chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; received improperly stored PROQUAD since it "was stored in the refrigerator for months" instead of the freezer; This spontaneous report was received from a registered nurse referring to a 11-year-old female patient.   The patient's medical history and concurrent conditions were not reported. Concomitant medications included polio vaccine inact 3v (Vero) (IPOL) (lot# Y1A201M), diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (BOOSTRIX) (lot# CX4HL), meningococcal vaccine A/C/Y/W conj (CRM197) (MENVEO) (lot# LN75D), and hepatitis B vaccine rHBsAg (yeast) (ENGERIX B) (lot# 998J9).  On 01-OCT-2024, the facility received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accommodate the shipment. The reporter was unaware that there were two Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), It was assumed that the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) received could be refrigerated and were moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until administration.   The dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) administered to this patient arrived to the facility on 13-JAN-2025, and on 29-JAN-2025, the patient was vaccinated with this second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (lot# Y017208, expiration date was not reported, but upon internal validation established as 13-APR-2026; strength and dose were not reported) subcutaneously in the left arm for prophylaxis (product storage error) at a public health clinic. No additional adverse event (AE).  This is one of several reports received from the same reporter.
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until administration; This spontaneous report was received from a registered nurse referring to a 6-year-old female patient. The patient's concomitant drugs included Hepatitis a vaccine inact (HAVRIX) and Diphtheria vaccine toxoid;Hepatitis b vaccine rHBsAg (yeast) (+) Pertussis vaccine acellular 3-component (+) Polio vaccine inact 3v (Vero) (+) Tetanus vaccine toxoid (PEDIARIX). The patient's medical history, historical drugs, past drug reactions or allergies, and concurrent conditions were not reported.   On 01-OCT-2024, the facility received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accommodate the shipment. The reporter was unaware that there were two Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), It was assumed that the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) received could be refrigerated and were moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenheit) until administration.  On 04-DEC-2024, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (lot#: Y013583, expiration date: 03-FEB-2026; strength and dose were not reported) subcutaneously in the left arm for prophylaxis (product storage error).  This case was received from the same reporter with the case US-009507513-2254349.
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; incorrect product storage; This spontaneous report was received from a registered nurse and refers to a 6-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Havrix (Hepatitis a vaccine inact), Infanrix (Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid), Flucelvax (Influenza vaccine inact sAg 3v). On 01-OCT-2024, the facility received a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accommodate the shipment. It was assumed that the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) received could be stored in both the freezer and refrigerator and both state and private Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were moved to the refrigerators where they remained within normal refrigerated temperature range until administration. The dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) administered to the client was received on 13-JAN-2025 and stored in the refrigerator until administered.  On 01-Feb-2025, the patient was vaccineated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Injection (lot #Y013579, expiration date: 03-Feb-2026), dose number 2, administered by Subcutaneous route in Left Arm. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT)(lot number and expiry dates were not provided).  No additional adverse event (AE) (No adverse event).  This case was one of several reports received from the same reporter with the case US-009507513-2254349.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 11/22/2018 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 10.0
Sex: M
Vaccine: MMRV, UNK
Symptoms: Product storage error
Clinical narrative: improper storage of product in use; This spontaneous report was received from a nurse referring to a 10-year-old male patient. Information regarding the patient's concurrent conditions, historical conditions and concomitant or historical medications was not provided.  On 08-Jan-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), for prophylaxis, lot number Y013579, which has been verified to be valid, expiration date reported and validated as 03-FEB-2026, second dose, subcutaneously, in left thigh. (strength not provided)  The administered dose of the vaccine was stored at multiple temperatures with a range  from 15 degree Fahrenheit to 46 degree Fahrenheit during an 1848 (unit not provided).; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 10/14/2014 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Sex: F
Vaccine: MMR
Symptoms: Device connection issue, Device leakage, Exposure via eye contact, Exposure via skin contact, No adverse event
Clinical narrative: No adverse event; after she administered the injection and a "few drops" splattered in her face in which she had to flush her face and eyes.; after she administered the injection and a "few drops" splattered in her face in which she had to flush her face and eyes.; The HCP reported that the hub/leur lock on the DILUENT syringe becomes loose causing the needle to fall off, usually prior to injection; The HCP reported that the hub/leur lock on the DILUENT syringe becomes loose causing the needle to fall off, usually prior to injection; The HCP reported that the hub/leur lock on the DILUENT syringe becomes loose causing the needle to fall off, usually prior to injection; This spontaneous report has been received from a nurse, regarding to herself a 25-year-old female patient.  The patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported. On an unknown date in 2024 (reported as few months ago), it was stated that the hub/leur lock on the sterile diluent solution for injection (BAXTER STERILE DILUENT) syringe became loose caused the needle to fell off, usually prior to injection and when they tried to screw the needle on tight, it caused the hub to became loose and detach and this was noticed immediately after removing from the tray, sometimes while attaching the needle, and once during an injection in which the needle was left in one patient (needle issue) (poor quality device used) (device connection issue). On 20-FEB-2025, after the nurse administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live lyophilisate and solvent for solution for injection (M-M-R II) injection, 0.5 mL, administered as prophylaxis (Lot No. Y011709 has been verified to be a valid lot number for [measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live lyophilisate and solvent for solution for injection], expiration date reported and upon internal validation established as 02-JUL-2026) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not reported) that was reconstituted with sterile diluent solution for injection (BAXTER STERILE DILUENT) injection, 0.5 mL, (Lot No. 2050911 has been verified to be a valid lot number for [sterile diluent solution for injection], expiration date was reported and upon internal validation established as 11-FEB-2027) (strength and route of administration were not provided) to an unspecified patient an unknown amount of few drops splattered in her face in which she had to flush her face and eyes (exposure via eye contact) (occupational exposure to product) On the same date (20-FEB-2025) the patient recovered from the events of exposure via eye contact and occupational exposure to product. No additional adverse event was provided (no adverse event).; Reporter's Comments: Keywords :
Sex: F
Vaccine: MMR
Symptoms: Occupational exposure to product
Clinical narrative: No adverse event; after she administered the injection and a "few drops" splattered in her face in which she had to flush her face and eyes.; after she administered the injection and a "few drops" splattered in her face in which she had to flush her face and eyes.; The HCP reported that the hub/leur lock on the DILUENT syringe becomes loose causing the needle to fall off, usually prior to injection; The HCP reported that the hub/leur lock on the DILUENT syringe becomes loose causing the needle to fall off, usually prior to injection; The HCP reported that the hub/leur lock on the DILUENT syringe becomes loose causing the needle to fall off, usually prior to injection; This spontaneous report has been received from a nurse, regarding to herself a 25-year-old female patient.  The patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported. On an unknown date in 2024 (reported as few months ago), it was stated that the hub/leur lock on the sterile diluent solution for injection (BAXTER STERILE DILUENT) syringe became loose caused the needle to fell off, usually prior to injection and when they tried to screw the needle on tight, it caused the hub to became loose and detach and this was noticed immediately after removing from the tray, sometimes while attaching the needle, and once during an injection in which the needle was left in one patient (needle issue) (poor quality device used) (device connection issue). On 20-FEB-2025, after the nurse administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live lyophilisate and solvent for solution for injection (M-M-R II) injection, 0.5 mL, administered as prophylaxis (Lot No. Y011709 has been verified to be a valid lot number for [measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live lyophilisate and solvent for solution for injection], expiration date reported and upon internal validation established as 02-JUL-2026) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not reported) that was reconstituted with sterile diluent solution for injection (BAXTER STERILE DILUENT) injection, 0.5 mL, (Lot No. 2050911 has been verified to be a valid lot number for [sterile diluent solution for injection], expiration date was reported and upon internal validation established as 11-FEB-2027) (strength and route of administration were not provided) to an unspecified patient an unknown amount of few drops splattered in her face in which she had to flush her face and eyes (exposure via eye contact) (occupational exposure to product) On the same date (20-FEB-2025) the patient recovered from the events of exposure via eye contact and occupational exposure to product. No additional adverse event was provided (no adverse event).; Reporter's Comments: Keywords :
Vaccine: HIBV, PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VFC immunization coordinator calling to report T/E for  PEDVAX HIB , ROTATEQ,  VAXNEUVANCE that was administered.   T/E date was on 2/18/2025 and PEDVAX HIB , ROTATEQ,  VAXNEUVANCE were administered on 3/03/2025.  Permission was given to contact HCP; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 03-MAR-2025, the patient was vaccinated with the first doses of haemophilus b conjugate  (PEDVAXHIB-LIQUID) suspension for injection, lot # Y006393, expiration date 07-NOV-2026 (exact dose, route of administration and anatomical location were not reported); and 15-valent pneumococcal conjugate vaccine (VAXNEUVANCE) suspension for injection, lot # Y005465, expiration date 08-JAN-2027 (exact dose, route of administration and anatomical location were not reported); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral solution, lot # Y009341, expiration date: 24-NOV-2025, administered orally (exact dose was not reported), all for prophylaxis. The aforementioned doses of vaccines underwent a temperature excursion of 32.0 Fahrenheit (F) degrees for 2 hours and 12 minutes on 18-FEB-2025 (Product storage error). There was no previous temperature excursion. No additional adverse event was reported.
Vaccine: HEPA, HIBV, PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE cases; VFC immunization coordinator calling to report T/E for VAQTA , PEDVAX HIB , VAXNEUVANCE that was administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 18-Feb-2025, a temperature excursion (TE) occurred (temperature: 32.0F; time frame: 2 hours 12 minutes 0 seconds). There was no previous temperature excursion. On 21-Feb-2025, following the TE, the patient was vaccinated with the fourth dose of with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) lot #Y005465, expiration date reported as and upon internal review confirmed to be: 08-Jan-2027 (exact dose and route of administration were not reported), with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) lot #Y008483, expiration date reported as and upon internal review confirmed to be: 26-Nov-2025 (exact dose and route of administration were not reported), and with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) lot #Y006393, expiration date reported as and upon internal review confirmed to be: 07-Nov-2026 (exact dose and route of administration were not reported) (product storage error). All vaccines were administered for prophylaxis. No additional adverse event (AE) cases were noted (no adverse event). No product quality complaint (PQC) was reported.
Sex: F
Vaccine: UNK
Symptoms: Menstruation irregular
Clinical narrative: Irregular menstrual cycle; This spontaneous report was received from a consumer and refers to a female patient of unknown age.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) administered for prophylaxis (lot # and expiration, strength, dose number, route, anatomical location of administration and vaccination scheme frequency were not provided).   On an unknown date, the patient experienced Irregular menstrual cycle. At the reporting time, the outcome of Irregular menstrual cycle was unknown.   The causal relationship between the event of Irregular menstrual cycle and Human Papillomavirus 9-valent Vaccine, Recombinant was not provided.
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional AEs were reported; patient received an expired VARIVAX; This spontaneous report was received from a Medical Assistant and refers to a patient of unspecified age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 04-MAR-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #X000532, expiration date: 04-JAN-2025), 1 dose, as prophylaxis (Expired product administered).
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Dysarthria, Dysphagia, Muscular weakness, Plasmapheresis
Clinical narrative: Loss of speech; patient was in hospital for speech swallowing gripping weakness progressive; This serious case was reported by a consumer and described the occurrence of slurred speech in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of dysarthria (Patient took 1 st dose on 10-APR-2024 case ID :US2025021777) and Shingrix with an associated reaction of aphasia (Patient took 1 st dose on 10-APR-2024 case ID :US2025021777). Concurrent medical conditions included miller fisher syndrome. Concomitant products included prednisone.   In AUG-2024, the patient received the 2nd dose of Shingrix. On 12-APR-2024, an unknown time after receiving Shingrix, the patient experienced slurred speech (Verbatim: patient was in hospital for speech swallowing gripping weakness progressive) (serious criteria hospitalization). On 02-AUG-2024, the patient experienced speech loss (Verbatim: Loss of speech) (serious criteria hospitalization). Rechallenge with Shingrix was positive. The outcome of the slurred speech and speech loss were not resolved.   It was unknown if the reporter considered the slurred speech and speech loss to be related to Shingrix.     The company considered the slurred speech and speech loss to be unrelated to Shingrix.   Linked case(s) involving the same patient:  US2025021777   Additional Information: GSK receipt date: 20-FEB-2025 The reporter reported patient had recived Shingrix vaccine and experienced speech swallowing gripping weakness progressive and loss of speech. The reporter mentioned that dates when patient was in hospital for speech swallowing gripping weakness progressive and loss of speech was unspecified to unspecified. The expiry date of Shingrix was unknown. The reporter reported that other products patient was recived such as prednisone and started in fall 2024 and continues. The reporter mentioned that symptoms started slowly after first immunizations in April 2024 then rapid progression after booster in August 2024 requiring two hospitalizations with ongoing progressive symptoms and now repeating plasmaphoresis and considerdering rituxin infusions.; Sender's Comments: Dysarthria and Aphasia are unlisted events which are considered unrelated to GSK vaccine Shingrix. US-GSK-US2025021777:Same patient. secodn dose case.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia, Somnolence
Clinical narrative: Chills; Fever; Fatigue/slept all day; body aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date). Concurrent medical conditions included atrial fibrillation. Concomitant products included methotrexate, prednisone and evolocumab (Repatha).   On 25-FEB-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml. On 25-FEB-2025, less than a day after receiving Shingrix, the patient experienced chills (Verbatim: Chills), fever (Verbatim: Fever), fatigue (Verbatim: Fatigue/slept all day) and general body pain (Verbatim: body aches). The patient was treated with paracetamol (Tylenol). The outcome of the chills, fever, fatigue and general body pain were not resolved.   It was unknown if the reporter considered the chills, fever, fatigue and general body pain to be related to Shingrix.     It was unknown if the company considered the chills, fever, fatigue and general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-FEB-2025 The patient received the 2nd dose of Shingrix shot at a local pharmacy.  The patient states that he was given a list to check of what medications he was taking, Methotrexate (3 tablets a week and ,physician  increased to 6 a week (strength not provided) and Prednisone, and they were in the list. He states, still gave the 2nd shot.  The patient reports that he was not taking Methotrexate when he received the 1st dose. The patient reports that he has atrial fibrillation and takes medications for the heart. He also reports taking Repatha 140 mcg every morning. The patient did not recall the date of Shingrix 1st dose, but states that he did not experience any side effects with the 1st dose.  The patient reports that the side effects of the 2nd dose started that same evening. He reported having chills that last about an hour, and fever of 100.6 when the fever started. The patient reports he was still hot on 26-February-2025.  The patient reports had fatigue and states he slept all day.  The patient reported body aches as well. The patient took Tylenol every 4 hours.  The patient reports about Shingrix 2nd shot, felt like crap and still not feeling better.
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I got my Shingles booster at 6 months and 1 week after original shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: I got my Shingles booster at 6 months and 1 week after original shot). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 24-FEB-2025 The patient self-reported this case. The patient got Shingles vaccine (Shingrix) booster at 6 months and 1 week after original shot and asked will it work. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule
Vaccine: RSV
Symptoms: Hypersensitivity
Clinical narrative: Nees allergy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergy in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced allergy (Verbatim: Nees allergy). The outcome of the allergy was not reported.   It was unknown if the reporter considered the allergy to be related to Arexvy.     It was unknown if the company considered the allergy to be related to Arexvy.   Additional Information: GSK Receipt Date: 27-FEB-2025 The reporter reported that patient received Arexvy vaccine and experienced allergy and needs alleygy information.
Vaccine: RVX
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had the vaccine last fall and just got over it after 2 weeks of agony; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: I had the vaccine last fall and just got over it after 2 weeks of agony). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was resolved (duration 2 weeks).   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine.     The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2025 This case was reported by a patient via interactive digital media. The patient had the RSV vaccine last fall and just got over it after 2 weeks of agony. This case was considered as suspected vaccination failure as details regarding time to onset for respiratory syncytial virus infection and laboratory confirmation regarding respiratory syncytial virus infection 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 RSV vaccine.
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; It is what you get after three vaccinations; came up with two vaccinations one month apart; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), extra dose administered (Verbatim: It is what you get after three vaccinations) and drug dose administration interval too short (Verbatim: came up with two vaccinations one month apart). The outcome of the vaccination failure and shingles were not reported and the outcome of the extra dose administered and drug dose administration interval too short were not applicable.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 01-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she received three vaccinations which led to extra dose administered. The first one admittedly (by provider) did not work so came up with two vaccinations one month apart which led to drug dose administration interval too short. It was reported that it was not so good as well. The patient had shingles three times after all was said and done. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine dose 1, Shingles vaccine dose 2 and Shingles vaccine dose 3.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspect vaccination failure; i know of a vaccinated lady who just got shingles; 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: suspect vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: i know of a vaccinated lady who just 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: 03-MAR-2025 This case was reported by a consumer via interactive digital media. The reporter knew the vaccinated patient who just got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspect vaccination failure; i took the shingles vaccine and still got a bad case of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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: suspect vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: i took the shingles vaccine and still got a bad case of shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that no more vaccines for him/her, he/she took the shingles vaccine and still got a bad case of shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles  were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; had them on his back/most painful/even the slightless breeze make them hurt; 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: had them on his back/most painful/even the slightless breeze make them hurt). 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: 02-MAR-2025 This case was reported by a patient's wife via interactive digital media The reporter saw what shingles could do to a person.  The patient received the shingles vaccine and had them (shingles) on his back and he told that the most painful thing to have, even the slightless breeze would make them hurt. The patient did not want to have shingles again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. US-GLAXOSMITHKLINE-US2021AMR202845:Same reporter/ Wife case (Dose 1) US-GLAXOSMITHKLINE-US2021AMR202848:Same reporter/ Wife case (Dose 2)
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: miss second shot of shingrix; 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 (Patient received first dose in APR-2024).   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: miss second shot of shingrix). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 04-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 asked if they missed the second dose, do they need to restart regime again. Till the time of reporting the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: RSV
Symptoms: Off label use
Clinical narrative: Prescription for Arexvy for patient under 60; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of off label use in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced off label use (Verbatim: Prescription for Arexvy for patient under 60). The outcome of the off label use was not applicable.   Additional Information: GSK Receipt Date: 26-FEB-2025 The pharmacist stated that a doctor wanted to administer Arexvy to a special need of patient who was 38 years old, which led to off label. The adverse event report completed as there was an active prescription.  The Vaccine Administration Facility is the same as Primary Reporter.
Age: 32.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Heplisav-B on October 21st 2024 and a dose of Engerix-B on January 24th 2025.; This non-serious case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 32-year-old male patient who received HBV (Engerix B) (batch number Y014323, expiry date 12-FEB-2027) for prophylaxis.   Co-suspect products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) for prophylaxis.   On 24-JAN-2025, the patient received Engerix B. On 21-OCT-2024, the patient received Heplisav b. On 24-JAN-2025, an unknown time after receiving Engerix B, the patient experienced interchange of vaccine products (Verbatim: Heplisav-B on October 21st 2024 and a dose of Engerix-B on January 24th 2025.). 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: 27-FEB-2025 The nurse mentioned that a patient got Heplisav-B on October 21st 2024 and a dose of Engerix-B on January 24th 2025, which led to interchange of vaccine products.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Shingles breakout; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In JUL-2023, the patient received the 2nd dose of Shingrix. On 02-JAN-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles breakout). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 03-MAR-2025 The pharmacist reported that it was uncertain if a patient had received the 2 doses of Shingrix and according to reporter, the 1st dose was administered to the patient and the second dose was potentially administered, but pharmacist told it was not confirmed.  Also, reporter mentioned that patient had a shingles breakout (no date specified). The Vaccine Administration Facility is the same as Primary Reporter. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; 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 Shingrix and Shingrix.
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: second dose of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 6-year-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   Concomitant products included Kinrix.   On 19-FEB-2025, the patient received the 2nd dose of Kinrix. On 19-FEB-2025, an unknown time after receiving Kinrix, the patient experienced extra dose administered (Verbatim: second dose of Kinrix ). 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: 03-MAR-2025 Nurse called to report that they administered a dose of Kinrix to a 6 years 11 months old female patient on 28 JAN-2025 and then on 19-FEB-2025 the patient received another dose of Kinrix. Patient received the second dose ok Kinrix, which led to extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not received her second dose within the recommended period; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of shingrix 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:  did not received her second dose within the recommended period). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date : 04-MAR-2025 The pharmacist mentioned that they did not have date of birth or initials for the patient, and they did not know date of administration, lot number or expiration date for the first dose.  They did not know if the first dose was administered at their facility.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix within the recommended period, which led to incomplete course of vaccination. This case was linked with US2021AMR128772, US2020221334 and US2020019136, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR128772:same reporter US-GSK-US2020221334:same reporter US-GLAXOSMITHKLINE-US2020019136:same reporter
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Engerix-B Pediatric Dose on a female adult patient; Engerix-B Pediatric Dose on a female adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 23-year-old female patient who received HBV (Engerix B pediatric) (batch number 47XP4, expiry date 16-JUL-2026) for prophylaxis.   On 04-MAR-2025, the patient received Engerix B pediatric. On 04-MAR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Engerix-B Pediatric Dose on a female adult patient) and underdose (Verbatim: Engerix-B Pediatric Dose on a female adult patient). The outcome of the adult use of a child product and underdose were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date 04-MAR-2025 Registered Nurse called to report the maladministration of an Engerix-B pediatric dose on a female adult patient and was seeking for advice on this situation (revaccination/how to proceed).
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Engerix-B pediatric dose to adult patient; Engerix-B pediatric dose to adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 47-year-old female patient who received HBV (Engerix B pediatric) (batch number 95D74, expiry date 28-MAR-2025) for prophylaxis.   On 14-FEB-2025, the patient received Engerix B pediatric. On 14-FEB-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Engerix-B pediatric dose to adult patient) and underdose (Verbatim: Engerix-B pediatric dose to adult patient). The outcome of the adult use of a child product and underdose were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-MAR-2025 The nurse reported that a pediatric dose of Engerix-B vaccine was given to an adult patient, which led to adult use of a child product and underdose The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: HEP, HEP
Symptoms: Extra dose administered
Clinical narrative: Engerix-B - Extra doses; Engerix-B - Extra doses; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 5-year-old female patient who received HBV (Engerix B) (batch number 7NX57, expiry date 12-DEC-2026) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 4D333, expiry date 14-AUG-2026) for prophylaxis.   On 04-MAR-2025, the patient received the 6th dose of Engerix B. On 15-NOV-2024, the patient received the 5th dose of Engerix B. On 15-NOV-2024, not applicable after receiving Engerix B and 365 days after receiving Engerix B, the patient experienced extra dose administered (Verbatim: Engerix-B - Extra doses). On 04-MAR-2025, the patient experienced extra dose administered (Verbatim: Engerix-B - Extra doses). The outcome of the extra dose administered 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: 05-MAR-2025 The health care provider reported that a patient received a fifth and sixth dose of Engerix-B, which led to extra dose administered. The patient received three doses in but due to lack of records this patient received a fifth and a sixth dose.  The patient was currently 5 years 11-month-old.  The fifth dose was administered on 11/15/2024 and the sixth dose was given on 3/4/2025.
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: Expired product administered
Clinical narrative: an expired dose of Arexvy was administered to a 63 years old male patient; 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 63-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4T5B5, expiry date 02-MAR-2025) for prophylaxis.   On 05-MAR-2025, the patient received Arexvy. On 05-MAR-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: an expired dose of Arexvy was administered to a 63 years old male patient). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK receipt date: 05-MAR-2025 The medical assistant called to reported that they administered an expired dose of Arexvy patient on the day of reporting which led to, expired vaccine used. The reported wanted to know was there any supplemental potency data.