chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash, Stress
Clinical narrative: Received shingles vaccinations then shingles/ suspected vaccination failure; Shingles; Nerve pain in back; Painful; Rash in back; Stress; 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Received shingles vaccinations then shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), post herpetic neuralgia (Verbatim: Nerve pain in back), pain (Verbatim: Painful), rash (Verbatim: Rash in back) and stress (Verbatim: Stress). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the post herpetic neuralgia, pain, rash and stress were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, pain, rash and stress to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, post herpetic neuralgia, pain, rash and stress to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received earlier Shingles vaccine since then this was his or her second time with shingles. The patient stated that first time shingles left him or her with nerve pain in his or her back which was four years ago. The patient have shingles now again and it was very painful. The patient stated that the rash is in his or her back again at different area. The physician stated that this was from stress. The patient reported that he or she have to wait to receive the more potent vaccine now because he or she did not wish this on anyone. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Received shingles vaccinations then shingles/ suspected vaccination failure; Shingles; Nerve pain in back; Painful; Rash in back; Stress; 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Received shingles vaccinations then shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), post herpetic neuralgia (Verbatim: Nerve pain in back), pain (Verbatim: Painful), rash (Verbatim: Rash in back) and stress (Verbatim: Stress). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the post herpetic neuralgia, pain, rash and stress were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, pain, rash and stress to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, post herpetic neuralgia, pain, rash and stress to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received earlier Shingles vaccine since then this was his or her second time with shingles. The patient stated that first time shingles left him or her with nerve pain in his or her back which was four years ago. The patient have shingles now again and it was very painful. The patient stated that the rash is in his or her back again at different area. The physician stated that this was from stress. The patient reported that he or she have to wait to receive the more potent vaccine now because he or she did not wish this on anyone. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included sickness (it had been over 6 years since he/she had any kind of sickness) and respiratory disorder (it had been over 6 years since he/she had any kind of respiratory sickness).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: Bells Palsy) (serious criteria GSK medically significant). The outcome of the bell's palsy was not reported.   It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine.   It was unknown if the company considered the bell's palsy to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient via interactive digital media. The patient was a healthy person. The reporter stated that he/she went ahead and got the shingles vaccine.  After the shingles vaccine he/she got bell's palsy 2 weeks later. The reporter further stated that it was coincidence. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took the shot still got shingles/suspected vaccination failure; Eternal shingles; 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, 4 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: took the shot still got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Eternal shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 20-MAR-2023 The case was received from the patient via interactive digital media. The patient took the Shingles shot and still got the shingles 4 years later and he/she had eternal shingles now (at the time of reporting). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took the poke and had an awful case of it/Suspected Vaccination Failure; awful case of it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In DEC-2022, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: took the poke and had an awful case of it/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: awful case of it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-MAR-2023 This case was reported by a patient's parent via interactive digital media. The patient took the poke (shingles vaccine) against his/her advice. She had an awful case of shingles this past summer into Christmas.  Now he/she had read more victims of the poke were getting it in their 30's and 40's.  The side effects of that poison would never end. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got vaccine still got a shingles/ suspected vaccination failure; Shingles; Painful; 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got vaccine still got a shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Painful). 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.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she was recommended to receive Shingles vaccine. The patient stated that it was a lot of less painful than shingles. The patient still experienced light case of shingles, but it was nothing like it could had been. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Herpes zoster, Neuralgia, Vaccination failure
Clinical narrative: so did I but still got shingles/Suspected Vaccination Failure; still got shingles; nerve pain; feel drained; 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: so did I but still got shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: still got shingles), nerve pain (Verbatim: nerve pain) and fatigue (Verbatim: feel drained). The outcome of the vaccination failure was unknown and the outcome of the shingles and fatigue were not reported and the outcome of the nerve pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve pain and fatigue to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, nerve pain and fatigue to be related to Shingles vaccine.   Additional Information: GSK receipt date: 20-MAR-2023 The case was received from the patient via interactive digital media. The patient stated so did he/she but still got shingles and now had the nerve pain (at the time of reporting). The patient was awful and felt drained and just started acupuncture. The patient hoped that help. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain, Vaccination failure
Clinical narrative: got the newer vaccine and got it/suspected vaccination failure; It got in eye; It got in eye, nose, scalp, mouth, ear, and left side of the face; like a painful death; 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.   The patient's past medical history included shingles (had shingles and it was worse than labor pains for all 3 of the kids), measles (had measles) and mumps (had mumps). Previously administered products included Zostavax (they came out with the first vaccine, it was learned that it was not effective and it was only one dose). Family history included chickenpox (patient's 3 kids got the mild cases of chickenpox when they were in their teen).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the newer vaccine and got it/suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: It got in eye) (serious criteria GSK medically significant), shingles (Verbatim: It got in eye, nose, scalp, mouth, ear, and left side of the face) and pain (Verbatim: like a painful death). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 20-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that they said the patient get shingles if he or she have had chicken pox. Not true, the patient never had chicken pox in his or her whole life which was verified by his or her mother. But still at that point, the patient did not get the chicken pox.  The physicians recommended the patient get the vaccine 6 months later and when they came out with the first vaccine, it was learned that the vaccine was not effective and it was only one dose.  So the patient got the newer vaccine which required 2 doses at different intervals and got in his or her eye, nose, scalp, mouth and ear. The patient stated that it was like a painful death and it was only contained on the left side of his or face. 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, Post herpetic neuralgia, Vaccination failure
Clinical narrative: had shingles shots and still got the shingles/suspected vaccination failure; shingles; nerve 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shingles shots and still got the shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and post herpetic neuralgia (Verbatim: nerve pain). The patient was treated with analgesic, nos (Pain Medicine (Medication Unknown)). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the post herpetic neuralgia was resolving.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-MAR-2023 This case was reported by a patient via interactive digital media. The patient had his/her shingles shots and still got the shingles.  The patient had nerve pain for three years now.  They had gotten better because he/she took pain medicine everyday since.  The reporter further stated that he/she felt sorry for anyone that got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got the shot had shingles on leg/ suspected vaccination failure; Shingles on legs; Hurt; 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.   The patient's past medical history included shingles (had 3 years ago prior to the reporting, it was severe case had horrible pain and it was lasted a year).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot had shingles on leg/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on legs) and pain (Verbatim: Hurt). 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.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine but he or she thought he or she again experienced shingles on his or her legs it was not as bad but it hurts. The patient stated that he or she going to try aloe vera as a treatment. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered
Clinical narrative: Vaccine not fully administered, needle not properly on; Vaccine was trickling down the arm; Vaccine was trickling down the arm; This non-serious case was reported by a pharmacist and described the occurrence of incomplete dose administered in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 7373X, expiry date 18-JUN-2024) for prophylaxis.   On 08-APR-2023, the patient received the 2nd dose of Shingrix. On 08-APR-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Vaccine not fully administered, needle not properly on), inadvertent exposure to vaccine (Verbatim: Vaccine was trickling down the arm) and exposure via skin contact (Verbatim: Vaccine was trickling down the arm). The outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 11-APR-2023 A pharmacist gave the Shingrix vaccine to a patient but the needle was not on properly so the vaccine was not fully administered. Vaccine was trickling down the arm according to the patient. It is unknown how much of the vaccine was actually administered. The reporter was trying to determine should he/she repeat the dose and when. Was it possible that no vaccine might have been injected and it all squirted out. The needle leaked at the time of administration, which made unsure if any dose was administered and trickled down the arm, which led to Inadvertent exposure to vaccine, exposure via skin contact and incomplete dose administered. The reporter consented to follow up. Case US2023052544 was found to be duplicate of this case, as cases have same patient. Therefore, the case US2023052544 was deleted. All future correspondence would be submitted to case US2023AMR052458 (case of record).
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Make them sicker for a week; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Make them sicker for a week). The outcome of the sickness was resolved.  The reporter considered the sickness to be related to Shingles vaccine.  The company considered the sickness to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 08-APR-2023 This case was reported by the patient via interactive digital media.  The reporter stated that the his/her friends had it and what it did was, it had made them sicker for more than a week.  Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: Feeling bad; Drug dose administration interval too long; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (first dose received in August 2020).   On 31-MAR-2023, the patient received the 2nd dose of Shingles vaccine. On 31-MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). On an unknown date, the patient experienced feeling bad (Verbatim: Feeling bad). The outcome of the feeling bad was not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-APR-2023 This case was reported by a patient via interactive digital media. The reporter was the patient. The patient had first dose of the vaccine in August 2020 and felt bad. The patient had second dose on last Friday. The reporter asked if another dose was required or it was ok with those two doses. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Arm I still red; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13-MAR-2023, the patient received the 1st dose of Shingles vaccine. In MAR-2023, less than a week after receiving Shingles vaccine, the patient experienced erythema of extremities (Verbatim: Arm I still red). The outcome of the erythema of extremities was not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities to be related to Shingles vaccine.     It was unknown if the company considered the erythema of extremities to be related to Shingles vaccine.   Additional Information: GSK receipt date: 19-Mar-2023 The case was received from the patient via interactive digital media. The patient had his or her first shingles shot exactly 7 days ago and his or her arm was still red. The patient asked that anyone did know why. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, HEP, HEPA, MNQ, TDAP, VARZOS
Symptoms: Product storage error
Clinical narrative: Maladministration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa (Infanrix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Shingrix, Pediarix, Infanrix, Menveo, Havrix, Engerix B and Boostrix. On an unknown date, an unknown time after receiving Shingrix, Pediarix, Infanrix, Menveo, Havrix, Engerix B and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Maladministration after temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 13-APR-2023 The other healthcare professional stated that several vaccines like Shingrix, Pediarix, Infanrix, Menveo (2 vials presentation), Havrix, Engerix-B and Boostrix suffered temperature excursion from 3rd February 2023 to 6th February 2023 at minus 1.07 degree Celsius for 62 hours and 15 minutes total below the recommended storage conditions for GlaxoSmithKline vaccines. The reporter consented to follow up and requested to send an email with all adverse event details instead of providing them on the phone. This case was linked with case US2023054677, reported by same reporter. The patient received Shingrix, Pediarix, Infanrix, Menveo, Havrix, Engerix B and Boostrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:Same reporter. US-GSK-US2023AMR056407:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient via interactive digital media. The patient never had shingles. The patient went to the facility and got the shingles shot and had the shingles the next day. The patient still had shingles 7 weeks later. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (has had shingles three times in his or her life).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 19-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that none of them was as bad as the shingles vaccine, it made him or her sick. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: vaccine hurts too; 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: vaccine hurts too). The outcome of the pain was not reported.   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: 20-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that the shingles vaccine hurt too. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: The shot is like flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza like illness 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 influenza like illness (Verbatim: The shot is like flu). The outcome of the influenza like illness was not reported.   It was unknown if the reporter considered the influenza like illness to be related to Shingles vaccine.     It was unknown if the company considered the influenza like illness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and stated that the shot is like the flu and it was horrible. Follow-up would not possible as no contact details were available.
Age: 6.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Patient got a 4th dose of Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 6-year-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   On 12-JAN-2022, the patient received the 4th dose of Engerix B pediatric. On 12-JAN-2022, an unknown time after receiving Engerix B pediatric, the patient experienced extra dose administered (Verbatim: Patient got a 4th dose of Engerix-B). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt Date: 11-APR-2023 The patient had been asymptomatic since receiving Engerix-B dose. The reporter consented to follow up. The reporter reported a patient who received an extra dose of Engerix-B, which led to extra dose administered.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Last Dtap 16Apr2022, Kinrix 30Aug2022; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 09-NOV-2023) for prophylaxis.   Previously administered products included DTaP (received last DTaP vaccine on 16th April 2022) and IPV (received last IPV vaccine on 3rd February 2020).   On 30-AUG-2022, the patient received Kinrix. On 30-AUG-2022, an unknown time after receiving Kinrix, the patient experienced drug dose administration interval too short (Verbatim: Last Dtap 16Apr2022, Kinrix 30Aug2022). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 11-APR-2023 A nurse reported a patient received a dose of Kinrix, but that dose was given 25 days before than when it was supposed to be administered.  The reporter reported that Kinrix was the patient's 5th dose of DTaP and 4th dose of IPV.  Phone number for follow up redacted. The reporter consented to follow up. The patient received a dose of Kinrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-month-old female patient who received Hib (Hiberix) (batch number ZE47D, expiry date 23-MAR-2023) for prophylaxis.   On 12-APR-2023, the patient received Hiberix. On 12-APR-2023, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Patient received an expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 12-April-2023 The nurse reported that the patient received an expired dose of Hiberix. The reporter consented to follow up. The patient was administered an expired dose of Hiberix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: small circle reddish spot at injection site; small circle whiteish spot at injection site; It was painful; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site redness in a male patient who received Herpes zoster (Shingrix) (batch number 2JA2N, expiry date 06-OCT-2023) for prophylaxis.   On 17-NOV-2022, the patient received the 1st dose of Shingrix (left arm). On 18-NOV-2022, 1 days after receiving Shingrix, the patient experienced injection site redness (Verbatim: small circle reddish spot at injection site), injection site discoloration (Verbatim: small circle whiteish spot at injection site) and injection site pain (Verbatim: It was painful). The outcome of the injection site redness and injection site discoloration were not resolved and the outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site redness, injection site discoloration and injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site redness, injection site discoloration and injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-APR-2023 The pharmacist called on behalf of a male patient that he received first dose Shingrix vaccine on 17th November 2022 in left arm.  The patient came into the pharmacy on 13th April 2023, for the administration of second dose of Shingrix vaccine. The patient reported that after first dose, a small reddish and whiteish spot in the shape of a circle showed up in the area where he received the vaccine.  It was painful at first, but the pain went away and the spot was still there today. The pharmacist did not want to provide any patient information without permission from the patient.  The pharmacist said that the spot was lower on the arm than he thought they would have given the injection, but it could be in that spot if the administrator gave the injection lower on the arm.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: misses 2nd dose within 2-6 months; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   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: misses 2nd dose within 2-6 months). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 13-APR-2023 The reporter enquired that if patient missed second dose within 2 to 6 months, could they still just get booster later. The reporter did not spoke with the provider, so please follow up with the sales rep for more info.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, HEP, HEPA, MNQ, TDAP, VARZOS
Symptoms: Product storage error
Clinical narrative: Maladministration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa (Infanrix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Shingrix, Pediarix, Infanrix, Menveo, Havrix, Engerix B and Boostrix. On an unknown date, an unknown time after receiving Shingrix, Pediarix, Infanrix, Menveo, Havrix, Engerix B and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Maladministration after temperature excursion). The action taken with Menveo was unknown. The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 13-APR-2023 The other healthcare professional stated that several vaccines like Shingrix, Pediarix, Infanrix, Menveo (2 vials presentation), Havrix, Engerix-B and Boostrix suffered temperature excursion on 31st December 2022 at 0.4 degree Celsius for 1 hour below the recommended storage conditions for GlaxoSmithKline vaccines. The reporter consented to follow up and requested to send an email with all adverse event details instead of providing them on the phone. The case was linked with case US2023AMR055743, reported by same reporter. The patient received Shingrix, Pediarix, Infanrix, Menveo, Havrix, Engerix B and Boostrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023AMR055743:Same reporter. US-GSK-US2023AMR056407:same reporter
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 8 weeks baby received by error Kinrix; Kinrix as a first dose instead of Dtap monovalent dose and IPV monovalent dose; 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 8-week-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26-MAY-2023) for prophylaxis.   On 10-APR-2023, the patient received the 1st dose of Kinrix. On 10-APR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 8 weeks baby received by error Kinrix) and inappropriate schedule of vaccine administered (Verbatim: Kinrix as a first dose instead of Dtap monovalent dose and IPV monovalent dose). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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: 13-APR-2023 The reporter reported that a patient received by error Kinrix as a first dose instead of Dtap monovalent dose and IPV monovalent dose. The reporter consented to follow up via email. The patient received Kinrix by error as first dose instead of Dtap monovalent dose and IPV monovalent dose which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Pediatric dose administered to an adult; Pediatric dose administered to an adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced underdose (Verbatim: Pediatric dose administered to an adult) and adult use of a child product (Verbatim: Pediatric dose administered to an adult). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 14-APR-2023 The registered nurse called to ask for recommendations about the administration of pediatric Engerix-B dose to an adult patient. The reporter declined sharing information about patient and the Engerix-B dose given.  The reporter consented to follow up but only shared her facility address. The adult patient received pediatric Engerix-B dose which led to underdose and adult use of a child product.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 5 months ago, no 2nd dose 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 patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received Twinrix first dose 5 months ago).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 5 months ago, no 2nd dose 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: 14-Apr-2023 The pharmacist did not want to provide any other information on this case. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the second dose of Twinrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Adult got pediatric dose, later got replacement dose; Adult patient got pediatric dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B 10 mcg) for prophylaxis.   On an unknown date, the patient received Engerix B 10 mcg. On an unknown date, an unknown time after receiving Engerix B 10 mcg, the patient experienced underdose (Verbatim: Adult got pediatric dose, later got replacement dose) and adult use of a child product (Verbatim: Adult patient got pediatric dose). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 14-Apr-2023 An adult patient was given a pediatric dose of Engerix B and then went back on the same day and received an adult dose of Engerix.  Remove patient identifier was asking, what would a GlaxoSmithKline advise for next steps. Unable to speak to healthcare provider for consent. An adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Mar2020, no 2nd dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in March 2020).   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: 1st dose Mar2020, no 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The patient had not receive his second dose. The reporter did not consent to follow-up. This case was linked with case US2023055329, reported by same reporter for his wife. Till the time of reporting, the patient receive second dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023055329:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Mar2020, not yet received 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in March 2020).   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: 1st dose Mar2020, not yet received 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The patient had not receive her second dose. The reporter did not consent to follow-up. This case was linked with case US2023055327, reported by same reporter for himself. Till the time of reporting, the patient receive second dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023055327:Same reporter.