chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Quadrantanopia
Clinical narrative: Quadrantanopia in his right eye and was diagnosed with an Acute Occipital Stroke.; Information has been received from a lawyer, regarding a case in litigation referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant therapies was not provided.     On or around 02-DEC-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, route, dose, lot # and expiration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Subsequently, on an unknown date, the patient experienced quadrantanopia in his right eye and was diagnosed with an acute occipital stroke (cerebrovascular accident). As a direct and proximate result of vaccination with zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to vaccination. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. Furthermore, the patient sustained severe and permanent personal injuries, also 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 defendants' conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  At the time of reporting, the outcome of cerebrovascular accident was determined as not recovered. The reporter considered cerebrovascular accident to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, cerebrovascular accident was determined to be serious due to disability and a medically significant event.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: consumer missed dose for VARIVAX; consumer missed dose for VARIVAX; No additional AE reported; This spontaneous report was received from the patient's mother referring to her relative, a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date many years ago, the patient was vaccinated with  a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, anatomical location, route of administration, lot #, and expiration date were not reported) for prophylaxis but never completed the dosing schedule (inappropriate schedule of product administration) and therefore missed a dose of the vaccine.      No additional adverse events were reported.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient was revaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) vaccine less than 5 years between doses; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (# 1902USA008705), concerning to a 67-year-old female patient.  On 01-JAN-2015 and 16-SEP-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacture unknown) (strength, dose, route, lot number and expiration date were unknown) for prophylaxis respectively (Inappropriate schedule of vaccine administered).  This is one of two reports from the same patient.; Sender's Comments:  US-009507513-1902USA008705:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Nasopharyngitis, Pain in extremity, SARS-CoV-2 test
Clinical narrative: COVID-19; Nasopharyngitis; Exposure to SARS-CoV-2; arm was a little sore; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm was a little sore), COVID-19 (COVID-19), NASOPHARYNGITIS (Nasopharyngitis) and EXPOSURE TO SARS-COV-2 (Exposure to SARS-CoV-2) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was a little sore). On 01-Feb-2021, the patient experienced COVID-19 (COVID-19) and NASOPHARYNGITIS (Nasopharyngitis). 01-Feb-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposure to SARS-CoV-2). At the time of the report, PAIN IN EXTREMITY (arm was a little sore), COVID-19 (COVID-19), NASOPHARYNGITIS (Nasopharyngitis) and EXPOSURE TO SARS-COV-2 (Exposure to SARS-CoV-2) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, SARS-CoV-2 test: positive (Positive) positive. On 04-Feb-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID 19 on 03/31/2021 and 04/02/2021.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received on 15-Jun-2021 contains updated suspect products with start date and different batch numbers events Nasopharyngitis
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: developed shingles on the same arm; nerve pain that lasted several weeks; 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, 1 week after receiving Shingrix, the patient experienced shingles and nerve pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the nerve pain was recovered/resolved.   It was unknown if the reporter considered the shingles and nerve pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. A nurse reported that the patient received dose of shingrix and after 1 week after experienced shingles on the same arm. The patient also experienced nerve pain that lasted several weeks. She had never had shingles prior to receiving the vaccine. She was unsure if this reaction was related to receiving her first dose of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction to Shingrix / messed up been in an out of urgent care three times; This case was reported by a consumer via media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that received shingrix vaccine and experienced allergic reaction. Also reported messed up in an out of urgent care three times. The patient stated need to take the shingrix off the market. The patient stated that it was 5th August and got the vaccine on 24th August please help. The reported to CDC and also your people took a report.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administrating only the diluent portion / administration of the diluent alone; administrating only the diluent portion / administration of the diluent alone; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received Shingrix. In July 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The account manager from GlaxoSmithKline called to report that he was informed by a third person, that an health care professional was administrating only the diluent portion of the Shingrix vaccine to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, the patient received Shingrix vaccine through 26th July 2021 to 29th July 2021. The reporter gave the health care professional contact information but did not specify if the health care professional agreed to be contacted for follow up or not. There was no further information regarding the date of the administration, nor lot number or expiration date of the vaccine. No further information was given to the account manager or to the agent. This case was 1 of 9 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165607:Same reporter US-GLAXOSMITHKLINE-US2021AMR167676:Same reporter US-GLAXOSMITHKLINE-US2021AMR167677:Same reporter US-GLAXOSMITHKLINE-US2021AMR167674:Same reporter US-GLAXOSMITHKLINE-US2021AMR167673:Same reporter US-GLAXOSMITHKLINE-US2021AMR167675:Same reporter US-GLAXOSMITHKLINE-US2021AMR167671:Same reporter US-GLAXOSMITHKLINE-US2021AMR167672:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administrating only the diluent portion / administration of the diluent alone; administrating only the diluent portion / administration of the diluent alone; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received Shingrix. In July 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The account manager from Glaxosmithkline called to report that he was informed by a third person, that an health care professional was administrating only the diluent portion of the Shingrix vaccine to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, the patient received Shingrix vaccine through 26th July 2021 to 29th July 2021. The reporter gave the health care professional contact information but did not specify if the health care professional agreed to be contacted for follow up or not. There was no further information regarding the date of the administration, nor lot number or expiration date of the vaccine. No further information was given to the account manager or to the agent. This case was 1 of 9 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165607:Same reporter US-GLAXOSMITHKLINE-US2021AMR167670:Same reporter US-GLAXOSMITHKLINE-US2021AMR167673:Same reporter US-GLAXOSMITHKLINE-US2021AMR167676:Same reporter US-GLAXOSMITHKLINE-US2021AMR167677:Same reporter US-GLAXOSMITHKLINE-US2021AMR167674:Same reporter US-GLAXOSMITHKLINE-US2021AMR167672:Same reporter US-GLAXOSMITHKLINE-US2021AMR167675:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administrating only the diluent portion / administration of the diluent alone; administrating only the diluent portion / administration of the diluent alone; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received Shingrix. In July 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The account manager from GlaxoSmithKline called to report that he was informed by a third person, that an health care professional was administrating only the diluent portion of the Shingrix vaccine to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, the patient received Shingrix vaccine through 26th July 2021 to 29th July 2021. The reporter gave the health care professional contact information but did not specify if the health care professional agreed to be contacted for follow up or not. There was no further information regarding the date of the administration, nor lot number or expiration date of the vaccine. No further information was given to the account manager or to the agent. This case was 1 of 9 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165607:Same reporter US-GLAXOSMITHKLINE-US2021AMR167670:Same reporter US-GLAXOSMITHKLINE-US2021AMR167671:Same reporter US-GLAXOSMITHKLINE-US2021AMR167675:Same reporter US-GLAXOSMITHKLINE-US2021AMR167677:Same reporter US-GLAXOSMITHKLINE-US2021AMR167676:Same reporter US-GLAXOSMITHKLINE-US2021AMR167673:Same reporter US-GLAXOSMITHKLINE-US2021AMR167674:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administrating only the diluent portion / administration of the diluent alone; administrating only the diluent portion / administration of the diluent alone; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received Shingrix. In July 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The account manager from GlaxoSmithKline called to report that he was informed by a third person, that an health care professional was administrating only the diluent portion of the Shingrix vaccine to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, the patient received Shingrix vaccine through 26th July 2021 to 29th July 2021. The reporter gave the health care professional contact information but did not specify if the health care professional agreed to be contacted for follow up or not. There was no further information regarding the date of the administration, nor lot number or expiration date of the vaccine. No further information was given to the account manager or to the agent. This case was 1 of 9 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165607:Same reporter US-GLAXOSMITHKLINE-US2021AMR167670:Same reporter US-GLAXOSMITHKLINE-US2021AMR167671:Same reporter US-GLAXOSMITHKLINE-US2021AMR167672:Same reporter US-GLAXOSMITHKLINE-US2021AMR167676:Same reporter US-GLAXOSMITHKLINE-US2021AMR167674:Same reporter US-GLAXOSMITHKLINE-US2021AMR167675:Same reporter US-GLAXOSMITHKLINE-US2021AMR167677:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: administrating only the diluent portion / administration of the diluent alone; administrating only the diluent portion / administration of the diluent alone; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received Shingrix. In July 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The account manager from Glaxosmithkline called to report that he was informed by a third person, that an health care professional was administrating only the diluent portion of the Shingrix vaccine to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, the patient received Shingrix vaccine through 26th July 2021 to 29th July 2021. The reporter gave the health care professional contact information but did not specify if the health care professional agreed to be contacted for follow up or not. There was no further information regarding the date of the administration, nor lot number or expiration date of the vaccine. No further information was given to the account manager or to the agent. This case was 6 of 9 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165607:Same reporter US-GLAXOSMITHKLINE-US2021AMR167670:Same reporter US-GLAXOSMITHKLINE-US2021AMR167671:Same reporter US-GLAXOSMITHKLINE-US2021AMR167672:Same reporter US-GLAXOSMITHKLINE-US2021AMR167673:Same reporter US-GLAXOSMITHKLINE-US2021AMR167676:Same reporter US-GLAXOSMITHKLINE-US2021AMR167675:Same reporter US-GLAXOSMITHKLINE-US2021AMR167677:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administrating only the diluent portion / administration of the diluent alone; administrating only the diluent portion / administration of the diluent alone; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received Shingrix. In July 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The account manager from Glaxosmithkline called to report that he was informed by a third person, that an health care professional was administrating only the diluent portion of the Shingrix vaccine to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, the patient received Shingrix vaccine through 26th July 2021 to 29th July 2021. The reporter gave the health care professional contact information but did not specify if the health care professional agreed to be contacted for follow up or not. There was no further information regarding the date of the administration, nor lot number or expiration date of the vaccine. No further information was given to the account manager or to the agent. This case was 7 of 9 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165607:Same reporter US-GLAXOSMITHKLINE-US2021AMR167670:Same reporter US-GLAXOSMITHKLINE-US2021AMR167671:Same reporter US-GLAXOSMITHKLINE-US2021AMR167672:Same reporter US-GLAXOSMITHKLINE-US2021AMR167673:Same reporter US-GLAXOSMITHKLINE-US2021AMR167674:Same reporter US-GLAXOSMITHKLINE-US2021AMR167677:Same reporter US-GLAXOSMITHKLINE-US2021AMR167676:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administrating only the diluent portion / administration of the diluent alone; administrating only the diluent portion / administration of the diluent alone; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received Shingrix. In July 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The account manager from Glaxosmithkline called to report that he was informed by a third person, that an health care professional was administrating only the diluent portion of the Shingrix vaccine to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, the patient received Shingrix vaccine through 26th July 2021 to 29th July 2021. The reporter gave the health care professional contact information but did not specify if the health care professional agreed to be contacted for follow up or not. There was no further information regarding the date of the administration, nor lot number or expiration date of the vaccine. No further information was given to the account manager or to the agent. This case was 8 of 9 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165607:Same reporter US-GLAXOSMITHKLINE-US2021AMR167670:Same reporter US-GLAXOSMITHKLINE-US2021AMR167671:Same reporter US-GLAXOSMITHKLINE-US2021AMR167672:Same reporter US-GLAXOSMITHKLINE-US2021AMR167673:Same reporter US-GLAXOSMITHKLINE-US2021AMR167674:Same reporter US-GLAXOSMITHKLINE-US2021AMR167675:Same reporter US-GLAXOSMITHKLINE-US2021AMR167677:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administrating only the diluent portion / administration of the diluent alone; administrating only the diluent portion / administration of the diluent alone; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received Shingrix. In July 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The account manager from Glaxosmithkline called to report that he was informed by a third person, that an health care professional was administrating only the diluent portion of the Shingrix vaccine to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, the patient received Shingrix vaccine through 26th July 2021 to 29th July 2021. The reporter gave the health care professional contact information but did not specify if the health care professional agreed to be contacted for follow up or not. There was no further information regarding the date of the administration, nor lot number or expiration date of the vaccine. No further information was given to the account manager or to the agent. This case was 9th of 9 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165607:Same reporter US-GLAXOSMITHKLINE-US2021AMR167670:Same reporter US-GLAXOSMITHKLINE-US2021AMR167671:Same reporter US-GLAXOSMITHKLINE-US2021AMR167672:Same reporter US-GLAXOSMITHKLINE-US2021AMR167673:Same reporter US-GLAXOSMITHKLINE-US2021AMR167674:Same reporter US-GLAXOSMITHKLINE-US2021AMR167675:Same reporter US-GLAXOSMITHKLINE-US2021AMR167676:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: have had two shots for shingles / A year later I have the shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine and more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had 2 shots of Shingles vaccine and a year later the patient had the shingles today. The patient stated that, no shot was 100 percent but he/she guess it helped a little. This case was considered as suspected vaccination failure as details regarding, laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shots last summer / got shingles this spring! / Suspected Vaccination failure; Got shingles this spring!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got the Shingles shots last summer and still got shingles this spring. The patient stated as not 100 percent effective. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pyrexia
Clinical narrative: Fever / 6 week following his first dose / continues to have a fever; This case was reported by a physician via sales rep and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. The physician reported that, the patient received his first dose of Shingrix in 2021, about 6 weeks ago of reporting date. He received the dose of Shingrix from another physician at another clinic, so knew very little other information about the administration of the Shingrix dose. Shortly after receiving his first dose of Shingrix, he experienced a fever over the 6 weeks following his first dose of Shingrix, the fever continued, and did not resolve. The physician was unsure of the initial fever, but it had been varying between 101 degrees Fahrenheit and 99 degrees Fahrenheit over the 6 week period. The patient was reluctant to receive his second dose of Shingrix due to the fever that he experienced. As of 6th August 2021, the patient continues to have a fever.  No further information were provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. In December 2020, less than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received both doses during first half of 2020 and still got shingles in December 2020. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Laboratory test normal, Muscular weakness, Nausea, Vaccination complication
Clinical narrative: bad headache; weakness in the legs; extreme nausea; This case was reported by a consumer via call center representative and described the occurrence of headache in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced headache, lower extremities weakness of and nausea. On an unknown date, the outcome of the headache, lower extremities weakness of and nausea were recovered/resolved.   The reporter considered the headache, lower extremities weakness of and nausea to be possibly related to Shingrix.  Additional details were provided are as follows: The case was reported for reporter's aunt. The age at vaccination was not reported. The patient received a dose of Shingrix and had bad headache, weakness in the legs and extreme nausea. The patient had an extreme reaction to Shingrix and within 18 months probably received the vaccine. The reporter thought that events came on later of the vaccination date. The patient went to the emergency and just ran basic tests and no conclusion was there other than it must have come from the vaccine. The reporter assumed that within 24 hours she was back to normal. The patient was not treated by a health care professional. The reporter did not consent to follow-up. The case has been linked with case US2021167540, reported by same reporter for different product.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021167540:Pharma case (Flonase)
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I have a fever of 101; This case was reported by a consumer via media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2021, the patient received the 2nd dose of Shingrix. On 7th August 2021, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received dose of Shingrix today (on the day of reporting) and experienced fever of 101 degree Fahrenheit. Also inquired was this typical
Sex: U
Vaccine: VARZOS
Symptoms: Raynaud's phenomenon
Clinical narrative: Diagnosed with Reynaud's; This case was reported by a consumer via(Shingrix GSK Chatbot) interactive digital media and described the occurrence of raynauds in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included covid-19 vaccine (Covid19 Vaccine).   On an unknown date, the patient received Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced raynauds. On an unknown date, the outcome of the raynauds was unknown.   It was unknown if the reporter considered the raynauds to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient stated that last December or this January, he/she received the Covid vaccine and 1 month later received shingrix vaccine because the healthcare provider was concerned the patient was vaccinated. Since then patient diagnosed with Reynaud's. The patient asked if the GSK (GlaxoSmithKline) had any reports of having Reynaud's after Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2 shots 2 weeks apart; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient had shinlges so decided to get vaccinated. The patient received 2 shots of shingles vaccine 2 weeks apart, which led to shortening of vaccination schedule . The patient was told that the arm was probably be sore for a couple of days. The patient reported no soreness or any kind of after effects. Also stated that get a flu shot every year.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR168290:same reporter
Sex: U
Vaccine: TDAP
Symptoms: Deafness, Immediate post-injection reaction
Clinical narrative: Had hearing loss with my TDAP booster / was permanent; This case was reported by a consumer via media and described the occurrence of hearing loss in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, immediately after receiving Tdap Vaccine, the patient experienced hearing loss (serious criteria disability and GSK medically significant). On an unknown date, the outcome of the hearing loss was unknown.   It was unknown if the reporter considered the hearing loss to be related to Tdap Vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself or himself. The age at vaccination was not reported. The reporter stated that, he or she had hearing loss with his or her TDAP booster, it happened shortly after receiving the TDAP booster vaccine and was permanent. The reporter stated that, he or she do not think would get it again.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Lip blister, Oral herpes
Clinical narrative: Lower lips full of fever blisters / days later / new blisters appeared; This case was reported by a consumer and described the occurrence of fever blister in a 59-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included fever blister (had 2 or 3 episodes in past).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 6 months after receiving Shingles vaccine, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patients wife reported that they both received first dose of shingles vaccine recently. Post vaccination exactly 2 weeks later they both experienced lower lips full of fever blisters,6 to 10 in numbers. 4 days later a few new blisters appeared. The patient thought the blisters must be a side effect of the shot because of the timing. The patient also stated that rarely she get fever blisters and had 2 or 3 episodes in her whole life, not sick or stressed. Also stated that none of them  exposed to someone with fever blisters either. Case created for husband refer linked case US2021AMR168314.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR168314:Same reporter. Husband's case.
Sex: M
Vaccine: VARZOS
Symptoms: Lip blister, Oral herpes
Clinical narrative: Lower lips full of fever blisters / days later / new blisters appeared; This case was reported by a consumer and described the occurrence of fever blister in a 61-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 6 months after receiving Shingles vaccine, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patients wife reported that they both received first dose of shingles vaccine recently. Post vaccination exactly 2 weeks later they both experienced lower lips full of fever blisters,6 to 10 in number. 4 days later a few new blisters appeared. The patient thought the blisters must be a side effect of the shot because of the timing. The patient had not had fever blister in over 2 years, not sick or stressed. Also stated that none of them  exposed to someone with fever blisters either. Refer linked case US2021AMR168312; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR168312:Same reporter. Wife's case.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; I have them now.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/herself. The age at vaccination was not reported. The patient had received both shots of Shingles vaccine but still got shingles and till the time of reporting, the patient still had them. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the vaccine but still got shingles\ suspected Vaccination failure; got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got the Shingles vaccine and still got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had both shots/ have the shingles\ suspected vaccination failure; have the shingles; very horrible pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated, he/she received both Shingles vaccine on firsthand and had shingles. The patient stated, he/she had shingles going on 2 weeks, very horrible pain, could not imagine if the pain would have been worse with no shingles shots. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: 3 vaccines / I still get shingles/suspected vaccination failure; I still get shingles; 3 vaccines / I still get shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received 3 dose of Shingles vaccine, which led to extra dose administered. The patient stated that 3 vaccines for 300 dollars and still got the shingles. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shingles /after getting the shot/suspected vaccination failure; had shingles 3 times; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had shingles 3 times after getting the Shingles shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot and still got shingles/suspected vaccination failure; got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was reported. The patient got the Shingles shot and still got shingles. The physician said it only work about 80 percent of the time. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.