chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse side effects were reported; HCP called regarding VARIVAX that was expired and administered to patients.  VARIVAX Lot and expiration date are W018830 and 6/14/2024, STERILE DILUENT Lot and expiration date 1973262  3/10/2026. Expired product was supported. HCP provided patient in; This spontaneous report was received from a nurse and refers to a 1 year old female patient. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. Concomitant medications included sterile diluent (BAXTER STERILE DILUENT) syringe.   On an 15-OCT-2024, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # W018830, expiration date: 14-JUN-2024 (strength, route of administration, anatomical location not provided) as prophylaxis. It was reported that the expired product was supported, and no adverse side effects were reported.  This is one of several cases reported by the same reporter.
Age: 42.0
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: No symptoms reported and no additional details provided. No other AE and no PQC; Pharmacist calling to report a missed dose of GARDASIL 9 for a 42 year old patient.  The patient received the first dose on 09/09/2024 and they have yet to receive the second dose.; This spontaneous report was received from Pharmacist and refers to a 42-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-SEP-2024, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On an unknown date in 2024, the patient missed the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), reported as hey have yet to receive the second dose. No symptoms reported and no additional details provided.  Lot # is being requested and will be submitted if received.
Age: 20.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP stated no side effects were reported; HCP called to report a patient inadvertently was administered VAQTA after its labeled expiry date. HCP stated no side effects were reported. HCP stated the expired VAQTA was administered on 11/14/2024. HCP stated there was no temperature excursion.; This spontaneous report was received from an other health professional (HCP) (nurse practitioner) and refers to a 20-year-old patient of an unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 14-NOV-2024, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (formulation pre-filled syringe), booster dose; strength: 50u/1.0ml, lot #X006702 (valid lot #) with expiration date: 01-OCT-2024, administered for prophylaxis (route of administration was not provided) (expired product administered). No side effects were reported (no adverse event). HCP stated there was no temperature excursion.
Age: 25.0
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: No additional AE; First dose was received 5/30/2017. The patient did not receive a 2nd dose until 10/12/2024.; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 30-MAY-2017 (at the age of 25 years old), the patient was vaccinated with 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (anatomical location, strength, lot #, expiry date, and route of administration were not provided). The patient did not receive a 2nd dose until 12-OCT-2024 (Inappropriate schedule of product administration) (no administration details). Patient did not received a 3rd dose at this time. No additional details provided. No additional AE reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Has not had any symptoms; Nurse called to report an expired dose of GARDASIL 9 was administered. Caller stated the GARDASIL 9 expired on 9/5/2024 and was administered 11/18/2024. Caller stated the patient is still in the office and has not had any symptoms. Caller stated the; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 18-NOV-2024, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, valid lot #W011264, expiration date reported and confirmed as 05-SEP-2024, administered for prophylaxis (strength, exact dose, route of administration, and anatomical location were not provided) (expired product administered). The reporter stated the patient was still in the office and had not experienced any symptoms (no adverse event). In addition, it was informed that the suspect vaccine was not involved in any temperature excursions. No additional adverse events reported.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Decreased appetite, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: I was, like, paralyzed; Not mobile; I can't really go any place because my energy isn't; I have no appetite; I am still very stiff; I couldn't move my back, my shoulder blades, my arms and legs; This spontaneous case, initially received on 11-Nov-2024, was reported by a non health professional and concerns an elderly female patient.  At the time of the event the patient had wheelchair.  Administration of company suspect drug(s): On 06-Nov-2024, the patient received Fluad (TIV) for Flu immunization, Dose regimen: .5 ml, route of administration and anatomical location were not provided. Lot number: No batch number available.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 06-Nov-2024, the patient experienced I was, like, paralyzed (Medically Significant, outcome: Not recovered / Not resolved), Not mobile (Medically Significant, outcome: Not recovered / Not resolved), I can't really go any place because my energy isn't (outcome: Not recovered / Not resolved), I have no appetite (outcome: Not recovered / Not resolved), I am still very stiff (outcome: Not recovered / Not resolved), I couldn't move my back, my shoulder blades, my arms and legs (outcome: Not recovered / Not resolved).  Patient was a person who took flu vaccines every year, and this year got the vaccine that was given by company at the local pharmacy, and patient was experiencing a very relatively severe reaction and was about four or five days already, and it was getting better, but she would like to know what was recommend. Patient had been using the heating pad and Tylenol, but was still very stiff and not mobile, and her energy was not that good, and patient had no appetite. It was worse. Like, she was in a wheelchair to begin with, but did not have the energy to push. It was not an electric wheelchair, it was just a regular one, and patient push it with her feet, but she did not have the energy now to go any distance. Patient had her Aide stay over the first night that it happened, because that was when it was the worst, because patient was, like, paralyzed. Patient couldn't move her back, shoulder blades, arms and legs. Patient just had to lay there. And assumed that since it was from the vaccine that it would wear off. And patient would say that it was wearing off. It was a lot better than it was, but still can't. Like, patient was not interested in food and can't really go any place because her energy isn't. Patient received, what she was assuming, what she asked for was the regular dose, not the dose that was higher for older people. So, patient assumed it was the regular dose that she got. Patient have had it in previous years.  Fluad (TIV) action taken: Not Applicable Treatment medication: Tylenol  Reporter's assessment: The reporter did not provide a causality opinion and considered the event as non-serious.; Reporter's Comments: Causality: Related due to plausible temporal relationships (on same day of vaccination).
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Coronary arterial stent insertion, Incomplete course of vaccination
Clinical narrative: I had a heart stent procedure soon after and another 6 months later; Incomplete course of vaccination; I had a heart stent procedure soon after and another 6 months later; This serious case was reported by a consumer via call center representative and described the occurrence of cardiac stent placement in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 01-JUL-2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 01-JUL-2022, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced cardiac stent placement (Verbatim: I had a heart stent procedure soon after and another 6 months later) (serious criteria clinically significant/intervention required). On an unknown date, the patient experienced cardiac stent placement (Verbatim: I had a heart stent procedure soon after and another 6 months later) (serious criteria clinically significant/intervention required) and incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The outcome of the cardiac stent placement and cardiac stent placement were not reported and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the cardiac stent placement and cardiac stent placement to be related to Shingrix.     The company considered the cardiac stent placement and cardiac stent placement to be unrelated to Shingrix and Shingrix.   Additional Information: GSK receipt date: 06-NOV-2024 and 07-NOV-2024  The patient took first dose of Shingrix on 1st July 2022. He had a heart stent procedure soon after and another 6 months later. At that time he was asked to hold off on his 2nd dose.  Looked at his records, he realized he never took his 2nd dose.  Patient questioned that should he start over with a new 2 dose regimen and was it safe to do so. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments: Coronary arterial stent insertion and Coronary arterial stent insertion are unlisted events which are considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Age: 17.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Extra dose administered
Clinical narrative: Patient received 3 doses of Menveo; Patient received 3 doses of Menveo; This non-serious case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (received first dose of Menveo on an unknown date).   On 18-OCT-2024, the patient received the 3rd dose of Menveo. On an unknown date, the patient received the 2nd dose of Menveo. On 18-OCT-2024, an unknown time after receiving Menveo and not applicable after receiving Menveo, the patient experienced extra dose administered (Verbatim: Patient received 3 doses of Menveo). On an unknown date, the patient experienced extra dose administered (Verbatim: Patient received 3 doses of Menveo). The outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 22-OCT-2024  The other health professional reported that the patient received 3 doses of Menveo which led to extra dose administered. The other health professional reported that last two doses of Menveo were given 4 weeks between second and third dose.
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden, Malaise
Clinical narrative: The vaccine makes you very sick for a day; cannot do anything but lay in bed; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness (Verbatim: The vaccine makes you very sick for a day) and bedridden (Verbatim: cannot do anything but lay in bed). The outcome of the sickness and bedridden were resolved (duration 1 day).   It was unknown if the reporter considered the sickness and bedridden to be related to Shingles vaccine.     It was unknown if the company considered the sickness and bedridden to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-OCT-2024 This case was reported by a patient via interactive digital media.  Reporter stated that the vaccine makes you very sick for a day and you could not do anything but lay in bed.
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Pain
Clinical narrative: chills; aching; Bedridden; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Influenza Vaccine with an associated reaction of no adverse event (On an unknown date, dose of Influenza vaccine was administered) and COVID-19 vaccine with an associated reaction of no adverse event (On an unknown date, dose of COVID-19 vaccine was administered).   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 chills (Verbatim: chills), pain (Verbatim: aching) and bedridden (Verbatim: Bedridden). The outcome of the chills and pain were not reported and the outcome of the bedridden was unknown (duration 24 hrs).   It was unknown if the reporter considered the chills, pain and bedridden to be related to Shingles vaccine.     It was unknown if the company considered the chills, pain and bedridden to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-OCT-2024 This case was reported by a patient via interactive digital media. The patient got the 1st of the 2 series shots and was informed about of the possible side effects.  The patient ended up having chills and aching so bad that he/she was in bed for 24 hours. The patient never had any side effects with prior immunizations, including influenza and COVID.  The patient asked that the side effects were normally that bad for everyone, or that were only for him/her and also the patient was due for the second vaccine, should he/she get it or not, and the reaction will be the same or worse since it was so bad for the first time.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; received the Shingrix vaccine 7 years ago and had a shingles outbreak this week.; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In NOV-2024, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: received the Shingrix vaccine 7 years ago and had a shingles outbreak this week.). 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: 07-NOV-2024 The patient received the Shingrix vaccine 7 years ago and had a shingles outbreak this week.  Her questioned was should she be revaccinated. But the patient thought that her former doctor who she was using 7 years ago would have the lot numbers and administration dates of Shingrix on record because that they were administered. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year 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 and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK receipt date: 13-NOV-2024 This case was reported by a patient via interactive digital media. The reporter reported that the patient got the shot of Shingle vaccine and within the year had the worst case of Shingles three physicians said they had ever seen. This case was considered as suspected vaccination failure as details regarding completion of time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.  The follow-up could not be possible as no contact details were available.; 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. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Age: 4.0
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the Menveo (1 vial) presentation was administered to a 4 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 4-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number X4T99, expiry date 30-SEP-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 age at vaccine administration (Verbatim: the Menveo (1 vial) presentation was administered to a 4 year old patient). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 22-OCT-2024 The staff supervisor reported that a patient received Menveo (1 vial) at an inappropriate age, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. This case is linked with US2024131274, reported by same reporter.; Sender's Comments:  US-GSK-US2024131274:ANOTHER PATIENT
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine/ she will get dose 2, as soon as possible; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in SEP-2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine/ she will get dose 2, as soon as possible). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-OCT-2024 The patient self-reported this case for herself. The reporter stated that, she received dose 1 of Shingrix, she was not aware that it was a 2-dose series. She would get dose 2, as soon as possible.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: use a different diluent/Different adjuvant; use a different diluent/Different adjuvant; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number Y5YH2, expiry date 11-APR-2026) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: use a different diluent/Different adjuvant) and inappropriate dose of vaccine administered (Verbatim: use a different diluent/Different adjuvant). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-OCT-2024 The pharmacist reported that the patient received Shingrix vaccine with the use of different diluent, like the Varivax, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter was ask did they need to revaccinate the patient. The vaccine administration facility was the same as primary reporter. The health care professional did not provide any information of the patient, and ask if any patient received this, she said that she only need the data for investigation. During the conversation the health care professional mentioned that this was probably the 1st dose of Shingrix for the patient and that the person received the vaccine in the zip code place that they provided. At health care professional was not clear about if this was related to a patient or not.
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 4th dose was subsequently administered on 10/3/2023, 21 days before he was supposed to receive it; Infanrix at the recommended timeframe but fell behind on the 3rd dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 3-year-old male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   Previously administered products included Infanrix (received 1st dose on unknown date) and Infanrix (received 2nd dose on unknown date).   On 03-OCT-2023, the patient received the 4th dose of Infanrix. On 04-APR-2023, the patient received the 3rd dose of Infanrix. On 04-APR-2023, not applicable after receiving Infanrix and an unknown time after receiving Infanrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Infanrix at the recommended timeframe but fell behind on the 3rd dose). On 03-OCT-2023, the patient experienced inappropriate schedule of vaccine administered (Verbatim: 4th dose was subsequently administered on 10/3/2023, 21 days before he was supposed to receive it). The outcome of the inappropriate schedule of vaccine administered and inappropriate schedule of vaccine administered were unknown.   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-OCT-2024 Healthcare Professional stated that they are trying to catch up on Infanrix for a 3 year old patient.  She stated that patient received the first two doses of Infanrix at the recommended timeframe but fell behind on the 3rd dose, which was administered at 19 months exact date of administration 4th April 2023.  The 4th dose was subsequently administered on 3rd October 2023, 21 days before he was supposed to receive it.  She stated that the patient was there for the 5th dose at the day of reporting, which led to Inappropriate schedule of vaccine administered.
Sex: U
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Product Storage Error and Administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   In SEP-2024, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error and Administration). The outcome of the incorrect storage of drug was unknown.   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-OCT-2024 The certified medical assistant reported that multiple temperature excursions for Bexsero ranging from 8.2 degree Celsius to 9.8 degree Celsius with administration to patients dating back to September 2024. The vaccine administration facility was the same as primary reporter. The health care professional did not have patients detail at the time of reporting. She states that she was out when administration occurred and did not probe for additional details.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix 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 male patient who received Herpes zoster (Shingrix) (batch number 559T9, expiry date 09-JUN-2026) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on 22nd February 2022).   On 16-AUG-2024, the patient received the 2nd dose of Shingrix. On 16-AUG-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Shingrix late second dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 23-OCT-2024  The pharmacist had an immunocompetent adult male patient with an appointment for a Shingrix third dose on the day of reporting. The patient received Shingrix first dose and second dose  The patient received second dose of Shingrix longer than the recommended interval which led to lengthening of vaccination schedule. At the time of reporting, Shingrix third dose had not been administered.  The Vaccine Administration Facility was the same as Primary Reporter.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation issue
Clinical narrative: without being mixed with the Lyophilized gE Antigen Component; received an injection of the adjuvant; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of inappropriate preparation of medication in a 78-year-old female 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: without being mixed with the Lyophilized gE Antigen Component) and inappropriate dose of vaccine administered (Verbatim: received an injection of the adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-OCT-2024  The pharmacist reported that a female patient received an injection of the adjuvant component of Shingrix vaccine without being mixed with the Lyophilized gE Antigen Component (powder) which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacist reported that after the event was noticed the patient was administered a second injection with both components mixed providing a full dose of Shingrix. The pharmacist reported that it was unknown if this was the first or second dose of the Shingrix series.  No additional event or information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: patients may have received the liquid adjuvant only portion; patients may have received the liquid adjuvant only portion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in specified number of patients who received Herpes zoster (Shingrix) (batch number 93ET2, expiry date 23-OCT-2026) 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: patients may have received the liquid adjuvant only portion) and inappropriate dose of vaccine administered (Verbatim: patients may have received the liquid adjuvant only portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-OCT-2024  The pharmacist reported that it was discovered that their clinic has three extra vials of lyophilized powder portion of Shingrix vaccine, so they therefore believe three patients may had received the liquid adjuvant only portion which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The pharmacist reported that the doses would have been administered sometime between mid September 2024 and 3rd October 2024.  The pharmacist reported that it was unknown which patients would have received the adjuvant only; they were reviewing charts on 80 something patients.  At the time of reporting, no repeat doses were administered.  The Vaccine Administration Facility was the same as Primary Reporter.
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix-B Used; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 28-year-old male patient who received HBV (Engerix B) (batch number 4JG5Y, expiry date 12-AUG-2024) for prophylaxis.   Previously administered products included Engerix b (received first dose of Engerix b on an unknown date).   On 17-OCT-2024, the patient received the 2nd dose of Engerix B. On 17-OCT-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired Engerix-B Used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 23-OCT-2024 The nurse reported that she administered a dose of Engerix-B to a patient and afterwards realized the product was expired which led to expired vaccine used.  The nurse reported that this was the patients second dose in the series.  At the time of reporting, a repeat dose has not been administered.  The Vaccine Administration Facility was the same as Primary Reporter.
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Kinrix was given in error to a 15-month-old patient; Patient had 3 previous Dtap doses; 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 15-month-old female patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   Previously administered products included Dtap (received first dose of Dtap on an unknown date), Dtap (received second dose of Dtap on an unknown date) and Dtap (received third dose of Dtap on an unknown date).   On 13-SEP-2024, the patient received Kinrix. On 13-SEP-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was given in error to a 15-month-old patient) and inappropriate schedule of vaccine administered (Verbatim: Patient had 3 previous Dtap doses). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   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-OCT-2024 The nurse reported that the Kinrix was given in error to a 15 month old patient which led to inappropriate age at vaccination.  The patient had 3 previous Dtap doses which led to inappropriate schedule of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient was administered expired Engerix-B vaccine; This non-serious case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) for prophylaxis.   On 24-OCT-2024, the patient received Engerix B. On 24-OCT-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Patient was administered expired Engerix-B vaccine). The outcome of the expired vaccine used was unknown.   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-OCT-2024 The nurse reported that the patient had administered an expired Engerix-B vaccine to a patient accidentally. which led to expired vaccine used. The patient age, gender, initial, and route of administration was unknown. The reporter notes they would try to gather more information.
Age: 48.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: fatigue; fever; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), PYREXIA (fever) and VACCINATION SITE PAIN (pain at injection site) in a 48-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    The patient's past medical history included COVID-19 in 2023.   On 08-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 09-Nov-2024, the patient experienced FATIGUE (fatigue), PYREXIA (fever) and VACCINATION SITE PAIN (pain at injection site). The patient was treated with Paracetamol (Tylenol) (oral use) at a dose of 200 milligram. On 11-Nov-2024, FATIGUE (fatigue), PYREXIA (fever) and VACCINATION SITE PAIN (pain at injection site) had resolved.            No concomitant medications were reported. The patient did not experience any additional symptoms/events. Treatment medications were not provided.
Age: 9.0
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: The 9y/o got the hives on 13Nov2024; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (The 9y/o got the hives on 13Nov2024) in a 9-year-old patient of an unknown gender who received mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer Covid-19 vaccine. Past adverse reactions to the above products included No adverse effect with Pfizer Covid-19 vaccine.    On 01-Nov-2024, the patient received first dose of mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (unknown route) 1 dosage form. On 13-Nov-2024,  after starting mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS), the patient experienced URTICARIA (The 9y/o got the hives on 13Nov2024). At the time of the report, URTICARIA (The 9y/o got the hives on 13Nov2024) had not resolved.        The action taken with mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  It was reported that no other symptoms to report.  Treatment information was not provided.  Reporter causality was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-777324 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2024: Live non-significant follow-up received, non new information was received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-777324:Same reporter different patient
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Myocardial infarction
Clinical narrative: heart attack; brain bleed; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) and CEREBRAL HAEMORRHAGE (brain bleed) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria death and medically significant) and CEREBRAL HAEMORRHAGE (brain bleed) (seriousness criteria death and medically significant). The reported cause of death was Heart attack and brain bleed. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Patient suffered a heart attack after receiving the Moderna Covid vaccine. His heart never recovered afterward and his brain bleed and he had died.  Treatment information was not provided.  Reporter causality was not reported.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Reported Cause(s) of Death: heart attack; brain bleed
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Pain, Pyrexia
Clinical narrative: her daughter gets extremely sick from the Moderna vaccine; aches and pains; chills; fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (her daughter gets extremely sick from the Moderna vaccine), PAIN (aches and pains), CHILLS (chills) and PYREXIA (fever) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (her daughter gets extremely sick from the Moderna vaccine), PAIN (aches and pains), CHILLS (chills) and PYREXIA (fever). At the time of the report, ILLNESS (her daughter gets extremely sick from the Moderna vaccine), PAIN (aches and pains), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Patient's relevant medical history/conditions, allergy, concomitant diseases and risk factor were unknown. It was unknown whether patient was had receive any other vaccines in the 4 weeks prior to COVID-19 vaccine or not. Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown. Patient got extremely sick from the Moderna vaccine. She had chills, fever, aches and pains that last her a couple of days. Reporter causality was not reported.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-776898 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-776898:Reporter's case
Sex: U
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Premature baby
Clinical narrative: prior history of prematurity. last delivery was 33w; delivered on early (days after receiving vaccine); This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2712004-1 (VAERS ID).  A neonate patient was exposed to BNT162b2 (BNT162B2), transplacental, administration details for the mother: not provided, on 18Dec2020 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The mother of the patient was in her 30's. The patient's relevant medical history was not reported. The mother's relevant medical history included: "Hypothyroidism" (ongoing). The mother was 33 weeks pregnant at the time of exposure to BNT162b2. The mother was 33 weeks pregnant at the event onset. The mother is expected to deliver one baby(s). The mother's concomitant medications were not reported. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (hospitalization) with onset 18Dec2020, outcome "unknown", described as "delivered on early (days after receiving vaccine)"; PREMATURE BABY (hospitalization) with onset 19Dec2020, outcome "unknown", described as "prior history of prematurity. last delivery was 33w". The baby was delivered premature. The baby weighed 2778.25 grams. Clinical course: The mother had received the COVID vaccine on 18Dec2020 at 32 weeks and 5 days of pregnancy and her water broke the day after receiving the COVID vaccine. Preterm premature rupture of the membranes (PPROM) was reported, and premature 33 week delivery of a newborn. Upon follow-up 23Sep2024, it had been stated that the mother had received the covid vaccine and her water broke after receiving the covid vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Follow-up (23Sep2024): This is a spontaneous follow-up report received from the same Consumer. Updated Information: Reporter (Other Health Professional) added and Clinical course updated.  Batch/lot number is not provided, and it cannot be obtained. Follow-up (21Nov2024): Follow-up attempts are completed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400003516 Mother case;
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Nervousness
Clinical narrative: they didn't administer it in the right place/it was not administered intramuscularly, it was administered in the back of her arm, in a fatty section; Nervous/ upset; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An elderly female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing); "overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pfizer covid-19 vaccine (vaccinated so much, had all the boosters, only ever used Pfizer, not mix them up), for COVID-19 immunization. The following information was reported: NERVOUSNESS (non-serious) with onset 2024, outcome "unknown", described as "Nervous/ upset"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset Sep2024, outcome "unknown", described as "they didn't administer it in the right place/it was not administered intramuscularly, it was administered in the back of her arm, in a fatty section".  Causality for "they didn't administer it in the right place/it was not administered intramuscularly, it was administered in the back of her arm, in a fatty section" and "nervous/ upset" was determined associated to device constituent of BNT162b2 omicron (kp.2).  Additional information: the patient stated a month before 28Oct2024 she received a Pfizer covid 19 vaccine on a Friday afternoon, she went back like 4 days later on a Monday because they didn't administer it in the right place. She stated it was not administered intramuscularly, it was administered in the back of her arm, in a fatty section. She stated the pharmacy called Pfizer and were told not to readminister the vaccine, but nobody had been able to answer if she has enough protection to get her through the year or at least the next six months. The patient concerned, she was very high risk, over 65 years old, very overweight, had asthma and type 2 diabetes,  she was very nervous, that she did not get the vaccine correctly and that her coverage now, as to whether she was protected against COVID-19 and she had a wedding to go in 2 weeks, she did not know if she was protected enough to go to the wedding, or to go out of the house without a mask. She was very upset. She was hypervigilant as she had underlying conditions. She stated she read online 'if it is not given intramuscularly, it doesn't absorb into the body', so she was putting herself and others at risk.  Follow-up (06Nov2024): Follow-up attempts are completed. Batch/lot number is not provided, and it cannot be obtained.  Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400289075 same patient, different dose/events;
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: got heart conditions; This is a spontaneous report received from a Consumer or other non HCP.  A female 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. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "got heart conditions".  Additional Information: Reporter said that the quality was trash and there were no basic manufacturing protocols. Reporter said that his female friend got the shot and she, her mom, her dad, and her brother all got heart conditions, after one shot.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.