chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: expired dose of ROTATEQ (2nd dose in the regimen) was administered to a baby; plagiocephaly; torticollis; This spontaneous report was received from a physician and refers to a 4 month old female patient. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.  On an unknown date in 2021, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, for prophylaxis (exact dose, lot number and expiration date were not provided).  On 06-OCT-2021, the patient was vaccinated with an expired dose, second dose in dosage regimen of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, for prophylaxis lot number: 1684166, expiration date: 27-JUN-2021 (exact dose was not provided) (expired product administered).  On an unknown date in 2021, the patient had two diagnosed minor conditions plagiocephaly and torticollis. It was unknown when these two additional diagnoses were made in relation to the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administration. There was no side effects thus far reported by the doctor. The baby was fine and was an otherwise healthy baby. No treatment was given. The patient did not seek for medical attention. The physician stated that it sounded like he should repeat the dose in 4 weeks given the questionable efficacy of an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  The outcome of the events was unknown.The causality assessment was not provided.
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE reported; Improperly stored vaccine were administered; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.      On 20-OCT-2021, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # T022311, has been verified to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live expiry date 30-JUN-2022 and hepatitis a vaccine, inactivated(VAQTA) lot # U013949, has been verified to be valid for  hepatitis a vaccine, inactivated expiry date 06-FEB-2023, 1 dosage form of both of them for prophylaxis (administration route was not provided) (product storage error). The vaccines were exposed to a temperature of 40 Fahrenheit degrees for 6 hours, no previous temperature excursions or adverse events were reported.
Sex: F
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 female 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 December 2014, 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 her 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/not resolved. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was considered disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: vision loss; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or about October 2014, the patient was inoculated with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered vision loss. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient symptoms had resulted in physical limitations not presented prior to using Zoster Vaccine Live (ZOSTAVAX). The patient 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 patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the reporting time, the outcome of the event was considered as not recovered and the reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporter considered blindness to be disabling event.  Upon internal review, blindness was determined to be medically significant event.
Sex: M
Vaccine: MMR
Symptoms: Blood glucose increased, Type 1 diabetes mellitus, Vomiting
Clinical narrative: type one diabetes; vomiting Ike crazy; This spontaneous report was received from a consumer and refers to a male child patient. No information regarding the patients medical history, concurrent conditions or concomitant medications was provided.  On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, lot # and expiration date were unknown) for prophylaxis.  On an unknown date, 12 hours after the vaccination the patient started vomiting. On an unknown date, four weeks after the vaccination the patient had blood sugar of 980 (units not provided) and  was diagnosed with type 1 diabetes mellitus. The patient was taken to the ER.  The outcome of type 1 diabetes mellitus and vomiting was unknown.       The causality assessment was not reported. The event of type 1 diabetes was considered life threatening. Upon internal review, the event of type 1 diabetes was considered to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Death
Clinical narrative: died; This spontaneous report was received from a other health professional who refers to a female patient of unknown age who was his aunt. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, she died. It was unknown if an autopsy was performed. The cause of death was reported as "unknown pneumococcal vaccine". The reporter considered the event to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown).; Reported Cause(s) of Death: Unknown pneumococcal vaccine
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: two doses on 24-FEB-2004 (3y 4m) and 28-AUG-2006 (5 y 10 m); Information has been received from a physician and a lawyer referring to a 3 years old female patient regarding a case in litigation. The patient's historical vaccines included hepatitis B vaccine (manufacturer unknown) (15-OCT-2000), Hib-Hepatitis vaccine (19-DEC-2000 and 26-FEB-2001), diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP) (19-DEC-2000, 26-FEB-2001, 26-APR-2001), pneumococcal vaccine conj 7v (CRM197) (PREVNAR 7) (19-DEC-2000, 26-FEB-2001, 26-APR-2001) and polio vaccine inact (IPV) (19-DEC-2000 and 26-FEB-2001). Concomitant vaccines included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP), polio vaccine inact (IPV) and varicella virus vaccine live (oka/merck) (VARIVAX). Concurrent condition and medical history were not provided.   On 24-FEB-2004 (also reported as at the age of 3 years and 4 months), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (therapy type unknown; route, dose, dose number, lot number and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).  This is one of two reports for the same patient (link # 2008USA012413).; Sender's Comments:  US-009507513-2008USA012413:
Age: 13.0
Sex: F
Vaccine: FLUN4
Symptoms: Fatigue, Headache, Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: SORE THROAT; HEADACHE; RUNNY NOSE; BODY ACHES; FATIGUE; A spontaneous report has been received from a consumer. The report concerns a female patient (age 12 years, height 62 in, weight 108 lb).    The patient's past and current medical history included viral asthma (dates not reported). The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received FluMist Quadrivalent (influenza vaccine live reassort 4v), via nasal route, for flu vaccine on 01-OCT-2021.     A Health Professional administered FLUMIST QUADRIVALENT. No malfunction has been reported for this combination product.    On 03-OCT-2021, the patient experienced sore throat (preferred term: Oropharyngeal pain), headache (preferred term: Headache), runny nose (preferred term: Rhinorrhoea), body aches (preferred term: Pain) and fatigue (preferred term: Fatigue).     Action taken with FluMist Quadrivalent was not applicable.    The patient recovered from the event(s) of sore throat, headache, runny nose, body aches and fatigue after 2 days on 04-OCT-2021.     The events were considered non-serious.     The reporter considered that there was a reasonable possibility of a causal relationship between FluMist Quadrivalent (influenza vaccine live reassort 4v) and the following event(s): fatigue, runny nose, body aches, sore throat and headache.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Sex: U
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased
Clinical narrative: brutal shot, couldn't use arm for 4 days; This case was reported by a consumer via interactive digital media and described the occurrence of injected limb mobility decreased 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 injected limb mobility decreased. On an unknown date, the outcome of the injected limb mobility decreased was recovered/resolved.   It was unknown if the reporter considered the injected limb mobility decreased 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 received the brutal shingles shot and patient could not use that arm for 4 days. As per the patient, worth the shot though. For the another dose, refer linked case US2021AMR224145, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR224145:Same patient, same reporter, differnet dose (2nd dose)
Sex: U
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Vaccine positive rechallenge
Clinical narrative: brutal shot, couldn't use arm for 4 days; This case was reported by a consumer and described the occurrence of injected limb mobility decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of injected limb mobility decreased (1st dose recevied on an unknown date and could not use that arm, refer case US2021AMR224142).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injected limb mobility decreased. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the injected limb mobility decreased was recovered/resolved.   It was unknown if the reporter considered the injected limb mobility decreased 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 received the brutal Shingles shot and patient could not use that arm for 4 days. As per the patient, worth the shot though. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR224142:Same patient, same reporter, differnet dose (1st dose)
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: ten days after shot, shingles, on face; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 10 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she few years ago had Shingles vaccine and about ten days after the Shingles shot, shingles came up on his/her face. The patient stated he/she had shingles intermittently since then. The shingles shot gave him/her shingles. The follow-up would not possible as no contact details were available. This case had been linked to the case US2021AMR224904 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR224904:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Product dose omission issue
Clinical narrative: first dose received 2019;This case was reported by another health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received SHINGRIX for prophylaxis.   Previously administered products included SHingrix (received 1st dose in 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 reporter stated that patient did not receive 2nd dose till the time of reporting, which led to incomplete course of vaccination. The reporter asked if the patient could receive 2nd dose now.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccines / now have shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via (Shingrix interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included gingival operation (4 weeks ago). Previously administered products included anesthesia (4 weeks ago).   On an unknown date, the patient received Shingrix and Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had very intensive and intrusive oral (gum) surgery that involved lots of anesthesia 4 weeks ago. The patient stated he/she had Shingles vaccines and had shingles under right arm close to the arm pit. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster oticus, Vaccination failure
Clinical narrative: Had the shots , but have shingles/ suspected vaccination failure; shingles on ear; 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 herpes zoster otitis externa (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and herpes zoster otitis externa were unknown.   It was unknown if the reporter considered the vaccination failure and herpes zoster otitis externa to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shots but had shingles on ear. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot and has Shingles right now.\ suspected vaccination failure; has 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: This case was reported for reporter's cousin. The age at vaccination was not reported. The reporter stated the patient had Shingles shot and had Shingles. 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 test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine and still got the shingles\ suspected vaccination failure; got the 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: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles vaccine and still got the shingles. The patient stated vaccine works for some but not for all. 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 test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: have shingles and vaccine\ 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: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles and Shingles vaccine. 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 test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot,but still got the shingles\ suspected vaccination failure; got the 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: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles shot but still got the shingles it was bad, but they told that the Shingrix shot helps and it was not as bad as with no shot, but four years and still had two places that gets bad. 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 test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had the shots / shingles now/ suspected vaccination failure; shingles; painful; 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, less than 9 months after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingrix shots six months ago of reporting and had shingles at the time of reporting it was so painful. The patient stated getting the shots did not mean positively would not get shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Infection, Surgery
Clinical narrative: had a serious operations and infection; Operation; have the first dose in 2018; This case was reported by a consumer via interactive digital media and described the occurrence of infection in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced infection (serious criteria other: serious by reporter), operation nos and incomplete course of vaccination. On an unknown date, the outcome of the infection, operation nos and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the infection and operation nos to be related to Shingrix.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine in 2018 and had serious operation and infection. Till the time of reporting, the patient did not received 2nd dose, which led to incomplete course of vaccination. The patient enquired if he/she could take second dose of shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: took the shot and shingles 5 months later/ suspected vaccination failure; shingles; pain; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 5 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported for reporter's sister. The age at vaccination was not reported. The reporter stated the patient took Shingrix shot and 5 months later was in dire pain from the shingles. 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 test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: received lot number involved in the Recall; received lot number involved in the Recall; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 31st December 2023) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pediatric office receptionist reported that between 18th July and 25th August 2021, the patient received recall Engerix-B lot, which led to recalled drug administered and drug dispensing error. The reporter consented to follow up. This case was 1 of 20 linked cases, reported by same reporter for different patients.
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: received lot number involved in the Recall; received lot number involved in the Recall; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 31st December 2023) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pediatric office receptionist reported that between 18th July and 25th August 2021, the patient received recall Engerix-B lot, which led to recalled drug administered and drug dispensing error. The reporter consented to follow up. This case was 1 of 20 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021224975:same reporter
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: received lot number involved in the Recall; received lot number involved in the Recall; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 31st December 2023) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   The reporter considered the recalled drug administered to be unrelated to Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The pediatric office receptionist reported that between 18th July and 25th August 2021, the patient received recall Engerix-B lot, which led to recalled drug administered and drug dispensing error. The reporter consented to follow up. This case was 1 of 20 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021224975:same reporter
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: received lot number involved in the Recall; received lot number involved in the Recall; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 31st December 2023) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pediatric office receptionist reported that between 18th July and 25th August 2021, the patient received recall Engerix-B lot, which led to recalled drug administered and drug dispensing error. The reporter consented to follow up. This case was 1 of 20 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021224975:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: had  shingles vaccine and get shingles\ suspected vaccination failure; shingles on eye; 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, 2 years 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 details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles vaccine and after two years he/she get the shingles on right eyes. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shingles shot 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 patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got the Shingles shot and got shingles. The patient stated they would not give the shot if you had the shingles, which was 130.00 after insurance, they had two new shots, the shot or shots already had, did not work. 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 test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Feeding disorder, Herpes zoster, Oral herpes, Oral pain, Pain
Clinical narrative: I received 2 shots/ had it on my face and in my my mouth/ suspected vaccination failure; I had it on my face and in my my mouth on the right side gosh; in pain\ it was that painful; couldn't eat; This case was reported by a consumer via  interactive digital media and described the occurrence ofsuspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (about 11 years ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and unable to eat. On an unknown date, the outcome of the vaccination failure, shingles, pain and unable to eat were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and unable to eat to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had shingle shot about 11 years ago then it was only 50 percent active that's why he/she got it a 4th time shot. The patient stated he/she received two Shingles shots earlier this year both were 95 percent active. The patient stated he/she the 4th time had it on face and in mouth on the right side gosh was in pain, he/she could not eat for two weeks it was that painful. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: I received 2 shots/ had it on my face and in my my mouth/ suspected vaccination failure; I had it on my face and in my my mouth on the right side gosh; in pain\ it was that painful; couldn't eat; This case was reported by a consumer via  interactive digital media and described the occurrence ofsuspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (about 11 years ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and unable to eat. On an unknown date, the outcome of the vaccination failure, shingles, pain and unable to eat were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and unable to eat to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had shingle shot about 11 years ago then it was only 50 percent active that's why he/she got it a 4th time shot. The patient stated he/she received two Shingles shots earlier this year both were 95 percent active. The patient stated he/she the 4th time had it on face and in mouth on the right side gosh was in pain, he/she could not eat for two weeks it was that painful. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: was vaccinated, still got them/ Suspected vaccination failure; was vaccinated, still got them; This case was reported by a consumer viainteractive 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 patient self reported this case. The age at vaccination was not reported. The patient received Shingles vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: has them now, got the shot/suspected vaccination failure; has them now; he is miserable; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 85-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient experienced 2 times shingles before vaccination).   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 details were reported as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient got the Shingles shot after the reporter had shingles. The patient had shingles now and this was his 3rd time and he was miserable. The reporter stated that it differently was not a fun thing to have and she would not want her worst enemy to had them. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown. The follow up would not possible as contact information was not available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Near death experience, Pain, Vaccination failure
Clinical narrative: Got both shots. Shingles.; Shingles; almost killed me; pain was excruciating; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization, GSK medically significant and life threatening), shingles (serious criteria hospitalization and life threatening), near death experience (serious criteria GSK medically significant and life threatening) and pain. On an unknown date, the outcome of the vaccination failure, shingles, near death experience and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, near death experience and pain 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 got both shots of shingles vaccine and experienced shingles. The patient stated that shingles put him/her in the hospital, almost killed him/her. The patient also experienced pain and the pain was excruciating. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: one dose more than 1 year ago; This case was reported by a other health professional via (Shingrix GSK Chatbot) interactive digital media 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 more than 1 year ago from 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 are as follows: The reporter was chatting from pharmacy. The age at vaccination was not applicable. The reporter had a client who did not received 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The reporter reported that the patient's doctor now only prescribed the patient one shot. The reporter asked that kindly advised to see if the patient needs the series or one was enough. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got my Shingrix shot in 2018,; 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 (received 1st dose in 2018).   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 are as follows: The case was reported by patient himself/herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd shot of Shingrix, which led to incomplete course of vaccination. The patient asked that he/she need another shot. The follow- up could not be possible as no contact details were available.