chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin discolouration, Vaccination failure
Clinical narrative: got the shingles weeks after the vaccine/suspected vaccination failure; got the shingles; still in pain; the rash turned my skin black; the rash turned my skin black; This serious 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, several weeks after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shingles weeks after the vaccine/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got the shingles), pain (Verbatim: still in pain), rash (Verbatim: the rash turned my skin black) and skin discoloration (Verbatim: the rash turned my skin black). The outcome of the vaccination failure was unknown and the outcome of the shingles, rash and skin discoloration were not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, rash and skin discoloration to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain, rash and skin discoloration to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-Mar-2023 The case was received from the patient via interactive digital media. The patient had got the shingles weeks after the vaccine and still in pain and the rash turned his/her skin black. 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: Back pain, Herpes zoster, Pain, Pain of skin, Vaccination failure
Clinical narrative: I got both shoot and got. It is horrible/Suspected vaccination failure; It is horrible; Hurts so bad, suffer with the pain; This serious 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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got both shoot and got. It is horrible/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: It is horrible) and pain (Verbatim: Hurts so bad, suffer with the pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 The case was received from the patient's sister/brother interactive digital media. The patient got both Shingles shot and got shingles. The patient stated it was horrible, he/she could not describe it. The patient stated it hurts so bad, from back to the scalp on my head.  The patient suffered with the pain.  The patient stated that he/she never had this kind of pain before.  It was worst than labor pains and child birth.  The patient stated that trust him/her you could not really explain it, as it was just horrible, and stated bless us all. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Inappropriate schedule of product administration
Clinical narrative: diarrhea daily; I have only taken the first shot about two years ago; This non-serious case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received about two years ago).   On 23-MAR-2023, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 23-MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: I have only taken the first shot about two years ago). On an unknown date, the patient experienced diarrhea (Verbatim: diarrhea daily). The outcome of the diarrhea was not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.     It was unknown if the company considered the diarrhea to be related to Shingrix.   Additional Information: The age at vaccination was not applicable for this report. The patient received the 1st dose of Shingrix shot about two years ago and never knew that the patient had to take a 2nd shot, which led to incomplete course of vaccination. The patient asking what do the patient do now.  The Food and drug administration approved dosing schedule for Shingrix was the 1st dose at month 0, followed by a second dose 2 to 6 months after the first dose. the Centers for disease control and prevention has provided guidance that if it's been more than 6 months since you got the first dose, you should get the second dose as soon as possible. The patient do not need to restart the vaccine series. We advise that you talk to your healthcare provider about this guidance and your individual situation.   Follow-up information received on 13-MAR-2023: The reporter was the patient. The patient reported that he got a Shingrix shot two days ago, on Wednesday. The shot was given intramuscularly in the left deltoid.  The patient had been experiencing diarrhea and wondering if it could be due to Shingrix.  The diarrhea occurred daily and had not resolved. The reporter did not had the lot number. The patient was okay with contacting him or his physician. Summary of Changes: Patient demographics', product details for patient route of administration, anatomical location, Vaers details, event, time to onset, casuality and narrative was updated.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: just had a sore arm so far; This non-serious 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 01-MAR-2023, the patient received Shingles vaccine. On 01-MAR-2023, less than a day after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: just had a sore arm so far). The outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 01-Mar-2023. This case was reported by the patient via interactive digital media. Follow-up would not possible as no contact details were available.  Upon internal review case was updated on 5th April 2023. Summary of changes: Case was processed as valid case.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Hurts to touched or to use the injected arm, more painful; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Tetanus vaccine with an associated reaction of pain (getting hit by a 1970).   On 08-MAR-2023, the patient received Shingrix (unknown arm). In MAR-2023, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Hurts to touched or to use the injected arm, more painful). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 24-Mar-2023 The reporter wanted to know why the vaccine for shingles is ten times more painful than the vaccine for tetanus. The patient being hit by a 1970 olds mobile hurt less than the accursed shingles vaccine. The patient received the vaccine it still hurts him/her to be touched or to use the injected arm. The patient was extremely angry about this.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pain, Ultrasound Doppler
Clinical narrative: Hurts to touched or to use the injected arm, more painful; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Tetanus vaccine with an associated reaction of pain (getting hit by a 1970).   On 08-MAR-2023, the patient received Shingrix (unknown arm). In MAR-2023, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Hurts to touched or to use the injected arm, more painful). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 24-Mar-2023 The reporter wanted to know why the vaccine for shingles is ten times more painful than the vaccine for tetanus. The patient being hit by a 1970 olds mobile hurt less than the accursed shingles vaccine. The patient received the vaccine it still hurts him/her to be touched or to use the injected arm. The patient was extremely angry about this.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Forgot to get 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: Forgot to get 2nd dose). The outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK receipt date 24-MAR-2023 The Healthcare Professional (HCP) had asked if a member (patient) forgot, if he had his shingles vaccine, could he get the series again. The reporter requested medical information (including product excursions or stability). Follow-up would not possible as no contact details were available. Till the time of reporting, the patient did not receive the second dose of vaccine, which had led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Bedridden
Clinical narrative: Could not get out of bed; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of bedridden in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced bedridden (Verbatim: Could not get out of bed). The outcome of the bedridden was not reported.   It was unknown if the reporter considered the bedridden to be related to Shingrix.     It was unknown if the company considered the bedridden to be related to Shingrix.   Additional Information: GSK receipt date: 24-Mar-2023 This case was self reported by the patient. The patient could not get out of bed day after first dose of Shingrix.  The patient did not had issues after the second dose. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I received a single Shingrix vaccination well over a year ago.; This non-serious case was reported by a consumer 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 (received a single Shingrix vaccination well over a year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: I received a single Shingrix vaccination well over a year ago.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-MAR-2023  Reporter asked what now. Start again with two, or just one. The patient received a single Shingrix vaccination well over a year ago and dose not yet which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 01OCt2020, 2nd 26Jan2023; This non-serious case was reported by a consumer and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 1st October 2020).   On 26-JAN-2023, the patient received the 2nd dose of Shingrix. On 26-JAN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 01OCt2020, 2nd 26Jan2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 29-Mar-2023 The patient asked that he/she should get another dose to be safe. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased appetite, Discomfort, Feeling abnormal, Injection site pain, Injection site pruritus
Clinical narrative: Pretty unconfortable after effects/Possible the worst of any vax I've ever gotten; Body aches/Burning pain; Electric feeling type of pain; Injection site was tender; Injection site was swollen; Injection site was eventually itchy; Lethargy; No appetite; Felt crappy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site tenderness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles many years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site tenderness (Verbatim: Injection site was tender), injection site swelling (Verbatim: Injection site was swollen), injection site itching (Verbatim: Injection site was eventually itchy), discomfort (Verbatim: Pretty unconfortable after effects/Possible the worst of any vax I've ever gotten), pain (Verbatim: Body aches/Burning pain), lethargy (Verbatim: Lethargy), appetite absent (Verbatim: No appetite), feeling bad (Verbatim: Felt crappy) and neuropathic pain (Verbatim: Electric feeling type of pain). The outcome of the injection site tenderness, injection site swelling, injection site itching, lethargy, appetite absent and feeling bad were resolved (duration 3 days) and the outcome of the discomfort was not reported and the outcome of the pain and neuropathic pain were resolved.   It was unknown if the reporter considered the injection site tenderness, injection site swelling, injection site itching, discomfort, pain, lethargy, appetite absent, feeling bad and neuropathic pain to be related to Shingles vaccine.   It was unknown if the company considered the injection site tenderness, injection site swelling, injection site itching, discomfort, pain, lethargy, appetite absent, feeling bad and neuropathic pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via interactive digital media. The shingles vaccine had pretty uncomfortable after effects. The reporter stated that possibly the worst of any vaccine he/she had ever gotten. The patient experienced body aches, lethargy, no appetite, felt crappy and his/her injection site was tender, swollen and eventually itchy too for nearly 3 days. All that being said it was a piece of a cake compared to the horrid and long lasting pain and rash associated with shingles. The reporter further stated that you could still get the shingles vaccine if you had shingles before by the way and the shingles would consume you.  The patient further stated that it was hard to describe burning and electric feeling type of pain that was nearly unbearable when anything touched it for weeks. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling, Lethargy, Neuralgia, Pain
Clinical narrative: Pretty unconfortable after effects/Possible the worst of any vax I've ever gotten; Body aches/Burning pain; Electric feeling type of pain; Injection site was tender; Injection site was swollen; Injection site was eventually itchy; Lethargy; No appetite; Felt crappy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site tenderness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles many years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site tenderness (Verbatim: Injection site was tender), injection site swelling (Verbatim: Injection site was swollen), injection site itching (Verbatim: Injection site was eventually itchy), discomfort (Verbatim: Pretty unconfortable after effects/Possible the worst of any vax I've ever gotten), pain (Verbatim: Body aches/Burning pain), lethargy (Verbatim: Lethargy), appetite absent (Verbatim: No appetite), feeling bad (Verbatim: Felt crappy) and neuropathic pain (Verbatim: Electric feeling type of pain). The outcome of the injection site tenderness, injection site swelling, injection site itching, lethargy, appetite absent and feeling bad were resolved (duration 3 days) and the outcome of the discomfort was not reported and the outcome of the pain and neuropathic pain were resolved.   It was unknown if the reporter considered the injection site tenderness, injection site swelling, injection site itching, discomfort, pain, lethargy, appetite absent, feeling bad and neuropathic pain to be related to Shingles vaccine.   It was unknown if the company considered the injection site tenderness, injection site swelling, injection site itching, discomfort, pain, lethargy, appetite absent, feeling bad and neuropathic pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via interactive digital media. The shingles vaccine had pretty uncomfortable after effects. The reporter stated that possibly the worst of any vaccine he/she had ever gotten. The patient experienced body aches, lethargy, no appetite, felt crappy and his/her injection site was tender, swollen and eventually itchy too for nearly 3 days. All that being said it was a piece of a cake compared to the horrid and long lasting pain and rash associated with shingles. The reporter further stated that you could still get the shingles vaccine if you had shingles before by the way and the shingles would consume you.  The patient further stated that it was hard to describe burning and electric feeling type of pain that was nearly unbearable when anything touched it for weeks. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: shot did ache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: shot did ache). The outcome of the pain was resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 The case was received from the patient interactive digital media. The patient stated that he/she would not know and stated that the immunization shot did ache for a couple of days though. The follow-up could not be possible as no contact details were available.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Rash
Clinical narrative: stomach cramps; rash on her face; This non-serious case was reported by a consumer via call center representative and described the occurrence of stomach cramps in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-MAR-2023, the patient received the 1st dose of Shingrix. On 11-MAR-2023, less than a day after receiving Shingrix, the patient experienced stomach cramps (Verbatim: stomach cramps) and exanthema facial (Verbatim: rash on her face). The outcome of the stomach cramps and exanthema facial were not recovered/not resolved.   It was unknown if the reporter considered the stomach cramps and exanthema facial to be related to Shingrix.     It was unknown if the company considered the stomach cramps and exanthema facial to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAR-2023 The patient self-reported this case. The patient stated that she received her dose of Shingrix and since that time had experienced a rash on her face and stomach cramps.  The reporter did not consent to follow-up.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose used; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 10-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 23-MAR-2023, the patient received the 1st dose of Havrix. On 23-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 23-MAR-2023 A nurse called in to report that an expired dose of Havrix was given on 23-MAR-2023 and provided the reporter information about the patient and vaccine. The Vaccine Administration Facility was the same as Primary Reporter. Consented to follow up. The patient received a Havrix vaccine which was already expired, which led to expired vaccine used.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose has not been administered yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included Twinrix adult (On 23rd January 2023, the first dose was received).   On an unknown date, the patient received the 2nd dose of Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose has not been administered yet). 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: 23-MAR-2023 The pharmacist called to inquire on how to proceed and go about the schedule with Twinrix series. The patient received a Twinrix first dose 2 months ago and would like to get the second dose. The reporter confirmed the second dose had not been administered yet. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never came back for the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose was received 2.5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never came back for the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-MAR-2023 Pharmacist reported a patient received her first Shingrix dose and never came back for the 2nd dose. The Vaccine Administration Facility was the same as Primary Reporter. Healthcare professional did not have date of birth for patient and did not ask about follow-up but pharmacy address was in healthcare professional details. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Details provided corresponding to the 1st dose.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2021, no second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 25th August 2021, the first dose was received).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose in 2021, no second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-MAR-2023 Pharmacist stated that the patient received the 1st dose of Shingrix in 2021. The reporter inquired if the patient supposed to start the series over or could get the 2nd dose now. The reporter consented to follow up via postal. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 63.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 63-year-old male patient who received HAV (Havrix) (batch number 7YA99, expiry date 30-SEP-2022) for prophylaxis.   On 13-MAR-2023, the patient received the 1st dose of Havrix. On 13-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 23-MAR-2023 The doctor reported that the patient received first expired dose of Havrix on 13-MAR-2023 however the expiration date of the vaccine was 30-SEP-2022. The reporter consented to follow up by email. The patient received a Havrix which was already expired, which led to expired vaccine used. This case had been linked with US2023039829 due to same reporter.; Sender's Comments:  US-GSK-US2023039829:Same reporter
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number A2X3Y, expiry date 28-FEB-2023) for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On 22-MAR-2023, the patient received the 2nd dose of Bexsero. On 22-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered). 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: 23-MAR-2023 On 23rd March 2023, the physician reported that the patient received the 2nd dose of Bexsero and the dose was already expired.  The first dose was received on 22nd February 2023. Reporter consented to follow up. The patient received a Bexsero vaccine which was already expired, which led to expired vaccine used.
Age: 1.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix given to a 19-month-old; Boostrix given instead of DTaP; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number KP547, expiry date 29-NOV-2024) for prophylaxis.   On 13-FEB-2023, the patient received the 4th dose of Boostrix. On 13-FEB-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix given to a 19-month-old) and wrong vaccine administered (Verbatim: Boostrix given instead of DTaP). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-MAR-2023 A nurse called to inform that the patient was supposed to receive the 4th dose of the DTap series however dose of Boostrix was administered. The reporter consented to follow up. A 19-month-old patient received a dose of Boostrix instead of DTap vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered
Clinical narrative: Administration of less than recommended dose; Vaccine leaked over patient's arm; Vaccine leaked over patient's arm; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 59-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number H242K, expiry date 09-JUN-2025) for prophylaxis.   On 23-MAR-2023, the patient received Boostrix. On 23-MAR-2023, an unknown time after receiving Boostrix, the patient experienced incomplete dose administered (Verbatim: Administration of less than recommended dose), exposure via skin contact (Verbatim: Vaccine leaked over patient's arm) and inadvertent exposure to vaccine (Verbatim: Vaccine leaked over patient's arm). The outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine 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: 23-MAR-2023 The reporter reported that the patient received a dose of Boostrix of which the needle was not attached correctly, and part of the vaccine leaked touching the patient's arm.  The asked about how to proceed. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up. The patient received a dose of Boostrix of which the needle was not attached correctly and part of the vaccine leaked touching the patient's arm which led to incomplete dose administered, exposure via skin contact, inadvertent exposure to vaccine.
Age: 55.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Asthenia, Chills, Oral herpes, Pyrexia
Clinical narrative: Massive cold sore in mouth; Knocked out for 1 and a half days; Fever; Chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of asthenia in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis.   On 20-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm) and COVID-19 BOOSTER. In MAR-2023, an unknown time after receiving Shingrix, the patient experienced asthenia (Verbatim: Knocked out for 1 and a half days), fever (Verbatim: Fever) and chills (Verbatim: Chills). On 23-MAR-2023, the patient experienced cold sore mouth (Verbatim: Massive cold sore in mouth). The outcome of the asthenia was resolved (duration 1 day) and the outcome of the fever and chills were resolved and the outcome of the cold sore mouth was unknown.   It was unknown if the reporter considered the asthenia, fever, chills and cold sore mouth to be related to Shingrix.     It was unknown if the company considered the asthenia, fever, chills and cold sore mouth to be related to Shingrix.   Additional Information: GSK Receipt date: 23-MAR-2023 The reporter was a female patient.  The Patient reported that she received the 1st dose of Shingrix vaccine on 20th March 2023 in her left arm  The patient received the vaccine at her doctors office.   The patient reports the vaccine knock me out for 1 & half days with fever and chills. The patient reports that she also had a covid vaccine booster on the same day of the Shingrix vaccine. The patient reports that 23rd March 2023 patient woke up with massive cold sore in her mouth.  Not all information is available, lot and expiration dates were unknown.  The customer provided consent to follow up with health care practitioner (HCP), but stated she does not have this information at this moment.  The customer reported he/she have provided enough information for now. The customer then disconnected without providing additional information. It was unknown if the reporter considered the asthenia, fever, chills and cold sore mouth to be related to covid 19 booster.    The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 08 Nov 2022, 2nd 23 Dec 2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number FD47S, expiry date 09-FEB-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 23-DEC-2022, the patient received the 2nd dose of Shingrix. On 23-DEC-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: 1st dose 08 Nov 2022, 2nd 23 Dec 2022). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 23-MAR-2023 The reporter was the pharmacist who stated that the 2nd dose of Shingrix was administered to a patient a month and a half after the 1st dose, instead of the recommended 2 months.  The reporter consented to follow up via postal. The patient received 2nd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: late for 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: late for 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-MAR-2023 The reporter had a lot of patients who comes for the second dose years after the first one. 4 to 5 patients asked reporter this winter, it comes to reporter as a question, and he/she referred them to their provider, but he/she would like to know how to approach them as well and administer if appropriate. The vaccine administration facility for 1st dose was the same as primary reporter. Details was reported for 1st dose. The reporter consented to follow up. Till the time of reporting, the patients did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose admiistered to adult; Adult use of a child product; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 20-year-old female patient who received HAV (Havrix 720) (batch number D7HA9, expiry date 27-AUG-2024) for prophylaxis.   On 23-MAR-2023, the patient received Havrix 720. On 23-MAR-2023, an unknown time after receiving Havrix 720, the patient experienced underdose (Verbatim: Pediatric dose admiistered to adult) and adult use of a child product (Verbatim: Adult use of a child product). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-MAR-2023 The health care professional reported the case for a patient. The patient received Havrix 720 (pediatric) dose. The reporter consented to follow up. The patient received pediatric dose of Havrix 720, which led to underdose and adult use of a child product.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles after 1st dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In FEB-2023, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles after 1st dose). The outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 24-Mar-2023 The pharmacist reported that the patient received the first dose of Shingrix on unknown date and then about a month ago from reporting developed shingles.  The shingles was clearing up at the time of reporting.  The healthcare professional stated that the first dose was not given at their pharmacy; he did not have vaccination information. The reporter consented to follow up via email.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Skin swelling, Swelling, Swelling face
Clinical narrative: Swelling neck (injection side); Swelling on cheek (injection side); Swelling on scalp (injection side); This non-serious case was reported by a physician via sales rep and described the occurrence of cheek swelling in a child male patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included atopic dermatitis, psoriasis and highly allergic.   In MAR-2023, the patient received the 1st dose of Bexsero (unknown arm). In MAR-2023, 72 hrs after receiving Bexsero, the patient experienced cheek swelling (Verbatim: Swelling on cheek (injection side)), neck swelling (Verbatim: Swelling neck (injection side)) and scalp swelling (Verbatim: Swelling on scalp (injection side)). The outcome of the cheek swelling, neck swelling and scalp swelling were unknown.   It was unknown if the reporter considered the cheek swelling, neck swelling and scalp swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the cheek swelling, neck swelling and scalp swelling 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: 24-Mar-2023 The patient received first dose of Bexsero a few weeks ago from reporting. The patient experienced swelling on his cheek, neck, and scalp on the same side as the injection, only on one side received the injection.  A GSK field representative did not have a specific date for the injection, which arm the injection received in, which side the swelling was on or any further details about the patient's history.  The reporter did not know when the historical atopic dermatitis, psoriasis, and being highly allergic began so, no specific date provided.  The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose given to adult; Pediatric dose given to adult; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 51-year-old female patient who received HBV (Engerix B pediatric) (batch number 3T5L9, expiry date 09-MAR-2025) for prophylaxis.   On 24-MAR-2023, the patient received Engerix B pediatric. On 24-MAR-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Pediatric dose given to adult) and adult use of a child product (Verbatim: Pediatric dose given to adult). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 24-Mar-2023 The reporter consented to follow up via email. A pediatric dose of Engerix-B was administered to an adult patient which led to underdose and adult use of a child product.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 44-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16-DEC-2022) for prophylaxis.   On 24-MAR-2023, the patient received Havrix. On 24-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Patient received an expired dose of Havrix). 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 Recipt Date: 27-MAR-2023 HCP (healthcare professional) reported that a patient received an expired dose of Havrix. The reporter consented to follow-up. The patient received a Havrix vaccine which was already expired, which led to expired vaccine used. This case has been linked to the case US2023AMR045953 reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR045953:Same reporter/different patient
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 01Dec2021, 2nd 29Mar2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number D9CB9, expiry date 24-SEP-2023) for prophylaxis.   Previously administered products included Shingrix  (received first dose on 1st December 2021).   On 29-MAR-2023, the patient received the 2nd dose of Shingrix. On 29-MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 01Dec2021, 2nd 29Mar2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 29-Mar-2023 The patient did not receive the second dose until the day of reporting. The reporter did not had lot number or expiration date information for the first dose. The reporter consented to follow-up. The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. The case was linked with case US2023047403, reported by same reporter.; Sender's Comments:  US-GSK-US2023047403:Same reporter/different patient
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 55-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 29-MAR-2023, the patient received Havrix. On 29-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered). 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: 29-Mar-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Never received the 2nd dose; This non-serious 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 (first dose received couple of years ago ).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Never received the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 31-Mar-2023  The pharmacist reported that the patient received Shingrix a couple of years ago and never received Shingrix second dose.  The reporter did not consent to follow up.  No further information was available at the moment of the interaction by phone. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.