chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral, SARS-CoV-2 test
Clinical narrative: Developed idiopathic neuropathy after receiving booster; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Htn" (unspecified if ongoing); "polycythemia" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE; METOPROLOL. Vaccination history included: BNT162b2 (dose number=2, lot number=EL0142, administration date=05Jan2021, vaccine location=Right arm), administration date: 05Jan2021, when the patient was 67-year-old, for COVID-19 immunization; coviD-19 vaccine (dose number=1, lot number=EH9899, administration date=18Dec2020, vaccine location=Right arm), administration date: 18Dec2020, when the patient was 67-year-old, for COVID-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (hospitalization, disability, medically significant) with onset 15Oct2021, outcome "not recovered", described as "Developed idiopathic neuropathy after receiving booster". The patient was hospitalized for neuropathy peripheral (hospitalization duration: 30 day(s)). The event "developed idiopathic neuropathy after receiving booster" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of neuropathy peripheral.  Clinical course: it was reported that, Other vaccine same date details [{other vaccine same date product= Pfizer, other vaccine same date lot number=F1E3590, other vaccine same date vaccine date=14Oct2021, other vaccine same date dose number=1, other vaccine same date vaccine location=Right arm}]. Patient did not received any other vaccine in four weeks. AE was resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Patient was in hospital for a month. Had to take physical therapy in order to walk.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event NEUROPATHY PERIPHERAL and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Histamine level, Histamine level increased
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21May2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 06Jun2021 at 15:00 as dose 2, single (Lot number: EW0172), in right arm and on 04Jan2022 at 15:00 as dose 3 (booster), single (Lot number: FJ1611) at the age of 20 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Tree Nuts" (unspecified if ongoing); "Known allergies: Fruits" (unspecified if ongoing); "Exercise induced anaphylaxis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Jun2022, outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jun2022) Positive.  Clinical course: Patient did not take any other vaccine in four weeks and also did not take any other medications in two weeks. Patient did not have COVID prior vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201067858 same patient, different dose, different AE;
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21May2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 06Jun2021 at 15:00 as dose 2, single (Lot number: EW0172), in right arm and on 04Jan2022 at 15:00 as dose 3 (booster), single (Lot number: FJ1611) at the age of 20 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Tree Nuts" (unspecified if ongoing); "Known allergies: Fruits" (unspecified if ongoing); "Exercise induced anaphylaxis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Jun2022, outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jun2022) Positive.  Clinical course: Patient did not take any other vaccine in four weeks and also did not take any other medications in two weeks. Patient did not have COVID prior vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201067858 same patient, different dose, different AE;
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Warm autoimmune haemolytic anaemia
Clinical narrative: covid test date 01Jan2022; covid test result Positive; covid test date 01Jan2022; covid test result Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EW0158), on 05May2021 as dose 2, single (Lot number: EW0173) and on 11Nov2021 at 16:30 as dose 3 (booster), single (Lot number: 32030BD) at the age of 36 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "unknown" and all described as "covid test date 01Jan2022; covid test result Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Clinical course:The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19.   No follow-up attempts are possible, no information is necessary.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test date 01Jan2022; covid test result Positive; covid test date 01Jan2022; covid test result Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EW0158), on 05May2021 as dose 2, single (Lot number: EW0173) and on 11Nov2021 at 16:30 as dose 3 (booster), single (Lot number: 32030BD) at the age of 36 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "unknown" and all described as "covid test date 01Jan2022; covid test result Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Clinical course:The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19.   No follow-up attempts are possible, no information is necessary.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Blood test, Deafness unilateral, Electronystagmogram, Labyrinthitis
Clinical narrative: I have permanent hearing loss in my left ear; along with Titinus; vertigo; balance issues; muscle  weakness; numbness in face, hands; numbness in face, hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2022 at 10:30 as dose 3 (booster), single (Lot number: Fk9895) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: ZYRTEC-D. Past drug history included: Erythromycin, reaction(s): "Known Allergies: Erythromycin", notes: Known Allergies: Erythromycin. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Ew0167, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 11Jun2021, when the patient was 42-year-old, for Covid-19 immunization, reaction(s): "Covid-19", "Covid-19"; BNT162b2 (Dose Number: 1, Batch/Lot No: Er8733, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 17May2021, when the patient was 42-year-old, for Covid-19 immunization, reaction(s): "Covid-19", "Covid-19". The following information was reported: DEAFNESS (disability) with onset 19Feb2022 at 11:45, outcome "not recovered", described as "I have permanent hearing loss in my left ear"; TINNITUS (disability) with onset 19Feb2022 at 11:45, outcome "not recovered", described as "along with Titinus"; BALANCE DISORDER (disability) with onset 19Feb2022 at 11:45, outcome "not recovered", described as "balance issues"; MUSCULAR WEAKNESS (disability) with onset 19Feb2022 at 11:45, outcome "not recovered", described as "muscle  weakness"; HYPOAESTHESIA (disability), HYPOAESTHESIA (disability) all with onset 19Feb2022 at 11:45, outcome "not recovered" and all described as "numbness in face, hands"; VERTIGO (disability) with onset 19Feb2022 at 11:45, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2021) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of deafness, tinnitus, vertigo, balance disorder, muscular weakness, hypoaesthesia, hypoaesthesia.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Presyncope, Tinnitus, Vertigo, Vestibular function test
Clinical narrative: I have permanent hearing loss in my left ear; along with Titinus; vertigo; balance issues; muscle  weakness; numbness in face, hands; numbness in face, hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2022 at 10:30 as dose 3 (booster), single (Lot number: Fk9895) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: ZYRTEC-D. Past drug history included: Erythromycin, reaction(s): "Known Allergies: Erythromycin", notes: Known Allergies: Erythromycin. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Ew0167, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 11Jun2021, when the patient was 42-year-old, for Covid-19 immunization, reaction(s): "Covid-19", "Covid-19"; BNT162b2 (Dose Number: 1, Batch/Lot No: Er8733, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 17May2021, when the patient was 42-year-old, for Covid-19 immunization, reaction(s): "Covid-19", "Covid-19". The following information was reported: DEAFNESS (disability) with onset 19Feb2022 at 11:45, outcome "not recovered", described as "I have permanent hearing loss in my left ear"; TINNITUS (disability) with onset 19Feb2022 at 11:45, outcome "not recovered", described as "along with Titinus"; BALANCE DISORDER (disability) with onset 19Feb2022 at 11:45, outcome "not recovered", described as "balance issues"; MUSCULAR WEAKNESS (disability) with onset 19Feb2022 at 11:45, outcome "not recovered", described as "muscle  weakness"; HYPOAESTHESIA (disability), HYPOAESTHESIA (disability) all with onset 19Feb2022 at 11:45, outcome "not recovered" and all described as "numbness in face, hands"; VERTIGO (disability) with onset 19Feb2022 at 11:45, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2021) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of deafness, tinnitus, vertigo, balance disorder, muscular weakness, hypoaesthesia, hypoaesthesia.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: I have permanent hearing loss in my left ear; along with Titinus; vertigo; balance issues; muscle  weakness; numbness in face, hands; numbness in face, hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2022 at 10:30 as dose 3 (booster), single (Lot number: Fk9895) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: ZYRTEC-D. Past drug history included: Erythromycin, reaction(s): "Known Allergies: Erythromycin", notes: Known Allergies: Erythromycin. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Ew0167, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 11Jun2021, when the patient was 42-year-old, for Covid-19 immunization, reaction(s): "Covid-19", "Covid-19"; BNT162b2 (Dose Number: 1, Batch/Lot No: Er8733, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 17May2021, when the patient was 42-year-old, for Covid-19 immunization, reaction(s): "Covid-19", "Covid-19". The following information was reported: DEAFNESS (disability) with onset 19Feb2022 at 11:45, outcome "not recovered", described as "I have permanent hearing loss in my left ear"; TINNITUS (disability) with onset 19Feb2022 at 11:45, outcome "not recovered", described as "along with Titinus"; BALANCE DISORDER (disability) with onset 19Feb2022 at 11:45, outcome "not recovered", described as "balance issues"; MUSCULAR WEAKNESS (disability) with onset 19Feb2022 at 11:45, outcome "not recovered", described as "muscle  weakness"; HYPOAESTHESIA (disability), HYPOAESTHESIA (disability) all with onset 19Feb2022 at 11:45, outcome "not recovered" and all described as "numbness in face, hands"; VERTIGO (disability) with onset 19Feb2022 at 11:45, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2021) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of deafness, tinnitus, vertigo, balance disorder, muscular weakness, hypoaesthesia, hypoaesthesia.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Deafness, Hypoaesthesia, Muscular weakness, SARS-CoV-2 test
Clinical narrative: I have permanent hearing loss in my left ear; along with Titinus; vertigo; balance issues; muscle  weakness; numbness in face, hands; numbness in face, hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2022 at 10:30 as dose 3 (booster), single (Lot number: Fk9895) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: ZYRTEC-D. Past drug history included: Erythromycin, reaction(s): "Known Allergies: Erythromycin", notes: Known Allergies: Erythromycin. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Ew0167, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 11Jun2021, when the patient was 42-year-old, for Covid-19 immunization, reaction(s): "Covid-19", "Covid-19"; BNT162b2 (Dose Number: 1, Batch/Lot No: Er8733, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 17May2021, when the patient was 42-year-old, for Covid-19 immunization, reaction(s): "Covid-19", "Covid-19". The following information was reported: DEAFNESS (disability) with onset 19Feb2022 at 11:45, outcome "not recovered", described as "I have permanent hearing loss in my left ear"; TINNITUS (disability) with onset 19Feb2022 at 11:45, outcome "not recovered", described as "along with Titinus"; BALANCE DISORDER (disability) with onset 19Feb2022 at 11:45, outcome "not recovered", described as "balance issues"; MUSCULAR WEAKNESS (disability) with onset 19Feb2022 at 11:45, outcome "not recovered", described as "muscle  weakness"; HYPOAESTHESIA (disability), HYPOAESTHESIA (disability) all with onset 19Feb2022 at 11:45, outcome "not recovered" and all described as "numbness in face, hands"; VERTIGO (disability) with onset 19Feb2022 at 11:45, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2021) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of deafness, tinnitus, vertigo, balance disorder, muscular weakness, hypoaesthesia, hypoaesthesia.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: I have permanent hearing loss in my left ear; along with Titinus; vertigo; balance issues; muscle  weakness; numbness in face, hands; numbness in face, hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2022 at 10:30 as dose 3 (booster), single (Lot number: Fk9895) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: ZYRTEC-D. Past drug history included: Erythromycin, reaction(s): "Known Allergies: Erythromycin", notes: Known Allergies: Erythromycin. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Ew0167, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 11Jun2021, when the patient was 42-year-old, for Covid-19 immunization, reaction(s): "Covid-19", "Covid-19"; BNT162b2 (Dose Number: 1, Batch/Lot No: Er8733, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 17May2021, when the patient was 42-year-old, for Covid-19 immunization, reaction(s): "Covid-19", "Covid-19". The following information was reported: DEAFNESS (disability) with onset 19Feb2022 at 11:45, outcome "not recovered", described as "I have permanent hearing loss in my left ear"; TINNITUS (disability) with onset 19Feb2022 at 11:45, outcome "not recovered", described as "along with Titinus"; BALANCE DISORDER (disability) with onset 19Feb2022 at 11:45, outcome "not recovered", described as "balance issues"; MUSCULAR WEAKNESS (disability) with onset 19Feb2022 at 11:45, outcome "not recovered", described as "muscle  weakness"; HYPOAESTHESIA (disability), HYPOAESTHESIA (disability) all with onset 19Feb2022 at 11:45, outcome "not recovered" and all described as "numbness in face, hands"; VERTIGO (disability) with onset 19Feb2022 at 11:45, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2021) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of deafness, tinnitus, vertigo, balance disorder, muscular weakness, hypoaesthesia, hypoaesthesia.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, UNK
Symptoms: Angiogram, Chest discomfort, Dizziness, Dyspnoea, Echocardiogram
Clinical narrative: PVC?s after first vaccine in 12/2020, none after 2nd or 3rd but 3 days after 4th dose started having frequent PVC?s and became symptomatic with chest pressure, dizziness, near syncope and shortness of breath. Was admitted to the hospital for 4 days with VTach and am now on beta blockers. MD?s were unsure if it was related to the vaccine or not
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, UNK
Symptoms: Electrocardiogram ambulatory, Extra dose administered, Presyncope, Scan, Ventricular extrasystoles
Clinical narrative: PVC?s after first vaccine in 12/2020, none after 2nd or 3rd but 3 days after 4th dose started having frequent PVC?s and became symptomatic with chest pressure, dizziness, near syncope and shortness of breath. Was admitted to the hospital for 4 days with VTach and am now on beta blockers. MD?s were unsure if it was related to the vaccine or not
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, UNK
Symptoms: Ventricular tachycardia
Clinical narrative: PVC?s after first vaccine in 12/2020, none after 2nd or 3rd but 3 days after 4th dose started having frequent PVC?s and became symptomatic with chest pressure, dizziness, near syncope and shortness of breath. Was admitted to the hospital for 4 days with VTach and am now on beta blockers. MD?s were unsure if it was related to the vaccine or not
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Infarction, Lower limb fracture, Magnetic resonance imaging abnormal
Clinical narrative: Had a blood clot TIA now have dizzy spells fell broken leg
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Transient ischaemic attack
Clinical narrative: Had a blood clot TIA now have dizzy spells fell broken leg
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Rash, Rash maculo-papular
Clinical narrative: Early Monday morning my arm was itching and I found a maculopapular rash on my left arm .
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: no adverse event; vaccine administered following multiple temperature excursion; This spontaneous report has been received from an office manager referring a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.  On 20-JUL-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-Merck) virus vaccine live (PROQUAD) 0.5ml once (lot number W006583 has been verified to be a valid lot number, expiration date 23-AUG-2023) (strength, route of administration, and anatomical location were not provided) for prophylaxis, the vial was reconstituted with sterile diluent (MERCK STERILE DILUENT) (strength, dose, lot number, and expiry date were not reported). Diluent was included because it was used to administer the measles, mumps, rubella and varicella (oka-Merck) virus vaccine live (PROQUAD), but the caller did not report a temperature excursion involving the sterile diluent.  The measles, mumps, rubella and varicella (oka-Merck) virus vaccine live (PROQUAD) vaccine experienced multiple temperature excursions: on 11-MAY-2022 was stored at a temperature of 5.7 Fahrenheit (F) for 7 minutes, 27-MAY-2022: 5.7 F for 5 minutes, 06-JUN-2022: 5.9 F for 6 minutes, 09-JUN-2022: 5.4 F for 4 minutes, 14-JUN-2022: 5.7 F for 7 minutes, 17-JUN-2022: 29.1 F for 39 minutes, 20-JUN-2022: 7.2F for 10 minutes, 22-JUN-2022: 8.4F for 15 minutes, and on 28-JUN-2022: 5.2F for 3 minutes. No temperature excursion occurred prior to the aforementioned dates. Total excursion time was 96 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA007867: US-009507513-2207USA007847: US-009507513-2207USA007928:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient had no adverse effects; vaccine was administered following multiple temperature excursions; This spontaneous report has been received from an office manager, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and previous drug allergies or reactions were not provided. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 18-JUL-2022, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) at a dose of 0.5 milliliter (ml), once, lot number W006583, expiration date: 23-AUG-2023 (route of administration was not provided) as prophylaxis (product storage error).  The suspect vaccine experienced multiple temperature excursions: on 11-MAY-2022 was stored at a temperature of 5.7 degrees Fahrenheit (F) for 7 minutes, 27-MAY-2022 5.7 F for 5 minutes, 06-JUN-2022 5.9 F for 6 minutes, 09-JUN-2022 5.4 F for 4 minutes, 14-JUN-2022 5.7 F for 7 minutes, 17-JUN-2022 29.1 F for 39 minutes, 20-JUN-2022 7.2 F for 10 minutes, 22-JUN-2022 8.4 F for 15 minutes, and 28-JUN-2022 5.2 F for 3 minutes.   Total excursion time was 96 minutes. No temperature excursion occurred prior to 11-MAY-2022.  No additional adverse events were reported  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA007847: US-009507513-2207USA007928: US-009507513-2207USA007867: US-009507513-2207USA007847: US-009507513-2207USA007985: US-009507513-2207USA007729: US-009507513-2207USA007826: US-009507513-2207USA008018: US-009507513-2207USA008097: US-009507513-2207USA007928: US-009507513-2207USA007847: US-009507513-2207USA007832:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; vaccine was administered following multiple temperature excursions; This spontaneous report has been received from an office manager, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and previous drug allergies or reactions were not provided. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 10-MAY-2022, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) at a dose of 0.5 milliliter (ml), once, lot number W006583, expiration date: 23-AUG-2023 (route of administration was not provided) as prophylaxis (product storage error).  The suspect vaccine experienced multiple temperature excursions: on 11-MAY-2022 was stored at a temperature of 5.7 degrees Fahrenheit (F) for 7 minutes, 27-MAY-2022 5.7 F for 5 minutes, 06-JUN-2022 5.9 F for 6 minutes, 09-JUN-2022 5.4 F for 4 minutes, 14-JUN-2022 5.7 F for 7 minutes, 17-JUN-2022 29.1 F for 39 minutes, 20-JUN-2022 7.2 F for 10 minutes, 22-JUN-2022 8.4 F for 15 minutes, and 28-JUN-2022 5.2 F for 3 minutes.   Total excursion time was 96 minutes. No temperature excursion occurred prior to 11-MAY-2022.  No additional adverse events were reported  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA007847: US-009507513-2207USA007928:
Sex: F
Vaccine: HEP
Symptoms: Blood test, Hepatitis B core antibody negative, Inappropriate schedule of product administration
Clinical narrative: negative for hepatitis B core antibody; second dose on 7/2/1996, and third dose on 1/6/1997.; her first dose on 4/3/1996, second dose on 7/2/1996; This spontaneous report has been received from a registered nurse concerning a 3-month-old female patient. The concomitant medications, medical history, drug reactions/allergies, and concurrent conditions were unknown.  On 03-APR-1996, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (dose, strength, route of administration, anatomical location, lot # and expiration date were unknown) for prophylaxis. On 02-JUL-1996, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # 1404B was evaluated and changed to the valid lot # 614913/1404B, expiration date was unknown but upon internal validation established as 30-JAN-1998; dose, strength, route of administration and anatomical location was unknown) (Inappropriate schedule of product administration). On 06-JAN-1997, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # 1156D was evaluated and changed to the valid lot # 619298/1156D, expiration date was unknown but upon internal validation established as 04-FEB-1999; dose, strength, route of administration and anatomical location was unknown) (Inappropriate schedule of product administration).  The reporter said she thought the immunization documentation may be incorrect, because the patient's first dose appears to have been administered on the day she was born (03-APR-1996). On unknown date, the patient's new hire blood work was negative for hepatitis B core antibody. The patient had sought medical attentions. The treatments were not given to the patient. The outcome of negative for hepatitis B core antibody was not reported.   The causal relationship between negative for hepatitis B core antibody and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was not reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported.  No further information provided.; Nurse called and reported that a patient received an expired PNEUMOVAX 23 today 7/29/2022.; This spontaneous report has been received from a licensed practical nurse concerning a patient of unknown age and gender. The patient's concomitant therapies, pertinent medical history, and drug reactions/allergies were not reported.  On 29-JUL-2022, the patient received an expired Pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# T032761, expiration date: 30-MAY-2022; 1 dose, strength and route were not provided) for prophylaxis (expired product administered). No additional adverse events were reported.
Age: 41.0
Sex: M
Vaccine: HPV9
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: He experienced "a little pain" at the injection site/ "pain picked up"/ paint "went down"/ "got worse"; This spontaneous report has been received from a consumer, regarding to himself as a 41-year-old male patient. The patient's current conditions included migraine and drug hypersensitivity. His historical drugs included fluticasone propionate (FLONASE). Patient's concomitant therapies included loratadine (also reported as generic version of loratadine (CLARITIN)) and unspecified migraine medication. The patient's pertinent medical history was not reported.   On 05-JUL-2022, the patient was vaccinated with the third dose of HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, in his left deltoid (also reported as shoulder) (strength, dosage, route of administration, vaccination scheme frequency, lot number, and expiration date were not reported) to prevent human papilloma virus (HPV) and future cancers. On unspecified dates, the patient received the first and second HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, as prophylaxis (doses, routes of administration, anatomical sites of injection, lot numbers, and expiration dates were not reported).    On 05-JUL-2022, the patient experienced a little pain at the injection site (vaccination site pain). On 06-JUL-2022, he suffered a pain picked up. On 07-JL-2022, the paint went down, but after that paint just got worse. Also, when he lifted anything at all, he felt a "sharp jab" of pain at the injection site. In addition, the patient did not seek medical attention. At the time of the reporting, the patient had not recovered from vaccination site pain.   The causality assessment between the event and the suspect vaccine was not provided.
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Vaccine excursion; This spontaneous report has been received from a medical assistant referring to a 5-year-old male patient. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 14-JUL-2022, a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin, rHA) (PROQUAD), experienced a temperature excursion and on an unknown date in 2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin, rHA) (PROQUAD), at the dose of 0,5 milliliter (ml), once, (lot number reported and validated as W016358, expiration date reported and validated as on 16-NOV-2023) (dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error).  This case is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA004135: US-009507513-2208USA003812: US-009507513-2208USA004011: US-009507513-2208USA004012: US-009507513-2208USA004255: US-009507513-2208USA004086: US-009507513-2208USA004105: US-009507513-2208USA004223: US-009507513-2208USA004255:
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; HCP reporting a patient received her first dose of ROTATEQ at age 4 months old.; This spontaneous report was received from registered nurse and refers to a 4-months-old female patient. The patient's concomitant medications included famotidine, and the patient's historical vaccine included diphtheria vaccine toxoid hepatitis b vaccine rhbsag (yeast) (VAXELIS) and pneumococcal vaccine conj 7v (crm197) (PREVNAR). The patient's concurrent conditions and pertinent medical history was not reported.   On 08-AUG-2022, the patient received her first rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis, lot number W004503 who had been verified to be a valid number and expiration date: 15-MAY-2023 (strength, dose, and frequency, were not provided) (product administered to patient of inappropriate age). It was reported that mistake was recognized and patient tolerated. Manufacturer was contacted for further instruction and they were told to complete the series. It was reported that after 7 days that the vaccine was given there was no known adverse reaction. It was reported that the patient was recovered from the event on an unknown date in August 2022.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Overdose, Product storage error
Clinical narrative: No additional AE details or PQC.; 2 doses of PNEUVMOAX 23 were administered after a supported temp excursion occurred.; 2 doses of PNEUVMOAX 23 were administered after a supported temp excursion occurred.; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drugs reactions/allergies were not reported.  On 09-AUG-2022, 2 doses of Pneumococcal vaccine, polyvalent (23-valent) (PNEUVMOAX 23) injection (lot number: U026796, expiration date: 28-JAN-2023; strength, dose and route of administration were not provided) were administered for prophylaxis after a supported temperature excursion occurred (product storage error; overdose). The temperature excursion was of 9.2 Celsius degrees for 48 minutes. It was reported that there was no previous temperature exclusion. No additional adverse event (AE) details were reported.  This is one of the three reports received from the same reporter. ; Sender's Comments:  US-009507513-2208USA005566: US-009507513-2208USA005835:
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: A pharmacist reported that a patient missed her third dose of GARDASIL 9 according to the dosage schedule. No additional AE's and no PQC's were reported.; A pharmacist reported that a patient missed her third dose of GARDASIL 9 according to the dosage schedule. No additional AE's and no PQC's were reported.; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 25-FEB-2021, the patient missed her third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date were not provided) according to the dosage schedule (Product dose omission issue) as directed to prevent human papilloma virus infection. No additional adverse event (AE) reported.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pneumonia vaccination on 2003, 2005, 2015, 2016 and 06-OCT-2021; Pneumonia vaccination on 2003, 2005, 2015, 2016 and 06-OCT-2021; Pneumonia vaccination on 2003, 2005, 2015, 2016 and 06-OCT-2021; Pneumonia vaccination on 2003, 2005, 2015, 2016 and 06-OCT-2021; This spontaneous report was received from a lawyer and the consumer referring to a 51-year-old female patient  the patient concomitant medications included asthma, depression, blood triglycerides increased, diabetes mellitus, gastrooesophageal reflux disease, restless legs syndrome, hypertension, blood cholesterol increased, blood cholesterol and hypersensitivity. The patient's medical history included varicella and tobacco user. Concomitant therapies included fish oil, calcium, cetirizine hydrochloride, mometasone furoate(ASMANEX), fluoxetine hydrochloride(PROZAC), omeprazole(PRILOSEC), salbutamol sulfate, atorvastatin calcium and losartan.      In 2003,  the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (strength, dose, anatomical site of administration, lot number and expiration date were not provided), the patient was revaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)  in 2005, 2015, 2016 and 06-OCT-2021 (inappropriate schedule of product administration).  This is one of 2 same patient reports.; Sender's Comments:  US-009507513-2202USA004321:
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, Flank pain
Clinical narrative: first dose prior to hospitalization for COVID; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lung cancer and herpes virus infection.   On an unknown date, the patient received the 1st dose of Shingrix. In February 2022, less than 6 months after receiving Shingrix, the patient experienced covid-19 (serious criteria hospitalization). On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     Linked case(s) involving the same patient:  US2022115888   Additional Information: GSK Receipt Date: 12-Aug-2022 Reporter's Comments: The reporter stated that the patient still had left-side pain.  The patient plans to see a specialist for the pain.  She mentioned her first Shingrix dose was the end of 2021, prior to hospitalization for COVID in FEB-2022.  The patient also mentioned second Shingrix dose was given in her left deltoid.  Additional supportive information: For tolerance of 2nd dose refer case US2022115888. .; Sender's Comments:  US-GSK-US2022115888:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Computerised tomogram abnormal, Diplopia, Impaired driving ability, Impaired work ability, Loss of personal independence in daily activities
Clinical narrative: Sixth nerve palsy at right eye; Double vision/ CAT scan at ER/ admitted to hospital/ MRI and other tests; Could not drive or work/hard to do anything; This case was reported by a consumer and described the occurrence of vith nerve palsy in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced vith nerve palsy (serious criteria hospitalization and GSK medically significant), double vision (serious criteria hospitalization) and activities of daily living impaired. On an unknown date, the outcome of the vith nerve palsy, double vision and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the vith nerve palsy, double vision and activities of daily living impaired to be related to Shingrix.     Additional Information: GSK receipt date: 15-AUG-2022 Reporter's comment: It was reported that the patient wanted to inform about an adverse event after receiving the Shingrix vaccine.  The patient stated that approximately 4 to 5 weeks after the Shingrix vaccine, the patient started getting double vision. The double vision got worse until the patient could not drive or work. The patient went to an Eye doctor two weeks ago who told that the patient needs to go to the Emergency Room. The patient received a CAT scan at the ER and was then admitted to the hospital to get an MRI and many other tests. The patient stated that the diagnosis was Sixth Nerve Palsy at right eye and at the time of reporting, it had still not corrected itself and the patient cannot work or drive. The patient stated that the double vision persists and makes it hard to do anything without covering one eye. The patient stated that after doing some research, the patient had found that there had been other reports of Six Nerve Palsy after the old 1 dose Shingles vaccine, but the patient could not find anything about Shingrix. The patient requested let him/her know of any other reports of Sixth Nerve Palsy after the Shingrix vaccine. The patient had also reported this to the Vaccine Adverse Event Reporting System.
Sex: U
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging abnormal, VIth nerve paralysis
Clinical narrative: Sixth nerve palsy at right eye; Double vision/ CAT scan at ER/ admitted to hospital/ MRI and other tests; Could not drive or work/hard to do anything; This case was reported by a consumer and described the occurrence of vith nerve palsy in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced vith nerve palsy (serious criteria hospitalization and GSK medically significant), double vision (serious criteria hospitalization) and activities of daily living impaired. On an unknown date, the outcome of the vith nerve palsy, double vision and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the vith nerve palsy, double vision and activities of daily living impaired to be related to Shingrix.     Additional Information: GSK receipt date: 15-AUG-2022 Reporter's comment: It was reported that the patient wanted to inform about an adverse event after receiving the Shingrix vaccine.  The patient stated that approximately 4 to 5 weeks after the Shingrix vaccine, the patient started getting double vision. The double vision got worse until the patient could not drive or work. The patient went to an Eye doctor two weeks ago who told that the patient needs to go to the Emergency Room. The patient received a CAT scan at the ER and was then admitted to the hospital to get an MRI and many other tests. The patient stated that the diagnosis was Sixth Nerve Palsy at right eye and at the time of reporting, it had still not corrected itself and the patient cannot work or drive. The patient stated that the double vision persists and makes it hard to do anything without covering one eye. The patient stated that after doing some research, the patient had found that there had been other reports of Six Nerve Palsy after the old 1 dose Shingles vaccine, but the patient could not find anything about Shingrix. The patient requested let him/her know of any other reports of Sixth Nerve Palsy after the Shingrix vaccine. The patient had also reported this to the Vaccine Adverse Event Reporting System.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Skin burning sensation, Vaccination failure
Clinical narrative: got the vaccines too, have shingles/suspected vaccination failure; shingles; Worst pain; burning skin like on fire; 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), shingles, pain and burning sensation skin. On an unknown date, the outcome of the vaccination failure, pain and burning sensation skin were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and burning sensation skin to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received Shingles vaccines too and was experiencing shingles. The patient also experienced worst pain and burning skin liked on fire. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary immunization, 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.