chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had the shot. the year after it came out four times/Suspected vaccination failure; I have had them four times; Now have meds that can help with the pain; 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.   The patient's past medical history included shingles (the patient was getting mild cases of shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year 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 and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's Comment: This case was reported by a patient via  interactive digital media. The patient had shingles shot but he/she was getting mild cases before that. The patient did not have covid shot. The patient got the shingles shot and had them four times shingles.  They now had meds that could help with the pain and the duration time. The patient had the shingles shot and the year after shingles came out .  The patient had them four times since then. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule 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: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got the vaccine and got shingles/Suspected vaccination failure; Got the vaccine and got shingles on my face a year later; worst pain I have ever experienced; 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, 1 year 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: 30-July-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the vaccine and got shingles on his/her face a year later, worst pain the patient ever had experienced in his/her life. The patient stated that child birth was not that painful. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot but still got the shingles/ Suspected Vaccination Failure; had the shot but still got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 10-Aug-2022 Reporter's comment: The case was received from the patient's friend via interactive digital media. The reporter reported that the patient had the shot but still got the shingles. The reporter stated that so there not preventable from shingles. The reporter had the shingles and physician said that you can still get the shingles. The reporter mentioned that her husband got the shot hoping he never get them. 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.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: never had them until the shot/Suspected vaccination failure; never had them until the shot; miserable; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure, shingles and feeling miserable were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.     Additional Information: GSK receipt date: 29-July-2022 Reporter's comment: The case was received from the patient's friend via interactive digital media. The reporter reported that the friend of him/her never ever had them until the patient got the shot about 4 months later he got them, he was miserable.  The patient said that he would not wish this on anyone.  The patient regretted getting the shot.  The reporter's heart goes out to you.  The reporter prayed for fast healing, and comfort bless your heart. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule 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.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shingle shot 2 times, still got shingles/Suspected vaccination failure; shingles/Got the shingle shot 2 times, still 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.   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: 29-July-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shingles shot 2 times and still got the shingles. The patient stated that they would not give the patient no more shots told the patient to talk to the his/her physician. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shots, now have shingles/suspected vaccination failure; shingles/had shots but now have 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 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: 29-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shots but now have had shingles. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Vaccination failure
Clinical narrative: I had my vaccines last year and caught shingles in June/ Suspected vaccination failure; caught shingles; painful; burning feeling; 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. In June 2022, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain and burning sensation. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and burning sensation were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and burning sensation to be related to Shingles vaccine.     Additional Information: GSK receipt date: 30-July-2022 Reporter's comment: The case received from the patient via interactive digital media. The patient had the vaccines last year and still caught shingles in June. The patient was painful and burning feeling but the patient was told that it could had been worse and only lasted a week too. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule 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. Based upon the reported verbatim, 'only lasted a week too', outcome was captured as recovered for all the symptoms.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles shot and he still got it/Suspected vaccination failure; shingles shot and he still got it; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 31-July-2022 Reporter's comment: The case was received from the patient's children via interactive digital media. The reporter's dad had a shingles shot a couple of years ago and still got them. The reporter was so not convinced about that shot. 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.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Neuralgia, Vaccination failure
Clinical narrative: had both shots and still got shingles/Suspected vaccination failure; had both shots and still got shingles; nerve pain in his right leg; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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), shingles and nerve pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and nerve pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 31-July-2022 Reporter's comment: The case was received from the patient's wife via interactive digital media. The reporter's hubby had both the shots and still got shingles. The patient has had nerve pain in his right leg still. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the 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.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pain in extremity, Somnolence
Clinical narrative: Arm hurts, still hurt; Feing sick; Cold chills; Sleepy; 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 5th August 2022, the patient received Shingles vaccine. On 6th August 2022, 1 days after receiving Shingles vaccine, the patient experienced feeling unwell, chills and sleepiness. On 7th August 2022, the patient experienced pain in arm. On 7th August 2022, the outcome of the feeling unwell, chills and sleepiness were recovered/resolved. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, feeling unwell, chills and sleepiness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 8-Aug-2022 Reporter's comment: The patient self-reported the case via via interactive digital media. The patient got shingles shot on Friday and by Saturday he/she felt sick, cold chills and sleepy and by Sunday felt fine just his/her arm still hurt. The patient asked if anyone else had gone through this. The patient stated that just got shot, yesterday (day before reporting) arm hurt but was worth it and hopefully it would feel better tomorrow. On 7th August 2022, 2 days after receiving Shingles vaccine, the patient experienced pain in arm. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Menveo was given instead of Bexsero; patient had received the Menveo booster already; This case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXH7108, expiry date unknown) for prophylaxis.   Previously administered products included menveo (booster already when patient  was 16 year of age).   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 9-Aug-2022 Reporter's Comments: The reporter stated that an additional dose of Menveo was administered to a 18 year old a patient that was scheduled for a dose of Bexsero and Menveo was given instead. The patient had received the Menveo booster already when she was 16 year old and no adverse events were reported by prescriber or patient, the reporter thinks it was a nurse mistake as she prepared and administered the wrong vaccine. The reporter did not give consent to follow up. Additional Supportive Information: The patient had received the Menveo booster already which leads to extra dose administered. Menveo was given instead of Bexsero which leads to wrong vaccine Administered
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: It's been about 2 1/2 years since first dose, second dose August 8, 2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received two and half year before the reporting date in left arm).   On 8th August 2022, the patient received the 2nd dose of Shingrix. On 8th August 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: 09-AUG-2022 Reporter's Comments: The patient received Shingrix in his left arm. The patient gave his consent to follow up with the pharmacy. Additional Supportive Information: The patient received 2nd dose delayed than the recommended vaccination schedule, which led to lengthening of the vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: arm is very red at injection site; injection site, It really hurts; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.     Additional Information: GSK receipt date: 10-Aug-2022 Reporter's comments; The patient had lingering side effects from Shingrex. The patient asked how long they should last. The patient just surprised the side effects were lasting this long. The patient experienced the arm was very red at injection site, it really hurts even 3.5 days later. The patient wanted to know if patient should get the 2nd dose or not. The patient wanted to know what would be considered an allergic reaction. Additional supportive information: Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose June 2019, 2nd never administered; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (1st dose received in Jun 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: 09-Aug-2022 Reporter's Comments: The case was received from the patient via interactive digital media. The patient had the first dose of Shingrix In June 2019 but never had the second dose. The patient was asking he/she protected just with one dose or not. Additional Supportive Information: Till the time of reporting the patient did not received the second dose of Shingrix, which led to incomplete course of vaccination. Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: 1st dose 4 years ago, the shortage prevented 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 4 years ago from reporting).   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 product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional Information: GSK Receipt Date: 09-Aug-2022. Reporter's Comments: This case was reported by the patient via interactive digital media. The reporter reported that the shortage prevented 2nd dose. The patient asked should he/she get 1 or 2 doses now. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm hurt for days but glad I got it; 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 an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-JUL-2022 Reporter's Comments:  The case was received from the patient via interactive digital media. The patient's arm hurt for days but patient was glad for getting vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: Got my third booster yesterday; arm a BIT sore; 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 29th July 2022, the patient received the 3rd dose of Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On 29th July 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the pain in arm and extra dose administered were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK receipt date: 30-Jul-2022 Reporter's comments: This case was reported by a patient via interactive digital media. The patient got third booster the day before reporting.  The patient had only thing, arm was a bit sore but having seen friends with shingles, the patient would not wish it on his/her worst enemy. Additional Supportive Information: As patient received 3rd dose of Shingles vaccine, which led to extra dose administered. The follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I got them again; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (5 years ago from the reporting date).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced shingles. Shingles vaccine was discontinued. 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: 08-AUG-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The reporter mentioned, he/she just got over shingles for the second time. The patient got his/her first Shingles shot and three weeks later got shingles again. The reporter mentioned, he/she would not get the second shot and that was for sure. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Impaired work ability, Pain, Pyrexia
Clinical narrative: 101 fever; body aches, stayed home from work; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On 28th July 2022, the patient received the 2nd dose of Shingles vaccine. On 29th July 2022, 1 days after receiving Shingles vaccine, the patient experienced fever and general body pain. On an unknown date, the outcome of the fever and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the fever and general body pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 29-Jul-2022. Reporter's Comment: This case was reported by the patient via interactive digital media. The patient had fever and body aches, due to which he/she stayed at home from work. The patient would take this over shingles. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: made my arm sore; 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 an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-JUL-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient received second shot and made his/her arm sore for a few days. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First shot in fall of 2019, no 2nd dose yet; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (the patient received 1st dose of Shingrix in fall of 2019).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt Date: 12-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter wanted to know If he/she got another shingles shot now and would be considered second in the series. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of shingles vaccine, which led to incomplete course of vaccination. The follow up would not possible as no contact details were available.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Administered an Expired Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received HAV (Havrix adult) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th June 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 17th June 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: 08-Aug-2022 Reporter comment: The pharmacist called to inquired what the time length for revaccination was. The pharmacist reported that a patient was administered with an expired dose of Havrix adult. The pharmacist was unable to provide vaccine details but stated expired Havrix was administered over 30 days from expiration but not over 90 days of expiration date. No additional details provided. The reporter did not consent to follow up. Additional Supportive Information: The patient was administered an expired dose of Havrix adult, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: Patient received only a partial dose as she lose some volume from the syringe during administration; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a elderly male patient who received Herpes zoster (Shingrix) (batch number FAN5A, expiry date 28th July 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 08-AUG-2022.  Reporter's Comments: The patient received only a partial dose of Shingrix vaccine as she loses some volume from the syringe during administration.  The consent to follow up was granted. Additional Supportive Information: As patient received only a partial dose of Shingrix, which led to incomplete dose administered.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expired Bexsero vaccine administered to a patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB39AB, expiry date 31st July 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 8th August 2022, the patient received Bexsero (intramuscular) .5 ml and Bexsero Pre-Filled Syringe Device. On 8th August 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: 09-AUG-2022 Reporter's Comments: The health care professional reported that an expired Bexsero vaccine was administered to the patient. Patient received the expired Bexsero in the left arm. The reporter consented to follow up. Additional Supportive Information: The patient was administered with expired Bexsero vaccine which led to expired vaccine used.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: patient received a third dose of Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number 94BS5, expiry date 31st March 2024) 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.   Previously administered products included Bexsero (1st dose received on 22nd October 2020) and Bexsero (2nd dose received on 7th January 2021).   On 9th August 2022, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 9th August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  This report was made by GSK without prejudice and did not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 09-Aug-2022. Reporter's Comments: The physician's assistant reported that the patient received a third dose of Bexsero after the patient finished the series previously.  No additional detail was provided. The reporter declined name and contact for database but confirmed title and zipcode. The reporter did not consent to follow-up.  Additional Supportive Information: The patient received a third dose of Bexsero, which led to extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose of Shingrix on 2019, and has not yet received the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received first dose on 20th August 2019 Batch number 4LH25 expiry date 30th September 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 09-AUG-2022. Reporter's Comments: The patient had not yet received the second dose.  The reporter gave consent to follow up. Additional Supportive Information: Till the time of reporting, the patient not received the second dose, which led to incomplete course of vaccination. The detail was reported for 1st dose.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: Headache; Pain on left side of body; This case was reported by a consumer via call center representative and described the occurrence of headache in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced headache and general body pain. On an unknown date, the outcome of the headache and general body pain were recovered/resolved.   It was unknown if the reporter considered the headache and general body pain to be related to Shingrix.  Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's Comments: The reporter was the patient herself. The reporter mentioned that, she received Shingrix and that night after vaccination, she experienced pain on the left side of her body as well as a headache. The symptoms lasted for 2 full days and resolved. The patient was worried about the second dose and she was looking for effectiveness information of one dose of Shingrix. The reporter did not consent to follow-up. The case US2022116932 was identified as duplicate of US2022116933. The case US2022116933 would be voided, and all the future correspondence would be added in this case US2022116932 which stands as a case of record for this patient.
Age: 1.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: adult dose administered to a child; adult dose administered to a child; This case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 1-year-old male patient who received HBV (Engerix B adult) (batch number 74EM4, expiry date 20th December 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 9th August 2022, the patient received the 3rd dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 9th August 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose 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: 09-AUG-2022 Reporter's comments: The Personal Assistant(PA) reported an adult dose of Engerix-B was administered to a child today (on the day of reporting). The reporter consented to follow up. Additional supportive information: The patient was given adult dose of Engerix-B instead of the pediatric dose, which led to overdose and adult product administered to child at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: herpes simplex, has not had a breakout; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic drug effect in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex. Concomitant products included famotidine (Pepcid Ac).   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced unexpected therapeutic drug effect. On an unknown date, the outcome of the unexpected therapeutic drug effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic drug effect to be related to Shingrix.     Additional Information: GSK Receipt Date: 9-Aug-2022 Reporter's comment: The patient self reported the case. The patient stated that he had contracted herpes simplex virus in college when he was younger and has had frequent breakouts for over 40 years. The patient received the Shingrix vaccine about two years ago and had not had a breakout since that day. Spoke per package insert and content. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles just a couple of days after 1st dose; This case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, couple of days after receiving Shingrix, 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 Shingrix.     Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's comment: The patient developed shingles just a couple of days after the Shingrix vaccination. The reporter asked how long must they wait to get 2nd dose. No other details were provided via request. The submission was marked by the representative that the HSI was resolved, however per Medical Information processes it was being submitted for safety review. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received in 2018).   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: 10-Aug-2022 Reporter comment: The pharmacist reported that patient received first dose of Shingrix and had not received second dose. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: was back for the second dose today; 1st shot on Jun2021, had shingles on April; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In June 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not received the 2nd dose of Shingrix. In April 2022, between 9 and 11 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-AUG-2022 Reporter's Comment: The reporter stated that the patient received Shingrix vaccine and experienced Shingles. The reporter stated that the patient was back for the second dose today (on the day of reporting). Additional supportive information: Till the time of reporting the patient did not received 2nd dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: she was told it was shingles; Rash scattered over her body; This case was reported by a physician via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th July 2022, the patient received the 2nd dose of Shingrix. In July 2022, 1 week after receiving Shingrix, the patient experienced shingles and generalized rash. On an unknown date, the outcome of the shingles and generalized rash were unknown.   It was unknown if the reporter considered the shingles and generalized rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-Aug-2022 Reporter's Comments: The physician reported that the patient had dose of Shingrix.  Over a week later she started with a rash that was scattered over her body, she told it was Shingles and a side effect of the vaccine. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Pruritus
Clinical narrative: patient is tired all the time now; experienced itchiness/itchiness started all over again; whole body redness (arms, legs, neck, and his left cheek); This case was reported by a consumer via call center representative and described the occurrence of pruritus in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shoulder soreness (pre existing condition) and neck pain (pre existing condition). Previously administered products included Zostavax (On an unknown date patient received Zostavax) and Covid Vaccine and Boosters (On an unknown date patient received Covid vaccine and Boosters). Concurrent medical conditions included drug allergy.   In July 2022, the patient received the 1st dose of Shingrix. In July 2022, less than a day after receiving Shingrix, the patient experienced pruritus and redness generalised. On an unknown date, the patient experienced tired all the time. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the pruritus and tired all the time were not recovered/not resolved and the outcome of the redness generalised was recovered/resolved.   It was unknown if the reporter considered the pruritus, redness generalised and tired all the time to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-AUG-2022 Reporter's comments: The reporter was the daughter of the patient. The reporter stated that the patient had received his first dose of Shingrix 2 weeks ago. He had received the injection in his left arm. About 8-9 hours after the injection, the patient had experienced itchiness, and the next day he had whole body redness (arms, legs, neck, and his left cheek). The patient had took Benadryl to alleviate symptoms, and the symptoms resolved. However, the patient woke up this morning and the itchiness had started all over again. The reporter stated that the patient was tired all the time now too. The reporter had given consent to follow up with Healthcare Professional (HCP) (pharmacy)
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient has not received 2nd or 3rd dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) 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.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient did not received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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:  10-AUG-2022 Reporter's comments: The patient that received her first dose of Twinrix of 29th June 2022. At the time of reporting the patient had not received second or third dose.  The reporter consented to follow-up via email. Additional supportive information: Until the time of reporting, the patient did not receive the 2nd dose of vaccine, which led to incomplete course of vaccination.