chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pallor, Seizure, Syncope
Clinical narrative: 6-8 minutes after injection my son passed out and fell on floor. He was extremely pale and having convulsions for 3-5 minutes until he came to and was very confused and weak. The paramedics arrived about 10 minutes after and his blood pressure was 70/30 and very slow pulse. They tried to sit him in a chair and he passed out again. They transported him to the hospital in an ambulance to the ER. The ER doctors did blood work and a CT which came back good. He was orthostatic positive for hours until he finally started having good results on the monitors and was released around 9pm.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, SARS-CoV-2 test, Urticaria
Clinical narrative: hives; I have a dermatitis that covers almost all my body and it does not go away with any of the medicines I have been; This is a spontaneous report from a contactable other hcp (patient).   A female patient of an unspecified age received BNT162b2 (CONMINTARY, Solution for injection, Lot No: EJ1686), via an unspecified route of administration, administered in Arm Left on 08Jan2021 14:30 as 1stdose, single for covid-19 immunisation (age at vaccination was 54 years). Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included paracetamol (PANADOL) taken for an unspecified indication, start and stop date were not reported.  The patient previously took Zyrtec allergy. Allergies to medications, food, or other products was no. The patient experienced hives, i have a dermatitis that covers almost all my body, and it does not go away with any of the medicines i have been on Jan2021.  The patient underwent lab tests and procedures which included sars-cov-2 test negative   on Jan2021.Therapeutic measures were taken as a result of hives, i have a dermatitis that covers almost all my body, and it does not go away with any of the medicines i have been. Treatment received was yes (various topical and oral medications, such as Zyrtec) and there was physician office visit also. Prior to vaccination, was the patient diagnosed with COVID-19 was no. Upon follow-up on 23Apr2021 new information has been updated. This is a follow-up spontaneous report received from a contactable other HCP. This 54-Year-old female other HCP reported for herself about reaction(s)/events, treatment received. The clinical outcome of the events was not recovered.  Follow-up (23Apr2021): This is a follow-up spontaneous report received from a contactable other HCP. This 54-Year-old female other HCP reported for herself about reaction(s)/events, treatment received.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; A patient received doses of Gardasil 9 on 18-FEB-2021, 04-MAY-2021 and 29-JUN-2021; This spontaneous report was received from an officer manager, referring to a 41-year-old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 18-FEB-2021, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0,5 ml, lot# T008151, expiration date 21-JUN-2022, for prophylaxis (strength, route and frequency were not reported).  On 04-MAY-2021, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0,5 ml, lot# 1659422 has been verified to be a valid lot number (expiration date not reported, but upon internal validation established as 04-SEP-2022), for prophylaxis (strength, route and frequency were not reported).  On 29-JUN-2021, the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0,5 ml, lot# T027789, expiration date 27-FEB-2023, for prophylaxis (strength, route and frequency were not reported) (inappropriate schedule of product administration). No additional adverse events reported.
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event; the patient was supposed to have received PREVNAR 13 but the pharmacist accidentaly gave the patient a second dose of PNEUMOVAX; the patient was supposed to have received PREVNAR 13 but the pharmacist accidentaly gave the patient a second dose of PNEUMOVAX; This spontaneous report was received from the patient's wife referring to her husband of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.     On an unspecified date approximately in 2020 (reported as "last year"), the patient received pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported).   On 04-OCT-2021, the patient was supposed to have received pneumococcal vaccine conj 13v (crm197)(PREVNAR 13), but the pharmacist accidentally gave the patient a second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported) (extra dose administered and wrong product administered).  No adverse events or product quality complains were reported.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation, concerning a 55-year-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 17-OCT-2016, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage information, lot number and expiration date were not provided) for its intended purpose: the prevention of shingles (herpes zoster). Subsequently on 25-OCT-2017, the patient suffered shingles, including any and all of its sequelae.  As a result of the receipt of the vaccination, the patient experienced sustained severe and permanent personal injuries, as well as significant pain, suffering, and emotional distress. The reporter considered the event of shingles to be related to suspect therapy. At the time of the report, the patient's outcome was not recovered.  Upon internal review, shingles was considered a disabling event.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: ill-defined disorder; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 73-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not provided. On or about 2016, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a healthcare provider for shingles and other zoster-related conditions. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: dose of PNEUMOV AX 23 was administered to a patient after a temperature excursion; No AE; Information has been received from a medical assistant, referring to a patient of unknown gender, who was currently 24 years old. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T027110 and expiration date 23-MAR-2022 (administration route and anatomical location were not provided) for prophylaxis. No adverse effects were reported.   The vaccine had a temperature excursions of 32.9 Fahrenheit (F) during a time frame of 24 hours. It was confirmed that no previous temperature excursions occurred.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; Medical assistant calling in a temperature excursion; Information has been received from a medical assistant, referring to a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-OCT-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # U008048, expiration date on 01-OCT-2021 (anatomical location and administration route were not reported)for prophylaxis. No additional adverse effects were reported.   The vaccine had a temperature excursions of 78 Fahrenheit (F) during a time frame of 49 hours. It was confirmed that no previous temperature excursion occurred.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: zoster-related inkuries; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided. On or about 12-AUG-2014, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of herpes zoster or shingles. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for shingles or zoster-related injuries. As a direct and proximate result of the use of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries, including but not limited to costs for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: She reported that 5 patient's received PROQUAD vaccine that had undergone temperature excursion; No additional AE; This spontaneous report was received from a nurse referring to a currently 4 years old male patient. Information about medical history, concurrent condition and concomitant therapy was not provided.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot # U002539 with an expiration date 24-JUL-2022; strength, dose, route and frequency were not reported) for prophylaxis. The vaccine had undergone temperature excursion at 13.8 Degrees Fahrenheit for 1 hour and 48 minutes (product storage error). No previous temperature excursion. No additional adverse event (AE) reported. The outcome of product storage error was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick; This case was reported and described the occurrence of sickness 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 sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness 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 shot and the side effects made the patient sick for almost a week. No contact details were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (got the 1st shot for shingles got shingles 3 years later ).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient got the new two shots but it had been a year and a half and he/she still get pain at night. The patient take medivations for the pain.  The patient stated that this pain was a walk in the park compared to having full blown shingles. He/she pray for all those going through this sickness its horrible.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR206648:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (got the 1st shot for shingles got shingles 3 years later) and Shingles vaccine with an associated reaction of pain (1st dose received on an unknown date, refer case US2021AMR206627).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient got the new two shots but it had been a year and a half and he/she still get pain at night. The patient take medivations for the pain.  The patient stated that this pain was a walk in the park compared to having full blown shingles. He/she pray for all those going through this sickness its horrible.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR206627:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a 3rd dose; This case was reported by a other health professional via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 3rd dose of Shingrix vaccine which led to extra dose administered. The reporter asked what were the effects if patient received 3rd dose of Shingrix. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got shot and shingles hurt/ suspected vaccination failure; shingles; shingles hurt; 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot and then the shingles hurt. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first shot two years ago, beneficial to get second shot now; 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 2 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The patient had first shot of Shingrix two years ago and needed to know if it was still beneficial to get second shot now. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: have received Shingrix vaccines. Why am I still getting 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 (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, 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: The patient self-reported this case. The age at vaccination was not reported. The patient had received Shingrix vaccines and still got shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received both shingles vaccines but i am still getting 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported that he/she received both the shingles vaccine and still got shingles. 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: Guillain-Barre syndrome
Clinical narrative: got GBS; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   The reporter considered the guillain barre syndrome to be possibly related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that they would tell you Guillain Barre syndrome was very rare, but the reporter knows the patient who had Guillain Barre syndrome. The reporter stated that he/she would never take the Shingles shot because it could cause Guillain Barre syndrome (GBS). The shot tells you that in the fine print. This case was 1 of the 4 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR208072:same reporter US-GLAXOSMITHKLINE-US2021AMR208073:same reporter US-GLAXOSMITHKLINE-US2021AMR208069:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: got GBS; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   The reporter considered the guillain barre syndrome to be possibly related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that they would tell you Guillain Barre syndrome was very rare, but the reporter knows the patient who had Guillain Barre syndrome. The reporter stated that he/she would never take the Shingles shot because it could cause Guillain Barre syndrome (GBS). The shot tells you that in the fine print. This case was 1 of the 4 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR208069:same reporter US-GLAXOSMITHKLINE-US2021AMR208073:same reporter US-GLAXOSMITHKLINE-US2021AMR208071:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: got GBS; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   The reporter considered the guillain barre syndrome to be possibly related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that they would tell you Guillain Barre syndrome was very rare, but the reporter knows the patient who had Guillain Barre syndrome. The reporter stated that he/she would never take the Shingles shot because it could cause Guillain Barre syndrome (GBS). The shot tells you that in the fine print. This case was 1 of the 4 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR208072:same reporter US-GLAXOSMITHKLINE-US2021AMR208069:same reporter US-GLAXOSMITHKLINE-US2021AMR208071:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19, Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: got Shingrix, lasted one year, my shingles returned/ suspected vaccination failure; my shingles returned; I have covid; 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 (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient had battled with shingles outbreaks for 8 years).   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and covid-19. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and covid-19 were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 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 got the Shingrix vaccine last year and now the shingles symptoms had returned. At the time of reporting, the patient had Covid-19. The patient enquired if the vaccine can be taken multiple times. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: she got vaccinated and she is having them/ suspected vaccination failure; started her 6th time having them; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (6 months 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) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The had shingles and the doctor had told her to wait for 6 months. The patient got the shingle shot and started her shingles 6th time having them. the patient was almost 90 at the time of reporting. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: both shots, still get 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 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, several months after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had received both doses of shingles shots but still get the shingles every couple of months. The patient asked why it keeps coming back. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, Product distribution issue, Product storage error
Clinical narrative: temperature excursion; This case was reported by a pharmacist via sales rep and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2021-2022 season .5 ml and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. On 27th September 2021, the retail pharmacy called GSK medical information to obtain temperature excursion data because their wholesaler had contacted them to inform them that there had been a temperature excursion. Wholesaler asked pharmacy to quarantine the product. The product had already been administered to the patient. On 27th September 2021 the pharmacy did not yet have the specifics of the temperature excursion. They did not yet know whether the product had been stored above or below refrigerated temperatures nor did they know for how long. On 04th October 2021 GSK employee (Director for GSK, retail) learned the specific details of the temperature excursion. The product was shipped from GSK to the wholesaler via, but the shipment was lost and was sitting on a loading dock unrefrigerated for 2 weeks. The wholesaler then put the Fluarix product back in the refrigerator and subsequently shipped it to the pharmacy. Fluarix Quadrivalent (Influenza Vaccine) injectable suspension was available in 0.5 mL single-dose, disposable, prefilled Tip-Lok syringes (packaged without needles). GlaxoSmithKline (GSK) employee (Director for GSK, retail) called GSK response center on 6th October 2021 to report that the patient was vaccinated with Fluarix (FLU.QIV PRTC X10 CT FS US NH21, NDC: 59160-0887-52) which had been stored outside of the refrigerator for 2 weeks, which led to incorrect storage of drug. The pharmacy correctly stored the product in the refrigerator and unknowingly administered 1 dose to the patient. The GSK employee (Director for GSK, retail) did not have any specific patient information (example: gender). This is 1 of the 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021208229:same reporter US-GLAXOSMITHKLINE-US2021AMR208519:same reporter
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: temperature excursion; This case was reported by a pharmacist via sales rep and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   It was unknown if the reporter considered the incorrect storage of drug to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. On 27th September 2021, the retail pharmacy called GSK medical information to obtain temperature excursion data because their wholesaler had contacted them to inform them that there had been a temperature excursion. Wholesaler asked pharmacy to quarantine the product. The product had already been administered to the patient. On 27th September 2021 the pharmacy did not yet have the specifics of the temperature excursion. They did not yet know whether the product had been stored above or below refrigerated temperatures nor did they know for how long. On 04th October 2021 GSK employee (Director for GSK, retail) learned the specific details of the temperature excursion. The product was shipped from GSK to the wholesaler via, but the shipment was lost and was sitting on a loading dock unrefrigerated for 2 weeks. The wholesaler then put the Fluarix product back in the refrigerator and subsequently shipped it to the pharmacy. Fluarix Quadrivalent (Influenza Vaccine) injectable suspension was available in 0.5 mL single-dose, disposable, prefilled Tip-Lok syringes (packaged without needles). GlaxoSmithKline (GSK) employee (Director for GSK, retail) called GSK response center on 6th October 2021 to report that the patient was vaccinated with Fluarix (FLU.QIV PRTC X10 CT FS US NH21, NDC: 59160-0887-52) which had been stored outside of the refrigerator for 2 weeks, which led to incorrect storage of drug. The pharmacy correctly stored the product in the refrigerator and unknowingly administered 1 dose to the patient. The GSK employee (Director for GSK, retail) did not have any specific patient information (example: gender). This is 1 of the 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR208518:same reporter US-GLAXOSMITHKLINE-US2021208229:same reporter
Sex: M
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive his 2nd dose; This case was reported by a pharmacist via other manufacturer and described the occurrence of incomplete course of vaccination in a male patient who received HAV (Havrix) for prophylaxis.   Previously administered products included HAVRIX (1st dose received 13 months ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional details were reported as follows: The age at vaccination was not applicable for this report. Pharmacist reported a patient was supposed to get his 2nd dose of 12 months later but the patient did not receive his 2nd dose of Havrix till the time of reporting for unknown reasons which led to incomplete course of vaccination.  The reporter wanted to know if the patient could get a dose of VAQTA now instead of Havrix. No additional adverse event were reported.  No product quality complaint PQC reported. No further information was provided. No contact details were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix shot 3 years, never received the 2nd dose; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about 3 years ago from the date of reporting).   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 reported as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. The patient had never received the 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination.  The reporter also asked what should he/she do if want to get vaccinate. No contact details were reported.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Accidental underdose, Syringe issue, Underdose
Clinical narrative: due to syringe malfunction a patient given less than 1/4 of the dose; syringe malfunction; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 24-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 52SA4, expiry date 30th June 2022) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal tiv dresden pre-filled syringe device (Fluarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Pre-Filled Syringe Device. On 30th September 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Pre-Filled Syringe Device, the patient experienced accidental underdose and syringe issue. On an unknown date, the outcome of the accidental underdose and syringe issue were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by the nurse. The nurse reported that due to syringe malfunction a patient was given less than 1/4 of the complete dose of Fluarix, which led to accidental underdose and syringe issue. The reporter consented to follow-up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 9/16/2021. 2nd dose on 10/1/21; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number HM24H, expiry date 25th March 2023) for prophylaxis.   Concomitant products included ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGRIX).   On 1st October 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 1st October 2021, unknown after receiving Shingrix and an unknown time 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 details were provided as follows: On 16th September 2021, the patient received 1st dose of shingrix 0.5 ml intramuscular in right deltoid.  The patient received 2nd dose in left deltoid. The pharmacist stated that a patient received the second dose early which led to shortening of vaccination schedule. The pharmacist seeking guidance on early second dose of Shingrix given to a patient. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Feeling hot, Insomnia, Micturition urgency
Clinical narrative: Increase urination frequency and urgency; Urinary urgency; felt unusual warm; painful arm; felt dizzy; Could not sleep; did not feel good; This case was reported by a consumer via call center representative and described the occurrence of increased urinary frequency in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (1st dose received on 20th June 2021, refer case US2021000069).   On 3rd October 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd October 2021, several hours after receiving Shingrix, the patient experienced increased urinary frequency, urinary urgency, feeling hot, painful arm, dizziness, insomnia and feeling bad. On an unknown date, the outcome of the increased urinary frequency, urinary urgency, feeling hot and dizziness were recovered/resolved and the outcome of the painful arm was not recovered/not resolved and the outcome of the insomnia and feeling bad were unknown.   It was unknown if the reporter considered the increased urinary frequency, urinary urgency, feeling hot, painful arm, dizziness, insomnia and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was unknown. The patient received dose of Shingrix vaccine in the left deltoid and could not sleep last night and did not feel good, felt dizzy, felt unusual warm, painful arm, and increased urination frequency and urgency (had to urinate about 6 to 7 times last night). The above side effects were experienced a couple of hours later. In October 2021, the side effects dizziness, unusual warm, and increase urination frequency and urgency were resolved except painful arm. The status about inability to sleep last night was unknown. The reporter did not have full mailing address, fax number or an email address to healthcare professional. The reporter did not provide his date of birth, only stated a year. Also the reporter did not provide lot number, expiration date, and dosage. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021000069:same reporter - 1st dose
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pollakiuria
Clinical narrative: Increase urination frequency and urgency; Urinary urgency; felt unusual warm; painful arm; felt dizzy; Could not sleep; did not feel good; This case was reported by a consumer via call center representative and described the occurrence of increased urinary frequency in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (1st dose received on 20th June 2021, refer case US2021000069).   On 3rd October 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd October 2021, several hours after receiving Shingrix, the patient experienced increased urinary frequency, urinary urgency, feeling hot, painful arm, dizziness, insomnia and feeling bad. On an unknown date, the outcome of the increased urinary frequency, urinary urgency, feeling hot and dizziness were recovered/resolved and the outcome of the painful arm was not recovered/not resolved and the outcome of the insomnia and feeling bad were unknown.   It was unknown if the reporter considered the increased urinary frequency, urinary urgency, feeling hot, painful arm, dizziness, insomnia and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was unknown. The patient received dose of Shingrix vaccine in the left deltoid and could not sleep last night and did not feel good, felt dizzy, felt unusual warm, painful arm, and increased urination frequency and urgency (had to urinate about 6 to 7 times last night). The above side effects were experienced a couple of hours later. In October 2021, the side effects dizziness, unusual warm, and increase urination frequency and urgency were resolved except painful arm. The status about inability to sleep last night was unknown. The reporter did not have full mailing address, fax number or an email address to healthcare professional. The reporter did not provide his date of birth, only stated a year. Also the reporter did not provide lot number, expiration date, and dosage. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021000069:same reporter - 1st dose
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 13-year-old female patient who received HBV (Engerix B pediatric) (batch number HN5BE, expiry date 16th September 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th October 2021, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 4th October 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received an expired dose of ENGERIX-B which led to expired vaccine used.  No further events were reported. The consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 47K47, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd August 2021, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The multiple patients received FluLaval Quadrivalent after the was stored at 17.6F by 40 minutes, which led to incorrect storage of drug. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 26-Sep-2020, 2nd 10-Oct-2020; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGRIX).   On 10th October 2020, the patient received the 2nd dose of Shingrix. On 10th October 2020, 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 details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix on 26th September 2020. The patient received 2nd dose of Shingrix early than the recommended trime interval, which led to shortening of vaccination schedule. The reporter consented to follow up.