was slowly killing him and he will not last the year. The only benefit he received was that he did not have Hepatitis C any more. The caller felt that all of this happened because TWINRIX was a type of alpha interferon and these are symptoms of alpha interferon. He said the agency will not release his medical records, and he will be taking this up with a lawyer and will be going to News. He said the agency claimed to have given him only 2 of the TWINRIX injections, but he knew he received all 4, one week apart. The agency tried to claim that one of the injections was a flu vaccine he received, but he said that he received a flu vaccine in addition to 4 TWINRIX injections.
Age: 57.0
Sex: F
Vaccine: HEPAB
Symptoms: Arthralgia
Clinical narrative: This case was reported by a nurse and described the occurrence of bilateral knee pain in a 57-year-old female subject who was vaccinated with TWINRIX adult, (GlaxoSmithKline). Concurrent medical conditions included possible allergy to antibiotics. Concurrent medications included ulcerative colitis medication. It was unknown whether the subject experienced any adverse events following previous vaccinations. On 28 May 201, at 09"05 am, the subject received 1st dose of TWINRIX adult (unknown route, left arm). On 28 May 2014, at 11:00 pm, approximately 14 hours after vaccination with TWINRIX adult, the subject experienced bilateral knee pain. The subject consulted a healthcare professional regarding the event. No diagnosis was reported. At the time of reporting, the event was unresolved.
Age: 31.0
Sex: M
Vaccine: FLUX, HEPAB, TYP
Symptoms: Pruritus, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hives in a 31-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). The subject's medical history included bee sting allergy. Concurrent medical conditions included asthma. Concurrent vacciantion included seasonal influenza vaccine (non-GSK manufacturer); typhoid vaccine (non-GSK manufacturer; oral) given on the same date as suspect vaccine. On 27 March 2014 the subject received 1st dose of TWINRIX (unknown route, right deltoid). On 29 March 2014, 2 days after vaccination with TWINRIX, the subject experienced hives and itching. The events resolved within 24 hours. On 30 March 2014, the events were resolved. After the next vacciantion with TWINRIX the events recurred. On 29 April 2014 the subject received 2nd dose of TWINRIX (unknown route, left deltoid). On 29 or 30 April 2014, 11 hours after vaccination with TWINRIX, the subject experienced hives and itching. The subject was treated with antihistamine. At the same time of reporting, the events were resolved. Follow up infromation received on 28 March 2014 from the healthcare professional: On 27 march 2014 the subject received 1st dose of TWINRIX (intramuscular, right deltoid). On 27 March 2014, less than one day after vaccination with TWINRIX, the subject experienced hives and itching. On 30 March 2014, the events were resolved. On 29 April 2014 the subject received 2nd dose of TWINRIX (intramuscular, left deltoid). On 29 April 2014, 11 hours after vaccination with TWINRIX, the subject experienced hives and itching. On 30 April 2014, the events were resolved. This case has been reported to regulatory authority.