chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Herpes zoster, Post herpetic neuralgia
Clinical narrative: balance problems; post herpetic neuralgia; herpes zoster; Information was received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. Information regarding the pt's current condition, historical condition and concomitant medication was unknown. On or about 20-APR-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster, post herpetic neuralgia, balance problems. As a result of these symptoms, the pt was seen and treated by her medical providers and was still under their care. As a direct and proximate result zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presented prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt 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 company's conduct, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).     The events of herpes zoster, post herpetic neuralgia, balance problems were considered as disabling.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T021639, expiration date: 21-DEC-2021, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-APR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T021639, expiration date: 21-DEC-2021, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-APR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T025507, expiration date: 23-JAN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-APR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T025507, expiration date: 23-JAN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-APR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T025507, expiration date: 23-JAN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-APR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T025507, expiration date: 23-JAN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-APR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T025507, expiration date: 23-JAN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 20-APR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T025507, expiration date: 23-JAN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-APR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T025507, expiration date: 23-JAN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-APR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T025507, expiration date: 23-JAN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-APR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T025507, expiration date: 23-JAN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T021639, expiration date: 21-DEC-2021, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-MAY-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T025507, expiration date: 23-JAN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: no adverse event; a dose of improperly stored ROTATEQ was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.  On 06-MAY-2021, the patient was vaccinated with for prophylaxis (vaccinated with an improperly stored dose of  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # T033510 expiring on 28-DEC-2021, for prophylaxis (dose, route and site of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of 48.7F for 1hours and 15minutes, as recorded by a data logger. The vaccines had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: no adverse event; an expired dose of MMR was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On 05-MAY-2021 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S013536, 0.5 milliliter for prophylaxis (route and site of administration were not reported) which had expired on 02-MAY-2021.    There was no adverse effect reported. No product quality complaint was involved.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No new AE; GARDASIL 9 was improperly stored and administered.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies.    From 09-MAR-2021 until 03-MAY-2021, doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccines had multiple excursions.   On 31-MAR-2021, the patient was vaccinated with one dose of the improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1687290 with expiration date of 06-SEP-2022 for prophylaxis (dose, frequency, route of administration and anatomical location were not provided), which were stored at a temperature of 34.50 Fahrenheit degrees for 3.5 hours. No new adverse event.  Digital data logger was involved.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002246: US-009507513-2105USA002236: US-009507513-2105USA002270:
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A month apart / they said to get the second one 3-6 months after the first one; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included Herpes zoster (Shingles vaccine).   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 provided as follows: The patient reported case for himself/herself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient was vaccinated with 2nd dose of Shingles vaccine a month apart from the 1st dose which led to shortening of vaccination schedule. The patient got shingles shot and it was said to get the second one 3-6 months after the first one. The patient was advised if the patient got the Covid shot, the patient had to wait and start over with the shingles two doses.  The repoter got the second shingles vaccine then found out cannot have the Covid vaccine for six months.  The patient was said to not get vaccine for six months before the patient gets the Covid shot. The patient did not always get vaccines but did not want shingles and sure did not want covid. The reporter was asked if was it supposed to be a year between the first and second or a month.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR100421:Same reporter.
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: case of shingles with ocular involvement after / case of shingles is currently occurring / suspected vaccination failure; case of shingles with ocular involvement after / second dose 9/7/18. / case of shingles is currently occurring; case of shingles with ocular involvement after; This case was reported by a physician and described the occurrence of suspected vaccination failure in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 7th September 2018, the patient received the 2nd dose of Shingrix. On 27th June 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The patient experienced shingles with ocular involvement after 2nd doses of Shingrix. The case of shingles was currently occurring with the patient. The patient did not had shingles between the two doses. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The reporter consented to follow up. This case has been linked with US2021AMR097927, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR097927:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: reactions consistent with grade 3 reactions/pain in the arm where the injection was given; reactions consistent with grade 3 reactions/ feeling flu-like symptoms; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and influenza-like symptoms. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The nurse reported that after Shingrix vaccination the patient experienced pain in arm where the injection was given, along with feeling flu-like symptoms for two to three days. Reactions were consistent with grade 3. No further information was provided. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Post herpetic neuralgia, Vaccination failure
Clinical narrative: don't know how bad shingles are since I had the vaccination last fall/ Suspected vaccination failure; don't know how bad shingles are since I had the vaccination last fall; horrible nerve pain from it; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 9 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The reporter considered the post herpetic neuralgia to be possibly related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient stated he/she did not know how bad shingles were since he/she had the vaccination in last fall (2020). The reporter further specified that might be he/she do know cause, ever since the vaccination he/she had horrible nerve pain from it and that was 8 months ago. The patient mentioned that the vaccinations were not for everyone. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Axillary pain, Breast pain, Breast swelling, Herpes zoster, Swelling
Clinical narrative: had both Shingrix vaccine shots. I've had shingles outbreaks in the last year / Suspected vaccination failure; shingles outbreaks; pain and swelling in my left breast and arm pit; pain and swelling in my left breast and arm pit; pain and swelling in my left breast and arm pit; pain and swelling in my left breast and arm pit; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 MRNA-1273 VACCINE (MODERNA (MRNA RIBONUCLEIC ACID VACCINE)) for prophylaxis.   Concomitant products included COVID-19 MRNA-1273 VACCINE (MODERNA (MRNA RIBONUCLEIC ACID VACCINE)).   On an unknown date, the patient received the 1st dose of Shingrix, the 2nd dose of Shingrix and the 2nd dose of MODERNA (MRNA RIBONUCLEIC ACID VACCINE). On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, breast swelling, breast pain, axillary pain and local swelling. The patient was treated with gabapentin. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the breast swelling, breast pain, axillary pain and local swelling were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the breast swelling, breast pain, axillary pain and local swelling to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received both the Shingrix vaccines in the left arm. In 2020, the patient experienced shingles outbreaks. The patient received both Moderna vaccine shots in right arm. At the time of reporting, the patient had pain and swelling in left breast and arm pit. Mammograms and ultrasound performed and found no cancer. The patient saw a report from the CDC (Centers for Disease Control and Prevention) a day before reporting, regarding lymph node swelling in the breast and arm pit in reaction to the Covid vaccine in women who had the Covid virus and was recovered and the patient asked if it was possible that his/her pain and swelling was a reaction to Shingrix. The patient was currently taking Gabapentin for pain. The patient asked if there was anything he/she could do to relieve pain and swelling, and would it go away eventually or get worse. It was unknown if the reporter considered the breast swelling, breast pain, axillary pain and local swelling to be related to Moderna vaccine. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Ultrasound scan, Vaccination failure, X-ray
Clinical narrative: had both Shingrix vaccine shots. I've had shingles outbreaks in the last year / Suspected vaccination failure; shingles outbreaks; pain and swelling in my left breast and arm pit; pain and swelling in my left breast and arm pit; pain and swelling in my left breast and arm pit; pain and swelling in my left breast and arm pit; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 MRNA-1273 VACCINE (MODERNA (MRNA RIBONUCLEIC ACID VACCINE)) for prophylaxis.   Concomitant products included COVID-19 MRNA-1273 VACCINE (MODERNA (MRNA RIBONUCLEIC ACID VACCINE)).   On an unknown date, the patient received the 1st dose of Shingrix, the 2nd dose of Shingrix and the 2nd dose of MODERNA (MRNA RIBONUCLEIC ACID VACCINE). On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, breast swelling, breast pain, axillary pain and local swelling. The patient was treated with gabapentin. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the breast swelling, breast pain, axillary pain and local swelling were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the breast swelling, breast pain, axillary pain and local swelling to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received both the Shingrix vaccines in the left arm. In 2020, the patient experienced shingles outbreaks. The patient received both Moderna vaccine shots in right arm. At the time of reporting, the patient had pain and swelling in left breast and arm pit. Mammograms and ultrasound performed and found no cancer. The patient saw a report from the CDC (Centers for Disease Control and Prevention) a day before reporting, regarding lymph node swelling in the breast and arm pit in reaction to the Covid vaccine in women who had the Covid virus and was recovered and the patient asked if it was possible that his/her pain and swelling was a reaction to Shingrix. The patient was currently taking Gabapentin for pain. The patient asked if there was anything he/she could do to relieve pain and swelling, and would it go away eventually or get worse. It was unknown if the reporter considered the breast swelling, breast pain, axillary pain and local swelling to be related to Moderna vaccine. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: patients sometimes do not return for 2nd dose of Shingrix; This case was reported by a pharmacist via sales rep and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse event (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter mentioned that, the patients sometimes did not return for 2nd dose of Shingrix because they experienced adverse events following the 1st dose, which led to incomplete course of vaccination. The reporter could not tell specific number of patients, but if she had to estimate she would say maybe around 10 patients. The reporter did not consent to follow-up. This case had been linked with US2021AMR101781, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR101781:husband´s case, same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: husband had myalgia for several days.; This case was reported by a pharmacist via sales rep and described the occurrence of myalgia 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, unknown after receiving Shingrix, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was unknown.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient's wife. The patient received the dose of Shingrix and experienced myalgia for several days. It was stated that patient did not receive the 2nd dose of Shingrix and patient was fine. The reporter did not consent to follow up. This case was linked with US2021AMR101778 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR101778:master case for the unspecific number of patients
Sex: M
Vaccine: MENB
Symptoms: Balance disorder, Fatigue, Syncope, Thirst
Clinical narrative: became faint; severe thirst; fatigue; loss of balance; This case was reported by a nurse via sales rep and described the occurrence of faint in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, 5 min after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced faint (serious criteria GSK medically significant), thirst, fatigue and loss of balance. On an unknown date, the outcome of the faint, thirst, fatigue and loss of balance were unknown.   It was unknown if the reporter considered the faint, thirst, fatigue and loss of balance to be related to Bexsero and Bexsero Pre-Filled Syringe Device.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient was requested to wait 15 minutes after administration of Bexsero vaccine. The patient waited 5 minutes, entered waiting area of clinic and became faint and additionally had severe thirst, fatigue, loss of balance. The patient was returned to room where kept for 30 minutes minutes. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: threw up for hours; This case was reported by a consumer and described the occurrence of vomiting in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose on an unknown date and it was fine).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown.   It was unknown if the reporter considered the vomiting to be related to Shingles vaccine.  Additional details were provided as follow: This case was reported by the consumer. The age at vaccination was not reported. The patient received the 2nd shot and after that it was fine for the first day and the second day it threw up for hours. No further information was provided. This case has been linked with US2021AMR101858, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR101858:same reporter (reporter´s case)
Sex: U
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: threw up for hours; This case was reported by a consumer via interactive digital media and described the occurrence of vomiting in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date and it was fine).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was recovered/resolved.   It was unknown if the reporter considered the vomiting to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd shot and after that it was fine for the first day and the second day it threw up for hours. No further details provided. This case has been linked with US2021AMR101848, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR101848:same reporter (reporter´s case)
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: mild side affects from the second shot /chills; mild side affects from the second shot /headache; mild side affects from the second shot / body aches; This case was reported by a consumer via media and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, headache and general body pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the chills, headache and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the chills, headache and general body pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had got both the shingrix shots and it was not covered in his Insurance.It cost him 190 dollars for the first and 100 dollars for the second. The patient had some mild side affects from the second shot like chills, headache and body aches. Patient had taken Tylenol as a treatment drug but it could not help. Consent to follow up was not asked.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Got the shot and would you believe, I got shingles the third time/ Suspected vaccination failure; Got the shot and would you believe, I got shingles the third time; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles 2 times, years ago and was painful).   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: The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient got the shot and still got shingles for the third time. The patient was suggesting everyone to get the shot as its effective and also stated that, it was a great improvement when he or she got their shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Shots didn't work for me. On my fifth year. Pain everyday/ suspected vaccination failure; Shots didn't work for me. On my fifth year. Pain everyday; Pain every day.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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, shingles and pain were unknown.   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: The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. The patient said shots did not work for him/her. On patient's fifth year, the patient had pain every day. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I got / series of two shots and ended up getting the internal shingles/Suspect vaccination failure; ended up getting the internal shingles; Excruciating pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (occurred in childhood).   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, shingles and pain were unknown.   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 reported as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The patient got the 2 shots of Shingles vaccine and ended up getting the internal shingles. The patient had excruciating pain and was told that since the patient had the chicken pox as a child that could still get it. The patient said of course someone else told the patient that after the fact. 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, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Recovering from shingles / have had the very first vaccine and the most recent two shot vaccine; This case was reported by a consumer via media and described the occurrence of vaccination failure in a adult 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 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and 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) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   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 provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that one should not think that,  just because they got the vaccine they won't have shingles. The patient was recovering from shingles and have had the very first vaccine of Shingles and the most recent two shot vaccine. This case was considered as suspected vaccination failure since the details regarding time to onset and lab test confirmation was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I got vaccinated for shingles and still got them/ Suspected vaccination failure; shingles and still got them but just no rash still aotvof pain; still aotvof pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient got vaccinated for Shingles vaccine and still got shingles, but no rash and still a lot of pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.