chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE info; TE evaluation of refrigerated products; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.   On 19-APR-2022, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot #1780867, expiration date: 08-AUG-2023 (strength, dose and route of administration were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event).  On an unknown date, before the vaccination, the sample of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) underwent a temperature excursion at 58.5 Fahrenheit degrees (F) for 4 hours and 2 minutes. No previous temperature excursions were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; 14 patients received possibly improperly stored vaccines due to lack of temperature readings.; This spontaneous report was received from a healthcare worker and refers to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 07-FEB-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (strength, dose, frequency, and route of administration were not provided); which lot # T028582 has been verified to be a valid lot number with expiration date: 04-MAR-2023, administered as prophylaxis. The administered dose of the vaccine possibly experienced a temperature excursion (product storage error) since 10-JAN-2022, due to lack of temperature readings (refrigerator and freezer temperatures were not recorded since that date). No previous temperature excursion occurred. There was no adverse event reported.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2205USA000544: US-009507513-2205USA000533: US-009507513-2205USA000524: US-009507513-2205USA000464: US-009507513-2205USA000503: US-009507513-2205USA000540: US-009507513-2205USA000560:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Not additional adverse event were reported; received possible improperly stored vaccines due to lack of temperature; This spontaneous report was received from a healthcare worker and refers to a patient of unspecified age and gender. The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 01-FEB-2022, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA), which lot # T020655 has been verified to be a valid lot number with expiration date: 16-JUN-2022, administered for prophylaxis (strength, dose, route of administration and anatomical location were not provided).  The reporter informed that the administered vaccine had been possibly improperly stored due to lack of temperature readings (product storage error). The refrigerator and freezer temperatures were not recorded since 10-JAN-2022 and temperature was unknown by the reporter. There was no previous temperature excursion. No additionally adverse events were reported, and no further information was provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA000524: US-009507513-2205USA000464: US-009507513-2205USA000467: US-009507513-2205USA000503: US-009507513-2205USA000533: US-009507513-2205USA000540: US-009507513-2205USA000544: US-009507513-2205USA000564: US-009507513-2205USA000560: US-009507513-2205USA000525: US-009507513-2205USA000535: US-009507513-2205USA000545: US-009507513-2205USA000553:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Nurse reported that a patient received a expired dose of PROQUAD.  No other issues or concerns noted. Administered on 5/2/2022 PROQUAD: LOT: T028298 EXP: Feb 16, 2022 NO PQC.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous dug reactions, or allergies were not reported.  On 02-MAY-2022, the patient was vaccinated with an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number T028298, expiration date 16-FEB-2022) as prophylaxis (expired product administered).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Inbound call from nurse to complete temperature excursion for VARIVAX. Complete excursion details collected from nurse, it was reported that the vaccine was administered after temperature excursion. No PQC. No additional information.         ?    N; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 27-APR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number U026207, expiration date 24-AUG-2023 and lot number U029496, expiration date 21-SEP-2023) as prophylaxis, after temperature excursion (product storage error).  The vaccine experienced a temperature excursion of minus 9 degrees Celsius (C) for 1 hour and 45 minutes. There was no previous temperature excursion.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information; LPN calling for stability data on vaccine that has been administered past expiration date.; This spontaneous report was received from a Licensed Practical Nurse (LPN) referring to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 30-APR-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, (strength, dose, frequency, and route of administration were not provided); which lot # T035721 has been verified to be a valid lot number with expiration date: 15-APR-2022, and was administered as prophylaxis. The reporter was calling for stability data on vaccine that had been administered past the expiration date (expired product administered). When asked about prior temperature excursions, was transferred to the person who was in charge of vaccine storage, and she confirmed that the expired administered vaccine was never stored at a temperature outside of its recommended storage range. No additional adverse event (AE) information. No product quality complaint (PQC) involved.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Inbound call from nurse to complete temperature excursion for VARIVAX. Complete excursion details collected from nurse, it was reported that the vaccine was administered after temperature excursion. No PQC. No additional information.         ?    N; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 29-APR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number U026207, expiration date 24-AUG-2023 and lot number U029496, expiration date 21-SEP-2023) as prophylaxis, after temperature excursion (product storage error).  The vaccines experienced a temperature excursion of minus (-) 9 degrees Celsius (C) for 1 hour and 45 minutes. There was no previous temperature excursion.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product use issue
Clinical narrative: No additional AE reported; Nurse does state second dose of GARDASIL 9 was administered to a patient 2 weeks from the first dose; This spontaneous report was received from a nurse referring to a patient of unknown gender and age. Information regarding the patient's historical conditions, past drugs reactions or allergies, concurrent conditions or concomitant therapies was not provided.  On an unknown date in March 2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and 2 weeks from the first administration was administered the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) instead of 2 months (product use issue). The nurse inquired if the third (3rd) still needed to be administered at 6 months. No additional adverse event details.
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported.; Nurse reports a 17.5 year old male patient was administered an adult dose of VAQTA; This spontaneous report was received from nurse and refers to a 17.5-year-old male patient.   The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not reported.  On 08-APR-2022, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) (lot #T036739 and expiration date: 22-APR-2022)(exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product administered to patient of inappropriate age). No additional adverse event was reported (No adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Herpes zoster, Post herpetic neuralgia
Clinical narrative: Post herpetic neuralgia; multiple outbreaks of herpes zoster; balance issues; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) gender not provided. The pt's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unspecified date, the pt received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage information, lot # and expiration date were not provided) for its intended purpose: the prevention of shingles (herpes zoster). On unspecified date, after the receipt of Zoster Vaccine Live (ZOSTAVAX), the patient suffered multiple outbreaks of herpes zoster, postherpetic neuralgia, and balance issues. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a result of the vaccination with Zoster Vaccine Live (ZOSTAVAX) the patient experienced sustained severe and permanent personal injuries, resulted in physical limitations not present prior using Zoster Vaccine Live (ZOSTAVAX). At the time of the report, the patient had not recovered from the events. The reporter considered the events to be related to the suspect therapy. Upon internal review, the events herpes zoster, postherpetic neuralgia and balance issues were considered disabling as they resulted in physical limitations not present prior using Zoster Vaccine Live (ZOSTAVAX).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Feeling hot, Injection site pain, Urticaria
Clinical narrative: Hives with hot sensation; Hives with burning sensation; Soreness and Tenderness at the injection site; Hives, started on her forehead and traveled all the way down her body to her legs/ again on 08-mar-2022 started on her forehead and stopped at her chest.; experienced hives again on 3/8/2022 but this time the hives started on her forehead and stopped at her chest. Consumer reported that the hives faded away after 2 hours.; This 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.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose in September 2021, refer link case US2022044816).   On 3rd March 2022, the patient received the 2nd dose of Shingrix. On 3rd March 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On 6th March 2022, the patient experienced hives, feeling hot and burning sensation. On 8th March 2022, the patient experienced hives. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, hives and hives were recovered/resolved and the outcome of the feeling hot and burning sensation were unknown.   It was unknown if the reporter considered the injection site pain, hives, hives, feeling hot and burning sensation to be related to Shingrix.     Linked case(s) involving the same patient:  US2022044816  Additional details were provided as follows: The patient reported that with the 2nd dose, patient experienced tenderness and soreness at the injection site that resolved 2 days later.  Three days after receiving vaccination, the patient experienced hives, that started on her forehead, that were a hot and burning sensation, and traveled all the way down her body to her legs within an hour of the hives appearing and it was faded away after 3 hours.  Five days after receiving vaccination, the patient experienced hives again but this time the hives started on her forehead and stopped at her chest and it was faded away after 2 hours.  The representative spoke from content and package insert. The reporter consented to follow up. Consent obtained to contact health care professional and consumer for follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022044816:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: neck and face are itchy; rash; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus facial in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 26th April 2022, the patient received Shingles vaccine. On 30th April 2022, 4 days after receiving Shingles vaccine, the patient experienced pruritus facial and rash. On an unknown date, the outcome of the pruritus facial and rash were not recovered/not resolved.   It was unknown if the reporter considered the pruritus facial and rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-April-2022 Reporter's comment: The patient had a shingles shot last Tuesday and on the reporting day patient's neck and face were itchy and had a rash asked did patient need to be concerned. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix- second dose after 8 months; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a 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 drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 2-MAY-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient received Shingrix second dose after 8 months. Additional Supportive Information: The patient received Shingrix 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only liquid portion; received only liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 72A32, expiry date 8th July 2023) for prophylaxis.   On 26th April 2022, the patient received Shingrix. On 26th April 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 2-MAY-2022 Reporter's Comment: Registered nurse reported that the patient received only liquid portion of Shingrix, without being reconstituted and wanted to know if they have to be revaccinated since it did not seem like a full dose and in case revaccination needed, which would be the recommended interval between doses. Healthcare professional did not have any demographic details from patient since she send them over to the manager. Healthcare professional was not sure if lot number was for liquid portion or lot number from the box. She was not sure and did not have any further details. The reporter consented to follow up. Additional Supportive Information: The patient received only liquid portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is one of 7 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070806:Same reporter US-GLAXOSMITHKLINE-US2022070807:Same reporter US-GLAXOSMITHKLINE-US2022070808:Same reporter US-GLAXOSMITHKLINE-US2022072616:Same reporter US-GLAXOSMITHKLINE-US2022AMR073093:Same reporter US-GLAXOSMITHKLINE-US2022AMR073094:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Lymph node pain
Clinical narrative: Area is still red; Area is still itchy; Lymph node under the arm pit is sore; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 26th April 2022, the patient received the 1st dose of Shingles vaccine. On 26th April 2022, less than a day after receiving Shingles vaccine, the patient experienced injection site erythema, injection site itching and lymph node pain. On an unknown date, the outcome of the injection site erythema, injection site itching and lymph node pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching and lymph node pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-MAY-2022 Reporter's comments: The case was reported via interactive digital media. The patient received first shingles vaccine last Tuesday and the area was red and itchy. The patient also noticed the lymph node under the arm pit was sore. The reporter asked as was this normal 6 days later.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on 2020 forgot to get second; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-MAY-2022 Reporter's comments: The patient received 1st dose on 26th October 2020, forgot to get the second dose. The reporter stated that it was 17 months since the first dose. Additional Supportive Information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: very sick; This case was reported by a consumer via call center representative and described the occurrence of sickness 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, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-May-2022 Reporter's Comments: The patient was very sick after receiving 1st dose of Shingrix. The patient said that second dose side effects of shingrix was as bad as first.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: horrible reaction; This case was reported by a consumer and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-MAY-2022 Reporter's Comments: The case was self reported by the patient. The patient reported that patient received a dose of Shingrix vaccine one week after patient experienced horrible reaction. The patient was going to see a doctor and asked for any suggestions. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles 4 years after 2 doses of Shingrix/suspected vaccination failure; Developed symptoms of Shingles; This case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In May 2018, the patient received the 2nd dose of Shingrix. In March 2018, the patient received the 1st dose of Shingrix. On an unknown date, 4 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 06-MAY-2022 Reporters comment: The patient self-reported the case. The patient developed symptoms of Shingles 4 years after receiving Shingrix.  The patient asked if it was possible to get a second round of the vaccine.  Pharmacist said no, but he would not ask GlaxoSmithKline representative. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding laboratory test confirming shingles was unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first shot on 7/21/20, did not get second yet; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received first Shingles shot on 21st July 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 8-MAY-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient did not get the second shot yet and asked could he/she still get the second shot now. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: administered an extra dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (2 dose schedule received on an unknown dates).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 2-May-2022 Reporter's comments: The clinic patient was administered an extra dose of Shingrix. The patient was fine and he only had general information. Follow-up from safety was asked to pharmacist through chat and he stated he only had general information and no further details to report. Additional Supportive Information: The patient received extra dose of Shingrix, which led to extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Rash macular, Skin warm, Swelling
Clinical narrative: Arm twinges on occasion; Broke out particularly around the eye and nose; Arm became spotty, swollen just below the injection site; Arm became hot, just below the injection site; Arm became spotty just below the injection site; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 4C493, expiry date 20th March 2023) for prophylaxis.   The patient's past medical history included shingles (10 years before the date of reporting).   On 29th October 2021, the patient received the 1st dose of Shingrix .5 ml. In October 2021, 2 days after receiving Shingrix, the patient experienced local swelling, skin warm and spot-like rash. In November 2021, the patient experienced shingles. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the shingles, local swelling, skin warm and spot-like rash were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the shingles, local swelling, skin warm, pain in arm and spot-like rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 2-May-2022 Reporter's comments: This case was reported by the patient. The patient stated that she had shingles approximately 10 years ago which started at the top of her head and spread to the right side of her face around the eye and nose. She stated she had no lasting symptoms after that. The patient received her first dose of Shingrix in her left upper arm. About 2 days later, her left arm became spotty, swollen and hot, just below the injection site. These symptoms subsequently abated. Less than 9 months after vaccination, her left arm twinges on occasion. About 1 week after receiving the Shingrix vaccine, the areas where she had shingles prior, she broke out particularly around the eye and nose. These also subsequently resolved. The reporter also stated that due to these effects, she declared she was not going to receive her second vaccine. The consented to follow up was given. The reporter gave consent to follow up with the healthcare professional (pharmacy).; Sender's Comments:  US-GLAXOSMITHKLINE-US2022072608:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Every one she knows had flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of patients 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.     Additional Information: GSK Receipt Date: 2-May-2022 Reporter's comments: The reporter stated that everyone she knows had a reaction to the Shingrix vaccine. She stated that the reaction were flu-like symptoms. Additional Supportive Information: This case was linked with case US2022072606, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022072606:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received 3 doses of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient received 2 dose schedule on an unknown dates).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 2-May-2022 Reporter's comments: The patient received 3 doses of Shingrix. No symptoms reported. The consent to follow up was given via mail. The healthcare did not have the patient's date of birth or vaccination information or dates at the time of report. Additional Supportive Information: The patient received 3 doses of Shingrix, which led to extra dose administered.
Age: 0.92
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Received by error Infanrix instead of Tdap; 11 yo patient received by error Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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 Information: GSK Receipt Date: 2-May-2022 Reporter's comments: Medical Assistant reported that a 11 years and 4 months old patient received Infanrix -Dtap pediatric dose by error instead of a Tdap adult dose. The consent to follow up was given by email. Additional Supportive Information: The patient received Infanrix instead of Tdap, which led to wrong vaccine used and inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only liquid portion; received only liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 72A32, expiry date 8th July 2023) for prophylaxis.   On 22nd April 2022, the patient received Shingrix. On 22nd April 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 2-MAY-2022 Reporter's Comment: Registered nurse reported that the patient received only liquid portion of Shingrix, without being reconstituted and wanted to know if they have to be revaccinated since it did not seem like a full dose and in case revaccination needed, which would be the recommended interval between doses. Healthcare professional did not have any demographic details from patient since she send them over to the manager. Healthcare professional was not sure if lot number was for liquid portion or lot number from the box. She was not sure and did not have any further details. The reporter consented to follow up. Additional Supportive Information: The patient received only liquid portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is one of 7 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070806:Same reporter US-GLAXOSMITHKLINE-US2022070807:Same reporter US-GLAXOSMITHKLINE-US2022070808:Same reporter US-GLAXOSMITHKLINE-US2022AMR073092:Same reporter US-GLAXOSMITHKLINE-US2022AMR073093:Same reporter US-GLAXOSMITHKLINE-US2022AMR073094:Same reporter
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose in 2019, second in 2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received in September 2019).   In April 2022, the patient received the 2nd dose of Shingrix. In April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 02-MAY-2022 Reporter's Comment: The case was reported by the patient. The patient asked, about the Shingrix vaccine, the shingles vaccine and the gentleman wasn't quite sure, he just kind of quoted something from the Disease Control, because he had two of the doses, one in 2019, and one in 2022. But he was kind of unable to tell that, whether he should schedule a second dose in 2022, or whether the 2019 and 2022 already made that the two doses, and he didn't need any more. So he referred me to other areas, other numbers for him to talk to.  But that was the only thing, he didn't know that he quite gave a yes or no.  He didn't need to schedule any more, that was the only negative comment he had received. The reporter consented to follow up. Additional Supportive Information: The patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: mixed in sterile solution instead of the proper diluent; mixed in sterile solution instead of the proper 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 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA591A, expiry date 31st August 2022) for prophylaxis.   On 29th April 2022, the patient received Menveo. On 29th April 2022, 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 Information: GSK Receipt Date: 03-MAY-2022 Reporter's Comment: The reporter was medical assistant. She stated that, she became aware of an administration of Menveo dose which was mixed in sterile solution instead of the proper diluent included in the packaging.  Transferred to medical information for further assistance and provided medical information agent with adverse event number. The reporter consented to follow up. Additional Supportive Information: She stated that, she became aware of an administration of Menveo dose which was mixed in sterile solution instead of the proper diluent included in the packaging, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pain in extremity, Paraesthesia
Clinical narrative: Tingling on the left side of her face radiating down her neck; She also began experiencing dizziness; Having a very sore arm that lasted 2 days after the vaccine; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number E99E7, expiry date 11th May 2023) for prophylaxis.   On 14th January 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In February 2022, 1 month after receiving Shingrix, the patient experienced tingling and dizziness. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the tingling and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, tingling and dizziness to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-MAY-2022 Reporter's Comment: The case was reported by the patient. She reported that after receiving vaccine in her left deltoid, having a very sore arm that lasted 2 days after the vaccine. About a month later, she began to experience tingling on the left side of her face radiating down her neck.  She also began experiencing dizziness. Neither of these symptoms were resolved. Healthcare professional information was provided. The reporter consented to follow up. Additional Supportive Information: The case had been linked to US2022073187,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022073187:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose of Shingrix 1 month after the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 03-MAY-2022 Reporter's Comment: The reporter reported that, a patient received their 2nd dose of Shingrix 1 month after the first dose was given.  The reporter wanted to know that, does the patient need to be redosed. The reporter stated that, he was an intermediary and did not have any additional information on the patient during the encounter. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, a patient received their 2nd dose of Shingrix 1 month after the first dose was given, which led to shortening of vaccination schedule.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain upper
Clinical narrative: Stomach started hurting; Stomach felt bloated; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, several weeks after receiving Shingrix, the patient experienced stomach pain and abdominal bloating. On an unknown date, the outcome of the stomach pain and abdominal bloating were recovered/resolved.   It was unknown if the reporter considered the stomach pain and abdominal bloating to be related to Shingrix.  Linked case(s) involving the same patient:US2022AMR073540   Additional Information: GSK Receipt Date: 03-MAY-2022 Reporter's Comment: The case was reported by the patient. The patient was stating that, a few weeks after getting his Shingrix vaccine, his stomach started hurting and felt bloated. He said that lasted about a month and then went away.  The reporter didn't have any information in regards to lot number or expiration of the vaccine. The reporter did not consent to follow-up. No health care professional for follow up. Additional Supportive Information: For tolerance of 2nd dose, refer case US2022073189.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR073540:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not administered yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received on 15th June 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-MAY-2022 Reporter's Comment: The reporter did not provide patients initials, DOB (date of birth) or vaccine lot number. The second dose of Shingrix was not administered yet. The reporter consented to follow up. Additional Supportive Information: The patient did not receive the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received 3 doses of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number NE49X, expiry date 23rd August 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th May 2018 with lot X3M27 and expiry date 29th August 2020) and Shingrix (received 2nd dose on 14th July 2018 with lot B9739 and expiry date 22nd November 2020).   On 29th November 2021, the patient received the 3rd dose of Shingrix. On 29th November 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 03-May-2022 Reporter's comment: Pharmacist reported that he/she had a patient that received 3 doses of Shingrix over a 3 year time period.  Consented to follow-up. Additional Supportive Information: The patient received 3 doses of Shingrix, which led to extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in 2019 has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 03-May-2022 Reporter's comment: Pharmacist reported that a patient had not received dose two. Consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: sore at the injection site; This 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.   On 27th April 2022, the patient received the 1st dose of Shingrix (intramuscular). On 27th April 2022, 1 hr after receiving Shingrix, the patient experienced injection site pain. On 1st May 2022, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Additional Information: GSK receipt date: 3-May-2022 Reporter's comment: The patient reported that she received a dose of Shingrix in left arm and about an hour after receiving the Shingrix vaccine she had a sore arm at the injection site. The reporter did not gave permission to contact health care professional. Did not consent to follow-up.
Age: 82.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect route of product administration
Clinical narrative: EngerixB intravenous instead of intramuscular; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 82-year-old female patient who received HBV (Engerix B) (batch number F73DG, expiry date 3rd July 2023) for prophylaxis.   On 4th May 2022, the patient received Engerix B (intravenous). On 4th May 2022, unknown after receiving Engerix B, 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 Information: GSK Receipt Date: 04-MAY-2022 Reporter's Comment: Registered nurse reported that on the day of reporting (today) another nurse accidentally gave Engerix B to a patient intravenous instead of intramuscular.  Health care provider wanted to knew if there was any information related to adverse event due to this situation or any information available regarding patient safety The reporter consented to follow up. Additional Supportive Information: The patient received Engerix B intravenous instead of intramuscular. which led to intramuscular formulation administered by other route.