chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient received a third dose at 6 months of age.; no adverse event; This spontaneous report was received from a registered nurse, concerning a 6-month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On an unknown date reported as "when the patient was 2 months of age", they received the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose, frequency, route of administration, anatomical location, vaccination scheme, lot number and expiration date were not reported). Subsequently, they received the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose, frequency, route of administration, anatomical location, vaccination scheme, lot number and expiration date were not reported) on an unknown date reported as "when the patient was 4 months of age". On an unspecified date reported as "a few weeks ago", the patient was administered a third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose, frequency, route of administration, anatomical location, vaccination scheme, lot number and expiration date were not reported) at 6 months of age in error (product administered to patient of inappropriate age). The three doses were administered as prophylaxis. No other adverse events were reported.
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: VAQTA that had undergone temperature excursion was administered to a patient; no additional AE reported; This spontaneous report was received from a healthcare worker concerning a currently 11 year old male patient. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On an unspecified date, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA) lot number reported as U026782 with expiration date 28-OCT-2022 (strength, dose, frequency and route of administration were not reported). Lot number U026782  is an invalid lot number for hepatitis a vaccine, inactivated(VAQTA) and it did not match any company product as confirmed by Lot verification team.   The temperature excursion was reported as 49.6F during a time frame of 32 minutes. There was no previous temperature excursion. No additional adverse event was reported.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs reported; Patient received booster shot of PEDVAX HIB too early / Patient received dose at 2 and 4 months and received booster at 6 months; This spontaneous report was received from a nurse referring to a 6-month-old patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in January 2022 (reported as at "2 months"), the patient was vaccinated with the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose, lot #, expiry date, and route of administration were not provided) administered for prophylaxis. The second dose was administered on an unspecified date in March 2022 (reported as at "4 months") (strength, dose, lot #, expiry date, and route of administration were not provided).  On 05-MAY-2022, the patient received a booster dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #U034520, expiration date: 29-MAR-2024) 0.5 mL (strength, and route of administration were not provided) which was administered too early (Inappropriate schedule of product administration). No additional adverse events (AEs) were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller reporting an AE for PROQUAD being administered after an excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-APR-2022, it was stated that measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live recombinant human albumin (rHA) (PROQUAD) was storage in a temperature of minus (-)10 Celsius degree (C))  up to 8C (7.3 C) for 2 hours 37 minutes 0 seconds; then a temperature excursion (temperature -2 C) (Incorrect product storage) occurred during 1 hour and 12 minutes. After the excursion, the vaccine temperature was reported as -10C up to 8C (0.7 C) for 2 hours 56 minutes 0 seconds.    On 05-MAY-2022, the patient was vaccinated with measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live recombinant human albumin (rHA) (PROQUAD) (lot #U029319 has been verified to be valid, expiration date: 19-MAR-2023) 0.5 milliliter (strength and route of administration were not provided) as prophylaxis.
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: HCP unknowingly administered GARDASIL 9 to a patient who was already fully vaccinated; No additional AE details; This spontaneous report was received from a company representative and refers to a 25-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient, who was already fully vaccinated, was unknowingly administered another extra dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, lot #, expiration date and route of administration were not provided) for prophylaxis (extra dose administered). No additional adverse events were reported (no adverse event).
Age: 0.75
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: An improperly stored vaccine was administered to 10 separate patients. No additional AE reported; An improperly stored vaccine was administered to 10 separate patients. No additional AE reported; This spontaneous report has been received from an office manager, concerning a 9-months-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  The Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number T042013 underwent a temperature excursion of 11.43 degrees Celsius (C) for a time frame of 4 hours and 45 minutes; no previous temperature excursion (product storage error).   Consequently, on 04-MAY-2022 the patient was vaccinated with the inappropriate storage Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number T042013 has been verified to be a valid lot, expiration date reported and stablished as 22-JUL-2023) as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical location were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA003266: US-009507513-2205USA003043: US-009507513-2205USA002913: US-009507513-2205USA002988: US-009507513-2205USA002848: US-009507513-2205USA003131: US-009507513-2205USA003118: US-009507513-2205USA002951: US-009507513-2205USA003121:
Age: 0.25
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: An improperly stored vaccine was administered to 10 separate patients. No additional AE reported; An improperly stored vaccine was administered to 10 separate patients. No additional AE reported; This spontaneous report has been received from an office manager, concerning a 3-months-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  The Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number T042013 underwent a temperature excursion of 11.43 degrees Celsius (C) for a time frame of 4 hours and 45 minutes; no previous temperature excursion (product storage error).   Consequently, on 25-APR-2022 the patient was vaccinated with the inappropriate storage Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number T042013 has been verified to be a valid lot, expiration date reported and stablished as 22-JUL-2023) as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical location were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA002988: US-009507513-2205USA003266: US-009507513-2205USA003043: US-009507513-2205USA002913: US-009507513-2205USA002848: US-009507513-2205USA003131: US-009507513-2205USA003118: US-009507513-2205USA002951: US-009507513-2205USA003121:
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Deafness, Herpes zoster, Neurological symptom, Post herpetic neuralgia
Clinical narrative: hearing loss; other serious neurological problems; postherpetic neuralgia; vision problems; balance issues; multiple outbreaks of herpes zoster; Initial information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. The pt's medical history, concurrent conditions or concomitant medications were not provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster, postherpetic neuralgia, vision problems, hearing loss, balance issues and other serious neurological problems. As a result of these symptoms, the pt was seen and treated by medical providers and at the time of report was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her 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, 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, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all events was not recovered/not resolved. The reporter considered all events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of hearing loss was determined to be medically significant. The lawyer reported all events as disabling, and the event of neurological problems to be serious (medically significant).
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: hearing loss; other serious neurological problems; postherpetic neuralgia; vision problems; balance issues; multiple outbreaks of herpes zoster; Initial information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. The pt's medical history, concurrent conditions or concomitant medications were not provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown dates, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster, postherpetic neuralgia, vision problems, hearing loss, balance issues and other serious neurological problems. As a result of these symptoms, the pt was seen and treated by medical providers and at the time of report was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her 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, 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, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all events was not recovered/not resolved. The reporter considered all events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of hearing loss was determined to be medically significant. The lawyer reported all events as disabling, and the event of neurological problems to be serious (medically significant).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event details; Pharmacist calling reports expired MMRII was administered to patient. Sterile diluent used to reconstitute was also expired. Date of administration 5/11/2022. No Additional AE details; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 11-MAY-2022, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live Albumin status rHA (recombinant Human albumin) (M-M-R II) lot# T013727, expiration date reported as 21-APR-2022, that was reconstituted with an expired sterile diluent lot# S025290, expiration date reported as 20-MAR-2022, for prophylaxis (strength, dose, route and frequency were not reported)(expired product administered). Neither vaccine nor sterile diluent experienced any temperature excursions. No additional adverse events details. No PQC.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Medical assistant calling to report a dose of VAQTA that was administered after its expiration date. Date expired: 5/2/2022, date administered: 5/12/2022. Caller verified that the vaccine had no undergone any temperature excursions. No PQC. No addtio; This spontaneous report was received from a medical assistant, referring to patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 12-MAY-2022, the patient was vaccinated with and expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) lot# U003450, expiration date 02-MAY-2022, for prophylaxis (strength, dose, route and frequency were not reported) (Expired product administered). The vaccine had not undergone any temperature excursions. No PQC. No additional information.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain upper
Clinical narrative: Stomach pain has not yet resolved; Stomach bloating has not yet resolved; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of abdominal pain upper (received 1st dose 0.5 ml on 27th October 2021 and also felt bloated, refer link case US2022073189).   On 2nd March 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced stomach pain and abdominal bloating. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the stomach pain and abdominal bloating were not recovered/not resolved.   It was unknown if the reporter considered the stomach pain and abdominal bloating to be related to Shingrix.     Linked case(s) involving the same patient:  US2022073189   Additional Information: GSK Receipt Date: 03-MAY-2022 Reporter's Comment: The case was reported by the patient. The patient was stating that, a few weeks after getting his Shingrix vaccine, his stomach started hurting and felt bloated. He said that lasted about a month and then went away. The patient said after his second Shingrix vaccine, the same thing happened. The stomach pain and bloating did not yet resolve since getting his second vaccine.  The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022073189:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Nausea, Pain, Pyrexia
Clinical narrative: I have 101 fever, it was oral thermometer; I feel absolutely awful; Chills; Bodyaches; Nausea to the extreme I am in bed; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th May 2022, the patient received the 2nd dose of Shingrix. In May 2022, less than a week after receiving Shingrix, the patient experienced fever, feels awful, chills, general body pain and nausea. On an unknown date, the outcome of the fever, feels awful, chills, general body pain and nausea were not recovered/not resolved.   It was unknown if the reporter considered the fever, feels awful, chills, general body pain and nausea to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-May-2022 Reporter's Comments: The patient self-reported this case. The patient had the second Shingrix vaccine a day before reporting in the afternoon and had 101 degree F fever and felt absolutely awful, the patient wanted to know if he/she needed to go to the hospital. The patient experienced nausea, chills, body aches to the extreme was in bed and fever, and asked if he/she should take an extra strength Tylenol or would this go away by next day. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR074314:Same reporter. Hearsay case.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccinated with the 2nd dose and after 15 days; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, 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 Information: GSK Receipt Date: 6-May-2022 Reporter's comments: This case was reported by a patient via interactive digital media. The patient received 2nd dose but after 15 days only. Additional Supportive Information: The 2nd dose was given earlier than the recommended timeframe, which led to shortening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the shot it would have been worse/suspected vaccination failure; had the shot it would have been worse; very painful; This case was reported by a consumer via interactive digital media and described the occurrence of 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), 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 Information: GSK Receipt Date: 09-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles. The patient had gone to one doctor and emergency department, they did not know what it was, then the patient went to another doctor who knew what it was the minute he saw. The patient stated that, it was very very painful, he/she had the shot it would have been worse. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Impaired work ability, Loss of personal independence in daily activities, Vaccination failure
Clinical narrative: get shingles after the vaccine/suspected vaccination failure; shingles; i cant work; This case was reported by a consumer via interactive digital media and described the occurrence of 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), shingles and activities of daily living impaired. On an unknown date, the outcome of the vaccination failure, shingles and activities of daily living impaired were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and activities of daily living impaired to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles. The patient thought he/she was the only one to get shingles after the vaccine. The patient stated that, pharmacist said, the patient might have too many shingles in his/her body and might possibly need another set of vaccine. The patient could not work for 4 to 5 days out of a month. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral, Stress, Vaccination failure
Clinical narrative: Had vaccination but I have still had shingles since/Suspected vaccination failure; Nerve endings are still healing on my neck and shoulder; I have still had shingles since; Try to destress but too much going on; This case was reported by a consumer via interactive digital media and described the occurrence of 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), neuropathy (serious criteria GSK medically significant), shingles and stress. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the neuropathy was recovering/resolving and the outcome of the stress was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, neuropathy, shingles and stress to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-MAY-2022 Reporters comment: The patient self-reported the case viainteractive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got shingles several times. The patient stated that, when he/she got super stressed it came out. The nerve endings were still healing on his/her neck and shoulder. The patient tried to destress but too much was going on at the time of reporting. The patient also stated that, shingles was horrendous. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Injury, Pain, Vaccination failure
Clinical narrative: I got the vaccine, and got shingles/Suspected vaccination failure; Got shingles on face and part of my head; Very painful; Trauma of the tooth pulled, brought out the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included tooth extraction.   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, pain and trauma. On an unknown date, the outcome of the vaccination failure, shingles, pain and trauma were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and trauma to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles on face and part of head which was very painful. The patient had tooth pulled and they said because of the trauma of getting the tooth pulled it brought out the shingles. The patient stated that, Shingles vaccine was not guaranteed, but it was less worse with the shot. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Vaccination failure
Clinical narrative: I still get them too/Suspected vaccination failure; I still get them too; Blisters are confined to a small area; Pain before blisters appear is real; This case was reported by a consumer via interactive digital media and described the occurrence of 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), shingles, blister and pain. On an unknown date, the outcome of the vaccination failure, shingles, blister and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, blister and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got shingles. The patient stated that, the blisters were confined to a small area but the pain right before the blisters appeared was real. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: After the vaccine, I have all over the place including my face/Suspected vaccination failure; I have all over the place including my face, maybe was a reaction; Is to pain full; This case was reported by a consumer via interactive digital media and described the occurrence of 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), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine. It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles all over the place including face. For the last two months from the date of reporting, the patient was not having shingles. The patient went to saw his/her doctor and she told that, might be was the reaction from the vaccine. The patient asked if the worst thing could happen was too painful. The patient was praying for all those people who had shingles. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Have shingles, had the vaccination/Suspected vaccination failure; Shingles, fourth time; Hurts, feels like bone is tearing through skin; This case was reported by a consumer via interactive digital media and described the occurrence of 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, several years 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 and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. The patient received Shingles vaccine several years ago from the date of reporting and thought he/she was through with them. After receiving Shingles vaccine, the patient got shingles for the fourth time and had them at the time of reporting for almost three weeks. The patient stated that, it hurt so bad sometimes it felt like his/her bone was tearing through skin. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: have shingles now and had the shot/Suspected vaccination failure; shingles; Miserable; This case was reported by a consumer via interactive digital media and described the occurrence of 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), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure and feeling miserable were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles and was miserable. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Oral herpes zoster, Vaccination failure
Clinical narrative: have them in mouth-had the vaccine/suspected vaccination failure; have them in mouth; This case was reported by a consumer via interactive digital media and described the occurrence of 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 oral herpes zoster. The patient was treated with gabapentin. On an unknown date, the outcome of the vaccination failure and oral herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and oral herpes zoster to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles in mouth. The patient's doctor said it happened. The patient stated that, Gabapentin did not help. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: I had the vaccine and still got shingles/suspected vaccination failure; Got shingles but a mild case was horrible- such intense itching; intense itching; This case was reported by a consumer via interactive digital media and described the occurrence of 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), shingles and pruritus. On an unknown date, the outcome of the vaccination failure, shingles and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-May-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient had the vaccine and still got shingles but a very mild case. The patient stated even a mild case was horrible- such intense itching. The patient could not imagine how bad a full-blown case would be. Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got vaccinated, I got shingles; I got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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 Information: GSK Receipt Date: 10-May-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient got vaccinated, still patient got shingles.  Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shingles with the shot/Suspected vaccination failure; Got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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 Information: GSK Receipt Date: 10-May-2022 Reporter's Comments: The patient self reported the case via interactive digital media. The patient stated that he/she got the shingles with the shingles shot and with having all of the childhood diseases. Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided.
Sex: U
Vaccine: COVID19, COVID19, VARZOS
Symptoms: Herpes zoster
Clinical narrative: I got the 1st shot and 4 days later broke out in shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis and COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of COVID-19 VACCINE and the 1st dose of COVID-19 VACCINE. On an unknown date, 4 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: Receipt Date: 7-May-2022 Reporter's Comments: : This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient got the 1st shot and 4 days later the patient broke out in shingles. The doctor said not a result of just the Shingles shot, but rather a result of getting the Shingles shot so soon after having received the first 2 covid vaccinations. Additional Supportive Information: The follow up would not be possible since no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Gait disturbance
Clinical narrative: After the first, I could hardly walk!; This case was reported by a consumer via interactive digital media and described the occurrence of walking difficulty 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 walking difficulty. On an unknown date, the outcome of the walking difficulty was unknown.   It was unknown if the reporter considered the walking difficulty to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and he/she could hardly walk. The patient asked did anyone had a bad reaction from the shot.   The patient was afraid to get the second one. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only liquid portion of vaccine was administered; Only liquid portion of vaccine was administered; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-MAY-2022 Reporter's Comments: The other health professional reported that a patient received only the liquid portion of the Menveo vaccine and the product was not reconstituted with both vials and then administered.  Medical information had also been contacted to assist with next steps. No specific patient or product information (lot number) was shared. Reporter did not agree to follow up from GlaxoSmithKline. Additional Supportive Information: The patient received only the liquid portion of the Menveo vaccine and the product was not reconstituted with both vials and then administered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shingles and had the vaccines/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of 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 Information: GSK Receipt Date: 8-May-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient.  The patient have had shingles 3 different times and have had the vaccines. The patient stated that vaccines did not prevent you from getting shingles. Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: got vaccinated, still got it/suspected vaccination failure; got it, around right eye; This case was reported by a consumer via interactive digital media and described the occurrence of 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 ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-May-2022 Reporter's Comments: The patient self reported the case via interactive digital media . The patient stated that It was the most horrible feeling in the world. The patient got vaccinated 3 years ago and still got shingles in and around right eye. The patient thought for sure he/she was gonna loose eye. Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Auditory disorder, Palpitations, Tinnitus
Clinical narrative: problems with hearing; hearing things, can hear heartbeat; tinnitus; This case was reported by a consumer via call center representative and described the occurrence of auditory disorder in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriatic arthritis.   On 23rd March 2022, the patient received the 1st dose of Shingrix. In April 2022, less than 2 weeks after receiving Shingrix, the patient experienced auditory disorder, palpitation and tinnitus. On an unknown date, the outcome of the auditory disorder, palpitation and tinnitus were not recovered/not resolved.   It was unknown if the reporter considered the auditory disorder, palpitation and tinnitus to be related to Shingrix.     Additional Information: GSK receipt date: 04-May-2022 Reporter's comment: The patient self reported this case. The patient received a dose of Shingrix in left arm and about a month ago she began to had problems with her hearing. She stated the hearing in her left ear was bad, was hearing things in her left ear.  She said she could hear her heartbeat thumping in her left ear.  She used the word, tinnitus when describing it.  She had been seeing her physician for this but it had not resolved.   She was going to see an ear, nose and throat specialist next.   She called GlaxoSmithKline response center to ask if Shingrix might have had anything to do with her hearing issue. She did not had the lot number of the Shingrix that was injected but did provided her pharmacy's phone number as they should had the lot number on file. Consented to follow-up.