chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: raised bump that is red, 4 inches from injection site, size of a thumb; raised bump that is red and hot to touch, 4 inches from injection site, size of a thumb; Swelling of injection site; hardening injection site; Fever; Headache; Fatigue; Chills; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21-FEB-2025, the patient received Shingrix (left deltoid) .5 ml. In FEB-2025, less than a week after receiving Shingrix, the patient experienced chills (Verbatim: Chills). On 22-FEB-2025, the patient experienced injection site swelling (Verbatim: Swelling of injection site), injection site induration (Verbatim: hardening injection site), fever (Verbatim: Fever), headache (Verbatim: Headache) and fatigue (Verbatim: Fatigue). On 28-FEB-2025, the patient experienced raised rash (Verbatim: raised bump that is red, 4 inches from injection site, size of a thumb) and feeling hot (Verbatim: raised bump that is red and hot to touch, 4 inches from injection site, size of a thumb). The patient was treated with cetirizine hydrochloride (Zyrtec) and ibuprofen. On 25-FEB-2025, the outcome of the injection site swelling, fever, headache, fatigue and chills were resolved and the outcome of the injection site induration was resolved (duration 3 days). The outcome of the raised rash and feeling hot were not resolved.   The reporter considered the injection site swelling, injection site induration, fever, headache, fatigue, chills, raised rash and feeling hot to be related to Shingrix.     The company considered the injection site swelling, injection site induration, fever, headache, fatigue, chills, raised rash and feeling hot to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-MAR-2025 Reporter was a pharmacist reporting for herself.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Pain, Pyrexia
Clinical narrative: body ache; fever; general malaise; headache; This non-serious case was reported by a nurse via call center representative and described the occurrence of headache in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 557PZ, expiry date 30-SEP-2025) for prophylaxis.   On 26-FEB-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 26-FEB-2025, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: headache). On 27-FEB-2025, the patient experienced general body pain (Verbatim: body ache), fever (Verbatim: fever) and general malaise (Verbatim: general malaise). On 04-MAR-2025, the outcome of the fever was resolved (duration 5 days). The outcome of the headache, general body pain and general malaise were unknown.   The reporter considered the headache, general body pain, fever and general malaise to be related to Shingrix.     The company considered the headache, general body pain, fever and general malaise to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-MAR-2025 The reporter reported that a female patient received her second dose of Shingrix on 26-FEB- 2025 and started having a headache that same evening.  The patient started also having body aches, on and off fever, and general malaise the next day, 27-FEB-2025 and the fever persisted until 4-MAR-2025.  The headache, body aches and general malaise were continuing at least through Friday 7-MAR-2025, and the reporter was unsure if they persist on, 10-MAR-2025.  They reported all that was provided about these adverse events.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: internal between 1st dose and 2nd dose was too long; 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 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (recived 1st dose on 04-DEC-2021).   On 30-DEC-2024, the patient received the 2nd dose of Shingrix. On 30-DEC-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: internal between 1st dose and 2nd dose was too long). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK receipt date: 10-MAR-2025 The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late dose; This non-serious case was reported by a pharmacist and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 22-NOV-2022).   On 13-JAN-2025, the patient received the 2nd dose of Shingrix. On 13-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: late dose). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 10-MAR-2025 The pharmacist reported that a patient received her first dose on 22-NOV-2022 and her second dose on 13-JAN-2025, which led to drug dose administration interval too long.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles flares after receiving both vaccine doses; This serious case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus.   On 17-JUL-2020, the patient received the 2nd dose of Shingrix. On 02-FEB-2020, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles flares after receiving both vaccine doses). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 11-MAR-2025  The patient self-reported this case for himself. The patient had reported shingles flares after receiving both vaccine doses. The provider did not have documented an official shingles diagnoses. 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 vaccine Shingrix (Dose 1 & 2).
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash everywhere; This non-serious case was reported by a consumer and described the occurrence of generalized rash in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included transcatheter aortic valve replacement. Concomitant products included apixaban (Eliquis).   On 17-FEB-2025, the patient received Shingrix. On 24-FEB-2025, 7 days after receiving Shingrix, the patient experienced generalized rash (Verbatim: Rash everywhere). The outcome of the generalized rash was not resolved.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.     It was unknown if the company considered the generalized rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-MAR-2025 The case was self reported by patient. The patient received Shingrix vaccine and experienced rash everywhere.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: already received 2 doses; This non-serious case was reported by a pharmacist via other manufacturer and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: already received 2 doses). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date: 07-MAR-2025 The reporter reported that the patient came into their pharmacy for a 2nd dose of shingles and after vaccination realized they already received 2 doses, which led to extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: My sister was very ill for 3 days after her first dose,it scared me; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of illness in a adult female patient who received Herpes zoster (Shingrix) 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 illness (Verbatim: My sister was very ill for 3 days after her first dose,it scared me). The outcome of the illness was resolved (duration 3 days).   The reporter considered the illness to be related to Shingrix.     The company considered the illness to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-MAR-2025 This case was reported by a consumer via interactive digital media. The reporter reported that he read about all the negative side effects that did not go away. A lot of people were now living with bad things caused by the vaccine that would never go away. The reporter sister was very ill for 3 days after her first dose, it scared the reporter.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I've had it 3 more times; 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.   The patient's past medical history included shingles.   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: I've had it 3 more times). 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: 10-MAR-2025 The case was received from the patient via interactive digital media. The patient had shingles, then got both shots.  The patient have had it 3 more times after the vaccine. 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles(1st dose)and Shingles(2nd dose)
Sex: M
Vaccine: VARZOS
Symptoms: Fall, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles on the face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly 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 facial herpes zoster (Verbatim: shingles on the face). The outcome of the vaccination failure and facial herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure and facial herpes zoster 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 facial herpes zoster to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2025 This case was reported by a patient via interactive digital media. Patient had shingles on the face from a fall. He reported that he also had the Shingles vaccine 3 years earlier.  The patient further stated that medical stuff was dumb. 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
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain in left knee to ankle; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in joint involving lower leg in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In SEP-2024, the patient received the 1st dose of Shingrix. In SEP-2024, 4 hrs after receiving Shingrix, the patient experienced pain in joint involving lower leg (Verbatim: pain in left knee to ankle). The outcome of the pain in joint involving lower leg was not resolved.   The reporter considered the pain in joint involving lower leg to be related to Shingrix.     The company considered the pain in joint involving lower leg to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-MAR-2025 This case was reported by a patient via interactive digital media. Consumer reported that the same happened to them and 4 hours after she had the first shot and had pain in left knee to ankle.  That was last September and still had problems with it.  Consumer didn't want to get the shot in the first place and deeply regret on that and Doctors, of course, she don't believe that was possible. The follow-up could not be possible as no contact details were available.
Vaccine: VARZOS
Symptoms: Chills, Nausea
Clinical narrative: Chills; nausea; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced chills (Verbatim: Chills) and nausea (Verbatim: nausea). The outcome of the chills and nausea were not reported.   It was unknown if the reporter considered the chills and nausea to be related to Shingrix.     It was unknown if the company considered the chills and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-MAR-2025 This case was reported by a patient via (Shingrix GSK chat BOT) interactive digital media. The patient received Shingrix vaccine and experienced chills and nausea.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got both shots and less than a year later I came down with the shingles in my right eye; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female 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, less than a year after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: I got both shots and less than a year later I came down with the shingles in my right eye) (serious criteria GSK medically significant). The outcome of the vaccination failure and ophthalmic herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingrix and Shingrix.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date : 10-MAR-2025 This case was reported by a patient via interactive digital media. The patient got both shots and less than a year later she came down with the shingles in her right eye. It was horrible. 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 clinical description, details regarding laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: a patient got an expired dose of Engerix-B on March 7th 2025; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-year-old male patient who received HBV (Engerix B) (batch number 9PG49, expiry date 28-DEC-2024) for prophylaxis.   Previously administered products included Hepatitis B vaccines (Patient got prior Hepatitis B vaccines 1 st  dose  on February 8th 2012) and Hepatitis B vaccines (Patient got  prior Hepatitis B vaccines  2nd on 30-APR-2012).   On 07-MAR-2025, the patient received Engerix B. On 07-MAR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: a patient got an expired dose of Engerix-B on March 7th 2025). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-MAR-2025 Certified Medical Assistant explained that a patient got an expired dose of Engerix-B on March 7th 2025, which led to Expired vaccine used. The dose was expired on December 28th, 2024.  Patient got 2 prior Hepatitis B vaccines on February 8th, 2012, and April 30th, 2012. Lot number and expiration date for the prior 2 doses were unknown by the caller, and brand name was not mentioned.  The reporter consented to follow up.
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: second dose recently on March Twenty-twenty five; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 11-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number AE2J7, expiry date 16-AUG-2025) for prophylaxis.   On 07-MAR-2025, the patient received the 2nd dose of FluLaval 2024-2025 season. On an unknown date, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced extra dose administered (Verbatim: second dose recently on March Twenty-twenty five). The outcome of the extra dose administered was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-MAR-2025 The reporter reported that a patient that was administered a first dose of Flulaval in September 2024 and a second dose recently in March 2025, which led to extra dose administered.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: was given the vaccine of the solute, but not of the mixture; was given the vaccine of the solute, but not of the mixture; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number BL473, expiry date 13-OCT-2026) for prophylaxis.   On 07-MAR-2025, the patient received Arexvy. On 07-MAR-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: was given the vaccine of the solute, but not of the mixture) and inappropriate dose of vaccine administered (Verbatim: was given the vaccine of the solute, but not of the mixture). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 10-MAR-2025 Reporter stated that they have a resident who gave the vaccine (Arexvy), was given the vaccine of the solute, but not of the mixture, the powder mix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. So was not reconstituted it and they were wondering what they do now.
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient under 4 years of age received Kinrix; patient under 4 years of age received Kinrix as their their 1st DTAP and IPV dose; 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-month-old male patient who received DTPa-IPV (Kinrix) (batch number 5G23D, expiry date 21-AUG-2026) for prophylaxis.   On 05-MAR-2025, the patient received the 1st dose of Kinrix. On 05-MAR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient under 4 years of age received Kinrix) and inappropriate schedule of product administration (Verbatim: patient under 4 years of age received Kinrix as their their 1st DTAP and IPV dose). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of product 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: 10-MAR-2025 Office manager reported patient under 4 years of age received Kinrix as their 1st DTAP and IPV dose, which led to an inappropriate age at vaccine administration and inappropriate schedule of product administration.
Age: 42.0
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: 42 years old patient received only the sterile saline diluent part of Hiberix; 42 years old patient received only the sterile saline diluent part of Hiberix; 42 years old patient received only the sterile saline diluent part of Hiberix; 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 42-year-old female patient who received Hib (Hiberix) (batch number 4J452, expiry date 15-MAR-2026) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate age at vaccine administration (Verbatim: 42 years old patient received only the sterile saline diluent part of Hiberix), inappropriate preparation of medication (Verbatim: 42 years old patient received only the sterile saline diluent part of Hiberix) and inappropriate dose of vaccine administered (Verbatim: 42 years old patient received only the sterile saline diluent part of Hiberix). The outcome of the inappropriate age at vaccine administration, inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 10-MAR-2025 Reporter stated that they administered only the sterile saline diluent part of Hiberix to a 42 years old female patient which led to inappropriate age at vaccination , inappropriate preparation of medication and inappropriate dose of vaccine administered. Also asked when can they revaccinate the patient.
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the second dose 2 months after the first 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 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 and an unknown time after receiving TWINRIX, the patient experienced drug dose administration interval too long (Verbatim: received the second dose 2 months after the first dose). The outcome of the drug dose administration interval too long was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-MAR-2025 The pharmacist called to enquire on behalf of a patient what would happen if patient receive the 3rd dose of Twinrix in less than 6 months, was there any problem.  Further the pharmacist asked, If they get the second dose 2 months from the 1st one, what could happen and at the beginning of the call the pharmacist said that it was a hypothetical situation.  However, later in the call the pharmacist mentioned that a patient had already received the second dose 2 months after the first dose. The patient received 2nd dose of Twinrix, which led to lengthening of vaccination schedule.
Age: 63.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: intramuscular administration of Priorix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 63-year-old female patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis.   On 11-MAR-2025, the patient received Priorix. On 11-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: intramuscular administration of Priorix). The outcome of the subcutaneous injection formulation administered by other route was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-MAR-2025 The reporter reported that the intramuscular administration of Priorix to 3 patients, which led to Subcutaneous injection formulation administered by other route.; Sender's Comments:  US-GSK-US2025029884:Same reporter/Different patient US-GSK-US2025029891:Same reporter/Different patient
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A dose of Kinrix was administered to a 20 weeks old female 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 20-week-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   Previously administered products included Pediarix (received doses on an unknown date).   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: A dose of Kinrix was administered to a 20 weeks old female patient.). The outcome of the inappropriate age at vaccine administration was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-MAR-2025 The health care professional reported that they administered a dose of Kinrix to a 20 weeks old female patient for their 2nd dose of DTaP and IPV, which led to inappropriate age at vaccine administration. The patient had previous doses of Pediarix.  The reporter was ask was this a mistake or would it be a problem for the baby.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received HAB (Twinrix) (expiry date 03-JAN-2025) for prophylaxis.   Previously administered products included Twinrix (received 1st dose of Twinrix in February 2023).   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: Shingrix late second dose). 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: 11-MAR-2025 The pharmacist wanted to know if they should restart the series or give directly the second dose of Twinrix after receiving the first dose in February 2023. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: The developed atrial fibrillation (afib); This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (The developed atrial fibrillation (afib)) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020f21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, the patient experienced ATRIAL FIBRILLATION (The developed atrial fibrillation (afib)) (seriousness criteria hospitalization and medically significant). At the time of the report, ATRIAL FIBRILLATION (The developed atrial fibrillation (afib)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       No concomitant medication was reported. Patient never had any heart problems in his life. About a month after started getting weird feeling in his chest. Patient then had heart palpitations. That got worse and worse ended up in the overnight with Afib and it comes and goes. Patient had every test possible. It was unknown if the patient experienced any additional symptoms and events. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2025-783005 (E2B Linked Report).; Reporter's Comments: Company Comments: The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-783005:Invalid case for lot of people
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cerebrovascular accident
Clinical narrative: AFib; Stroke; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) 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: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "AFib"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Stroke".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event
Clinical narrative: The serum fell on the table which is where it got into contact with her wrist (skin) later on with no reported adverse event; The serum fell on the table which is where it got into contact with her wrist (skin) later on with no reported adverse event; Initial information received on 10-Mar-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves unknown age adult medical assistant female patient who was exposed to influenza USP trival A-B subvirion no preservative vaccine [Fluzone] after it fell on the table, where it got into contact with her wrist (skin) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, patient was exposed to an unknown dose of influenza USP trival A-B subvirion no preservative vaccine, Unknown strength, Suspension for injection, Expiry date 30-Jun-2025 and lot UT8514A via unknown route in unknown administration site for inlufenza due to serum fell on the table which is where it got into contact with her wrist (skin) later on with no reported adverse event (accidental exposure to product) (exposure via skin contact) (latency Same day)  Reportedly, the vaccine serum leaked on the table during preparation, due to which it came in contact with medical assistant's wrist later on. This incident did not occurred with other vaccines when caps were opened, and she was advised to contact the manufacturer.  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 29.0
Vaccine: FLU3, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient received Fluzone HD yesterday instead of Fluzone Tri with no reported adverse event; Initial information received on 07-Mar-2025 (with live follow up processed together CSD: 07-Mar-2025) regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 29 years old (unknown gender) patient who received influenza USP trival A-B high dose subvirion vaccine [Fluzone high dose] yesterday instead of influenza USP trival A-B subvirion no preservative vaccine [Fluzone] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Mar-2025, the patient received an unknown dose of suspect influenza USP trival A-B high dose subvirion vaccine, Suspension for injection in pre-filled syringe instead of influenza USP trival A-B subvirion no preservative vaccine, Suspension for injection both with (lot number, strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) with no reported adverse event (wrong product administered) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, The caller would like to know if there are any next steps. The caller was asked for additional AE information and she states, that is all I have and that the patient was given the wrong dose. The caller called again to report that a 5/8 inch needle was used for administration instead of the recommended 1 inch needle.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: FLUZONE NP is given with Varivax on the same day. Both were given in the left arm, with no reported AE; Initial information received on 10-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 13 years old female patient who was administered Quadrivalent Influenza Vaccine [FLUZONE] NP with Varicella zoster vaccine live (Oka/Merck) [Varivax] on the same day and both were given in the left arm, with no reported AE (adverse event).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Varicella zoster vaccine live (Oka/Merck) (Varivax) for influenza immunization.  On 05-Mar-2025, the patient received 0.5mL of suspect Quadrivalent Influenza Vaccine, Suspension for injection (lot UT8468MA, expiry date 30-Jun-2025, strength standard and frequency once) via intramuscular route in the left arm for Influenza (Influenza immunisation) and fluzone np is given with varivax on the same day. both were given in the left arm, with no reported adverse event (Lack of vaccination site rotation) (latency same day).  Action taken was not applicable.
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: administration of an expired pentacel to a patient with no reported ae; Initial information received on 12-Mar-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in 2025, the patient received an expired dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] Suspension for injection, unknown strength expiry date 12-Feb-2025 and lot number not reported via unknown route in unknown administration site for immunization with no reported adverse event(Expired product administered) (Latency same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, Reporter relationship : Healthcare professional, Product used : Used; Age Group: Unknown  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: daptacel to a patient that was already 8 years old with no reported ae instead of adacel; Initial information received on 12-Mar-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 8 years old male patient who received Diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] to a patient that was already 8 years old instead of Diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported ae (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Polio vaccine for Polio immunisation; and Influenza vaccine for Influenza immunisation.  On 17-Feb-2025, the patient received an unknown dose 4 of suspect Diphtheria-15/tetanus/5 AC pertussis vaccine suspension for injection (formulation, strength-unknown) (lot 3CA11C1) via intramuscular route in the right arm for Immunization instead of Diphtheria-2/tetanus/5 AC pertussis vaccine with no reported AE (wrong product administered).  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: administered a second dose of FLUZONE NP to a pregnant patient with no reported adverse event; administered a second dose of FLUZONE NP to a pregnant patient with no reported adverse event; Initial information received on 13-Mar-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 21 years old pregnant female patient who received a second dose of influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone] with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported event occurred at 17 weeks of pregnancy.  The date of last menstrual period was reported as 28-Nov-2024. The estimated due date is 04-Sep-2025. The patient's past vaccination(s) included Influenza vaccine in OCT-2021 and Influenza vaccine on 13-JAN-2025. The patient's past medical history, medical treatment(s) and family history were not provided. The patient had unknown number of previous pregnancy/ies.   On 12-Mar-2025, the pregnant patient received 0.5 ml of dose 3 of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (strength- unknown, expiry date- 30-JUN-2025 and lot UT8514NA) via intramuscular route in the left deltoid for Influenza immunization. with no reported adverse event (exposure during pregnancy) (extra dose administered) (latency- same day).   There was no information regarding relevant prenatal testing after exposure.   Action taken was not applicable.  Additionally, at time of reporting, the pregnancy is still ongoing.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vaccine: UNK
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Wheezing
Clinical narrative: Shortness of breath; Wheezing; Site of injection erythema and pain; Site of injection erythema and pain; This spontaneous case, initially received on 25-Feb-2025, was reported by a health professional and concerns a patient of unknown age/gender.  Administration of company suspect drug: On an unknown date, the patient received Afluria (TIV) for unknown indication, dose, route of administration and anatomical location not reported. Lot number: AW1696A.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Shortness of breath (outcome: Not Reported), Wheezing (outcome: Not Reported), Site of injection erythema and pain (outcome: Not Reported), Site of injection erythema and pain (outcome: Not Reported).  Afluria (TIV) action taken: Not Applicable  Reporter assessment: the reporter did not provide seriousness and causality assessment for the events.; Reporter's Comments: The events are related to Afluria
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: The patient was reported to be infected with Influenza A variant subtype H1N1, although the patient was vaccinated in the year of presentation; This literature report (initial receipt: 04-Mar-2025) concerns an elderly female patient (Patient 3) diagnosed with Influenza A.  The patient was reported to be infected with Influenza A variant subtype H1N1, although the patient was vaccinated with influenza virus vaccine (trade name, manufacturer and lot number not reported - to be requested upon follow up)  in the year of presentation.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. 100% success rate cannot be reasonably assumed in every patient. Furthermore, due to lack of more detailed information (e.g. patients risk factors and medical history, dosing details and brand of vaccine) causality cannot be excluded.
Vaccine: VARCEL, VARCEL
Symptoms: Product storage error
Clinical narrative: incorrect product storage; This spontaneous report was received from nurse and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 10-Feb-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), (lot #Y015108, expiration date: 06-Sep-2026) 0.5 mL (0.5ML, route of administration was not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). The vaccine was administered after temperature excursion.