chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: to be hospitalized with shingles, suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: to be hospitalized with shingles, suspected vaccination failure) (serious criteria hospitalization and GSK medically significant) and shingles (Verbatim: shingles) (serious criteria hospitalization). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 02-MAR-2023 This case was reported by a consumer via interactive digital media. The reporter reported that got chicken pox as a full grown adult even after he or she had childhood shots doctor said to get the shingles shot because of this.  The reporter had really bad side effects and his or her coworker had to be hospitalized with shingles. The reporter said great that he or she did not get shingles chicken pox was the worst. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming Shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR038391:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: i had the shot got mild case of shingle / suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: i had the shot got mild case of shingle / suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The patient was treated with medication unknown (Pill (Medication Unknown)). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the Shingles shot but got a mild case of them (shingles) and got a pill within 72 hours.  The patient reported that the mild cases were not picnic either. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: i have them even though had shot / suspected vaccination failure; shingles; pain in certain areas; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: i have them even though had shot / suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pain (Verbatim: pain in certain areas). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she had them (shingles) even though he/she had the shot, the patient still had pain in certain areas. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure, Vaccination site pain
Clinical narrative: Suspected vaccination failure/shingles hurts more; Shingles hurts more; Shot hurts; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/shingles hurts more) (serious criteria GSK medically significant), shingles (Verbatim: Shingles hurts more) and pain (Verbatim: Shot hurts). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported the patient via interactive digital media. The patient reported that the vaccine shot hurts and shingles hurts more, much more. The follow-up could not be 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 shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: she still gets them/ suspected vaccination failure; had the shot and she still gets them; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: she still gets them/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had the shot and she still gets them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 This case was reported by a consumer via interactive digital media. The reporter was the patient's cousin. The patient had the shot and she still get them and had to take medications. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Guillain-Barre syndrome, Intensive care
Clinical narrative: Guillione barre syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine and Shingles vaccine. On an unknown date, an unknown time after receiving Flu vaccine and Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillione barre syndrome) (serious criteria hospitalization and GSK medically significant). The outcome of the guillain barre syndrome was not reported.   It was unknown if the reporter considered the guillain barre syndrome to be related to Flu vaccine and Shingles vaccine.     It was unknown if the company considered the guillain barre syndrome to be related to Flu vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 03-Mar-2023 This case was reported by a patient via interactive digital media. The reporter reported that the patient (friend) received the Flu and both shingles vaccine shot and ended up in ICU with guillione barre syndrome. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR038431 and US2023AMR038429 reported by same reporter. This case was found as duplicate of case US2023AMR038432. All the information from the case US2023AMR038432 was merged into this case. The case US2023AMR038432 was deleted and this case stand as case of record for this patient.; Sender's Comments:  US-GSK-US2023AMR038431:Same patient US-GSK-US2023AMR038429:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Illness, Vaccination failure
Clinical narrative: Suspected vaccination failure; I've had it; Sick/Ended up in the ER both; two shingles shots made me sick/Ended up in the ER both; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I've had it), sickness (Verbatim: Sick/Ended up in the ER both) and sickness (Verbatim: two shingles shots made me sick/Ended up in the ER both). The outcome of the vaccination failure and shingles were unknown and the outcome of the sickness was not reported and the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and sickness to be related to Shingles vaccine. It was unknown if the company considered the vaccination failure, shingles and sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 The case was received from the patient via interactive digital media. The patient had shingles and it was awful.  The patient stated that two Shingles shots made him/her sick for two weeks.  The patient ended up in the emergency room (ER) both times. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: Get shingles shot took 5 days to get over it/suspected vaccination failure; I get my Shingles shot every year; 5 days to get over it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Get shingles shot took 5 days to get over it/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: 5 days to get over it) and inappropriate schedule of vaccine administered (Verbatim: I get my Shingles shot every year). The outcome of the vaccination failure and inappropriate schedule of vaccine administered were unknown and the outcome of the shingles was recovered/resolved (duration 5 days).   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that now he/she received Shingles vaccine every year. The patient stated that he/she experienced shingles and it took 5 days to get over from shingles and all was okay now. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. As the patient stated that he/she now receive Shingles vaccine every year, which led to inappropriate schedule of vaccine administered. Follow-up would not possible as no contact details were available. Note:Only one suspect coded as dose number we cannot confirm how many received but as per 2 dose schedule and received every year medication error was added.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Lost diluent, need to take 2nd dose; Lost diluent, need to take 2nd dose; This non-serious case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Lost diluent, need to take 2nd dose) and inappropriate dose of vaccine administered (Verbatim: Lost diluent, need to take 2nd dose). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-MAR-2023  This report was submitted via the online direct entry reporting system The patient lost diluent so need to take his second dose.  The patient received Shingrix vaccine and lost diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: DTAP, DTAPIPV, DTAPIPV, DTAPIPVHIB, FLU4, HEP, HIBV, MEN, MNQ, RV5, TDAP, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccines administered after temperature excursion; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HEPATITIS B VACCINE (RECOMBIVAX) for prophylaxis, ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylaxis, INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT (INFLUENZA VIRUS VACCINE)) for prophylaxis, HIB VACCINE (ACT-HIB) for prophylaxis, MENQUADFI for prophylaxis, MENACTRA for prophylaxis, DIPHTHERIA VACCINE TOXOID + PERTUSSIS TOXOID + TETANUS VACCINE TOXOID (ADACEL) for prophylaxis, DIPHTHERIA VACCINE TOXOID + PERTUSSIS TOXOID + POLIO VACCINE + TETANUS VACCINE TOXOID (QUADRACEL) for prophylaxis, PENTACEL for prophylaxis and DIPHTHERIA VACCINE TOXOID + PERTUSSIS TOXOID + TETANUS VACCINE TOXOID (DAPTACEL) for prophylaxis.   On 15th December 2022, the patient received Engerix B, Kinrix, Kinrix Pre-Filled Syringe Device, RECOMBIVAX, ROTATEQ, FLUZONE QUADRIVALENT (INFLUENZA VIRUS VACCINE), ACT-HIB, MENQUADFI, MENACTRA, ADACEL, QUADRACEL, PENTACEL and DAPTACEL. On 15th December 2022, unknown after receiving Engerix B, Kinrix and Kinrix 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 Information: GSK receipt date: 02-Feb-2023 Reporter's comment: The reporter reported that the patients administered Engerix B, Kinrix, Kinrix Pre-Filled Syringe Device, Recombivax, Rotateq, Fluzone quadrivalent (influenza virus vaccine), Act-hib, Menquadfi, Menactra, Adacel, Quadracel, Pentacel and Daptacel that had total time of excursion to 2.75 hours and maximum temperature of excursion was 47 F with no reported adverse events. On 15th December 2022 it was total time of excursion to 2.75 hours. No laboratory data reported. Drug IPOL was removed as it was not involved in temperature excursion. Additional supportive information: As all vaccines experienced temperature excursion which led to incorrect storage of drug.   Follow-up information received on 19-FEB-2023 Reporter's Comments: The reporter called to cancel the adverse event because the incorrect information was given. The reporter stated no adverse event happened and asked to please cancel it. Summary of changes: case will be invalidated on follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Impaired work ability, Loss of personal independence in daily activities, Malaise
Clinical narrative: Shingles on back; Missed 2 days of work; Feeling unwell; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 10 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles on back), activities of daily living impaired (Verbatim: Missed 2 days of work) and feeling unwell (Verbatim: Feeling unwell). The outcome of the shingles, activities of daily living impaired and feeling unwell were not reported.   It was unknown if the reporter considered the shingles, activities of daily living impaired and feeling unwell to be related to Shingrix.     It was unknown if the company considered the shingles, activities of daily living impaired and feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-Mar-2023 The reporter said patient missed 2 days of work due to not feeling well and 10 days after administering 1st dose of Shingrix, patient had a case of shingles on her back.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Possible adjuvant  administered by itself; Possible adjuvant  administered by itself; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Possible adjuvant  administered by itself) and inappropriate dose of vaccine administered (Verbatim: Possible adjuvant administered by itself). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-MAR-2023 The reporter asked about whether Shingrix adjuvant was sold separately due to there being two extra vials of powder.  The reporter stated she did not feel like adjuvant was given by itself.  This was just being reported as a possible adverse event of (possible) adjuvant being administered by itself to be on the safe side (compliance).  Health care professional feeling like it was not administered by itself (diluent).  Health care professional did not feel like an adverse event occurred. This was being reported at the guidance of the manager to avoid non-compliance. No other information was provided. The reporter did not consent to follow-up.  The reporter stated she does not feel like adjuvant was given by itself which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case was linked with case US2023034040, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2023034040:Same reporter. Patient 1
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Limb discomfort, Pain
Clinical narrative: Arm feeling like shot with a gun; Whole body was sore radiating; Felt like the flu, most of the day in bed, horrible; Headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced arm discomfort (Verbatim: Arm feeling like shot with a gun), radiating pain (Verbatim: Whole body was sore radiating), influenza-like symptoms (Verbatim: Felt like the flu, most of the day in bed, horrible) and headache (Verbatim: Headache). The outcome of the arm discomfort, radiating pain, influenza-like symptoms and headache were not reported.   It was unknown if the reporter considered the arm discomfort, radiating pain, influenza-like symptoms and headache to be related to Shingles vaccine.     It was unknown if the company considered the arm discomfort, radiating pain, influenza-like symptoms and headache to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-Mar-2023 The patient had his/her first shingles vaccine, the next day was horrible.  Aside from his/her arm feeling like he/she was actually shot with a gun, his/her whole body was sore radiating from my shoulder/ neck down, felt like the flu, headache, most of the day in bed. The patient had to get a second shot.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: had shot and it didn't do any good; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of malaise in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced malaise (Verbatim: had shot and it didn't do any good). The outcome of the malaise was not reported.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.     It was unknown if the company considered the malaise to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the shingles shot and it did not do any good.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got it again; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had a shingles).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Got it again). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-MAR-2023 This case was reported by the patient via interactive digital media.  The reporter stated that, he/she had the Shingrix shot and guess what, he/she had it again (Shingles).  He/She never had a reaction before to any another shot in his/her life.  He/She does not think that, he/she would get the second one. The reporter had stated that, you really need to test it more before you recommend it to everyone, to get it. Follow-up would not possible, as no contact details were available.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Device issue, Exposure via skin contact, Underdose
Clinical narrative: Patient did not get any of the dose; Medication spilled on patient's arm; Medication spilled on patient's arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 5L3HB, expiry date 20-MAY-2024) for prophylaxis.   On 02-MAR-2023, the patient received the 2nd dose of Shingrix. On 02-MAR-2023, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: Patient did not get any of the dose), accidental exposure to product (Verbatim: Medication spilled on patient's arm) and exposure via skin contact (Verbatim: Medication spilled on patient's arm). The outcome of the accidental underdose, accidental exposure to product and exposure via skin contact were unknown.   Additional Information: GSK receipt date: 2-Mar-2023 The reporter consented to follow-up via postal. The patient was administered a dose of Shingrix and while administering, the needle detached from the syringe and the medication spilled on the patient's arm and she is fairly certain that she did not get any of the dose, which led to accidental underdose, accidental exposure to product and exposure via skin contact.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact, Inappropriate schedule of product administration, Product leakage
Clinical narrative: All the vaccine leaked out; Leaked into the patient's arm; Leaked into the patient's arm; 1st dose on 03Aug2022, 2nd on 02Mar2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number DP2x9, expiry date 05-OCT-2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 3rd August 2022 intramuscularly).   On 02-MAR-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 02-MAR-2023, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: All the vaccine leaked out), exposure via skin contact (Verbatim: Leaked into the patient's arm), inadvertent exposure to vaccine (Verbatim: Leaked into the patient's arm) and drug dose administration interval too long (Verbatim: 1st dose on 03Aug2022, 2nd on 02Mar2023). The outcome of the accidental underdose, exposure via skin contact, inadvertent exposure to vaccine and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt date: 06-Mar-2023 A medical assistant from a clinic. She states that when giving a patient their second Shingrix vaccine on day of reporting, all the vaccine did not go into the patient's arm but leaked out and down the patient's arm.   She also reports that the patient got his first Shingrix vaccine which was past the 2 to 6 month recommended dosing schedule. Did not consent to follow-up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: All the vaccine leaked out; Leaked into the patient's arm; Leaked into the patient's arm; 1st dose on 03Aug2022, 2nd on 02Mar2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number DP2x9, expiry date 05-OCT-2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 3rd August 2022 intramuscularly).   On 02-MAR-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 02-MAR-2023, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: All the vaccine leaked out), exposure via skin contact (Verbatim: Leaked into the patient's arm), inadvertent exposure to vaccine (Verbatim: Leaked into the patient's arm) and drug dose administration interval too long (Verbatim: 1st dose on 03Aug2022, 2nd on 02Mar2023). The outcome of the accidental underdose, exposure via skin contact, inadvertent exposure to vaccine and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt date: 06-Mar-2023 A medical assistant from a clinic. She states that when giving a patient their second Shingrix vaccine on day of reporting, all the vaccine did not go into the patient's arm but leaked out and down the patient's arm.   She also reports that the patient got his first Shingrix vaccine which was past the 2 to 6 month recommended dosing schedule. Did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Injection site pain, Sneezing, Somnolence
Clinical narrative: Sore arm at injection site; Sneezing; Swollen eyes; Feeling sleepy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included seasonal allergy and systemic lupus erythematosus. Concomitant products included fexofenadine hydrochloride (Allegra).   On 01-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular). On 01-MAR-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Sore arm at injection site), sneezing (Verbatim: Sneezing), eye swelling (Verbatim: Swollen eyes) and sleepiness (Verbatim: Feeling sleepy). The outcome of the injection site pain, sneezing, eye swelling and sleepiness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, sneezing, eye swelling and sleepiness to be related to Shingrix.     It was unknown if the company considered the injection site pain, sneezing, eye swelling and sleepiness to be related to Shingrix.   Additional Information: GSK Receipt date: 02-Mar-2023 Patient was the caller asking if sneezing was an expected side effect of the Shingles vaccine or not. She also mentioned that she had a sore arm at the injection site, swollen eyes and was feeling sleepy. The reporter provided education, offered medical disclaimer, referred to HCP. The patient stated she did not want to bother them. Did not consent to follow-up.
Age: 17.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Shingrix given instead of meningitis shot; Shingrix given to a 17-year-old; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received Herpes zoster (Shingrix) (batch number 7FF7C, expiry date 28-MAY-2024) for prophylaxis.   On 01-MAR-2023, the patient received the 1st dose of Shingrix. On 01-MAR-2023, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: Shingrix given instead of meningitis shot) and inappropriate age at vaccine administration (Verbatim: Shingrix given to a 17-year-old). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt date: 02-Mar-2023 The reporter informed that a 17-year-old patient came at his/her family practice clinic a day before reporting and was mistakenly given a Shingrix vaccine instead of meningitis vaccine that she was scheduled to get by staff error. The reporter asked if any danger to patient besides possible pain at injection site or not. The reporter thought that she should still get 2 shot series after age 50 as this dose would be considered as invalid. The reporter asked if any data about how often patients get this vaccine out of the FDA recommended age window. The reporter asked if any adverse effects that they were aware of. The reporter would call her mom to explain the situation but want to be fully informed before he/she call. The reporter consented to follow up. The 17.5-year-old patient received shingrix vaccine instead of mengitis vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-Mar-2023 Registered pharmacist reported that a patient got shingles 2 weeks after their first dose of Shingrix.  The reporter asked how long the patient had to wait before they get the second dose.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Antiviral treatment, Disturbance in attention, Feeling abnormal, Herpes zoster
Clinical narrative: spots & rash it was shingles, hospitalized for colon cancer surgery; pimples on back; itched like crazy; felt like sand; does not remember anything, was not alert; spots and rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included colon cancer (had colon cancer prior to shingrix vaccination).   On 03-OCT-2022, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: spots & rash it was shingles, hospitalized for colon cancer surgery), pimples (Verbatim: pimples on back), pruritus (Verbatim: itched like crazy), feeling abnormal (Verbatim: felt like sand), disturbance in attention (Verbatim: does not remember anything, was not alert) and spot-like rash (Verbatim: spots and rash). The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). The outcome of the shingles, pimples, pruritus and feeling abnormal were not reported and the outcome of the disturbance in attention was unknown and the outcome of the spot-like rash was recovering/resolving.   It was unknown if the reporter considered the shingles, pimples, pruritus, feeling abnormal, disturbance in attention and spot-like rash to be related to Shingrix.     It was unknown if the company considered the shingles, pimples, pruritus, feeling abnormal, disturbance in attention and spot-like rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-Mar-2023 Reporter was a female patient and reports that she received the 1st dose of Shingrix on 3rd October 2022.  She was admitted to the hospital for a week 29th November 2022 for colon cancer surgery to have part of her colon taken out.  Her cardiologist and pulmonologist both had to be aware of what was going on with her prior to performing the colon cancer surgery, and were checking her all over, and the pulmonologist saw spots and a rash on the patient's back, on her left shoulder beyond where her underarm was on her left side, and a few at her waist on her right side.  The pulmonologist told the patient these spots and rash were shingles. 29th November 2022, while she was preparing for the colon surgery, and the patient was put on an antiviral (unknown product) for about a week.  The patient did not remember anything about the week she was in the hospital as the surgery took 11 hours, and she was not alert for the entire week after. The patient did say a couple of the places (spots and rash) took a long time to heal over, and a couple of the places on her back were like pimples, and the areas involved felt like sand and itched like crazy. Did not consent to follow-up.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash macular
Clinical narrative: spots & rash it was shingles, hospitalized for colon cancer surgery; pimples on back; itched like crazy; felt like sand; does not remember anything, was not alert; spots and rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included colon cancer (had colon cancer prior to shingrix vaccination).   On 03-OCT-2022, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: spots & rash it was shingles, hospitalized for colon cancer surgery), pimples (Verbatim: pimples on back), pruritus (Verbatim: itched like crazy), feeling abnormal (Verbatim: felt like sand), disturbance in attention (Verbatim: does not remember anything, was not alert) and spot-like rash (Verbatim: spots and rash). The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). The outcome of the shingles, pimples, pruritus and feeling abnormal were not reported and the outcome of the disturbance in attention was unknown and the outcome of the spot-like rash was recovering/resolving.   It was unknown if the reporter considered the shingles, pimples, pruritus, feeling abnormal, disturbance in attention and spot-like rash to be related to Shingrix.     It was unknown if the company considered the shingles, pimples, pruritus, feeling abnormal, disturbance in attention and spot-like rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-Mar-2023 Reporter was a female patient and reports that she received the 1st dose of Shingrix on 3rd October 2022.  She was admitted to the hospital for a week 29th November 2022 for colon cancer surgery to have part of her colon taken out.  Her cardiologist and pulmonologist both had to be aware of what was going on with her prior to performing the colon cancer surgery, and were checking her all over, and the pulmonologist saw spots and a rash on the patient's back, on her left shoulder beyond where her underarm was on her left side, and a few at her waist on her right side.  The pulmonologist told the patient these spots and rash were shingles. 29th November 2022, while she was preparing for the colon surgery, and the patient was put on an antiviral (unknown product) for about a week.  The patient did not remember anything about the week she was in the hospital as the surgery took 11 hours, and she was not alert for the entire week after. The patient did say a couple of the places (spots and rash) took a long time to heal over, and a couple of the places on her back were like pimples, and the areas involved felt like sand and itched like crazy. Did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Receivd a Shingrix that was stored improperly; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number ZG744, expiry date 28-AUG-2023) for prophylaxis.   In SEP-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Receivd a Shingrix that was stored improperly). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 02-MAR-2023 The pharmacist reported that a patient received his first dose of Shingrix at a different, but was informed that the vaccines were stored improperly.  The reporter did not know the temperatures the vaccine were exposed to. The reporter consented to follow up. Additional supportive information: The patient received Shingrix which was  stored improperly, which led to incorrect storage of drug.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain in left arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number l32mf, expiry date 31-MAY-2024) for prophylaxis.   On 27-FEB-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: pain in left arm). The patient was treated with ibuprofen (Advil) and paracetamol (Tylenol). The outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt date: 02-Mar-2023 Reporter was the patient, who received her first dose of Shingrix on Monday.  She stated that after receiving the dose, she experienced pain in her left arm.  She had tried ice, Tylenol, and Advil for the pain.  The pain was not as bad on day of reporting but had not yet resolved. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Possible adjuvant  administered by itself; administered by itself; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Possible adjuvant  administered by itself) and inappropriate dose of vaccine administered (Verbatim: administered by itself). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-MAR-2023 The reporter asked about whether Shingrix adjuvant was sold separately due to there being two extra vials of powder.  The reporter stated she does not feel like adjuvant was given by itself.  This is just being reported as a possible adverse event of (possible) adjuvant being administered by itself to be on the safe side (compliance).  Health care professional feeling like it was not administered by itself (diluent). Health care professional does not feel like an adverse event  occurred. This was being reported at the guidance of my manager to avoid non-compliance. The reporter did not consent to follow-up.  The reporter stated patient does not feel like adjuvant was given by itself which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. This case had been linked with US2023AMR034657, reported by the same reporter different patient.; Sender's Comments:  US-GSK-US2023AMR034657:Same reporter. Patient 2
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix administered to a 5-year-old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2LG35, expiry date 09-MAY-2025) for prophylaxis.   On 11-FEB-2023, the patient received Boostrix. On 11-FEB-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix administered to a 5-year-old). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 06-MAR-2023 The vaccine administration facility was the same as primary reporter. A dose of Boostrix was inadvertently administered to a 5 year old patient, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: Low back pain, it is worse; This non-serious case was reported by a consumer via call center representative and described the occurrence of low back pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of injection site pain (received 1st dose on an unknown date, refer link case US2023AMR035986).   On 03-MAR-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid). On 03-MAR-2023, less than a day after receiving Shingrix, the patient experienced low back pain (Verbatim: Low back pain, it is worse). The patient was treated with paracetamol (Tylenol). The outcome of the low back pain was not recovered/not resolved.   It was unknown if the reporter considered the low back pain to be related to Shingrix.     It was unknown if the company considered the low back pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR035986   Additional Information: GSK Receipt date: 06-Mar-2023 The reporter was the patient, a 65-year-old female.  She received her second dose of Shingrix and within a few hours she developed low back pain.  It was worse on day of reporting. She treated the pain with one Tylenol daily.  Nothing else was reported. The reporter declined to provide HCP contact information at this time as she was switching doctors however, they might follow up with the reporter. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2023AMR035986:Same reporter