chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: female patient was accidentally administered a 3rd dose of Menveo vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 40-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 3E99M, expiry date 31-DEC-2025) for prophylaxis.   Previously administered products included Menveo (1st dose on 15th November 2024). Concomitant products included Meningococcal vaccine A/C/Y/W conj (CRM197) (Menveo).   On 06-FEB-2025, the patient received Menveo (intramuscular, right deltoid) .5 ml. On 06-FEB-2025, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: female patient was accidentally administered a 3rd dose of Menveo vaccine). On 06-FEB-2025, the outcome of the extra dose administered was not applicable.   It was unknown if the reporter considered the extra dose administered to be related to Menveo.     It was unknown if the company considered the extra dose administered to be related to Menveo.   Additional Information: GSK receipt date: 19-MAR-2025 The reporter stated that a female patient was accidentally administered a 3rd dose of Menveo vaccine on February 6th, 2025, in the right deltoid due to a charting error, which led to extra dose administered; the 2nd dose was not documented in the chart, The HCP reported that the patient was administered the 1st dose of Menveo on November 15, 2024, and the 2nd dose on January 15th, 2025. The HCP reported as medical history for this patient that she does not have a spleen.
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: hurts; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of pain 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 (Verbatim: hurts). The outcome of the pain was resolved.   The reporter considered the pain to be related to Shingrix.     The company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-MAR-2025 Pharmacist shared that although patients complain about the first dose hurting more than other vaccines since they usually co-administer Shingrix with other vaccines, patients still return for the second dose. Patients that return for 2nd dose usually states that the second dose was not nearly as bad as the first dose. This was not related to an existing case.
Sex: F
Vaccine: MMR
Symptoms: Measles post vaccine
Clinical narrative: Vaccine deprived measles; This serious case was reported by a nurse via sales rep and described the occurrence of measles in a 9-month-old female patient who received MMR (Priorix) (batch number X027446, expiry date 27-NOV-2025) for prophylaxis.   On 20-FEB-2025, the patient received the 1st dose of Priorix (left thigh). On 23-FEB-2025, 3 days after receiving Priorix, the patient experienced measles (Verbatim: Vaccine deprived measles) (serious criteria other: Other medically imp. condition). On 01-MAR-2025, the outcome of the measles was resolving.   The reporter considered the measles to be related to Priorix and Priorix Pre-Filled Syringe Device.     The company considered the measles to be unrelated to Priorix and Priorix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-MAR-2025 Nurse reported that patient took 1st dose of Priorix  vaccine and experienced vaccine deprived measles.; Sender's Comments: Measles  is a listed event which, due to the following criteria (insufficient information provided about the clinical description and laboratory confirmation of disease) is considered unrelated to GSK vaccine Priorix and Priorix Pre-Filled Syringe Device.
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Pruritus
Clinical narrative: had the first one injection vaccine before getting shingles; itchy; annoying feelings; 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.   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, not applicable after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: had the first one injection vaccine before getting shingles), pruritus (Verbatim: itchy) and feeling abnormal (Verbatim: annoying feelings). The outcome of the shingles was resolved and the outcome of the pruritus and feeling abnormal were not resolved.   It was unknown if the reporter considered the pruritus and feeling abnormal to be related to Shingles vaccine. It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the pruritus and feeling abnormal 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: 15-MAR-2025 The reporter said that get your vaccines. It has been over a year since the patient have had it. However, his/her neck still had these strange symptoms itchy and annoying feelings. The patient had the first one injection vaccine before getting shingles so his/her shingles might have been milder. The patient did get the two injections vaccine and so far, it was good.
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure; 6 months later dealing with post herpetic neuralgia; 15 years later got a triple dose of 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 and Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (twice).   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), post herpetic neuralgia (Verbatim: 6 months later dealing with post herpetic neuralgia) and extra dose administered (Verbatim: 15 years later got a triple dose of shingles). The outcome of the vaccination failure and post herpetic neuralgia were not reported and the outcome of the extra dose administered was not applicable.   It was unknown if the reporter considered the vaccination failure and post herpetic neuralgia to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and post herpetic neuralgia to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she had shingles twice, got the vaccine, 15 years later got a triple dose of Shingles and 6 months later dealing with post herpetic neuralgia and it was horrendous. The reporter further stated, the physician said she wanted his/her body healed for a full year and then get the new vaccine and the booster shot. Patient received a triple dose of Shingles vaccine, which led to an extra dose administered. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding post herpetic neuralgia were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (h/o shingles, insufficient information provided about the clinical description, details regarding laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1, Dose 2 and extradose)
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got the 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant and other: Serious as per reporter) and shingles (Verbatim: still got the shingles) (serious criteria other: Serious as per reporter). The outcome of the vaccination failure was not reported 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.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-MAR-2025 The case was received from the patient via interactive digital media. The patient took the vaccine still got the shingles.  Five years later the patient still have pain.  This was some serious stuff. 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 vaccine Shingles vaccine  Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I have had them for over a year. Still not totally gone. Nothing helped. Had both shots.; 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: I have had them for over a year. Still not totally gone. Nothing helped. Had both shots.). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving.   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: 21-MAR-2025 This case was reported by a patient via interactive digital media. The patient had both the Shingles shots. The patient had shingles for over a year and still not totally gone, nothing helped. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming 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 vaccine Shingles vaccine(1st dose)and Shingles vaccine (2nd dose).
Vaccine: VARZOS
Symptoms: Herpes zoster, 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.   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 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: 21-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. Reporter stated that two friends they know got the Shingles vaccine and they both got shingles. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: got shingles 4 weeks after getting my second shot/ painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult female 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, 4 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got shingles 4 weeks after getting my second shot/ painful). 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: 23-MAR-2025 This case was reported by a patient via interactive digital media. The patient got shingles 4 weeks after getting her second shot. She was lucky they were on her arm but painful. This was 1 of 3 linked cases reported by same reporter.; Sender's Comments:  US-GSK-US2025AMR036210:Different Patient US-GSK-US2025AMR036211:Different Patient
Vaccine: VARZOS
Symptoms: Herpes zoster, 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year 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 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: 21-MAR-2025 This case was reported by a patient via interactive digital media. The patient had the vaccines and had shingles a year later. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got the 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got the 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 : 21-MAR-2025 This case was reported by a patient via interactive digital media. He/she got the shingles shot and still got the shingles but not. As bad as they could be This report is one of several cases received as part of a line-listing, each containing minimal information. No further information is expected.; 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 vaccine Shingles vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vccination failure; I had both vaccines and still got 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: suspected vccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had both vaccines and still got 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 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: 24-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had received both vaccines and still got shingles. It was painful for about 2 weeks. The reporter mentioned that he/she never got the rash which they believe was suppressed from the vaccine. He/she had nothing to compare it to but he/she thinks it would had been much worse if he/she had not been vaccinated. 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,  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."
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected Vaccination failure; shingles on face and head; 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 (years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles on face and head). The outcome of the vaccination failure was not reported 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.     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: 23-MAR-2025 This case was reported by a patient via interactive digital media. The patient had shingles years ago, got the shingles vaccine and now have shingles on face and head. Truly was the worst pain patient have ever had. 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 completion of primary vaccination schedule, time to onset for shingles  and laboratory confirmation regarding  shingles ) is considered unrelated to GSK vaccine Shingles vaccine
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: painful; 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 the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: painful). 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: 23-MAR-2025 This case was reported by a patient via interactive digital media. The patient just got his/her first Shingles shot and boy was it painful.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; I currently have shingles right side on my head and face; 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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I currently have shingles right side on my head and face). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving.   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: 22-MAR-2025 The reporter reported that he/she currently had shingles right side on head and face but it was getting better after three days and it was painful, but the reporter had the vaccine because his/her doctor asked if the reporter had chicken pox and she recommended the 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine  Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took the shingles vaccine andhad shingles 3 times since vaccine/ suspected vaccination failure; had shingles 3 times since vaccine and each time it became worse; 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: took the shingles vaccine andhad shingles 3 times since vaccine/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles 3 times since vaccine and each time it became worse). 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: 24-MAR-2025 This case was reported by a patient via interactive digital media. The patient took the shingles vaccine and had shingles 3 times since the vaccine and each time it became worse. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: adult patient received a pediatric dose of Engerix B; adult patient received a pediatric dose of Engerix B; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 47-year-old female patient who received HBV (Engerix B pediatric) (batch number 233FT, expiry date 12-DEC-2025) for prophylaxis.   On 14-MAR-2025, the patient received Engerix B pediatric. On 14-MAR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: adult patient received a pediatric dose of Engerix B) and underdose (Verbatim: adult patient received a 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: 18-MAR-2025 The nurse called to inform that on 14th March 2025 an adult patient received a pediatric dose of Engerix B which led to adult use of a child product and underdose.  Should administer another pediatric dose? The vaccine administration facility is the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received first Shingrix vaccine about 10 months ago, and they receive their second now; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a adult female patient who received Herpes zoster (Shingrix) (batch number X5J23, expiry date 25-JAN-2026) for prophylaxis.   Previously administered products included Shingrix (first Shingrix vaccine about 10 months ago).   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 drug dose administration interval too long (Verbatim: patient received first Shingrix vaccine about 10 months ago, and they receive their second now). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 18-MAR-2025 The patient received their first Shingrix vaccine about 10 months ago, and they receive their second now which led to Drug dose administration interval too long. No further details were collected.
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: Administration of only the liquid portion; Administration of only the liquid portion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis.   In MAR-2025, the patient received Priorix. In MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Administration of only the liquid portion) and inappropriate dose of vaccine administered (Verbatim: Administration of only the liquid portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered 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: 18-MAR-2025 The pharmacist reported that they had a new pharmacist here the other day, she think she gave the Priorix the new MMR, and she do not think she add it the stuff that was inside the little vial to it. The pharmacist think she only gave the syringe liquid which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacist mentioned that she was not sure that this was administer to a patient. The pharmacist mentioned that they just had the vaccine since 1 week ago, so in case that this was administer this happened just a few days ago.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient had not received the 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 Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in SEP-2018).   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: patient had not received the 2nd dose yet). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 20-MAR-2025 The pharmacist reported that they had a patient whose first Shingrix vaccine and had not received the 2nd dose yet. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: one of the powder vials (diluent) was not mixed; one of the powder vials (diluent) was not mixed; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 82-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 52Z52, expiry date 16-OCT-2025) for prophylaxis.   On 20-MAR-2025, the patient received Arexvy. On 20-MAR-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: one of the powder vials (diluent) was not mixed) and inappropriate dose of vaccine administered (Verbatim: one of the powder vials (diluent) was not mixed). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 20-MAR-2025  The pharmacist reported that after mixing doses, he/she realized that after vaccination one of the powder vials (diluent) was not mixed and the patient was given an incomplete dose which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The pharmacist does not know which of these patients was given the incomplete dose. No further information was obtained The Vaccine Administration Facility was the same as Primary Reporter. This case was linked with US2025034231, reported by same reporter.; Sender's Comments:  US-GSK-US2025034231:same reporter different patient
Age: 63.0
Sex: M
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received Priorix vaccine intramuscularly; Out of recommended age range; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 63-year-old male patient who received MMR (Priorix) (batch number 4N222, expiry date 13-MAR-2026) for prophylaxis.   On 21-MAR-2025, the patient received Priorix (intramuscular). On 21-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: received Priorix vaccine intramuscularly) and inappropriate age at vaccine administration (Verbatim: Out of recommended age range). The outcome of the subcutaneous injection formulation administered by other route and inappropriate age at vaccine administration 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: 21-MAR-2025 The pharmacist reported that the patient received an intramuscular dose of Priorix which led to, subcutaneous injection formulation administered by other route. The reporter mentioned that aside from the administration error, it was also noted that the patient was outside of the age range described in the prescribing information which led to, inappropriate age at vaccine administration. The Vaccine Administration Facility is the same as Primary Reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Intercepted product prescribing error
Clinical narrative: Shingrix prescribed under age with shingles episode; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles, tingling (tingling in trunk, legs and arms) and burning sensation.   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced intercepted drug prescribing error (Verbatim: Shingrix prescribed under age with shingles episode). The outcome of the intercepted drug prescribing error was not applicable.   Additional Information: GSK Receipt Date: 24-MAR-2025 The pharmacist reported that they have a patient that was younger than 50 years of age but they had shingles and they are having tingling in trunk, legs and arms, and burning sensation in the skin, without rash.  The doctor prescribed Shingrix but caller did not feel comfortable giving the vaccine if patient was having symptoms.
Vaccine: COVID19
Symptoms: Abdominal distension, Chills, Faeces discoloured, Pyrexia
Clinical narrative: chills; fever; digestions feel like bloated, very gassy; stool is kind of yellowish color/gassy yellow stool; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 20Mar2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset Mar2025, outcome "unknown"; ABDOMINAL DISTENSION (non-serious) with onset Mar2025, outcome "unknown", described as "digestions feel like bloated, very gassy"; PYREXIA (non-serious) with onset Mar2025, outcome "unknown", described as "fever"; FAECES DISCOLOURED (non-serious) with onset Mar2025, outcome "unknown", described as "stool is kind of yellowish color/gassy yellow stool".  Additional information: the patient got a shot about a week ago, couple of days after he got it, the patient experienced chills and fever but did not take temperature. Started digestions feel like bloated, very gassy and stool was kind of yellowish color.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia
Clinical narrative: had a lot of troubles swallowing; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 77-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (ongoing). Concomitant medication(s) included: ALDACTONE [SPIRONOLACTONE] taken for hypertension; PREVACID. Vaccination history included: Bnt162b2 (Dose number unknown, Patient thought he had had three previous immunization with Pfizer covid-19 vaccine, but was not sure), for covid-19 immunisation. The following information was reported: DYSPHAGIA (non-serious) with onset Dec2024, outcome "recovered", described as "had a lot of troubles swallowing". The event "had a lot of troubles swallowing" required emergency room visit. Therapeutic measures were not taken as a result of dysphagia.  Additional information: The patient did not receive any other vaccine administered on the same day as the Pfizer Covid-19 Vaccine. When probed if consumer took any vaccine 4 weeks prior taking the Pfizer Covid-19 Vaccine, patient stated that all the vaccines the patient took were from Pfizer. Patient mentioned that he took a shot of the COVID-19 (it was just a normal dose ) and then after that he had a lot of troubles swallowing in December of 2024 for about 6 hours and it did not go totally away for about 2 days. It got better over the next two days and it was totally gone after two days. Patient had had lab test but not for this. For this patient almost went for emergency room but now with no treatment.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive for Covid; I tested positive for Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "lung cancer" (ongoing), notes: since patient had lung cancer. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed, Manufacture Unknown, Lot: Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), Manufacture Unknown, Lot: Unknown), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Mar2025, outcome "unknown" and all described as "I tested positive for Covid". The event "i tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Mar2025) Positive. Clinical course: Wednesday (19Mar2025) patient tested positive for Covid for the first time. Patient had all the Covid booster shots. Patient's doctor prescribed Paxlovid and when patient's husband picked it up we had to pay dollar 735 out of pocket. That was half of patient's insurance check for the whole month. Patient felt the need to take it since patient had lung cancer but patient would never buy a Pfizer product again.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngeal swab, SARS-CoV-2 test
Clinical narrative: gotten Covid; gotten Covid/ they swabbed me for the Flu and they swabbed me for the COVID and it came back positive; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 50-year-old male patient received BNT162b2 (BNT162B2 NOS), in Jan2024 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Vaccination for the flu, administration date: Nov2023, for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "gotten Covid"; COVID-19 (medically significant), outcome "unknown", described as "gotten Covid/ they swabbed me for the Flu and they swabbed me for the COVID and it came back positive". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: positive; Unknown Results; SARS-CoV-2 test: I have COVID.  Clinical course: The Caller stated, "This is my second time I've gotten Covid." When asked if they had taken Paxlovid previously, the Caller stated, "No I didn't. I got it when it first came out and I didn't get sick at all. Nothing. But it's so weird cause I didn't get sick; the only thing that happened to me was that I lost my sense of smell and taste. I took the vaccination in Jan2024 and I got it again" "They said cause you got high blood pressure we're gonna put you on Paxlovid" "The only symptom I had was I was sneezing my nose was runny all days I can't have the Flu, there's no way that I can have the Flu because I got the vaccination for the flu last Nov2023" "And then, so when I went and got vaccinated for the COVID, they have me some home test kits, so I said I'm going to test myself here at the house, and I tested myself and I told my wife, it's showing that I have COVID, she said for real? Let's go to the doctor So yeah, they swabbed me for the Flu and they swabbed me for the COVID and it came back positive It was horrible yesterday, but then I have allergies, so I thought maybe it's my allergies I knew something was wrong yesterday, because I went to sleep because I started like, I mean, it wasn't even cold when I was laying down and I was shivering I was shaking".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: Non-cardiac chest pain
Clinical narrative: I had an unrelated health condition when I tried switching to pfizer but it caused chest pain (supposedly non cardiac); This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (COMIRNATY NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna vaccine (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: NON-CARDIAC CHEST PAIN (non-serious), outcome "unknown", described as "I had an unrelated health condition when I tried switching to pfizer but it caused chest pain (supposedly non cardiac)".  Additional information: The patient received the Comirnaty COVID-19 Vaccine; they wrote, in relation to Moderna vaccine: Patient had an unrelated health condition when patient tried switching to Pfizer but it caused chest pain (supposedly non cardiac) so I am never getting pfizer again if can avoid it. It was probably not caused by the vaccine but I am being cautious.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Faeces discoloured, Flatulence
Clinical narrative: gassy yellow stool; gassy yellow stool; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Mar2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FAECES DISCOLOURED (non-serious), FLATULENCE (non-serious) all with onset Mar2025, outcome "unknown" and all described as "gassy yellow stool".  Additional information: Caller, a patient got Pfizer Covid vaccine shot a week ago (Mar2025) and she was having gassy yellow stool, she wanted to know if that is a side effect of getting a shot.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: a little swore injection site; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An elderly female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "a little swore injection site". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.