chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Electrocardiogram ambulatory
Clinical narrative: Re-appearance of Afib following 4 years post ablation without any Afib detected. Rapid Afib began about 24 hours following vaccination.; 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 (BNT162B2), on 08Jun2022 at 10:30 as dose 3 (booster), single (Lot number: FN2908) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure: under med, control.; "medical tape adhesives" (unspecified if ongoing), notes: known allergies: some medical tape adhesives,Amlodipine. Concomitant medication(s) included: LISINOPRIL; HCT; ATORVASTATIN. Past drug history included: Amlodipine, reaction(s): "Drug allergy", notes: known allergies: some medical tape adhesives,Amlodipine. Vaccination history included: covid-19 vaccine (Vaccine Brand: Johnson & Johnson, Dose Number: 1, Batch/Lot No: 1805018, Vaccine Administration Date: 13Mar2021, Vaccine Administration Time: 09:00, Location of injection: Arm Right), administration date: 13Mar2021, when the patient was 69-year-old, for COVID-19 immunisation; moderna covid-19 vaccine (Vaccine Brand: Moderna, Dose Number: 2, Batch/Lot No: 051F21A, Vaccine Administration Date: 12Nov2021, Vaccine Administration Time: 17:00, Location of injection: Arm Left), administration date: 12Nov2021, when the patient was 70-year-old, for COVID-19 immunisation. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 09Jun2022 at 10:45, outcome "not recovered", described as "Re-appearance of Afib following 4 years post ablation without any Afib detected. Rapid Afib began about 24 hours following vaccination.". The event "re-appearance of afib following 4 years post ablation without any afib detected. rapid afib began about 24 hours following vaccination." required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Electrocardiogram ambulatory: (2022) Unknown results, notes: Now on Holter monitor @24 hours. Therapeutic measures were taken as a result of atrial fibrillation with unspecified medication. The patient did not receive any other vaccines within four weeks prior to the vaccination.. Visited ER on 2 successive days. Stress Echocardiogram in 2 weeks to see if he was still a candidate for another Ablation procedure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest discomfort, Nasal congestion, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: Caller states "my husband and I both had 4 Pfizer Covid19 shots; Caller states "my husband and I both had 4 Pfizer Covid19 shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Caller states "my husband and I both had 4 Pfizer Covid19 shots". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course includes, patient who started taking Paxlovid yesterday and had her 3rd dose this morning. Patient stated my husband and I both had 4 Pfizer Covid19 shots. she had developed a strong persistent nasty metallic taste in her mouth which is stronger at night when she stopped drinking and doesn't go away. Patient asked was that a side effect of Paxlovid or was that because she had a lot of fillings in her mouth. Patient asked was that ok to take a Tums/Calcium Carbonate while taking Paxlovid. Paxlovid has made both feel better after the first 2 doses.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller states "my husband and I both had 4 Pfizer Covid19 shots; Caller states "my husband and I both had 4 Pfizer Covid19 shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Caller states "my husband and I both had 4 Pfizer Covid19 shots". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course includes, patient who started taking Paxlovid yesterday and had her 3rd dose this morning. Patient stated my husband and I both had 4 Pfizer Covid19 shots. she had developed a strong persistent nasty metallic taste in her mouth which is stronger at night when she stopped drinking and doesn't go away. Patient asked was that a side effect of Paxlovid or was that because she had a lot of fillings in her mouth. Patient asked was that ok to take a Tums/Calcium Carbonate while taking Paxlovid. Paxlovid has made both feel better after the first 2 doses.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 89.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine administered that went under temperature excursion of plus1.9C to  plus 6.4 C; Vaccine administered that went under temperature excursion of Plus1.9C to  plus6.4 C; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion of plus1.9C to  plus 6.4 C) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion of Plus1.9C to  plus6.4 C) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     Patient allergies were none.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion of Plus1.9C to  plus6.4 C). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion of plus1.9C to  plus 6.4 C). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion of plus1.9C to  plus 6.4 C) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion of Plus1.9C to  plus6.4 C) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. 2 doses/vials were impacted (1 punctured and 1 not punctured).  The vial moved from freezer to refrigerator on 08-Jun-2022 and 1 vial 15-Jun-2022. The vial was first punctured on 15-Jun-2022 at 9.15 AM. The vial was stored in portable fridge post puncture.  The vial undergoes temperature excursions on +1.9C to +6.4 C. Excursion duration was 15 min. If unknown, was the vial exposed to room temperature for greater than 24 hours. All were in fridge. The visual inspection noted vaccine state change stated to thawed. The proposed desired use by date was stated as afternoon. No treatment information was reported.   This case was linked to MOD-2022-589894 (Patient Link).
Age: 89.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered that went under temperature excursion of plus1.9C to  plus 6.4 C; Vaccine administered that went under temperature excursion of Plus1.9C to  plus6.4 C; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion of plus1.9C to  plus 6.4 C) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion of Plus1.9C to  plus6.4 C) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     Patient allergies were none.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion of Plus1.9C to  plus6.4 C). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion of plus1.9C to  plus 6.4 C). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion of plus1.9C to  plus 6.4 C) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion of Plus1.9C to  plus6.4 C) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. 2 doses/vials were impacted (1 punctured and 1 not punctured).  The vial moved from freezer to refrigerator on 08-Jun-2022 and 1 vial 15-Jun-2022. The vial was first punctured on 15-Jun-2022 at 9.15 AM. The vial was stored in portable fridge post puncture.  The vial undergoes temperature excursions on +1.9C to +6.4 C. Excursion duration was 15 min. If unknown, was the vial exposed to room temperature for greater than 24 hours. All were in fridge. The visual inspection noted vaccine state change stated to thawed. The proposed desired use by date was stated as afternoon. No treatment information was reported.   This case was linked to MOD-2022-589894 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eyelid oedema, Skin lesion
Clinical narrative: Lower eyelid edema with internal lesions resembling styes.  Bilateral, chronic, and/or recurring with a minimum of 4 instances.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: Swollen eye every other week
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Haematocrit decreased, Haemoglobin decreased, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Uterine Shredding- Extremely, extremely heavy menstrual bleeding that occurred outside of my normal menstrual cycle which are very regular.  This was the first booster shot.  This heavy bleeding also occurred with my 2nd dose in April of 2021 but I did not report it because I was not completely sure if was from the vaccine.  Now that the heavy bleeding occurred again with the booster I KNOW it was related to the COVID vaccine.  I heard others also experienced the same heavy periods once I expressed my experience with some of my female co-workers.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Cardiac monitoring, Electrocardiogram, Laboratory test, Palpitations
Clinical narrative: Heart flutters/palpitations started as I was leaving the clinic.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Atrial fibrillation, Cardiac valve disease, Concussion, Depressed level of consciousness
Clinical narrative: Atrial Fibulation
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Fall, Fatigue, Head injury
Clinical narrative: Atrial Fibulation
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Surgery
Clinical narrative: Atrial Fibulation
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The time interval between second dose and third dose exceeded 25-35 days timeline) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A, 008B21A and 011A21A) for COVID-19 vaccination. The patient's past medical history included Knee replacement on 26-Jan-2022. Concurrent medical conditions included Gluten sensitivity, Lactose intolerance, Drug allergy (Several Antibiotics.), Hodgkin's lymphoma, Immunocompromised, Blood pressure high (Diagnosed in 2016-2017) and Cancer. Concomitant products included HYDROCHLOROTHIAZIDE, ASPIRIN [ACETYLSALICYLIC ACID], FISH OIL, MULTIVITAMINS [VITAMINS NOS], MAGNESIUM OXIDE, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), PYRIDOXINE HYDROCHLORIDE (VITAMIN B-6), COLECALCIFEROL (VITAMIN D 3), IMMUNOGLOBULIN HUMAN NORMAL (GAMUNEX) and SELENIUM for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The time interval between second dose and third dose exceeded 25-35 days timeline). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The time interval between second dose and third dose exceeded 25-35 days timeline) outcome was unknown. It was reported that the patient did not experience any COVID or was tested positive. Consumer received 3rd full dose because of cancer and immunocompromise. No treatment medication was provided. This case was linked to MOD-2022-590654 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Procedural pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The time interval between second dose and third dose exceeded 25-35 days timeline) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A, 008B21A and 011A21A) for COVID-19 vaccination. The patient's past medical history included Knee replacement on 26-Jan-2022. Concurrent medical conditions included Gluten sensitivity, Lactose intolerance, Drug allergy (Several Antibiotics.), Hodgkin's lymphoma, Immunocompromised, Blood pressure high (Diagnosed in 2016-2017) and Cancer. Concomitant products included HYDROCHLOROTHIAZIDE, ASPIRIN [ACETYLSALICYLIC ACID], FISH OIL, MULTIVITAMINS [VITAMINS NOS], MAGNESIUM OXIDE, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), PYRIDOXINE HYDROCHLORIDE (VITAMIN B-6), COLECALCIFEROL (VITAMIN D 3), IMMUNOGLOBULIN HUMAN NORMAL (GAMUNEX) and SELENIUM for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The time interval between second dose and third dose exceeded 25-35 days timeline). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The time interval between second dose and third dose exceeded 25-35 days timeline) outcome was unknown. It was reported that the patient did not experience any COVID or was tested positive. Consumer received 3rd full dose because of cancer and immunocompromise. No treatment medication was provided. This case was linked to MOD-2022-590654 (Patient Link).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AEs were reported; Pharmacist reported that a patient was given an expired MMR II vaccine on 05/20/2022.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-MAY-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 1 dose, lot # t003384, expiration date: 28-JAN-2022, administered for prophylaxis (strength, exact dose and route of administration were not provided) (expired product administered).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Nurse calling for TE evaluation states dose of VARIVAX was administered to a patient. Temperature 8F for 16 hours; no additional AE details; 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 were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # U020244, expiration date: 28-JUN-2023, administered for prophylaxis (strength, exact dose and route of administration were not provided) (product storage error).  Administered dose of vaccine experienced the temperature excursion of 8 degrees Fahrenheit for 16 hours.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; Improperly stored vaccine adminsistered; This spontaneous report has been received from an other, referring to a patient of unknown age and gender. The patient's historical condition and current condition were not reported. Concomitant therapy included sterile diluent.   On an unknown date in May 2022 (reported as between 11-MAY-2022 and 24-MAY-2022), the patient was vaccinated with a varicella virus vaccine live (oka/merck) (VARIVAX)(lot#U039949 with expiration date: 16-DEC-2023; dose, strength and route were not reported) that underwent a temperature excursion (TE) (Product storage error).   Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion below -14 degree Celsius (C) up to-10C for 2 hours 5 minutes 0 seconds ; -10C up to 8C (-0.4C) for 1 hour 25 minutes 0 seconds. Previous temperature excursions reported as -14C up to-10C (-12C) for 0 hours 50 minutes 0 seconds. No additional adverse event (AE) details.  This one of the thirteen reports from the same reporter.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; the temperate excuration occurred, vaccines have been administered; This spontaneous report was received from a medical assistant and referred to 1-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-MAR-2022, the temperate excursion occurred to varicella virus vaccine live (oka/merck) (VARIVAX). The vaccines underwent temperature excursion of -14 degrees Celsius up to -10 degrees Celsius during a time frame of 3 hours; -10 degrees Celsius up to 8 degrees Celsius during a time frame of 1 hour and 30 minutes. There was no previous temperature excursion.  On 25-APR-2022, at a private doctor's officer/hospital, the patient was vaccinated by a healthcare professional with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (valid lot # U025790 with expiration date: 19-AUG-2023; dose not provided) administered subcutaneously for prophylaxis (product storage error). This initially used vaccine was not available for return/evaluation due to being given to the patient. There was no prescription drug treatment for the experience required. No adverse event was reported (no adverse event).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2204USA009330:
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details/ What was the patient's response?: None; temp excursion/ TE evaluation states vaccines have been administered; This spontaneous report as received from a certified medial assistant refers to a 6-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. The patient did not have any illness at the time of vaccination.  On 23-MAR-2022, a virus vaccine live (oka/merck) (VARIVAX), lot # U025790, expiry date 19-AUG-2023, experienced a temperature excursions of -14 degrees Celsius (C) up to -10 degrees C for 3 hours, and -10 degrees C up to 8 degrees C for 1 hours 30 minutes. There was not previous excursion.  On 25-APR-2022, the patient was vaccinated by a healthcare professional at the private doctor's office/hospital with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX), which experienced above mentioned temperature excursion (product storage error), lot # and expiry date as above, subcutaneously (SQ) for prophylaxis. It was reported that there was no patient's response. No additional adverse event details were reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA009330: US-009507513-2205USA008051: US-009507513-2205USA008004: US-009507513-2205USA007852: US-009507513-2205USA007821:
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: no adverse event; patient received PROQUAD instead of MMR II; patient received PROQUAD instead of MMR II; This spontaneous report was received from a medical assistant referring to a 30-year-old female.  The patient's concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 27-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 1 dose, (lot #U029319 has been verified to be valid, expiration date 19-MAR-2023, administered for prophylaxis (strength, and route of administration were not provided) (product administered to patient of inappropriate age), instead of received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Wrong product administered) this was supposed to be her first dose of the M-M-R II vaccine. It was reported that the patient had a previous positive varicella titer but it was unknown if she had natural immunity or vaccine-induced immunity. No adverse event was reported.
Age: 29.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: A patient called and reported an AE. The patient stated that she was supposed to receive TDap but instead received GARDASIL 9 while being pregnant. No additional AEs were reported. No further information provided; A patient called and reported an AE. The patient stated that she was supposed to receive TDap but instead received GARDASIL 9 while being pregnant. No additional AEs were reported. No further information provided; A patient called and reported an AE. The patient stated that she was supposed to receive TDap but instead received GARDASIL 9 while being pregnant. No additional AEs were reported. No further information provided; This spontaneous report has been received from the patient referring to herself a 29-year-old pregnant female patient. Information regarding the patient's historical conditions, past drugs reactions or allergies, concurrent conditions or concomitant therapies was not provided. The patient became pregnant with last menstrual period (LMP) calculated as 20-NOV-2021 (and estimated date of delivery (EDD) of 01-SEP-2022), based on a pregnancy gestation reported as 28 weeks at the time of the report.  On 03-JUN-2021, the patient was supposed to receive diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) but instead received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (formulation, strength, dose, vaccination scheme, route of administration and anatomical location, indication, lot number and expiration date were not provided) while being pregnant (wrong product administered, exposure during pregnancy). At the time of the report, the pregnancy outcome was pending, the fetal outcome was not provided, and the patient did not experience any additional adverse events.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The caller said they have a patient who had received a second dose of PNEUMOVAX 23 by mistake.; redness, swelling and pain at injection site; redness, swelling and pain at injection site; redness, swelling and pain at injection site; This spontaneous report was received from a customer referring to a 32-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions included  depression,  anxiety,  sulfonamide allergy,  latex allergy,  allergic rhinitis, and drug hypersensitivity to sumatriptan (IMITREX). Concomitant medications included methylprednisolone acetate (MEDROL), zinc gluconate, cyanocobalamin (VITAMIN B12), vitamin d3, iron , aripiprazole (ABILIFY), levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC ), venlafaxine hydrochloride (EFFEXOR), hydroxyzine embonate (VISTARIL), paracetamol (TYLENOL), multivitamins (unspecified), ondansetron (ZOFRAN), omeprazole (PRILOSEC) and ibuprofen.   On 10-DEC-2020, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). Then, on 18-MAY-2022, the patient went to the clinic and received a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) instead of ''pneumococcal 15 or 20'' (interchanged of vaccine products).   Then on an unspecified date in May 2022, the patient developed redness, swelling and pain at the injection site (left deltoid muscle). On 19-MAY-2022, the patient went to the emergency room for these symptoms but it was confirmed that the patient was not admitted to the hospital. The patient was seen at the clinic on 20 and 23 of May 2022. On 23-MAY-2022, the patient recovered from the events of  redness, swelling and pain at the injection site.   The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details provided; Temperature BELOW 2°C (1.3C) for 0 hours 25 minutes and 0 seconds/One dose of GARDASIL 9 was administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-JUN-2022, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot # 1775808, expiration date: 20-AUG-2023, administered for prophylaxis (strength, anatomical location, and route of administration were not provided). The vaccine experienced a temperature excursion of 1.3 degrees Celsius for 25 minutes (product storage error). There was no previous temperature excursion. No additional adverse event details provided (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse calling for TE evaluation on frozen products states products have been administered.     Names of vaccines involved (including lot/exp) VARIVAX   U033046   10/20/2023        ?    Temperature 6°F up to 14°F (8F) for 0 hours 18 minutes 0 seco; No additional AE details.; This spontaneous report was received from a nurse referring to a 2-year-old.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U033046, expiration date: 21-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided); which was reconstituted with sterile diluent (STERILE DILUENT)(product storage error).  The administered dose of the vaccine was stored with the lowest temperature of 6 degrees Fahrenheit up to 14 degrees Fahrenheit (mean of 8 degrees Fahrenheit) for 0 hours and 18 minutes 0 seconds; and  with the lowest temperature of 14 degrees Fahrenheit up to 46 degrees Fahrenheit (mean of 18.4 degrees Fahrenheit) for 0 hours and 45 minutes 0 seconds. There was no previous temperature excursion. No additional adverse events.; Sender's Comments:  US-009507513-2206USA002264: US-009507513-2206USA002231:
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event, Product storage error
Clinical narrative: No additional AE information reported; GARDASIL 9 was out of refrigeration for 24 hours before administration; This spontaneous report was received from a consumer referring to his daughter, an adult female patient who was 26 years old at the time of the report. The patient's pertinent medical history, concomitant medications, concurrent conditions and previous drug reactions or allergies were not reported.   On an unspecified date in January 2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection (exact dose, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis.   The vaccine was out of refrigeration (room temperature) for 24 hours before administration (product storage error). It was reported that the patient did not receive the second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). In addition, the reporter stated that the patient did not have a primary care provider. No additional adverse event information was reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional AEs or PQC reported.; Caller reports vaccine administered after temperature excursion.  No other information provided.  No additional AEs or PQC reported.     Include in the Description (cut and paste with responses) details of the improperly stored temperature excursion.; This spontaneous report was received from  a medical assistance and referred to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 02-JUN-2022, the patient was vaccinated with an improperly dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, lot #U034712, expiration date: 30-JUL-2023, administered intramuscularly for prophylaxis (strength was not provided)(product storage error).   The administered dose of the vaccine was stored with the temperature of 34.2 degrees Fahrenheit, the time frame was 12 hours. There was no previous temperature excursion. No adverse effect reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported; Caller reports vaccine administered after temperature excursion.  No other information provided.  No additional AEs or PQC reported.        ?    Names of vaccines involved (including lot/exp) PNEUMOVAX 23  U034712  7/30/2023        ?    Temperatu; This spontaneous report was received from  a medical assistance, referring to a patient of unknown age and gender.   The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 07-JUN-2022, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, lot #U034712, expiration date: 30-JUL-2023, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine was stored with the temperature of 34.2 degrees Fahrenheit, the time frame was 12 hours. There was no previous temperature excursion. No adverse effect reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported.; Caller reports vaccine administered after temperature excursion.  No other information provided.  No additional AEs or PQC reported.        ?    Names of vaccines involved (including lot/exp) PNEUMOVAX 23  U034712  7/30/2023        ?    Temperatu; This spontaneous report was received from a medical assistance, referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 09-JUN-2022, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 ml im, lot #U034712, expiration date: 30-JUL-2023, administered for prophylaxis (strength, and route of administration were not provided).  The administered doses of the vaccines were stored with the temperature of 34.2 degrees Fahrenheit, the time frame was 12 hours. There was no previous temperature excursion. No adverse effect reported.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: ROTATEQ was administered to a patient on 06/09/2022. No additional AE information. No additional AEs/no PQCs.; Medical Assistant calling in to report a temperature excursion; This spontaneous report has been received from a medical assistant, referring to a 8-weeks-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, allergies or concomitant medications were not reported.  On 09-JUN-2022, the patient was vaccinated with rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) for prophylaxis (dose, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number, and expiration date were not reported), following a temperature excursion (product storage error). No additional AEs/no PQCs were reported (no adverse event).
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient had no adverse effects or symptoms from receiving this dose; an adult patient received a 0.5 ml dose of VAQTA rather than the 1 ml dose; This spontaneous report was received from a nurse referring to a 19 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.   On 07-JUN-2022, the patient received a 0.5 ml dose of hepatitis a vaccine, inactivated (VAQTA) rather than the 1 ml dose (lot number U033212 with expiration date 07-NOV-2022) (inappropriate dose of vaccine administered). The patient had no adverse effects or symptoms from receiving this dose.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Medical assistant calling to report administered vaccine temperature excursion on multiple patients. Per caller vaccines went out of range yesterday and it was not discovered until this morning when checking the data logger. Multiple AE's filed. See; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 13-JUN-2022, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot # U0326586, expiry date 21-OCT-2023) (strength, and route of administration were not provided) administered for prophylaxis (Product storage error). Lot number U0326586 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  Administered dose of vaccine experienced the temperature excursion. It was reported that the vaccine went out of range on 13-JUN-2022 (reported as "yesterday") and it was not discovered until the morning on 14-JUN-2022 when checking the data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA004154: US-009507513-2206USA004187: US-009507513-2206USA004337: US-009507513-2206USA004511: US-009507513-2206USA004506: US-009507513-2206USA004557:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Caller reported VARIVAX administered after temperature excursion.; This spontaneous report was received from an administrator and refers to patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. There was no information regarding the patient's allergies or drug reactions.   On 20-MAY-2022, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0,5 ml, administered subcutaneously, lot #U022321, expiration date: 15-JUL-2023, (strength and anatomical location were not provided) for prophylaxis (product storage error). No additional adverse events was provided (no adverse event).  For varicella virus vaccine live (oka/merck) (VARIVAX), temperature excursion was reported as 6 Fahrenheit (F) degrees for 30 minutes. There was no previous temperature excursion reported.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional AE; Caller reported that M-M-R II, ROTATEQ and VAQTA that underwent temperature excursions were administered/VAQTA - ED: 6/1/2022; This spontaneous report was received from a pharmacist and refers to a patient of unknown age ang gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 01-JUN-2022, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, unk, lot #W002889, expiration date: 06-MAR-2023, administered for prophylaxis (strength, anatomical location and route of administration were not provided).  The vaccine was stored at the temperature that was reported as above 47 degrees of Fahrenheit (46.9 F) for 25 minutes. There was a previous temperature excursion reported as above 47 F (47.2 F) for 25 minutes.  No additional adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2206USA000873: US-009507513-2206USA005640:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional AE; Caller reported that M-M-R II, ROTATEQ and VAQTA that underwent temperature excursions were administered/VAQTA - HGS: 5/31/2022; This spontaneous report was received from a pharmacist and refers to a patient of unknown age ang gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 31-MAY-2022, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, unk, lot #W002889, expiration date: 06-MAR-2023, administered for prophylaxis (strength, anatomical location and route of administration were not provided).  The vaccine was stored at the temperature that was reported as above 47 degrees of Fahrenheit (46.9 F) for 25 minutes. There was a previous temperature excursion reported as above 47 F (47.2 F) for 25 minutes.  No additional adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2206USA005639: US-009507513-2206USA000873:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental overdose, Exposure via skin contact, Syringe issue
Clinical narrative: probably received 50% of it, almost half of dose leaked out of arm; was dripping out of her arm; vaccine was dripping out of her arm; This case was reported by a physician via patient support programs and described the occurrence of accidental underdose in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th June 2022, the patient received the 2nd dose of Shingrix 25 mcg/mg. On 8th June 2022, unknown after receiving Shingrix, the patient experienced accidental underdose, accidental exposure while administering drug and exposure via skin contact. On an unknown date, the outcome of the accidental underdose, accidental exposure while administering drug and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's comment: This case was reported by a physician via patient support programs The patient mentioned she received 2nd dose of Shingrix on the reporting day.  The patient said that when the registered pharmacist administered the dose almost half of the dose leaked out of her arm and per the pharmacists at said she probably received 50 percentage of it in her arm. No other information was provided. The reporter consented to follow up. Additional supportive information: Th patient received the 50 percentage of the dose which leaked out of her arm, which led to accidental underdose, accidental exposure while administering drug and exposure via skin contact.   Case update: Case corrected as per information received on 17th June 2022. The information was as follow: The case duration was updated. The value for duration 0 was removed.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Pain, Pain in extremity
Clinical narrative: my arm was sore; stil feeling pain in my hip; stil feeling pain in my lower back; feel like I'm reliving shingles all over again with pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles over 5 months before reporting date).   In May 2022, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm, pain in hip, low back pain and pain. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the pain in hip, low back pain and pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in hip, low back pain and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-Jun-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient had a shot of Shingrix over a week ago manufactured by GlaxoSmithKline. Patient had reaction to shot and still feeling pain in hip and lower back. The patient's arm was sore for short time and then it went directly to that areas. The patient felt like he/she was reliving shingles all over again with pain. Patient had shingles over 5 months before reporting date and that was were all began. The patient's doctor said it was fine to get the shot. The patient asked if they do this for further research. In the meantime, patient would like an answer, as to his/her reaction to shingrix shot. Additional Supportive: The follow-up would not possible as no contact details were available. This case had been linked with the case US2022AMR088947, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR088947:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine for shingles, now they say I have them internally/suspected vaccination failure; I have them internally; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comments: The case was self-reported by the patient via interactive digital media. The patient received dose of Shingles vaccine for shingles and now they said the patient had them internally.  The patient asked that how this could be. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on May 11th 2022 planning to receive second on Jun 29th 2022; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK receipt date: 15-June-2022 Reporter's comment: The pharmacist asked how to proceed if the patient was late for Engerix-B second dose. The first dose was on 11th May 2022 but due internal issues, they were planning to received Engerix-B second dose on 29th June 2022. The reporter did not consent to follow-up.  Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination. This is one of 5 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093620:Same reporter US-GLAXOSMITHKLINE-US2022AMR093988:Same reporter US-GLAXOSMITHKLINE-US2022AMR093989:Same reporter US-GLAXOSMITHKLINE-US2022AMR093990:Same reporter