chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles/Herpes zoster; Information was received from a lawyer regarding a case in litigation concerning a patient (pt) of unspecified age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On or about 12-NOV-2015 (at the age of 63-years-old), the pt was vaccinated with zoster vaccine live (ZOSTAVAX), administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions (Strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). Subsequently, on an unknown date, as result of the zoster vaccine live (ZOSTAVA) use, the patient experienced shingles/herpes zoster and was treated (unspecified) by a physician. Loss of consortium was filed. The outcome of the event was not provided. Causality was related.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles/herpes zoster; Initial information has been received from a lawyer and a currently 74 year old patient (gender unknown). The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On or 03-DEC-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location not provided) for the long-term prevention of shingles and zoster-related conditions at a pharmacy. Subsequently, on an unspecified date, the patient was treated by a health care provider at a medical center for the following injury resulting from patient's zoster vaccine live (ZOSTAVAX) use: shingles/herpes zoster. At the reporting time, the outcome of the event was unknown. The reporters considered shingles/herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE reported; administration of an improperly stored dose of PROQUAD on 25Oct2021; This spontaneous report was received from an office manager and refers to a female patient of an unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 25-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) 0.5 mL one time, lot # T035411, expiration date 14-APR-2022 (route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced excursion reported as -10 degrees Celsius to 8 degrees Celsius (-0.1 degrees Celsius) for 2 hours and 3 minutes. Previous temperature excursion was reported as -10 degrees Celsius to 8 degrees Celsius (6.6 degrees Celsius) for 5 hours and 23 minutes. There was no additional adverse event reported.
Sex: U
Vaccine: HPV9, HPV9, RV5, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; doses of ROTATEQ, GARDASIL 9 and VARIVAX were administered following excursion; This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender.  Information regarding concurrent conditions, medical history and concomitant medications was not reported.  On 15-NOV-2021, the patients were vaccinated with an unspecified number of doses of improperly stored of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1821247, expiration 23-JUL-2022 and lot # 1707471, expiration date 21-JUL-2022) orally (dose and frequency not reported), varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # U016065, expiration date 20-MAY-2023) (dose, frequency and route not reported) and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot # T029523, expiration date 13-MAR-2023 and lot # T039466, expiration date 20-MAY-2023) (dose, frequency and route not reported), all administered for prophylaxis.  The refrigerated products were stored at 29.1 degrees Celsius (C) for 8 hours and frozen products were stored at 25.5 C for 8 hours (Product storage error). It was not specified which products were stored at which temperature and the presence of a digital data logger was not reported. No additional adverse events (AEs) were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot and still 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 female 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 age at vaccination was not reported. The reporter stated get the Shingles shot but could still get shingles, they said not as bad than if did not get the Shingles shot. The reporter stated personally know people who got the Shingles shot and still got shingles. The reporter stated the patient experienced shingles after having the Shingles shot.  The reporter saw patient suffer every day and they never went away. 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: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still come back in a different spot; 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.   The patient's past medical history included shingles (experienced very mild case of shingles).   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 case was reported by patient. The age at vaccination was not reported. The patient got the shingles vaccine and still experienced shingles in a different spot, every 4 months or 6 months. The physician gave him/her oral medication. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. The case had been linked with the case US2021AMR233775 reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR233775:multiple outbreak
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.  On 10th November 2021, the patient received the 1st dose of Shingrix. On 11th November 2021, 1 days after receiving Shingrix, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got 1st shot the day before the reporting day and had fever and chills on the day of reporting, was this normal. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced 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.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed shingles after having gotten vaccinated with Shingrix. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.    The reporter did not agree to follow up with GlaxoSmithKline. This case is one of 3 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR233841:Same reporter US-GLAXOSMITHKLINE-US2021AMR233842:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced 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.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed shingles after having gotten vaccinated with Shingrix. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.    The reporter did not agree to follow up with GlaxoSmithKline. This case is one of 3 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR233842:Same reporter US-GLAXOSMITHKLINE-US2021AMR233832:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced 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.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed shingles after having gotten vaccinated with Shingrix. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.    The reporter did not agree to follow up with GlaxoSmithKline. This case is one of 3 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR233841:Same reporter US-GLAXOSMITHKLINE-US2021AMR233832:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a nurse via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age  at vaccination was not reported. The patient received the Shingrix vaccine and 2 to 3 weeks/ within weeks later developed Shingles. This case was linked with US2021AMR234679 and US2021AMR234703, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR234703:same reporter US-GLAXOSMITHKLINE-US2021AMR234679:same reporter US-GLAXOSMITHKLINE-US2021235278:same reporter - initial
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Influenza like illness, Overdose, Pain in extremity
Clinical narrative: received Bexsero and Trumemba at same visit; flu like symptoms; sore arm; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB36AA, expiry date unknown) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 8th November 2021, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device and TRUMENBA. On 8th November 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced overdose. In November 2021, the patient experienced influenza-like symptoms and pain in arm. On an unknown date, the outcome of the influenza-like symptoms and pain in arm were recovered/resolved and the outcome of the overdose was unknown.   It was unknown if the reporter considered the influenza-like symptoms and pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received dose of both Bexsero and Trumemba vaccines at same visit, which led to overdose. The patient experienced flu like symptoms and sore arm 24 hours after immunizations and lasted for 1 day. No further information reported. The reporter consented to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 41-year-old patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provide as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of flu vaccine last year and experienced shingles. The patient asked his/her insurance was not cover Shingrix since he/she was not 50 years old yet, were there other options to mitigate the cost of the vaccine. No further information reported.
Sex: U
Vaccine: VARZOS
Symptoms: Eye pruritus, Eye swelling
Clinical narrative: swollen eyes; itchy eyes; This case was reported by a consumer via interactive digital media and described the occurrence of eye swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th October 2021, the patient received the 2nd dose of Shingrix. On 26th October 2021, 1 days after receiving Shingrix, the patient experienced eye swelling and eye pruritus. On an unknown date, the outcome of the eye swelling and eye pruritus were unknown.   It was unknown if the reporter considered the eye swelling and eye pruritus 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 second dose of Shingrix vaccine and experienced itchy swollen eyes on right side starting on next day of the vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash, Swelling
Clinical narrative: rash; swelling; fever; pain; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2021, the patient received the 2nd dose of Shingrix. In November 2021, less than a week after receiving Shingrix, the patient experienced rash, swelling, fever and pain. The patient was treated with non-drug therapy (Ice Pack (No Medication)) and paracetamol (Tylenol). On an unknown date, the outcome of the rash, swelling, fever and pain were unknown.   It was unknown if the reporter considered the rash, swelling, fever and pain to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingrix series of shots for shingles, the 2nd one on Monday from the day of reporting, 8th November.  The 2nd one had given the patient a rash, swelling, fever.  The reporter asked what could he/she take to alleviate the pain and swelling of the rash.  The patient was icing it and taking Tyleno. No contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: got 1 Shingrix shot, then covid hit, never received the 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter said that, the patient got 1 Shingrix shot, then covid hit.  Till the time of reporting, the patient had never received the 2nd shot.  The reporter asked if he should get a 2nd shot or if it was  too late.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles very bad.; lot of pain / hurting; itching; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (experienced shingles about 10 year ago), pain and pruritus.   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 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The reporter stated that shingles shot did not work for her husband. He had both his Shingles vaccinations a year ago. The patient experienced Shingles very bad. The patient had Shingles eight years ago, they were not this bad. The patient experienced hurting and itching more than he did when he had Shingles before about ten years ago. He had been to the doctor. The patient went to the doctor next day after he started breaking out. He get a lot of medications and a ointment. The patient was still having a lot of pain. This case was considered as suspected vaccination failure since the details laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Urticaria, Vaccination failure
Clinical narrative: mild case of shingles/ suspected vaccination failure; shingles; Got hives; 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 COVID-19 VACCINE (COVID 19 PANDEMIC VACCINE) for prophylaxis.   Concurrent medical conditions included food allergy.   On an unknown date, the patient received Shingles vaccine and COVID 19 PANDEMIC VACCINE at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and hives. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and hives were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and hives 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. It was unknown if the reporter considered the vaccination failure, shingles and hives to be related to Covid vaccine. 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: M
Vaccine: COVID19, VARZOS
Symptoms: COVID-19, Herpes zoster, Vaccination failure
Clinical narrative: had the shots / had them/suspected vaccination failure; had them lightly; had them lightly; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and covid-19. On an unknown date, the outcome of the vaccination failure, shingles and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's spouse. The age at vaccination was not reported. The patient got the Shingle vaccine and Covid vaccine and still got them both (shingles and covid-19) lightly. It was unknown if the reporter considered the shingles and covid-19 to be related to Covid-19 vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: leg muscle pain; This case was reported by a consumer via interactive digital media and described the occurrence of myalgia of lower extremities 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 myalgia of lower extremities. On an unknown date, the outcome of the myalgia of lower extremities was unknown.   It was unknown if the reporter considered the myalgia of lower extremities 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. Patient had the shingles shot and experienced leg muscle pain. The follow-up would not possible as no contact details were available
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I had my Shingrix vaccines one month apart; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had Shingrix vaccines one month apart, which led to shortening of vaccination schedule. The reporter asked if that was dangerous.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Rash, Vaccine positive rechallenge
Clinical narrative: rash, feels like sandpaper; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of rash (1st dose received on an unknown date, refer case US2021AMR237256).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Additional details were provided as follows: The patient received vaccine shot and still got a rash.  The rash felt like sandpaper. For tolerance of 3rd dose refer case US2021AMR237273.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR237256:Same reporter US-GLAXOSMITHKLINE-US2021AMR237273:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes simplex
Clinical narrative: broke out with herpes simplex 1 on my nose.; This case was reported by a consumer via interactive digital media and described the occurrence of herpes simplex in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th November 2021, the patient received the 1st dose of Shingrix. On 15th November 2021, 5 days after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced herpes simplex. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the herpes simplex was unknown.   It was unknown if the reporter considered the herpes simplex 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 dose of Shingrix vaccine and yesterday (day before reporting) broke out with herpes simplex 1 on his/her nose. The patient took 2 tabs of valacyclovir as a treatment medication, and asked that would it interfere with. The patient asked to GlaxoSmithKline that had the GlaxoSmithKline heard of anyone experiencing this as a side effect. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 15 month old patient received Kinrix; received Kinrix instead of Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number 705JF, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th May 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 11th May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported that, 15 month old patient received Kinrix instead of Infanrix, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site discolouration, Injection site pain
Clinical narrative: discoloration (bruise) / were the vaccine was injected; soreness in the area where the vaccine; developed black and blue discoloration (bruise) in the area where the vaccine was applied.; This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2021, the patient received the 1st dose of Shingrix. In November 2021, less than a week after receiving Shingrix, the patient experienced injection site bruising, injection site pain and injection site discoloration. On an unknown date, the outcome of the injection site bruising, injection site pain and injection site discoloration were unknown.   It was unknown if the reporter considered the injection site bruising, injection site pain and injection site discoloration to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose and developed black and blue discoloration (bruise) and also developed soreness in the area where the vaccine was applied. The reporter agreed to be contacted for follow up.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021235306:same reporter
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix-b was administered, Expiration 11/12/2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B adult) (batch number 54A32, expiry date 12th November 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 15th November 2021, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 15th November 2021, unknown after receiving Engerix B adult 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 health care professional reported that an expired adult Engerix-B was administered to the patient.  The reporter had not provided identifiable information. The reporter had not reported any reactions. The consent to follow up granted by email.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old patient who received Men B NVS (Bexsero) (batch number ABXA68AA, expiry date 31st October 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th November 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 15th November 2021, unknown after receiving Bexsero and Bexsero 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 practice lead from a medical facility reported that, the patient received an expired dose of Bexsero, which led to expired vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: On 05Oct2021 patient received Fluzone, on 11Nov2021 received Fluarix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 48-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 977EN, 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.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE (FLU SHOT)).   On 11th November 2021, the patient received Fluarix Tetra 2020-2021 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. On 11th November 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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 Fluarix Tetra in the left deltoid. The patient received the Fluzone flu shot, however the patient inadvertently received a second flu shot, Fluarix, which led to extra dose administered. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: first dose administered subcutaneously.; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number EZ4TD, expiry date 4th November 2022) for prophylaxis.   On 16th September 2021, the patient received the 1st dose of Shingrix (subcutaneous). On 16th September 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix subcutaneously, which led to intramuscular formulation administered by other route. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose administered on 5Apr2021, 2nd on 19Apri2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 7F94C, expiry date 11th November 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 19th April 2021, the patient received the 2nd dose of Shingrix. On 19th April 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: The patient received 1st dose of Shingrix on 5th April 2021. The practice manager reported that, the patient received 2nd dose early than the recommended time interval, which led to shortening of vaccination schedule. The reporter consented to follow up.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: accidentally given a 2nd dose of Fluarix on 15Nov2021; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 36-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 4L97X, 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.   Concomitant products included Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season).   On 15th November 2021, the patient received the 2nd dose of Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 15th November 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device and an unknown time after receiving Fluarix Tetra 2020-2021 season, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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 patient received  a dose of Fluarix on 28th October 2021 and was accidentally given a 2nd dose of Fluarix on 15th November 2021, which led to extra dose administered. No symptoms reported. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex
Clinical narrative: got an outbreak on her nose / herpes simplex; This case was reported by a consumer via call center representative and described the occurrence of herpes simplex in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In November 2021, several days after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced herpes simplex. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the herpes simplex was not recovered/not resolved.   It was unknown if the reporter considered the herpes simplex to be related to Shingrix.  Additional details provided were as follows: The patient received a dose of Shingrix in right arm and patient stated that she was prone to to herpes simplex outbreaks and got an outbreak on her nose a few days after receiving the first dose of shingrix. She took valacyclovir to treat the outbreak which has not yet resolved. Spoke per Doctor and patient was referred to health care professional (HCP) for follow up. The reporter did not consented to follow-up. The case was linked with case US2021AMR237385, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR237385:Same Patient
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: MenA reconstituted with another company diluent; MenA reconstituted with another company diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA584A, expiry date 31st August 2022) for prophylaxis.   On 3rd November 2021, the patient received Menveo. On 3rd November 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received menveo reconstituted with another company diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: sterile water was used  to reconstitute roatrix instead of the diluent provided; sterile water was used  to reconstitute roatrix instead of the diluent provided; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, sterile water was used  to reconstitute roatrix instead of the diluent provided, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Anaemia
Clinical narrative: A BOUT OF ANAEMIA; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 13-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-JUN-2021, the patient experienced a bout of anaemia, and was hospitalized on 25-JUN-2021 for 5 days and was discharged on 29-JUN-2021. On 01-OCT-2021, Laboratory data included: Laboratory test (NR: not provided) Normal, and RBC count (NR: not provided) 13 points. On 15-OCT-2021, Laboratory data included: Laboratory test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bout of anaemia on 01-OCT-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211133607-Covid-19 vaccine ad26.cov2.s-A bout of anaemia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapeutic response unexpected, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; LUPUS SYMPTOMS WERE GONE; This spontaneous report received from a patient (retired nurse) via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's past medical history included that she had rods, pins and donor bone implantation, was paralysed on her left side, had broken her neck twice and was very athletic. The patient's concurrent conditions includes lupus, but only a form in her in abdomen, cancer in both eyes, and premalignant tumor in breast for which she was supposed to have a double mastectomy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, with frequency time 1 total, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included cortisone for an unknown indication which is given into her SI periodically. The patient stated that, on an unspecified date her lupus symptoms were gone (unexpected therapeutic benefit from vaccine) after the vaccination. She had been undergoing extensive antibody testing which concluded zero antibodies, this indicates suspected immunological vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lupus symptoms were gone and suspected immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority 90000202779.; Sender's Comments: V0: 20211134666-Covid-19 vaccine ad26.cov2.s- suspected immunological vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS