chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Addendum: Patient made aware of HM vaccines due which included Influenza, Covid-19 and Hepatitits B (3rd dose). During provider visit, patient questioned regarding HM vaccines due, stated she want to receive the Hepatitis B and Influenza vaccines and did not want to receive the Covid vaccine at this time, which was heard by the writer as her agreeing to receive the Covid-19 vaccine and not the Influenza vaccine.   The administering CA did initially verbally verify with patient that she was going to be administering the Covid-19 and Hepatitis B 3rd dose vaccine. After CA administered both vaccines, the patient questioned which shot she received on each respective arm, at which point she realized that she had received Covid-19 but was expecting to receive the Influenza vaccine. The patient became upset as she had not wanted to receive Covid-19 vaccine today (has received 4 doses prior).    The writer went to speak with patient and clarify the incident. She was noted to be tearful and stated she was worried about side effects of the Covid vaccine, discussed the new vaccine (pfizer monovalent) has been well tolerated with no side effects or minor side effects reported. She expressed understanding and noted no immediate reaction or side effects.
Age: 69.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Underdose, Wrong product administered
Clinical narrative: PATIENT CAME IN TO RECEIVE THEIR COVID VACCINE AND THE FLU VACCINE. TECHNICIAN VERIFIED WITH THE IMMUNIZATION SELECTION TOOL AND ENTERED INTO SYSTEM THE CORRECT VACCINATIONS. THE PHARMACIST ADMINISTERING THE VACCINES HAD GRABBED THE PEDIACTRIC DOSE OF THE COVID INSTEAD OF THE ADULT DOSE.  ONE TECHNICIAN WAS SCANNING INTO THE SYSTEM WHEN WE NOTICED THE VACCINE STICKER WAS INCORRECT FOR THE PATIENT, WE IMMEDIATELY NOTIFIED THE PHARMACIST AND THEN HE PROCEEDED TO CALL THE PATIENT AND CDC.
Age: 73.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Underdose, Wrong product administered
Clinical narrative: PATIENT CAME IN TO RECEIVE THEIR COVID VACCINE AND THE FLU VACCINE. TECHNICIAN VERIFIED WITH THE IMMUNIZATION SELECTION TOOL AND ENTERED INTO SYSTEM THE CORRECT VACCINATIONS. THE PHARMACIST ADMINISTERING THE VACCINES HAD GRABBED THE PEDIACTRIC DOSE OF THE COVID INSTEAD OF THE ADULT DOSE.  ONE TECHNICIAN WAS SCANNING INTO THE SYSTEM WHEN WE NOTICED THE VACCINE STICKER WAS INCORRECT FOR THE PATIENT, WE IMMEDIATELY NOTIFIED THE PHARMACIST AND THEN HE PROCEEDED TO CALL THE PATIENT AND CDC.
Age: 80.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Platelet count decreased
Clinical narrative: Dangerously low platelets on CBC (8 K/uL) on 11/7/23. It improved and normalized after 1 week. Was sent to ER for consideration of platelet transfusion and went to hematology for evaluation.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal pain upper, Defaecation urgency, Myalgia, Nausea
Clinical narrative: had myalgias as I expected. Developed severe unrelenting upper abdominal pain with nausea.  Lasted Almost 10 hours. This pain felt very much like a gallbladder atack. I have had a cholestectomy many years ago. No fever or shaking chills. No vomiting but did not eat or drink.Did have mild sensation of needing a bowel movement but did not.  This sensation lasted only about 2 hours. Symptoms resolved by next morning on 11.19.2023.  Have beeen in usual state of health since then.  I reviewed all my contacts that I had had for the preceeding 2 days prior to vaccination and no one had any GI symptoms. No one had GI symptoms after my episode.  Checed with contacts on Monday 11.20.2023 and no one had any GI sympotoms.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Malaise, Pain, Pyrexia
Clinical narrative: Very red arm, aches, malaise, fever, and chills
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, FLU4
Symptoms: Incorrect product formulation administered, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pt was here to receive his Covid vaccine. He was given the 6mo-11yr formulation of the Moderna vaccine accidentally. The error was caught before the pt left. CDC recommendation for lower than authorized dose was looked up and found to be to repeat vaccination with correct dosage immediately (no minimum interval). Error was explained to patient and family and they agreed to be vaccinated with correct dosage. The invalid dose was Moderna 6mo-11yr, lot #AU5509B, NDC 80777-0287-07, exp date 5/19/24. Administered in right deltoid. Correct vaccine given; see Covid checklist; patient was advised to wait 15 minutes after vaccine before leaving.
Age: 66.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Injection site pain, Muscle fatigue, Pain
Clinical narrative: Patient states she has had muscle fatigue and achiness of her entire body since receiving the Moderna spikevax vaccine and the fluad vaccine on Nov 2, 2023.  She also stated she had soreness not only at injection site but all around the injection sites.
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Injection site pruritus
Clinical narrative: PATIENT WAS FEELING ITCHY AT /AROUND SITE OF INJECTION AND IN THE EVENING HAD LABORED BREATHING .  SHE SAID SHE TOOK  BENADRYL THAT SHE HAD ON HAND AND ALSO SHE  USED ALBUTEROL INHALER - 2 PUFFS AND THAT HELPED HER.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: pt broke up in rash over neck and face
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Drainage, Fatigue, Increased need for sleep, Musculoskeletal stiffness
Clinical narrative: After a month of getting this vaccine I developed a lump on my right collarbone area.  My physician at the time wanted to just to monitor it and not do any testing.  I went to clinic and they sent me into  Radiology to scan the bump and then they withdrew the fluid out of it.  They didnt feel it needed to be tested.   I have also had joint pain and stiffness and fatigue since this vaccine.  The day after the shot I had severe leg pain and didnt want to move just sleep for 2 days.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Nodule, Pain in extremity, Scan
Clinical narrative: After a month of getting this vaccine I developed a lump on my right collarbone area.  My physician at the time wanted to just to monitor it and not do any testing.  I went to clinic and they sent me into  Radiology to scan the bump and then they withdrew the fluid out of it.  They didnt feel it needed to be tested.   I have also had joint pain and stiffness and fatigue since this vaccine.  The day after the shot I had severe leg pain and didnt want to move just sleep for 2 days.
Age: 32.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: Patient complained of mild to moderate pain at injection site x2 days after vaccine administration. No other complications noted.  Patient perceived injection was given higher in the deltoid muscle and wanted to rule out SIRVA
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 55 YEAR OLD PATIENT WAS GIVE A FLUZONE HD VACCINATION
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Exposure to communicable disease, Respiratory syncytial virus test positive
Clinical narrative: Tested positive for RSV on 11/22/2023 Exposed to an infant that tested positive to RSV.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hypertension
Clinical narrative: Post Vaccine hypertension BP went from approx 135/70 to 180/105 requeiring doubling the dose of my antihypertensive medication  My hypertension started 1 year ago after last COVID vaccine - Prior VAERs files on than  Blood pressure had improved some over the yera but never returned to normal
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Immediate post-injection reaction, Impaired driving ability, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Patient had severe pain on injection and has had persistent right arm pain causing pain with movement/position, radiation of pain into the right shoulder.  Pain is causing difficulty with driving, teaching, reaching overhead. Pain is getting progressively worse since injection. No history of arm or joint issues.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient had severe pain on injection and has had persistent right arm pain causing pain with movement/position, radiation of pain into the right shoulder.  Pain is causing difficulty with driving, teaching, reaching overhead. Pain is getting progressively worse since injection. No history of arm or joint issues.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Nausea, Vomiting
Clinical narrative: Nausea, vomiting and fatigue, soreness on injection site
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Patient was immunized and within 20 minutes of inject felt arm go numb and painful down to finger tips. Patient has been seen by 2 different providers, Dr and PA-C, to report injury.  Patient has also been seen by chiropractor, for continued pain and has requires 2 therapeutic massages to reduce the pain. Patient came back to the pharmacy today report left arm is still in pain from the immunization.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Allergic respiratory symptom, Chills, Cough, Dizziness, Gastrointestinal disorder
Clinical narrative: One week after receiving the latest Moderna Covid vaccine I started to get periodically, lasting to the present time, allergic type symptoms such as sneezing, coughing, itching, chills, light headedness, and digestive problems. I never had any such reactions like this, or any other reactions, from the five previous Moderna vaccines I received, nor from any other vaccines I've ever received.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Pruritus, Sneezing
Clinical narrative: One week after receiving the latest Moderna Covid vaccine I started to get periodically, lasting to the present time, allergic type symptoms such as sneezing, coughing, itching, chills, light headedness, and digestive problems. I never had any such reactions like this, or any other reactions, from the five previous Moderna vaccines I received, nor from any other vaccines I've ever received.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Irritable bowel syndrome, Rhinorrhoea, Sneezing
Clinical narrative: One week after receiving the latest Moderna Covid vaccine I started to get periodically, lasting to the present time, allergic type symptoms such as sneezing, coughing, itching, chills, light headedness, and digestive problems. I never had any such reactions like this, or any other reactions, from the five previous Moderna vaccines I received, nor from any other vaccines I've ever received.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Dermatitis contact, Injection site rash, Injection site urticaria, Rash macular
Clinical narrative: Pt developed hives at the injection site where the adhesive from the bandages were. Pt developed a macular rash that started on the thighs/groin area and spread to the rest of the body.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Pyrexia, Wrong product administered
Clinical narrative: Given vaccine Moderna age 12+ and child was 11 years old. Patient didn't have any major side effects in the office. Per Mom at home only had a fever.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: expired product given
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patient
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eye pain, Swelling of eyelid
Clinical narrative: Lower eyelid swelling and orbital socket pain, right eye only
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired vaccine given to pt
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to pt
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: expired vaccine given to patient
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patient
Age: 1.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: expired vaccine
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient given vaccine past the 30 day BUD. Vaccine was placed in the refrigerator on 10/19/2023, BUD 11/18/2023, vaccine given on 11/20/2023. Pt states that she has a bump on her arm and her arm is sore and there is some heat and itchiness but otherwise, she is doing ok.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Hep A was given by mistake at visit with PCP patient should have recieved a HBV, PCP was notified and spoke with family on 10/31/23 about vaccine error explained that recieving an extra Hep A not biologically harmful and can start Hep B series anytime the family is comfortable to do so
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC; inadvertent administration of PROQUAD to a patient after a temperature excursion that occurred on 10/12/2023; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-OCT-2023, a temperature excursion occurred on the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot# X007087, expiration date: 04-SEP-2024), which was stored at -12.4 degree Celsius for 18 minutes 0 seconds. There was no temperature excursion previously. On the same day, the patient was inadvertently vaccinated with the improper stored vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #X007087, expiration date: 04-SEP-2024 (strength, route of administration, and indication were not provided) (PT: Product storage error).
Age: 0.17
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inappropriate schedule of vaccine administered (Hep B vaccine administered on 20-MAR-2000 and on 13-SEP-2000); inappropriate schedule of vaccine administered (Hep B vaccine administered on 14-JAN-2000 and on 20-MAR-2000); This spontaneous report has been received from a physician, via medical records from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (2309USA001668), concerning a 4-month-old female patient.  Her medical history and concurrent conditions were not provided. Concomitant vaccinations included unspecified diphtheria vaccine toxoid (+) pertussis vaccine (+) tetanus vaccine toxoid (DTP), diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP), diphtheria vaccine toxoid (+) tetanus vaccine toxoid (DT) vaccines, unspecified polio vaccine (POLIO) and unspecified haemophilus b conjugate vaccine (meningococcal protein conjugate) manufacturer unknown.   On 14-JAN-2000, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown)intramuscular injection, administered for prophylaxis (exact dose, anatomical location, lot #, expiry date, and route of administration were not provided). On 20-MAR-2000, the patient received the second dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (exact dose, anatomical location, lot #, expiry date, and route of administration were not provided) (inappropriate schedule of product administration). On 13-SEP-2000, the patient received the third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (exact dose, anatomical location, lot #, expiry date, and route of administration were not provided) (inappropriate schedule of product administration).  This is one of several reports regarding the same patient.; Sender's Comments:  US-009507513-2309USA001668:Original Case
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: administered on 25-JUL-1991; This spontaneous report has been received from an other health professional, via a medical records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (2310USA002169), concerning a 11-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 03-DEC-1980, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) injection, administered for prophylaxis (strength, dose lot #, expiry date, and route of administration were not provided). On 01-JAN-1984, the patient was vaccinated with the 2nd dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown). On 25-JUL-1991, the patient was vaccinated with the 3rd dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (extra dose administered).; Sender's Comments:  US-009507513-2310USA002169:
Sex: F
Vaccine: PNC15
Symptoms: Accidental exposure to product, Blood test, Device safety feature issue, HIV test, Injury associated with device
Clinical narrative: The luer lock needle attachment snapped off causing the needle to go into her finger; stick/injury due to the VAXNEUVANCE breakage.; The luer lock needle attachment snapped off causing the needle to go into her finger; The luer lock needle attachment snapped off causing the needle to go into her finger; This solicited report was received from  a registered nurse (conflicting information reported as physician) referring to herself, a female patient.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 15-NOV-2023 (also reported as today), the nurse reported that she had another pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) 0.5 ml, injection PFS from the same lot (lot number X012044, has been verified to be valid, expiration date 10-JAN-2025) (route and anatomical location were not reported) that she administered successfully to a patient, however, when she went to close the flip cap over the needle, after applying just a little pressure to the flip cap, the luer lock needle attachment snapped off causing the needle to go into her finger (Accidental needle stick, occupational exposure while administering product, and inadvertent exposure to vaccine). Nurse reported they drew her blood after the needle stick to test for HIV and other bloodborne diseases (results not reported) and the mother of the patient who the pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection was administered to initially denied her child having any medical issues. The initial patient was able to receive the full dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection successfully and was uninjured. It was reported that the operator of device was a healthcare professional. Product was not available for retrieval and pictures were not available as this product had been discarded in the sharps container at this time.   This is one of the several cases from the same reporter.
Sex: F
Vaccine: PNC15
Symptoms: Occupational exposure to product
Clinical narrative: The luer lock needle attachment snapped off causing the needle to go into her finger; stick/injury due to the VAXNEUVANCE breakage.; The luer lock needle attachment snapped off causing the needle to go into her finger; The luer lock needle attachment snapped off causing the needle to go into her finger; This solicited report was received from  a registered nurse (conflicting information reported as physician) referring to herself, a female patient.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 15-NOV-2023 (also reported as today), the nurse reported that she had another pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) 0.5 ml, injection PFS from the same lot (lot number X012044, has been verified to be valid, expiration date 10-JAN-2025) (route and anatomical location were not reported) that she administered successfully to a patient, however, when she went to close the flip cap over the needle, after applying just a little pressure to the flip cap, the luer lock needle attachment snapped off causing the needle to go into her finger (Accidental needle stick, occupational exposure while administering product, and inadvertent exposure to vaccine). Nurse reported they drew her blood after the needle stick to test for HIV and other bloodborne diseases (results not reported) and the mother of the patient who the pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection was administered to initially denied her child having any medical issues. The initial patient was able to receive the full dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection successfully and was uninjured. It was reported that the operator of device was a healthcare professional. Product was not available for retrieval and pictures were not available as this product had been discarded in the sharps container at this time.   This is one of the several cases from the same reporter.
Age: 24.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient did not experience any issues or side effects; expired; This spontaneous report was received from a pharmacy technician and referred to a 24-year-old male patient. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 17-NOV-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milligram, lot #W007035, expiration date: 20-OCT-2023, administered intramuscularly via injection in left deltoid for prophylaxis (strength was not provided). The patient did not experience any issues or side effects (no adverse event, Expired vaccine used). The dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) had not been exposed to any previous temperature excursions and was supported on the Post Expiry Memo Vaccines and Biologics Administered and the appropriate disclaimer was provided to the reporter.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; A HCP called to report that a dose of PNEUMOVAX 23 was inadvertently administered to a patient today (11/17/2023) that expired on 10/20/2023.  The patient did not experience any issues or side effects.  The dose of PNEUMOVAX 23 had not been exposed t; This spontaneous report was received from physician and refers to a 35-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-NOV-2023, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter in left deltoid, (lot# was reported as W029647 which was verified as invalid, expiration date reported as 20-OCT-2023), administered for prophylaxis (strength and route of administration were not provided). The patient did not experience any issues or side effects. The dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) had not been exposed to any previous temperature excursions and was supported on the post expiry memo vaccines and biologics administered. No PQC.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The paramedic is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) PROQUAD x019557   1/19/2025 Temperature: 5.6C Time frame:; This spontaneous report was received from a paramedic and refers to a patient of unknown age nad gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-NOV-2023, the patient was vaccinated with impeoper stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, lot #x019557, expiration date: 19-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion in 5.6 degree Celsius for 3 hours (product storage error). No additional adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pharmacist confirmed that the patient has reported no additional AEs.; Pharmacist reported that an expired dose of GARDASIL 9 (expiration date 30OCT2023) was administered to a patient at their pharmacy on 17NOV2023. Pharmacist confirmed that the patient has reported no additional AEs. No PQC/additional AE reported.; This spontaneous report has been received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 17-NOV-2023, the patient was vaccinated an expired vaccine of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (valid lot number U019412 [expiration date 30-OCT-2023]) (dose, dose number, frequency, route of administration, anatomical location, and vaccination scheme were not provided) for prophylaxis (expired product administered).   The reporter confirmed that the patient had reported no additional adverse events (AEs).
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: After Receiving Heplisav-B Series , A Few Years Ago Titers Are Showing No Immunity; Initial Report Received on 19-Jul-2023   A physician reported to a sales representative that she, a female patient (race and ethnicity not provided), received the HEPLISAV-B (hepatitis B vaccine) series for hepatitis B immunization a few years ago and her titers showed no immunity.     No medical history, allergies, or concomitant medications at the time of vaccination were reported.    On unknown dates, the patient received the HEPLISAV-B series (Lot #s, expiration dates, NDC #s, route, and injection sites were not reported) when she started work at a hospital a "few years ago."     On an unknown date, she recently had a titer drawn and it showed no immunity to hepatitis B.    The patient declined to provide further information.   Company Comment: The company assessed the event as non-serious and not immunologically confirmed for vaccine failure. The dosing schedule and serological marker are not specified, and the time to titer was a "few years ago".; Sender's Comments: The company assessed the event as non-serious and not immunologically confirmed for vaccine failure. The dosing schedule and serological marker are not specified, and the time to titer was a "few years ago".
Sex: U
Vaccine: HEP
Symptoms: Incorrect route of product administration, Product administration error
Clinical narrative: 2nd dose of Heplisav-B SQ By Error; Initial report received on 07-Aug-2023    A registered nurse reported that a 60-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   No medical history, allergies, or concomitant medications were reported.     On 10-Jul-2023, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not reported).  On an unknown date, the patient received the second dose of HEPLISAV-B (Lot # 941581, expiration date 18-Jan-2025, NDC # 43528-003-05) subcutaneously by error in the right arm.     No additional information was provided.     Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Received First Dose of Heplisav-B, and 2nd Does of Twinrix; IInitial report received on 14-Aug-2023  A registered nurse reported that a 25-year-old patient (gender, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first injection and Twinrix (hepatitis A and hepatitis B vaccine) as the second injection.  No relevant medical history, concomitant medications, or allergies at the time of vaccination were reported.  On 30-Jun-2023, the patient received the first dose of HEPLISAV-B (Lot # 942761, expiration date 31 Aug-2025, NDC # not available) intramuscularly in the left deltoid.  On 14-Aug-2023, 46 days after having been vaccinated with HEPLISAV-B, the patient received Twinrix (no details were provided) as the second injection.     No additional information was provided.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.   ?
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Temperature Excursion; Initial report received on 24-Aug-2023.  A certified medical assistant reported that a 35-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after a temperature excursion occurred.   No relevant medical history was reported.  No relevant concomitant medications were reported.    On 17-Jul-2023, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, route, site, and NDC # not reported). On 21-Aug-2023, the patient received the second dose of HEPLISAV-B (Lot # 941428, expiration date: 30-Aug-2025 and NDC # 43528-003-01; route not reported) in the left arm.   On 21-Aug-2023, the patient received HEPLISAV-B after a temperature excursion occurred. No adverse effects were reported.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Temperature Excursion; Initial report received on 24-Aug-2023.  A certified medical assistant reported that a 44-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after a temperature excursion occurred.   No relevant medical history was reported.  No relevant concomitant medications were reported.    On 13-Jul-2023, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, route, site, and NDC # not reported). On 21-Aug-2023, the patient received the second dose of HEPLISAV-B (Lot # 941428, expiration date: 30-Aug-2025 and NDC # 43528-003-01; route not reported) in the left arm.   On 21-Aug-2023, the patient received HEPLISAV-B after a temperature excursion occurred. No adverse effects were reported.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Temperature Excursion; Initial report received on 24-Aug-2023.  A certified medical assistant reported that a 37-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after a temperature excursion occurred.   No relevant medical history was reported.  No relevant concomitant medications were reported.    On 12-Jun-2023, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, route, site, and NDC # not reported). On 21-Aug-2023, the patient received the second dose of HEPLISAV-B (Lot # 941428, expiration date: 30-Apr-2025 and NDC # 43528-003-01; route not reported) in the left arm.   On 21-Aug-2023, the patient received HEPLISAV-B after a temperature excursion occurred. No adverse effects were reported.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Temperature Excursion; Initial report received on 24-Aug-2023.  A certified medical assistant reported that a 49-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after a temperature excursion occurred.   No relevant medical history was reported.  No relevant concomitant medications were reported.    On 17-Apr-2023, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, route, site, and NDC # not reported). On 21-Aug-2023, the patient received the second dose of HEPLISAV-B (Lot # 941428, expiration date: 30-Apr-2025 and NDC # 43528-003-01; route not reported) in the left arm.   On 21-Aug-2023, the patient received HEPLISAV-B after a temperature excursion occurred. No adverse effects were reported.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Temperature Excursion; Initial report received on 24-Aug-2023.  A certified medical assistant reported that a 50-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after a temperature excursion occurred.   No relevant medical history was reported.  No relevant concomitant medications were reported.    On 21-Aug-2023, the patient received the first dose of HEPLISAV-B (Lot # 941428, expiration date: 30-Apr-2025 and NDC # 43528-003-01; route not reported) in the left arm.   On 21-Aug-2023, the patient received HEPLISAV-B after a temperature excursion occurred. No adverse effects were reported.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Received First Dose of Heplisav-B, and Second Dose Engerix; Initial Report Received on 07-Sep-2023  A pharmacist reported that a 45-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and ENGERIX B as the second dose.  The patient has no allergies and has had no previous reactions to other vaccines.  No concomitant medications were reported.    On 21-Feb-2023, the patient received HEPLISAV-B (Lot #941054, expiration date 23-Nov-2024, NDC # 43528-003-05) in the right deltoid as the first dose for hepatitis B immunization. On 16-Aug-2023, the patient received ENGERIX B (no Lot # or expiration date were reported) in the left deltoid as the second dose for hepatitis B immunization.  No adverse events were reported.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No adverse event
Clinical narrative: Received 2 Doses of The Series, Titer Was Drawn 28 Days Was Negative; Initial report received on 20-Sep-2023  A pharmacy intern reported that a 22-year-old male patient (race and ethnicity not provided) received a series of 2 doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and had a negative titer 28 days after the second dose of HEPLISAV-B.  Medical history, allergies, and concomitant medications at the time of vaccination were not reported.   On 26-Jul-2023, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, and route not reported) in the right arm.  On 23-Aug-2023, 29 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot # 941590, expiration date 31-Aug-2025, NDC # 43528-003-05; injection site not reported) intramuscularly.   On 19-Sep-2023, 28 days after having been vaccinated with second dose of HEPLISAV-B, the patient had a titer drawn, which was negative. No adverse effects were reported.  No additional information was provided.  Company Comment:  The company considers the event as non-serious, and not immunologically confirmed for vaccine failure as the serological marker was not specified.; Sender's Comments: The company considers the event as non-serious, and not immunologically confirmed for vaccine failure as the serological marker was not specified.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired 2nd Dose Given of the Series; Initial Report Received on 26-Sep-2023  A retail pharmacist reported that a 69-year-old female patient (race and ethnicity unknown) was given an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and it was the 2nd dose of the series.  Medical history and allergies at the time of vaccination were not reported. Medications at the time of vaccination were not reported.  On 21-Aug-2023, the patient received the first dose of HEPLISAV-B vaccine (Lot # 937228, expiration date 30-Aug-2023, NDC # 43528-003-05) intramuscularly in the right arm.  On 26-Sep-2023, the patient received an expired second dose of HEPLISAV-B vaccine (Lot # 937228, expiration date 30-Aug-2023, NDC # 43528-003-05) intramuscularly in the right arm. No adverse reactions were experienced by the patient to the reporter's knowledge.    No further information was provided.  Company Comment:  The company considers the event as non-serious.; Sender's Comments: The company considers the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Chest discomfort
Clinical narrative: feel like i have a lump in my chest almost like heartburn; This non-serious case was reported by a consumer via call center representative and described the occurrence of chest abnormal feeling of in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced chest abnormal feeling of (Verbatim: feel like i have a lump in my chest almost like heartburn). The outcome of the chest abnormal feeling of was not reported.   It was unknown if the reporter considered the chest abnormal feeling of to be related to Shingles vaccine.     It was unknown if the company considered the chest abnormal feeling of to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 13-NOV-2023 The patient self-reported this case. The patient felt like he/she had a lump in his/her chest almost like heartburn since taking the 2nd Shingles shot. The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Probable 3rd dose; first dose was given in December 2022 and the second in September 2023, longer than recommended interval.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received in December 2022).   On 07-NOV-2023, the patient received the 3rd dose of Shingrix. On 01-SEP-2023, the patient received the 2nd dose of Shingrix. On 01-SEP-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first dose was given in December 2022 and the second in September 2023, longer than recommended interval.). On 07-NOV-2023, the patient experienced extra dose administered (Verbatim: Probable 3rd dose). The outcome of the drug dose administration interval too long and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 07-NOV-2023 The reporter asked about Shingrix and available information about the administration of their dose of Shingrix.  The reporter reported that the second was given longer than recommended interval, which led to lengthening of vaccination schedule and the patient received the probable 3rd dose, which led to extra dose administered. The reporter did not consent to follow-up.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Live birth, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 39 year old patient who received Arexvy while pregnant; Live birth; 39 year old patient who received Arexvy while pregnant; This non-serious retrospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 39-year-old female 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 vaccine exposure during pregnancy (Verbatim: 39 year old patient who received Arexvy while pregnant), live birth (Verbatim: Live birth) and inappropriate age at vaccine administration (Verbatim: 39 year old patient who received Arexvy while pregnant). The outcome of the vaccine exposure during pregnancy, live birth and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Live neonate with no apparent congenital anomaly   Additional Information: GSK receipt date: 13-Nov-2023 Pharmacist had a patient who received Arexvy while pregnant (no date was available).  She already delivered and nursing the patient. No other details were available. Did not consent to follow-up. The pregnant patient received a dose of Arexvy at an inappropriate age, which led to vaccine exposure during pregnancy, inappropriate age at vaccine administration.
Sex: F
Vaccine: DTAP
Symptoms: Product storage error
Clinical narrative: Administration after exposure to freezing temperature; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old female patient who received DTPa (Infanrix) (batch number 9R2D7, expiry date 23-MAY-2025) for prophylaxis.   On 08-NOV-2023, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced incorrect storage of drug (Verbatim: Administration after exposure to freezing temperature). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-NOV-2023 An HCP contacted GSK via phone inquiring about Infanrix and what information was available about the administration of Infanrix after the vaccines were exposed to freezing temperatures and administered which led to incorrect storage of vaccine. They gave partial information about vaccines, patient and event. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late second dose in October 2023; 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 72-year-old male patient who received HBV (Engerix B) (batch number 79S54, expiry date 04-APR-2025) for prophylaxis.   Previously administered products included Engerix B (received first dose in July 2023). Concomitant products included hepatitis B vaccine rhbsag (yeast) (Engerix B).   In OCT-2023, the patient received the 2nd dose of Engerix B. In OCT-2023, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: late second dose in October 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 13-NOV-2023 A pharmacist reported that a patient received two doses of Engerix-B in which 2nd dose was taken too late. No specific vaccination date was reported. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up. The patient received 2nd dose of Engerix B later than the recommended interval, which led to lengthening of vaccine schedule.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: received a extra dose 12-JAN-2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number G9N2M) for prophylaxis.   Previously administered products included Kinrix (On 10th February 2022, received dose). Additional patient notes included the patient was asymptomatic..   On 12-JAN-2023, the patient received Kinrix. On 12-JAN-2023, an unknown time after receiving Kinrix, the patient experienced extra dose administered (Verbatim: received a extra dose 12-JAN-2023). 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: 13-NOV-2023 The reporter reported that the patient received extra dose of Kinrix, which led to extra dose administered. The patient was asymptomatic. The reporter consented to follow up.