chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Syncope
Clinical narrative: Dizzy and fainted
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Back pain, Fatigue, Joint swelling, Magnetic resonance imaging
Clinical narrative: After first dose on 8.4.21 (Lot EW0172) within 24 hours had tingling sensation in hands and feet and itching palms and soles of feet. Around mid-January 2022, joint swelling noted in hands and feet. Now suffering from dorsalgia, fatigue, myalgia, paresthesia of skin, inflammatory polyarthropathy
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia, Pruritus, Spinal X-ray
Clinical narrative: After first dose on 8.4.21 (Lot EW0172) within 24 hours had tingling sensation in hands and feet and itching palms and soles of feet. Around mid-January 2022, joint swelling noted in hands and feet. Now suffering from dorsalgia, fatigue, myalgia, paresthesia of skin, inflammatory polyarthropathy
Age: 74.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Blister, Laboratory test, Myalgia, Paraesthesia
Clinical narrative: Blisters on full length of left arm, muscle pain and severe tingling all day starting on 8/22/2022   Valcyclovir prescribed
Age: 74.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Arthralgia, Pain, Pain in extremity, Rash vesicular, Varicella virus test positive
Clinical narrative: Blisters on full length of left arm, muscle pain and severe tingling all day starting on 8/22/2022   Valcyclovir prescribed
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Fatigue, Pain, Pain in extremity, Rheumatoid arthritis
Clinical narrative: THE EVENING OF MY FIRST SHINGRIX VACCINE MY ARM FELT QUITE SORE AND I WAS TIRED AND A BIT ACHEY. WITHIN A DAY (OR MAYBE A COUPLE OF DAYS) I BEGAN TO FEEL VERY ACHY. I HAVE HAD RHEUMATOID ARTHRITIS SINCE 2003. FOR SEVERAL YEARS I HAVE BEEN IN COMPLETE REMISSION, WTH MINOR SYMPTOMS THAT WERE HANDLED WITHOUT RA MEDICATION, ONLY TYLENOL. WE MOVED IN 2016 AND I NEVER SOUGHT CARE FROM A NEW RHEUMATOLOGIST.  AS THIS FLARE CONTINUED I GOT A RECOMMENDATION FROM MY CURRENT PERSONAL PHYSICIAN FOR A RHEUMATOLOGIST. I HAVE AN APPOINTMENT TO SEE THAT NEW RA DOCTOR, FOR A COMPLETE WORK-UP. THE FLARE CONTINUES, SO I AM EAGER TO SEE THE DOCTOR. I DO NOT KNOW IF THIS NEW AND TROUBLESOME RA FLARE IS MERELY A COINCIDENCE.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Amnesia, Bedridden, Biopsy, Blood test, Colitis microscopic
Clinical narrative: Each vax resulted in one week bedridden, fever only first 3 days, inflammation  since first vaccination. Extreme fatigue, memory fog,  hot flashes (previously went away by 2018). Two major health conditions arose after vaccinating between the first and second: undiagnosed IBS diarrhea (unable to work full time, 25+ visits to toilet per day); bloodwork, thyroid and fecal tests at lab; diagnostic and excision biopsies both EGD and colonoscopy; diagnosed collagenous colitis 4/29/2022; undiagnosed breast tumor from mammogram 4/25/2022; primary dr referred me to oncologist for more scans and another outpatient diagnostic excision biopsy on one breast. I am unable to work full time despite Collagenous Colitis drug therapy, I?m always tired, I?m unable to focus at work and home, I?ve been healthy without disease prior to 2018 having one bad cold November 2019 which is rare.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Colonoscopy, Disturbance in attention, Fatigue, Full blood count, Hot flush
Clinical narrative: Each vax resulted in one week bedridden, fever only first 3 days, inflammation  since first vaccination. Extreme fatigue, memory fog,  hot flashes (previously went away by 2018). Two major health conditions arose after vaccinating between the first and second: undiagnosed IBS diarrhea (unable to work full time, 25+ visits to toilet per day); bloodwork, thyroid and fecal tests at lab; diagnostic and excision biopsies both EGD and colonoscopy; diagnosed collagenous colitis 4/29/2022; undiagnosed breast tumor from mammogram 4/25/2022; primary dr referred me to oncologist for more scans and another outpatient diagnostic excision biopsy on one breast. I am unable to work full time despite Collagenous Colitis drug therapy, I?m always tired, I?m unable to focus at work and home, I?ve been healthy without disease prior to 2018 having one bad cold November 2019 which is rare.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Impaired work ability, Inflammation, Irritable bowel syndrome, Mammogram, Oesophagogastroduodenoscopy
Clinical narrative: Each vax resulted in one week bedridden, fever only first 3 days, inflammation  since first vaccination. Extreme fatigue, memory fog,  hot flashes (previously went away by 2018). Two major health conditions arose after vaccinating between the first and second: undiagnosed IBS diarrhea (unable to work full time, 25+ visits to toilet per day); bloodwork, thyroid and fecal tests at lab; diagnostic and excision biopsies both EGD and colonoscopy; diagnosed collagenous colitis 4/29/2022; undiagnosed breast tumor from mammogram 4/25/2022; primary dr referred me to oncologist for more scans and another outpatient diagnostic excision biopsy on one breast. I am unable to work full time despite Collagenous Colitis drug therapy, I?m always tired, I?m unable to focus at work and home, I?ve been healthy without disease prior to 2018 having one bad cold November 2019 which is rare.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia, Stool analysis, Thyroid function test
Clinical narrative: Each vax resulted in one week bedridden, fever only first 3 days, inflammation  since first vaccination. Extreme fatigue, memory fog,  hot flashes (previously went away by 2018). Two major health conditions arose after vaccinating between the first and second: undiagnosed IBS diarrhea (unable to work full time, 25+ visits to toilet per day); bloodwork, thyroid and fecal tests at lab; diagnostic and excision biopsies both EGD and colonoscopy; diagnosed collagenous colitis 4/29/2022; undiagnosed breast tumor from mammogram 4/25/2022; primary dr referred me to oncologist for more scans and another outpatient diagnostic excision biopsy on one breast. I am unable to work full time despite Collagenous Colitis drug therapy, I?m always tired, I?m unable to focus at work and home, I?ve been healthy without disease prior to 2018 having one bad cold November 2019 which is rare.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood test normal, Cardiac stress test normal, Chest discomfort, Chest pain
Clinical narrative: On May 6th 2022, I had a sudden onset rapid heart rate and chest pressure. I could feel my pulse and blood rushing through my carotid artery. It became difficult to take a deep breath and was feeling short of breath. I checked my blood pressure and it was severely elevated at 220/130. I have no history of heart conditions nor hypertension. This episode began at 9:00 AM and I went to the ER at 5:30 PM because the symptoms had not subsided. They gave me a beta blocker to decrease my heart and blood pressure. I was discharged given a prescription for hydrachlorothiazide. I followed up with my primary care provider and has been on a care plan since than. I?ve also had multiple repeat episodes, and have been to the ER on multiple occasions for chest pain and palpitations as well as severely elevated blood pressure with symptoms of blurred vision, intense headache.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram normal, Dyspnoea, Electrocardiogram normal, Headache, Heart rate increased
Clinical narrative: On May 6th 2022, I had a sudden onset rapid heart rate and chest pressure. I could feel my pulse and blood rushing through my carotid artery. It became difficult to take a deep breath and was feeling short of breath. I checked my blood pressure and it was severely elevated at 220/130. I have no history of heart conditions nor hypertension. This episode began at 9:00 AM and I went to the ER at 5:30 PM because the symptoms had not subsided. They gave me a beta blocker to decrease my heart and blood pressure. I was discharged given a prescription for hydrachlorothiazide. I followed up with my primary care provider and has been on a care plan since than. I?ve also had multiple repeat episodes, and have been to the ER on multiple occasions for chest pain and palpitations as well as severely elevated blood pressure with symptoms of blurred vision, intense headache.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Vision blurred
Clinical narrative: On May 6th 2022, I had a sudden onset rapid heart rate and chest pressure. I could feel my pulse and blood rushing through my carotid artery. It became difficult to take a deep breath and was feeling short of breath. I checked my blood pressure and it was severely elevated at 220/130. I have no history of heart conditions nor hypertension. This episode began at 9:00 AM and I went to the ER at 5:30 PM because the symptoms had not subsided. They gave me a beta blocker to decrease my heart and blood pressure. I was discharged given a prescription for hydrachlorothiazide. I followed up with my primary care provider and has been on a care plan since than. I?ve also had multiple repeat episodes, and have been to the ER on multiple occasions for chest pain and palpitations as well as severely elevated blood pressure with symptoms of blurred vision, intense headache.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Gait inability
Clinical narrative: Morning after the 1st booster I couldn?t walk and was confused. According to my family this lasted for 2 days.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: Covid symptoms for two days 7/28+29/2022 with negative home tests, tested positive on July 30, 2022. Treated with Monoclonal Antibodies on 7/30/2022
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Swelling  of arm that the patient received injection on. Started the same day as injection but seemed to be better the next day.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth, Vomiting
Clinical narrative: pt came in and stated she was having redness, swelling, and heat in her arm at the injection site. She also stated that she had vomited multiple times the night before (the day of the vaccine). She also stated she felt very flu-like. I recommended she take benadryl, use ice and hydrocortisone cream topically.  I told her to stay hydrated and that I would call and check on her. I called her this evening she stated the redness was spreading despite the benadryl and ice and I asked her to let us know if she went to the doctor or the hospital.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Nausea, Pain, Vomiting
Clinical narrative: patient complains of dizziness, shooting pain, headache, nausea and vomiting
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Malaise
Clinical narrative: Pharmacist working at verification station was informed by an out-window staff that a patient was not feeling well after a vaccination. The patient was administered the 1st dose of Covid 19 vaccine (Moderna) by our tech immunizer. Before administering the vaccine the RPH went over common side effects and reactions. Upon calling RPH ran out with emergent kit with EpiPen, Benadryl and first aid kits. By the time the RPH approached the patient, he was sitting on a chair next to his parent. The pharmacist offered to call 911, however the patient's dad declined the offer.  The pharmacist asked few questions to patient to see his health status. Patient was well oriented and no signs of any adverse reactions, and patient stated that he was doing fine. Patient's dad commented that his son is scared of needles all the time and it happens frequently when he's getting immunizations. Pharmacist recommended to patient and his dad in the future it would be advisable to get vaccines at medical facility under doctor's supervision. Pharmacist stayed with the patient for a while for observation until the patient left pharmacy to grab some snacks. No further adverse reactions observed. However earlier today, after few weeks of the incident, patient's dad showed up to the pharmacy counter stating that his son had breathing problems on after Covid vaccination and he was administered an inhaler. In addition, the patient's dad wanted us to report the incident because his doctor's office is requesting an incident report. We filed the incident report internally and communicated to patient's dad we reported VAERS.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Heart rate irregular
Clinical narrative: Irregular heart beat over 120bpm
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Pain in extremity, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Woke up 7-29-22 with sore calf. Woke up Saturday 7-30-22 and went to urgent care. No ppler ultrasound was done and Xarelto was started due to dot.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Respiratory rate decreased, Unresponsive to stimuli
Clinical narrative: Narrative:  Patient was found non-responsive in the home, barely breathing by HH or PT on the morning of 8/5/22. Paramedics were called, patient passed away 8/5/22. Patient expired less than 24 hours after receiving Moderna booster. Booster was given during a primary care provider visit in the patient's home 8/4/22. Patient also had extensive health issues in addition to the recent hospital stay. Reported during home visit 8/4/22 he was getting low BP readings after dialysis - last dialysis 8/3/22. He was on home oxygen, but only reported using it if SOB or at night. In general he was feeling weak. From Hospital discharge 7/23/22 DISCHARGE DIAGNOSES: 1. Sepsis present on admit now resolved. 2. Left-sided pleural effusion, possibly parapneumonic with underlying pneumonia s/p thoracocentesis. 3. Acute hypoxemic respiratory failure 4. End-stage renal disease 5. Peripheral arterial disease 6. Debility HOSPITAL COURSE: This is a 61 y.o. male that was admitted for evaluation of nausea, vomiting and fever after undergoing hemodialysis. Initial evaluation revealing left-sided pleural effusion, requiring patient to be placed on IV antibiotics. He underwent thoracocentesis thereafter. Overall his fever has resolved and his respiratory status has improved however he still required 1 to 2 L of oxygen especially with ambulation. Suspected that his effusion may have been parapneumonic and patient did complete IV antibiotics while inpatient.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Narrative: Patient fully vaccinated but admitted to hospital d/t COVID 19
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: Narrative: Patient presented to ED 3 days after receiving 3rd dose of Moderna COVID-19 Vaccine with s/s of swelling and urticaria. Patient was discharged to home without admission.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of personal independence in daily activities
Clinical narrative: dizziness; missed several days of work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9261, Expiration Date: 31May2021) at the age of 56 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MEDROXYPROGESTERONE oral taken for menopause (ongoing); ESTRADIOL oral taken for menopause (ongoing). The following information was reported: DIZZINESS (disability) with onset 05Feb2021, outcome "not recovered"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset Feb2021, outcome "unknown", described as "missed several days of work". The event "dizziness" required physician office visit. Therapeutic measures were taken as a result of dizziness, loss of personal independence in daily activities. Clinical course: 2 weeks after the patient first vaccine dose patient experienced severe dizziness (Vertigo-like). Patient missed several days of work, The doctor suggested doing Eppley Manouver. That did not help. Then tried physical therapy and other exercise for vestibular system. Did not help. Tried work exercise. Tried acupuncture. Nothing got rid of it.  Follow-up attempts are completed. No further information is expected.
Age: 7.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive nasal swab test; positive nasal swab test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 8-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 at 15:30 as dose 1 (orange cap), single (Lot number: FK5127), in left arm and on 28Nov2021 at 11:00 as dose 2 (orange cap), single (Lot number: FK5127) at the age of 7 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27May2022, outcome "unknown" and all described as "positive nasal swab test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) Positive, notes: Nasal Swab.  Clinical Course: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.
Age: 7.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Anger, Arthralgia, Dyslexia, Gait inability
Clinical narrative: positive nasal swab test; positive nasal swab test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 8-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 at 15:30 as dose 1 (orange cap), single (Lot number: FK5127), in left arm and on 28Nov2021 at 11:00 as dose 2 (orange cap), single (Lot number: FK5127) at the age of 7 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27May2022, outcome "unknown" and all described as "positive nasal swab test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) Positive, notes: Nasal Swab.  Clinical Course: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.
Age: 7.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intrusive thoughts, Migraine, Panic attack, SARS-CoV-2 test, Speech disorder
Clinical narrative: positive nasal swab test; positive nasal swab test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 8-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 at 15:30 as dose 1 (orange cap), single (Lot number: FK5127), in left arm and on 28Nov2021 at 11:00 as dose 2 (orange cap), single (Lot number: FK5127) at the age of 7 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27May2022, outcome "unknown" and all described as "positive nasal swab test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) Positive, notes: Nasal Swab.  Clinical Course: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.
Age: 7.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Visual impairment
Clinical narrative: positive nasal swab test; positive nasal swab test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 8-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 at 15:30 as dose 1 (orange cap), single (Lot number: FK5127), in left arm and on 28Nov2021 at 11:00 as dose 2 (orange cap), single (Lot number: FK5127) at the age of 7 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27May2022, outcome "unknown" and all described as "positive nasal swab test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) Positive, notes: Nasal Swab.  Clinical Course: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Alopecia, Anosmia, COVID-19, COVID-19 pneumonia
Clinical narrative: intermittent ringing in my ears; strange scalp tightening sensations; long-term neurological impact; Dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 2, single (Lot number: EN6198, Expiration Date: 30Jun2021) at the age of 56 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Menopause Sx" (ongoing). Concomitant medication(s) included: MEDROXYPROGESTERONE oral taken for menopause (ongoing); ESTRADIOL oral taken for menopause (ongoing). Vaccination history included: BNT162b2 (Dose number: 1, Lot number: EL9261, Expiry: 31May2021, Route: Intramuscular, Site of injection: Left arm.), administration date: 22Jan2021, when the patient was 56-year-old, for Covid-19 Immunization, reaction(s): "severe dizziness (vertigo-like)". The following information was reported: DIZZINESS (medically significant) with onset 26Feb2021, outcome "recovered" (2021), described as "Dizzy"; TINNITUS (non-serious), outcome "unknown", described as "intermittent ringing in my ears"; SKIN TIGHTNESS (non-serious), outcome "unknown", described as "strange scalp tightening sensations"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "long-term neurological impact". The events "dizzy", "intermittent ringing in my ears", "strange scalp tightening sensations" and "long-term neurological impact" required physician office visit. Therapeutic measures were taken as a result of dizziness. Additional information: Concomitant medications medroxyprogesterone and estradiol were started 5 years ago. Two weeks after the patient's first vaccine dose, she experienced severe dizziness (vertigo-like). She missed several days of work and her doctor suggested doing eppley maneuver which didn't help. Then tried physical therapy & other exercises for vestibular system which also didn't help. Tried neck exercises, tried acupuncture and nothing got rid of it. During second vaccine dose 6 weeks later, the patient was so dizzy after the shot, they had to bring the patient to the car on a wheelchair (the patient's husband was driving since the patient didn't feel safe driving all that time). Dizziness continued for several months. Gradually improved and was finally gone by May or Jun2021. Then on 21Sep2021, she tested positive for COVID. 5 days later, she developed the same dizziness again. That's when she associated the first episode with the vaccines. Even today, she still experiences dizziness every day. It's manageable because it happens when she lays down to get up then mostly goes away. The patient also experienced intermittent ringing in ears and strange scalp tightening sensations. Best as she can figure, this appears to be a long-term neurological impact from the first vaccine and then from the virus itself. The patient went to PT, Audiologist, Ear, Nose MD due to the events.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oropharyngeal pain, Oxygen saturation decreased, Pain, Pyrexia, Vertigo
Clinical narrative: intermittent ringing in my ears; strange scalp tightening sensations; long-term neurological impact; Dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 2, single (Lot number: EN6198, Expiration Date: 30Jun2021) at the age of 56 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Menopause Sx" (ongoing). Concomitant medication(s) included: MEDROXYPROGESTERONE oral taken for menopause (ongoing); ESTRADIOL oral taken for menopause (ongoing). Vaccination history included: BNT162b2 (Dose number: 1, Lot number: EL9261, Expiry: 31May2021, Route: Intramuscular, Site of injection: Left arm.), administration date: 22Jan2021, when the patient was 56-year-old, for Covid-19 Immunization, reaction(s): "severe dizziness (vertigo-like)". The following information was reported: DIZZINESS (medically significant) with onset 26Feb2021, outcome "recovered" (2021), described as "Dizzy"; TINNITUS (non-serious), outcome "unknown", described as "intermittent ringing in my ears"; SKIN TIGHTNESS (non-serious), outcome "unknown", described as "strange scalp tightening sensations"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "long-term neurological impact". The events "dizzy", "intermittent ringing in my ears", "strange scalp tightening sensations" and "long-term neurological impact" required physician office visit. Therapeutic measures were taken as a result of dizziness. Additional information: Concomitant medications medroxyprogesterone and estradiol were started 5 years ago. Two weeks after the patient's first vaccine dose, she experienced severe dizziness (vertigo-like). She missed several days of work and her doctor suggested doing eppley maneuver which didn't help. Then tried physical therapy & other exercises for vestibular system which also didn't help. Tried neck exercises, tried acupuncture and nothing got rid of it. During second vaccine dose 6 weeks later, the patient was so dizzy after the shot, they had to bring the patient to the car on a wheelchair (the patient's husband was driving since the patient didn't feel safe driving all that time). Dizziness continued for several months. Gradually improved and was finally gone by May or Jun2021. Then on 21Sep2021, she tested positive for COVID. 5 days later, she developed the same dizziness again. That's when she associated the first episode with the vaccines. Even today, she still experiences dizziness every day. It's manageable because it happens when she lays down to get up then mostly goes away. The patient also experienced intermittent ringing in ears and strange scalp tightening sensations. Best as she can figure, this appears to be a long-term neurological impact from the first vaccine and then from the virus itself. The patient went to PT, Audiologist, Ear, Nose MD due to the events.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Nervous system disorder, Skin tightness, Tinnitus
Clinical narrative: intermittent ringing in my ears; strange scalp tightening sensations; long-term neurological impact; Dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 2, single (Lot number: EN6198, Expiration Date: 30Jun2021) at the age of 56 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Menopause Sx" (ongoing). Concomitant medication(s) included: MEDROXYPROGESTERONE oral taken for menopause (ongoing); ESTRADIOL oral taken for menopause (ongoing). Vaccination history included: BNT162b2 (Dose number: 1, Lot number: EL9261, Expiry: 31May2021, Route: Intramuscular, Site of injection: Left arm.), administration date: 22Jan2021, when the patient was 56-year-old, for Covid-19 Immunization, reaction(s): "severe dizziness (vertigo-like)". The following information was reported: DIZZINESS (medically significant) with onset 26Feb2021, outcome "recovered" (2021), described as "Dizzy"; TINNITUS (non-serious), outcome "unknown", described as "intermittent ringing in my ears"; SKIN TIGHTNESS (non-serious), outcome "unknown", described as "strange scalp tightening sensations"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "long-term neurological impact". The events "dizzy", "intermittent ringing in my ears", "strange scalp tightening sensations" and "long-term neurological impact" required physician office visit. Therapeutic measures were taken as a result of dizziness. Additional information: Concomitant medications medroxyprogesterone and estradiol were started 5 years ago. Two weeks after the patient's first vaccine dose, she experienced severe dizziness (vertigo-like). She missed several days of work and her doctor suggested doing eppley maneuver which didn't help. Then tried physical therapy & other exercises for vestibular system which also didn't help. Tried neck exercises, tried acupuncture and nothing got rid of it. During second vaccine dose 6 weeks later, the patient was so dizzy after the shot, they had to bring the patient to the car on a wheelchair (the patient's husband was driving since the patient didn't feel safe driving all that time). Dizziness continued for several months. Gradually improved and was finally gone by May or Jun2021. Then on 21Sep2021, she tested positive for COVID. 5 days later, she developed the same dizziness again. That's when she associated the first episode with the vaccines. Even today, she still experiences dizziness every day. It's manageable because it happens when she lays down to get up then mostly goes away. The patient also experienced intermittent ringing in ears and strange scalp tightening sensations. Best as she can figure, this appears to be a long-term neurological impact from the first vaccine and then from the virus itself. The patient went to PT, Audiologist, Ear, Nose MD due to the events.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: intermittent ringing in my ears; strange scalp tightening sensations; long-term neurological impact; Dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 2, single (Lot number: EN6198, Expiration Date: 30Jun2021) at the age of 56 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Menopause Sx" (ongoing). Concomitant medication(s) included: MEDROXYPROGESTERONE oral taken for menopause (ongoing); ESTRADIOL oral taken for menopause (ongoing). Vaccination history included: BNT162b2 (Dose number: 1, Lot number: EL9261, Expiry: 31May2021, Route: Intramuscular, Site of injection: Left arm.), administration date: 22Jan2021, when the patient was 56-year-old, for Covid-19 Immunization, reaction(s): "severe dizziness (vertigo-like)". The following information was reported: DIZZINESS (medically significant) with onset 26Feb2021, outcome "recovered" (2021), described as "Dizzy"; TINNITUS (non-serious), outcome "unknown", described as "intermittent ringing in my ears"; SKIN TIGHTNESS (non-serious), outcome "unknown", described as "strange scalp tightening sensations"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "long-term neurological impact". The events "dizzy", "intermittent ringing in my ears", "strange scalp tightening sensations" and "long-term neurological impact" required physician office visit. Therapeutic measures were taken as a result of dizziness. Additional information: Concomitant medications medroxyprogesterone and estradiol were started 5 years ago. Two weeks after the patient's first vaccine dose, she experienced severe dizziness (vertigo-like). She missed several days of work and her doctor suggested doing eppley maneuver which didn't help. Then tried physical therapy & other exercises for vestibular system which also didn't help. Tried neck exercises, tried acupuncture and nothing got rid of it. During second vaccine dose 6 weeks later, the patient was so dizzy after the shot, they had to bring the patient to the car on a wheelchair (the patient's husband was driving since the patient didn't feel safe driving all that time). Dizziness continued for several months. Gradually improved and was finally gone by May or Jun2021. Then on 21Sep2021, she tested positive for COVID. 5 days later, she developed the same dizziness again. That's when she associated the first episode with the vaccines. Even today, she still experiences dizziness every day. It's manageable because it happens when she lays down to get up then mostly goes away. The patient also experienced intermittent ringing in ears and strange scalp tightening sensations. Best as she can figure, this appears to be a long-term neurological impact from the first vaccine and then from the virus itself. The patient went to PT, Audiologist, Ear, Nose MD due to the events.
Age: 67.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient. A 67-year-old patient received BNT162b2 (BNT162B2), on 14Jun2022 at 09:00 as dose 4 (booster), single (Lot number: FM0698, Expiration Date: 10Apr2022) at the age of 67 years intramuscular, in left deltoid for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Jan2021 as dose 1, single (Lot number: 025L20A), in left deltoid, on 04Feb2021 as dose 2, single (Lot number: 010M20A), in left deltoid and on 20Sep2021 as dose 3 (booster), single (Lot number: 939901), in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Aug2022, outcome "unknown" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Aug2022) Positive. Clinical information: The vaccine was given past expiration date of 10Apr2022 and mild Flu-like symptoms resulted for approx. 1.5 days. Patient tested positive for COVID-19 (self-test) on 05Aug2022 after having very mild symptoms for 3 days. Symptoms included runny nose, sneezing, slight chill and temporary loss of taste and smell. A previous diagnosis of COVID-19 on Apr2020- had severe case with many symptoms. Pfizer product had a causal effect to the adverse event.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events of drug ineffective and COVID-19 and the suspect drug.
Age: 67.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Expired product administered, Influenza like illness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient. A 67-year-old patient received BNT162b2 (BNT162B2), on 14Jun2022 at 09:00 as dose 4 (booster), single (Lot number: FM0698, Expiration Date: 10Apr2022) at the age of 67 years intramuscular, in left deltoid for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Jan2021 as dose 1, single (Lot number: 025L20A), in left deltoid, on 04Feb2021 as dose 2, single (Lot number: 010M20A), in left deltoid and on 20Sep2021 as dose 3 (booster), single (Lot number: 939901), in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Aug2022, outcome "unknown" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Aug2022) Positive. Clinical information: The vaccine was given past expiration date of 10Apr2022 and mild Flu-like symptoms resulted for approx. 1.5 days. Patient tested positive for COVID-19 (self-test) on 05Aug2022 after having very mild symptoms for 3 days. Symptoms included runny nose, sneezing, slight chill and temporary loss of taste and smell. A previous diagnosis of COVID-19 on Apr2020- had severe case with many symptoms. Pfizer product had a causal effect to the adverse event.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events of drug ineffective and COVID-19 and the suspect drug.
Age: 67.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient. A 67-year-old patient received BNT162b2 (BNT162B2), on 14Jun2022 at 09:00 as dose 4 (booster), single (Lot number: FM0698, Expiration Date: 10Apr2022) at the age of 67 years intramuscular, in left deltoid for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Jan2021 as dose 1, single (Lot number: 025L20A), in left deltoid, on 04Feb2021 as dose 2, single (Lot number: 010M20A), in left deltoid and on 20Sep2021 as dose 3 (booster), single (Lot number: 939901), in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Aug2022, outcome "unknown" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Aug2022) Positive. Clinical information: The vaccine was given past expiration date of 10Apr2022 and mild Flu-like symptoms resulted for approx. 1.5 days. Patient tested positive for COVID-19 (self-test) on 05Aug2022 after having very mild symptoms for 3 days. Symptoms included runny nose, sneezing, slight chill and temporary loss of taste and smell. A previous diagnosis of COVID-19 on Apr2020- had severe case with many symptoms. Pfizer product had a causal effect to the adverse event.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events of drug ineffective and COVID-19 and the suspect drug.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fall, Loss of consciousness, Neck pain, Pain
Clinical narrative: not able to breathe well; nor could I see clearly; heart rate getting slower; fallen; neck pain; hurting a bit more than usual; passed out; 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 17-year-old patient received BNT162b2 (BNT162B2), on 16Jan2022 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: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "passed out"; DYSPNOEA (hospitalization), outcome "unknown", described as "not able to breathe well"; VISION BLURRED (hospitalization), outcome "unknown", described as "nor could I see clearly"; HEART RATE DECREASED (hospitalization), outcome "unknown", described as "heart rate getting slower"; FALL (non-serious), outcome "unknown", described as "fallen"; NECK PAIN (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "hurting a bit more than usual". The events "passed out", "not able to breathe well", "nor could i see clearly", "heart rate getting slower", "fallen", "neck pain" and "hurting a bit more than usual" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Electrocardiogram: Unknown results.  Clinical Course: While receiving the shot, I felt like it was hurting a bit more than usual. After receiving my shot, I got up and stood to the side as it was my sister's turn to take her shot. After she sat down to take her shot I remember the light fading away and next thing I know is opening my eyes to see a stranger staring at me. The stranger turned out to be a pharmacist. I soon found out that I had fallen adn passed out after receiving my covid 19 shot. I waited for the EMTs to arrive while the staff asked me question as to how I was feeling and what happened. When the EMTs arrived, they got me off the floor and almost immediately I started to feel the light darkening and heart rate getting slower. I was not able to breathe well, nor could I see clearly. Seeing my condition, the EMTs took me to the ER in an ambulance. In the ER the doctor performed a few tests such as EKG and blood work. I was released from the ER as I was feeling better though I was still having neck pain and had other minor injuries.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dyspnoea, Electrocardiogram, Fall, Heart rate decreased
Clinical narrative: not able to breathe well; nor could I see clearly; heart rate getting slower; fallen; neck pain; hurting a bit more than usual; passed out; 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 17-year-old patient received BNT162b2 (BNT162B2), on 16Jan2022 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: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "passed out"; DYSPNOEA (hospitalization), outcome "unknown", described as "not able to breathe well"; VISION BLURRED (hospitalization), outcome "unknown", described as "nor could I see clearly"; HEART RATE DECREASED (hospitalization), outcome "unknown", described as "heart rate getting slower"; FALL (non-serious), outcome "unknown", described as "fallen"; NECK PAIN (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "hurting a bit more than usual". The events "passed out", "not able to breathe well", "nor could i see clearly", "heart rate getting slower", "fallen", "neck pain" and "hurting a bit more than usual" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Electrocardiogram: Unknown results.  Clinical Course: While receiving the shot, I felt like it was hurting a bit more than usual. After receiving my shot, I got up and stood to the side as it was my sister's turn to take her shot. After she sat down to take her shot I remember the light fading away and next thing I know is opening my eyes to see a stranger staring at me. The stranger turned out to be a pharmacist. I soon found out that I had fallen adn passed out after receiving my covid 19 shot. I waited for the EMTs to arrive while the staff asked me question as to how I was feeling and what happened. When the EMTs arrived, they got me off the floor and almost immediately I started to feel the light darkening and heart rate getting slower. I was not able to breathe well, nor could I see clearly. Seeing my condition, the EMTs took me to the ER in an ambulance. In the ER the doctor performed a few tests such as EKG and blood work. I was released from the ER as I was feeling better though I was still having neck pain and had other minor injuries.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Neck pain, Pain, Vision blurred
Clinical narrative: not able to breathe well; nor could I see clearly; heart rate getting slower; fallen; neck pain; hurting a bit more than usual; passed out; 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 17-year-old patient received BNT162b2 (BNT162B2), on 16Jan2022 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: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "passed out"; DYSPNOEA (hospitalization), outcome "unknown", described as "not able to breathe well"; VISION BLURRED (hospitalization), outcome "unknown", described as "nor could I see clearly"; HEART RATE DECREASED (hospitalization), outcome "unknown", described as "heart rate getting slower"; FALL (non-serious), outcome "unknown", described as "fallen"; NECK PAIN (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "hurting a bit more than usual". The events "passed out", "not able to breathe well", "nor could i see clearly", "heart rate getting slower", "fallen", "neck pain" and "hurting a bit more than usual" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Electrocardiogram: Unknown results.  Clinical Course: While receiving the shot, I felt like it was hurting a bit more than usual. After receiving my shot, I got up and stood to the side as it was my sister's turn to take her shot. After she sat down to take her shot I remember the light fading away and next thing I know is opening my eyes to see a stranger staring at me. The stranger turned out to be a pharmacist. I soon found out that I had fallen adn passed out after receiving my covid 19 shot. I waited for the EMTs to arrive while the staff asked me question as to how I was feeling and what happened. When the EMTs arrived, they got me off the floor and almost immediately I started to feel the light darkening and heart rate getting slower. I was not able to breathe well, nor could I see clearly. Seeing my condition, the EMTs took me to the ER in an ambulance. In the ER the doctor performed a few tests such as EKG and blood work. I was released from the ER as I was feeling better though I was still having neck pain and had other minor injuries.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.