chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Barium double contrast, Enema administration, Intussusception, Procedure aborted, Ultrasound abdomen abnormal
Clinical narrative: Patient developed recurrent bilious emesis on 4/11/24 and was referred to the emergency room.  Family took patient to Medical Center where an ultrasound diagnosed an ileocolic intussusception.   Pediatric surgeon was not available at this facility, so the patient was transferred to the Hospital where enema reduction was attempted with partial success.  Patient was admitted for observation and plan for repeat imaging the next day.IMAGING XR Barium Enema w/ Air Contrast  Final Result  Incomplete intussusception reduction. Intussusceptus was pushed  from splenic flexure to ileocecal valve, but could not be completely  reduced, despite high pressure on the insufflator valve. Small amount  of air seen leaking into the small bowel. Procedure stopped to  prevent colon perforation. Recommend repeat ultrasound tomorrow for  reassessment.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Patient developed recurrent bilious emesis on 4/11/24 and was referred to the emergency room.  Family took patient to Medical Center where an ultrasound diagnosed an ileocolic intussusception.   Pediatric surgeon was not available at this facility, so the patient was transferred to the Hospital where enema reduction was attempted with partial success.  Patient was admitted for observation and plan for repeat imaging the next day.IMAGING XR Barium Enema w/ Air Contrast  Final Result  Incomplete intussusception reduction. Intussusceptus was pushed  from splenic flexure to ileocecal valve, but could not be completely  reduced, despite high pressure on the insufflator valve. Small amount  of air seen leaking into the small bowel. Procedure stopped to  prevent colon perforation. Recommend repeat ultrasound tomorrow for  reassessment.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Breast pain, Breast swelling, Herpes zoster
Clinical narrative: doctor said I had herpes zoster. I got a a lot of blister on my breast area and its swollen and very painful.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: cellulitis
Age: 89.0
Sex: F
Vaccine: COVID19-2
Symptoms: Brain fog, Lip erythema, Lip swelling, Syncope
Clinical narrative: PT described that about 20 minutes after she received the latest Covid vaccine (04/08/24) she felt off (mental cloudiness), had some lip redness/swelling and had an episode of syncope when she arrive home which resulted in her falling on the floor.  She was able to call 911 and received medical attention within minutes.  Since then, she reports she has been recovering little by little each day.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: PT REPORTED SWOLLEN, PAINFUL, RED ARM NEXT DAY AFTER INJECTION - WENT TO MD OFFICE AND THEY PRESCRIBED DICLOFENAC GEL
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: RIGHT THIGH SWOLLEN AND RED
Age: 58.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 58 years old. Vaccine is for 60 years and older
Age: 56.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 56 years old. Vaccine is recommended for 60 years and over
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site infection, Injection site pain
Clinical narrative: - Initially paged on 4/10/24 for reports of small focal swelling (approx size of a quater). No evidence of anaphylaxis at the time (denies respiratory changes, hives, facial swelling, GI symptoms). Advised to monitor for additional symptoms such as worsening swelling or allergic reaction.  - Mother reports that after phone call patient continue to have left thigh swelling that extended to nearly entirety of left thigh. Swelling was reportedly erythematous, hard/ indurated, and tender to touch. - Went to the ER on the evening of 4/10/24 for evaluation. Evaluating physician was reportedly unsure if the reaction was a localized allergic reaction vs. infection. Advised patient to take Benadryl Q12h and Rx'd cephalexin 6.5mL Q12h x5days (day 1: 4/11/24) - Mother reports interval improvement in swelling since starting medication
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site swelling
Clinical narrative: - Initially paged on 4/10/24 for reports of small focal swelling (approx size of a quater). No evidence of anaphylaxis at the time (denies respiratory changes, hives, facial swelling, GI symptoms). Advised to monitor for additional symptoms such as worsening swelling or allergic reaction.  - Mother reports that after phone call patient continue to have left thigh swelling that extended to nearly entirety of left thigh. Swelling was reportedly erythematous, hard/ indurated, and tender to touch. - Went to the ER on the evening of 4/10/24 for evaluation. Evaluating physician was reportedly unsure if the reaction was a localized allergic reaction vs. infection. Advised patient to take Benadryl Q12h and Rx'd cephalexin 6.5mL Q12h x5days (day 1: 4/11/24) - Mother reports interval improvement in swelling since starting medication
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Death
Clinical narrative: Death
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Erythema, Injection site pain, Pain, Pain in extremity
Clinical narrative: ARM SORENESS, HOT TO TOUCH, REDNESS, PAIN IN ARM AFTER REDNESS HAS GONE. PATIENT SAYS PAIN RADIATES FROM SITE OF INJECTION TO HER BACK.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: ARM SORENESS, HOT TO TOUCH, REDNESS, PAIN IN ARM AFTER REDNESS HAS GONE. PATIENT SAYS PAIN RADIATES FROM SITE OF INJECTION TO HER BACK.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient came in stating that her arm still hurts at the injection site, she pointed to the area affected, and it is well below the shoulder capsule.  She has retained normal movement, but has had a persistent dull pain at the original injection site.  I called GSK and they said that 3.3% of patients do experience pain at the injection site longer than 7 days, and it is documented to be a potential risk.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inflammation, Injection site inflammation, Injection site pain, Mobility decreased, Pain
Clinical narrative: Inflammation and pain at the injection site continued to full shoulder, upper arm, and underarm inflammation and intense paid and now frozen shoulder. The frozen shoulder developed in February and has gotten worse. I have decreased range of motion (cannot raise the arm much above my head, cannot reach behind me, cannot push myself with the arm, cannot lay on the arm), periods of worsening pain, wake throughout the night due to the shoulder. I have seen my primary care physician several times, done 5 sessions of physical therapy so far, and I have seen an orthopedist. I received a cortisone shot in the left shoulder 4/12/2024.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Periarthritis, Sleep disorder, X-ray normal
Clinical narrative: Inflammation and pain at the injection site continued to full shoulder, upper arm, and underarm inflammation and intense paid and now frozen shoulder. The frozen shoulder developed in February and has gotten worse. I have decreased range of motion (cannot raise the arm much above my head, cannot reach behind me, cannot push myself with the arm, cannot lay on the arm), periods of worsening pain, wake throughout the night due to the shoulder. I have seen my primary care physician several times, done 5 sessions of physical therapy so far, and I have seen an orthopedist. I received a cortisone shot in the left shoulder 4/12/2024.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; Temperature 31F (one cycle below 32F); Time frame 48 Hours 0 Minutes 0 Seconds; This spontaneous report was received from "HBP" and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-MAR-2024, the patient was vaccinated with a single dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, lot #X018278, expiration date reported as and upon internal review confirmed to be: 24-NOV-2024, administered (exact dose, route of administration and vaccination site were not provided) for prophylaxis. A temperature excursion was reported as follows: temperature at 31 degrees Fahrenheit (F) (one cycle below 32F) and time frame reported as 48 Hours 0 Minutes 0 Seconds (product storage error). No previous temperature excursion was noted. No additional adverse event (AE) information was noted (no adverse event). No product quality complaint (PQC) was noted.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There have been no adverse reports from the patient's family. No additional AE; Medical assistant calling to report an AE for MMRII and PROQUAD. She states a 12 month old patient was accidentally given a dose of MMRII and PROQUAD at the same visit. There have been no adverse reports from the patient's family. No additional AE,; This spontaneous report has been received from a medical assistant, regarding a 12-months-old patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 05-APR-2024, the patient was accidentally vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection (lot number: X000178, which was determined to be valid, with an expiration date on 02-JAN-2025. Therapy type: rHA) and a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (lot number: X011982, which was determined to be valid, with an expiration date on 22-OCT-2024. Therapy type: rHA), both at a dose of 0.5 milliliters as prophylaxis (strength, scheme, route and anatomical location of administration were not reported) (Accidental overdose).  There have been no adverse reports from the patient's family.  No additional information was reported.
Sex: U
Vaccine: HEP
Symptoms: Malaise, Nausea
Clinical narrative: Sick to Her Stomach; Received 1st Dose, and Had Malaise and Was Sick To Stomach; Initial report received on 18-Jan-2024.    A nurse in the reported that a 26-year-old female patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and had malaise and felt sick to her stomach.  Medical history, allergies, and concomitant medications at the time of vaccination were not reported.   On an unreported date, the patient received the first dose of HEPLISAV-B (Lot number, expiration date, NDC number, route, and injection site not reported). The patient went home and had malaise and was sick to her stomach. The patient refused the second dose of HEPLISAV-B.   No additional information was available.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had all vaccines and still got it/was vaccinated 2x and still go shingles/Suspected Vaccination failure; still go 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had all vaccines and still got it/was vaccinated 2x and still go shingles/Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still go shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 06-APR-2024 and 08-APR-2024 This case was reported by a patient's wife via interactive digital media. She reported that her husband was vaccinated two times (2x) with all the Shingrix vaccine and still got shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got it anyway; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got it anyway). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   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: 05-APR-2024 This case was reported by a patient via interactive digital media. The patient had the shots and got it anyway. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: RVX
Symptoms: Somnolence
Clinical narrative: Sleepiness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sleepiness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sleepiness (Verbatim: Sleepiness). The outcome of the sleepiness was not reported.   It was unknown if the reporter considered the sleepiness to be related to RSV vaccine.     It was unknown if the company considered the sleepiness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 30-MAR-2024. This case was reported by a patient via interactive digital media. Patient had no side effects except a little sleepiness, not even a sore arm and patient got the flu shot at the same time or was it the covid booster patient forgotten now. The follow-up could not be possible as no contact details were available.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 34 month old child received a dose of Kinrix; child received two doses of diphtheria, tetanus, and acellular pertussis and polio before the Kinrix 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 34-month-old male patient who received DTPa-IPV (Kinrix) (batch number 34MS9, expiry date 13-FEB-2026) for prophylaxis.   On 21-MAR-2024, the patient received Kinrix. On 21-MAR-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 34 month old child received a dose of Kinrix) and inappropriate schedule of vaccine administered (Verbatim: child received two doses of diphtheria, tetanus, and acellular pertussis and polio before the Kinrix dose). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-APR-2024 The medical assistant called to know if there were information parents should have after having their 34-month-old child a dose of Kinrix. The child (patient) received two doses of diphtheria, tetanus, and acellular pertussis and polio before the Kinrix dose at earlier age, which led to an inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The vaccine administration facility was the same as primary reporter.  The reporter did not consent to follow-up.
Sex: M
Vaccine: MENB
Symptoms: Intercepted product prescribing error
Clinical narrative: Pharmacist states that a prescription was received for a 72 y/o asplenic male patient for Bexsero; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Concurrent medical conditions included asplenia.   On an unknown date, the patient did not receive Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced intercepted drug prescribing error (Verbatim: Pharmacist states that a prescription was received for a 72 y/o asplenic male patient for Bexsero). The outcome of the intercepted drug prescribing error 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: 01-APR-2024 The pharmacist requested data on use of Bexsero in asplenic patients above the age of 25 year old.  The pharmacist stated that a prescription was received for a 72 year old asplenic patient for Bexsero, which led to intercepted drug prescribing error.
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: felt a burning sensation when Shingrix was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site burning in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On 01-APR-2024, the patient received Shingrix. On 01-APR-2024, immediately after receiving Shingrix, the patient experienced injection site burning (Verbatim: felt a burning sensation when Shingrix was administered). The outcome of the injection site burning was unknown.   It was unknown if the reporter considered the injection site burning to be related to Shingrix.     It was unknown if the company considered the injection site burning to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-APR-2024. The pharmacist had patients said that they felt burning at the site of injecting Shingrix, the reporter asked was that preventable. The reporter did not had patient name or information. The reporter administered the dose yesterday (day before reporting) and they said that they felt a burning sensation when Shingrix was administered. The reporter heard before and he/she was not sure if the temperature at the time of injection or other causes.  The reporter did not had that information, he/she was just looking for possible ideas that help with dissolving the powder or the temperature of the mixed vaccine that could help with preventing the burning sensation. The reporter unable to provide any patient or vaccine details.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: pediatric patient that received an adult vaccine; pediatric patient that received an adult vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 5-year-old female patient who received HAV (Havrix adult) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis.   On 02-APR-2024, the patient received Havrix adult. On 02-APR-2024, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: pediatric patient that received an adult vaccine) and adult product administered to child (Verbatim: pediatric patient that received an adult vaccine). The outcome of the overdose and adult product administered to child 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: 02-APR-2024 The medical assistant informed about Havrix that they had the pediatric patient that received an adult Havrix vaccine, which led to overdose and adult product administered to child.  The vaccine administration facility was the same as primary reporter.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Melanocytic naevus, Rash, Rash pruritic, Sleep disorder
Clinical narrative: Painful rash predominantly on the upper left side of his body; Itching rash on upper left side of body; Painful welts predominantly on the upper left side of his body/ welts are itchy and painful; interfering with his sleep; Discomfort; several moles on body and after receiving the vaccine a mole on his chest and another mole (unspecified area) turned completely white; This non-serious case was reported by a consumer via call center representative and described the occurrence of painful rash in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number N2954) for prophylaxis.   On 20-MAR-2024, the patient received Shingrix (left deltoid). On 22-MAR-2024, 2 days after receiving Shingrix, the patient experienced painful rash (Verbatim: Painful rash predominantly on the upper left side of his body), itchy rash (Verbatim: Itching rash on upper left side of body), welts (Verbatim: Painful welts predominantly on the upper left side of his body/ welts are itchy and painful), sleep disturbance (Verbatim: interfering with his sleep), discomfort (Verbatim: Discomfort) and mole of skin (Verbatim: several moles on body and after receiving the vaccine a mole on his chest and another mole (unspecified area) turned completely white). The patient was treated with diphenhydramine hydrochloride (Benadryl). The outcome of the painful rash, itchy rash, welts, sleep disturbance, discomfort and mole of skin were unknown.   It was unknown if the reporter considered the painful rash, itchy rash, welts, sleep disturbance, discomfort and mole of skin to be related to Shingrix.     It was unknown if the company considered the painful rash, itchy rash, welts, sleep disturbance, discomfort and mole of skin to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-APR-2024 The patient self reported this case.  The patient called to report adverse event after receiving the Shingrix vaccine. Two or three days after receiving the vaccine the patient began experiencing painful welts or rash predominantly on the upper left side of his body.  The patient stated that the welts were itchy and painful and were interfering with his sleep due to discomfort.  The patient also stated that he had several moles on his body and after receiving the vaccine one mole on his chest and another in an unspecified area turned completely white.  The patient stated he had been taking Benadryl to help with the itching and this had helped his sleep some.  The patient also stated he has an appointment with his dermatologist soon and will discuss the moles at this appointment. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Painful rash predominantly on the upper left side of his body; Itching rash on upper left side of body; Painful welts predominantly on the upper left side of his body/ welts are itchy and painful; interfering with his sleep; Discomfort; several moles on body and after receiving the vaccine a mole on his chest and another mole (unspecified area) turned completely white; This non-serious case was reported by a consumer via call center representative and described the occurrence of painful rash in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number N2954) for prophylaxis.   On 20-MAR-2024, the patient received Shingrix (left deltoid). On 22-MAR-2024, 2 days after receiving Shingrix, the patient experienced painful rash (Verbatim: Painful rash predominantly on the upper left side of his body), itchy rash (Verbatim: Itching rash on upper left side of body), welts (Verbatim: Painful welts predominantly on the upper left side of his body/ welts are itchy and painful), sleep disturbance (Verbatim: interfering with his sleep), discomfort (Verbatim: Discomfort) and mole of skin (Verbatim: several moles on body and after receiving the vaccine a mole on his chest and another mole (unspecified area) turned completely white). The patient was treated with diphenhydramine hydrochloride (Benadryl). The outcome of the painful rash, itchy rash, welts, sleep disturbance, discomfort and mole of skin were unknown.   It was unknown if the reporter considered the painful rash, itchy rash, welts, sleep disturbance, discomfort and mole of skin to be related to Shingrix.     It was unknown if the company considered the painful rash, itchy rash, welts, sleep disturbance, discomfort and mole of skin to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-APR-2024 The patient self reported this case.  The patient called to report adverse event after receiving the Shingrix vaccine. Two or three days after receiving the vaccine the patient began experiencing painful welts or rash predominantly on the upper left side of his body.  The patient stated that the welts were itchy and painful and were interfering with his sleep due to discomfort.  The patient also stated that he had several moles on his body and after receiving the vaccine one mole on his chest and another in an unspecified area turned completely white.  The patient stated he had been taking Benadryl to help with the itching and this had helped his sleep some.  The patient also stated he has an appointment with his dermatologist soon and will discuss the moles at this appointment. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: given the Arexvy adjuvant only rather than the reconstituted vaccine; given the Arexvy adjuvant only rather than the reconstituted vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 77-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number A9KY9, expiry date 21-AUG-2025) for prophylaxis.   On 02-APR-2024, the patient received Arexvy. On 02-APR-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: given the Arexvy adjuvant only rather than the reconstituted vaccine) and inappropriate dose of vaccine administered (Verbatim: given the Arexvy adjuvant only rather than the reconstituted vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-APR-2024 The reporter was the healthcare professional (HCP) (pharmacy student). Today, (on the day of reporting) a patient was mistakenly given the Arexvy adjuvant only rather than the reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 59.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 2nd dose on 05th October 2023 and 3rd dose on 02nd April 2024; patient had received second dose too early; 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 59-year-old female patient who received HAB (Twinrix) (batch number H7RF2, expiry date 17-JAN-2026) for prophylaxis.   Co-suspect products included HAB (Twinrix) (batch number 797F9, expiry date 30-DEC-2025) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX).   On 02-APR-2024, the patient received the 3rd dose of Twinrix. On 05-OCT-2023, the patient received the 2nd dose of Twinrix. On 05-OCT-2023, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: patient had received second dose too early). On 02-APR-2024, the patient experienced drug dose administration interval too long (Verbatim: received 2nd dose on 05th October 2023 and 3rd dose on 02nd April 2024). The outcome of the drug dose administration interval too long and drug dose administration interval too short 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: 02-APR-2024 The pharmacist reported that the patient received 1st dose of Twinrix on 12-SEP-2023 from batch number 797F9 with expiry date 30-DEC-2025, 2nd dose of Twinrix received by the patient earlier, which led to shortening of vaccination schedule. It was not realized until today (on the day of reporting) that the patient had received second dose too early. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received 3rd dose of Twinrix (on the day of reporting) later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 54.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: expired drug used; 54-year-old patient received Bexsero; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 54-year-old female patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis.   On 02-APR-2024, the patient received Bexsero. On 02-APR-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: expired drug used) and inappropriate age at vaccine administration (Verbatim: 54-year-old patient received Bexsero). The outcome of the expired vaccine used and inappropriate age at vaccine administration 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: 02-APR-2024 The pharmacist reported that a patient received an expired Bexsero vaccine, which led to an expired vaccine used. The patient received Bexsero vaccine later than the recommended age, which led to an inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Drug Used; 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 4-day-old female patient who received HBV (Engerix B pediatric) (batch number DD7K7, expiry date 31-MAR-2024) for prophylaxis.   On 01-APR-2024, the patient received Engerix B pediatric. On 01-APR-2024, an unknown time after receiving Engerix B pediatric, the patient experienced expired vaccine used (Verbatim: Expired Drug Used). 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: 02-APR-2024 The MA (medical assistant) reported a data that a patient vaccinated with an expired Engerix B (Engerix B pediatric) vaccine, which led to an expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: giving an expired dose of Engerix-B to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received HBV (Engerix B) (expiry date 18-MAR-2024) for prophylaxis.   On 02-APR-2024, the patient received Engerix B. On 02-APR-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: giving an expired dose of Engerix-B to a patient). 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: 02-APR-2024 The nurse reported that the patient received the Engerix B vaccine which was expired one which led expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: patient was administered a dose of the 2 vial formulation of Menveo/realized the liquid component had an expiration date of 31Jan2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA791A, expiry date 31-JAN-2024) and (batch number AMXA791A, expiry date 30-SEP-2024) for prophylaxis.   On 26-MAR-2024, the patient received Menveo. On 26-MAR-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: patient was administered a dose of the 2 vial formulation of Menveo/realized the liquid component had an expiration date of 31Jan2024). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 02-APR-2024 The nurse manager reported that the patient was administered a dose of the 2 vial formulation of Menveo vaccine, and afterward the nurse realized that the liquid component had been expired, which led to expired vaccine used. The reporter reported that at the time of reporting, a repeat dose had not been administered. The vaccine administration facility was the same as primary reporter. The reporter consented to the follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: patient experiencing persistent lymphadenopathy over 6 months following vaccination with Shingrix; This non-serious case was reported by a physician via call center representative and described the occurrence of lymphadenopathy axillary in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 2Z9N3, expiry date 26-SEP-2025) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SAG 4V (FLUCELVAX QUAD).   On 03-OCT-2023, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). On 03-OCT-2023, immediately after receiving Shingrix, the patient experienced lymphadenopathy axillary (Verbatim: patient experiencing persistent lymphadenopathy over 6 months following vaccination with Shingrix). The outcome of the lymphadenopathy axillary was not resolved.   It was unknown if the reporter considered the lymphadenopathy axillary to be related to Shingrix.  It was unknown if the company considered the lymphadenopathy axillary to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-APR-2024 The physician reported the patient experiencing persistent lymphadenopathy over 6 months following vaccination with Shingrix and Flucelvax Quad.  Symptom began immediately following vaccination and had been ongoing since October 2023. Pretty impressive in right axilla.  Occurring bilaterally but worse on right side. It was unknown where Flucelvax was administered. The reporter consented to follow up.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: NO ADVERSE EVENT, PT WAS GIVEN SECOND DOSE TOO EARLY.
Age: 65.0
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Patient reported vomiting , nausea and diarrhea that started to become severe around 2am  on 2/12/24
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthma, Condition aggravated, Depression, Fatigue
Clinical narrative: worsening asthma symptoms, sore throat, fatigue, rash, headache, achy joints. I also noticed after the first Hep B, I got really depressed, it went away after about 3 weeks. After first hep b. Then again after the second one.  Not sure if that is a side effect or not.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Oropharyngeal pain, Rash
Clinical narrative: worsening asthma symptoms, sore throat, fatigue, rash, headache, achy joints. I also noticed after the first Hep B, I got really depressed, it went away after about 3 weeks. After first hep b. Then again after the second one.  Not sure if that is a side effect or not.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: NO ADVERSE EVENT, SECOND DOSE GIVEN TOO EARLY, WILL NEED ANOTHER DOSE AT AGE 16.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Brain fog, Fatigue, Muscular weakness
Clinical narrative: fatigue, muscle weakness, brain fog
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Four days after vaccination, patient continued to experience soreness at injection site. On morning of day 4, she had a red, hot, swollen and itchy area around injection site. Inflamed area spread from deltoid to elbow and around arm. Patient took motrin and benadryl and applied topical steroids to area. Nine days post injection adverse reaction had resolved.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Alopecia, Blood creatine phosphokinase, Blood iron
Clinical narrative: Sensation of body tightness which starts from abdomen and spreads, accompanied by tremor, pressure, fullness inside the body, chills, pounding HA, elevated BP, palpitations, irregular HR (palpitations improved with starting metoprolol), dilated and painful veins over the extremities, low grade fever. Then she gets chest tightness, cold hands and feet. Then gets RUQ pain, burning pain in upper abdomen and burning pain in head and extremities. Feeling cold and hot intermittently. Poor sleep. Recurrent symptoms at night. Developed hair loss, neck pain in about 1 month.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood thyroid stimulating hormone, Burning sensation, C-reactive protein, Cardiac monitoring
Clinical narrative: Sensation of body tightness which starts from abdomen and spreads, accompanied by tremor, pressure, fullness inside the body, chills, pounding HA, elevated BP, palpitations, irregular HR (palpitations improved with starting metoprolol), dilated and painful veins over the extremities, low grade fever. Then she gets chest tightness, cold hands and feet. Then gets RUQ pain, burning pain in upper abdomen and burning pain in head and extremities. Feeling cold and hot intermittently. Poor sleep. Recurrent symptoms at night. Developed hair loss, neck pain in about 1 month.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Discomfort, Electrocardiogram, Feeling of body temperature change
Clinical narrative: Sensation of body tightness which starts from abdomen and spreads, accompanied by tremor, pressure, fullness inside the body, chills, pounding HA, elevated BP, palpitations, irregular HR (palpitations improved with starting metoprolol), dilated and painful veins over the extremities, low grade fever. Then she gets chest tightness, cold hands and feet. Then gets RUQ pain, burning pain in upper abdomen and burning pain in head and extremities. Feeling cold and hot intermittently. Poor sleep. Recurrent symptoms at night. Developed hair loss, neck pain in about 1 month.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Headache, Heart rate irregular, International normalised ratio, Metabolic function test
Clinical narrative: Sensation of body tightness which starts from abdomen and spreads, accompanied by tremor, pressure, fullness inside the body, chills, pounding HA, elevated BP, palpitations, irregular HR (palpitations improved with starting metoprolol), dilated and painful veins over the extremities, low grade fever. Then she gets chest tightness, cold hands and feet. Then gets RUQ pain, burning pain in upper abdomen and burning pain in head and extremities. Feeling cold and hot intermittently. Poor sleep. Recurrent symptoms at night. Developed hair loss, neck pain in about 1 month.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Palpitations, Peripheral coldness, Poor quality sleep
Clinical narrative: Sensation of body tightness which starts from abdomen and spreads, accompanied by tremor, pressure, fullness inside the body, chills, pounding HA, elevated BP, palpitations, irregular HR (palpitations improved with starting metoprolol), dilated and painful veins over the extremities, low grade fever. Then she gets chest tightness, cold hands and feet. Then gets RUQ pain, burning pain in upper abdomen and burning pain in head and extremities. Feeling cold and hot intermittently. Poor sleep. Recurrent symptoms at night. Developed hair loss, neck pain in about 1 month.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Red blood cell sedimentation rate, Tremor, Vascular pain, Vasodilatation
Clinical narrative: Sensation of body tightness which starts from abdomen and spreads, accompanied by tremor, pressure, fullness inside the body, chills, pounding HA, elevated BP, palpitations, irregular HR (palpitations improved with starting metoprolol), dilated and painful veins over the extremities, low grade fever. Then she gets chest tightness, cold hands and feet. Then gets RUQ pain, burning pain in upper abdomen and burning pain in head and extremities. Feeling cold and hot intermittently. Poor sleep. Recurrent symptoms at night. Developed hair loss, neck pain in about 1 month.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Lethargy
Clinical narrative: High temperature  100.8F and lethargy
Age: 15.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Pt came in to get vaccine administer, MA was informed Pt was ready to receive vaccine. MA started to gather and prep Vaccine at moment of getting all vaccine all vaccine were on hand and prep. MA enter pt room and verified pt information and started to enter orders. MA administer 5 vaccine total, 3 on right and 2on left arm and one SQ. Once vaccine was administer MA started to enter Vaccine information and notice the MA had two varicella vials in hand and notice there was something wrong. Right away MA let Other MA and CTS know of incident. CTS advice to let Pt and provider know about incident. MA enter to Pt room and let mother know Pt was accidently administer 2 varicella vaccine, MA was informed provider advice to let MOC to be aware for any fever and body rash. Mother was concerned about what to give Pt if she had a fever MA informed that provider would come into room and talk to her about vaccine administer and any concerns she might have. MA also let MOC know that we can still administer MMR missing vaccine if MOC agreed or she can wait more than 28 day to get MMR vaccine. Mother agree to wait after 28 days to receive MMR Vaccine. Pt was schedule to come back on May 14. When MA was informing about incident to Pt and mother of child CTS and another MA were present.
Sex: F
Vaccine: PNC15
Symptoms: Syringe issue
Clinical narrative: MA stated that on 4/5/2024, when a nurse at their facility was preparing a VAXNEUVANCE syringe for use, the finger flange broke and the nurse cut her finger.; MA stated that on 4/5/2024, when a nurse at their facility was preparing a VAXNEUVANCE syringe for use, the finger flange broke and the nurse cut her finger.; the finger finger flange broke as a needle was being attached; This spontaneous report was received from a medical assistant reporting on behalf of a 34-year-old female patient (nurse). No information on the patient's medical history, current conditions and concomitant medications was provided.  On 05-APR-2024, when a nurse at their facility was preparing a pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), (lot #Y002963 and expiration date established as 04-OCT-2026) 0.5 milliliter for prophylaxis syringe for use, the finger flange broke as a needle was being attached to the syringe (syringe issue). The medical assistant stated that only one side of the finger flange was broken off, creating a jagged edge on the syringe. The medical assistant stated that as a result of the finger flange breaking, the nurse who was preparing the pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringe cut their finger (injury associated with device). The medical assistant stated that the nurse did not seek any medical attention or had any treatments as a result of the cut on her finger from the finger flange break of the syringe. The medical assistant stated that the nurse fully recovered from the cut on her finger on the same day. Action taken with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) regarding the events was not applicable. The medical assistant stated that the pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringe was not reported to have any additional defects prior to the finger flange breaking as the nurse was attaching the needle to the syringe.  The medical assistant confirmed that the pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringe was not used for administration.   The causality between a pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) and the event skin laceration was unknown.
Age: 0.5
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Administered an expired dose to a Patient; 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 6-month-old female patient who received HBV (Engerix B pediatric) (batch number DD7K7, expiry date 31-MAR-2024) for prophylaxis.   On 02-APR-2024, the patient received Engerix B pediatric. On 02-APR-2024, an unknown time after receiving Engerix B pediatric, the patient experienced expired vaccine used (Verbatim: Administered an expired dose to a Patient). 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: 02-APR-2024 The reporter reported that patient was administered an expired dose of Engerix-B pediatric formula, which led to expired vaccine used. The reporter consent to follow up.