chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: They administered Boostrix, the patient was supposed to get a ppd instead; Patient received Boostrix in the left lower fore arm intradermal; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong product administered in a 22-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 333SK, expiry date 28-SEP-2025) for prophylaxis.   Co-suspect products included tuberculin ppd (Ppd Disposable) for product used for unknown indication.   On an unknown date, the patient received Boostrix (intradermal, left lower forearm) and did not receive Ppd Disposable. On an unknown date, an unknown time after receiving Boostrix, the patient experienced wrong product administered (Verbatim: They administered Boostrix, the patient was supposed to get a ppd instead) and intramuscular formulation administered by other route (Verbatim: Patient received Boostrix in the left lower fore arm intradermal). The action taken with Ppd Disposable was unknown. The outcome of the wrong product administered and intramuscular formulation administered by other route were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-APR-2025 On 14 April 2025 an office manager called to report that they administer Boostrix in error and in a wrong area to a 22 years old male patient. They administered Boostrix in the left lower fore arm intradermal. The patient was supposed to get a ppd instead which led to wrong product administered and intramuscular formulation administered by other route. The reporter wanted to know if there are any possible side effects to consider. Consented to follow up.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: only diluent portion was accidentally given to female; only diluent portion was accidentally given to female; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMA8030A, expiry date 30-APR-2025) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: only diluent portion was accidentally given to female) and inappropriate dose of vaccine administered (Verbatim: only diluent portion was accidentally given to female). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 14-APR-2025 The nurse reported that a dose of Menveo after only the diluent portion was accidentally given to a female 12 year  old patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; I know several people who were vaccinated and still had bad cases of shingles and they had them in very unusual places; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patients 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: I know several people who were vaccinated and still had bad cases of shingles and they had them in very unusual places). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-APR-2025 This case was reported by a consumer via interactive digital media. The reporter knew several patients who were vaccinated with Shingles vaccine and still had bad cases of shingles and they had them in very unusual places and a private area. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case is linked with US2025AMR046807, reported by same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. US-GSK-US2025AMR046807:same reporter different patient
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: burning on my back; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of burning sensation 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 burning sensation (Verbatim: burning on my back). The outcome of the burning sensation was not reported.   It was unknown if the reporter considered the burning sensation to be related to Shingrix.     It was unknown if the company considered the burning sensation to be related to Shingrix.   Additional Information: GSK receipt date: 14-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that after Shingrix vaccination patient experienced burning on his/her back.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Paraesthesia, Skin warm, Vaccination failure
Clinical narrative: Suspected vaccination failure; I've had shingles on my face; hasn't shown, or caused the severe pain; hot to the touch; Poke on the hairline above my ear on both sides of my face months apart, I feel like slivers of glass; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), facial herpes zoster (Verbatim: I've had shingles on my face), pain (Verbatim: hasn't shown, or caused the severe pain), feeling hot (Verbatim: hot to the touch) and tingling skin (Verbatim: Poke on the hairline above my ear on both sides of my face months apart, I feel like slivers of glass). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster, pain, feeling hot and tingling skin were not resolved.   It was unknown if the reporter considered the vaccination failure, facial herpes zoster, pain, feeling hot and tingling skin 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 facial herpes zoster, pain, feeling hot and tingling skin to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 16-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she had got the 2 shingles shots, and twice he/she had felt like he/she had shingles on face.  It just had not shown, or caused the severe pain that it can. Poke on the hairline above ear on both sides of his/her face months apart.  He/she felt like slivers of glass.  It was in his/her face.  It was hot to touch.  But when he/she put a cold compass on it, it felt 10 times better.  He/she was going through that right now.  For the second time on the right side of his/her cheek near ear and hairline.  He/she was told that the shingles vaccine did not prevent the shingles.  It just prevents the shingles from being at its worst, any feedback. 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: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; several friends who got the shingles from the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in the unspecified number of patients 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: several friends who got the shingles from the vaccine). The outcome of the vaccination failure and shingles were not reported.   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. The company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-APR-2025 This case was reported by a patient via interactive digital media. The reporter stated that he/she had several friends who got the shingles from the (Shingles) vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; 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.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Dose administered after temperature excursion/patient given MMR(Priorix) that was frozen prior to reconstitution; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 1-year-old male patient who received MMR (Priorix) (batch number 3D72S, expiry date 01-SEP-2025) for prophylaxis.   Concomitant products included Priorix.   On 10-MAR-2025, the patient received Priorix (subcutaneous) .5 ml. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: Dose administered after temperature excursion/patient given MMR(Priorix) that was frozen prior to reconstitution). The outcome of the incorrect storage of drug was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-APR-2025 The reporter stated they given Priorix that was frozen prior reconstitution which le to, which led to incorrect storage of vaccine. This was 1 of 6 linked report, reported by same reporter.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: patient given MMR(Priorix) that was frozen prior to reconstitution; 53 year old patient received priorix vaccine; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 53-year-old female patient who received MMR (Priorix) (batch number 3D72S, expiry date 01-SEP-2025) for prophylaxis.   Concomitant products included Priorix.   On 12-FEB-2025, the patient received Priorix (subcutaneous) .5 ml. On 12-FEB-2025, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: 53 year old patient received priorix vaccine). On an unknown date, the patient experienced incorrect storage of drug (Verbatim: patient given MMR(Priorix) that was frozen prior to reconstitution). The outcome of the incorrect storage of drug 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: 15-APR-2025 The reporter stated they given Priorix that was frozen prior reconstitution which le to, which led to incorrect storage of vaccine. The 53 year old patient received a dose of Priorix vaccine which led to inappropriate age at vaccine administration. This was 1 of 6 linked report, reported by same reporter.
Age: 63.0
Sex: F
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: patient given MMR(Priorix) that was frozen prior to reconstitution; Priorix received to 63 years patient; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 63-year-old female patient who received MMR (Priorix) (batch number 3D72S, expiry date 01-SEP-2025) for prophylaxis.   Concomitant products included Priorix.   On 07-JAN-2025, the patient received Priorix (subcutaneous) .5 ml. On 07-JAN-2025, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: Priorix received to 63 years patient). On an unknown date, the patient experienced incorrect storage of drug (Verbatim: patient given MMR(Priorix) that was frozen prior to reconstitution). The outcome of the incorrect storage of drug 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: 15-APR-2025 Healthcare Provider stated they stored Priorix in the freezer instead of the fridge and lowest temperature reached would be probably minus 17 degrees Fahrenheit and the vaccine was administered after the temperature excursion, which led to incorrect storage of vaccine. Caller did not have any patient demographics or dates of administration. The Priorix administered to 63 years patient which led to inappropriate age at vaccine administration. The reporter consented to follow up. Reporter stated that patient given Mmr (Priorix) that was frozen prior to reconstitution.; Sender's Comments:  US-GSK-US2025034230:Same reproter diffrent patient
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Suspected Vaccination failure; mild shingles rash; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: mild shingles rash). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 15-APR-2025 This case was reported by a patient via interactive digital media. The patient had all his/her Shingles shots and had a very, very mild shingles rash.  The patient said that he/she had hated to think what it would have been like without being vaccinated. 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  clinical description, time to onset and  laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1 & 2).
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; i got shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and 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: i 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 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: 17-APR-2025 The patient reported that he/she had the two shot Shingrix vaccine several years ago and got shingles. The patient asked that he/she should had a second round of the vaccine and/or how long the vaccine was effective. This case was considered as suspected vaccination failure since the details regarding 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 vaccine Shingrix (dose 1 and 2)
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; after i had the vaccine i got shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: after i had the vaccine i 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 Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-APR-2025 The patient had the Shingrix vaccine and got shingles.  The reporter asked should have the vaccine again. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; most of patients that got the shot, got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients 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: most of patients that got the shot, 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: 17-APR-2025 This case was reported via interactive digital media. The reporter's doctor advised the reporter not to get the shot because most of her patients that got the shot, got shingles. The reporter had the Shingles last year for a month and it was painful. 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.
Vaccine: VARZOS
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: was more painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Tetanus vaccine with an associated reaction of pain (received tetanus shot and was painful) and Shingles vaccine with an associated reaction of pain (received 1st dose of Shingles vaccine with event pain for tolerance refer 1st dose case US2025AMR044144.).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: was more painful). Rechallenge with Shingles vaccine was positive. The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2025AMR044144   Additional Information: GSK Receipt Date : 09-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got the two shots of shingles and was more painful than a tetanus shot for him/her.  The patient suggested that took it on a Friday so you have the weekend to recover.; Sender's Comments:  US-GSK-US2025AMR044144:same patient dose 1
Vaccine: RVX
Symptoms: Headache, Injection site pain, Pain
Clinical narrative: soreness at the injection site; headaches; body aches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received 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 injection site pain (Verbatim: soreness at the injection site), headache (Verbatim: headaches) and general body pain (Verbatim: body aches). The outcome of the injection site pain, headache and general body pain were not reported.   It was unknown if the reporter considered the injection site pain, headache and general body pain to be related to RSV vaccine.     It was unknown if the company considered the injection site pain, headache and general body pain to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 16-APR-2025 This case was reported by a patient via interactive digital media. The soreness at the injection site, some headaches and body aches. Actually, some of the mildest problems of all the vaccines. The alternative was horrible sickness or death. Easy decision.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected Vaccination failure; got the Shingles vaccine and still got Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the Shingles vaccine and still got Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     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: 17-APR-2025 This case was reported by a patient via interactive digital media. The patient got the Shingles vaccine and still got shingles and was one of the most painful things the patient had ever experienced. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination 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, 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 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: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-APR-2025 The patient had taken the vaccines and the doctor had told him he would never get them, but he did and had them now.  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.
Age: 66.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: early third dose; Potential late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Previously administered products included Hepatitis A-B combo vaccine (Received 1st dose of Hepatitis A-B combo vaccine on 26-JUL-2023).   On 13-SEP-2024, the patient received the 2nd dose of Twinrix. On 11-OCT-2024, the patient received the 3rd dose of Twinrix. On 13-SEP-2024, an unknown time after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Potential late second dose). On 11-OCT-2024, the patient experienced drug dose administration interval too short (Verbatim: early third dose). The outcome of the drug dose administration interval too long 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: 11-APR-2025 Pharmacist stated that a patient got what they thought it was a first dose of Twinrix on 13 September 2024 and second dose on 11 October 2024. But later they discovered that patient forgot that they received a prior dose of a Hepatitis A-B combo vaccine (unknown brand or lot number) on 26JUL2023 which led to drug dose administration interval too long and drug dose administration interval too short. The reporter did not have lot number or expiration date for none of the 2 Twinrix vaccines. Consented to follow up.; Sender's Comments:  US-GSK-US2025038452:SAME REPORTER
Age: 57.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of Kinrix to a 57 year old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 57-year-old male patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 10-APR-2025, the patient received Kinrix. On 10-APR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Kinrix to a 57 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: 14-APR-2025 A medical assistant called to report about the administration of Kinrix vaccine to a 57 year old patient which led to inappropriate age at vaccine administration.  The medical assistant enquired if the patient should be revaccinated with an appropriate vaccine.
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Shingrix adjuvant only given; Shingrix adjuvant only given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication 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 inappropriate preparation of medication (Verbatim: Shingrix adjuvant only given) and inappropriate dose of vaccine administered (Verbatim: Shingrix adjuvant only given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK receipt date: 14-APR-2025 Pharmacy director's assistant called to report the adjuvant portion of the Shingrix vaccine was administered which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. During the call the healthcare professional reported event happened in one of their offsite offices so when details were asked about the patient, lot number or vaccination date, the information was declined because it was not available at that moment.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: HCP mentioned that the 1st Twinrix dose was administer on 02-Mar-2025, and who have given the 2nd dose of Heplisav instead of Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old male patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: HCP mentioned that the 1st Twinrix dose was administer on 02-Mar-2025, and who have given the 2nd dose of Heplisav instead of Twinrix). The outcome of the incomplete course of vaccination was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-APR-2025 The pharmacist reported that they were giving a patient a dose of Twinrix and they were following the 0,1,6 month vaccine schedule, but apparently they had a floater pharmacist in there who had given the 2nd dose of Heplisav instead of Twinrix. The Vaccine Administration Facility was the same as Primary Reporter. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: Only diluent administered; Only diluent administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis.   On 10-APR-2025, the patient received Priorix. On 10-APR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Only diluent administered) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-APR-2025 On 14th April 2025, a pharmacist called to inform that on 10th April 2025, a patient had received only the diluent component of Priorix, meaning it had not been reconstituted, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; diagnosed today as having an active shingles outbreak; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 16-APR-2025, 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: diagnosed today as having an active shingles outbreak). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to 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: 16-APR-2025 The doctor reported that a patient who was diagnosed today having an active shingles outbreak.  The doctor reported that the patient had already received two doses of Shingrix vaccine It was unknown when the patient finished the first two doses. The Health Care Professional (doctor) enquired about getting another series 5 years post first series.  The doctor stated that the patient was diagnosed with shingles today and found information online advising a 2nd dose of Shingrix series was needed 5 years after receiving initial 2 dose vaccine. This case was considered as suspected vaccination failure as details regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration of Kinrix under age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number 42Y93, expiry date 05-JUN-2026) for prophylaxis.   On 16-APR-2025, the patient received Kinrix. On 16-APR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration of Kinrix under age). 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: 21-APR-2025 The reporter reported that a 2-year-old patient received by error Kinrix to continue Dtap and IPV series, which led to inappropriate age at vaccine administration. This was the second dose in the series.  The Vaccine Administration Facility is the same as Primary Reporter.
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number PG3RP, expiry date 11-JUL-2027) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug 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: 21-APR-2025 The nurse called to report a temperature excursion and to determine the next steps regarding the vaccines.  The vaccine in question was Boostrix, the only one affected.  The highest temperature it reached was 11.2 degrees Celsius, and it had been out of temperature range for 55 days.  These dose had already been administered to patient. This case is linked with US2025048454, reported by same reporter.; Sender's Comments:  US-GSK-US2025048454:same reporter
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDITIS (myocarditis) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that, one of the reporter's nieces had myocarditis.  No treatment information was provided.  Company comment:  Reportedly, it was stated that the patient developed myocarditis after vaccination, however, no additional details regarding medical history of the patient, clinical course of the event, treatment details, as well as temporal relationship between vaccination and the event of myocarditis were provided at the time of this report. The benefit-risk relationship of the product is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2021-307118 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Mar-2025: Live non-significant follow up received included reference number added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-307118:master case
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Coronary artery occlusion
Clinical narrative: My LAD artery has become 70% blocked / it appears the vaccine caused the blockage; This spontaneous case was reported by a patient and describes the occurrence of CORONARY ARTERY OCCLUSION (My LAD artery has become 70% blocked / it appears the vaccine caused the blockage) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2020, the patient experienced CORONARY ARTERY OCCLUSION (My LAD artery has become 70% blocked / it appears the vaccine caused the blockage) (seriousness criterion medically significant). At the time of the report, CORONARY ARTERY OCCLUSION (My LAD artery has become 70% blocked / it appears the vaccine caused the blockage) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2019, Cardiac stress test: All arteries were completely clear.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       No concomitant and treatment medication were reported.  It was unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: headache; body aches; chills; fatigue; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache), PAIN (body aches), CHILLS (chills) and FATIGUE (fatigue) in a 68-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Mar-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 24-Mar-2025, the patient experienced HEADACHE (headache), PAIN (body aches), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, HEADACHE (headache), PAIN (body aches), CHILLS (chills) and FATIGUE (fatigue) was resolving.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.  The patient experienced events 10 hours after vaccine and two days later symptoms persisted but lessened.  The patient had no medical history, concomitant disease or risk factor.   It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Gait disturbance, Sleep disorder
Clinical narrative: shortness of breath; sleep issues; gait/problems walking; experiencing fatigue for years; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (shortness of breath), SLEEP DISORDER (sleep issues), GAIT DISTURBANCE (gait/problems walking) and FATIGUE (experiencing fatigue for years) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004D21A, 006D21A and 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 16-Jan-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath), SLEEP DISORDER (sleep issues), GAIT DISTURBANCE (gait/problems walking) and FATIGUE (experiencing fatigue for years). At the time of the report, DYSPNOEA (shortness of breath), SLEEP DISORDER (sleep issues), GAIT DISTURBANCE (gait/problems walking) and FATIGUE (experiencing fatigue for years) outcome was unknown.            No concomitant medication was reported.  Patient was inquired regarding the PVS test. Patient shared experiencing multiple side-effects. It was unknown if the patient experienced any additional symptoms/events.  No treatment information was reported.