chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: adverse reaction or side effects experienced (if any): arm red, warm, then itchy for a couple of days; adverse reaction or side effects experienced (if any): arm red, warm, then itchy for a couple of days; adverse reaction or side effects experienced (if any): arm red, warm, then itchy for a couple of days; This spontaneous report has been received from a lawyer, from a case in litigation for zoster vaccine live (ZOSTAVAX) (regulatory authority # 2108USA004562, in which the reported adverse reactions/side effects for COVID-19 VACCINE MRNA (MRNA 1273) (COVID-19 VACCINE MODERNA) were captured as well), concerning a female patient (pt) who at the time of vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was 69 years old. The pt's historical conditions included chickenpox and smoking cigarettes. The pt's historical vaccines included zoster vaccine live (ZOSTAVAX), diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (Tdap), and pneumococcal vaccine conj 13v (CRM197) (PREVNAR 13).  On 25-OCT-2017, the pt was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided).  On unknown dates, the pt experienced arm red, warm, then itchy for a couple of days ("a couple of days" considered to refer to the duration of events only, with onset dates remaining unknown). The outcome of the events was not reported. The reporter considered the events to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), as they were provided as adverse reactions to or side effects of the suspect vaccine.; Sender's Comments:  US-009507513-2108USA004562:
Sex: F
Vaccine: PNC13, PPV
Symptoms: Wrong product administered
Clinical narrative: got a Prevnar 13 and then went to another doctor to get the Pneumovax 23 and inadvertently got the Prevnar 13 again; This spontaneous report was received from a pharmacist via Pfizer and refers to a female patient of unknown age. The patient's concurrent conditions, medical history, allergies, and concomitant therapies were not reported.  The reporter indicated that on 23-SEP-2020, the patient was vaccinated with an unspecified dose of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (strength, dosage schedule, indication, route, lot number and expiration date were not reported). On unspecified date in October 2021, the patient went to another doctor's office and she was vaccinated with another dose of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (strength, dosage schedule, indication, route, lot number and expiration date were not reported) by mistake, instated of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (wrong product administered).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additonal adverse events reported; dose of PROQUAD that was admnistered improperly stored during a temperature excusion; This spontaneous report was received from a medical assistance and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On 07-SEP-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml, lot number T034614 with expiration date 10-APR-2022 (route of administration and anatomical location were not reported) for prophylaxis, which was improperly stored during a temperature excursion at 6°F to 14°F (8.5F) for 0 hours 18 minutes and 0 seconds, and 6°F to 14°F (11.9F) for 1 hours 0 minutes and 0 seconds (product storage error). No additional adverse events reported (No adverse events). There were no previous temperature excursions.
Age: 0.5
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; she accidentally admnistered PNEUMOVAX 23  to a 6 months old instead of PREVNAR 13; she accidentally admnistered PNEUMOVAX 23  to a 6 months old instead of PREVNAR 13; This spontaneous report was received from a nurse and refers to a 6 month old male patient. The patient's current conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  The nurse reported that on 28-OCT-2021, she accidently administered pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot number U010533 with expiration date 29-OCT-2022 (dosage, route of administration and anatomical location were not reported) for prophylaxis, to the patient instead of the third dose of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (Wrong product administered and product use issue). No additional adverse event (AE) reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion; No other AE; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On an unknown date, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX) lot # U015845, expiration date 19-MAY-2023, 1 time dose (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of 17 degree Fahrenheit (°F) for 30 minutes. There was no previous temperature excursion reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion; No other AE; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On an unknown date, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX) lot # U015845, expiration date 19-MAY-2023, 1 time dose (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of 17 degree Fahrenheit (°F) for 30 minutes. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion; No other AE; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On an unknown date, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck) (VARIVAX) lot # U015845, expiration date 19-MAY-2023, 1 time dose (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of 17 degree Fahrenheit (°F) for 30 minutes. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion; No other AE; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On an unknown date, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX) lot # U015845, expiration date 19-MAY-2023, 1 time dose (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of 17 degree Fahrenheit (°F) for 30 minutes. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness, Deafness, Neuropathy peripheral
Clinical narrative: vision loss; hearing loss; neuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. No information was provided regarding the pt's medical history, allergies, drug reactions, concurrent conditions or concomitant medications. On an unknown date in or around October 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered vision loss, hearing loss and neuropathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, 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 vaccine, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of vision loss, hearing loss and neuropathy was considered to be not recovered/not resolved. The reporter considered all of the events to be related to zoster vaccine live (ZOSTAVAX).  The events of vision loss, hearing loss and neuropathy were considered to be disabling.  Upon internal review, the events of vision loss, hearing loss, neuropathy were determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information was provided regarding the pt's medical history, allergies, drug reactions, concurrent conditions or concomitant medications. On an unknown date in or around December 2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, 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 vaccine, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).  The event of herpes zoster was considered disabling.
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE. No PQC.; Patient was administered both improperly stored RECOMBIVAX HB and improperly stored ROTATEQ; This spontaneous report was received from a Medical Assistant referring to patient, of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 01-NOV-2021, the patient was vaccinated with an improperly stored doses (Product storage error) of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) thimerosal status free,  lot # T032918, expiration date reported as 12-NOV-2022 for prophylaxis (dose,  and route of administration were not reported) and a dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally, lot #: 1742078, expiration date: 06-JUL-2022 for prophylaxis (dose was not reported).   The administered doses of the vaccines experienced a temperature excursion 62.2 Fahrenheit for 6 hours. Additionally, it was mentioned that the vaccines experienced previous temperature excursions from 36°F to 46°F (46.07°F) for 15 Minutes There was no adverse effect reported.  No product quality complaint was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; multiple outbreaks of herpes zoster; multiple outbreaks of herpes zoster; Information has been received from a lawyer regarding a case in litigation which referred to a patient (pt) of unknown gender and age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Afterwards, on an unknown date (reported as after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered multiple outbreaks of herpes zoster (herpes zoster and herpes zoster reactivation) and post herpetic neuralgia (PHN). As a result of those symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. In addition, the pt sustained severe and permanent personal injuries. Further, the pt had 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. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), 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 causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster, herpes zoster reactivation and PHN were considered as disabling events by the reporter.
Sex: M
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: His response to Pneumovax was poor/ Repeated pneumococcal vaccines both Pneumovax and Prevnar were required to maintain his protective antibodies; Literature report.  This literature marketed report was received from the authors as stated above, concerning a 66-year-old male patient with history adult-onset asthma and bilateral orbital masses that showed IgG4 lymphoproliferative disease on biopsy. Systemic review was positive for fatigue, easy bruising and bleeding, cough, shortness of air, wheezing, hypertension, joint pain, red dry eyes, and postnasal drip. He did not smoke, denied recurrent infection other than rhinitis, and had no pertinent family history.  On an unknown date, the patient was vaccinated with his first dose pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis. After vaccination, tree of 14 pneumococcal antibody titers were at a protective level (higher than 1.3 mcg/ml) and his response to pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was poor (vaccination failure). Pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) booster and one pneumococcal vaccine conj 7v (crm197)(PREVNAR) booster dose were administered while the patient was off immunosuppression.An additional pneumococcal vaccine conj 7v (crm197)(PREVNAR) booster was given while he was on low-dose prednisone to maintain his protective antibodies, and overall, he had a much weaker than expected polysaccharide response, only increasing from 3 to 4 protective antibodies after vaccination.  The outcome of vaccination failure was unknown.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: HPV9
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Weight bearing difficulty
Clinical narrative: CIPD; This spontaneous report was received from a nurse practitioner via company representative and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date in September 2021, the patient was not able to put weight on her left lower leg and had to go to see a specialist. The specialist reported that the patient had chronic inflammatory demyelinating polyneuropathy (CIPD). The outcome of the event was unknown.  Causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the event was reported as related.  Upon internal review, the event of chronic inflammatory demyelinating polyneuropathy was considered to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional information available or provided; GARDASIL 9 had a temperature excursion and then was administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 02-NOV-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL, lot # T026323, expiration date 22-FEB-2023 (route of administration and anatomical location were not provided) for prophylaxis (incorrect product storage). The administered vaccine experienced multiple temperature excursions over approximately 9 weeks, the warmest recorded temperature was 73.1 degrees Fahrenheit (F). Previous temperature excursion was also reported as multiple, details were unknown. No additional information was available nor provided (no adverse event).  This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-2111USA002448:
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Circumstance or information capable of leading to medication error, Incorrect route of product administration, No adverse event
Clinical narrative: No AE; The patient states she was also administered an influenza vaccine on 04-NOV-2021, which the patient stated she thought was intramuscular and that it was the same location on her arm the VARIVAX was administered.; The patient states she was also administered an influenza vaccine on 04-NOV-2021, which the patient stated she thought was intramuscular and that it was the same location on her arm the VARIVAX was administered.; This spontaneous report was received from a 46-year-old female patient, who was referring to herself. There was no information regarding her medical history or concurrent conditions provided. Her concomitant vaccination included influenza vaccine.  On an unspecified date in September 2021, the patient received her initial dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 mL, in the back of her upper arm (route of administration, lot # and expiration date were not provided) for prophylaxis. On 04-NOV-2021, she was vaccinated with the next dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 mL, possibly intramuscularly in the deltoid (lot # and expiration date were not provided, the patient was not able to confirm exact location on the deltoid). The patient stated that the varicella virus vaccine live (Oka/Merck) (VARIVAX) was administered in the same location on her arm as the influenza vaccine she received on the same day, and she thought influenza vaccine was administered intramuscularly (incorrect route of product administration, circumstance or information capable of leading to medication error). The patient was not able to confirm the needle size used to administer the vaccine. She stated she has not contacted her prescriber to discuss the situation at the time of the call. No adverse event (AE) was reported.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional information available or provided; multiple excursions over approximately 9 weeks / warmest recorded was 73.1 F; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 04-NOV-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL, lot # T026323, expiration date 22-FEB-2023 (route of administration and anatomical location were not provided) for prophylaxis (incorrect product storage). The administered vaccine experienced multiple temperature excursions over approximately 9 weeks, the warmest recorded temperature was 73.1 degrees Fahrenheit (F). Previous temperature excursion was also reported as multiple, details were unknown. No additional information was available nor provided (no adverse event).  This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-2111USA002429:
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: painful shots, hurt; This case was reported by a consumer and described the occurrence of pain in a 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, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient stated that the first shingles shots really hurt, and it would worth the painful shots. The second was no problem at all. Then the patient got two Moderna shots. It was so easy, and the patient asked why do people make such a big deal out keeping themselves and others safer. The follow-up would not possible as no contact details were available.
Age: 11.0
Sex: U
Vaccine: MENB
Symptoms: Product administration error, Wrong product administered
Clinical narrative: Bexsero instead of Menveo; error was made because the medical assistant thought that Bexsero and Menveo were indicated to prevent the same type of meningococcal disease; This case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 11-year-old 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 2nd November 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd November 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and product administration error. On an unknown date, the outcome of the wrong vaccine administered and product administration error were unknown.   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: A newly hired medical assistant inadvertently received Bexsero instead of the prescribed vaccine Menveo, which led to wrong vaccine administered. Patient had not yet been notified at the time of report.  The error was made because the medical assistant thought that Bexsero and Menveo were indicated to prevent the same type of meningococcal disease, which led to product administration error. This case was linked with US2021220233, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021220233:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Fibromyalgia, Herpes zoster, Insomnia, Neck pain, Pain
Clinical narrative: lupus; Fibromyala; itchy; suffering with them now,; haven't had a good night sleep; hurt/ neck scalp are the worse; hurt; This case was reported by a consumer via media and described the occurrence of systemic lupus erythematosus in a 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, unknown after receiving Shingles vaccine, the patient experienced systemic lupus erythematosus (serious criteria GSK medically significant), fibromyalgia, pruritus, shingles, difficulty sleeping, scalp pain and pain. On an unknown date, the outcome of the systemic lupus erythematosus, fibromyalgia, pruritus, shingles, difficulty sleeping, scalp pain and pain were not recovered/not resolved.   It was unknown if the reporter considered the systemic lupus erythematosus, fibromyalgia, pruritus, shingles, difficulty sleeping, scalp pain and pain 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 was suffering with shingles at the time of reporting, and had a lot of pain and itchy, also had lupus and fibromyalgia this was no joke. The patient did not have a good night sleep in 5 days, shingles seem to hurt and itch at night, in neck scalp were the worse. The patient stated he/she had one part of the shot and hoped if he/she could get the rest of it when this gets better. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain of skin, Poor quality sleep, Pruritus, Systemic lupus erythematosus
Clinical narrative: lupus; Fibromyala; itchy; suffering with them now,; haven't had a good night sleep; hurt/ neck scalp are the worse; hurt; This case was reported by a consumer via media and described the occurrence of systemic lupus erythematosus in a 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, unknown after receiving Shingles vaccine, the patient experienced systemic lupus erythematosus (serious criteria GSK medically significant), fibromyalgia, pruritus, shingles, difficulty sleeping, scalp pain and pain. On an unknown date, the outcome of the systemic lupus erythematosus, fibromyalgia, pruritus, shingles, difficulty sleeping, scalp pain and pain were not recovered/not resolved.   It was unknown if the reporter considered the systemic lupus erythematosus, fibromyalgia, pruritus, shingles, difficulty sleeping, scalp pain and pain 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 was suffering with shingles at the time of reporting, and had a lot of pain and itchy, also had lupus and fibromyalgia this was no joke. The patient did not have a good night sleep in 5 days, shingles seem to hurt and itch at night, in neck scalp were the worse. The patient stated he/she had one part of the shot and hoped if he/she could get the rest of it when this gets better. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: exceeded six-month for their second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received a year ago of reporting 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 inquired how to proceed if the patient had exceeded the six month window for their second dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter consented to follow up via postal channel. The reporter had no further details on patient or product.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021227440:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first shot in December 2019, never took the second; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2019).   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 patient never took the second dose of Shingrix, which led to incomplete course of vaccination. The patient asked whether they need to get the second one now, almost two years later or need to start over with the first shot.
Sex: M
Vaccine: VARZOS
Symptoms: Death, Herpes zoster, Vaccination failure
Clinical narrative: He died four years later and still complained with them; Got vx, three weeks later got a bad case, died four years later; This case was reported by a consumer via interactive digital media and described the occurrence of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced death (serious criteria death and GSK medically significant) and shingles. On an unknown date, the outcome of the death was fatal and the outcome of the shingles was not recovered/not resolved. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the death and shingles to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient's friend. Age at vaccination was not reported. The patient received a dose of Shingles vaccine and three weeks later got a bad case of shingles. He died four years later and still complained with them. Follow-up would not be possible as no contact details provided.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/ Had both doses; after this had shingles, recently had them for 2nd time; Recently had shingles for the 2nd time on the left side; This case was reported by a consumer via interactive digital 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 COVID-19 VACCINE for prophylaxis.   The patient's past medical history included shingles (had shingles on right side, refer case US2021AMR209401) and shingles (previously had shingles on right side). Previously administered products included Shingles vaccine (received the original shingles shot on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and the 2nd dose of COVID-19 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 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 reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient has had both doses of the Shingles vaccines and recently had Shingles for the second time on the left side and it was a month after the second Covid shot. The patient looked on the internet and found that shingles frequently occurred in the individuals after any of the 3 Covid shots used. It was unknown if the reporter considered the shingles to be related to Covid vaccine. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR209401:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male 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 provided were as follows: The case was reported by patient's brother's wife. The age at vaccination was not reported. The patient had the shingles shot and still got the shingles bad. The reporter stated that they would not ever get the shingles shot as Medicare would not pay for it anyway and even if they did, they still would not get that crazy shot. Follow-up would not be possible as no contact details available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case was linked with case US2021AMR231049, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR231049:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/had both shots , still had shingles; shingles; This case was reported by a consumer via  interactive digital 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 provided were as follows: The case was reported by patient himself/herself. The patient received both the doses of Shingles vaccine and still experienced shingles. The patient stated that shingles would hang on for months. Follow-up would not be possible as no contact details 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: Incomplete course of vaccination
Clinical narrative: has not completed the series to date; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in July 2020).   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. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter askeddid  they only get 1 more dose now or did they need to start the 2-dose series again.  The reporter have received varying answers from the providers and nursing staff in his office.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccination and got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In October 2021, more than 2 years 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.  Additional details were provided as follows: The case was reported by the patient's wife. The age at vaccination was not reported. In 2018, the patient had the vaccination and still got shingles. He was suffering for 3 weeks so far and was not much better. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital 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: The reporter was patient. The age at vaccination was not reported. The patient had the Shingles shot and 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had the 2 vaccinations & got them; This case was reported by a consumer via interactive digital 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.   The patient's past medical history included shingles (experienced shingles on an unknown date).   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) 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 as follows: The reporter was patient. The age at vaccination was not reported. The patient had two Shingles shots then developed shingles again. The patient stated that it was not as bad as previous. 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 confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Acupuncture, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; chronic shingles; This case was reported by a consumer via interactive digital 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) and shingles. The patient was treated with non-drug therapy (Acupuncture). 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 as follows: The reporter was patient. The age at vaccination was not reported. The patient had two Shingles shots and then developed chronic shingles. The patient finally got relief with electro acupuncture. 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 confirmation of shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 years ago, no information on 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago).   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 reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient declined to provide patient demographic information. The reporter did not consent to follow up. This case was linked with case US2021230194, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021230194:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: passed the 6 month mark; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   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 asked was Shingrix recommended for patient with no known history of chicken pox.  The reported stated that the patient had passed the 6-month mark for second dose of Shingrix and till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter asked when should second be administered or should series be restarted. The consent to follow up was granted. No further details provided via web form.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: adult dosage vs the pediatric dosage; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HBV (Engerix B adult) (batch number 4ea77, expiry date 11th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th September 2021, the patient received the 1st dose of Engerix B adult (intramuscular) 1 ml and Engerix B Pre-Filled Syringe Device. On 29th September 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   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 reporter was the phaarmacy tech. The patient received dose of Engerix B in the left arm. The 18 years old patient was given the adult dosage of Engerix-B versus the pediatric dosage, which led to overdose. It was the first shot in the series and the patient was now asking how to proceed with the series. The patient was not experiencing any side effects at this point from the overdose. The overdose was realized when the patient called to reschedule her second dose. The reporter did not consent to follow up.