chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took it have gotten shingles/ Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients 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: 7-Jul-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter reported that she/he know many patients that took Shingles vaccine and gotten shingles. 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 were unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: arm is sore/The muscle at the shots site felt worse; The muscle at the shots site felt worse; 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 6th July 2022, the patient received Shingles vaccine. On 6th July 2022, less than a day after receiving Shingles vaccine, the patient experienced pain in arm and injection site muscle pain. On an unknown date, the outcome of the pain in arm and injection site muscle pain were unknown.   It was unknown if the reporter considered the pain in arm and injection site muscle pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-July-2022 Reporter's Comment: The patient got his/her shot the day before reporting actually and by the nighttime the muscle at the shots site felt worse than the Covid shot. Same arm too lol but they really stick you lol. The patient's arm was sore. Additional supportive information: This case has been linked to the case US2022AMR105380 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105380:tag at post
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash macular, Vaccination failure
Clinical narrative: had it in Nov and got 2nd part of the shot in May. I got a small patch of it again 2 weeks ago; small patch of it again; Spots/ patch; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In June 2022, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced spot-like rash. On an unknown date, 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 and the outcome of the spot-like rash was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles and spot-like rash to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient had it in November and got 2nd part of the shot in late May.  The patient got a small patch of it again about 2 weeks before date of reporting, but it never got worse than when he/ she noticed and no pain with it this time.  Spots were almost gone so he/she was hoping that means the shot was doing its job. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. Also year of vaccination was not reported hence its not captured. It was unknown whether patient received 1st dose in November or had Shingles in November, conservatively coded as shingles episode. The follow-up would not possible as no contact details were available
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine but now has shingles; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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: 8-Jul-2022 Reporter's Comments: The patient's family member reported the case via interactive digital media. The reporter stated that his/ her family member had the vaccine but at the time of reporting had shingles. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got the shingles vaccine in April,but still got it; still got it; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 8-Jul-2022 Reporter's Comments: The patient's brother/ sister reported the case via interactive digital media. The reporter stated that his/ her brother got the shingles vaccine in April, but still got it.  The patient said it was the worst pain he ever felt. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot n still got it; still got it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) 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: 8-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient stated that he/ she got the shot and still got it. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shot and still got shingles; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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: 8-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient stated that he/ she got the shot and still got it. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot and got shingles; got the shot and got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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: 10-Jul-2022 Reporter's Comments: The patient's wife reported the case via interactive digital media. The reporter stated that her husband got the shot and still got shingles. She stated that it was really bad. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shingles vaccine got shingles; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients 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: 9-Jul-2022 Reporter's Comments: The consumer reported the case via interactive digital media. The reporter stated that everyone he/ she know who got the shingles vaccine got shingles multiple times afterwards. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case was 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105391:same report, other patient
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Intensive care, Near death experience, Vaccination failure
Clinical narrative: nearly died, being in ICU for weeks; got shingles internally/shingles; got shingles internally/suspected vaccination failure; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience 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 near death experience (serious criteria hospitalization, GSK medically significant and life threatening), vaccination failure (serious criteria GSK medically significant) and shingles (serious criteria hospitalization). On an unknown date, the outcome of the near death experience, vaccination failure and shingles were unknown.   It was unknown if the reporter considered the near death experience, vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 9-Jul-2022 Reporter's comment: The case was reported by the patient's friend via interactive digital media. The reporter reported that one of his/her friend got shingles internally and nearly died, being in intensive care unit (ICU) for weeks. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR105388, reported by same reporter for different patient. As per reported information, the patient was in ICU for weeks therefore hospitalization was captured for all events except vaccination failure.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105388:same report, other patient
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety
Clinical narrative: horrific reaction. Literally thought I was going to die; This case was reported by a consumer via interactive digital media and described the occurrence of impending doom in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced impending doom. On an unknown date, the outcome of the impending doom was unknown.   It was unknown if the reporter considered the impending doom to be related to Shingles vaccine.     Additional Information: GSK receipt date: 10-Jul-2022 Reporter's comment: The case was reported by the patient via interactive digital media. The patient had a horrific reaction to the shingles shot.  The patient literally thought that he/she was going to die and wanted to at one point. The patient never went back for second shot, no way and so beware and aware. Additional supportive information: Follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR105416 and US2022AMR105421, reported by same reporter for different patient. As per reported verbatim, ' I was going to die', event impending doom was coded as it was closed match event and for second dose there is a medical reason was reported for not receiving therefore it was coded as suspect with incomplete course of vaccination.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105416:same report, other patient US-GLAXOSMITHKLINE-US2022AMR105421:tag at post
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety, Coma
Clinical narrative: had same thing (Literally thought I was going to die); three day coma; This case was reported by a consumer via interactive digital media and described the occurrence of coma 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 coma (serious criteria GSK medically significant) and impending doom. On an unknown date, the outcome of the coma was recovered/resolved and the outcome of the impending doom was unknown.   It was unknown if the reporter considered the coma and impending doom to be related to Shingles vaccine.     Additional Information: GSK receipt date: 10-Jul-2022 Reporter's comment: The case was reported by the patient's neighbor via interactive digital media. The reporter reported that the patient had same thing (horrific reaction to the shingles shot and thought was going to die) and a three day coma. Additional supportive information: Follow-up could be not possible as no contact details were available. The case was linked with case US2022AMR105421 and US2022AMR105409, reported by same reporter for different patient. As per reported narrative the patient had same thing as reporter therefore conservatively same events were coded this patient also.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105409:same report, other patient US-GLAXOSMITHKLINE-US2022AMR105421:tag at post
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine and then ended up getting shingles; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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: 10-Jul-2022 Reporter's Comments: The patient's mother/father in law reported the case via interactive digital media. The reporter stated that her/ his son in law got the vaccine and then ended up getting shingles. The patient said that he never again to these New vaccines. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105409:tag at post US-GLAXOSMITHKLINE-US2022AMR105416:tag at post
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: been suffering for 6 weeks; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad 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 feeling bad. On an unknown date, the outcome of the feeling bad was not recovered/not resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-JUL-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and had been suffering for 6 weeks now. The GlaxoSmithKline said it would have been much worse without a vaccine. The patient couldn't even imagine. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Hemiplegia
Clinical narrative: left my side paralyzed; This case was reported by a consumer via interactive digital media and described the occurrence of paralysis 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 paralysis (serious criteria GSK medically significant). On an unknown date, the outcome of the paralysis was recovering/resolving.   It was unknown if the reporter considered the paralysis to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-JUL-2022 Reporter's comment: This case was reported by a consumer via interactive digital media.The reporter stated patient had shot which left patient side paralyzed for a week. The patient was doing better at the time of reporting.  Additional supportive information: Follow up would not be possible since no contact details provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both set of shots, shingles/suspected vaccination failure; shingles would be gone forever and that's a lie; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 11-JUL-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient stated that he/she had both set of Shingles shots, GlaxoSmithKline told him/her shingles would be gone forever and that was a lie. Additional supportive information: This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-JUL-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient asked was a rash common after receiving a Shingles vaccine shot. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Administration of expired Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received HAV (Havrix adult) (batch number unknown, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st July 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 1st July 2022, unknown after receiving Havrix adult and Havrix 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: 05-Jul-2022 Reporter's Comments: The reporter called in to enquire about expired Havrix. The reporter stated they inadvertently administered an expired Havrix (expiration date: 18th June 2022) dose to a patient on 1st July 2022. The reporter was unable to provide full vaccine and patient details. Additional Supportive Information: The patient was administered with expired Havrix vaccine, which led to expired vaccine used. This case has been linked to US2022102704, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022102704:Same reporter. Patient 1
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Administration of expired Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix adult) (batch number unknown, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st July 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 1st July 2022, unknown after receiving Havrix adult and Havrix 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: 05-Jul-2022 Reporter's Comments: The reporter called in to enquire about expired Havrix. The reporter stated they inadvertently administered an expired Havrix (expiration date: 18th June 2022) dose to a patient on 1st July 2022. The reporter was unable to provide full vaccine and patient details. Additional Supportive Information: The patient was administered with expired Havrix vaccine, which led to expired vaccine used. This case has been linked to US2022102705, reported by the same reporter. Vaccine administration facility is same as primary reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022102705:Same reporter. Patient 2
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: small blistery rash on her upper buttocks/rash; This case was reported by a pharmacist via call center representative and described the occurrence of blistery rash in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 54tf4, expiry date 18th May 2023) for prophylaxis.   On 13th June 2022, the patient received the 1st dose of Shingrix. In June 2022, less than a week after receiving Shingrix, the patient experienced blistery rash. On an unknown date, the outcome of the blistery rash was recovered/resolved.   It was unknown if the reporter considered the blistery rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's Comments: The reporter stated that patient experienced a small blistery rash on her upper buttocks after dose of Shingrix. The rash appeared within the first week.  The reporter did not consent to follow-up.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired dose of Bexsero administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXB28AA, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st July 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-Jul-2022 Reporter's Comments: The reporter stated that on 01st July 2022, the patient received a dose of Bexsero that had expired on 30th June 2022. The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: Inadvertently administered an Engerix adult dose to an 18 year old patient; Inadvertently administered an Engerix adult dose to an 18 year old patient; This case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 18-year-old male patient who received HBV (Engerix B adult) for prophylaxis.   On 2nd June 2022, the patient received Engerix B adult. On 2nd June 2022, unknown after receiving Engerix B adult, the patient experienced accidental overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the accidental overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's comments: The reporter stated that they inadvertently administered an Engerix adult dose to an 18 year old patient. The reporter was unable to provide patient details. Additional Supportive Information: The patient received adult dose of the Engerix-B vaccine instead of the pediatric dose of the Engerix-B vaccine which led to accidental overdose andinappropriate age at vaccine administration. VAERS details were not disclosed hence not added.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: received a dose of Boostrix that had been frozen; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 40-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st July 2022, the patient received Boostrix (intramuscular) .5 ml and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's Comments: The reporter reported that the patient received a dose of Boostrix in right arm that had been frozen. The patient was getting the vaccine because he was due for his 10 year booster. The patient was not exhibiting any symptoms. The reporter consented to follow up. Additional Supportive Information:  The patient received Boostrix that had been frozen, which led to incorrect storage of drug.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: adult received pediatric dose; adult received pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 49-year-old female patient who received HBV (Engerix B pediatric) (batch number 2H575, expiry date 12th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th July 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 5th July 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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: 05-JUL-2022 Reporter's Comments: A nurse reported that an adult patient received a pediatric dose of Engerix B. The reporter consented to follow up. Additional Supportive Information:  An adult patient received a pediatric dose of Engerix B, which led to underdose and adult use of a child product.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: exposed to 5°F, already administered / Administration of vaccine after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) (batch number 95G27, expiry date 10th September 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 05-JULY-2022 Reporter's comment: Pharmacist reported on July 5th 2022 that Shingrix was exposed to 5 degree F for between 10 or 12 days. 1st excursion. HCP stated that the vaccine was already administered to other patients more than 6 patients but they would have to confirm with their reports. No additional information on patients was provided by email
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative, Incomplete course of vaccination
Clinical narrative: Pt received 1st dose only. Antibodies checked, were negative; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 23-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 12th July 2021 with batch number 74EM4 and expiration date 20th December 2022).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, 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: 06-July-2022 Reporter's Comments: The patient received first dose of Engerix-B, but never returned for more doses. The patient was paying out of pocket, so he only got one dose. The patient had antibodies checked for school, and they were negative and at the time of reporting he was in pharmacy requesting second dose, but it has not been administered at the time of reporting. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Engerix B, which led to incomplete course of vaccination. VAERS details provided was corresponding to the 1st dose as the 2nd dose was not received yet.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose 2 years ago, series not completed; This case was reported by a other health professional via sales rep 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 of Shingrix 2 years ago.).   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: Analysis tab: GSK receipt date: 6-Jul-2022 Reporter's comment: The case was sent over on behalf of an health care professional. The reporter reported that medical assistant received 1st dose of Shingrix 2 years ago and also wanted to know if they should restart the series or if they should just get 2nd dose. The reporter reported but unclear if an adverse event had been filed. The reporter had no patient identifiers at this time.  Unknown if follow up was permissible. No additional details as this was the only information provided. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case was linked with US2022103211 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022103211:Same reporter. Patient 1
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: patient received Engerix-B expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 33-year-old female patient who received HBV (Engerix B) (batch number 239TF, expiry date 4th June 2022) for prophylaxis.   On 5th July 2022, the patient received Engerix B. On 5th July 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter's Comment: Nurse reports that an MA gave a patient an expired dose of Engerix-B. The vaccine administration facility was the same as primary reporter. The reporter did not ask about follow up as health care professional wanted to remain anonymous. The reporter did not consent to follow up. Additional supportive information: The patient received Engerix B, which was already expired in 4th June 2022, which led to expired vaccine used.
Age: 2.0
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: 2 year old patient received boostrix on 6-July-2022 instead of infanrix; 2 year old patient received boostrix; 2 year old patient received boostrix on 6-July-2022 instead of infanrix; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 2-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 6th July 2022, the patient received Boostrix. On 6th July 2022, unknown after receiving Boostrix, the patient experienced underdose, inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the underdose, inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter's Comments:  The nurse reported that the patient received Boostrix on 6th July 2022 instead of infanrix. The reporter consented to follow up Additional Supportive Information: The patient received Boostrix instead of Infanrix, which ed to underdose, inappropriate age at vaccine administration, wrong vaccine administered. This case has been linked to the case US2022089285 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022089285:Same reporter
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 1/13/22 and the 2nd dose on 2/15/22; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 58-year-old female patient who received HAV (Havrix adult) (batch number K4Y4L, expiry date 17th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 15th February 2022, the patient received the 2nd dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 15th February 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, 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.   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: 06-JUL-2022 Reporter's comment: Registered nurse reported that they inadvertently administered Havrix first dose on 13th January 2022 and the second dose on 15th February 2022 to a patient. The reporter asked how to proceed. The reporter consented to follow-up. Additional Supportive Information: The patient received 2nd dose of Havrix adult earlier than the recommended interval, which led to shortening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 27Oct2020 and 2nd dose on 11Jan2022; This case was reported by a pharmacist via call center representative 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 27th October 2020).   On 11th January 2022, the patient received the 2nd dose of Shingrix. On 11th January 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: 06-JUL-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter did not have any patient details or lot number, expiration date of dose 2 at time of call. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. This case has been linked to the case US2022103219 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022103219:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: pt developed shingles after receipt of both doses of Shingrix / Suspected Vaccination failure; Shingles; This case was reported by a pharmacist via call center representative 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.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional Information: GSK Receipt Date: 06-July-2022 Reporter's Comments: The reporter knew of one patient who had developed shingles after receipt of both doses of Shingrix. The reporter did not consent to follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation for shingles were unknown at the time of reporting. This case was linked with case US2022103217, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022103217:Same reporter
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2 doses of the Dtap and IPV. 1st dose was Pentacel on 6/20/17 and 2nd dose Kinrix on 12/7/2021; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 4-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pentacel (1st dose received on 20th June 2017).   On 7th December 2021, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 7th December 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 7-July-2022 Reporter's Comment: The reporter reported that 5-year-old patient received only 2 doses of the Dtap and IPV. 1st dose was Pentacel on 20th June 17 and 2nd dose Kinrix on 7th Dec 2021. Patient was 4 years old. Patient was late in the Dtap/IPV series. No side effects reported. According to the CDC catchup schedule the patient would complete the Dtap series by administering Dtap dose 3-now, 6 months in between dose 3 and 4 and 6 months in between dose 4 and 5. The reporter consented to follow up.  Additional supportive information: 4-year-old patient received Kinrix as 2nd dose of Kinrix which led to inappropriate schedule of vaccine administered.