chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: SYMPTOMS OF SHINGLES; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received Shingrix. In July 2020, less than a week after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and hydroxyzine (Hydroxyzin). On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the shingrix vaccine about 8 or 7 days ago from the date of reporting and still has symptoms of shingles.  The patient stated that she was breaking out in new areas each day.  The patient stated that on 9th July 2020 was her 4th day on valacyclov and hydroxyzin and she was still breaking out. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Feeling abnormal, Frustration tolerance decreased, Herpes zoster, Injection site pain, Injection site swelling
Clinical narrative: SYMPTOMS OF SHINGLES; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received Shingrix. In July 2020, less than a week after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and hydroxyzine (Hydroxyzin). On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the shingrix vaccine about 8 or 7 days ago from the date of reporting and still has symptoms of shingles.  The patient stated that she was breaking out in new areas each day.  The patient stated that on 9th July 2020 was her 4th day on valacyclov and hydroxyzin and she was still breaking out. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Insomnia, Rash
Clinical narrative: SYMPTOMS OF SHINGLES; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received Shingrix. In July 2020, less than a week after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and hydroxyzine (Hydroxyzin). On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the shingrix vaccine about 8 or 7 days ago from the date of reporting and still has symptoms of shingles.  The patient stated that she was breaking out in new areas each day.  The patient stated that on 9th July 2020 was her 4th day on valacyclov and hydroxyzin and she was still breaking out. The reporter did not consent to follow-up.
Age: 40.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Urticaria
Clinical narrative: Severe Hives
Age: 40.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dyspnoea, Lip swelling, Throat irritation, Urticaria
Clinical narrative: Severe Hives
Age: 0.17
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaqta was administred to a 2 month old; No patient experienced symptoms; This spontaneous report was received from a physician via a company representative regarding a 2-month-old infant. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug allergies or reactions were not reported.   On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) injection (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse events were reported, nor product quality complains involved.   This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA006351:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient received a dose of PEDVAX HIB following a temperature excursion; No other adverse effects were reported in the patient; This spontaneous report as received from a medical assistant referring to a patient of unknown age. Information about concomitant medication, pertinent medical history, drug reactions or allergies was not provided.  On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter (lot # T000886, expiration date: 29-MAY-2022, route was not reported) for prophylaxis. The vaccine was exposed to temperature above 47 Fahrenheit degree (also reported as 8.8 degree Celsius) for 31 minutes (product storage error). No previous temperature excursion was reported. Data logger was involved. No other adverse effects were reported.    This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA001399: US-009507513-2007USA001231: US-009507513-2007USA001265:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms or additional adverse effects reported.; Patient received first dose in MMR II immunization series that was administered past its expiry.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous durg reactions or allergies, and concomitant medications were not reported.  On 07-JUL-2020, the patient received an expired first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, at a dose of 0.5 milliliter (ml) (vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number R025335, which has been verified to be valid, expiration date reported and validated as 06-APR-2020) as prophylaxis (expired product administered).  As concomitant therapy, a sterile diluent (MERCK STERILE DILUENT) (lot number S008564 which has been verified to be valid, and expiration date reported and validated as 05-AUG-2021) was used to reconstitute the vaccine. No additional adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Post herpetic neuralgia; Herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.  On an unknown date, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) for routine health maintenance and prevention of shingles (herpes zoster).   On an unknown date (reported as "shortly after receiving vaccine"), the patient suffered from multiple bouts of herpes zoster and post-herpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers.  It was reported that the patient's symptoms had resulted in physical limitations not present prior to used zoster vaccine live (ZOSTAVAX). Further, the patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. Also, the patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the patient's conduct, patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  At the time of the report, the outcome of shingles and post-herpetic neuralgia was reported as not recovered/not resolved.    Upon internal review, shingles were considered to be disabling due to permanent and incurable injuries.  The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects were reported in the patient.; a patient received a dose of VARIVAX following a temperature excursion.; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 10-JUL-2020, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 1 dosage form (strength, dose, vaccination scheme, route of vaccination and anatomical site of site vaccination were not reported, lot number S022755, which has been verified to be valid, expiration date reported and validate as 21-JUL-2021) as prophylaxis, following a temperature excursion (product storage error). As concomitant therapy sterile diluent (MERCK STERILE DILUENT) was used to reconstitute the vaccines at a dose of 0.5 milliliter (ml). The administered dose of the vaccine experienced a temperature and time frame in the range of 6 Fahrenheit (F) to 14 (F) (-14 Celcius (C) to -10 (C)) (9.3 F) for 50 minutes, as record by data logger. There was no previous temperature excursion. No additional adverse effects were reported.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; pt was inadvertently administered a dose of Recombivax that had been improperly stored; Information has been received from the licensed practical nurse (also reported as medical assistant), concerning a 4 weeks old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies, and concomitant medications were not provided.  On 10-JUL-2020, the patient received a dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), Lot # R034547, expiration date on 09-JUN-2021, (route and frequency were not provided) for prophylaxis.  The reporter stated that this dose was improperly stored (product storage error) for 1 hour and 49 minutes, under 0.5 grades centigrade. No previous temperature excursion was reported, and this report was obtained because of data logger. No additional adverse event was reported.
Age: 14.0
Sex: F
Vaccine: HEPA, UNK
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional adverse effect reported; Adult dose 50U Ped dose 25U, administered 1ml syringe of adult dose; This spontaneous report was received from a primary health care provider (PHCP) referring to a 14 years old female patient. The patient's pertinent medical history, concomitant medication and concurrent condition were not provided.    On 09-JUL-2020, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (50 U, 1 ml syringe; lot# and expiration date were not provided) intramuscularly for prophylaxis. The pediatric dose was 25U. The patient was administered 1ml syringe of adult dose (incorrect dose administered). The patient tolerated well. No additional adverse effect was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 16 year old patient was inadvertently administered a dose of PRQOUAD; No effects reported; This spontaneous report was received from a medical assistant referring to a 16 years old patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.   On an unknown date, the patient was inadvertently administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)(strength, exact dose, route, lot number and expiration date were not reported) for prophylaxis (inappropriate age at vaccine administration). No effects reported.
Sex: F
Vaccine: PPV
Symptoms: Dysstasia, Joint range of motion decreased, Monoplegia, Muscular weakness, Myalgia
Clinical narrative: PNEUMOVAX which caused patients arm to be "paralyzed"; not because it was infected, but because it was swollen; she lost her range of motion; she could not stand up; during sleep, her arm still aches/I still have pain and weakness in my arm; feels weak and she has pain in the muscle; feels weak and she has pain in the muscle; sometimes the injection can cause nerve injury; This spontaneous report was received from a female patient of unknown age referring to herself. The patient's medical history, concomitant therapies and concurrent condition were not provided.     On 12-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose detail, strength, route, lot# and expiration date were not provided) for prophylaxis. On 13-FEB-2020 (reported as the same night, after midnight), the patient had to go to the emergency room because her arm (unknown if left or right) was paralyzed (monoplegia). The patient was prescribed an antibiotic, not because it was infected, but because it was swollen (peripheral swelling). The skin was stretched 3 times the size of her other arm. The patient reported that she lost her range of motion (joint range of motion decreased). And the patient could not stand up (dysstasia). After a while, the swelling was improved. However, during sleep, the patient's arm was still ache and feeling weak (muscular weakness and pain in extremity). The patient had pain in the muscle (myalgia). The patient reported that she still had pain and weakness in her arm after 5 months of vaccination. She spoke with her pharmacist who stated that sometimes the injection could cause nerve injury. The patient was recommended to try gabapentin. The outcome of monoplegia, nerve injury, myalgia, dysstasia and joint range of motion decreased was unknown. The outcome of peripheral swelling was reported as recovering. The outcome of muscular weakness and pain in extremity was not recovered.   The reporter considered monoplegia, nerve injury, myalgia, muscular weakness, pain in extremity, joint range of motion decreased and peripheral swelling to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The causality between dysstasia and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.  Upon internal review, arm paralyzed was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin tightness
Clinical narrative: PNEUMOVAX which caused patients arm to be "paralyzed"; not because it was infected, but because it was swollen; she lost her range of motion; she could not stand up; during sleep, her arm still aches/I still have pain and weakness in my arm; feels weak and she has pain in the muscle; feels weak and she has pain in the muscle; sometimes the injection can cause nerve injury; This spontaneous report was received from a female patient of unknown age referring to herself. The patient's medical history, concomitant therapies and concurrent condition were not provided.     On 12-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose detail, strength, route, lot# and expiration date were not provided) for prophylaxis. On 13-FEB-2020 (reported as the same night, after midnight), the patient had to go to the emergency room because her arm (unknown if left or right) was paralyzed (monoplegia). The patient was prescribed an antibiotic, not because it was infected, but because it was swollen (peripheral swelling). The skin was stretched 3 times the size of her other arm. The patient reported that she lost her range of motion (joint range of motion decreased). And the patient could not stand up (dysstasia). After a while, the swelling was improved. However, during sleep, the patient's arm was still ache and feeling weak (muscular weakness and pain in extremity). The patient had pain in the muscle (myalgia). The patient reported that she still had pain and weakness in her arm after 5 months of vaccination. She spoke with her pharmacist who stated that sometimes the injection could cause nerve injury. The patient was recommended to try gabapentin. The outcome of monoplegia, nerve injury, myalgia, dysstasia and joint range of motion decreased was unknown. The outcome of peripheral swelling was reported as recovering. The outcome of muscular weakness and pain in extremity was not recovered.   The reporter considered monoplegia, nerve injury, myalgia, muscular weakness, pain in extremity, joint range of motion decreased and peripheral swelling to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The causality between dysstasia and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.  Upon internal review, arm paralyzed was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Influenza
Clinical narrative: Flu-ish symptoms; Achy joints; This spontaneous report was received from a physician reporting on herself, a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date in 2013, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported).   On an unknown date in 2013, the patient had a strong response to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), and she felt achy joints (arthralgia) and "flu-ish" symptoms (influenza like illness). She considered this response to be normal, predictable and consistent with the label. She did not report any serious or lasting problems. In 2013, she recovered from influenza like illness and arthralgia.  The reporter considered arthralgia and influenza like illness to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered
Clinical narrative: Expired VAQTA was given to patient; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On 13-JUL-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 1 ml, lot # S007265, with expiration date of 07-JUL-2020, by intramuscular route (strength, dose, frequency, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007265; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, Product dose omission
Clinical narrative: Pharmacist reported patient received first dose at age 9 and did not receive any further doses; missed dose; This spontaneous report was received from a pharmacist and refers to a 9 year old patient of unknown gender. The patient's medical histrory, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with the first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dose, frequency, lot # and expiration date were not provided) for prophylaxis. The pharmacist had questions regarding hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) missed dose. Pharmacist reported that patient did not receive any further doses. Doctor's office called in prescription for 2 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) to pharmacy and pharmacist wanted to clarify recommended dose schedule with only 1 dose given prior to filling hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prescription on 14-JUL-2020.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; the patient was inadvertently administered a dose of VAQTA that was expired; This spontaneous report was received from a medical assistant referring to a 20 years old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.        On 15-JUL-2020, the patient was inadvertently vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S018419, expiration date 12-JUL-2020; strength, dose and route were not reported) which was expired for prophylaxis (expired product administered). No additional adverse event was reported.
Age: 0.5
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaqta was administred to a 6 month old infant; No patient experienced symptoms; This spontaneous report was received from a physician via a company representative regarding a 6-month-old infant. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug allergies or reactions were not reported.   On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) injection (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse events were reported, nor product quality complains involved.   This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA001379:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th February 2020, the patient received the 1st dose of Shingrix. On 9th February 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient recived Shingrix and experienced sore arm. The reporter consented to follow up. For tolerance after 2nd dose refer case US2020123381.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020123381:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Arthropod bite, Herpes zoster
Clinical narrative: had a bug bite or shingles; bug bite; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. In July 2020, less than 9 months after receiving Shingrix, the patient experienced shingles and bug bite. On an unknown date, the outcome of the shingles and bug bite were unknown.   It was unknown if the reporter considered the shingles and bug bite to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had a bug bite or shingles.  The reporter consented to follow up. No more information was provided.  The pharmacist agrees to FUP via email or postal. For tolerance after 2nd dose refer case US2020123366.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020123366:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included umeclidinium bromide, vilanterol trifenatate (Anoro).   On 7th July 2020, the patient received Shingrix. On 7th July 2020, less than a day after receiving Shingrix and Anoro and less than a day after starting Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient just got the first dose and had hives relieved by H2 blockers.  The patient wanted to know should he or she get the second dose in 3 months. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pyrexia, Rash
Clinical narrative: shingles outbreak; rash; This case was reported by a pharmacist and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2020, the patient received Shingrix. In July 2020, 24 hrs after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced shingles and rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable. On 6th July 2020 at 2.30 pm, the patient was vaccinated Shingrix in left deltoid. On 8th July 2020, the patient possibly having a shingles outbreak along the dermatome originating at C4. The rash was on the opposite side (right side).  The rash became apparent twenty-four hours post vaccination. It was not blistering at this point. It was pyretic and non-purpuric.  The patient had been prescribed Valtrex 1 gram by mouth three times daily for seven days.  The reporter asked, is there any recommended treatment for patients experiencing a shingles outbreak soon after a Shingrix vaccination. In our pharmacy, we have had approximately thirty doses from this lot and we had no other reported incidents. We had not spoken with all the other patients but we were in the process of making contact with them just to check-in.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Dyspnoea
Clinical narrative: since I start using anoro My breathing is worse now when I don't use it; This case was reported by a consumer via call center representative and described the occurrence of dyspnea exacerbated in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included umeclidinium bromide, vilanterol trifenatate (Anoro) inhalation powder for difficulty breathing.   Concurrent medical conditions included difficulty breathing.   On an unknown date, the patient received Shingrix and Anoro at an unknown dose and frequency. On an unknown date, immediately after receiving Shingrix and Anoro, the patient experienced dyspnea exacerbated. Anoro was discontinued. On an unknown date, the outcome of the dyspnea exacerbated was unknown.   It was unknown if the reporter considered the dyspnea exacerbated to be related to Shingrix and Anoro.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had breathing problem. The patient notice since start using Anoro the breathing was worse and when did not use it then before started using it was it normal after starting use you cannot go back to not using.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR124296:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Feeling abnormal, Headache, Myalgia
Clinical narrative: muscle pain; headache; stomach discomfort/upset stomach; feel bad/side effects; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 52-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced muscle pain, headache, stomach discomfort and feeling bad. On an unknown date, the outcome of the muscle pain, headache, stomach discomfort and feeling bad were unknown.   It was unknown if the reporter considered the muscle pain, headache, stomach discomfort and feeling bad to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. After receiving the Shingrix vaccine the patient experienced Having muscle pain, head ache, stomach discomfort on day 2. The patient asked how long do shingles vaccine side effects last. The patient also asked how long should I wait to get the Flu vaccine after receiving the SHINGRIX vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Muscle fatigue
Clinical narrative: sore injection site; muscle fatigue/side effects; tired; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2020, the patient received the 2nd dose of Shingrix. In July 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, muscle fatigue and tiredness. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the injection site pain, muscle fatigue and tiredness were unknown.   It was unknown if the reporter considered the injection site pain, muscle fatigue and tiredness to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. On 08th July 2020 at evening, the patient received 2nd dose of Shingrix. On 9th July 2020 at morning, the patient woke up with very sore injection site and tired. The patient also experienced have General muscle fatigue. These were common side effects. The patient asked to have Motrin for them.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Furuncle, Lethargy, Malaise, Pain in extremity, Pyrexia
Clinical narrative: fluid-filled blisters; fluid-filled boils; painful rash; noticing red spots on left ankle; red spots breakouts are described as itchy; skin discoloration; pain in left arm/Injection as painful; being sick all weekend; having a fever all day; feeling lethargic; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (three occurrences of Shingles). Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on February 2020, refer case US2020126228).   On 3rd July 2020, the patient received the 2nd dose of Shingrix. On 4th July 2020, 1 days after receiving Shingrix, the patient experienced pain in arm, sickness, fever and lethargy. On 6th July 2020, the patient experienced red rash, itchy rash, skin discoloration and painful rash. On 7th July 2020, the patient experienced blistery rash and boil. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, lethargy, red rash, itchy rash, skin discoloration, blistery rash, boil and painful rash were unknown and the outcome of the sickness was not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the pain in arm, sickness, fever, lethargy, red rash, itchy rash, skin discoloration, blistery rash, boil and painful rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and injection described as painful. The patient being sick all weekend described as having a fever all day and feeling lethargic, and pain in left arm.  The reporter stated had no fever but still feeling lethargic and right thigh developed an outbreak and noticed red spots on left ankle that spread halfway up left shin and noted 2 spots on right ankle that was still localized.  The red spots breakouts are described as itchy and red a cause skin discoloration and describes the spots as becoming raised up with fluid-filled blisters and fluid-filled boils. Affected areas with spots, blisters and boils also described as painful. The reporter consented to follow up. The reporter reported shingles cases before receiving Shingrix covered a huge area of her body.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020126228:same patient, 1st dose
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Rash vesicular, Skin discolouration
Clinical narrative: fluid-filled blisters; fluid-filled boils; painful rash; noticing red spots on left ankle; red spots breakouts are described as itchy; skin discoloration; pain in left arm/Injection as painful; being sick all weekend; having a fever all day; feeling lethargic; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (three occurrences of Shingles). Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on February 2020, refer case US2020126228).   On 3rd July 2020, the patient received the 2nd dose of Shingrix. On 4th July 2020, 1 days after receiving Shingrix, the patient experienced pain in arm, sickness, fever and lethargy. On 6th July 2020, the patient experienced red rash, itchy rash, skin discoloration and painful rash. On 7th July 2020, the patient experienced blistery rash and boil. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, lethargy, red rash, itchy rash, skin discoloration, blistery rash, boil and painful rash were unknown and the outcome of the sickness was not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the pain in arm, sickness, fever, lethargy, red rash, itchy rash, skin discoloration, blistery rash, boil and painful rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and injection described as painful. The patient being sick all weekend described as having a fever all day and feeling lethargic, and pain in left arm.  The reporter stated had no fever but still feeling lethargic and right thigh developed an outbreak and noticed red spots on left ankle that spread halfway up left shin and noted 2 spots on right ankle that was still localized.  The red spots breakouts are described as itchy and red a cause skin discoloration and describes the spots as becoming raised up with fluid-filled blisters and fluid-filled boils. Affected areas with spots, blisters and boils also described as painful. The reporter consented to follow up. The reporter reported shingles cases before receiving Shingrix covered a huge area of her body.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020126228:same patient, 1st dose
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: swelling; redness; soreness; my arm is pretty sore; This case was reported by a consumer and described the occurrence of injection site swelling in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 1st dose of Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site pain and pain in arm. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site pain and pain in arm were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and approximately after 48 hours prior to the reporting, whilst patient realize some swelling, redness and soreness was to be expected. The patient was little concerned about second dose in 2 to 6 months time. The patient's arm was pretty sore, but functionally normal.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site rash
Clinical narrative: swelling about 10 centimeters wide around the injection site.; redness; rash; This case was reported by a physician via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site rash. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site rash were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced swelling, redness and a rash about 10 centimeters wide around the injection site. No hives or facial, lip or other swelling nor other systemic.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Immediate post-injection reaction, Urticaria
Clinical narrative: Lookns like hives on my arms; Weak; Fatigued; This case was reported by a consumer via call center representative and described the occurrence of weakness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd July 2020, the patient received Shingrix. On 2nd July 2020, immediately after receiving Shingrix, the patient experienced weakness and fatigue. On 8th July 2020, the patient experienced hives. On an unknown date, the outcome of the weakness, fatigue and hives were unknown.   It was unknown if the reporter considered the weakness, fatigue and hives to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient had been weak and fatigued since getting the shot 7 days ago and on the day of reporting, what looks like hives on my arms.  On 8th July 2020, 6 days after vaccination the patient experienced hives The patient asked could this be a reaction to the shot..
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Vaccination complication
Clinical narrative: itching; shingles reaction; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy Ellipta).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after starting Trelegy Ellipta, the patient experienced pruritus and adverse reaction. On an unknown date, the outcome of the pruritus and adverse reaction were unknown.   It was unknown if the reporter considered the pruritus and adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per the vaccine indication. After receiving Shingrix, the patient experianced itching and shingles vaccine reaction. The patient was asking that what home remedy could the patient use for the itching and shingles vaccine reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: shortness of breath; faster heartbeat; This case was reported by a consumer via interactive digital media and described the occurrence of shortness of breath in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th July 2020 01:30, the patient received Shingrix. On 10th July 2020, less than a day after receiving Shingrix, the patient experienced shortness of breath and heartbeats increased. On an unknown date, the outcome of the shortness of breath and heartbeats increased were unknown.   It was unknown if the reporter considered the shortness of breath and heartbeats increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per the vaccine indication. After receiving Shingrix, the patient experianced shortness of breath and faster heartbeat.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: severe shingles rash; severe shingles rash; This case was reported by a nurse via sales rep and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 8 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient developed severe shingles rash on side/stomach 8 days after receiving 1st dose of shingles. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Near death experience
Clinical narrative: it almost killed me; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   It was unknown if the reporter considered the near death experience to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient stated that the first injection of vaccine almost killed him/her, so doctor told to not take the 2nd dose.  The patient stated that he/she wont take this one either, if they ever even come out with vaccine. No other information was reported.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Pain in extremity, Somnolence
Clinical narrative: slept for the full afternoon; tiredness; weakness; arm hurt; This case was reported by a consumer via call center representative and described the occurrence of sleepiness in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th January 2020).   On 23rd June 2020, the patient received the 2nd dose of Shingrix. On 23rd June 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 24th June 2020, the patient experienced sleepiness, tiredness and weakness. In June 2020, the outcome of the pain in arm was recovered/resolved. On 25th June 2020, the outcome of the sleepiness, tiredness and weakness were recovered/resolved.   It was unknown if the reporter considered the sleepiness, tiredness, weakness and pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter was reported for his wife. The patient did not experience any side effects with the 1st dose.  After the 2nd dose, her arm hurt.  The patient experienced the weakness or tiredness on the second day after the injection. She also slept for the full afternoon.  Symptoms were gone the following day. This case was linked with case US2020115707, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020115707:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Inappropriate schedule of product administration, Vaccine positive rechallenge
Clinical narrative: late for dose two of Shingrix and administered a second dose; shingles which had worsened; shingles which had worsened; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of herpes zoster (for 1st dose refer case US2020AMR124024). Concurrent medical conditions included shingles.   On 1st July 2020, the patient received the 2nd dose of Shingrix. On 1st July 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In July 2020, the patient experienced shingles and condition aggravated. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the shingles, condition aggravated and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the shingles and condition aggravated to be related to Shingrix.  Additional details were reported as follows: On 1st July 2020, the patient came to the pharmacy and the patient told the pharmacist he had a bug bite or shingles. The pharmacist realized the patient was late for dose two of Shingrix and administered a second dose. Later, a physician diagnosed the patient´s condition as shingles which had worsened after the administration of the vaccine. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthtening of vaccination schedule.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR124024:same reporter