chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Damn that shot hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In FEB-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Damn that shot hurt). The outcome of the injection site pain was not reported.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she got his/her first shot two months ago.  Damn that shot hurt.  Fighting to go for second.; Sender's Comments:  US-GSK-US2025AMR046350:Same reporter
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: only diluent administered; only diluent administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received MMR (Priorix) for prophylaxis.   On 10-APR-2025, the patient received Priorix. On 10-APR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: only diluent administered) and inappropriate dose of vaccine administered (Verbatim: only diluent administered). 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: 14-APR-2025 Other HCP reported that on 10th Apr 2025, a patient received only the diluent component of Priorix, that means, without being reconstituted. The patient received only diluent of Priorix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Havrix was administered after a temperature excursion to one patient; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Havrix was administered after a temperature excursion to one patient). The outcome of the incorrect storage of drug was not applicable.   Additional Information: GSK Receipt Date: 16-APR-2025 Nurse practitioner reported Havrix was administered after a temperature excursion to one patient, which led to Incorrect storage of drug. Nurse practitioner did not provide patient information or date of administration at the time of the call. No further information provided.  No additional adverse event reported.
Sex: M
Vaccine: HEP, HEPAB
Symptoms: Interchange of vaccine products
Clinical narrative: Interchangeability (first dose: TWINRIX, second dose: HEPLISAV).; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 63-year-old male patient who received HAB (Twinrix) (batch number 324BY, expiry date 28-AUG-2026) for prophylaxis.   Co-suspect products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) for prophylaxis.   On 11-MAR-2025, the patient received the 1st dose of Twinrix. On 08-APR-2025, the patient received Heplisav b. On an unknown date, an unknown time after receiving Twinrix, the patient experienced interchange of vaccine products (Verbatim: Interchangeability (first dose: TWINRIX, second dose: HEPLISAV).). The outcome of the interchange of vaccine products 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 : 11-APR-2025 Other HCP reported a patient received a first dose of Twinrix, and afterwards received an Heplisav dose, which led to interchange of vaccine products. Reporter asked for any advice in this situation.
Age: 1.0
Sex: M
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Twinrix to pediatric patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old male patient who received HAB (Twinrix adult) (batch number h7rf2, expiry date 17-JAN-2026) for prophylaxis.   On 01-APR-2025, the patient received the 1st dose of Twinrix adult. On 01-APR-2025, an unknown time after receiving Twinrix adult, the patient experienced inappropriate age at vaccine administration (Verbatim: Twinrix to pediatric patient). The outcome of the inappropriate age at vaccine administration 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: 11-APR-2025 Other HCP reported about the administration of Twinrix to a 12 month old male patient, who was given the dose on April 1st, 2025, which led to inappropriate age at vaccine administration. They accepted follow-up.
Age: 77.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Underdose; immunization to an adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 77-year-old female patient who received HBV (Engerix B 10 mcg) (batch number 7NX57, expiry date 12-DEC-2026) for prophylaxis.   On 11-APR-2025, the patient received Engerix B 10 mcg. On 11-APR-2025, an unknown time after receiving Engerix B 10 mcg, the patient experienced underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: immunization to an adult). The outcome of the underdose and adult use of a child product were not applicable.   Additional Information: GSK Receipt Date: 11-APR-2025 The reporter reported that gave a hepatitis b pediatrics immunization to an adult and they like to know the recommendations which led to Adult use of a child product and underdose. The Vaccine Administration Facility is the same as Primary Reporter.
Sex: M
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: I have long covid now; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (I have long covid now) in a male patient of an unknown age 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 POST-ACUTE COVID-19 SYNDROME (I have long covid now). At the time of the report, POST-ACUTE COVID-19 SYNDROME (I have long covid now) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No concomitant medication was reported. The only time patient had Covid was when he was injected with Moderna shots. He never tested positive. However, he had long covid.  It was unknown if the patient experienced any additional symptoms or events. No treatment information was reported.
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Injection site reaction, Pain
Clinical narrative: patient given tenivac describing that it was like a painful burning sensation while injecting the vaccine; Initial information received on 14-Apr-2025 regarding an unsolicited valid non-serious case received from a Nurse.  This case was linked with US-SA-2025SA109153 and US-SA-2025SA109935.  This case involves a 12 years old female patient where patient was given Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] describing that it was like a painful burning sensation while injecting the vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Polio vaccine for Immunisation.  On 14-Apr-2025, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (strength- standard) Suspension for injection lot U8492AA and expiry date- 28-FEB-2027 via intramuscular route in the right arm for immunisation.  On 14-APR-2025, the patient given tenivac describing that it was like a painful burning sensation while injecting the vaccine (vaccination site pain) (latency- same day).  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.; Sender's Comments:  US-SA-2025SA109153: US-SA-2025SA109935:
Age: 13.0
Sex: F
Vaccine: TD
Symptoms: Injection site reaction, Pain
Clinical narrative: patient given tenivac describing that it was like a painful burning sensation while injecting the vaccine; Initial information received on 14-Apr-2025 regarding an unsolicited valid non-serious case received from a Nurse.  This case was linked with US-SA-2025SA109105 and US-SA-2025SA109935.  This case involves a 13 years old female patient where patient was given Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] describing that it was like a painful burning sensation while injecting the vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Polio vaccine for Immunisation.  On 14-Apr-2025, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (strength- standard) Suspension for injection lot U8492AA and expiry date- 28-FEB-2027 via intramuscular route in the left arm for immunisation.  On 14-APR-2025, the patient given tenivac describing that it was like a painful burning sensation while injecting the vaccine (vaccination site pain) (latency- same day).  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.; Sender's Comments:  US-SA-2025SA109105: US-SA-2025SA109935:
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine administration with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 18 years old female patient who received expired meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included covid-19 vaccine; influenza vaccine; and hepatitis B vaccine, all for Immunisation.  On 16-Apr-2025, the patient received 0.5 ml of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection of standard strength once with lot U7616AB and expiry date 11-Apr-2025   via intramuscular route in the right deltoid for immunisation (expired product administered) (Latency same day)  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received one dose of of Shingrix and never received the second; 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 (patient received one dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received one dose of of Shingrix and never received the second). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 14-APR-2025 The pharmacist reported that the patient received one dose of Shingrix vaccine and never received the second. She did not have any patient demographics. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: i did not have a reaction to the shot except a little soreness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a 85-year-old 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: i did not have a reaction to the shot except a little soreness). 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: 10-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got his/her single shot at the age of 85 year old and both of his/her sisters get the singles and never got over them, burning stinging for years, his/her older sister singles went inside of her and it hit so many of her nerves the pain was unbearable, he/she honestly think it pushed her over and she passed away, his/her older daughter got singles when she was fairly young so she recovered but his/her other daughter got her shot at 50. The patient mentioned that get single shot, it can be so painful and maybe never go away if they were older. The patient reported that he/she did not had a reaction to the shot except a little soreness.; Sender's Comments:  US-GSK-US2025AMR045222:Same reporter /different patient
Vaccine: VARZOS
Symptoms: Blood glucose decreased
Clinical narrative: shingle vaccine lower blood sugar; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of blood sugar decreased in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced blood sugar decreased (Verbatim: shingle vaccine lower blood sugar). The outcome of the blood sugar decreased was not reported.   The reporter considered the blood sugar decreased to be related to Shingrix.     The company considered the blood sugar decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-APR-2025 The Shingle vaccine lower blood sugar.; Sender's Comments:  US-GSK-US2025AMR046239:same reporter US-GSK-US2025AMR046237:same reporter US-GSK-US2025AMR046252:same reporter US-GSK-US2025AMR046250:same reporter US-GSK-US2025AMR046246:same reporter
Age: 10.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain
Clinical narrative: patient given tenivac describing that it was like a painful burning sensation while injecting the vaccine; Initial information received on 14-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case was linked with US-SA-2025SA109153 and US-SA-2025SA109105.  This case involves a 10 years old female patient given tenivac describing that it was like a painful burning sensation while injecting the vaccine after receiving diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Polio vaccine and measles vaccine, mumps vaccine, rubella vaccine (MMR) both for Immunisation.  On 14-Apr-2025, the patient received an unknown dose (0.5ml) of suspect receiving diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult; Suspension for injection with unknown strength (lot U8492AA with expiry date 28-FEB-2027) via intramuscular route in the right arm for Immunization.  On 14-APR-2025 the patient given tenivac describing that it was like a painful burning sensation while injecting the vaccine (vaccination site pain) (latency: same day).  Reportedly: she noticed the change in the color of the TENIVAC box from green to blue. It was the first time they had a complaint from all patients given TENIVAC describing that it was like a painful burning sensation while injecting the vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.; Sender's Comments:  US-SA-2025SA109105: US-SA-2025SA109153:
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 7.0
Sex: M
Vaccine: PNC20
Symptoms: Local reaction
Clinical narrative: Local reaction 4cm left arm
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site infection, Injection site scab, Injection site vesicles
Clinical narrative: 2/15/25 blisters with redness surrounding site 2/25/25 swollen red with white surrounding site. Looks dark and similar to a burn mark. Measures 1 1/2 x 1 3/8/25 dark red with infection surrounding site 3/23/25 red with a large scab and a dip in the middle of site 3/25/25 referred to a plastic surgeon  Have photos if needed
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Rash
Clinical narrative: Varicella rash (mild)
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: She got it in her eye; This serious case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a female 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 ophthalmic herpes zoster (Verbatim: She got it in her eye) (serious criteria GSK medically significant). The outcome of the ophthalmic herpes zoster was not reported.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingles vaccine.     The company considered the ophthalmic herpes zoster to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-APR-2025 This case was reported by a patient via interactive digital media. Reporter's friend did not receive the second shot.  She got it in her eye, which required transportation to a university hospital.  The issue lasted for 4 months and returned months later in the eye again, just missing the optic nerve.; Sender's Comments: Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Vomiting
Clinical narrative: vomiting; Diarrhea; Chills; Weakness; This non-serious case was reported by a consumer via call center representative and described the occurrence of vomiting in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-APR-2025, the patient received the 1st dose of Shingrix. On 11-APR-2025, 1 days after receiving Shingrix, the patient experienced vomiting (Verbatim: vomiting), diarrhea (Verbatim: Diarrhea), chills (Verbatim: Chills) and weakness (Verbatim: Weakness). The outcome of the vomiting, diarrhea, chills and weakness were not resolved.   It was unknown if the reporter considered the vomiting, diarrhea, chills and weakness to be related to Shingrix.     It was unknown if the company considered the vomiting, diarrhea, chills and weakness to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-APR-2025 The husband of the patient reports she received dose of Shingrix and next morning she woke up with chills, vomiting, diarrhea and weakness.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial discomfort, Facial pain, Head discomfort, Headache, Paraesthesia
Clinical narrative: Facial neuralgia; Facial pressure sensation; Facial pain; Head pain/feels like a pressure headache; Swelling face; Tingling; This non-serious case was reported by a consumer via call center representative and described the occurrence of facial neuralgia in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included benign meningioma. Concomitant products included ezetimibe (Zetia), zolpidem and escitalopram.   On 05-JUN-2024, the patient received Shingrix (intramuscular, unknown deltoid). On 05-JUN-2024, less than a day after receiving Shingrix, the patient experienced facial neuralgia (Verbatim: Facial neuralgia), facial pressure sensation (Verbatim: Facial pressure sensation), facial pain (Verbatim: Facial pain), headache (Verbatim: Head pain/feels like a pressure headache), facial swelling (Verbatim: Swelling face) and tingling (Verbatim: Tingling). The outcome of the facial neuralgia, facial pressure sensation, facial pain, headache, facial swelling and tingling were not resolved.   The reporter considered the facial neuralgia, facial pressure sensation, facial pain, headache, facial swelling and tingling to be related to Shingrix.     The company considered the facial neuralgia, facial pressure sensation, facial pain, headache, facial swelling and tingling to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-APR-2025 The reporter reported that she began experiencing facial pressure, pain, tingling, headache, swelling.  She reported that these sensations appear on the following points of her face/head on right cheek, right temple up into her head, right side of face above cheek, trigeminal nerve to the ear in the back, into neck and down front of neck, stating it was primarily on the right cheek almost to the nose, all the way to the lip area.  She stated that when the pain travels up to her temple/head area it felt like a pressure headache.  Her right cheek felt like she was hit in the face with a baseball.  She reported that the intensity of the pain, tingling and pressure were increased just as it was beginning to subside.  These symptoms occur intermittently, daily.  She reported that she had an MRI which revealed a meningioma, which, according the neurologist, was unrelated to the current symptoms.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face, Trigeminal neuralgia
Clinical narrative: Facial neuralgia; Facial pressure sensation; Facial pain; Head pain/feels like a pressure headache; Swelling face; Tingling; This non-serious case was reported by a consumer via call center representative and described the occurrence of facial neuralgia in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included benign meningioma. Concomitant products included ezetimibe (Zetia), zolpidem and escitalopram.   On 05-JUN-2024, the patient received Shingrix (intramuscular, unknown deltoid). On 05-JUN-2024, less than a day after receiving Shingrix, the patient experienced facial neuralgia (Verbatim: Facial neuralgia), facial pressure sensation (Verbatim: Facial pressure sensation), facial pain (Verbatim: Facial pain), headache (Verbatim: Head pain/feels like a pressure headache), facial swelling (Verbatim: Swelling face) and tingling (Verbatim: Tingling). The outcome of the facial neuralgia, facial pressure sensation, facial pain, headache, facial swelling and tingling were not resolved.   The reporter considered the facial neuralgia, facial pressure sensation, facial pain, headache, facial swelling and tingling to be related to Shingrix.     The company considered the facial neuralgia, facial pressure sensation, facial pain, headache, facial swelling and tingling to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-APR-2025 The reporter reported that she began experiencing facial pressure, pain, tingling, headache, swelling.  She reported that these sensations appear on the following points of her face/head on right cheek, right temple up into her head, right side of face above cheek, trigeminal nerve to the ear in the back, into neck and down front of neck, stating it was primarily on the right cheek almost to the nose, all the way to the lip area.  She stated that when the pain travels up to her temple/head area it felt like a pressure headache.  Her right cheek felt like she was hit in the face with a baseball.  She reported that the intensity of the pain, tingling and pressure were increased just as it was beginning to subside.  These symptoms occur intermittently, daily.  She reported that she had an MRI which revealed a meningioma, which, according the neurologist, was unrelated to the current symptoms.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: Swelling of lips; This non-serious case was reported by a consumer and described the occurrence of lip swelling in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-JAN-2022, the patient received Shingrix. On 16-JAN-2022, less than a day after receiving Shingrix, the patient experienced lip swelling (Verbatim: Swelling of lips). On 16-JAN-2022, the outcome of the lip swelling was resolved.   It was unknown if the reporter considered the lip swelling to be related to Shingrix.     It was unknown if the company considered the lip swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-APR-2025 Reporter wanted to know what the ingredients are in vaccine, so they can check future vaccines.  Patient had swelling of lips and it was treated.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got the vaccine 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.   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 the vaccine 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.     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-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that the patient got the vaccine still got shingles and still recommended that crap lol.  Not everyone gets that shingles, gets them bad.  The vaccines was crap and have even given people shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case was linked with US2025AMR046321, 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-US2025AMR046321:Same reporter
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: shot hurts; 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 (Shingrix) for prophylaxis.   Family history included trigeminal neuropathy and facial pain (Screaming pain in face, it felt like walking into fire with acid in her ears).   In FEB-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: shot hurts). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-APR-2025 The patient's family member who ended up with trigeminal neuropathy, had screaming pain in her face and said that it felt like walking into fire with acid in her ears. The patient got first shot two months ago and that shot did hurt. The patient was fighting with self to go for second shot.; Sender's Comments:  US-GSK-US2025AMR046345:Same reporter
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inappropriate vaccine schedule/2nd dose taken on 03 FEB 2025; 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 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on 17 FEB 2023).   On 03-FEB-2025, the patient received the 2nd dose of Shingrix. On 03-FEB-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: inappropriate vaccine schedule/2nd dose taken on 03 FEB 2025). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 14-APR-2025 The patient received first dose on 17 Feb 2023 and second dose on 03 Feb 2025. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Vaccine: VARZOS, VARZOS
Symptoms: Malaise
Clinical narrative: I felt like crap; 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.   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 feeling abnormal (Verbatim: I felt like crap). The outcome of the feeling abnormal was not reported (duration 2 days).   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 14-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she had it 2 times not too happy about it received the new shots . Both times he/she felt like crap for 2 days after he/she got the shot, hope fully it works.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster oticus, Vaccination failure
Clinical narrative: Suspected Vaccination failure; bad cases of shingles inside his ear; 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 herpes zoster otitis externa (Verbatim: bad cases of shingles inside his ear) (serious criteria GSK medically significant). The outcome of the vaccination failure and herpes zoster otitis externa were not reported.   It was unknown if the reporter considered the vaccination failure and herpes zoster otitis externa to be related to Shingles vaccine.     The company considered the vaccination failure and herpes zoster otitis externa to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-APR-2025 This case was reported by a consumer via interactive digital media. The reporter know friend vaccinated and still had bad cases of shingles. He had them inside his ear. 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 US2025AMR046801, 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 Shingles vaccine. Herpes zoster oticus is an unlisted event which is considered unrelated to GSK Shingles vaccine. US-GSK-US2025AMR046801:same reporter different patient
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got the 3rd vaccine in 5 months; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too short (Verbatim: got the 3rd vaccine in 5 months). The outcome of the drug dose administration interval too short was not applicable.   Additional Information: GSK Receipt Date: 15-APR-2025 The patient self reported this case for himself/herself This case was reported by a patient via interactive digital media. Patient was taking the series of Hepatitis B (Recombinant) Engerix-B vaccine.  He/she had gotten the third vaccine in 5 months, which led to shortening of vaccination schedule.
Sex: F
Vaccine: MMR
Symptoms: Underdose
Clinical narrative: the majority of the vaccine was injected but some leaked to the table; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete dose administered in a 13-month-old female patient who received MMR (Priorix) (batch number XX9N4, expiry date 01-JUN-2026) for prophylaxis.   On 10-APR-2025, the patient received Priorix. On 10-APR-2025, an unknown time after receiving Priorix, the patient experienced incomplete dose administered (Verbatim: the majority of the vaccine was injected but some leaked to the table). The outcome of the incomplete dose administered was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-APR-2025 Physician reported that a patient moved during the administration of Priorix, the majority of the vaccine was injected but some leaked to the table which led to incomplete dose administered.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired dose of Engerix-B pediatric that was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-month-old male patient who received HBV (Engerix B pediatric) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis.   On 08-APR-2025, the patient received Engerix B pediatric. On 08-APR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced expired vaccine used (Verbatim: expired dose of Engerix-B pediatric that was administered to a patient). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 11-APR-2025 The nurse reported that an expired dose of Engerix-B that was administered to a patient which led to, expired vaccine used.
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: potential wrong vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old patient who received Men B NVS (Bexsero) (batch number PX7E2) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine) for prophylaxis.   On 31-DEC-2024, the patient received Bexsero. On an unknown date, the patient did not receive Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. On 31-DEC-2024, an unknown time after receiving Bexsero and not applicable after receiving Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, the patient experienced wrong vaccine administered (Verbatim: potential wrong vaccine). The outcome of the wrong vaccine administered was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-APR-2025 Nurse mentioned that a 17 year old patient required by the school to get a meningococcal vaccine for types A, C, W, and Y.  In their chart it states that they already received a Meningococcal b vaccine on December 31st 2024 that is Bexsero.  The caller was unclear as to whether Bexsero was mistakenly administered instead of the required meningococcal vaccine for types A, C, W, and Y (potential wrong vaccine), or whether Bexsero was a different vaccine administered regardless of school requirements. Patient received Bexsero instead of meningococcal vaccine for types A, C, W, and Y, which led to wrong vaccine administered.
Age: 63.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Infanrix administered to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 63-year-old male patient who received DTPa (Infanrix) (batch number 223Y9, expiry date 07-SEP-2026) for prophylaxis.   On 11-APR-2025, the patient received Infanrix. On 11-APR-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Infanrix administered to an adult patient). The outcome of the inappropriate age at vaccine administration 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: 11-APR-2025 A medical assistant called to report the administration of Infanrix to a 63 year-old patient which led to inappropriate age at vaccine administration. The HCP asked for guidance on this situation
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: stated they had to receive and extra dose; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 50-year-old female patient who received HBV (Engerix B adult) (batch number 4BX39) for prophylaxis.   On 11-APR-2025, the patient received Engerix B adult. On 11-APR-2025, an unknown time after receiving Engerix B adult, the patient experienced extra dose administered (Verbatim: stated they had to receive and extra dose). The outcome of the extra dose administered was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date : 11-APR-2025 A physician reported that about the administration of Engerix-B to a patient who previously completed a dose but was stated they had to receive and extra dose, even though they had titers present which led to extra dose administered. They also stated that the patient would probably get Heplisav and requested recommendations.
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Menveo after only the diluent portion; Menveo after only the diluent portion; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMA8030A, expiry date 30-APR-2025) for prophylaxis.   In JAN-2025, the patient received Menveo. In JAN-2025, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo after only the diluent portion) and inappropriate dose of vaccine administered (Verbatim: Menveo after only the diluent portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 14-APR-2025 The nurse reported that how to proceed and the validity of a dose of Menveo after only the diluent portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: zero point five milliliter instead of one milliliter; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 48-year-old male patient who received HBV (Engerix B) (batch number AZ453, expiry date 12-FEB-2027) for prophylaxis.   Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b).   On 14-APR-2025, the patient received the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced underdose (Verbatim: zero point five milliliter instead of one milliliter). The outcome of the underdose 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: 15-APR-2025 The pharmacist called to report an adult patient that was administered half the dose that is 0.5 milliliter instead of 1 milliliter, which led to underdose.  It had been 24 hours since the maladministered dose. The Vaccine Administration Facility is the same as Primary Reporter. 1st dose vaccination date was March 16th 2025 and 2nd dose vaccination date on April 14th 2025.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid/Fever/sick; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid/Fever/sick) in a 79-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2024, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2024, the patient experienced COVID-19 (Covid/Fever/sick). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) in 2024 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid/Fever/sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2024, Body temperature: 102 Degree.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Patient took any medication before or had fever was reported as not known.  The concomitant medication was not reported.  It was reported that, patient's voice was kind of a wreck because she got Covid, and her doctors had sent a prescription for Paxlovid. She was working a little slow there because she had a high temperature. Later in the call the patient stated, she had Covid last year and took medicine. She couldn't even think then that she did not have to go through all this after Plaxavil. Also, she didn't take the Pfizer vaccine, she took the Moderna vaccine. Representative clarified that the patient took Paxlovid, the patient stated, she did take that. Patient then mentioned, "she got a 102-degree fever and was really sick."
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: he brought Covid home from the gym on Friday; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (he brought Covid home from the gym on Friday) in an 80-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Tozinameran (Comirnaty) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Tozinameran (Comirnaty) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (he brought Covid home from the gym on Friday). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (he brought Covid home from the gym on Friday) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       The information about off label event was reported as not known. Concomitant medication was not reported. It was reported that, the physician had prescribed Paxlovid a year ago to patient in case they got it but did not get it a year ago. Both patient and his wife had Covid and both were sharing a box and physician called in another Paxlovid prescription for both patient and his wife to take it together. Patient and his wife got a box about a year and a half ago because they were going on vacation and then they didn't use it. Patient came back home from the gym on Friday, and got Covid and on the day before reporting, patient and his wife took the test, and they were both positive, so they shared the beginning of the first box and by next day night, there would be like one sheet left. They were splitting the first box and after dosage use, only one of them would be able to go another day. The area was supposed to have really high instances of Covid then. Later in the call, the reporter stated, neither one of them had ever gotten Covid previously. They had all the vaccines, every single one of them including Pfizer vaccine, and the last one was Moderna vaccine. Patient received Comirnaty 2023-2024 formula vaccine. Paxlovid caused bad taste.   This case was linked to US-MODERNATX, INC.-MOD-2025-784935 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-784935:Patient 2 of 2 (Wife case)