chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS
Symptoms: Bedridden, Pain
Clinical narrative: was in bed all day yesterday; The body aches were tremendous; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of bedridden in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14-MAR-2025, the patient received Shingles vaccine. On 15-MAR-2025, 1 days after receiving Shingles vaccine, the patient experienced bedridden (Verbatim: was in bed all day yesterday). In MAR-2025, the patient experienced general body pain (Verbatim: The body aches were tremendous). The outcome of the bedridden was resolved and the outcome of the general body pain was not reported.   It was unknown if the reporter considered the bedridden and general body pain to be related to Shingles vaccine.     It was unknown if the company considered the bedridden and general body pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date : 16-MAR-2025 This case was reported by a patient via interactive digital media. The patient got shingles shot Friday and was in bed all day the day before reporting.  The body aches were tremendous.
Vaccine: VARZOS, VARZOS
Symptoms: Ear pain, Eye pain, Facial pain, Headache, Herpes zoster
Clinical narrative: Suspected vaccination failure; still got shingles in my ear; still got shingles in my eye; the side of my 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.   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), herpes zoster otitis externa (Verbatim: still got shingles in my ear) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: still got shingles in my eye) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: the side of my face). The outcome of the vaccination failure, herpes zoster otitis externa, ophthalmic herpes zoster and facial herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, ophthalmic herpes zoster and facial herpes zoster to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure, herpes zoster otitis externa and ophthalmic herpes zoster to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the facial herpes zoster to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date : 16-MAR-2025  This case was reported by a patient via interactive digital media. Reporter reported that he/she had two shingles shots and still got shingles in his/her ear, eye, the side of his/her face. Excruciated pain in his/her eye, ear and side of his/her head and face. 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2). Herpes zoster oticus and Ophthalmic herpes zoster are unlisted events which are considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2).
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster oticus, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles in my ear; still got shingles in my eye; the side of my 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.   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), herpes zoster otitis externa (Verbatim: still got shingles in my ear) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: still got shingles in my eye) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: the side of my face). The outcome of the vaccination failure, herpes zoster otitis externa, ophthalmic herpes zoster and facial herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, ophthalmic herpes zoster and facial herpes zoster to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure, herpes zoster otitis externa and ophthalmic herpes zoster to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the facial herpes zoster to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date : 16-MAR-2025  This case was reported by a patient via interactive digital media. Reporter reported that he/she had two shingles shots and still got shingles in his/her ear, eye, the side of his/her face. Excruciated pain in his/her eye, ear and side of his/her head and face. 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2). Herpes zoster oticus and Ophthalmic herpes zoster are unlisted events which are considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2).
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, 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: 15-MAR-2025 This case was reported by a patient via interactive digital media. The patient self reported this case for himself/herself. Patient had gotten the shot, hoping to protect himself/herself, but ended up with full-blown shingles.  It was extremely painful and something he/she would not have wished on anyone. 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 vaccine Shingles vaccine.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Had 1st Shingles shot a year ago; 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 (had 1st Shingles shot a year ago).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Had 1st Shingles shot a year ago). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 15-MAR-2025 The patient had 1st Shingles shot a year ago and asked ok to get his/her 2nd shot now. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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: 16-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 got the vaccine and months later got Shingles.  Patient stated that should have passed on the vaccine.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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 (1st dose)and Shingles vaccine( 2nd dose)          .
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; just had 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, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: just had shingles). 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: 14-MAR-2025 The patient's wife reported this case via interactive digital media. The reporter and her husband (patient) had the shots 2 years ago (from the date of reporting) in 2023. The hubby (patient) just had shingles.  The patient went on medications that day and they started drying up in a week or two. 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 completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Patient did not feel great after 2nd dose of vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine (received first dose of Shingles vaccine on an unknown date).   On 14-MAR-2025, the patient received the 2nd dose of Shingles vaccine. In MAR-2025, less than a week after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: Patient did not feel great after 2nd dose of vaccine). The outcome of the feeling abnormal was not reported.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.     It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2025 This case was reported by a patient via interactive digital media. The patient got 2nd vaccine yesterday on 14 MAR 2025 and did not feel great but think it was better than getting shingles especially with skin.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles a few days apart; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. 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 a few days apart). 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: 15-MAR-2025 This case was reported by a patient via interactive digital media. Reporter and husband got the vaccines and they both got shingles. They got the shots at the same time and shingles a few days apart. They hoped that they never get them again. They told themselves that they got milder cases than if had not gotten the vaccines. But reporter often wonder if they did not get it because of the 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. This case is linked with US2025AMR033943 reported by same reporter.; 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. US-GSK-US2025AMR033943:same reporter different patient
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; got 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: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 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.     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: 15-MAR-2025 This case was reported by a patient's wife via interactive digital media. The patient (husband) and reporter got the vaccines and they both got shingles and they got the shots at the same time and shingles a few days apart. 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. This case is linked with US2025AMR033905 reported by same reporter.; 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. US-GSK-US2025AMR033905:same reporter different patient
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles three times in a year; 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: shingles three times in a year). 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 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: 15-MAR-2025 This case was reported by a patient via interactive digital media. The patient self reported this case for himself/herself. Patient got the two shot vaccine but still had shingles three times in a year. 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix administration instead of Pediarix; Kinrix administration to a 6-month-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a male patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 05-MAR-2025, the patient received Kinrix. On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Kinrix and Pediarix, the patient experienced wrong vaccine administered (Verbatim: Kinrix administration instead of Pediarix) and inappropriate age at vaccine administration (Verbatim: Kinrix administration to a 6-month-old patient). The outcome of the wrong vaccine administered 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: 12-MAR-2025 The practitioner nurse called to ask the safety and efficacy of given Kinrix instead of Pediarix to a 6-month-old patient, which led to wrong vaccine administered and inappropriate age at vaccine administration. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 1.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Potential 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 11-year-old female patient who received Hepatitis B vaccine (batch number X9LB7, expiry date 10-FEB-2012) for prophylaxis.   On 29-DEC-2014, the patient received Hepatitis B vaccine. On 29-DEC-2014, an unknown time after receiving Hepatitis B vaccine, the patient experienced expired vaccine used (Verbatim: Potential expired dose administered). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 12-MAR-2025 The patient who received a dose of Hepatitis B vaccine (unknown brand, but manufactured by GlaxoSmithKline according to patient's records) on 29-December-2014 but their records stated expiration date was 10-February-2012, which led expired vaccine used. The reporter did not consent to follow-up.
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: received a dose of Twinrix on September 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received a dose in September 2024).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: received a dose of Twinrix on September 2024). The outcome of the incomplete course of vaccination 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: 13-MAR-2025 The pharmacist reported that a patient received a dose of Twinrix on September 2024 and in October a dose of Havrix Hepatitis A was administered in unknown location. The reporter asked how to continue with the schedule. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Vaccine: MMR
Symptoms: Product preparation error
Clinical narrative: reconstituted with a different diluent; inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received MMR (Priorix) for prophylaxis.   Co-suspect products included mmr vaccine pre-filled syringe device (Priorix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12-MAR-2025, the patient received Priorix. On an unknown date, the patient started Priorix Pre-Filled Syringe Device. On an unknown date, an unknown time after receiving Priorix and an unknown time after starting Priorix Pre-Filled Syringe Device, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with a different diluent) and inappropriate dose of vaccine administered (Verbatim: inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution 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: 13-MAR-2025 The pharmacist called to report Priorix was reconstituted with a different diluent than the one supplied and administered to a pediatric patient.  Diluent used was sterile water, which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered.  The Vaccine Administration Facility is the same as Primary Reporter.
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: early 3rd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 60-year-old female patient who received HAB (Twinrix adult) (batch number 324BY, expiry date 28-SEP-2026) for prophylaxis.   Previously administered products included Twinrix (Patient received first dose on 29-NOV-2024) and Twinrix (Patient received second dose on 29-DEC-2024).   On 19-FEB-2025, the patient received the 3rd dose of Twinrix adult. On 19-FEB-2025, an unknown time after receiving Twinrix adult, the patient experienced drug dose administration interval too short (Verbatim: early 3rd dose). The outcome of the drug dose administration interval too short 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: 13-MAR-2025 The patient received third dose of Twinrix, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: received 4 doses of Engerix-B inadvertently; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received HBV (Engerix B) (batch number MD9SL, expiry date 08-DEC-2026) for prophylaxis.   Previously administered products included Engerix b (received first dose of Engerix b on an unknown date), Engerix b (received second dose of Engerix b on an unknown date) and Engerix b (received third dose of Engerix b on an unknown date).   On an unknown date, the patient received the 4th dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced extra dose administered (Verbatim: received 4 doses of Engerix-B inadvertently). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date: 13-MAR-2025 The pharmacist reports a patient received 4 doses of Engerix b inadvertently which led to extra dose administered.
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Incorrect Route of Administration; 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 male patient who received MMR (Priorix) (batch number KH2BD, expiry date 01-JAN-2026) for prophylaxis.   On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Incorrect Route of Administration). The outcome of the subcutaneous injection formulation administered by other route 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: 13-MAR-2025  The pharmacist had a question regarding one of GlaxoSmithKline vaccines the Mmr vaccine, the Priorix.  So, it was this only subcutaneously only. The pharmacist asked but what happens if it actually had been given intramuscularly which led to subcutaneous injection formulation administered by other route. The pharmacist reported, like was there any side effects for that.
Age: 48.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered, Underdose
Clinical narrative: gave a pediatric dose Hepatitis A to an adult patient; gave a pediatric dose Hepatitis A to an adult patient; 3rd dose of havrix was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 48-year-old male patient who received HAV (Havrix pediatric) (batch number X2233, expiry date 14-NOV-2025) for prophylaxis.   On 13-MAR-2025, the patient received the 3rd dose of Havrix pediatric. On 13-MAR-2025, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: gave a pediatric dose Hepatitis A to an adult patient), underdose (Verbatim: gave a pediatric dose Hepatitis A to an adult patient) and extra dose administered (Verbatim: 3rd dose of havrix was administered). The outcome of the adult use of a child product, underdose and extra dose 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: 13-MAR-2025 The reporter reported that one of staff members gave a pediatric dose Hepatitis A to an adult patient and just needed to call to see what the next dosing will be for the patient? The adult patient received Havrix pediatric vaccine which led to adult use of child product and underdose. And the received dose was 3rd dose of Havrix which led to extra dose administration.
Sex: F
Vaccine: RSV
Symptoms: Unevaluable event
Clinical narrative: one was sent to the hospital because she's really bad/patient was hospitalized; This serious case was reported by a consumer via call center representative and described the occurrence of hospitalization in a 80-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 27NG7, expiry date 31-OCT-2025) for prophylaxis.   On 20-NOV-2024, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced hospitalization (Verbatim: one was sent to the hospital because she's really bad/patient was hospitalized) (serious criteria hospitalization). The outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Arexvy.     The company considered the hospitalization to be unrelated to Arexvy.   Additional Information: GSK Receipt Date: 14-MAR-2025 The two patients that received Arexvy one was in the hospital, and one was in the nursing home. Both patients stay in the nursing home, one was sent to the hospital because she's really bad. They did not provide details as to what really bad.  The sales representative did not know which patient was hospitalized or what occurred with the other patient. She stated that information was not relayed to her and what was provided was all the information she had. She also stated that the organization wanted to remain anonymous but that she would call back if they had any additional information to provide. The reporter did not consent to follow-up. This case was linked with case US2025031537 reported by the same reporter, for different patient.; Sender's Comments: Hospitalization  is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This non-serious case was reported by a other health professional via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22-NOV-2024, the patient received the 1st dose of Shingrix. On 05-MAR-2025, 103 days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-MAR-2025 The patient received dose of Shingrix vaccine and developed Shingles.  The reporter was ask when should receive the second dose of Shingrix vaccine.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count decreased
Clinical narrative: The white blood cell ones decreased a ton since 2023; This spontaneous case was reported by a patient and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (The white blood cell ones decreased a ton since 2023) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Family history included Cancer (sister just died of cancer when she was 67, and patient's whole side of the mom's family, well, actually both sides, a lot of cancer.) and Leukemia (grandmother had leukemia).   In February 2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In 2023, the patient experienced WHITE BLOOD CELL COUNT DECREASED (The white blood cell ones decreased a ton since 2023). At the time of the report, WHITE BLOOD CELL COUNT DECREASED (The white blood cell ones decreased a ton since 2023) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, White blood cell count: decreased a ton since 2023.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered WHITE BLOOD CELL COUNT DECREASED (The white blood cell ones decreased a ton since 2023) to be related.    Patient had received 11 Moderna vaccines since February 2021. Concomitant product use was not provided by the reporter. The white blood cell ones decreased a ton since 2023 and patient thought that it might be from these vaccines because patient took so many of them and patient took them every 3 to 4 months. Patient never got COVID. Treatment information was not provided.   This case was linked to MOD-2025-782473, MOD-2023-716619 (Patient Link).
Vaccine: COVID19
Symptoms: Breast cancer stage IV
Clinical narrative: finally diagnosed with stage 4 metastatic breast cancer; This spontaneous case was reported by a patient and describes the occurrence of BREAST CANCER STAGE IV (finally diagnosed with stage 4 metastatic breast cancer) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BREAST CANCER STAGE IV (finally diagnosed with stage 4 metastatic breast cancer) (seriousness criterion medically significant). The patient was treated with Curcuma longa root (Turmeric) at an unspecified dose and frequency and Zingiber officinale (Ginger) at an unspecified dose and frequency. At the time of the report, BREAST CANCER STAGE IV (finally diagnosed with stage 4 metastatic breast cancer) had not resolved.            No Concomitant medications provided by the reporter.  It was reported that patient was received two Covid 19 shots in 2021 and post vaccination patient body was reacted horribly. Post vaccination patient lymph nodes were swelled up, included under arms, behind the neck, under breasts. Patient was consulted with three doctors and two years before patient was finally diagnosed with stage 4 metastatic breast cancer. It was reported that patient lymph nodes were still enlarged at the time of reporting.  It was reported that patient had ascites also, hence patient used to go for drainage every month for a year.  Patient started to drink treatment medication of turmeric and ginger every day which subsided the swelling for patient.  It was reported that patient had positive symptom due to covid-vaccination.  Patient went to cancer center for treatment at present.  Patient was refused to take any boosters Covid 19 vaccine or any other vaccines at this point.; Reporter's Comments: Causality for Breast cancer stage IV was assessed as not related, due to mechanism of action. The benefit-risk relationship of product is not affected by this report.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Colitis ulcerative, Colonoscopy, Endoscopy, Parasite stool test
Clinical narrative: was diagnosed with Very Early Onset Ulcerative Colitis; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (was diagnosed with Very Early Onset Ulcerative Colitis) in a 3-year-old male patient who received mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (batch no. 3044210) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2024, the patient received dose of mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 19-Oct-2024,  after starting mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS), the patient experienced COLITIS ULCERATIVE (was diagnosed with Very Early Onset Ulcerative Colitis) (seriousness criterion medically significant). The patient was treated with Mesalazine (Mesalamine) for Ulcerative colitis, at an unspecified dose and frequency and Prednisone for Ulcerative colitis, at an unspecified dose and frequency. At the time of the report, COLITIS ULCERATIVE (was diagnosed with Very Early Onset Ulcerative Colitis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: (Positive) very elevated levels of calprotectin indicating inflammation. On an unknown date, Colonoscopy: Test Result (Qualifier):- EQ, Colonoscopy showed ulcers throughout large intestine and was diagnosed with Very Early Onset Ulcerative Colitis. On an unknown date, Endoscopy: Endoscopy and colonoscopy showed ulcers throughout large instestine and was diagnosed with Very Early Onset Ulcerative Colitis. On an unknown date, Parasite stool test: Negative.         The patient had no medical history, concomitant disease or risk factor. No concomitant medication was reported. Next day patient had loose stool, and within 3 days had mucous and blood with stool. It was resolved in 20 days but came back a few weeks later even worse. The patient did not experience any additional symptoms or events. Reporter causality was not reported.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: itchy scalp first then red marks on legs and some on arms. Dermatologist diagnosed as Psoriasis; This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (itchy scalp first then red marks on legs and some on arms. Dermatologist diagnosed as Psoriasis) in a 67-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (itchy scalp first then red marks on legs and some on arms. Dermatologist diagnosed as Psoriasis). At the time of the report, PSORIASIS (itchy scalp first then red marks on legs and some on arms. Dermatologist diagnosed as Psoriasis) had not resolved.      The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that patient noticed itchy scalp first then red marks on legs and some on arms. Dermatologist diagnosed as Psoriasis which patient never had before. It was unknown if the patient experienced any additional symptoms/events.   No treatment medications were reported.  Reporter causality was not reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Pain, Thyroid mass, Weight
Clinical narrative: she had nodules in her thyroid so she had half of her thyroid removed a couple of few weeks ago; terrible body pains over all body pains; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 50-year-old female patient received BNT162b2 (BNT162B2), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), administration date: Jun2021, for COVID-19 treatment; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), administration date: Jul2021, for COVID-19 treatment. The following information was reported: PAIN (non-serious) with onset 2022, outcome "unknown", described as "terrible body pains over all body pains"; THYROID MASS (medically significant), outcome "unknown", described as "she had nodules in her thyroid so she had half of her thyroid removed a couple of few weeks ago". The event "terrible body pains over all body pains" required physician office visit. The patient underwent the following laboratory tests and procedures: Body height: 5 8, notes: She is about 5 8; Weight: 120, notes: her weight 120 something like that. Therapeutic measures were taken as a result of thyroid mass, pain.  Clinical course: The caller was reporting on behalf of her daughter who was the patient. The patient complained of terrible body pain for the last 3 years. She got her first Pfizer Covid vaccine shot on Jun2021, second shot on Jul2021, and Pfizer Covid booster on Jan2022. She wanted to know any possibility that the terrible body pain was due to the shots. They have expanded all their options and had consulted 9 different specialists, and no one seems to know what was causing the pain. When the patient first experienced the pain, the caller remembered that it was like right shortly after she got the booster. She had no other vaccines except these three shots of Covid vaccine. The patient had this pain for three years and she finally about a month ago had half of her thyroid removed but it had nothing to do with this pain according to the caller. The patient had Hashimoto's disease, and the caller was thinking that it can be the cause of pain too. She had been seen by a lot of different doctors, but no one had been able to help her. She tried massage, physical therapy and acupuncture but nothing had helped her with the pain. She just had her thyroid removed but the caller thinks that was not related to the pain. She had nodules in her thyroid, and she had half of her thyroid removed a couple of few weeks ago. They were trying to narrow down what could be causing this pain that she had, if it was vaccine or the Hashimoto's disease, no one seems to know.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick in the ER; This is a spontaneous report received from a Physician from medical information team.  A 44-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "got covid", start date: Jan2022 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 Immunization; Bnt162b2 (dose 2), administration date: Nov2021, for COVID-19 Immunization, reaction(s): "hands puffier", "fingers puffier", "body felt bigger", "lot of vaginal bleeding", "gained weight". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick in the ER". The event "got sick in the er" required physician office visit.  Additional information: The patient was calling to report side effects from the Pfizer Covid-19 vaccine and to see if the side effects she experienced were known with the covid vaccine. She consulted with another doctor in which they were unsure what her side effects were from. She was a physician working and she got sick in the ER. She tried to apply for temporary medical exemption, as she wasn't sure if her reactions were related to the vaccine and needed to do a workup.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500061109 same patient, different dose/events;
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Tremor
Clinical narrative: internal tremor; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 1, single and as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "internal tremor". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller states that she received the COVID vaccines when COVID first came out. Caller confirms that she got the Pfizer COVID vaccines twice. Caller adds that she has a problem with the MRI for her back where she was told that she lost bones in her lumbar and she is losing bones because she is getting older. Caller mentions that she has internal tremor which the vaccine caused. Caller mentions that there was a borderline with the vaccine thing.