chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administered after temperature excursion; This spontaneous report has been received from other health professional (nurse) referring to a 4-year-old female patient. The patients' concurrent conditions, medical history and concomitant medications were not provided.    On 18-APR-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) subcutaneous injection, administered subcutaneously, lot number X021130 that was verified to be a valid lot number (expiration date reported as 12-FEB-2025) as prophylaxis (strengths, specific dosage, vaccination scheme, and anatomical site of application were not provided) (product storage error). Review of the data logger printout showed that the dose was exposed to a temperature excursion (TE) of -9.0C, for a time range between of 2 hours 46 minutes 0 seconds. The TE was not noted by employee checking thermometer reading (occurred after hours on weekend) due to power outage for a couple of hours. No previous excursion was reported. No additional adverse events.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administered after temperature excursion; This spontaneous report has been received from other health professional (nurse) referring to a 4-year-old male patient. The patients' concurrent conditions, medical history and concomitant medications were not provided.    On 18-APR-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) subcutaneous injection, administered subcutaneously, lot number X021130 that was verified to be a valid lot number (expiration date reported as 12-FEB-2025) as prophylaxis (strengths, specific dosage, vaccination scheme, and anatomical site of application were not provided) (product storage error). Review of the data logger printout showed that the dose was exposed to a temperature excursion (TE) of -9.0C, for a time range between of 2 hours 46 minutes 0 seconds. The TE was not noted by employee checking thermometer reading (occurred after hours on weekend) due to power outage for a couple of hours. No previous excursion was reported. No additional adverse events.
Age: 0.58
Sex: M
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administered after temperature excursion; This spontaneous report has been received from other health professional (nurse) referring to a 7-month-old male patient. The patients' concurrent conditions, medical history and concomitant medications were not provided.    On 16-APR-2024, the patient was vaccinated with an improperly stored dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection, administered intramuscular, lot number X019438 that was verified to be a valid lot number (expiration date reported as 07-NOV-2025) as prophylaxis (strengths, specific dosage, vaccination scheme, and anatomical site of application were not provided) (product storage error). Review of the data logger printout showed that the dose was exposed to a temperature excursion (TE) of +11.2C, for a time range between of 2 hours 7 minutes 0 seconds. The TE was not noted by employee checking thermometer reading (occurred after hours on weekend) due to power outage for a couple of hours. No previous excursion was reported. No additional adverse events.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administered after temperature excursion; This spontaneous report has been received from other health professional (nurse) referring to a12-month-old male patient. The patients' concurrent conditions, medical history and concomitant medications were not provided.    On 16-APR-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, administered subcutaneously, lot number X024648 that was verified to be a valid lot number (expiration date reported as 20-AUG-2025, but upon internal validation established as 11-OCT-2025) as prophylaxis (strengths, specific dosage, vaccination scheme, and anatomical site of application were not provided) (product storage error). Review of the data logger printout showed that the dose was exposed to a temperature excursion (TE) of -9.0C, for a time range between of 2 hours 46 minutes 0 seconds. The TE was not noted by employee checking thermometer reading (occurred after hours on weekend) due to power outage for a couple of hours. No previous excursion was reported. No additional adverse events.
Age: 0.33
Sex: F
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administered after temperature excursion; This spontaneous report has been received from other health professional (nurse) referring to a 4-month-old female patient. The patients' concurrent conditions, medical history and concomitant medications were not provided.    On 19-APR-2024, the patient was vaccinated with an improperly stored dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection, administered intramuscular, lot number X019438 that was verified to be a valid lot number (expiration date reported as 07-NOV-2025) as prophylaxis (strengths, specific dosage, vaccination scheme, and anatomical site of application were not provided) (product storage error). Review of the data logger printout showed that the dose was exposed to a temperature excursion (TE) of +11.2C, for a time range between of 2 hours 7 minutes 0 seconds. The TE was not noted by employee checking thermometer reading (occurred after hours on weekend) due to power outage for a couple of hours. No previous excursion was reported. No additional adverse events.
Age: 0.25
Sex: M
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administered after temperature excursion; This spontaneous report has been received from other health professional (nurse) referring to a 12-week-old male patient. The patients' concurrent conditions, medical history and concomitant medications were not provided.    On 19-APR-2024, the patient was vaccinated with an improperly stored dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection, administered intramuscular, lot number X019438 that was verified to be a valid lot number (expiration date reported as 07-NOV-2025) as prophylaxis (strengths, specific dosage, vaccination scheme, and anatomical site of application were not provided) (product storage error). Review of the data logger printout showed that the dose was exposed to a temperature excursion (TE) of +11.2C, for a time range between of 2 hours 7 minutes 0 seconds. The TE was not noted by employee checking thermometer reading (occurred after hours on weekend) due to power outage for a couple of hours. No previous excursion was reported. No additional adverse events.
Age: 0.5
Sex: M
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administered after temperature excursion; This spontaneous report has been received from other health professional (nurse) referring to a 06-month-old male patient. The patients' concurrent conditions, medical history and concomitant medications were not provided.    On 24-APR-2024, the patient was vaccinated with an improperly stored dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection, administered intramuscular, lot number X019438 that was verified to be a valid lot number (expiration date reported as 07-NOV-2025) as prophylaxis (strengths, specific dosage, vaccination scheme, and anatomical site of application were not provided) (product storage error). Review of the data logger printout showed that the dose was exposed to a temperature excursion (TE) of +11.2C, for a time range between of 2 hours 7 minutes 0 seconds. The TE was not noted by employee checking thermometer reading (occurred after hours on weekend) due to power outage for a couple of hours. No previous excursion was reported. No additional adverse events.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: dealing with the shingles/suspected vaccination failure; dealing with the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In FEB-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: dealing with the shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: dealing with the shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAY-2024 The case was received via interactive digital media.   The reporter stated that his brother has been dealing with the shingles. Since last of February, he had it on the right side of his face, neck and chest and started to get over it now.  The reporter asked people to do favor and get the Shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The case had been linked to US2024AMR060434, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2024AMR060434:Same reporter different patirnt
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Product administration error
Clinical narrative: Cellulitis; improper administration; This non-serious case was reported by a nurse via sales rep and described the occurrence of cellulitis in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-MAY-2024, the patient received Shingrix (right arm). On 03-MAY-2024, an unknown time after receiving Shingrix, the patient experienced product administration error (Verbatim: improper administration). On 04-MAY-2024, the patient experienced cellulitis (Verbatim: Cellulitis). The outcome of the cellulitis was not resolved and the outcome of the product administration error was unknown.   The reporter considered the cellulitis to be related to Shingrix.     The company considered the cellulitis to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-MAY-2024 The dose of the vaccine was reported as a subsequent dose. The health care professional believed it was due to improper administration.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This non-serious case was reported by a consumer via sales rep and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number L32MF) for prophylaxis.   On 12-MAY-2023, the patient received the 1st dose of Shingrix (left deltoid). On 15-MAY-2023, 3 days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). On 16-JUN-2023, the outcome of the shingles was resolved (duration 1 month 1 day).   The reporter considered the shingles to be related to Shingrix.     The company considered the shingles to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR061387   Additional Information: GSK receipt date: 14-MAY-2024 The patient had with shingles 3 days after 1st vaccine. The case is link with US2024AMR061387, by same reporter.; Sender's Comments:  US-GSK-US2024AMR061387:
Sex: U
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: is not reconstituting Hiberix according to the package insert instructions; This non-serious case was reported by a nurse via sales rep and described the occurrence of wrong technique in product usage process in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced wrong technique in product usage process (Verbatim: is not reconstituting Hiberix according to the package insert instructions). The outcome of the wrong technique in product usage process 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: 06-MAY-2024 The reporter reported that a Hiberix vaccine was not reconstituting according to the package insert instructions. They are using a double syringe method; the diluent prefilled syringe was discarded after diluent was added to the vial. Then they use a separate labeled syringe to pull up the vaccine and then administer which led to wrong technique in product usage process. The reporter denied permission for consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Hypersomnia, Pain
Clinical narrative: sleeping a lot; Body Aches; Feeling horrible; This non-serious case was reported by a other health professional via sales rep and described the occurrence of sleep excessive in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of hypersomnia (1st dose received on 16 February 2024).   On 08-MAY-2024, the patient received the 2nd dose of Shingrix. In MAY-2024, an unknown time after receiving Shingrix, the patient experienced sleep excessive (Verbatim: sleeping a lot), general body pain (Verbatim: Body Aches) and feels awful (Verbatim: Feeling horrible). Rechallenge with Shingrix was positive. The outcome of the sleep excessive, general body pain and feels awful were not resolved.   It was unknown if the reporter considered the sleep excessive, general body pain and feels awful to be related to Shingrix.     It was unknown if the company considered the sleep excessive, general body pain and feels awful to be related to Shingrix.   Additional Information: GSK receipt date: 09-MAY-2024 A GSK Field Representative reports that a Certified Medical Assistant (CMA) stated yesterday, in her office, and also in a follow up conversation with the GlaxoSmithKline field Representative,that a female patient received both her first and second dose of Shingrix in the Doctor's office and experienced feeling horrible body aches and sleeping after receiving both doses. The CMA stated that the patient was sleeping a lot after the first dose and was sleeping off and on after having received the second dose 2 days before reporting on 8th MAY 2024. The patient was still experiencing feeling horrible, body aches and sleeping off and on day of reporting, after having received the second dose. The GlaxoSmithKline Field Representative did not have the patient's date of birth, nor a lot/Expiry, route of administration, or location of administration to provide. The GlaxoSmithKline Field Representative reported that the patient was not on a lot of other medications (unknown product information). For tolerance of 1st dose refer case US2024059770.; Sender's Comments:  US-GSK-US2024059770:SECOUND DOSE/ SAME PATIENT
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Product complaint
Clinical narrative: Product Complaint; had injection site pain; have had extreme injection site redness; had injection site swelling; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis. This case was associated with a product complaint.   On 03-MAY-2024, the patient received Kinrix. In MAY-2024, an unknown time after receiving Kinrix, the patient experienced injection site pain (Verbatim: had injection site pain), injection site erythema (Verbatim: have had extreme injection site redness) and injection site swelling (Verbatim: had injection site swelling). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the injection site pain, injection site erythema, injection site swelling and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Kinrix and Kinrix Pre-Filled Syringe Device.   It was unknown if the company considered the injection site pain, injection site erythema and injection site swelling to be related to Kinrix and Kinrix Pre-Filled Syringe Device.   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: 06-MAY-2024 The nurse had concerns about Kinrix lot number 34MF9. The nurse had noticed patients receiving this Kinrix vaccine had extreme injection site redness, swelling, and pain. The vaccine was administered to a patient who experienced these symptoms. The reporter did not know injection site location, or duration of symptoms. The vaccine administration facility was the same as primary reporter. This was 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GSK-US2024057404:Same reporter/Diffrent patient US-GSK-US2024057402:Same reporter/Diffrent patient US-GSK-US2024057400:Same reporter/Diffrent patient
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: administered a patient with powder reconstituted with saline solution instead of the adjuvant; administered a patient with powder reconstituted with saline solution instead of the 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 29Y9K, expiry date 25-JAN-2026) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: administered a patient with powder reconstituted with saline solution instead of the adjuvant) and inappropriate dose of vaccine administered (Verbatim: administered a patient with powder reconstituted with saline solution instead of the adjuvant). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-MAY-2024  A pharmacist reported that they accidentally administered a patient with powder reconstituted with saline solution instead of the adjuvant component which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not had patient's demographics or date of vaccination. This case was linked with case US2024057418, reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2024057418:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: the powder portion of Shingrix mixed with saline solution; the powder portion of Shingrix mixed with saline solution; 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 29Y9K, expiry date 25-JAN-2026) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: the powder portion of Shingrix mixed with saline solution) and inappropriate dose of vaccine administered (Verbatim: the powder portion of Shingrix mixed with saline solution). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-MAY-2024  The pharmacist mentioned they accidentally administered a patient with powder reconstituted with saline solution instead of the adjuvant component, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024057405:Same reporter/ 2nd patient US-GSK-US2024057420:Same reporter US-GSK-US2024057411:Same reporter
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: administration of a pediatric Engerix-B vaccine to a 40 year-old patient; administration of a pediatric Engerix-B vaccine to a 40 year-old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 40-year-old female patient who received HBV (Engerix B pediatric) (batch number 9K74F, expiry date 27-OCT-2025) for prophylaxis.   On 06-MAY-2024, the patient received the 1st dose of Engerix B pediatric. On 06-MAY-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: administration of a pediatric Engerix-B vaccine to a 40 year-old patient) and adult use of a child product (Verbatim: administration of a pediatric Engerix-B vaccine to a 40 year-old patient). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 06-MAY-2024 The HCP (health care professional) reported that the pediatric dose of Engerix B vaccine administered to an adult patient, which led to an underdose and adult use of a child product. The health care professional asked for recommendation on this situation. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error, Single component of a two-component product administered
Clinical narrative: Only adjuvant administered; Only adjuvant administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 29Y9K, expiry date 25-JAN-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: Only adjuvant administered) and inappropriate dose of vaccine administered (Verbatim: Only adjuvant administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-MAY-2024 The pharmacist mentioned only adjuvant administered (diluent portion of Shingrix) to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024057420:same reporter diffrent patient. US-GSK-US2024057418:Same reporter US-GSK-US2024057405:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue, Single component of a two-component product administered
Clinical narrative: Only adjuvant administered; Only adjuvant administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 29Y9K, expiry date 25-JAN-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: Only adjuvant administered) and inappropriate dose of vaccine administered (Verbatim: Only adjuvant administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-MAY-2024 The pharmacist mentioned only adjuvant administered (diluent portion of Shingrix) to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024057411:same reporter diffrent patient. US-GSK-US2024057418:Same reporter US-GSK-US2024057405:Same reporter
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate Age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix (unknown thigh). On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate Age). The outcome of the inappropriate age at vaccine administration 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: 06-MAY-2024 The reporter was other health professional (a Practice Supervisor).   The other health professional  reported that a 2 month old patient received Kinrix which led to inappropriate age at vaccine administration. The other health professional reported, the patient received vaccine in an unspecified leg / thigh.   The other health professional does not have initials, date of birth, lot number or date of vaccination.   The reporter consented to follow up.
Age: 1.5
Sex: U
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix was the patient's 4th dose of DTaP and IPV; 18 month old patient received Kinrix instead of DTaP; received Kinrix instead of DTaP; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 18-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 01-APR-2024, the patient received Kinrix. On 01-APR-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Kinrix was the patient's 4th dose of DTaP and IPV), inappropriate age at vaccine administration (Verbatim: 18 month old patient received Kinrix instead of DTaP) and wrong vaccine administered (Verbatim: received Kinrix instead of DTaP). The outcome of the inappropriate schedule of vaccine administered, inappropriate age at vaccine administration and wrong 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: 06-MAY-2024 The reporter reported that 18 month old patient received Kinrix instead of DTaP, which led to wrong vaccine administered and inappropriate age at vaccine administration. Kinrix was the patient's 4th dose of DTaP and IPV which led to inappropriate schedule of vaccine administered. The reporter said that no further patient details were available, no product information was available.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose given; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 32-year-old male patient who received HBV (Engerix B) for prophylaxis.   On 03-MAY-2024, the patient received the 1st dose of Engerix B. On 03-MAY-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired dose given). 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: 06-MAY-2024 The nurse called in and requested data about the administration of an expired dose of Engerix-B to a patient which led to expired vaccine used.  They gave information about vaccine, patient and event. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection
Clinical narrative: herpes outbreak; This non-serious case was reported by a consumer via call center representative and described the occurrence of herpes virus infection in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-MAY-2024, the patient received Shingrix. In MAY-2024, an unknown time after receiving Shingrix, the patient experienced herpes virus infection (Verbatim: herpes outbreak). The outcome of the herpes virus infection was unknown.   It was unknown if the reporter considered the herpes virus infection to be related to Shingrix.     It was unknown if the company considered the herpes virus infection to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-MAY-2024 The reporter was the patient. The reported that she received the dose of shingrix vaccine 2 days ago, The reported that she had a herpes outbreak after received the dose of shingrix vaccine. The reporter did not consent to follow-up.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: she had administered an expired vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received DTPa (Infanrix) (batch number 9HP9Z, expiry date 21-APR-2024) for prophylaxis.   On 06-MAY-2024, the patient received Infanrix. On 06-MAY-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: she had administered an expired 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: 06-MAY-2024 A nurse reported that she had administered an expired vaccine. Such administration had been earlier that day, and a patient received an expired dose of Infanrix which led to expired vaccine used.  The vaccine administration facility was the same as primary reporter. This case was linked with case US2024057452.; Sender's Comments:  US-GSK-US2024057452:same reporter different patient
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received DTPa (Infanrix) (batch number 9HP9Z, expiry date 21-APR-2024) for prophylaxis.   On 06-MAY-2024, the patient received Infanrix. On 06-MAY-2024, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: patient received an expired dose of Infanrix). 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: 06-MAY-2024 The nurse called and informed that she had administered an expired dose of Infanrix vaccine on the day of reporting, which led to expired vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. This case is linked with US2024057453, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR058617:Same reporter different patient
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient got her shingrix vaccines 9 months apart. Is this ok or does she need to do the series again?; 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 Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on  an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient got her shingrix vaccines 9 months apart. Is this ok or does she need to do the series again?). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 9th May 2024 The reporter noticed that a patient got her shingrix vaccines 9 months apart, which led to drug dose administration interval too long.  The reporter asked if this was ok or if she need to do the series again?  The reporter did not give consent for follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; Itching; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (developed first case of shingles on 08-MAY-2018 on his left upper chest and left side of his neck).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix (intramuscular, unknown arm) .5 ml. 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), shingles (Verbatim: shingles) and pruritus (Verbatim: Itching). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the pruritus was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles and pruritus to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 14-MAY-2024 Caller was the patient and reported that he received both doses of Shingrix at the end of 2020 or the beginning of 2021. The patient reported that he had signs of shingles when he received the Shingrix dose 1 and dose 2. Caller reported that he developed his first case of shingles on May 8, 2018 on his left upper chest and left side of his neck. The shingles cleared up for a week or two and then comes right back in the same spot. The patient still received both doses of the Shingrix vaccine during this time when the shingles cleared up. The patient reported that he had shingles for 6 years now as of May 8, 2024. The healthcare professional (HCP) just told him to use HC cream for itching. The reporter consented to follow up. Caller gave permission to contact his HCP in this case. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine brand=Pfizer / BioNTech and vaccine brand other=Moderna; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose number unknown (booster), single (Lot number: 62524) at the age of 62 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09May2022 as dose number unknown, single (Lot number: 049L21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "13 years post stage 4 breast cancer" (unspecified if ongoing). Concomitant medication(s) included: LETROZOLE, start date: 01Apr2018. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Oct2022, outcome "unknown", described as "vaccine brand=Pfizer / BioNTech and vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 from 04May2024 till 08May2024.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 as dose 1, single (Lot number: HF9275) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: he got covid; he got covid; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): LRN5181239 (Genentech, Inc.).  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (ongoing). Concomitant medication(s) included: OCREVUS. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "he got covid". Clinical course: Patient's concurrent condition included: curled over like a "C". The patient reported that he got his first 2 covid vaccines and then when he got his first booster on 22Dec2022. Then a year later in Jul2023, he got covid. The patient reported his last infusion prior to getting covid was in Mar2023 and his first one after covid was in Sep2023 and he did not have his immune response tested. All vaccines he got were from Pfizer.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400063337 same patient/product, different dose/event;
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraplegia
Clinical narrative: he got covid; he got covid; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): LRN5181239 (Genentech, Inc.).  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (ongoing). Concomitant medication(s) included: OCREVUS. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "he got covid". Clinical course: Patient's concurrent condition included: curled over like a "C". The patient reported that he got his first 2 covid vaccines and then when he got his first booster on 22Dec2022. Then a year later in Jul2023, he got covid. The patient reported his last infusion prior to getting covid was in Mar2023 and his first one after covid was in Sep2023 and he did not have his immune response tested. All vaccines he got were from Pfizer.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400063337 same patient/product, different dose/event;
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: completely paralyzed below the waist that lasted 4-5 hours; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): LRN5181239.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (ongoing), notes: concurrent condition: curled over like a "C". Concomitant medication(s) included: OCREVUS. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: PARAPLEGIA (hospitalization, medically significant) with onset 22Dec2022, outcome "recovered" (Dec2022), described as "completely paralyzed below the waist that lasted 4-5 hours". The patient was hospitalized for paraplegia (hospitalization duration: 3 day(s)). Clinical course: On 22Dec2022, it was reported that patient experienced: The patient reported that he got his first 2 covid vaccines and then when he got his first booster on 22Dec2022, he became completely paralyzed below the waist that lasted 4-5 hours. Then a year later in Jul2023, he got covid and again became paralyzed below the waist and was hospitalized for 3 days. It had resolved within 24-36 hours, and he was treated with steroid course similar to what the give people with relapsing remitting MS when they have a relapse. The patient reported his last infusion prior to getting covid was in Mar2023 and his first one after covid was in Sep2023 and he did not have his immune response tested. All vaccines he got were from Pfizer.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400108115 same patient/drug, different dose/event (LOE);
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraplegia
Clinical narrative: completely paralyzed below the waist that lasted 4-5 hours; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): LRN5181239.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (ongoing), notes: concurrent condition: curled over like a "C". Concomitant medication(s) included: OCREVUS. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: PARAPLEGIA (hospitalization, medically significant) with onset 22Dec2022, outcome "recovered" (Dec2022), described as "completely paralyzed below the waist that lasted 4-5 hours". The patient was hospitalized for paraplegia (hospitalization duration: 3 day(s)). Clinical course: On 22Dec2022, it was reported that patient experienced: The patient reported that he got his first 2 covid vaccines and then when he got his first booster on 22Dec2022, he became completely paralyzed below the waist that lasted 4-5 hours. Then a year later in Jul2023, he got covid and again became paralyzed below the waist and was hospitalized for 3 days. It had resolved within 24-36 hours, and he was treated with steroid course similar to what the give people with relapsing remitting MS when they have a relapse. The patient reported his last infusion prior to getting covid was in Mar2023 and his first one after covid was in Sep2023 and he did not have his immune response tested. All vaccines he got were from Pfizer.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400108115 same patient/drug, different dose/event (LOE);