chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product administration duration
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 69.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Injection site bruising, Injection site swelling, Pyrexia
Clinical narrative: Swelling,very sore, fever at shot area,  I still have a big open sore.   Still hurts.  Doctor has pictures of the sore.  Doctor monitored for infection.   Supposedly reported this reaction. Store saw it.    Very tired of this reaction and will leave a bad scare.
Age: 69.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Wound
Clinical narrative: Swelling,very sore, fever at shot area,  I still have a big open sore.   Still hurts.  Doctor has pictures of the sore.  Doctor monitored for infection.   Supposedly reported this reaction. Store saw it.    Very tired of this reaction and will leave a bad scare.
Age: 90.0
Sex: M
Vaccine: FLU4, RSV, FLU3, RSV
Symptoms: Computerised tomogram, Computerised tomogram head, Transient ischaemic attack, Ultrasound Doppler
Clinical narrative: Roughly 2 hours later he suffered with stroke; Transient ischemic attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 90-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 26Sep2023 at 16:15 as dose number unknown, single (Batch/Lot number: unknown) at the age of 90 years intramuscular, in arm for immunisation; for immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 26Sep2023 at 16:15 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history included: "Congestive heart failure" (unspecified if ongoing), notes: Congestive heart failure; "Chronic kidney disease" (unspecified if ongoing), notes: Chronic kidney disease; "Type 2 Diabetes" (unspecified if ongoing). Concomitant medication(s) included: JANUVIA; METOPROLOL; GLIMEPIRIDE; ALLOPURINOL; BUMEX. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization), outcome "unknown", described as "Roughly 2 hours later he suffered with stroke"; TRANSIENT ISCHAEMIC ATTACK (hospitalization, medically significant), outcome "unknown", described as "Transient ischemic attack". The patient was hospitalized for cerebrovascular accident, transient ischaemic attack (start date: 26Sep2023, discharge date: 27Sep2023, hospitalization duration: 2 day(s)). The events "roughly 2 hours later he suffered with stroke" and "transient ischemic attack" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: unknown results, notes: Reporter stated, "What exactly are you looking for? He has blood work done every week."; Body height: "Roughly 5 foot 11 inches; Computerised tomogram: unknown results, notes: Reporter stated, "Correct and while he was in the emergency in the hospital they did performed two CT Scans and ultrasound of his carotid arteries."; Ultrasound scan: unknown results, notes: Reporter stated, "Correct and while he was in the emergency in the hospital they did performed two CT Scans and ultrasound of his carotid arteries."; Weight: roughly 150 pounds. Therapeutic measures were taken as a result of cerebrovascular accident, transient ischaemic attack.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Age: 90.0
Sex: M
Vaccine: FLU4, RSV, FLU3, RSV
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Transient ischaemic attack, Ultrasound Doppler
Clinical narrative: Roughly 2 hours later he suffered with stroke; Transient ischemic attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 90-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 26Sep2023 at 16:15 as dose number unknown, single (Batch/Lot number: unknown) at the age of 90 years intramuscular, in arm for immunisation; for immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 26Sep2023 at 16:15 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history included: "Congestive heart failure" (unspecified if ongoing), notes: Congestive heart failure; "Chronic kidney disease" (unspecified if ongoing), notes: Chronic kidney disease; "Type 2 Diabetes" (unspecified if ongoing). Concomitant medication(s) included: JANUVIA; METOPROLOL; GLIMEPIRIDE; ALLOPURINOL; BUMEX. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization), outcome "unknown", described as "Roughly 2 hours later he suffered with stroke"; TRANSIENT ISCHAEMIC ATTACK (hospitalization, medically significant), outcome "unknown", described as "Transient ischemic attack". The patient was hospitalized for cerebrovascular accident, transient ischaemic attack (start date: 26Sep2023, discharge date: 27Sep2023, hospitalization duration: 2 day(s)). The events "roughly 2 hours later he suffered with stroke" and "transient ischemic attack" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: unknown results, notes: Reporter stated, "What exactly are you looking for? He has blood work done every week."; Body height: "Roughly 5 foot 11 inches; Computerised tomogram: unknown results, notes: Reporter stated, "Correct and while he was in the emergency in the hospital they did performed two CT Scans and ultrasound of his carotid arteries."; Ultrasound scan: unknown results, notes: Reporter stated, "Correct and while he was in the emergency in the hospital they did performed two CT Scans and ultrasound of his carotid arteries."; Weight: roughly 150 pounds. Therapeutic measures were taken as a result of cerebrovascular accident, transient ischaemic attack.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: None from vaccines except sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Apr2023 as dose 5 (booster), single (Lot number: GJ3268) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Sulfonamide" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/lot number: EL9262,), administration date: 22Jan2021, for COVID-19 immunisation, reaction(s): "None from vaccines except sore arm"; bnt162b2 (DOSE 2, SINGLE, Batch/lot number: EL9266), administration date: 02Feb2021, for COVID-19 immunisation, reaction(s): "None from vaccines except sore arm", "BNT162B2 Dose 1- 22Jan2021, Dose 2- 02Feb2021"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE , Batch/lot number: FJ9943), administration date: 16Apr2022, for COVID-19 immunisation, reaction(s): "None from vaccines except sore arm"; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE , Batch/lot number: G49694), administration date: 14Sep2022, for COVID-19 immunisation, reaction(s): "None from vaccines except sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "recovered" (2023), described as "None from vaccines except sore arm". Therapeutic measures were not taken as a result of pain in extremity.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300324615 Same patient/vaccine, different vaccine dose/event;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: None from vaccines except sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Apr2023 as dose 5 (booster), single (Lot number: GJ3268) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Sulfonamide" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/lot number: EL9262,), administration date: 22Jan2021, for COVID-19 immunisation, reaction(s): "None from vaccines except sore arm"; bnt162b2 (DOSE 2, SINGLE, Batch/lot number: EL9266), administration date: 02Feb2021, for COVID-19 immunisation, reaction(s): "None from vaccines except sore arm", "BNT162B2 Dose 1- 22Jan2021, Dose 2- 02Feb2021"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE , Batch/lot number: FJ9943), administration date: 16Apr2022, for COVID-19 immunisation, reaction(s): "None from vaccines except sore arm"; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE , Batch/lot number: G49694), administration date: 14Sep2022, for COVID-19 immunisation, reaction(s): "None from vaccines except sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "recovered" (2023), described as "None from vaccines except sore arm". Therapeutic measures were not taken as a result of pain in extremity.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300324615 Same patient/vaccine, different vaccine dose/event;
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/no PQC; Medical assistant reported VAQTA was administered after temperature excursion; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 25-SEP-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 dose (lot number Y3ME2 is an invalid number for hepatitis a vaccine, inactivated (VAQTA) and so the formulation could not be confirmed) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). The vaccine had suffered a temperature excursion prior to administration (product storage error) within timeframes of 12 hours 20 minutes and 8 hours 20 minutes at a temperature of 8.9 degree Celsius (C) and 9.4 C, respectively. No adverse events were reported for this patient.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; HCP called to report a TE with PROQUAD.  Improperly stored.; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 14-JUL-2023, the patient was vaccinated with improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, at a dose of 0.5 milliliters as prophylaxis (lot number: W029555, which was determined to be valid, with an expiration date on 14-MAR-2024) (strengths, scheme, route and anatomical location of administration were not reported).  The administered dose underwent a temperature excursion of unreported temperature during an unspecified period time. Previous temperature excursion was not reported.    No additional adverse event was provided.  This is one of several reports from the same reporter.
Sex: U
Vaccine: UNK
Symptoms: Device leakage
Clinical narrative: tried to mix it, put adapter on it, looks like product leaked out; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 02Oct2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Pharmacist and Consumer or other non HCP) from product quality group.  A patient (no qualifiers provided) received for immunisation. The patient didn't receive rsv vaccine prot.subunit pref 2v (ABRYSVO). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE LEAKAGE (non-serious), outcome "unknown", described as "tried to mix it, put adapter on it, looks like product leaked out".  The reporter considered "tried to mix it, put adapter on it, looks like product leaked out" associated to device constituent of rsv vaccine prot.subunit pref 2v. Causality for "tried to mix it, put adapter on it, looks like product leaked out" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: Additional information: Initially a reporter was on the call to Pfizer, and stated they needed to report an item that was damaged, and clarified the product was the 'RSV vaccination.' The reporter was not sure why the product was defective, stating the owner was the one who gave the vaccine, and the owner would be coming onto the call to complete the report. Then the second reporter and came onto the call to complete the entire report. The second reporter had been doing a lot of these vaccines, and this one when the reporter tried to mix it, put the adapter on it, looked like the product leaked out. The powder was still there, but nothing mixed in there, and the reporter saved everything. The product "all spilled onto the table." The second reporter was going to administer the vaccine to a patient, but the product "pretty much kind of exploded", so the second reporter used another one. The suspect vaccine was not administered to a patient. RSV vaccination vial adapter: the reporter regarding the adapter, did not have the manufacturer, NDC, lot, or expiry. The adapter came in another container and peeled off the top, so maybe the information was on top of that, but the reporter threw out that part. RSV vaccination dry powder in the vial: Manufacturer: There was a sticker around that part that the reporter took off and slapped on a sheet where the patient signs their name for the vaccine. The reporter had already taken the sticker off, but usually was the same as lot, expiry, and NDC on the box. The reporter confirmed there was just one vaccine with the issue.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: M
Vaccine: RSV
Symptoms: Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: had a small hive on the injection appear, it was itchy and sore; had a small hive on the injection appear, it was itchy and sore; had a small hive on the injection appear, it was itchy and sore; he had a slight sore on his arm for a couple of days; 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 92-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 19Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE URTICARIA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset Sep2023, outcome "recovered with sequelae" (2023) and all described as "had a small hive on the injection appear, it was itchy and sore"; VACCINATION SITE PAIN (non-serious) with onset Sep2023, outcome "recovered" (2023), described as "had a small hive on the injection appear, it was itchy and sore"; PAIN IN EXTREMITY (non-serious) with onset Sep2023, outcome "recovered" (2023), described as "he had a slight sore on his arm for a couple of days". Additional information: The patient was given Abrysvo RSV vaccine on 19Sep, had mild reaction but this past week he noticed there is a small looks like hive in his skin/a small hive on the injection appear, it was itchy and sore. He had a slight sore on his arm for a couple of days and then it went away. The itching went away. He would like to know if it Is possible to have a reaction that long after getting the shot.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: M
Vaccine: RSV
Symptoms: Device connection issue, Occupational exposure to product
Clinical narrative: the vial adapter and the syringe adapter, were not connected to the syringe, so when caller picked up the vaccine the stopper on the syringe stayed in the box and fell off syringe right away; Vaccine poured out all over caller; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 26-year-old male patient was exposed to rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF5023, Expiration Date: Feb2025) to be used for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious) with onset 08Oct2023, described as "Vaccine poured out all over caller"; DEVICE ISSUE (non-serious) with onset 08Oct2023, described as "the vial adapter and the syringe adapter, were not connected to the syringe, so when caller picked up the vaccine the stopper on the syringe stayed in the box and fell off syringe right away".   Causality for "the vial adapter and the syringe adapter, were not connected to the syringe, so when caller picked up the vaccine the stopper on the syringe stayed in the box and fell off syringe right away" and "vaccine poured out all over caller" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: Reporter was a pharmacy technician calling about Abrysvo which he was going to administer yesterday however, the product was broken before he even took it out of the box. The product was in the actual Abrysvo manufacturer box, the individual Abrysvo. He stated that "the little things you open up to compound the vaccine, the vial adapter and the syringe adapter, were not connected to the syringe, so when caller picked up the vaccine the stopper on the syringe stayed in the box and fell off syringe right away. Faulty product." Vaccine poured out all over caller. He confirmed no patients were involved, however since he stated the vaccine poured out all over him, his information was placed in patient formal fields. He was wondering if it was possible to get a replacement. Sample of the product was available to be returned, if requested; they can return the vial adapter. Packaging was sealed and intact. NDC number of Abrysvo: 00069034405; of Abrysvo antigen vial: 0069020701.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Cardiac disorder, Echocardiogram, Electrocardiogram, Myocardial fibrosis
Clinical narrative: heart changes; left ventricular remodeling with fibrosis of the left ventricle; left ventricular remodeling with fibrosis of the left ventricle; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (batch/lot number: GJ3274) at the age of 60 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "type II diabetes" (unspecified if ongoing); "emphysema" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM; EDARBI; FARXIGA; ASPIRIN [ACETYLSALICYLIC ACID]. Past drug history included: Oxycodone, reaction: "drug allergy". Vaccination history included: Bnt162b2 (dose 1, batch/lot number EP6955, anatomical location arm left), for COVID-19 immunization; Bnt162b2 (dose 2, batch/lot number ER8729, anatomical location arm left), for COVID-19 immunization; Bnt162b2 (dose 3, batch/lot number 301358A, anatomical location arm left), for COVID-19 immunization. The following information was reported: VENTRICULAR REMODELLING (disability), MYOCARDIAL FIBROSIS (disability) all with onset Aug2022, outcome "recovered with sequelae" and all described as "left ventricular remodeling with fibrosis of the left ventricle"; CARDIAC DISORDER (disability) with onset Oct2023, outcome "unknown", described as "heart changes". The events "left ventricular remodeling with fibrosis of the left ventricle" and "heart changes" required physician office visit. The patient underwent the following laboratory tests and procedures: angiogram: (unspecified date) unremarkable, notes: with any stenosis seen under 25%; echocardiogram: (Oct2023) heart changes; EKG: (Aug2021) normal; (Aug2022) unknown results; (Aug2022) left ventricular remodeling, notes: with fibrosis of the left ventricle; nasal swab (covid-19 test): (Jun2023) negative. Therapeutic measures were not taken as a result of ventricular remodelling, myocardial fibrosis, cardiac disorder.  Clinical course: The patient had no covid prior vaccination. The vaccination facility type was pharmacy/drug store. The left ventricular remodeling with fibrosis of the left ventricle, first detected by EKG changes in Aug2022, confirmed in Aug2023. The patient recovered with lasting effects.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Ventricular remodelling
Clinical narrative: heart changes; left ventricular remodeling with fibrosis of the left ventricle; left ventricular remodeling with fibrosis of the left ventricle; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (batch/lot number: GJ3274) at the age of 60 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "type II diabetes" (unspecified if ongoing); "emphysema" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM; EDARBI; FARXIGA; ASPIRIN [ACETYLSALICYLIC ACID]. Past drug history included: Oxycodone, reaction: "drug allergy". Vaccination history included: Bnt162b2 (dose 1, batch/lot number EP6955, anatomical location arm left), for COVID-19 immunization; Bnt162b2 (dose 2, batch/lot number ER8729, anatomical location arm left), for COVID-19 immunization; Bnt162b2 (dose 3, batch/lot number 301358A, anatomical location arm left), for COVID-19 immunization. The following information was reported: VENTRICULAR REMODELLING (disability), MYOCARDIAL FIBROSIS (disability) all with onset Aug2022, outcome "recovered with sequelae" and all described as "left ventricular remodeling with fibrosis of the left ventricle"; CARDIAC DISORDER (disability) with onset Oct2023, outcome "unknown", described as "heart changes". The events "left ventricular remodeling with fibrosis of the left ventricle" and "heart changes" required physician office visit. The patient underwent the following laboratory tests and procedures: angiogram: (unspecified date) unremarkable, notes: with any stenosis seen under 25%; echocardiogram: (Oct2023) heart changes; EKG: (Aug2021) normal; (Aug2022) unknown results; (Aug2022) left ventricular remodeling, notes: with fibrosis of the left ventricle; nasal swab (covid-19 test): (Jun2023) negative. Therapeutic measures were not taken as a result of ventricular remodelling, myocardial fibrosis, cardiac disorder.  Clinical course: The patient had no covid prior vaccination. The vaccination facility type was pharmacy/drug store. The left ventricular remodeling with fibrosis of the left ventricle, first detected by EKG changes in Aug2022, confirmed in Aug2023. The patient recovered with lasting effects.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: patient had COVID-19 multiple times; patient had COVID-19 multiple times; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001227.  A 68-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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 "unknown" and all described as "patient had COVID-19 multiple times".  Additional information:  it was reported that the patient started treatment on unreported dates with Pfizer BioNTech COVID-19 vaccine primary series and booster. It was reported the patient had COVID-19 multiple times.  The information on the batch/lot number for bnt162b2 omi xbb.1.5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300168692 same patient, different events after different doses of the vaccine;
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Body temperature, Cough, Diarrhoea
Clinical narrative: Flu; articulations pain; Cough; Fever; stomach pain; diarrhea; body discomfort; This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 15Aug2020 as DOSE 3 (BOOSTER), SINGLE (batch/lot number: unknown) at the age of 55 years, administered in the right arm for COVID-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine ("Primary Immunization series complete; unknown manufacturer") for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 08Oct2023, outcome "not recovered"; PYREXIA (non-serious) with onset 08Oct2023, outcome "not recovered" described as "Fever"; INFLUENZA (non-serious) with onset 08Oct2023, outcome "not recovered" described as "Flu"; ARTHRALGIA (non-serious) with onset 08Oct2023, outcome "not recovered" described as "articulations pain"; DISCOMFORT (non-serious) with onset 08Oct2023, outcome "not recovered" described as "body discomfort"; DIARRHOEA (non-serious) with onset 08Oct2023, outcome "not recovered" described as "diarrhea"; ABDOMINAL PAIN UPPER (non-serious) with onset 08Oct2023, outcome "not recovered" described as "stomach pain." Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of influenza, arthralgia, cough, pyrexia, abdominal pain upper, diarrhoea, discomfort.  Additional information: Patient had no known allergies.  No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300324030 same patient, different vaccine dose and events;
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Influenza, Pyrexia
Clinical narrative: Flu; articulations pain; Cough; Fever; stomach pain; diarrhea; body discomfort; This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 15Aug2020 as DOSE 3 (BOOSTER), SINGLE (batch/lot number: unknown) at the age of 55 years, administered in the right arm for COVID-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine ("Primary Immunization series complete; unknown manufacturer") for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 08Oct2023, outcome "not recovered"; PYREXIA (non-serious) with onset 08Oct2023, outcome "not recovered" described as "Fever"; INFLUENZA (non-serious) with onset 08Oct2023, outcome "not recovered" described as "Flu"; ARTHRALGIA (non-serious) with onset 08Oct2023, outcome "not recovered" described as "articulations pain"; DISCOMFORT (non-serious) with onset 08Oct2023, outcome "not recovered" described as "body discomfort"; DIARRHOEA (non-serious) with onset 08Oct2023, outcome "not recovered" described as "diarrhea"; ABDOMINAL PAIN UPPER (non-serious) with onset 08Oct2023, outcome "not recovered" described as "stomach pain." Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of influenza, arthralgia, cough, pyrexia, abdominal pain upper, diarrhoea, discomfort.  Additional information: Patient had no known allergies.  No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300324030 same patient, different vaccine dose and events;
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: None from vaccines except sore arm; BNT162B2 Dose 1- 22Jan2021, Dose 2- 02Feb2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old patient received bnt162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EL9266) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "allergies: Sulpha" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, vaccine brand: Pfizer / BioNTech,, vaccine brand unknown: False,, vaccine administration date: 22Jan2021,, vaccine lot number: EL9262, vaccine lot unknown: False, Vaccine dose number: 1, vaccine dose number unknown: False), administration date: 22Jan2021, for COVID-19 Immuniztion. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "None from vaccines except sore arm"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "BNT162B2 Dose 1- 22Jan2021, Dose 2- 02Feb2021". Therapeutic measures were not taken as a result of pain in extremity, inappropriate schedule of product administration.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: None from vaccines except sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old patient received bnt162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9262) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "known allergies: Sulpha" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "None from vaccines except sore arm". Therapeutic measures were not taken as a result of pain in extremity.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300324615 Same patient/vaccine, different vaccine dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: None from vaccines except sore arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 76-year-old patient received bnt162b2 (BNT162B2), on 16Apr2022 as dose 3 (booster), single (Lot number: FJ9943) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "known allergies: Sulpha" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pfizer / Biontech COVID-19 vaccine (DOSE 1, SINGLE, Lot number: EL9262), administration date: 22Jan2021, for COVID-19 immunization, reaction: "None from vaccines except sore arm"; Pfizer / Biontech COVID-19 vaccine (DOSE 2, SINGLE, Lot number: EL9266), administration date: 02Feb2021, for COVID-19 immunization, reaction: "None from vaccines except sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "recovered" (2022), described as "None from vaccines except sore arm". Therapeutic measures were not taken as a result of pain in extremity.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: None from vaccines except sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster), single (Lot number: G49694) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "known allergies: Sulpha" (unspecified if ongoing), notes: Known allergies: Sulpha. The patient's concomitant medications were not reported. Past drug history included: Bnt162b2, start date: 22Jan2021, stop date: 22Jan2021, for COVID-19 Immunization, reaction(s): "Sore arm", notes: DOSE 1, SINGLE, Batch/Lot No: EL9262. Vaccination history included: bnt162b2 (DOSE 3, SINGLE, Batch/Lot No: FJ9943), administration date: 16Apr2022, for COVID-19 Immunization, reaction(s): "Sore arm"; bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EL9266), administration date: 02Feb2021, for COVID-19 Immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "None from vaccines except sore arm". Therapeutic measures were not taken as a result of pain in extremity.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: 102 fever; Exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 33-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HPV VACCINE taken for immunisation as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 10Oct2023, outcome "recovering", described as "102 fever"; FATIGUE (non-serious) with onset 10Oct2023, outcome "recovering", described as "Exhaustion". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Covid prior vaccination and covid tested post vaccination was reported as unknown.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, FLUA4
Symptoms: Chills, Headache, Myalgia, Night sweats, Pyrexia
Clinical narrative: night sweats; fever; chills; muscle pain; severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; AMLODIPINE. Vaccination history included: bnt162b2 (At 12:30, DOSE 4 (BOOSTER), SINGLE, Anatomical location: Left arm, Route of administration: Intramuscular), administration date: 19Oct2022, for COVID-19 immunisation, reaction(s): "General tiredness, sore arm", "General tiredness, sore arm"; Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Left arm), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 10Oct2023 at 21:00, outcome "recovering"; PYREXIA (non-serious) with onset 10Oct2023 at 21:00, outcome "recovering", described as "fever"; MYALGIA (non-serious) with onset 10Oct2023 at 21:00, outcome "recovering", described as "muscle pain"; NIGHT SWEATS (non-serious) with onset 10Oct2023 at 21:00, outcome "recovering"; HEADACHE (non-serious) with onset 10Oct2023 at 21:00, outcome "recovering", described as "severe headache". Therapeutic measures were not taken as a result of night sweats, pyrexia, chills, myalgia, headache.  Additional information: COVID did not occur prior to vaccination. Patient did not test for COVID post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201241827 Same patient, different dose/AEs.;
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, FLUA4
Symptoms: Chills, Headache, Night sweats, Pyrexia
Clinical narrative: night sweats; fever; chills; muscle pain; severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; AMLODIPINE. Vaccination history included: bnt162b2 (At 12:30, DOSE 4 (BOOSTER), SINGLE, Anatomical location: Left arm, Route of administration: Intramuscular), administration date: 19Oct2022, for COVID-19 immunisation, reaction(s): "General tiredness, sore arm", "General tiredness, sore arm"; Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Left arm), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 10Oct2023 at 21:00, outcome "recovering"; PYREXIA (non-serious) with onset 10Oct2023 at 21:00, outcome "recovering", described as "fever"; MYALGIA (non-serious) with onset 10Oct2023 at 21:00, outcome "recovering", described as "muscle pain"; NIGHT SWEATS (non-serious) with onset 10Oct2023 at 21:00, outcome "recovering"; HEADACHE (non-serious) with onset 10Oct2023 at 21:00, outcome "recovering", described as "severe headache". Therapeutic measures were not taken as a result of night sweats, pyrexia, chills, myalgia, headache.  Additional information: COVID did not occur prior to vaccination. Patient did not test for COVID post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201241827 Same patient, different dose/AEs.;
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, FLUA4
Symptoms: Chills, Headache, Myalgia, Night sweats, Pyrexia
Clinical narrative: Fever, chills, night sweats, headache (onset 12 hours after vaccination through the following evening).  Symptoms subsided 36 hours after injections.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, FLUA4
Symptoms: Chills, Headache, Night sweats, Pyrexia
Clinical narrative: Fever, chills, night sweats, headache (onset 12 hours after vaccination through the following evening).  Symptoms subsided 36 hours after injections.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 71-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: Patient got two doses of the Comirnaty 18 days apart. The first one on 22Sept2023. She mentioned, She had not have any side effects other than a sore arm.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300324867 same reporter/patient/product, different dose/AE;
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: Sore arm; Two doses of the Comirnaty 18 days apart/Inappropriate schedule of Vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 71-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (2023-2024 formula) (DOSE 1, SINGLE), administration date: 22Sep2023, for Covid-19 Immunization, reaction(s): "sore arm". The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset Oct2023, outcome "unknown", described as "Two doses of the Comirnaty 18 days apart/Inappropriate schedule of Vaccine administered"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  Additional information: Patient got two doses of the Comirnaty 18 days apart. The first one on 22Sep2023. She mentioned, She had not have any side effects other than a sore arm.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300324833 same reporter/patient/product, different dose/AE;