chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19-2, DTPPVHBHPB, PNC13, RV5, COVID19, DTPPVHBHPB, PNC13, RVX
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was given Moderna Bivalent Pink cap, as first dose. No known symptoms.; Underdose; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2638479-1. The original narrative from the sender is the following:  "Patient was given Moderna Bivalent Pink cap, as first dose. No known symptoms. Patient will be revaccinated. Primary care provider called and advised parents of the incident.".  The assessment of causal relationship between Vaxelis and the events, " Patient was given Moderna Bivalent Pink cap, as first dose. No known symptoms. Patient will be revaccinated. Primary care provider called and advised parents of the incident" and "underdose" was not applicable.  No further information is expected.  Notes: Based on the available information, the events were not related to Vaxelis but to Covid-19 vaccine. Vaxelis should have been considered a concomitant, however the case was retrieved from VAERS and information was kept as reported in the form.  Is not working, added State under vaccine facility information and Reporter State.
Sex: F
Vaccine: COVID19-2, DTPPVHBHPB, PNC13, RV5, COVID19, DTPPVHBHPB, PNC13, RV5
Symptoms: No adverse event, Underdose
Clinical narrative: UNDERDOSE; No Adverse Event; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2638482-1. The original narrative from the sender is the following:  Patient was given Moderna Bivalent Pink cap, as first dose. No known symptoms. Patient will be revaccinated. Primary care provider called and advised parents of the incident.  The causal relationship between Vaxelis and the events " Underdose and no adverse event" was assessed as not applicable due to the nature of the reported event.  No further information is expected.  Is not working, added State under vaccine facility information and Reporter State.
Age: 70.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired 8/29/2023
Age: 70.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Expired product administered
Clinical narrative: Vaccine expired 8/29/2023
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal chest pain, Pain
Clinical narrative: pain in my right ribs associated with pain on breathing; pain in my right ribs associated with pain on breathing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 10:15 as dose 7 (booster), single (Lot number: HG4629) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "arthritis of back" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing); "constipation" (unspecified if ongoing); "dry eye syndrome" (unspecified if ongoing); "enlarged prostate" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE HIGH DOSE, on 08Sep2023 as dose 1, single; FLONASE [FLUTICASONE PROPIONATE]; MONTELUKAST; HYDROEYE; DOCUSATE SODIUM. Past drug history included: Thimerosal, reaction(s): "known allergies: Thimerosal". Vaccination history included: bnt162b2, bnt162b2 omi ba.4-5 (Dose Number: 6, Batch/Lot No: GJ3268, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 20Apr2023, when the patient was 69-year-old, for COVID-19 immunization; bnt162b2 (Dose Number: 5, Batch/Lot No: GJ2524, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 15Sep2022, when the patient was 69-year-old, for COVID-19 immunization; bnt162b2 (Dose Number: 4, Batch/Lot No: FP4554, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 31Mar2022, when the patient was 68-year-old, for COVID-19 immunization; bnt162b2 (Dose Number: 3, Batch/Lot No: 301308A, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 26Sep2021, when the patient was 68-year-old, for COVID-19 immunization; bnt162b2 (Dose Number: 2, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: 04Mar2021, when the patient was 67-year-old, for COVID-19 immunization; bnt162b2 (Dose Number: 1, Batch/Lot No: EN6201, Location of injection: Arm Left, Vaccine Administration Time: 11:30 AM), administration date: 11Feb2021, when the patient was 67-year-old, for COVID-19 immunization. The following information was reported: MUSCULOSKELETAL CHEST PAIN (non-serious), PAINFUL RESPIRATION (non-serious) all with onset 26Sep2023 at 08:30, outcome "recovered" (26Sep2023 at 11:30) and all described as "pain in my right ribs associated with pain on breathing". Therapeutic measures were taken as a result of musculoskeletal chest pain, painful respiration. Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19. The patient used heat and lay down and the pain subsided in about 3 hours without further recurrence. Patient was not certain that this is related to the vaccine but feel that it should be reported.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal chest pain, Painful respiration
Clinical narrative: pain in my right ribs associated with pain on breathing; pain in my right ribs associated with pain on breathing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 10:15 as dose 7 (booster), single (Lot number: HG4629) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "arthritis of back" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing); "constipation" (unspecified if ongoing); "dry eye syndrome" (unspecified if ongoing); "enlarged prostate" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE HIGH DOSE, on 08Sep2023 as dose 1, single; FLONASE [FLUTICASONE PROPIONATE]; MONTELUKAST; HYDROEYE; DOCUSATE SODIUM. Past drug history included: Thimerosal, reaction(s): "known allergies: Thimerosal". Vaccination history included: bnt162b2, bnt162b2 omi ba.4-5 (Dose Number: 6, Batch/Lot No: GJ3268, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 20Apr2023, when the patient was 69-year-old, for COVID-19 immunization; bnt162b2 (Dose Number: 5, Batch/Lot No: GJ2524, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 15Sep2022, when the patient was 69-year-old, for COVID-19 immunization; bnt162b2 (Dose Number: 4, Batch/Lot No: FP4554, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 31Mar2022, when the patient was 68-year-old, for COVID-19 immunization; bnt162b2 (Dose Number: 3, Batch/Lot No: 301308A, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 26Sep2021, when the patient was 68-year-old, for COVID-19 immunization; bnt162b2 (Dose Number: 2, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: 04Mar2021, when the patient was 67-year-old, for COVID-19 immunization; bnt162b2 (Dose Number: 1, Batch/Lot No: EN6201, Location of injection: Arm Left, Vaccine Administration Time: 11:30 AM), administration date: 11Feb2021, when the patient was 67-year-old, for COVID-19 immunization. The following information was reported: MUSCULOSKELETAL CHEST PAIN (non-serious), PAINFUL RESPIRATION (non-serious) all with onset 26Sep2023 at 08:30, outcome "recovered" (26Sep2023 at 11:30) and all described as "pain in my right ribs associated with pain on breathing". Therapeutic measures were taken as a result of musculoskeletal chest pain, painful respiration. Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19. The patient used heat and lay down and the pain subsided in about 3 hours without further recurrence. Patient was not certain that this is related to the vaccine but feel that it should be reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; GARDASIL 9 given during a temperature excursion.; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 01-SEP-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, during a temperature excursion. (product storage error) (lot number w026152 has been determined to be valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), with an expiration date established as 29-JAN-2025), administered for prophylaxis (strength, and route of administration were not provided). No adverse events were reported.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Vaccination site nodule
Clinical narrative: nodule on her left deltoid after receiving the second dose of GARDASIL 9; This spontaneous report has been received from a medical assistant, regarding an 18-years-old female patient. The patient's pertinent medical history included allergy to amoxicillin trihydrate (+) clavulanate potassium (AUGMENTIN), concomitant medications included salbutamol (ALBUTEROL).  On 05-NOV-2022 and 06-JAN-2023, the patient was vaccinated with the first and second dose respectively of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, as prophylaxis (lot number: W001498, which was determined to be valid, with an expiration date on 15-SEP-2024, for first dose it was also reported as W0011498, conflicting information and confirmed as non-valid by the validation lot team) (strengths, doses, routes and anatomical locations of administration were not reported).  On 07-JAN-2023, after receiving the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), the patient developed a nodule on her left deltoid (vaccination site nodule). By the time of the report, the patient has not gotten the third dose yet, and the nodule got smaller but it's still on her arm (recovering).  No further information provided.  The causal relationship between vaccination site nodule and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC.; HCP reported AE on behalf of a patient who was administered an expired dose of RECOMBIVAXHB with no prior TEs (SUPPORTED). No symptoms reported. Obtained consent to contact HCP. No additional AE/PQC.; This spontaneous report has been received from other Health Professional and referring to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB SYRINGE (DEVICE)) intramuscular injection, 0.5 milliliters (strength, dose description, lot #, expiry date, route of administration, and indication were not provided) with no prior TEs (SUPPORTED) (Expired product administered). There was no adverse effect reported (No adverted event).
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Cervical dysplasia, Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: abnormal PAP smear after receiving GARDASIL or GARDASIL 9/ high rates for subtype HPV and a diagnosis of low-grade intraepithelial lesions; adenomyosis of the uterus; diagnosis of low-grade intraepithelial lesions; high rates for subtype HPV; This spontaneous report has been received from a company representative and refers to a 32-year-old female patient.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date (also reported as back in 7th grade), the patient was vaccinated with either quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, she could not remember, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 20-SEP-2023, the patient was made aware of an abnormal Papanicolaou test (PAP) smear after having completed the dosage regimen back in 7th grade (smear cervix abnormal). Such PAP smear showed high rates for subtype human papilloma virus (HPV) (human papillomavirus test positive) and a diagnosis of low-grade intraepithelial lesions (cervical dysplasia) and that it might have been adenomyosis of the uterus (adenomyosis). At the time of reporting, the patient had not recovered from the events.  The causal relationship between the events and the suspect therapies was not established.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; Caller reported AE on behalf of a patient who was administered improperly stored PROQUAD.; This spontaneous report was received from a nurse referring to male patient. The patient's pertinent medical history, concomitant therapies or known drug allergies or reactions were not reported.  On 19-SEP-2023, the patient was vaccinated with an improperly stored doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin (rHA)) (PROQUAD) injection 0.2 mL (lot number: X014622 was verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), expiration date was provided and upon internal validation was confirmed to be 18-NOV-2024) administered as prophylaxis (strength, route of administration, and frequency were not reported) (product storage error).  The administered doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) experienced a temperature excursion of -14 degrees Celsius up to -10 degrees Celsius for 4 hours 15 minutes and -8.33 degrees Celsius or -10 degrees Celsius up to 8 degrees Celsius for 7 hours and 45 minutes; with a total duration of 12 hours. No adverse events were reported.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/no PQC.; PROQUAD dose that was administered to a patient over the age of 13; This spontaneous report has been received from a nurse and refers to a 28-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 23-AUG-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, at a dose of 0.5 milliliter (product administered to patient of inappropriate age) (lot number X007358 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), with an expiration date established as 09-AUG-2024), administered for prophylaxis (strength, and route of administration were not provided). No adverse events were reported for this patient.
Sex: F
Vaccine: RSV
Symptoms: Erythema, Mass, Pain
Clinical narrative: redness is quite large beyond the injection site; extremely painful; lump is large; This non-serious case was reported by a consumer and described the occurrence of erythema in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included hypothyroidism and allergy. Concomitant products included levothyroxine, liothyronine (Armour Thyroid).   On 18-SEP-2023, the patient received Arexvy. On 18-SEP-2023, less than a day after receiving Arexvy, the patient experienced erythema (Verbatim: redness is quite large beyond the injection site), pain (Verbatim: extremely painful) and mass (Verbatim: lump is large).The outcome of the erythema, pain and mass were not resolved.   It was unknown if the reporter considered the erythema, pain and mass to be related to Arexvy.     It was unknown if the company considered the erythema, pain and mass to be related to Arexvy.   Additional Information: GSK Receipt Date: 21-SEP-2023 This report was submitted via the online direct entry reporting system.  The reporter wanted to know what the ingredients were in Arexvy.  The information said that a person should not take the vaccine if they were allergic to any of the ingredients. Since they were not listed how would she knew that if she were allergic to it. The redness was quite large beyond the injection site.  It was extremely painful and the lump was large. The reporter also wanted to know how long this was going to last.  This was the third day.
Sex: F
Vaccine: RSV
Symptoms: Injection site pruritus
Clinical narrative: Continues itching at site of innoculation; This non-serious case was reported by a consumer and described the occurrence of injection site itching in a 82-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included osteoarthritis (Osteo arthritis knees). Concomitant products included denosumab (Prolia).   On 18-SEP-2023, the patient received Arexvy. On 18-SEP-2023, less than a day after receiving Arexvy, the patient experienced injection site itching (Verbatim: Continues itching at site of innoculation).  The outcome of the injection site itching was not resolved.   It was unknown if the reporter considered the injection site itching to be related to Arexvy.     It was unknown if the company considered the injection site itching to be related to Arexvy.   Additional Information: GSK receipt date: 21-SEP-2023 The patient had continues itching at site of inoculation. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Myalgia, Pyrexia
Clinical narrative: Muscle pain; fever; shivering; feeling weak; light-headed; This non-serious case was reported by a consumer and described the occurrence of muscle pain in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included ATORVASTATIN CALCIUM (received on 1st February 2023 for High cholesterol). Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT).   On 21-SEP-2023, the patient received the 1st dose of Shingrix (left arm). On 22-SEP-2023, 1 days after receiving Shingrix, the patient experienced muscle pain (Verbatim: Muscle pain), fever (Verbatim: fever), shivering (Verbatim: shivering), feelings of weakness (Verbatim: feeling weak) and light headedness (Verbatim: light-headed).  The outcome of the muscle pain, fever, shivering, feelings of weakness and light headedness were not resolved.   It was unknown if the reporter considered the muscle pain, fever, shivering, feelings of weakness and light headedness to be related to Shingrix.     It was unknown if the company considered the muscle pain, fever, shivering, feelings of weakness and light headedness to be related to Shingrix.   Additional Information: GSK receipt date: 21-SEP-2023 The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Oxygen saturation decreased
Clinical narrative: Low O2 saturation; This non-serious case was reported by a consumer and described the occurrence of oxygen saturation decreased in a 94-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chronic obstructive pulmonary disease.   On 20-SEP-2023, the patient received the 2nd dose of Shingrix. On 21-SEP-2023, 1 days after receiving Shingrix, the patient experienced oxygen saturation decreased (Verbatim: Low O2 saturation).  The outcome of the oxygen saturation decreased was not resolved.   It was unknown if the reporter considered the oxygen saturation decreased to be related to Shingrix.     It was unknown if the company considered the oxygen saturation decreased to be related to Shingrix.   Additional Information: GSK Receipt date: 25-SEP-2023 The reporter consent to follow up.
Sex: F
Vaccine: FLUX, PNC, RSV
Symptoms: Pyrexia
Clinical narrative: had a fever of 101; This non-serious case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylaxis and INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)) for prophylaxis.   On an unknown date, the patient received Arexvy, PREVNAR and FLU VACCINE (NAME UNKNOWN). On an unknown date, an unknown time after receiving Arexvy, the patient experienced fever (Verbatim: had a fever of 101).  The outcome of the fever was resolved (duration 2 days).   It was unknown if the reporter considered the fever to be related to Arexvy.     It was unknown if the company considered the fever to be related to Arexvy.   Additional Information: GSK Receipt Date: 21-SEP-2023 The patient was given Arexvy, flu and Prevnar at the same time and had a fever of 101 for 2 days following vaccination. Information regarding formulation, dose, frequency, lot, start/stop date (duration if dates) were not known. The reporter denied the consent to follow up
Sex: F
Vaccine: RVX
Symptoms: Pain in extremity
Clinical narrative: no side effects other than a sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female 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 pain in arm (Verbatim: no side effects other than a sore arm).  The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt date: 21-SEP-2023 This case was reported by patient via interactive digital media. The reporter reported that the patient got the RSV vaccine as soon as it was available, no side effects other than a sore arm. Follow up was not possible as no contact details were available. This case was linked with case US2023AMR132094, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR132094:same reporter, different patient
Sex: U
Vaccine: RVX
Symptoms: Musculoskeletal stiffness, Pain in extremity, Swelling
Clinical narrative: stiffness in arm; soreness in arm; knot in arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of limbs stiffness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 18-SEP-2023, the patient received RSV vaccine. In SEP-2023, less than a week after receiving RSV vaccine, the patient experienced limbs stiffness (Verbatim: stiffness in arm), pain in arm (Verbatim: soreness in arm) and local swelling (Verbatim: knot in arm).  The outcome of the limbs stiffness and pain in arm were not resolved and the outcome of the local swelling was resolving.   It was unknown if the reporter considered the limbs stiffness, pain in arm and local swelling to be related to RSV vaccine.     It was unknown if the company considered the limbs stiffness, pain in arm and local swelling to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 22-SEP-2023 This case was reported by a patient via interactive digital media. The patient took the vaccine on Monday, got a big fat knot on arm. On the day of reporting the patient stated that the knot was small but still had stiffness and soreness in arm. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RVX
Symptoms: Pain in extremity
Clinical narrative: arm is definitely sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 21-SEP-2023, the patient received RSV vaccine. In SEP-2023, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: arm is definitely sore).  The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt date: 22-SEP-2023 This case was reported by patient via interactive digital media. The patient reported that he or she just got the shot Thursday a little reaction and arm was definitely sore. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Tachycardia
Clinical narrative: tachycardia.; This non-serious case was reported by a nurse via sales rep and described the occurrence of tachycardia in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced tachycardia (Verbatim: tachycardia.).  The patient was treated with metoprolol. The outcome of the tachycardia was not reported.   It was unknown if the reporter considered the tachycardia to be related to Arexvy.     It was unknown if the company considered the tachycardia to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-SEP-2023 The nurse mentioned that she had conducted a site for the Arexvy clinical trials. She mentioned that during the Arexvy trial a patient reported tachycardia. The patient was treated with metoprolol (a beta blocker) for a few days.
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Occupational exposure to product
Clinical narrative: Got some adjuvant suspension in my eye when I was preparing the arexvy dose; Adjuvant suspension in my eye; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while preparing product for administration in a 33-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number Jc7z5, expiry date 01-FEB-2025) for prophylaxis.   On an unknown date, the patient did not receive Arexvy. On 20-SEP-2023, an unknown time after receiving Arexvy, the patient experienced occupational exposure while preparing product for administration (Verbatim: Got some adjuvant suspension in my eye when I was preparing the arexvy dose) and exposure via eye contact (Verbatim: Adjuvant suspension in my eye).  The outcome of the occupational exposure while preparing product for administration and exposure via eye contact were unknown.   Additional Information: GSK Receipt Date: 20-SEP-2023 The reporter reported that he got some adjuvant suspension his eye when he was preparing the arexvy vaccine dose, which led to occupational exposure while preparing product for administration and exposure via eye contact. The reporter wanted to know what he need to do and as of did not sting or cause any sort of reaction so far. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Accidental exposure to product, Device leakage, Exposure via skin contact, Incorrect dose administered, Underdose
Clinical narrative: Medication leaked out during administration/leaked down the patients arm; Medication leaked out during administration/leaked down the patients arm; Medication leaked out during administration/leaked down the patients arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 65-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number A7TN9, expiry date 22-OCT-2024) for prophylaxis.   On 20-SEP-2023, the patient received Arexvy. On 20-SEP-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: Medication leaked out during administration/leaked down the patients arm), inadvertent exposure to vaccine (Verbatim: Medication leaked out during administration/leaked down the patients arm) and exposure via skin contact (Verbatim: Medication leaked out during administration/leaked down the patients arm).The outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 21-SEP-2023 The reporter reported that Arexvy leaked out between the needle hub and the needle when she pressed the plunger to administer the vaccine and the reporter noted the vaccine leaked down the patient's arm, which led to incomplete dose administered, inadvertent exposure to the vaccine and exposure via skin contact. No other details were provided. The reporter consented to follow up.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Administered a pediatric dose of Engerix-B to an adult patient; Administered a pediatric dose of Engerix-B to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 55-year-old male patient who received HBV (Engerix B pediatric) (batch number 3T5L9, expiry date 09-MAR-2025) for prophylaxis.   On 20-SEP-2023, the patient received Engerix B pediatric. On 20-SEP-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Administered a pediatric dose of Engerix-B to an adult patient) and adult use of a child product (Verbatim: Administered a pediatric dose of Engerix-B to an adult patient). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 21-SEP-2023 The reporter was a office manager. The reporter reported that the nurse administered a pediatric dose of Engerix-B to an adult patient, which led to underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email.
Age: 1.5
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age, Wrong technique in product usage process
Clinical narrative: was administered to an 18-month old by mistake due to the wording on the PI; vaccinator only looked at the top of the PI/vaccinator only looked at the top of the PI; 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 18-month-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 20-SEP-2023, the patient received Menveo (intramuscular). On 20-SEP-2023, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: was administered to an 18-month old by mistake due to the wording on the PI) and wrong technique in drug usage process (Verbatim: vaccinator only looked at the top of the PI/vaccinator only looked at the top of the PI).The outcome of the inappropriate age at vaccine administration and wrong technique in drug usage process were unknown.   Additional Information: GSK Receipt Date: 21-Sep-2023 The report received from field personnel.  The Menveo one vial (pink cap) was administered to an 18-month old by mistake due to the wording on the PI, which led to inappropriate age at vaccine administration. The vaccinator only looked at the top of the PI which stated that it was appropriate for patients age 2 months to 55 years and they did not look further down to see that the one vial (pink top) presentation was only appropriate for patients aged 10 years through 55 years, which led to wrong technique in drug usage process. The reporter consented to follow up via email.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Infanrix was administered instead of Boostrix; 11 year old that time received Infanrix vaccine; Infanrix was the 6th Dtap dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number XG942, expiry date 22-AUG-2022) for prophylaxis.   On 18-FEB-2022, the patient received the 6th dose of Infanrix. On 18-FEB-2022, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Infanrix was administered instead of Boostrix), inappropriate age at vaccine administration (Verbatim: 11 year old that time received Infanrix vaccine) and extra dose administered (Verbatim: Infanrix was the 6th Dtap dose). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and extra dose 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: 21-SEP-2023 The reporter reported that the 11 years old patient received Infanrix vaccine instead of Boostrix vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter stated that the Infanrix was the 6th Dtap dose, which led to extra dose administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Malaise, Nausea, Pyrexia
Clinical narrative: Tiredness; Nausea; Headaches; Fever; feeling very sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-SEP-2023, the patient received the 1st dose of Shingrix. In SEP-2023, an unknown time after receiving Shingrix, the patient experienced tiredness (Verbatim: Tiredness), nausea (Verbatim: Nausea), headache (Verbatim: Headaches), fever (Verbatim: Fever) and sickness (Verbatim: feeling very sick).  The outcome of the tiredness and fever were not resolved and the outcome of the nausea, headache and sickness were unknown.   It was unknown if the reporter considered the tiredness, nausea, headache, fever and sickness to be related to Shingrix.     It was unknown if the company considered the tiredness, nausea, headache, fever and sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-SEP-2023 The reporter stated that she received Shingrix first dose on Monday and that night started with fever, headaches and nauseas, feeling very sick Monday and Tuesday. On the day of reporting, still had low fever and tiredness. Treating physician was not aware. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had her first dose of Shingrix administered 10 months ago (late dose); This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (1st dose received 10 months ago prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: had her first dose of Shingrix administered 10 months ago (late dose)).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-SEP-2023 The reporter reported that there was no further information was known. The reporter declined to gave any demographic information. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 57.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Inflammation, Lymphadenopathy, Peripheral swelling, Skin warm, Swelling
Clinical narrative: Lump on neck; Inflammation; Right arm swollen; Right arm hot to touch; Swollen lymph nodes in neck/ swollen lymph nodes in her underarms; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inflammation in a 57-year-old female patient who received MMR (Priorix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis and HBV (Engerix B) (batch number 4jg5y) for prophylaxis.   On 16-AUG-2023, the patient received Priorix, Boostrix (intramuscular, right deltoid) and Engerix B (intramuscular). On 19-AUG-2023, 3 days after receiving Priorix, Boostrix and Engerix B, the patient experienced inflammation (Verbatim: Inflammation), swelling arm (Verbatim: Right arm swollen), skin warm (Verbatim: Right arm hot to touch) and lymphadenopathy cervical (Verbatim: Swollen lymph nodes in neck/ swollen lymph nodes in her underarms). On 20-SEP-2023, the patient experienced local swelling (Verbatim: Lump on neck). The outcome of the inflammation, swelling arm and skin warm were resolved and the outcome of the lymphadenopathy cervical and local swelling were not resolved.   It was unknown if the reporter considered the inflammation, swelling arm, skin warm, lymphadenopathy cervical and local swelling to be related to Priorix, Priorix Pre-Filled Syringe Device, Boostrix and Engerix B.     It was unknown if the company considered the inflammation, swelling arm, skin warm, lymphadenopathy cervical and local swelling to be related to Priorix, Priorix Pre-Filled Syringe Device, Boostrix and Engerix B.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-SEP-2023 The reporter Reported that the patient received 3 vaccination and they were all given on the same day. This reporter stated that the vaccines were given in the right deltoid.  On 19th August 2023, 3 days after receiving the vaccines the patient went to let the pharmacist see her right arm and the pharmacist noticed the right arm was swollen and warm to touch.  The patient got home and she noticed her lymph nodes in her underarms and neck were swollen and she did go see her health care professional about this reaction.   The reporter stated that all of these symptoms had resolved with exception of the lymph nodes in her neck are still swollen. The reporter consented to follow up.
Sex: U
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: child was given 3 doses of Rotarix (Extra Dose); This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: child was given 3 doses of Rotarix (Extra Dose)).  The outcome of the extra dose administered 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: 21-SEP-2023 Healthcare professional called today stating 8 months ago a child was given 3 doses of Rotarix, which led to extra dose administered. No further information was known. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: more than a year between doses/Longer than recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 03-OCT-2022, 1st dose was received).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: more than a year between doses/Longer than recommended interval).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-SEP-2023 The pharmacist called in to request information about how to proceed after a patient waited more than a year between doses. Partial information about event, vaccine and patient given. The reporter consented to follow up. VAERS details provided corresponding to the 1st dose and the case is an incomplete course of vaccination
Sex: F
Vaccine: VARZOS
Symptoms: Device leakage, Exposure via skin contact, Occupational exposure to product, Product complaint
Clinical narrative: the vaccine leaked on her hand; the vaccine leaked on her hand; Product Complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while preparing product for administration in a adult female patient who received Herpes zoster (Shingrix) (batch number zm749, expiry date 22-AUG-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration (Verbatim: the vaccine leaked on her hand), exposure via skin contact (Verbatim: the vaccine leaked on her hand) and pharmaceutical product complaint (Verbatim: Product Complaint).  The outcome of the occupational exposure while preparing product for administration, exposure via skin contact and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt date: 21-SEP-2023 HCP reported she was a difficult time withdrawing Shingrix after reconstitution and the vaccine leaked on her hand (solution-0010-vial leaking) All operations were performed appropriately before defect was discovered. The defect was discovered during preparation. The mixing/shaking performed after reconstitution, gently the vial held upside-down when the vaccine was being withdrawn. The product was not administered. The HCP preparing/administering vaccine is a experienced user. The reconstituted product was impacted, adjuvant had been injected into antigen vial. The customer inject air from the syringe into the vial during preparation at the step of reconstitution small amount of air injected. The leak coming from the stopper at the neck of the vial. The customer remove only the plastic flip-off of the vial before handling. There was no evidence of leakage in package or carton. The stopper pierced in the circular area dedicated to perforation. Small amount of air injected into the vial. The vaccine leaked on her hand which led to occupational exposure while preparing product for administration and Exposure via skin contact. The reporter Consented to follow up.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, MENB
Symptoms: Product storage error
Clinical narrative: temperature excursion with a high of 11.2 degrees Celsius for 34 minutes occurred; This non-serious case was reported by a physician via call center representative and described the occurrence of product storage error in an unspecified number of patients who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis and Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patients received Infanrix, Pediarix, Kinrix, Havrix, Engerix B and Bexsero. On an unknown date, an unknown time after receiving Infanrix, Pediarix, Kinrix, Havrix, Engerix B and Bexsero, the patient experienced product storage error (Verbatim: temperature excursion with a high of 11.2 degrees Celsius for 34 minutes occurred).  The outcome of the product storage 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: 21-SEP-2023 The physician stated that an unknown number of patients received Infanrix, Pediarix, Kinrix, Havrix, Engerix-B, and/or Bexsero after a temperature excursion with a high of 11.2 degrees Celsius for 34 minutes occurred on September 7.  The facility did not call for stability data before administering vaccine.  No other information known at the time of reporting.  In house stability data supported use of vaccines. The patients was administered with temperature excursed products, which led to product storage error. The reporter consented to follow up.
Sex: M
Vaccine: MMR
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Priorix that was reconstituted using the Merck MMR diluent to reconstitute; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 15-month-old male patient who received MMR (Priorix) (batch number 2AR75, expiry date 11-MAY-2024) for prophylaxis.   On 21-SEP-2023, the patient received the 1st dose of Priorix. On 21-SEP-2023, an unknown time after receiving Priorix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Priorix that was reconstituted using the Merck MMR diluent to reconstitute) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose 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: 21-SEP-2023 The nurse reported one of her staff members administered a dose of Priorix that was reconstituted using the Merck MMR diluent to reconstitute.   The diluent was sterile water, but she notes it was a different volume than the supplied Priorix diluent.   At the time of reporting, no further doses have been administered. The vaccine administration facility was the same as primary reporter. Wrongly reconstituted vaccine was administered to a patient , which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered The reporter consented to follow up via email.