chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 77-year-old patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: sulfa medications" (unspecified if ongoing), notes: Known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Negative antigen home test 10 days after onset; (Dec2023) Positive, notes: Positive antigen home test 11 days after onset; (Dec2023) Positive, notes: Positive antigen home test 12 days after onset. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received Paxlovid (Lot number: GK0261) from 28Nov2023 to 02Dec2023 for the treatment of COVID-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist). The reporter is the patient.  An elderly female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose number unknown, 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) all with onset 2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19, which included treatment with Paxlovid form Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, a causal relationship between the suspected drug and the reported events Drug ineffective, COVID-19 cannot be excluded
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: eh9899), in left arm and on 06Jan2021 as dose 2, single (Lot number: ek9321), in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing); "hysterectomy" (unspecified if ongoing); "back pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received other medication with in 2weeks was reported as yes. The patient received Anti viral COVID 19 Treatment paxlovid from 27Nov2023 to Dec2023. The patient had no known allergies.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Reporter's Comments: Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The anti-viral COVID 19 Treatment with Paxlovid from 18Nov2023 to 29Nov2023. The patient had no known allergies.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Lot number: Hg4628) at the age of 39 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received Paxlovid from 26Nov2023 to 30Nov2023, for the treatment of COVID-19. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dementia
Clinical narrative: dementia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "dementia". The following information was reported: DEMENTIA (medically significant), outcome "unknown".  Clinical course: Caller said her husband has dementia and he is currently in a care home. The caller said the care home needs proof that he had his three COVID-19 shots but the card he was given got lost. The caller said all his shots were from Pfizer and she was looking for a way to get a copy of all three of her husband's shots because they were not given in the same place.  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-PV202300199507 same patient/event, different vaccine dose;US-PFIZER INC-202300439331 same patient/event, different vaccine dose;
Sex: M
Vaccine: COVID19
Symptoms: Dementia
Clinical narrative: dementia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "dementia"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "dementia". The following information was reported: DEMENTIA (medically significant), outcome "unknown".  Clinical course: The caller's said her husband has dementia and he is currently in a care home. Caller said the care home needs proof that he has had his three COVID-19 shots but the card he was given got lost. The caller said all his shots were from Pfizer and she was looking for a way to get a copy of all three of her husband's shots because they were not given in the same place. Resolution: Gathered caller's demographics -Utilized the FAQ for COVID - Lost Vaccination Card (Article Number) - Created a manual AE form because the caller stated her husband has dementia and he has already taken vaccine shots  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300439330 same patient/event, different vaccine dose;US-PFIZER INC-PV202300199507 same patient/event, different vaccine dose;
Sex: U
Vaccine: COVID19
Symptoms: Wound
Clinical narrative: developing open wounds on body that will not heal; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Open wound". The following information was reported: WOUND (medically significant), outcome "not recovered", described as "developing open wounds on body that will not heal". The event "developing open wounds on body that will not heal" required physician office visit.  Clinical course: Ever since the patient received the first 3 Covid shots, the patient was developing open wounds on body that would not heal. The patient had been to several doctors including a dermatologist and had never seen something like this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300199560 same patient/event, different vaccine dose;US-PFIZER INC-202300439450 same patient/event, different vaccine dose;
Sex: U
Vaccine: COVID19
Symptoms: Wound
Clinical narrative: developing open wounds on body that will not heal; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "developing open wounds on body that will not heal"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "developing open wounds on body that will not heal". The following information was reported: WOUND (medically significant), outcome "not recovered", described as "developing open wounds on body that will not heal". The event "developing open wounds on body that will not heal" required physician office visit.  Clinical course: Ever since the patient received the first 3 Covid shots, the patient was developing open wounds on body that would not heal. The patient had been to several doctors including a dermatologist and had never seen something like this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300439449 same patient/event, different vaccine dose;US-PFIZER INC-PV202300199560 same patient/event, different vaccine dose;
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, COVID-19, Cardiac arrest, SARS-CoV-2 test
Clinical narrative: had an arrhythmia which lead to him going into cardiac arrest; had an arrhythmia which lead to him going into cardiac arrest; Binax COVID test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 67-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 1, single (Lot number: HG4659) at the age of 67 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diagnosed with dilated cardiomyopathy in 2009", start date: 2009 (unspecified if ongoing). Concomitant medication(s) included: XARELTO; ENTRESTO. The following information was reported: COVID-19 (medically significant) with onset 01Oct2023, outcome "unknown", described as "Binax COVID test result=Positive"; ARRHYTHMIA (hospitalization, life threatening), CARDIAC ARREST (hospitalization, life threatening) all with onset 10Oct2023 at 03:30, outcome "recovering" and all described as "had an arrhythmia which lead to him going into cardiac arrest". The patient was hospitalized for arrhythmia, cardiac arrest (hospitalization duration: 9 day(s)). The event "had an arrhythmia which lead to him going into cardiac arrest" required physician office visit and emergency room visit. The patient did not have COVID prior to vaccination. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Oct2023) Positive, notes: COVID test type post vaccination=Nasal swab. Therapeutic measures were taken as a result of arrhythmia, cardiac arrest. Treatment included cardiac resuscitation, medically induced coma for 6 days, and surgery for a pacemaker /defibrillator.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Paraesthesia
Clinical narrative: feet, legs, thighs, gluts, tingling
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Debridement, Rectal abscess, SARS-CoV-2 test positive
Clinical narrative: Procedure Performed: Procedure(s) (LRB): PERINEAL INCISION AND DEBRIDEMENT (N/A)   Date of Admission: 11/21/2023   Date of Discharge: 11/22/2023   Reason for Admission (Admitting Diagnosis): Pre-Op Diagnosis Codes:    * ANORECTAL ABSCESS [K61.2]   Hospital Course:  No Complications   Medications, instructions, follow up information: See patient Discharge Instructions/AVS.   Discharge Condition: Stable.   Discharge Diagnosis:  Post-Op Diagnosis Codes:    * ANORECTAL ABSCESS [K61.2]    * COVID-19 TEST POSITIVE BY OUTSIDE LABORATORY [U07.1]       Note Details  Author (M.D.) File Time 11/22/2023 11:08 PM Author Type Physician Status Signed Last Editor (M.D.) Specialty Surgery, General Hospital Acct # Admit Date 11/21/2023  ED to Hosp-Admission (Discharged) on 11/21/2023  ED to Hosp-Admission (Discharged) on 11/21/2023   Detailed Report  Note shared with patient Additional Orders and Documentation   Results    Meds    Orders    Flowsheets   Encounter Info:  History, Allergies, Education, Care Plan, Detailed Report   Linked Episodes  PERINEAL INCISION AND DE From 11/21/2023 to 11/26/2023  Hospital Problem List   None Care Timeline  11/22   Admitted from ED (Observation) 0026    PERINEAL INCISION AND DEBRIDEMENT    Discharged 2003  Discharge   Home or Self Care.   Discharge Instructions (AVS) (Printed 11/22/2023) Medication List at Discharge   acetaminophen 500 mg Take 1 to 2 tablets by mouth every 6 hours as needed for pain or fever. Do not exceed 6 tablets in 24 hours  aripiprazole 20 mg Oral DAILY  cetirizine HCl 10 mg Take one-half tablet by mouth daily as needed for nasal congestion (allergies)  docusate sodium 100 mg Take 1 to 2 capsules by mouth at bedtime as needed for constipation  hydroxyzine HCl 100 mg Oral EVERY BEDTIME  levonorgestrel/ethin.estradiol   0.1-20 mg-mcg Tab, 1 tablet Oral DAILY  0.1-20 mg-mcg Tab, 1 tablet Oral DAILY, for birth control  lidocaine 5 % 1 mL Topical  AS NEEDED  meloxicam 15 mg Oral DAILY  mirtazapine 15 mg Oral EVERY BEDTIME, for sleep  oxycodone HCl 5 mg Oral EVERY 6 HOURS AS NEEDED  psyllium husk/aspartame 3.4 gram Mix the content of 1 packet in 8 ounces of water and drink 2 times a day. Drink additional fluid after taking medication  sennosides 8.6 mg Take 1 tablet by mouth daily as needed for constipation. May increase up to 2 tablets by mouth 2 times a day as needed for severe constipation. Do not exceed 4 tablets in 24 hours
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Pain at injection sight and achy arm making it hard to raise- 9 pm  12/7 Left side neck pain  Friday 12/8 Low grade fever by mid day, nausea and vomiting by 6pm
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Pain at injection sight and achy arm making it hard to raise- 9 pm  12/7 Left side neck pain  Friday 12/8 Low grade fever by mid day, nausea and vomiting by 6pm
Age: 0.25
Sex: M
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received erroneous dose of MMR vaccine at age 3 months --- no side effect noted as of report
Age: 73.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Rash
Clinical narrative: BROKE OUT IN RASH HEAD TO TOE, STARTING WITH NECK APPROXIMATELY 24 HOURS AFTER RECIEVING VACCINES.  WAS SEEN BY PCP AND RECEIVED STEROID SHOT.
Age: 78.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Pain in extremity
Clinical narrative: per patient ever since he received two vaccines in his right arm (also received two doses in his left, his right arm has been hurting him ever since. He stated he was going to talk with his doctor about it at his next appointment if it still hurts.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient was supposed to receive an RSV vaccine but was inadvertently given her husband's COVID vaccine which she last received on 9/23/23.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Amnesia, Balance disorder, Confusional state, Dizziness, Fatigue
Clinical narrative: Patient reports extreme mental and physical fatigue and pain. Dizziness and loss of balance is present. States memory loss and confusion is present, not able to recall times and dates.   Condition had started approximately 5.5 hours after vaccination and continued until report given to pharmacist on 12/08/2023
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Mental fatigue, Pain
Clinical narrative: Patient reports extreme mental and physical fatigue and pain. Dizziness and loss of balance is present. States memory loss and confusion is present, not able to recall times and dates.   Condition had started approximately 5.5 hours after vaccination and continued until report given to pharmacist on 12/08/2023
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: PT STARTED TO FEEL DIZZY, ALMOST FAINTED, MOM WAS ABLE TO CATCH PT.  PT WAS ABLE TO FEEL BETTER AFTER DRINKING WATER AND EATING CHIPS. PT HAS HAD THIS HAPPEN BEFORE, 5 YEARS AGO WITH ANOTHER VACCINE PER MOM AT AGE 11. MOM REPORTS THAT THIS ALSO HAPPENS TO HER AFTER VACCINES AND L AB DRAWS.
Age: 83.0
Sex: M
Vaccine: RSV
Symptoms: Amnesia, Confusional state, Fatigue, Mental fatigue
Clinical narrative: Patient reports confusion, loss of memory, and physical and mental exhaustion that started approximately 5.5 hours post vaccination.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Injection site pain, Muscle fatigue
Clinical narrative: Fatigue, Weak Joints, Soreness around injection site, Muscle Fatigua.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Mobility decreased
Clinical narrative: PATIENT STATED HE CANNOT RAISE HIS RIGHT ARM FULLY ANYMORE.   HE HAS LOST RANGE OF MOTION FOR MORE THAN A YEAR AFTER GETTING VACCINATED WITH MODERNA COVID VACCINE.  HE STATED HIS ARM HAS NOT GOTTEN BETTER.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache
Clinical narrative: Evening of vaccination, developed headache on right side of head.  Has appeared & disappeared spradically.  taking advil for discomfort.   Doesn't affect sleep or anything else, just pops up and causes moderate pain.  Appears to be lessening a bit 72 hours after injection, but still borherson.
Age: 52.0
Sex: F
Vaccine: FLUR4
Symptoms: Chest pain
Clinical narrative: Per patient she was experiencing mild chest pain after the vaccine. The mild chest pain lasted a few minutes and resolved on its own.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth, Rash
Clinical narrative: Started Thursday night with a red rash on both arms where the shots were given. Then moved down arms to the elbows. Was warm to the touch and itchy. Put hydrocortisone cream on it and went to bed. Woke up at 6 am on Friday morning and the rash had spread down both arms from the elbows to the palm of both hands. Also across the chest and on the knees down legs and on top of the feet.  Took him to the doctor and was told to give him  Zyrtec and if needed Benadryl. Came home gave Zyrtec and by the evening still has the rash and started to become very itchy so I gave him Benadryl and put hydrocortisone cream on it.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Started Thursday night with a red rash on both arms where the shots were given. Then moved down arms to the elbows. Was warm to the touch and itchy. Put hydrocortisone cream on it and went to bed. Woke up at 6 am on Friday morning and the rash had spread down both arms from the elbows to the palm of both hands. Also across the chest and on the knees down legs and on top of the feet.  Took him to the doctor and was told to give him  Zyrtec and if needed Benadryl. Came home gave Zyrtec and by the evening still has the rash and started to become very itchy so I gave him Benadryl and put hydrocortisone cream on it.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cardiac ablation, Chest X-ray, Chest pain, Computerised tomogram heart
Clinical narrative: On 10/20/23 I underwent a cardiac ablation for atrial fibrillation. I subsequently experienced chest and back pain and saw a provider on 10/21/23. I began a course of treatment of colchicine but was unable to tolerate after two pills. On 10/28/23 I was admitted to the hospital with severe chest pain which was determined to be pericarditis.  I was discharged on 10/29/23 and am on a course of colchichine every other day, prednisone and pantoprazole. I am currently under the care of my rheumatologist, cardiologist and electrophysiologist.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Full blood count, Metabolic function test, Pericarditis
Clinical narrative: On 10/20/23 I underwent a cardiac ablation for atrial fibrillation. I subsequently experienced chest and back pain and saw a provider on 10/21/23. I began a course of treatment of colchicine but was unable to tolerate after two pills. On 10/28/23 I was admitted to the hospital with severe chest pain which was determined to be pericarditis.  I was discharged on 10/29/23 and am on a course of colchichine every other day, prednisone and pantoprazole. I am currently under the care of my rheumatologist, cardiologist and electrophysiologist.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Troponin
Clinical narrative: On 10/20/23 I underwent a cardiac ablation for atrial fibrillation. I subsequently experienced chest and back pain and saw a provider on 10/21/23. I began a course of treatment of colchicine but was unable to tolerate after two pills. On 10/28/23 I was admitted to the hospital with severe chest pain which was determined to be pericarditis.  I was discharged on 10/29/23 and am on a course of colchichine every other day, prednisone and pantoprazole. I am currently under the care of my rheumatologist, cardiologist and electrophysiologist.
Age: 29.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Blood test, Chest pain, Immunisation reaction, Palpitations, Pericarditis
Clinical narrative: No reaction until awoken with chest pain and racing heart around 0430 the night after booster vaccination. Previous vaccines were all Pfizer, this was my fourth Covid vaccination in total and my first since having been infected with and recovered from COVID-19  over a year prior. Also received flu shot at the same time. Pain was worse with deep breath, better with leaning forward or lying on stomach. Was not bad enough that I felt I needed to be seen, did not make me tired or feel sick, just palpitations, rapid heart beat, and mild pain. Continued for 3 days about the same, then worsened during the day. Researched on my own and saw pericarditis as the likely cause, started a course of 400mg ibuprofen 4x a day, pain resolved within 4 days. Followed up with doctor at urgent care about a month later with upper respiratory infection and mentioned it, doctor agreed that it was likely a pericarditis reaction to booster vaccine. I was sick with Covid-19 August of 2022, and did have similar chest pain and palpitations, but I attributed it to lung inflammation as my cough was very severe, never evaluated or treated for it outside of normal ibuprofen/tylenol cycling for fever control with Covid infection. Chest pain, heart rate, and palpitations have not returned or reoccurred since ibuprofen course.
Age: 29.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Upper respiratory tract infection
Clinical narrative: No reaction until awoken with chest pain and racing heart around 0430 the night after booster vaccination. Previous vaccines were all Pfizer, this was my fourth Covid vaccination in total and my first since having been infected with and recovered from COVID-19  over a year prior. Also received flu shot at the same time. Pain was worse with deep breath, better with leaning forward or lying on stomach. Was not bad enough that I felt I needed to be seen, did not make me tired or feel sick, just palpitations, rapid heart beat, and mild pain. Continued for 3 days about the same, then worsened during the day. Researched on my own and saw pericarditis as the likely cause, started a course of 400mg ibuprofen 4x a day, pain resolved within 4 days. Followed up with doctor at urgent care about a month later with upper respiratory infection and mentioned it, doctor agreed that it was likely a pericarditis reaction to booster vaccine. I was sick with Covid-19 August of 2022, and did have similar chest pain and palpitations, but I attributed it to lung inflammation as my cough was very severe, never evaluated or treated for it outside of normal ibuprofen/tylenol cycling for fever control with Covid infection. Chest pain, heart rate, and palpitations have not returned or reoccurred since ibuprofen course.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: pt states one week after getting the shot, she had a rash below the vaccine site with red spots. it didn't hurt , or was not hot to touch.
Age: 32.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Foetal growth restriction, Laboratory test normal, Premature delivery, Premature labour
Clinical narrative: I went into labor and I had my baby. Her due date was 1/4/24. A week before delivery she was diagnosed with IUGR because she measured 6th percentile during a growth ultrasound. All other tests were normal. She was 27th percentile when she was born. Birth weight was 5lb .6 oz
Age: 32.0
Sex: F
Vaccine: RSV
Symptoms: Ultrasound antenatal screen abnormal
Clinical narrative: I went into labor and I had my baby. Her due date was 1/4/24. A week before delivery she was diagnosed with IUGR because she measured 6th percentile during a growth ultrasound. All other tests were normal. She was 27th percentile when she was born. Birth weight was 5lb .6 oz
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Night chills, low fever, muscle aches, joint pain, fatigue
Age: 72.0
Sex: M
Vaccine: FLUA4
Symptoms: Rash, Rash macular, Rash pruritic, Urticaria
Clinical narrative: 20 days after shot I developed a rash throughout body, very itchy. Began as small granules, eventually growing in size and connecting with other surrounding granules to the point where entire area was one red blotch. Diagnosed by Urgent Care Doctor at Medical as URTICARIA. I had same reaction last year [2022] 23 days after shot but medical community did not suspect flu shot because they felt it had been too many days. I was given the High Dose both years.
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Acute myocardial infarction, Arterial angioplasty, Cardiac arrest, Cardioversion, Catheterisation cardiac abnormal
Clinical narrative: Acute myocardial infarction with cardiac arrest requiring cpr and cardioversion. Patient was taken to hospital and subjected to immediate cardiac catheterization. Cath showed a thrombus causing a 99% obstruction in the mid-portion of the LAD, Vessel was dilated with a balloon and two stents were inserted. Flow was restored to normal. All other coronary vessels were normal. Patient required artificial ventilation for 12 hours. Patient spent 5 days in intensive Care Unit. Gradually she recovered mental function. No overt signs of heart failure. Patient had no previous signs or symptoms of heart disease. Her only risk factor was hypertension.
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Coronary arterial stent insertion, Coronary artery occlusion, Coronary artery thrombosis, Intensive care, Mechanical ventilation
Clinical narrative: Acute myocardial infarction with cardiac arrest requiring cpr and cardioversion. Patient was taken to hospital and subjected to immediate cardiac catheterization. Cath showed a thrombus causing a 99% obstruction in the mid-portion of the LAD, Vessel was dilated with a balloon and two stents were inserted. Flow was restored to normal. All other coronary vessels were normal. Patient required artificial ventilation for 12 hours. Patient spent 5 days in intensive Care Unit. Gradually she recovered mental function. No overt signs of heart failure. Patient had no previous signs or symptoms of heart disease. Her only risk factor was hypertension.
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Mental impairment, Resuscitation
Clinical narrative: Acute myocardial infarction with cardiac arrest requiring cpr and cardioversion. Patient was taken to hospital and subjected to immediate cardiac catheterization. Cath showed a thrombus causing a 99% obstruction in the mid-portion of the LAD, Vessel was dilated with a balloon and two stents were inserted. Flow was restored to normal. All other coronary vessels were normal. Patient required artificial ventilation for 12 hours. Patient spent 5 days in intensive Care Unit. Gradually she recovered mental function. No overt signs of heart failure. Patient had no previous signs or symptoms of heart disease. Her only risk factor was hypertension.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; 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 67-year-old female patient received bnt162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm".  Additional Information: She said for all the vaccine she always went with Pfizer and never had any side effect. However, she did report a sore arm from the needle that goes away in 3 days after the injection. She said it's the same thing as the flu shot." (Later clarified that the consumer was not administered the Flu shot).  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received. Follow-up (08Dec2023): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300332493 Same patient/event, different vaccine doses;
Age: 67.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Appetite disorder, Dysgeusia, Nausea
Clinical narrative: In less than 24 hours of receiving the flu shot I developed an awful metalic/medicinal taste in my mouth which caused a loss of appetite and nausea for a period of 12 days. Since I was averse to food, I lost weight (not a problem for me, but could be a problem for someone else). This nasty taste/nausea wore off eventually during the next couple of weeks. So, overall, I was affected by this shot for a month.
Age: 67.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Decreased appetite, Dysgeusia, Nausea, Weight decreased
Clinical narrative: In less than 24 hours of receiving the flu shot I developed an awful metalic/medicinal taste in my mouth which caused a loss of appetite and nausea for a period of 12 days. Since I was averse to food, I lost weight (not a problem for me, but could be a problem for someone else). This nasty taste/nausea wore off eventually during the next couple of weeks. So, overall, I was affected by this shot for a month.
Sex: M
Vaccine: COVID19-2, RSV, COVID19, RSV
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Transfusion
Clinical narrative: Guillain-Barre Syndrome; Asthenia; losing feeling/strength in feet and within 24 hrs loss of feeling/strength in whole body; muscular weakness/ losing feeling/strength in feet and within 24 hrs loss of feeling/strength in whole body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: 2710914-1 (VAERS ID).  A 74-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 10Oct2023 as dose number unknown, single (Lot number: HF5017) intramuscular, in left arm for immunisation; for immunisation; bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Lot number: HG2282) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL TARTRATE; LEVOTHYROXINE; VALSARTAN & HCTZ; NIFEDIPINE. The following information was reported: ASTHENIA (hospitalization, disability) with onset 19Oct2023, outcome "not recovered"; GUILLAIN-BARRE SYNDROME (hospitalization, disability) with onset 19Oct2023, outcome "not recovered"; HYPOAESTHESIA (hospitalization, disability) with onset 19Oct2023, outcome "not recovered", described as "losing feeling/strength in feet and within 24 hrs loss of feeling/strength in whole body"; MUSCULAR WEAKNESS (hospitalization, disability) with onset 19Oct2023, outcome "not recovered", described as "muscular weakness/ losing feeling/strength in feet and within 24 hrs loss of feeling/strength in whole body". The patient was hospitalized for guillain-barre syndrome, asthenia, hypoaesthesia, muscular weakness (hospitalization duration: 14 day(s)). The events "guillain-barre syndrome", "asthenia", "losing feeling/strength in feet and within 24 hrs loss of feeling/strength in whole body" and "muscular weakness/ losing feeling/strength in feet and within 24 hrs loss of feeling/strength in whole body" required emergency room visit. Therapeutic measures were taken as a result of guillain-barre syndrome. Patient was currently in hospital getting plasma transfusion for Guillain-Barre syndrome.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19-2, RSV, COVID19, RSV
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness
Clinical narrative: Guillain-Barre Syndrome; Asthenia; losing feeling/strength in feet and within 24 hrs loss of feeling/strength in whole body; muscular weakness/ losing feeling/strength in feet and within 24 hrs loss of feeling/strength in whole body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: 2710914-1 (VAERS ID).  A 74-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 10Oct2023 as dose number unknown, single (Lot number: HF5017) intramuscular, in left arm for immunisation; for immunisation; bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Lot number: HG2282) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL TARTRATE; LEVOTHYROXINE; VALSARTAN & HCTZ; NIFEDIPINE. The following information was reported: ASTHENIA (hospitalization, disability) with onset 19Oct2023, outcome "not recovered"; GUILLAIN-BARRE SYNDROME (hospitalization, disability) with onset 19Oct2023, outcome "not recovered"; HYPOAESTHESIA (hospitalization, disability) with onset 19Oct2023, outcome "not recovered", described as "losing feeling/strength in feet and within 24 hrs loss of feeling/strength in whole body"; MUSCULAR WEAKNESS (hospitalization, disability) with onset 19Oct2023, outcome "not recovered", described as "muscular weakness/ losing feeling/strength in feet and within 24 hrs loss of feeling/strength in whole body". The patient was hospitalized for guillain-barre syndrome, asthenia, hypoaesthesia, muscular weakness (hospitalization duration: 14 day(s)). The events "guillain-barre syndrome", "asthenia", "losing feeling/strength in feet and within 24 hrs loss of feeling/strength in whole body" and "muscular weakness/ losing feeling/strength in feet and within 24 hrs loss of feeling/strength in whole body" required emergency room visit. Therapeutic measures were taken as a result of guillain-barre syndrome. Patient was currently in hospital getting plasma transfusion for Guillain-Barre syndrome.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Death, Myocarditis
Clinical narrative: sudden death
Age: 64.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Sudden death
Clinical narrative: sudden death
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; a dose of expired PNEUMOVAX 23 was given to a patient; This spontaneous report has been received from other health professional referring to 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 25-OCT-2023, the patient was vaccinated with 1 dose of pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) lot number W007035 which was verified to be a valid lot number, with an expiry date of 20-OCT-2023, (exact dose, vaccination scheme, frequency, indication, route of administration and anatomical site of injection were not reported) (expired product administered).  Follow up was received from Other Health Professional on 05-DEC-2023: The patients details were updated and the case was already valid
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema multiforme, Pyrexia
Clinical narrative: developed erythema multiforme (EM) with fever; This spontaneous report has been received from other health care professional, regarding to a 1-year-old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications not reported. The patient had allergy to amoxicillin and ibuprofen.  On 16-NOV-2023, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) lot # X010374, (expiration date:13-NOV-2024) (strength reported as 25U/0.5mL), intramuscular, for prevention of hepatitis A (prophylaxis) (anatomical location and exact dose was not reported). On the same day, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # X010525 (expiration date: 11-APR-2025), subcutaneous, for prevention of varicella (prophylaxis) (exact dose and anatomical location was not provided) and  with the first dose of , measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II) lot # W019423, expiration date: 20-JUN-2024 (exact dose was not provided), subcutaneous, for Prevention of measles/Mumps/Rubella (prophylaxis) (exact dose and anatomical location was not provided).  On 25-NOV-2023, the patient experienced erythema multiforme with fever. Afterwards, the patient went to an office visit (seeked for medical attention) and these events were noted. Moreover, the patient received treatment with cetirizine (ZYRTEC), prednisolone, famotidine (PEPCID)  and paracetamol (TYLENOL) (at unknown doses and frequencies).On 29-NOV-2023, the patient went to an office visit and the event was noted. At the reporting time, the outcome of the event of erythema multiforme was not provided.  Action taken with the suspected vaccines and causal relationship with the vaccines regarding erythema multiforme were not provided; nonetheless, it was reported that therapy was not discontinued.  Upon internal review, erythema multiforme was considered as medically significant (OME).
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dehydration, Pain in extremity, Unevaluable event
Clinical narrative: Dehydrated; Weak; Slightly sore arm; Now she has this; On 03-NOV-2023, 08-NOV-2023, and 09-NOV-2023, a spontaneous case was received from a consumer via social media monitoring.  This case was assessed as Invalid based on: Incomplete ICSR: no identifiable adverse drug reaction.  On 02-DEC-2023, significant additional information was received by Novavax from a consumer via social media monitoring. A valid adverse event, and this case was reassessed as valid. A valid narrative was generated as follows:  This serious, initial spontaneous safety report was received by Novavax on 03-NOV-2023 from a consumer via social media monitoring. Additional information was received on 06-NOV-2023, 08-NOV-2023, 09-NOV-2023, and 02-DEC-2023 from a consumer via social media monitoring.  A female of an unspecified age and race was vaccinated with Covid-19 Vaccine and Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect Covid-19 vaccine unspecified dose on 03-NOV-2023.  The following medical history was reported: Immunodeficiency, Small cell lung cancer, Chemotherapy (probably last one), and Immunotherapy (Unevaluable event).  No concomitant medications were reported.  On an unspecified day in NOV-2023, after vaccination, the individual became weak (PT: Asthenia) (Serious: Hospitalization) and dehydrated (PT: Dehydration) (Serious: Hospitalization) and was admitted to the hospital. On an unspecified date in 2023, after hospitalization, it was reported  "and now she has this" (PT: Unevaluable event). Additionally, they are trying to get her healthy to resume immunotherapy.  At the time of reporting, the event outcomes of Dehydration, Asthenia and Unevaluable event were not recovered/not resolved.  Lot number was not provided in the report.  On 05-DEC-2023, significant additional information was received by Novavax from a consumer via social media monitoring. The following information has been updated in the case: On an unspecified day in NOV-2023, the individual experienced a slightly sore arm (PT: Pain in extremity). No other problems or noticeable side effects were experienced. The event outcome of Pain in extremity was unknown.  A discrepancy was identified in the source document regarding the receipt dates due to time zone differences. The earliest date was captured as the IRD (initial receipt date) and company aware date.; Sender's Comments: This female of an unspecified age experienced: Asthenia, Dehydration, Unevaluable event and Pain in extremity after vaccination with Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter. The events Asthenia and Dehydration were reported as serious. The events Unevaluable event and Pain in extremity were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) and the reported events is considered Possible.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Blood immunoglobulin G, COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: COVID-19 infections were noted; COVID-19 infections were noted; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "chronic lymphocytic leukemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 infections were noted". The patient underwent the following laboratory tests and procedures: Antibody test: Unknown results; Positive; Blood immunoglobulin G (214-1016): Unknown results; SARS-CoV-2 antibody test: Unknown results, notes: Unit: AU/ml.  The reporter considered "covid-19 infections were noted" related to bnt162b2.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got Covid after around 10-20 days of pfizer Covid vaccine; got Covid after around 10-20 days of pfizer Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), as dose number unknown, 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got Covid after around 10-20 days of pfizer Covid vaccine".; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300197561 Same reporter/product, different patient;