chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Office manager responsible for storage and handling of vaccines reported patient administered MMRII and VARIVAX that experienced supported temperature excursion.  See related AE 02151018 and AE  02151019.  No additional AE information.  No PQC.; Office manager responsible for storage and handling of vaccines reported patient administered MMRII and VARIVAX that experienced supported temperature excursion.  See related AE 02151018 and AE  02151019.  No additional AE information.  No PQC.; This spontaneous report was received from an office manager referring to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant therapies, concurrent conditions and previous drug reactions or allergies were not reported.   On 13-APR-2022, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rha) (M-M-R II) 0.5 milliliters (mL), once (lot number  T027937 has been verified to be valid, expiration date reported and established as 18-AUG-2022 ) and one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (mL), once (lot number U019904  has been verified to be valid, expiration date reported and established as 24-JUN-2023) (routes of administration, anatomical sites of vaccination, and vaccine schemes were not reported). Both vaccines were administered as prophylaxis.   It was reported that the vaccines were exposed to supported temperature excursion before being administered. No additional adverse event was reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA007163:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Caller reports expired PROQUAD administered.  No other information provided.  No additional AEs or PQC reported.; Caller reports expired PROQUAD administered.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender. The concomitant medications included sterile diluent (STERILE DILUENT). Information regarding the patient's pertinent medical history, concurrent conditions, , previous drug reactions or allergies was unknown.  On 21-APR-2022, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live human recombinant albumin (rHA) (PROQUAD) at a dose of 0.5 milliliters (mL) administered subcutaneously (SQ) as prophylaxis (lot number T035409 has been verified to be a valid lot, expiration date reported and stablished as 14-APR-2022) (formulation, strength, anatomical location were not provided) (expired product administered). No adverse events (AE) reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pruritus
Clinical narrative: Itching; Paining; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Got shingles twice on back).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pruritus and pain. On an unknown date, the outcome of the pruritus and pain were unknown.   It was unknown if the reporter considered the pruritus and pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR066750   Additional Information: GSK Receipt Date: 18-APR-2022  Reporter's Comments: This case was received from the patient via interactive digital media. The patient got Shingles shots and still had itching and paining years after. Additional Supportive Information: The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR066750:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Paraesthesia
Clinical narrative: swollen lymph nodes; tingling in my left facial trigeminal area; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes 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, less than a week after receiving Shingrix, the patient experienced enlargement of lymph nodes and tingling. On an unknown date, the outcome of the enlargement of lymph nodes and tingling were unknown.   It was unknown if the reporter considered the enlargement of lymph nodes and tingling to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine on Monday and on Thursday he/she had two swollen lymph nodes at the collar bone on the same side of the injection (left).  No other symptoms of disease to explain this reaction. The patient stated that as the next nodes swelled he/she felt tingling in his/her left facial trigeminal area.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: itching; breaking out; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox as a kindergartener and another bout when patient was in his/her 60's).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced shingles and pruritus. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the pruritus was unknown.   It was unknown if the reporter considered the shingles and pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and the next day after vaccination broke out itching so caught it early. The patient stated that his/her was gone in 5 days. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had it twice! Had shots too !/Suspected vaccination failure; Had it twice; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 20-Apr-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had them twice, it was not fun. The patient had shots too. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: A little arm soreness; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 19th April 2022, the patient received the 1st dose of Shingles vaccine. In April 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient had no problem except a little arm soreness. The patient was exercising it and it was better. Follow-up would not possible, as no contact, details were available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: It itches; Suspected vaccination failure; Broke out now; Water blister on left hand, on finger; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Family History) (shingles for daughter and niece).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 21st April 2022, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blister. On an unknown date, the patient experienced pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, blister and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister and pruritus to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 21-Apr-2022 Reporter's Comments: This case was reported by the patient. The patient was vaccinated in 2019 with both doses and had a blister on her left hand finger when waking up the morning of the day of reporting and wanted to know if she needed to be revaccinated, the patient described it was a water blister and it itched, only one blister so far but had been itching between all fingers on left hand. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Recalled product administered
Clinical narrative: administrated with engerix-b batch recall; administrated with engerix-b batch recall; This case was reported by a nurse via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 7th December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   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: 18-APR-2022 Reporter's comments: No patient's identifiers were provided.  The patient was administrated with Engerix B batch recall for October.  The reporter had been on maternity leave and had just found out about it. No vaccination date was provided. No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The nurse reported that a patient was administered with Engerix B batch recall, which led to recalled drug administered and drug dispensing error. The vaccine administration facility was the same as primary reporter. This case is one of the 8 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066344:Same reporter US-GLAXOSMITHKLINE-US2022AMR068022:Same reporter US-GLAXOSMITHKLINE-US2022AMR068023:Same reporter US-GLAXOSMITHKLINE-US2022AMR068024:Same reporter US-GLAXOSMITHKLINE-US2022AMR068025:Same reporter US-GLAXOSMITHKLINE-US2022AMR068026:Same reporter US-GLAXOSMITHKLINE-US2022AMR068027:Same reporter
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Recalled product administered
Clinical narrative: administrated with engerix-b batch recall; administrated with engerix-b batch recall; This case was reported by a nurse via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 7th December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   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: 18-Apr-2022 Reporter's comments: No patient's identifiers were provided.  The patient was administrated with Engerix B batch recall for October.  The reporter had been on maternity leave and had just found out about it. No vaccination date was provided. No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The patient was administered with Engerix B batch recall, which led to recalled drug administered and drug dispensing error. This was 1 of the 8 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066344:Same reporter US-GLAXOSMITHKLINE-US2022AMR068021:Same reporter US-GLAXOSMITHKLINE-US2022AMR068023:Same reporter US-GLAXOSMITHKLINE-US2022AMR068024:Same reporter US-GLAXOSMITHKLINE-US2022AMR068025:Same reporter US-GLAXOSMITHKLINE-US2022AMR068026:Same reporter US-GLAXOSMITHKLINE-US2022AMR068027:Same reporter
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administration error, Product dispensing error
Clinical narrative: administrated with engerix-b batch recall; administrated with engerix-b batch recall; This case was reported by a nurse via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 7th December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   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: 18-Apr-2022 Reporter's comments: No patient's identifiers were provided.  The patient was administrated with Engerix B batch recall for October.  The reporter had been on maternity leave and had just found out about it. No vaccination date was provided. No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The nurse reported that a patient was administered with Engerix B batch recall, which led to recalled drug administered and drug dispensing error. The vaccine administration facility was the same as primary reporter. This was 1 of the 8 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR068022:Same reporter US-GLAXOSMITHKLINE-US2022066344:Same reporter US-GLAXOSMITHKLINE-US2022AMR068021:Same reporter US-GLAXOSMITHKLINE-US2022AMR068024:Same reporter US-GLAXOSMITHKLINE-US2022AMR068025:Same reporter US-GLAXOSMITHKLINE-US2022AMR068026:Same reporter US-GLAXOSMITHKLINE-US2022AMR068027:Same reporter
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product dispensing error, Recalled product administered
Clinical narrative: administrated with engerix-b batch recall; administrated with engerix-b batch recall; This case was reported by a nurse via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 7th December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   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: 18-APR-2022 Reporter's comments: No patient's identifiers were provided.  The nurse reported that a patient was administrated with Engerix B batch recall for October.  The reporter had been on maternity leave and had just found out about it. No vaccination date was provided. No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The patient was administered with Engerix B batch recall, which led to recalled drug administered and drug dispensing error. This is 1 of the 8 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066344:Same reporter US-GLAXOSMITHKLINE-US2022AMR068023:Same reporter US-GLAXOSMITHKLINE-US2022AMR068021:Same reporter US-GLAXOSMITHKLINE-US2022AMR068022:Same reporter US-GLAXOSMITHKLINE-US2022AMR068025:Same reporter US-GLAXOSMITHKLINE-US2022AMR068026:Same reporter US-GLAXOSMITHKLINE-US2022AMR068027:Same reporter
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Recalled product administered
Clinical narrative: administrated with engerix-b batch recall; administrated with engerix-b batch recall; This case was reported by a nurse via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 7th December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   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:18-APR-2022 Reporter's comments: No patient's identifiers were provided.  The nurse reported that a patient was administrated with Engerix B batch recall for October.  The reporter had been on maternity leave and had just found out about it. No vaccination date was provided. No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The nurse reported that a patient was administered with Engerix B batch recall, which led to recalled drug administered and drug dispensing error. The Vaccine Administration Facility is the same as primary reporter. This case is one of 8 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066344:Same reporter US-GLAXOSMITHKLINE-US2022AMR068023:Same reporter US-GLAXOSMITHKLINE-US2022AMR068022:Same reporter US-GLAXOSMITHKLINE-US2022AMR068026:Same reporter US-GLAXOSMITHKLINE-US2022AMR068024:Same reporter US-GLAXOSMITHKLINE-US2022AMR068025:Same reporter US-GLAXOSMITHKLINE-US2022AMR068021:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: pretty sore arm; slight fever; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2022, the patient received the 1st dose of Shingrix. In March 2022, several hours after receiving Shingrix, the patient experienced pain in arm and fever. On an unknown date, the outcome of the pain in arm and fever were recovered/resolved.   It was unknown if the reporter considered the pain in arm and fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-Apr-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient got the first Shingrix shot about a month ago and had zero pain getting shot but pretty sore arm developed hours later and lasted for days. Also had slight fever for about 24 hours. The patient would get 2nd shot in about 2 months. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy, Herpes zoster, Pain of skin, Vaccination failure, Varicella
Clinical narrative: shingles/ suspected vaccination failure; Had chicken pox and Bell's palsy and shingles; shingles; chicken pox; skin hurt; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), bell's palsy (serious criteria GSK medically significant), shingles, chickenpox and skin pain. On an unknown date, the outcome of the vaccination failure, bell's palsy, shingles and chickenpox were unknown and the outcome of the skin pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, bell's palsy, shingles, chickenpox and skin pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had chicken pox and Bell's palsy and shingles. The patient had the vaccination and still had days that skin hurts.  Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination 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: Arthralgia, Pain in extremity
Clinical narrative: Severe stabbing pain in my right foot; Moderate to severe pain in my right ankle; This case was reported by a consumer via interactive digital media and described the occurrence of foot pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2022, the patient received the 1st dose of Shingrix. On 2nd April 2022, 1 days after receiving Shingrix, the patient experienced foot pain and pain ankle. The patient was treated with morphine. On 2nd April 2022, the outcome of the foot pain was recovered/resolved. On an unknown date, the outcome of the pain ankle was not recovered/not resolved.   It was unknown if the reporter considered the foot pain and pain ankle to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient received dose of Shingrix vaccine and went to the ER (Emergency Room Visit) with severe stabbing pain in his/her right foot.  The patient was given morphine which did help and by 2nd April 2022 the foot pain was gone, but he/she continued to had moderate to severe pain in his/her right ankle. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: My husband got Bells Palsy; This case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's comment: This case was reported by patient's wife via interactive digital media. The patient got Shingles vaccine and experienced bell's palsy which was one of the side effect.  Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles/suspected vaccination failure; SHINGLES; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-APR-2022 Reporter's comment: This case was reported by a consumer via  interactive digital media. The reporter's husband and reporter had the shots and reporter's husband still got the shingles. Additional supportive information: 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. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; But still got the shingles; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-APR-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had shingles vaccines but still got the shingles. Additional supportive information: 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. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose several years ago didn´t get 2nd dose; 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 (1st dose received several years before the date of reporting).   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: 24-Apr-2022 Reporter's comments: This case was received from Shingrix. This case was reported by the patient. The patient did not know that two doses of Shingles vaccine were needed. The patient did not receive 2nd dose of Shingles vaccine and asked if there would be a need to start the both doses again. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got the vaccine, a week after she got them; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-APR-2022 Reporter's Comment: This case was reported by the patient's son/daughter via interactive digital media. The patient received dose of Shingles vaccine and a week after she broke out with them (Shingles). Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product dispensing error, Recalled product administered
Clinical narrative: administrated with engerix-b batch recall; administrated with engerix-b batch recall; This case was reported by a nurse via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 7th December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.     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: 18-APR-2022 Reporter's comments: No patient's identifiers were provided.  The patient was administrated with Engerix B batch recall for October.  The reporter had been on maternity leave and had just found out about it. No vaccination date was provided. No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The nurse reported that a patient was administered with Engerix B batch recall, which led to recalled drug administered and drug dispensing error. The vaccine administration facility was the same as primary reporter. This case is one of the eight cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR068021:Same reporter US-GLAXOSMITHKLINE-US2022AMR068022:Same reporter US-GLAXOSMITHKLINE-US2022AMR068023:Same reporter US-GLAXOSMITHKLINE-US2022AMR068024:Same reporter US-GLAXOSMITHKLINE-US2022AMR068025:Same reporter US-GLAXOSMITHKLINE-US2022AMR068026:Same reporter US-GLAXOSMITHKLINE-US2022AMR068027:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Became very sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced 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: 19-Apr-2022 Reporter's Comments: The reporter was an acquaintance of the patient. The reporter stated that the patient became very sick (undefined) after receiving the Shingrix vaccine. Reporter provided limited information. The reporter did not consent to follow-up. Additional Supportive Information: This case has been linked to US2022066904, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066904:Same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Did not reconstitute the vaccine; Administering only Shingrix adjuvant; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number A725Y, expiry date 30th May 2023) for prophylaxis.   On 19th April 2022, the patient received the 1st dose of Shingrix. On 19th 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: 19-Apr-2022 Reporter's comment: The registered nurse reported that an employee administering only Shingrix adjuvant and did not reconstituted the vaccine. The reporter consented to follow-up. Additional Supportive Information: The patient was administered only Shingrix adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 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, for tolerance refer case US2022067612).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, 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.     Linked case(s) involving the same patient:  US2022067612   Additional Information: GSK Receipt Date: 20-APR-2022  Reporter's Comments: The reporter was the patient's husband.  Reporter did not know lot number or expiration date.  Patient not available to give consent for follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022067612:Same Reporter
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Inappropriate schedule of product administration, Injection site swelling, Injection site warmth, Neuralgia
Clinical narrative: feels like shingles except blister; Right arm hot and swollen at injection site; hot injection site; Itchy painful , 3 inch in circumference rash; painful rash; Hives on forearm, feels like shingles; Itchy, painful, nerve pain right arm; Low grade fever; Tired; Patient received 2nd dose on 14-apr-2022 in her right arm, she states 1st dose was given a year ago.; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix (1st dose received 1 year before the date of reporting).   On 14th April 2022, the patient received the 2nd dose of Shingrix. On 14th April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 15th April 2022, the patient experienced low grade fever and tiredness. On 19th April 2022, the patient experienced vesicular rash, injection site swelling, injection site warmth, itchy rash, pain, hives and nerve pain. On an unknown date, the outcome of the vesicular rash, injection site warmth, itchy rash, pain, hives, nerve pain and drug dose administration interval too long were unknown and the outcome of the injection site swelling was not recovered/not resolved and the outcome of the low grade fever and tiredness were recovered/resolved.   It was unknown if the reporter considered the vesicular rash, injection site swelling, injection site warmth, low grade fever, tiredness, itchy rash, pain, hives and nerve pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-Apr-2022 Reporter's comments: This case was reported by the patient. The patient received Shingrix in her right arm. One day after receiving Shingrix, the patient experienced low grade fever and tired. Five days after receiving Shingrix, the patient developed an itchy painful, 3 inch in circumference rash. On right arm, she felt like nerve pain. The patient had hot, swollen injection site, hives on forearm. The patient felt this like shingles except the blisters. The patient was referred to the healthcare professional. The consent to follow up was given. Additional Supportive Information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of interval between vaccine doses.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash pruritic, Rash vesicular, Urticaria
Clinical narrative: feels like shingles except blister; Right arm hot and swollen at injection site; hot injection site; Itchy painful , 3 inch in circumference rash; painful rash; Hives on forearm, feels like shingles; Itchy, painful, nerve pain right arm; Low grade fever; Tired; Patient received 2nd dose on 14-apr-2022 in her right arm, she states 1st dose was given a year ago.; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix (1st dose received 1 year before the date of reporting).   On 14th April 2022, the patient received the 2nd dose of Shingrix. On 14th April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 15th April 2022, the patient experienced low grade fever and tiredness. On 19th April 2022, the patient experienced vesicular rash, injection site swelling, injection site warmth, itchy rash, pain, hives and nerve pain. On an unknown date, the outcome of the vesicular rash, injection site warmth, itchy rash, pain, hives, nerve pain and drug dose administration interval too long were unknown and the outcome of the injection site swelling was not recovered/not resolved and the outcome of the low grade fever and tiredness were recovered/resolved.   It was unknown if the reporter considered the vesicular rash, injection site swelling, injection site warmth, low grade fever, tiredness, itchy rash, pain, hives and nerve pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-Apr-2022 Reporter's comments: This case was reported by the patient. The patient received Shingrix in her right arm. One day after receiving Shingrix, the patient experienced low grade fever and tired. Five days after receiving Shingrix, the patient developed an itchy painful, 3 inch in circumference rash. On right arm, she felt like nerve pain. The patient had hot, swollen injection site, hives on forearm. The patient felt this like shingles except the blisters. The patient was referred to the healthcare professional. The consent to follow up was given. Additional Supportive Information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of interval between vaccine doses.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Noted after giving that the expiration date for the Men A portion of the vaccine was 3/2022; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA466A, expiry date 31st March 2022) for prophylaxis.   On 20th April 2022, the patient received Menveo. On 20th April 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's comments: The registered nurse reported that Meningococcal ACWY vaccine was given to patient and it was noted that Men A portion of the vaccine was already expired. The nurse was wondering if they need to call this patient back in to revaccinate them. The Men CYW portion of the vaccine had an expiration date of October 2022. When asked for the patient's demographics, nurse stated that he/she could not give. The reporter disconnected after asked if follow up could be made, so permission was not granted or denied.  Email address were provided. Additional Supportive Information: The use of Menveo dose which was already expired on 31st March 2022, which led to expired vaccine used.
Age: 0.58
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expired dose of infanrix was administered to a patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 7-month-old male patient who received DTPa (Infanrix) (batch number J947T, expiry date 30th May 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th June 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 14th June 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's comments: The health care professional reported that a dose of Infanrix was given to the patient and it was already expired. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: received an adult dose of ENGERIX-B; received an adult dose of ENGERIX-B; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a neonate patient who received HBV (Engerix B adult) for prophylaxis.   In April 2022, the patient received Engerix B adult. In April 2022, unknown after receiving Engerix B adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 21-Apr-2022 Reporter's comments: The 2 days old patient received an adult dose of Engerix-B over the last 2-3 days of the reporting date. The consent to follow up was given. No additional information was available regarding patient or product at the time of reporting. Additional Supportive Information: The neonate patient received adult dose of Engerix B, which led to overdose and adult product administered to child. Note: The age at event onset 2 days was not captured due to validation error.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm pain got so bad, she could not move the arm; Her arm was mildly sore; This case was reported by a consumer via call center representative and described the occurrence of mobility decreased in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th April 2022, the patient received the 1st dose of Shingrix. On 10th April 2022, 3 days after receiving Shingrix, the patient experienced mobility decreased. In April 2022, the patient experienced pain in arm. On an unknown date, the outcome of the mobility decreased and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the mobility decreased and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's comment:  Member of public reported that his wife (patient) received dose of Shingrix series.  Afterward less than a week after vaccination her arm was mildly sore, as to be expected after a vaccine.  However, on 10th April 2022 arm pain got so bad that by the end of the day she could not move the arm.  The pain returned to being mildly sore (as expected after vaccine) on 17th April 2022 and mobility returned as well. The vaccine administration facility was the same as primary reporter. The reporter gave permission to follow-up with the health care professional.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: adult dose given to pediatric patient; adult dose given to pediatric patient; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 3-year-old female patient who received HBV (Engerix B adult) (batch number LG5RN, expiry date 20th August 2022) for prophylaxis.   On 18th February 2022, the patient received Engerix B adult (intramuscular). On 18th February 2022, unknown after receiving Engerix B adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's comment: The reporter was nurse from pediatric clinic and stated, the patient received an adult Engerix-B dose. No further information was known.  The reporter consented to follow up. Additional Supportive Information: The pediatric patient received an adult Engerix-B dose, which led to adult product administered to child and overdose.