chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Aplisol was mistaken as diluent and mixed with the Menveo vaccine was given to the patient; Aplisol was mistaken as diluent and mixed with the Menveo vaccine was given to the patient; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of wrong solution used in drug reconstitution in a 73-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included tuberculin ppd (Aplisol) for product used for unknown indication.   On 06-MAR-2025 11:30, the patient received Menveo (intramuscular, unknown deltoid) and Aplisol (intramuscular) .1 ml. On 06-MAR-2025 11:30, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Aplisol was mistaken as diluent and mixed with the Menveo vaccine was given to the patient) and inappropriate dose of vaccine administered (Verbatim: Aplisol was mistaken as diluent and mixed with the Menveo vaccine was given to the patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 01-APR-2025 A spontaneous report was received from a nurse practitioner, concerning a 73 year old patient of an unknown gender, who experienced product preparation error, product administration error and incorrect route of product administration while using Aplisol for an unknown indication. Medical history and concomitant medications were not reported. On 06th March 2025 at 11:30 hour, the patient started Aplisol single dose via an intramuscular (IM) route in the deltoid (unknown dose). Co suspect medication included Menveo (meningococcal vaccine) via the IM route in the deltoid at an unknown dose and frequency, which was initiated on 06th March 2025 at 11:30 hour.  It was reported that Aplisol was mistaken as diluent and mixed with the Menveo vaccine was given to the patient. At the time of this report, the action taken with Aplisol and Menveo was not applicable.  The outcome of the events of product preparation error, product administration error and incorrect route of product administration was recovered.
Vaccine: VARZOS
Symptoms: Herpes zoster, Stress, Vaccination failure
Clinical narrative: Suspected vaccination failure; 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.   Family history included shingles (patient's father had it for 4 years), emotional distress (too much), neuropathy (destroyed for 30 years after recovery, meditation, relaxation was ticket out of the cycle) and death (patient's mother died).   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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-APR-2025 The patient had discovered he/she get shingles very mild if he/she put his/her body in stress mode such as too much exercise or emotional stress. The patient had the Shingles vaccine in 2019. It would be a lot worse if patient did not have the Shingles vaccine. 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.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine."
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction
Clinical narrative: took the shot and shortly afterwards got shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: took the shot and shortly afterwards got shingles). The outcome of the shingles was not reported.   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: 03-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that his/her sister took the shot and shortly afterwards got shingles.
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pain
Clinical narrative: Bodyaches; Nausea; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced general body pain (Verbatim: Bodyaches) and nausea (Verbatim: Nausea). The outcome of the general body pain and nausea were not reported.   It was unknown if the reporter considered the general body pain and nausea to be related to Shingles vaccine.     It was unknown if the company considered the general body pain and nausea to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-APR-2025 This case was reported by a patient via interactive digital media. The second dose made the patient so sick with body aches and nausea but still worth it.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: took booster dose and stil got shingles/ suspected vaccination failure; had the original and several decades later a booster; 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.   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: took booster dose and stil got shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and drug dose administration interval too long (Verbatim: had the original and several decades later a booster). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 3 days) and the outcome of the drug dose administration interval too long was not applicable.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 02-APR-2025 This case was reported by a patient via interactive digital media. Patient had the original and several decades later a booster shingles vaccine and still got shingles, but it was less severe and cleared in about 3 days. The patient received 2nd dose of Shingles vaccine later than the recommended schedule, which led to lengthening of vaccination schedule. This case was considered as suspected vaccination failure as details regarding completion time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about time to onset for shingles, completion of primary vaccination schedule and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1& 2).
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure, Vision blurred
Clinical narrative: my vision is blurry in my right eye; Suspected vaccination failure; shingles including my eye; On the right side of my head had 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In DEC-2024, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: shingles including my eye) (serious criteria GSK medically significant) and shingles (Verbatim: On the right side of my head had shingles). On an unknown date, the patient experienced blurred vision (Verbatim: my vision is blurry in my right eye). The outcome of the vaccination failure, ophthalmic herpes zoster and shingles were not reported and the outcome of the blurred vision was not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and blurred vision to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and blurred vision to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 03-APR-2025 This case was reported by a patient via interactive digital media. The patient self reported this case for himself/herself. Patient had received the two shot vaccine four years earlier and developed shingles in December 2024.  The shingles affected the right side of his/her head, including his/her eye.  By April 2025, his/her vision in the right eye remained blurry, and he/she were still on medication. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and ophthalmic herpes zoster and laboratory confirmation regarding shingles and ophthalmic herpes zoster were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).  Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: was sick and  after dose 1 of Shingrix; did not feel well; This non-serious case was reported by a nurse via sales rep and described the occurrence of sickness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: was sick and  after dose 1 of Shingrix) and feeling unwell (Verbatim: did not feel well). The outcome of the sickness and feeling unwell were not reported.   It was unknown if the reporter considered the sickness and feeling unwell to be related to Shingrix.     It was unknown if the company considered the sickness and feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-APR-2025 The patient had been vaccinated with Shingrix.  The patient was sick and did not feel well after dose 1 of Shingrix.  She did get the 2nd dose of Shingrix vaccine. It is unknown if that dose also made her feel bad.
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: deathly 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 (had shingles).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: deathly 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: 03-APR-2025 This case was reported by a patient via interactive digital media. The patient was deathly sick from the first dose of Shingles vaccine, did not get the second .  The patient had shingles when was 20 and it was awful.  The second time was very mild.
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; 2nd outbreak has left residual nerve damage; 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 (1st time).   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: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and nerve damage (Verbatim: 2nd outbreak has left residual nerve damage). The outcome of the vaccination failure, shingles and nerve damage were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and nerve damage to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and nerve damage to be related to Shingles vaccine.   Additional Information: GSK Receipt Date : 03-APR-2025 This case was reported by a patient via interactive digital media. Believed every bad and shocking thing had heard about shingles. Some people were more susceptible and harder hit than others, but shingles did not play. It could affect skin and organs even your eyes.  Affliction during and after could both be mild  his/her 1st time or nightmare his/her second time Yes he/she got the new Shingles shot. The 2nd outbreak has left residual nerve damage .  He/she will not took the Covid shots never got Covid by the way but gladly took the shingles shot. It lessened the second episode and he/she believed had prevented a third eruption.  If they were over 50 do yourself a big favour and check out the preventative vaccine. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Breast pain, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; had 2 shingles vaccines and shingles 2 times also /Under right arm still hurts and under right breast/ back still itches; 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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had 2 shingles vaccines and shingles 2 times also /Under right arm still hurts and under right breast/ back still itches). The patient was treated with pregabalin (Lyrica). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 03-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had two Shingles vaccines and shingles 2 times also.  The patient reported it to be under his/her right arm still hurts and under right breast.  The patient reported that his/her back still itches like crazy. The patient took Lyrica for pain. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity
Clinical narrative: few chills later in day; arm being sore; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm being sore) and chills (Verbatim: few chills later in day). The outcome of the pain in arm was resolved (duration 1 day) and the outcome of the chills was resolved.   It was unknown if the reporter considered the pain in arm and chills to be related to Shingrix.     It was unknown if the company considered the pain in arm and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-APR-2025 The patient just got first dose of shingrix and would go for the 2nd dose in May. The patient had heard that the shingles are awful so he/she got the vaccine. The patient have had no problem with vaccine other than arm being sore and had a few chills later in day. But chills didn't last long and soreness in arm gone after a day.
Vaccine: VARZOS
Symptoms: Blindness unilateral, Blister, Deafness unilateral, Diarrhoea, Discoloured vomit
Clinical narrative: suspected vaccination failure; lost sight in my right eye; throwup yellowstuff and had runs now I had them; lost sight in my right eye and right ear; it has took my life away from me; 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: suspected vaccination failure) (serious criteria GSK medically significant), loss of vision (Verbatim: lost sight in my right eye) (serious criteria GSK medically significant), shingles (Verbatim: throwup yellowstuff and had runs now I had them), ear disorder (Verbatim: lost sight in my right eye and right ear) and activities of daily living impaired (Verbatim: it has took my life away from me). The outcome of the vaccination failure and activities of daily living impaired were not reported and the outcome of the loss of vision and ear disorder were not resolved and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure, loss of vision, shingles, ear disorder and activities of daily living impaired to be related to Shingles vaccine.     The company considered the vaccination failure and loss of vision to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, ear disorder and activities of daily living impaired to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-APR-2025 The case was received from the patient via interactive digital media. The patient was been told he/she need to get Shingles shots so he/she did and was so sick he/she did not know if make it home. The patient was throw up yellow stuff and had runs now, had them (shingles) for 5 years they had destroyed body as they never came out. He/she lost sight in my right eye and right ear plus spent a lot of money on physician, the patient stated he/she on medication for them. A few blisters would come out and go away for two years. The patient cannot go anywhere because mess herself/himself and did not know when it happened it just running yellow stuff it has took life away from he/she. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Blindness is an unlisted event which is considered unrelated to GSK Shingles vaccine. US-GSK-US2025AMR041581:Same reporter/ Diferent patient
Vaccine: VARZOS
Symptoms: Herpes zoster, Loss of personal independence in daily activities, Vaccination failure
Clinical narrative: suspected vaccination failure; lost sight in my right eye; throwup yellowstuff and had runs now I had them; lost sight in my right eye and right ear; it has took my life away from me; 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: suspected vaccination failure) (serious criteria GSK medically significant), loss of vision (Verbatim: lost sight in my right eye) (serious criteria GSK medically significant), shingles (Verbatim: throwup yellowstuff and had runs now I had them), ear disorder (Verbatim: lost sight in my right eye and right ear) and activities of daily living impaired (Verbatim: it has took my life away from me). The outcome of the vaccination failure and activities of daily living impaired were not reported and the outcome of the loss of vision and ear disorder were not resolved and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure, loss of vision, shingles, ear disorder and activities of daily living impaired to be related to Shingles vaccine.     The company considered the vaccination failure and loss of vision to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, ear disorder and activities of daily living impaired to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-APR-2025 The case was received from the patient via interactive digital media. The patient was been told he/she need to get Shingles shots so he/she did and was so sick he/she did not know if make it home. The patient was throw up yellow stuff and had runs now, had them (shingles) for 5 years they had destroyed body as they never came out. He/she lost sight in my right eye and right ear plus spent a lot of money on physician, the patient stated he/she on medication for them. A few blisters would come out and go away for two years. The patient cannot go anywhere because mess herself/himself and did not know when it happened it just running yellow stuff it has took life away from he/she. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Blindness is an unlisted event which is considered unrelated to GSK Shingles vaccine. US-GSK-US2025AMR041581:Same reporter/ Diferent patient
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; 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.   Previously administered products included varicella zoster vaccine with an associated reaction of pain in extremity. Family history included shingles (sister had shingles) and depression (sister had depression).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm). Rechallenge with Shingles vaccine was positive. The outcome of the pain in arm was not reported.   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.   Linked case(s) involving the same patient:  US2025AMR037979   Additional Information: GSK Receipt Date: 27-MAR-2025 This case was reported by a patient via interactive digital media. The follow-up could not be possible as no contact details were available. Patient had a sore arm from the shot, also stated that shingles can last for years for some people. For tolerance of first dose refer case US2025AMR037979.; Sender's Comments:  US-GSK-US2025AMR037979:
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I got the first vaccine and got shingles back within a couple days; 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 the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: I got the first vaccine and got shingles back within a couple days). The outcome of the shingles was not reported.   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: 05-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that doctor would not allow to get the vaccine as they have never fully gone away the reporter got the first vaccine and got shingles back within a couple days.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I received one shot three years ago. Is it too late for the second dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st shot three 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: I received one shot three years ago. Is it too late for the second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 05-APR-2025 The patient self-reported this case. The patient received one shot three years ago and asked was it too late for the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: made me feel horrible for 2-3; 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 (Shingrix) for prophylaxis.   The patient's past medical history included post herpetic neuralgia (had it in my sciatic nerve when patient was 23, the post heretic neuralgia lasted about 6 months).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling bad (Verbatim: made me feel horrible for 2-3). The outcome of the feeling bad was resolved (duration 3 days).   It was unknown if the reporter considered the feeling bad to be related to Shingrix.     It was unknown if the company considered the feeling bad to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she had it in my sciatic nerve when he/she was 23.  The post heretic neuralgia lasted about 6 months.  It was awful.  As soon as I could get the vaccine I did and even though it made me feel horrible for 2-3, I did not hesitate to get the 2nd dose.  I did not ever want to have shingles again.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; got the vaccine and he got a small version of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the vaccine and he got a small version of shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 08-APR-2025 This case was reported by a consumer via interactive digital media. The patient wife reported that her husband got the vaccine, and he got a small version of shingles he did not even remember if he ever had chicken pox when he was a kid, or not. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late second dose; 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 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 74NC9, expiry date 13-NOV-2026) for prophylaxis.   Previously administered products included Shingrix (Patient had first dose in 30-AUG-2023 with batch number 2GG34 and expiry date 21-AUG-2024).   On 09-JAN-2025, the patient received the 2nd dose of Shingrix. On 09-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 27-MAR-2025 Patient got their first dose of Shingrix on August 30th 2023 and a late second dose on January 9th 2025, and patient was recommended to restart the series.  Patient did not tell her anything about being immunocompromised. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 11-year-old patient received an adult dose of Havrix this morning; 11-year-old patient received an adult dose of Havrix this morning; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 11-year-old male patient who received HAV (Havrix 1440 adult) (batch number HR4RB, expiry date 18-DEC-2025) for prophylaxis.   On 31-MAR-2025, the patient received the 1st dose of Havrix 1440 adult. On 31-MAR-2025, an unknown time after receiving Havrix 1440 adult, the patient experienced adult product administered to child (Verbatim: 11-year-old patient received an adult dose of Havrix this morning) and overdose (Verbatim: 11-year-old patient received an adult dose of Havrix this morning). The outcome of the adult product administered to child and overdose were not applicable.   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: 31-MAR-2025 Other Health Professional stated an 11-year-old patient received an adult dose of Havrix this morning, which led to Adult product administered to child and overdose.  It was the first dose for the patient. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: inappropriate reconstitution technique; received only the diluent portion of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 30-SEP-2024, the patient received Menveo. On 30-SEP-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: inappropriate reconstitution technique) and inappropriate dose of vaccine administered (Verbatim: received only the diluent portion of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 31-MAR-2025 The registered nurse reported that a patient received only the diluent portion of Menveo (two vial), which led to an inappropriate dose of vaccine administered and inappropriate preparation of medication. The reporter wanted to know what they need to do.
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: wrong vaccine schedule/ approximately 20 patients, about 50/50 male and female, were affected by this; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in an unspecified number of patients who received Men B NVS (Bexsero) (batch number 3L339) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate schedule of vaccine administered (Verbatim: wrong vaccine schedule/ approximately 20 patients, about 50/50 male and female, were affected by this). The outcome of the inappropriate schedule of vaccine administered was not applicable.   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: 31-MAR-2025 A registered nurse contacted GlaxoSmithKline to report that they were having issues interpreting the information that was presented in the prescribing information for Bexsero, as it stated that two doses of Bexsero could be given at least one month apart but in the (CDC) Centers for Disease Control and Prevention it stated that the interval had to be a zero- and six-month schedule.  The prescribing information was revised, using the most up-to-date version which included the zero- and six-month vaccination schedule or the 0, 1 to 2 and six-month vaccination schedule.  The health care professional stated that the reason for which they used the incorrect vaccination schedule was due to the fact that the package insert that had been included in their vaccine container was the prescribing information before the 2024 revision, which led to an inappropriate schedule of vaccine administered They mentioned that approximately 20 patients, about 50 by 50 male and female, were affected by this. The vaccine administration facility was the same as primary reporter. This case was linked with US2025AMR044125, reported by same reporter for a different female patients.; Sender's Comments:  US-GSK-US2025AMR044125:same reporter different patient
Sex: M
Vaccine: DTAP
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered
Clinical narrative: A 2 years old male patient received Infanrix and when administering the dose the patient pulled away the syringe so he received an incomplete dose of Infanrix.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 2-year-old male patient who received DTPa (Infanrix) (batch number 223Y9, expiry date 07-SEP-2026) for prophylaxis.   On an unknown date, the patient received the 1st dose of Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced incomplete dose administered (Verbatim: A 2 years old male patient received Infanrix and when administering the dose the patient pulled away the syringe so he received an incomplete dose of Infanrix.). The outcome of the incomplete dose administered was not applicable.   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: 31-MAR-2025 On 31/MARCH/2025 a registered nurse called to report that a male patient received Infanrix and when administering the dose, the patient pulled away the syringe so the patient received an incomplete dose of Infanrix, which led to Incomplete dose administered. The series of Dtap vaccine that the patient has: 3 months, 7 months and 16 months.  The patient was 2 years old now.  Reporter wants to ask about should the patient receive a secondary dose or not  Other Health Professional mentioned that she was ready to revaccinate the patient.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient recived first dose of Shingrix in 2021 and not recived 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 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient received first dose of in 2021).   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: The patient recived first dose of Shingrix in 2021 and not recived second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 03-APR-2025 No personal information provided and no other information such as lot number, expiration date, patient's initials were provided. The vaccine administration facility was the same as primary reporter.  Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: patient received an extra dose of Menveo 1 year after her last dose.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 9M2R7, expiry date 31-DEC-2025) for prophylaxis.   On 03-APR-2025, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: patient received an extra dose of Menveo 1 year after her last dose.). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date: 04-APR-2025 The reporter reported that on 04 APRIL 2025 a Registered Medical Assistant called to report that yesterday on 3 April 2025 they administered an extra dose of Menveo to a 17 years 7 months old female patient, which led to extra dose administered. A year ago, was her last dose of Menveo on 1 April 2024, so the patient received the extra dose yesterday.  Were there any side effects that would hurt the patient.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix-B - Administration of expired vaccine.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received HBV (Engerix B) (batch number 3T5L9, expiry date 09-MAR-2025) for prophylaxis.   On 03-APR-2025, the patient received Engerix B. On 03-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B - Administration of expired vaccine.). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 04-APR-2025 A nurse practitioner mentioned that the patient received an expired dose of Engerix-B, which led expired vaccine used.  The reporter consented to follow up; Sender's Comments:  US-GSK-US2025040983:same reporter/ Different patient US-GSK-US2025040985:same reporter/ Different patient
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Dose Administered; 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 43-year-old female patient who received HBV (Engerix B adult) (batch number 9JG23, expiry date 10-FEB-2025) for prophylaxis.   On 04-APR-2025, the patient received Engerix B adult. On 04-APR-2025, an unknown time after receiving Engerix B adult, the patient experienced expired vaccine used (Verbatim: Expired Dose Administered). The outcome of the expired vaccine used was not applicable.   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: 04-APR-2025 Other HCP had a Hepatitis B vaccine that was given to an adult patient on the day of reporting and after it was given it was noticed that the vaccine had expired in February two months ago, so reporter was wondering what the protocol for that was. If there was like a window or anything. Patient received expired Engerix B, which led to expired vaccine used.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Engerix-B two pediatric 10 micrograms doses to make one of 20 micrograms given to an adult; This non-serious case was reported by a physician via call center representative and described the occurrence of adult use of a child product in a 41-year-old female patient who received HBV (Engerix B pediatric) (batch number H2B22, expiry date 07-MAR-2026) for prophylaxis.   On 04-APR-2025, the patient received Engerix B pediatric. On 04-APR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Engerix-B two pediatric 10 micrograms doses to make one of 20 micrograms given to an adult). The outcome of the adult use of a child product was not applicable.   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: 04-APR-2025 A physician wanted to get information regarding giving two pediatric doses of Engerix-B to an adult, which led adult use of a child product.  They first gave one pediatric dose and after realizing this, gave the second one to administer a total of 20 micrograms of Engerix-B.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: received pediatric dose of Engerix-B; received pediatric dose of Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 55-year-old male patient who received HBV (Engerix B Junior) (batch number 47XT4, expiry date 16-JUL-2026) for prophylaxis.   On 04-APR-2025, the patient received Engerix B Junior. On 04-APR-2025, an unknown time after receiving Engerix B Junior, the patient experienced adult use of a child product (Verbatim: received pediatric dose of Engerix-B) and underdose (Verbatim: received pediatric dose of Engerix-B). The outcome of the adult use of a child product and underdose were not applicable.   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: 04-APR-2025 On 04th April 2025, a pharmacist called to inform that they had a patient, that earlier that day received pediatric dose of Engerix-B which led to adult use of child product and underdose.