chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: RVX
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Came down with RSV, spent 19 days in the hospital; Suspected vaccination failure; 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: Came down with RSV, spent 19 days in the hospital) (serious criteria hospitalization). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported.   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 and respiratory syncytial virus infection to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 24-APR-2025 This case was reported by a patient via interactive digital media. Patient stated that at the suggestion of his/her pulmonologist patient had the RSV vaccine last fall in 2024. The patient came down with RSV (respiratory syncytial virus infection), spent 19 days in the hospital, and was told that if he/she had not been vaccinated it could have been fatal. This case was considered as suspected vaccination failure as details regarding time to onset for RSV and laboratory confirmation regarding RSV 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  details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine RSV vaccine Respiratory syncytial virus infection  is an unlisted event which is considered unrelated to GSK  vaccine RSV vaccine
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chemotherapy, Herpes zoster, Herpes zoster oticus, Pain
Clinical narrative: Suspected vaccination failure; Ramsay Hunt Syndrome; PHN; 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.   The patient's past medical history included knee replacement (had two total knee replacements), neck surgery (had neck surgery with titanium plates and screws) and cesarean section (had three children, one was a C-section).   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), ramsay-hunt syndrome (Verbatim: Ramsay Hunt Syndrome) (serious criteria GSK medically significant) and post herpetic neuralgia (Verbatim: PHN). The outcome of the vaccination failure was not reported and the outcome of the ramsay-hunt syndrome and post herpetic neuralgia were not resolved.   It was unknown if the reporter considered the vaccination failure, ramsay-hunt syndrome and post herpetic neuralgia to be related to Shingles vaccine.     The company considered the vaccination failure and ramsay-hunt syndrome to be unrelated to Shingles vaccine. It was unknown if the company considered the post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-APR-2025 This case was reported by a patient via interactive digital media. Patient stated that she was dealing with Ramsay-hunt syndrome and PHN (post herpetic neuralgia) right now (at the time of reporting) and she had never experienced pain like this in her life. Patient indicated that she had three children, one was a C section, two total knee replacements, neck surgery with titanium plates and screws and more but none of it compared to the pain she had been experiencing for two months. Patient stated that, in her case it was on the left side of her face and head with ear involvement and blisters all around her eye. Patient got the vaccine, but chemo treatments wiped out the vaccine, also she ask everyone to get vaccinated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding Ramsay-hunt syndrome 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. Herpes zoster oticus is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure; Ramsay Hunt Syndrome; PHN; 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.   The patient's past medical history included knee replacement (had two total knee replacements), neck surgery (had neck surgery with titanium plates and screws) and cesarean section (had three children, one was a C-section).   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), ramsay-hunt syndrome (Verbatim: Ramsay Hunt Syndrome) (serious criteria GSK medically significant) and post herpetic neuralgia (Verbatim: PHN). The outcome of the vaccination failure was not reported and the outcome of the ramsay-hunt syndrome and post herpetic neuralgia were not resolved.   It was unknown if the reporter considered the vaccination failure, ramsay-hunt syndrome and post herpetic neuralgia to be related to Shingles vaccine.     The company considered the vaccination failure and ramsay-hunt syndrome to be unrelated to Shingles vaccine. It was unknown if the company considered the post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-APR-2025 This case was reported by a patient via interactive digital media. Patient stated that she was dealing with Ramsay-hunt syndrome and PHN (post herpetic neuralgia) right now (at the time of reporting) and she had never experienced pain like this in her life. Patient indicated that she had three children, one was a C section, two total knee replacements, neck surgery with titanium plates and screws and more but none of it compared to the pain she had been experiencing for two months. Patient stated that, in her case it was on the left side of her face and head with ear involvement and blisters all around her eye. Patient got the vaccine, but chemo treatments wiped out the vaccine, also she ask everyone to get vaccinated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding Ramsay-hunt syndrome 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. Herpes zoster oticus is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; going through shingles right now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 86-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: going through shingles right now). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 22-APR-2025 This case was reported by a patient via interactive digital media. The patient had the 1 to 2 vaccines 2 years ago (from the date of reporting) and going through shingles right now (at the time of reporting), the patient just got medication from pharmacy salve was easing, the itching, burning and pain a good bit. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(Dose 1 & 2).
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: extra dose of vaccine adminstered; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered 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 extra dose administered (Verbatim: extra dose of vaccine adminstered). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date: 23-APR-2025 Patient received extra dose of Shingrix by accident, which led to extra dose of vaccine administered.
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Pyrexia, Sluggishness
Clinical narrative: shot site was very itchy; shot site was very red; fever; felt a little sluggish; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site itching in a 75-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In APR-2025, the patient received the 1st dose of Shingles vaccine. In APR-2025, less than 2 weeks after receiving Shingles vaccine, the patient experienced injection site itching (Verbatim: shot site was very itchy) and injection site erythema (Verbatim: shot site was very red). On an unknown date, the patient experienced fever (Verbatim: fever) and sluggishness (Verbatim: felt a little sluggish). The outcome of the injection site itching and injection site erythema were resolved (duration 1 week) and the outcome of the fever and sluggishness were resolved (duration 2 days).   It was unknown if the reporter considered the injection site itching, injection site erythema, fever and sluggishness to be related to Shingles vaccine.     It was unknown if the company considered the injection site itching, injection site erythema, fever and sluggishness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-APR-2025 The case was received from the patient via interactive digital media. The patient was 75 years old and about a week and a half ago had his/her first shingles shot of the two.  The patient had a reaction for about a week.  The shot site was very red and itchy, about the size of a lid on a jar of mayonnaise.  The patient had a little fever felt a little sluggish for a day or two. The patient could not say that he/she was looking forward to the next one.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-APR-2025 This case was reported by a patient via interactive digital media. The reporter mother never got shingles until she got the vaccine for it. 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  clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: knocked patient out for a couple days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unwell (Verbatim: knocked patient out for a couple days). The outcome of the unwell was resolved.   It was unknown if the reporter considered the unwell to be related to Shingles vaccine.     It was unknown if the company considered the unwell to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-APR-2025 This case was reported by a patient via interactive digital media. The patient took 1st dose of vaccine and it really knocked the patient out for a couple days.
Vaccine: RVX
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; tired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in an unspecified number of patients 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 pain in arm (Verbatim: sore arm) and tiredness (Verbatim: tired). The outcome of the pain in arm was not reported and the outcome of the tiredness was resolved (duration 1 day).   It was unknown if the reporter considered the pain in arm and tiredness to be related to RSV vaccine.     It was unknown if the company considered the pain in arm and tiredness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 13-APR-2025 The reporter reported patients had very little reaction to all the vaccines, just to sore arm and tired for a day. This case was linked with case US2025AMR047722 reported by the same reporter, for different patient.; Sender's Comments:  US-GSK-US2025AMR047722:case created for multiple patient, same reporter
Age: 10.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Infanrix administration instead of Boostrix; Infanrix administration out of the recommended age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 10-year-old male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number X449Y) for prophylaxis.   On 17-MAR-2025, the patient received Infanrix. On an unknown date, the patient did not receive Boostrix. On 17-MAR-2025, an unknown time after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Infanrix administration instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: Infanrix administration out of the recommended age). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-APR-2025 Office Manager wanted to get safety information regarding the Infanrix administration to a patient that should have received Boostrix but received Infanrix which led wrong vaccine administered The received Infanrix in non-recommended age which led inappropriate age at vaccine administration The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up.
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Potential administration of Engerix-B 20 MGRS DOSE TO 19 YEAR-OLD PATIENTS; Potential administration of Engerix-B 20 MGRS DOSE TO 19 years old patinets; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a patient who received HBV (Engerix B adult) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: Potential administration of Engerix-B 20 MGRS DOSE TO 19 YEAR-OLD PATIENTS) and adult product administered to child (Verbatim: Potential administration of Engerix-B 20 MGRS DOSE TO 19 years old patinets). The outcome of the overdose and adult product administered to child were not applicable.   Additional Information: GSK Receipt Date:22-APR-2025 The reporter just noticed that Engerix-B 20 mgrs. dose was indicated for 20 years-old and older.  She was not sure, but she believed that some 19 year-old patients could potentially receive Engerix-B 1 ml dose at her clinic, which led to overdose and adult product administered to child. She accepted a follow up to clarify.  No further information available at the moment of the call. The Vaccine Administration Facility is the same as Primary Reporter. No further information available at the moment of the call. The reporter consented to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Use of a Non-approved Diluent to Reconstitute and Administer the Lyophylized Meningococcal Group A Component of the 2-vial Presentation of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB056A, expiry date 31-AUG-2025) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Use of a Non-approved Diluent to Reconstitute and Administer the Lyophylized Meningococcal Group A Component of the 2-vial Presentation of Menveo). The outcome of the wrong solution used in drug reconstitution was not applicable.   Additional Information: GSK Receipt Date: 22-APR-2025 The nurse colleague administered a Menveo reconstituted with sterile water to a patient which led to wrong solution used in drug reconstitution. The vaccine administration facility was the same as primary reporter.
Age: 6.0
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: received a dose of Boostrix instead of a DTap vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 6-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received Boostrix and DTPa vaccine. On an unknown date, an unknown time after receiving Boostrix and DTPa vaccine, the patient experienced wrong vaccine administered (Verbatim: received a dose of Boostrix instead of a DTap 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: 22-APR-2025 Other HCP reported that a 6-year-old patient had received a dose of Boostrix instead of a DTap vaccine (no brand name reported), which led to wrong vaccine administered. Reporter didn't have any more additional details on this event.
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration
Clinical narrative: Patient is pregnant; 3th dose: April 18th 2025: 28 weeks of gestation; 2nd dose: March 21st 2025: 24 weeks of gestation; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 27-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B).   On 18-APR-2025, the patient received the 3rd dose of Engerix B. On 21-MAR-2025, the patient received the 2nd dose of Engerix B. On 21-MAR-2025, an unknown time after receiving Engerix B and Engerix B, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose: March 21st 2025: 24 weeks of gestation). On 18-APR-2025, the patient experienced drug dose administration interval too short (Verbatim: 3th dose: April 18th 2025: 28 weeks of gestation). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Patient is pregnant). The outcome of the drug dose administration interval too short, drug dose administration interval too short and vaccine exposure during pregnancy were not applicable.   Pregnancy exposure: Pregnancy Exposure (Engerix B): To mother in third trimester Pregnancy Exposure (Engerix B): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   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 : 22-APR-2025 Registered nurse calleds to report an early third dose for a patient on ENGERIX-B. Patient was pregnant.  The patient received 2nd and 3rd dose of engerix b earlier than recommended interval, which led to shortening of vaccination schedule.
Age: 0.5
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Inappropriate Age at Vaccine Series Administration; Inappropriate schedule of vaccine; Inappropriate Age at Vaccine Series Administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received HAV (Havrix 720) (batch number MZ474, expiry date 24-APR-2026) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis.   In NOV-2024, the patient received the 2nd dose of Havrix 720. In OCT-2024, the patient received the 1st dose of Havrix. In OCT-2024, not applicable after receiving Havrix 720 and an unknown time after receiving Havrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate Age at Vaccine Series Administration). In NOV-2024, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate Age at Vaccine Series Administration) and drug dose administration interval too short (Verbatim: Inappropriate schedule of vaccine). The outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration and drug dose administration interval too short 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: 22-APR-2025 The nursing supervisor stated that the first dose of Havrix was administered to a 6-month-old patient in October 2024 which led to inappropriate age at vaccine administration. The patient also received the 2nd dose in November 2024 which also led to inappropriate age at vaccine administration and drug dose administration interval too short.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Incorrect dose administered
Clinical narrative: 2 years of age received 2/3 of an Infanrix vaccine, this situation happened 22-Apr-2025; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 2-year-old male patient who received DTPa (Infanrix) for prophylaxis.   On 22-APR-2025, the patient received Infanrix. On 22-APR-2025, an unknown time after receiving Infanrix, the patient experienced incomplete dose administered (Verbatim: 2 years of age received 2/3 of an Infanrix vaccine, this situation happened 22-Apr-2025). 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: 22-APR-2025 Practice manager called and reported that patient received 2o/3 of an Infanrix vaccine, this situation happened on the day of reporting, which led to incomplete dose administered. The vaccine administration facility was the same as primary reporter. The reporter did not have the lot number nor expiry date of the vaccine. During the call, the reporter mentioned the vaccine as Boostrix, and then, she mentioned that actually it was the DTap Infanrix vaccine.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired Drug Used; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number PE24L, expiry date 11-APR-2025) for prophylaxis.   On 22-APR-2025, the patient received Pediarix. On 22-APR-2025, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired Drug Used). 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: 23-APR-2025 The nurse reported that an expired Pediarix was administered to a patient which led to expired vaccine used.  The nurse asked data that allows use within a certain time after expiration.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd dose administered.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 2nd dose on 07-SEP-2022) and Shingrix (received 1st dose on an unknown date).   On 08-APR-2025, the patient received the 3rd dose of Shingrix. On 08-APR-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd dose administered.). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date: 23-APR-2025 The pharmacist called to inform that back in 08th April 2025 somebody received an extra dose of a vaccine, such vaccine was Shingrix which led to extra dose administration. According to reporter, the Shingrix series was completed back on 07th September 2022.
Age: 80.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired drug administered in a 80-year-old male patient who received HBV (Engerix B) (batch number 4H297, expiry date 06-APR-2025) for prophylaxis.   Concurrent medical conditions included hemodialysis.   On 23-APR-2025, the patient received Engerix B. On 23-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired drug administered (Verbatim: Expired dose administered). The outcome of the expired drug 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: 23-APR-2025 Patient Supervisor called to inform that earlier that day, a dose of Engerix-B was given 15 days after expiration date which led to Expired drug administered. According to the reporter, the patient was under the hemodialysis schedule, so they receive 2 syringes (40 mcg) of Engerix-B. Reporter did not specify if in that visit the two syringes were administered, and if so, if it was only one of the two syringes that was expired.
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: administration of a pediatric dose of Hep B vaccine to an adult patient; administration of a pediatric dose of Hep B vaccine to an 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 48-year-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   On 22-APR-2025, the patient received the 3rd dose of Engerix B pediatric. On 22-APR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: administration of a pediatric dose of Hep B vaccine to an adult patient) and underdose (Verbatim: administration of a pediatric dose of Hep B vaccine to an 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 : 23-APR-2025 A nurse called to reported the administration of a pediatric dose of Hep B vaccine to an adult patient which led to adult use of child product  and underdose. The nurse mentioned this was the third dose of the Hepatitis B series.  The nurse could not provide the brand name nor the lot number of the vaccine but confirmed it was a GSK vaccine.  The nurse asked for recommendations on this situation.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: accidentally gave an extra dose of Shingrix to a patient not realizing she already completed the 2 shot series in 2023..."; 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 Herpes zoster (Shingrix) (batch number X5T42, expiry date 30-JAN-2027) for prophylaxis.   Previously administered products included Shingrix (received 2 doses in 2023).   On 23-APR-2025, the patient received the 3rd dose of Shingrix. On 23-APR-2025, not applicable after receiving Shingrix, the patient experienced extra dose administered (Verbatim: accidentally gave an extra dose of Shingrix to a patient not realizing she already completed the 2 shot series in 2023..."). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date: 23-APR-2025 The physician reported that a nurse accidentally gave an extra dose of Shingrix to a patient not realizing she already completed the 2 shot series in 2023, which led to extra dose administered. The vaccine administration facility was the same as primary reporter.
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered Infanrix to a 12-year old patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old patient who received DTPa (Infanrix) for prophylaxis.   On 22-APR-2025, the patient received Infanrix. On 22-APR-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administered Infanrix to a 12-year old 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: 24-APR-2025 The reporter reported that he/she administered Infanrix to a 12-year-old patient, which led to Inappropriate age at vaccine administration. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain, Pain in extremity
Clinical narrative: the arm was achy/Arm pain; little body ache; had some chills; Muscle ache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (the arm was achy/Arm pain), PAIN (little body ache), CHILLS (had some chills) and MYALGIA (Muscle ache) in a 75-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8081260) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: SPIKEVAX 2024-2025 PFS (First Booster dose) in September 2024. Past adverse reactions to the above products included No adverse effect with SPIKEVAX 2024-2025 PFS.    On 28-Mar-2025, the patient received second dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 28-Mar-2025, the patient experienced PAIN IN EXTREMITY (the arm was achy/Arm pain), PAIN (little body ache), CHILLS (had some chills) and MYALGIA (Muscle ache). On 30-Mar-2025, PAIN IN EXTREMITY (the arm was achy/Arm pain) and MYALGIA (Muscle ache) had resolved. At the time of the report, PAIN (little body ache) and CHILLS (had some chills) had resolved.            Patient did not receive any vaccines within the past 4 weeks. The concomitant medication was not reported.  Patient had received second Booster shot from Moderna. Patient had sore arm for two days, felt a little chilly, no fever but then a little achy, the little bit body ache, but that was it. The symptoms started on 28-MAR-2025 in the morning, and it was started after 12 hours exactly for patient. Within the 24 hours, the first 12 hours, patient generally didn't feel anything, and then the arm got sore and sore and then the next day it was really sore. But that didn't bother her. 2 days later, that is 30th, basically it was mostly gone. She had said, it was 48 hrs. Patient had Moderna COVID vaccines all the way through since day one. It was unknown if the patient experienced any additional symptoms/events The treatment drug information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-785217 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2025: Live follow up received that contains significant information includes reporter details, initials, historical vaccine, lot number, dose details, event latency and date of birth was added and event verbatim and coding for arm pain was updated. On 22-Apr-2025: Live Significant follow up received includes new event of Muscle ache and reference were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-785217:Husband case
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: we've always gotten the Pfizer vaccine, you know Covid vaccine; we've always gotten the Pfizer vaccine, you know Covid vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 67-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Previous Pfizer Covid vaccine), for COVID-19 IMMUNIZATION. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "we've always gotten the Pfizer vaccine, you know Covid vaccine". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500087820 same reporter drug AE different patient;
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: redness at injection site, slight swelling and warm to the touch; redness at injection site, slight swelling and warm to the touch; redness at injection site, slight swelling and warm to the touch; This is a spontaneous report received from a Consumer or other non HCP.  A 19-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 26Apr2025 as dose 1, single (Batch/Lot number: unknown) at the age of 19 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "dysautonomia" (unspecified if ongoing); "nut allergy" (unspecified if ongoing); "crohn" (unspecified if ongoing); "EOE" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 27Apr2025 at 10:00, outcome "unknown" and all described as "redness at injection site, slight swelling and warm to the touch". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site swelling, vaccination site warmth. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Blood glucose increased, Blood thyroid stimulating hormone increased, Erythema, Injection site erythema, Joint swelling
Clinical narrative: increase in glucose (measured by CGM), increase in TSH (from previous level of 3 to about 7), swelling in joints, swollen knee, redness at injection site and neck, itchiness all over body, swollen lymph nodes
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Pruritus
Clinical narrative: increase in glucose (measured by CGM), increase in TSH (from previous level of 3 to about 7), swelling in joints, swollen knee, redness at injection site and neck, itchiness all over body, swollen lymph nodes
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ataxia, Blood test normal, Burning sensation, Cognitive disorder, Computerised tomogram normal
Clinical narrative: Total body dystonia. Seizures. Extreme confusion and disorientation. Ataxia. Paranoia. Terror. Whole body and brain on fire. Loss of cognitive abilities. Lost ability to function or take care of myself. Still not able to work or leave house for long periods of time.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Disorientation, Dystonia, Fear, Impaired work ability
Clinical narrative: Total body dystonia. Seizures. Extreme confusion and disorientation. Ataxia. Paranoia. Terror. Whole body and brain on fire. Loss of cognitive abilities. Lost ability to function or take care of myself. Still not able to work or leave house for long periods of time.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Paranoia, Seizure
Clinical narrative: Total body dystonia. Seizures. Extreme confusion and disorientation. Ataxia. Paranoia. Terror. Whole body and brain on fire. Loss of cognitive abilities. Lost ability to function or take care of myself. Still not able to work or leave house for long periods of time.
Age: 11.0
Sex: M
Vaccine: TYP
Symptoms: Lip pruritus, Throat irritation, Urticaria
Clinical narrative: Client's mother came back into office with client. Client has hives to trunk, bilateral shoulders, neck, bilateral legs. Mother notes allergy to peanuts, no allergy to latex, gelatin or eggs. Mother gave 25mg diphenhydramine PO in office. O2 98% room air, 78 BPM. At approximately 1256, client states lips are itchy, and mild itchiness in throat. This RN proceeded with administering 0.3mL diphenhydramine IM at 1258. Client was monitored for an additional ten minutes. Client remained stable and no complaints of itching or tingling in airway. Client's color within normal limits, patent airway. Informed mother we can call 911, however, mother felt comfortable driving client to urgent care five min away. Mother is going to take client to urgent care. Client also has epi pen and rescue inhaler on person.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC15, VARCEL, VARCEL, HEPA, MMR, PNC15, UNK, VARCEL
Symptoms: Cough, Food refusal, Irritability, Laboratory test, Rhinorrhoea
Clinical narrative: Approximately a week after receiving the above vaccines, patient showed increased irritability and refusal to eat foods that required chewing, presumably due to mouth pain. Patient also showed a runny nose. On 4/25/2025, patient developed spots on body, which started at the hairline and progressed downward across the face and onto the trunk and limbs over the next few days. Spots were raised and crusty and looked like chicken pox. Patient was estimated to have >200 spots on body. Patient also developed spots in the mouth. Patient showed increasing irritability/fussiness, decreased appetite, fewer wet diapers, refusal to eat foods that required chewing, and developed a cough.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC15, VARCEL, VARCEL, HEPA, MMR, PNC15, UNK, VARCEL
Symptoms: Scab, Skin discolouration, Urine output decreased
Clinical narrative: Approximately a week after receiving the above vaccines, patient showed increased irritability and refusal to eat foods that required chewing, presumably due to mouth pain. Patient also showed a runny nose. On 4/25/2025, patient developed spots on body, which started at the hairline and progressed downward across the face and onto the trunk and limbs over the next few days. Spots were raised and crusty and looked like chicken pox. Patient was estimated to have >200 spots on body. Patient also developed spots in the mouth. Patient showed increasing irritability/fussiness, decreased appetite, fewer wet diapers, refusal to eat foods that required chewing, and developed a cough.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC15, VARCEL, VARCEL, HEPA, MMR, PNC15, UNK, VARCEL
Symptoms: Irritability, Rash vesicular
Clinical narrative: Approximately a week after receiving the above vaccines, patient showed increased irritability and refusal to eat foods that required chewing, presumably due to mouth pain. Patient also showed a runny nose. On 4/25/2025, patient developed spots on body, which started at the hairline and progressed downward across the face and onto the trunk and limbs over the next few days. Spots were raised and crusty and looked like chicken pox. Patient was estimated to have >200 spots on body. Patient also developed spots in the mouth. Patient showed increasing irritability/fussiness, decreased appetite, fewer wet diapers, refusal to eat foods that required chewing, and developed a cough.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC15, VARCEL, VARCEL, HEPA, MMR, PNC15, UNK, VARCEL
Symptoms: Cough, Food refusal, Irritability, Laboratory test, Oral pain
Clinical narrative: Approximately a week after receiving the above vaccines, patient showed increased irritability and refusal to eat foods that required chewing, presumably due to mouth pain. Patient also showed a runny nose. On 4/25/2025, patient developed spots on body, which started at the hairline and progressed downward across the face and onto the trunk and limbs over the next few days. Spots were raised and crusty and looked like chicken pox. Patient was estimated to have >200 spots on body. Patient also developed spots in the mouth. Patient showed increasing irritability/fussiness, decreased appetite, fewer wet diapers, refusal to eat foods that required chewing, and developed a cough.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC15, VARCEL, VARCEL, HEPA, MMR, PNC15, UNK, VARCEL
Symptoms: Rash maculo-papular, Rhinorrhoea
Clinical narrative: Approximately a week after receiving the above vaccines, patient showed increased irritability and refusal to eat foods that required chewing, presumably due to mouth pain. Patient also showed a runny nose. On 4/25/2025, patient developed spots on body, which started at the hairline and progressed downward across the face and onto the trunk and limbs over the next few days. Spots were raised and crusty and looked like chicken pox. Patient was estimated to have >200 spots on body. Patient also developed spots in the mouth. Patient showed increasing irritability/fussiness, decreased appetite, fewer wet diapers, refusal to eat foods that required chewing, and developed a cough.
Age: 0.17
Sex: M
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Patient was to get dose of Vaxelis. When reviewing chart after finding discrepancy in weekly vaccination counts, it was found that the lot number and expiration date did not match up to a Vaxelis dose but did match an influenza dose. Patient appears to have been given a flu shot and not his scheduled Vaxelis. Notified Clinical Services for direction. Incident report filed. Provider notified. Clinical Services reached out to CDC for guidance. Will be having discussion of incident with staff involved tomorrow 4/29/25 and will instruct them to call family to notify of the incident and to schedule patient to come in to get the scheduled Vaxelis dose. Working with Clinical Services on immunization administration process and will be creating new workflow to prevent further incidents.
Age: 61.0
Sex: M
Vaccine: HEPAB, PNC21, VARZOS
Symptoms: Aphasia, Hypoaesthesia oral
Clinical narrative: The day after vaccine , patient went in hot tub for 15-20 minutes and after he came out his tongue was numb and he could not speak - patient's wife called ER and upon their arrival his vitals were normal.
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt got Prevnar 20 3/21/2023 and another Prevnar 20 4/25/25 (duplication of vaccine). No side effects per pt.
Age: 62.0
Sex: M
Vaccine: CHIK, CHOL, JEV1, TYP
Symptoms: Bell's palsy
Clinical narrative: 4/7/25  Received: Ixchiq, Cholera, JE, Typhoid Vi.    4/22/25  in ER.  4/28/25 Per patient, he is home, dx with Bell's Palsy, currently being treated with steroids, his doctors aware of vaccine hx.