chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shot and still have them /Suspected vaccination failure; Still have them; 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-MAR-2023  Reporter's comments: This case was reported by the patient via interactive digital media. The reporter stated that the he/she got the shot and still had them (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: i had the shots and still got shingles/Suspected vaccination failure; Got 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: 02-MAR-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the Shingles vaccine and still got shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Cataract, Cataract operation, Herpes zoster, Inappropriate schedule of product administration, Pain
Clinical narrative: Got two doses, have shingles now, suspected vaccination failure; Cataract, cataract surgery; Shingles around left eye; Painful; 5 years since last shot; Outbreak in December; 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.   In January 2023, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. In December 2022, not applicable after receiving Shingles vaccine and more than 2 years after receiving Shingles vaccine, the patient experienced shingles. In January 2023, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), cataract (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, cataract, shingles, pain and drug dose administration interval too long were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, cataract, shingles and pain to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-MAR-2023 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient reported that he/she was experiencing a shingles outbreak around left eye. The patient reported that just had cataract surgery last week so he/she was wearing safety glasses which rub the outbreak. The patient reported that just got the shot in January 2023 after an outbreak in December 2022. The patient reported that it had been 5 years since his/her last shot. The patient reported that you all had sympathy as he/she knew how painful it was. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test and time to onset confirming shingles were unknown at the time of reporting. The patient received 2nd dose of Shingles vaccine later than the recommended interval, which led to lengthening of vaccine schedule. Follow-up would not possible as no contact details were available. From the narrative it was not clear when the cataract was started hence it was considered as adverse event for both suspect.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Got two doses, have shingles now, suspected vaccination failure; Cataract, cataract surgery; Shingles around left eye; Painful; 5 years since last shot; Outbreak in December; 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.   In January 2023, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. In December 2022, not applicable after receiving Shingles vaccine and more than 2 years after receiving Shingles vaccine, the patient experienced shingles. In January 2023, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), cataract (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, cataract, shingles, pain and drug dose administration interval too long were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, cataract, shingles and pain to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-MAR-2023 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient reported that he/she was experiencing a shingles outbreak around left eye. The patient reported that just had cataract surgery last week so he/she was wearing safety glasses which rub the outbreak. The patient reported that just got the shot in January 2023 after an outbreak in December 2022. The patient reported that it had been 5 years since his/her last shot. The patient reported that you all had sympathy as he/she knew how painful it was. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test and time to onset confirming shingles were unknown at the time of reporting. The patient received 2nd dose of Shingles vaccine later than the recommended interval, which led to lengthening of vaccine schedule. Follow-up would not possible as no contact details were available. From the narrative it was not clear when the cataract was started hence it was considered as adverse event for both suspect.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Know of people vaccinated and got it/Suspected vaccination failure; Got it (shingles); This case was reported by a consumer via interactive digital media and described the occurrence of 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: 02-MAR-2023 Reporter's Comment: This case was reported by the consumer via interactive digital media. The reporter reported that terrible and he/she knew of people who were vaccinated against it and got it. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Pain so bad, went to hospital; 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), 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: 02-Mar-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received vaccine a fewyears ago. The patient had them and the pain was so bad that the patient went to the hospital and that time they told that the patient had shingles. Additional Supportive Information: The follow up would not possible, as no contact, details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Neuropathy peripheral, Psoriasis
Clinical narrative: neuropathy in my feet; psoriasis breakout; This case was reported by a consumer via interactive digital media and described the occurrence of peripheral neuropathy in a 64-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In January 2023, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced peripheral neuropathy (serious criteria GSK medically significant) and psoriasis. On an unknown date, the outcome of the peripheral neuropathy and psoriasis were not recovered/not resolved.   It was unknown if the reporter considered the peripheral neuropathy and psoriasis to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the first shot last month and thought the shots were to prevent it. The patient did not need shingles. The patient was trying to get rid of a first-time psoriasis breakout right now. The patient did not need anything else right now. The patient had neuropathy in his/her feet was bad enough and trying not to get covid either. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Age: 1.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Therapy non-responder
Clinical narrative: Not showing immunity; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 4-year-old female patient who received HAV (Havrix) (batch number J34DR, expiry date 28th January 2022) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number A9RM9, expiry date 27th May 2021) for prophylaxis.   Previously administered products included Pediarix (1st dose received on.19th September 2018), Pediarix (2nd dose received on 29th November 2018), Pediarix (3rd dose received on 30th January 2019) and Infanrix (1st dose received on 27th December 2021).   On 22nd July 2020, the patient received the 2nd dose of Havrix. On 29th August 2019, the patient received the 1st dose of Havrix. On an unknown date, unknown after receiving Havrix and Havrix, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   Linked case(s) involving the same patient:  US2023031972   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's comment: The registered nurse (RN) reported that patient received the 2 doses of Havrix vaccine and did not show any immunity. The nurse consented to follow up Additional supportive information: The patient received 2 doses of Havrix and showed no immunity, which led to therapy non-responder. This case is linked with US2023031972, reported by same reporter for same patient.; Sender's Comments:  US-GSK-US2023031972:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; 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.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, immediately 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: 27-FEB-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The reporter reported that he/she got shingles right after he/she got the first shingles vaccine shot within days. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives; Chickenpox blisters; Chickenpox blisters; This case was reported by a consumer via interactive digital media and described the occurrence of hives 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 hives, chickenpox and blister. On an unknown date, the outcome of the hives, chickenpox and blister were unknown.   It was unknown if the reporter considered the hives, chickenpox and blister to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comments: This case was reported by a patient via interactive digital media. The reporter reported that patient had shingles vaccination and broke out in hives and chicken pox blisters. The physician said that patient was one in 10,000. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Did not use diluent in the box; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's comment: The reporter reported that someone at their clinic had given a Menveo vaccine without using the diluent in the box. The reporter assuming they used sterile diluent that they kept on the counter. The reporter asked for guidance to know how that affects the individual receiving it. Additional supportive information: The patient had Menveo reconstituted with sterile diluent, instead of the supplied diluents, which led to wrong solution used in drug reconstitution. The follow-up could not be possible as no contact details were available. This is 1 of 4 linked cases reported by same reporter for different patients. Conservatively case was processed with event wrong solution used in drug reconstitution considering the sterile diluent was used in vaccine reconstitution.; Sender's Comments:  US-GSK-US2023AMR032664:Same reporter US-GSK-US2023AMR032665:Same reporter US-GSK-US2023AMR032666:Same reporter
Sex: U
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Did not use diluent in the box/I am assuming they uses sterile diluent that we keep on the counter; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's comment: The reporter reported that someone at their clinic had given a Menveo vaccine without using the diluent in the box. The reporter assuming they used sterile diluent that they kept on the counter. The reporter asked for guidance to know how that affects the individual receiving it. Additional supportive information: The patient had Menveo reconstituted with sterile diluent, instead of the supplied diluents, which led to wrong solution used in drug reconstitution. The follow-up could not be possible as no contact details were available. This is 1 of 4 linked cases reported by same reporter for different patients. Conservatively case was processed with event wrong solution used in drug reconstitution considering the sterile diluent was used in vaccine reconstitution.; Sender's Comments:  US-GSK-US2023AMR032644:Same reporter US-GSK-US2023AMR032666:Same reporter US-GSK-US2023AMR032665:Same reporter
Sex: U
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Did not use diluent in the box/I am assuming they uses sterile diluent that we keep on the counter; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's comment: The reporter reported that someone at their clinic had given a Menveo vaccine without using the diluent in the box. The reporter assuming they used sterile diluent that they kept on the counter. The reporter asked for guidance to know how that affects the individual receiving it. Additional supportive information: The patient had Menveo reconstituted with sterile diluent, instead of the supplied diluents, which led to wrong solution used in drug reconstitution. The follow-up could not be possible as no contact details were available. This is 1 of 4 linked cases reported by same reporter for different patients. Conservatively case was processed with event wrong solution used in drug reconstitution considering the sterile diluent was used in vaccine reconstitution.; Sender's Comments:  US-GSK-US2023AMR032666:Same reporter US-GSK-US2023AMR032664:Same reporter US-GSK-US2023AMR032644:Same reporter
Sex: U
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Did not use diluent in the box/I am assuming they uses sterile diluent that we keep on the counter; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's comment: The reporter reported that someone at their clinic had given a Menveo vaccine without using the diluent in the box. The reporter assuming they used sterile diluent that they kept on the counter. The reporter asked for guidance to know how that affects the individual receiving it. Additional supportive information: The patient had Menveo reconstituted with sterile diluent, instead of the supplied diluents, which led to wrong solution used in drug reconstitution. The follow-up could not be possible as no contact details were available. This is 1 of 4 linked cases reported by same reporter for different patients. Conservatively case was processed with event wrong solution used in drug reconstitution considering the sterile diluent was used in vaccine reconstitution.; Sender's Comments:  US-GSK-US2023AMR032664:Same reporter US-GSK-US2023AMR032644:Same reporter US-GSK-US2023AMR032665:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: severe illness; This case was reported by a consumer via interactive digital media and described the occurrence of illness 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 illness. On an unknown date, the outcome of the illness was unknown.   It was unknown if the reporter considered the illness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's comments: This case was reported by the patient via interactive digital media.  The reporter stated that the he/she got the first shot and had severe illness from the shot and he/she would not get the second shot. Hope he/she never get the shingles as the shot had almost got him/her. Additional supportive information: Shingles was not coded as an event, as per the verbatim it was unclear whether the patient had got shingles or not and seems to be referring it to the illness only and was raised to confirm the same. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose not the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received first dose in 2017 or in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-Feb-2023 Reporter's comment: The reporter did not provided information about first Shingrix dose (lot number/expiration date/ date of administration). The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. As it was not clearly whether the patient received the first dose in 2017 or in 2019, therefore in worst approach case was kept valid and further clarification request was raised.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Infection, Pyrexia
Clinical narrative: Fever; Infection; This case was reported by a consumer via call center representative and described the occurrence of fever in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th February 2023, the patient received the 2nd dose of Shingrix (intramuscular). In February 2023, unknown after receiving Shingrix, the patient experienced infection. On 26th February 2023, the patient experienced fever. On an unknown date, the outcome of the fever and infection were unknown.   It was unknown if the reporter considered the fever and infection to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comment: The reporter was the patient. She received Shingrix shot in right deltoid on Saturday.  She did not had the lot number of the Shingrix which was administered.  On Sunday night, she began experiencing a fever. The patient had a lot of fever last night. She was wondering if Shingirx could had caused the fever (or alternatively if she might had caught an infection because she felt the onset of the fever was later than she would had expected, and she considered the onset two days later).  She did not want to share her physician contact information. The reporter did not consent to follow-up.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrixadministered; 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 HAV (Havrix) (batch number unknown, expiry date 24th February 2023) for prophylaxis.   On 27th February 2023, the patient received Havrix. On 27th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 27-FEB-2023 Reporter's comment: The reporter did not consent to follow-up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 24.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered/inadvertently administered an expired Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 24-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th February 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 25th February 2023, unknown after receiving Twinrix and Twinrix 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: 27-FEB-2023 Reporter's Comments: The reporter inquired whether the patient should be revaccinated or was it was still good. The reporter did not give the consent to follow up. Additional Supportive Information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Age: 74.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles on lips; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis.   The patient's past medical history included herpes zoster (Shingles on lips in the past).   On 23rd February 2023, the patient received the 1st dose of Shingrix and the 1st dose of PNEUMOCOCCAL VACCINE. On 23rd February 2023, immediately after receiving Shingrix and an unknown time after receiving PNEUMOCOCCAL VACCINE, the patient experienced shingles. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR033913   Additional Information: GSK Receipt Date: 27-FEB-2023  Reporter's comment: The patient reported that, she and her husband both received 1 dose of Shingrix. The patient received Shingrix on left arm and Pneumonia vaccine in right arm on the same day.  She stated that the minutes within receiving Shingrix, she felt like she had shingles on her lips again.  She reached out to health care professional (HCP) who ordered her Valocyclovir 4 pills.  She took them and stated that her symptoms did not resolved.  Medical disclaimer and phone number were provided. The HCP consented to follow up. Additional Supportive Information: This case had been linked with US2023031971 and US2023AMR033913, reported by the same reporter. Valocyclovir was considered as typo error for Valacyclovir; Sender's Comments:  US-GSK-US2023031971:same reporter US-GSK-US2023AMR033913:same pt
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Aug2019, 2nd not yet/patient had not received the 2nd Shingrix vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comments: The reporter reported a patient came in this weekend to get the 2nd Shingrix vaccines after receiving the 1st Shingrix vaccine in August 2019. It was reported that at time of call, the patient had not received the 2nd Shingrix vaccine.  The 1st Shingrix vaccine was not given to the patient at the pharmacy that called.  No lot number or expiration date were available. The reporter gave the consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 15.0
Sex: M
Vaccine: DTAPHEPBIP, TDAP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 15 YO received Pediarix; 1st  TDAP Oct2021, 2nd Feb2022; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number B4722, expiry date 17th February 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe (batch number B4722, expiry date 17th February 2024) for prophylaxis and DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Previously administered products included Hepatitis B (1st dose received at age 14 years), Hepatitis B (2nd dose received at age 15 years), Polio (1st dose received in 2021), Polio (2nd dose received in 2022) and TDAP (1st dose of TDAP in October 2021).   On 24th February 2023, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. In February 2022, the patient received the 2nd dose of Tdap Vaccine. In February 2022, unknown after receiving Tdap Vaccine, the patient experienced drug dose administration interval too long. On 24th February 2023, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration and drug dose administration interval too long 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: 27-Feb-2023 Reporter's Comments: The nurse reported that Pediarix was administered to a patient as a catch up vaccination. All reported adverse event information contained within adverse event report. The reporter consented to follow up. Additional Supportive Information: The patient received the 2nd dose of TDAP later than the recommended interval, which led to lengthening of vaccine schedule. The patient received a dose of Pediarix at inappropriate age, which led to inappropriate age at vaccine administration. The case was processed in worst approach with inappropriate age at vaccine administration for Pediarix and lengthening of vaccine schedule for TDAP due to limited information was provided and further clarification request was raised.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix 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 HAV (Havrix pediatric) (batch number KY35X, expiry date 16th February 2023) for prophylaxis.   On 27th February 2023, the patient received Havrix pediatric. On 27th February 2023, unknown after receiving Havrix pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 27-FEB-2023  Reporter's comment: The healthcare professional (HCP) reported that nurse administered an expired dose of Havrix on the day of reporting. No patient details were available. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient was administered with expired Havrix vaccine, which led to expired vaccine used.
Age: 76.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Skin disorder
Clinical narrative: Blemishes on face and neck; This case was reported by a consumer via call center representative and described the occurrence of skin disorder in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On 23rd February 2023, the patient received the 1st dose of Shingrix and Tdap Vaccine (intramuscular). In February 2023, 2 days after receiving Shingrix and Tdap Vaccine, the patient experienced skin disorder. On an unknown date, the outcome of the skin disorder was not recovered/not resolved.   It was unknown if the reporter considered the skin disorder to be related to Shingrix and Tdap Vaccine.     Additional Information: GSK Receipt Date: 27-FEB-2023  Reporter's comment: The wife of the patient reported that herself and her husband both received dose 1 of shingrix.  The reporter stated that patient received shingrix in right arm and Tdap in left arm  at the same time.  Medical disclaimer and phone number were provided.  The reporter consented to follow up. Additional Supportive Information: This case had been linked with US2023031968, reported by the same reporter.; Sender's Comments:  US-GSK-US2023031968:same reporter
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP, DTAPHEPBIP
Symptoms: Therapy non-responder
Clinical narrative: Not showing immunity; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 4ZH95, expiry date 30th October 2020) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 4CH95, expiry date 30th October 2020) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 4TG43, expiry date 18th September 2020) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th January 2019, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 29th November 2018, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 19th September 2018, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2023AMR032485   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's comment: The registered nurse (RN) reported that patient received the 3 doses of Pediarix vaccine and did not show any immunity. The patient also received 1 dose of Infanrix and 2 doses of Havrix. The nurse consented to follow up Additional supportive information: The patient received 3 doses of Pediarix and showed no immunity, which led to therapy non-responder. This case is linked with US2023AMR032485, reported by same reporter for same patient.; Sender's Comments:  US-GSK-US2023AMR032485:same reporter
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Neck pain
Clinical narrative: injection site became sensitive; been shaky; neck pain; shoulder pain; back pain, worse on left side; This case was reported by a consumer via call center representative and described the occurrence of injection site hypersensitivity in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th February 2023, the patient received the 1st dose of Shingrix. In February 2023, 3 days after receiving Shingrix, the patient experienced neck pain, shoulder pain and back pain. On an unknown date, the patient experienced injection site hypersensitivity and shivers. On an unknown date, the outcome of the injection site hypersensitivity, neck pain, shoulder pain, back pain and shivers were not recovered/not resolved.   The reporter considered the injection site hypersensitivity to be related to Shingrix. It was unknown if the reporter considered the neck pain, shoulder pain, back pain and shivers to be related to Shingrix.     Additional Information: GSK receipt date: 27-FEB-2023 Reporter's comment: The patient self-reported this case. The patient stated that she got their 1st Shingrix vaccine and about 3 days later, she started to had pain in her neck, shoulder, and back.  She stated, that the pain was worse on her left side.   She also stated the injection site became sensitive and she had been shaky (did not know at what point these 2 symptoms started after the vaccine).   She was still experiencing all of the symptoms. The reporter did not consent to follow up.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix Administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 27th February 2023, unknown after receiving Havrix 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: 27-Feb-2023 Reporter's Comments: Nurse called to report an expired dose Havrix was administered to a female patient.  The reporter did not consent to follow-up. Additional Supportive Information: The patient was administered with Havrix vaccine, which was already expired, which led to expired vaccine used.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Infanrix given as 4th DTap 3 months after last Pediarix; Infanrix given as 4th DTap 3 months after last Pediarix; 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 12-month-old female patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received first dose on 30th March 2022), Pediarix (received second dose on 16th August 2022) and Pediarix (received third dose on 20th October 2022).   On 27th January 2023, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 27th January 2023, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to Infanrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's comment: Coordinator mentioned a 12-month-old patient was administered Infanrix as a 4th dose in a DTap series. Coordinator mentioned the patient had Pediarix Then at the patient's 12 month well baby checkup received the Infanrix on 27th January 2023 as an early 4th Dtap dose. No additional details provided. Did not consent to follow-up. Additional supportive information: the patient received 4th dose of DTap vaccine, which led to inappropriate schedule of vaccine administered and inappropriate age at vaccine administration
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Skin exfoliation
Clinical narrative: shingles on face, lips and mouth; shingles on face, lips and mouth; rash; scaling; nerve pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th February 2023, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. In February 2023, unknown after receiving Shingrix, the patient experienced skin scaly and post herpetic neuralgia. On 17th February 2023, the patient experienced shingles, oral herpes zoster and rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and skin scaly were recovering/resolving and the outcome of the oral herpes zoster was recovered/resolved and the outcome of the rash and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the shingles, oral herpes zoster, rash, skin scaly and post herpetic neuralgia to be related to Shingrix.     Additional Information: GSK receipt date: 27-FEB-2023 Reporter Comment: The reporter was the patient.  The patient reports she realized had shingles when she received her first Shingrix vaccine in the left arm.  The patient reports the rash appeared the afternoon after she received the Shingrix vaccine.  The patient doctor confirmed shingles and prescribed Valtrex for 7 days. The patient reports the shingles was on the right side of her face, lips, and mouth.  The shingles in her mouth resolved quickly in a day or two.  The shingles on her face and lips is scaling right now but resolving.  The patient reports she has nerve pain from the shingles on the right-side of her face.  The patient would like Safety to email her on if the vaccine was still effective since she has shingles and on Valtrex.  The patient will provide health care practitioner info after Safety contacts her by phone or email. The reporter did not consent to follow up.
Sex: U
Vaccine: MENB
Symptoms: Discomfort
Clinical narrative: Discomfort; This case was reported by a other health professional via call center representative and described the occurrence of discomfort in a patient who received Men B NVS (Bexsero) 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 an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was unknown.   It was unknown if the reporter considered the discomfort to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's comment: The reported asked about needle size recommendations as Bexsero was administered to patient who expressed discomfort.  The reported stated that they were using 25 gauge needles but since the solution was thicker she was enquiring if there were any recommendations for a larger bore needle. The reported stated that this was not really a safety issue and that most people feel discomfort with vaccines, therefore she was opting out of providing additional information or follow up. The reporter did not consent to follow up. Additional supportive information: This was 1 of the 6 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR032491:Same reporter - Bexsero US-GSK-US2023AMR032492:Same reporter - Bexsero US-GSK-US2023AMR032493:Same reporter - Bexsero US-GSK-US2023AMR032489:Same reporter - Invalid case US-GSK-US2023031935:Same reporter - Flu Vaccine