chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pyrexia, Rheumatoid arthritis, Vertigo
Clinical narrative: At first I had a headache and nausea. I was trying to concentrate on work, I felt tired and dizzy, and My headache was really bad. i left work early. When I got home I had body aches, I couldn't eat because of nausea. I developed fever of 102 and chills, It flared up my RA whole body hurt to move, tingling all over it hurt to even blink my eyes. It hurt to pee. I developed vertigo.  On the third I went to work still had headache, body aches, and nausea. It it took a week for me to feel better.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Pruritus, Rash, Skin burning sensation
Clinical narrative: While working in garden, notice two purple dot. No puncture, no itching,  no swelling,. Dot had lasted 3l lasted 3 weeks. Then four days after the shot, itching, oozing, blisters, rash, burning,  grew to 6in  by 2in  purple "road rash."  Went to  demetologist, Urgent care, ER within 4 days.  Follow up with with dermetologist.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Skin weeping
Clinical narrative: While working in garden, notice two purple dot. No puncture, no itching,  no swelling,. Dot had lasted 3l lasted 3 weeks. Then four days after the shot, itching, oozing, blisters, rash, burning,  grew to 6in  by 2in  purple "road rash."  Went to  demetologist, Urgent care, ER within 4 days.  Follow up with with dermetologist.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Within 5 minutes of receiving the injection, my heart rate increased to 125 BPM
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient tested positive for Covid19 after being vaccinated with the Pfizer vaccine eua 4/1/2021-4/22/2021
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Death, Nucleic acid test, Polymerase chain reaction, Small intestinal obstruction
Clinical narrative: Death  5/2/2021 Causes of death listed on death certificate: 1) Small-bowel obstruction  2) Carcinoma of small-bowel
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Small intestine carcinoma
Clinical narrative: Death  5/2/2021 Causes of death listed on death certificate: 1) Small-bowel obstruction  2) Carcinoma of small-bowel
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test normal, Burning sensation, Chills, Dizziness
Clinical narrative: Initial symptoms were normal (chills, fever, fatigue) and stopped in a day. Over next few weeks, began having tingles all over both legs, including a burning/throbbing sensation in my calves. I also noticed any physical exertion could lead to extreme light-headedness where I felt like I was going to pass out. This stopped within a few days. By week 3, I began having pretty significant (and constant 24x7) joint pain in both knees, making it difficult to walk. I have never had issues with my joints before and am healthy / active / young. I did not change anything about my routine or life, and my doctor agreed it was likely from the vaccine so I am reporting it here. The joints in my fingers also become painful if I spend too much time typing or on the phone. It's now 2 months of this joint pain and really hoping for some relief soon. Please contact me or my doctor if you have any thoughts or updates!
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Initial symptoms were normal (chills, fever, fatigue) and stopped in a day. Over next few weeks, began having tingles all over both legs, including a burning/throbbing sensation in my calves. I also noticed any physical exertion could lead to extreme light-headedness where I felt like I was going to pass out. This stopped within a few days. By week 3, I began having pretty significant (and constant 24x7) joint pain in both knees, making it difficult to walk. I have never had issues with my joints before and am healthy / active / young. I did not change anything about my routine or life, and my doctor agreed it was likely from the vaccine so I am reporting it here. The joints in my fingers also become painful if I spend too much time typing or on the phone. It's now 2 months of this joint pain and really hoping for some relief soon. Please contact me or my doctor if you have any thoughts or updates!
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: Initial symptoms were normal (chills, fever, fatigue) and stopped in a day. Over next few weeks, began having tingles all over both legs, including a burning/throbbing sensation in my calves. I also noticed any physical exertion could lead to extreme light-headedness where I felt like I was going to pass out. This stopped within a few days. By week 3, I began having pretty significant (and constant 24x7) joint pain in both knees, making it difficult to walk. I have never had issues with my joints before and am healthy / active / young. I did not change anything about my routine or life, and my doctor agreed it was likely from the vaccine so I am reporting it here. The joints in my fingers also become painful if I spend too much time typing or on the phone. It's now 2 months of this joint pain and really hoping for some relief soon. Please contact me or my doctor if you have any thoughts or updates!
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Asthenia, Chills, Myalgia, Pain
Clinical narrative: Severe muscle aches, chills, pain, arthritis, weakness  Pfizer-BioNTech COVID-19 Vaccine EUA
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: I had a UTI 2 days after each dose of the vaccine; This is a spontaneous report from a contactable pharmacist (patient). A  patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: En5318), dose 2 via an unspecified route of administration, in Left Arm on 25Feb2021 as 2nd dose, single for Covid-19 immunisation. The patient medical history included allergic to sulfonamide. The patient did not receive any other vaccine in four weeks of vaccination. Patient was not diagnosed to COVID, prior vaccination. Patient did not test for COVID, post vaccination. The patient had received first dose of bnt162b2 (Solution for injection, Batch/Lot Number: En5318) via an unspecified route of administration, in Left Arm on 04Feb2021  as 1st dose, single for Covid-19 immunisation. The patient concomitant medications were not reported. The patient had experienced a UTI 2 days after each dose of the vaccine" on 27Feb2021. The event led the patient to doctor or other healthcare professional office/clinic visit. Patient received the treatment as ciprofloxacin for the events. The outcome of the event was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Feeling hot, Headache, Sleep disorder
Clinical narrative: Around 6:30pm I became very hot and dizzy, I sat down and splashed cold water on my face which seemed to help a little. I took tylenol (acetaminophen 500mg) and two glasses of water. As the night progressed, my lower back started to hurt and my headache continued to progress. I went to bed early to sleep it off but was woken up by overheating and headache. I took more tylenol around 3am and grabbed an icepack, this seemed to help alleviate the symptoms.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after the expiration date of 04/28/21. Patient reports no adverse events.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Atrial fibrillation, COVID-19 pneumonia, Condition aggravated, Death
Clinical narrative: Death   5/15/2021 Causes of death listed on death certificate: 1) COVID 19 pneumonia  2) Acute respiratory failure with hypoxia  3) Pulmonary embolism  4) Paroxysmal atrial fibrillation  Other: obesity, hypertension
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Nucleic acid test, Obesity, Polymerase chain reaction, Pulmonary embolism
Clinical narrative: Death   5/15/2021 Causes of death listed on death certificate: 1) COVID 19 pneumonia  2) Acute respiratory failure with hypoxia  3) Pulmonary embolism  4) Paroxysmal atrial fibrillation  Other: obesity, hypertension
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: After being vaccination my mensural cycles became shorter, periods are heavier and last longer.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Pyrexia
Clinical narrative: Extreme exhaustion, high fever (topped at 105.2). Fever continued at a lower temp through most of May 5. Started taking Tylenol and Ibuprofen on morning of May 5 which helped. Lethargy continued until morning of May 6 after which I felt fine, almost immediately.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient's parent wrote  on the vaccine consent form to make the child 12 years old and eligible for the Pfizer vaccine. The patient's true date(11 years old- not eligible for the vaccine). This was found when our central processing team recognized that  was already a patient of our pharmacy under the true date
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Feeling abnormal, Hypoaesthesia, Malaise, Nausea
Clinical narrative: PATIENT RECEIVED THE VACCINE AT 9:00AM, SAT IN STORE FOR 15 MINUTES AND LEFT THE BUILDING. AT ABOUT 9:20 SHE CAME BACK TO THE PHARMACY SAYING SHE IS NOT FEELING WELL AND FELT WEIRD. PHARMACIST ASKED HER TO DESCRIBED THE FEELING, PATIENT SAID SHE JUST FEEL WEIRD LIKE NAUSEA AND NUMBNESS AROUND HER LEGS AND HER CHEST FELT TIGHT. PHARMACIST OFFERED HER TO SIT DOWN AGAIN AND ASKED HER IF SHE HAS ANY HISTORY OF ALLERGIES OR REACTIONS TO OTHER VACCINES BEFORE. PATIENT SAID NO REACTION TO HER YEARLY FLU SHOTS AND NEVER FELT LIKE THIS BEFORE AND STATED SHE'S ALLERGIC TO AMOXICILLIN ONLY. PHARMACIST OFFERED TO CALL THE AMBULANCE FOR HER AND GAVE HER SOME WATER.  AMBULANCE CAME IN AROUND 9:40AM AND ASKED PATIENT SOME QUESTIONS AND TOOK HER TO THE ER.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The second dose of Moderna COVID-19 vaccine was administered 6 days after the first dose.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory distress syndrome, Bronchopulmonary aspergillosis, COVID-19, COVID-19 pneumonia, Cardiac failure
Clinical narrative: Death 5/26/2021 Causes of death listed on death certificate: 1. COVID 19 pneumonia  2. acute respiratory distress syndrome due to COVID 19  3. Acute heart failure with reduced ejection fraction  4. aspergillus pneumonia  5. history of prostate cancer, history hypertension
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure acute, Death, Nucleic acid test, Polymerase chain reaction
Clinical narrative: Death 5/26/2021 Causes of death listed on death certificate: 1. COVID 19 pneumonia  2. acute respiratory distress syndrome due to COVID 19  3. Acute heart failure with reduced ejection fraction  4. aspergillus pneumonia  5. history of prostate cancer, history hypertension
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Neck pain, Physical examination, X-ray
Clinical narrative: Bilateral shoulder/neck pain-right shoulder pain requiring injection 4 months later
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: On Thursday June 24th at approximately 6:00am I woke up drenched in sweat, took my temp, it was 100.7, muscle aches, severe fatigue, headache, sore arm where injection took place. I took a bath and started feeling better around 10pm Thursday evening, no fever, only a little fatigue, muscle ache, headache, chills. On Friday June 25th around 4am I started feeling feverish again, took temp, it was 100.4. I feel very fatigued again, muscle aches got better, headache got worse now sensitive to light.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Photophobia
Clinical narrative: On Thursday June 24th at approximately 6:00am I woke up drenched in sweat, took my temp, it was 100.7, muscle aches, severe fatigue, headache, sore arm where injection took place. I took a bath and started feeling better around 10pm Thursday evening, no fever, only a little fatigue, muscle ache, headache, chills. On Friday June 25th around 4am I started feeling feverish again, took temp, it was 100.4. I feel very fatigued again, muscle aches got better, headache got worse now sensitive to light.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Palpitations
Clinical narrative: Patient reported elevated blood pressure and heart palpitations at her doctor's visit on 6/1/21 @8:15 am. She made 2 trips to the ER for elevated blood pressure/heart palpitations on both 6/7 (MD follow up on 6/8) and 6/10 which included an admission to the hospital for 4 days. Patients thinks it is due to the vaccine as nothing else has changed.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered after the expiration date of 04/28/21. Patient reports no adverse events.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Erythema, Joint swelling, Joint warmth
Clinical narrative: Hot, swollen, painful joints in hands; painful lumbar and sacrum/lower back--incapacitating. Saw primary care physician March 29, 2021 when OTC anti-inflammatories were ineffective.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Joint range of motion decreased, Nausea, Pain in extremity
Clinical narrative: My whole upper left arm felt like someone punched me over and over (very sore).  Had a hard time lifting my arm. Upper arm was feverish and a little swollen.  Felt nauseated and had a headache. The soreness in my arm lasted for 4 days. The fever and swelling lasted for 2 days. nausea and headache only lasted for a day. Took Tylenol for the pain and headache.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: My whole upper left arm felt like someone punched me over and over (very sore).  Had a hard time lifting my arm. Upper arm was feverish and a little swollen.  Felt nauseated and had a headache. The soreness in my arm lasted for 4 days. The fever and swelling lasted for 2 days. nausea and headache only lasted for a day. Took Tylenol for the pain and headache.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Echocardiogram, Pericarditis
Clinical narrative: Pain in chest began on April 15, 2021. Continued through weekend. Saw cardiologist on April 20 and was diagnosed with pericarditis. Fluid was seen around heart on ultrasound.  Colchicine .6mg and tart cherry extract started and continued for 8 weeks for inflammation. Low dose aspirin was discontinued during this time.   Outcome: inflammation and fluid decreased during this time. Additional followup visit scheduled for August 2021.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations. Palpitations were gone around June 17, 2021. It lasted about 7 weeks.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, Mood swings, Muscular weakness
Clinical narrative: Pt states weakness in his arm four days after dose, has not visited with Physician. General fatigue, weakness, excessive night sweats. States low appetite, mood swings, and possible hot flashes.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: Pt states weakness in his arm four days after dose, has not visited with Physician. General fatigue, weakness, excessive night sweats. States low appetite, mood swings, and possible hot flashes.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I developed hives, hands, legs feet and arms. The next day it got worsen, It went into my head, neck, ears and back. So I called my doctor and he stated that I go to the ER. They gave me injection of histamine and steroids. They gave me a script of histamine to take for 10 days. I then got some over the counter histamine and took that. The hives started going away and then they will come back and then go away again. It eventually started to get better.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered after the expiration date of 04/28/21. Patient reports no adverse events.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Paraesthesia oral, Swollen tongue
Clinical narrative: Was monitored for 15 min afterwards. Left facility, tingling on roof of mouth, swollen tongue, shortness of breath. Stopped at nearest emergency room on way home.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram, Pericarditis
Clinical narrative: acute pericarditis. improved with tx of NSAIDs. echo showed pericardial effusion. symptoms of acute chest pain, follow up echo pending
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Injection site induration, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Tuesday evening on the 26th, the injection site felt warm and started to swell and hardened to the size of a tennis ball it was flesh tone and didn't get red, it was hot to touch. I took Advil, it helped with pain, the swelling didn't go down for 3 days. The pain was not localized, the pain was shooting down my rib cage and abdomen .
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bone densitometry, Osteoporosis
Clinical narrative: I was diagnosed with osteoporosis in May. It's probably unrelated to the vaccine, but the form asked me to report any new medical conditions, so I did, and the CDC then followed up and requested this form. If the condition is related to the vaccine, that would be really interesting.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, SARS-CoV-2 test
Clinical narrative: Shortness of breath and slight chest pain Had my doctor check me and he heard slight diminished sound in my left lung Needed an inhaler; Shortness of breath and slight chest pain Had my doctor check me and he heard slight diminished sound in my left lung Needed an inhaler; This is a spontaneous report received from a contactable other-health care professional (Patient). A 48-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EN6201), via an unspecified route of administration, administered in the left arm on 12Feb2021 12:30 as 1st dose, single for covid-19 immunization in the hospital. The patient's medical history was not reported. Patient had no Known allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. Vaccine facility received in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, patient has been tested for COVID-19. On 03Mar2021, the patient experienced shortness of breath and slight chest pain had my doctor check me and he heard slight diminished sound in my left lung needed an inhaler. On 22Feb2021, the patient underwent lab tests and procedures which included sars-cov-2 test: negative. Therapeutic measures were taken as Inhaler breo Ellipta for events. The outcome of the events was reported as recovering.   No follow- up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cubital tunnel syndrome, Impaired work ability, Muscular weakness, Pain in extremity
Clinical narrative: Cubital tunnel syndrome in injected arm.   Hands "fall asleep" occasionally, but this time it did not resolve, resulting in weakness in hand and arm that have only partially recovered in the weeks following.  Unable to use left hand since onset to use most tools, turn a valve, etc.  Uncertain at this point whether full recovery is possible, but progress seems to be stalled at perhaps 50%-75% capacity.  Icing helps with pain, along with regular acetaminophen and occasional ibuprofen.  Exercise (including ulnar nerve "flossing") helps with recovery but has plateaued.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram normal, Myocarditis, Troponin increased
Clinical narrative: chest pain developed 6/21, admitted to the hospital with diagnosis of myocarditis 6/22
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram normal, Blood test, Computerised tomogram, Electrocardiogram, Headache
Clinical narrative: Sudden onset headache accompanied with nausea and vomiting around noon. ER visit MRI showed grade 1 SAH at basilar artery. Transported to ICU. Angiogram negative, nonaneurysmal unknown cause. No history of high cholesterol or high BP or trauma  to head.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Intensive care, Magnetic resonance imaging head abnormal, Nausea, Scan with contrast abnormal, Subarachnoid haemorrhage
Clinical narrative: Sudden onset headache accompanied with nausea and vomiting around noon. ER visit MRI showed grade 1 SAH at basilar artery. Transported to ICU. Angiogram negative, nonaneurysmal unknown cause. No history of high cholesterol or high BP or trauma  to head.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler, Vomiting
Clinical narrative: Sudden onset headache accompanied with nausea and vomiting around noon. ER visit MRI showed grade 1 SAH at basilar artery. Transported to ICU. Angiogram negative, nonaneurysmal unknown cause. No history of high cholesterol or high BP or trauma  to head.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received the dose after manufacturer recommended freezer storage duration.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: After 2 months of vaccine blood pressure shot up about 4 weeks. My typical blood pressure range 130 over mid 90's it has increased to 168/105. It has since went down to normal past few weeks.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site bruising, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: this was administered into fat (ie. not IM); First injection site was erythematous, not swollen or painful, covering ~10cm x 10cm; First injection site was erythematous/began to itch after 8-10 days; large diffuse, blotchy bruise surrounded by erythema; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) via an unspecified route of administration in right leg on 03Feb2021 09:30 (at the age of 48-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included hx of (TIA) transient ischaemic attack from an unknown date and unknown if ongoing, found to be heterozygous for factor V Leiden and diagnosed PFO (repaired) from an unknown date and unknown if ongoing, PFO from an unknown date and unknown if ongoing diagnosed PFO (repaired). Known allergies were azithromycin and penicillin. Concomitant medications included minerals nos, vitamins nos (ONE A DAY [MINERALS NOS;VITAMINS NOS]) taken for an unspecified indication, start and stop date were not reported; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) 81 mg taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No treatment received for adverse event, no covid prior vaccination and did not tested covid post vaccination. On Feb2021, it was reported that first injection site was erythematous, not swollen or painful, covering ~10cm x 10cm; began to itch after 8-10 days; now appears as a large diffuse, blotchy bruise surrounded by erythema. I am as sure as I can be that this was administered into fat (i.e. not IM) on 03Feb2021 09:30. The clinical outcome for the events was unknown.   Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Herpes simplex
Clinical narrative: Over 10 years of very few outbreaks of HSV2, and now I'm having consecutive back to back outbreaks, and everything that comes with that including chronic fatigue. I was diligent about my diet and health to manage this, and now it won't seem to stop after 2+ months. I know the medical community doesn't care much about HSV, and there's news about it not giving you the zoster virus, but it seems that it can absolutely trigger outbreaks in people who already have HSV. This should've been disclosed, as having ongoing outbreaks is no way to live.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Ear infection, Middle ear effusion, Tinnitus
Clinical narrative: I woke up 6 days after my shot with ringing in my right ear and fluid build up. I waited approximately 1 week before going to the doctor. The doctor diagnosed me with an ear infection and prescribed amoxicillin. After completing my prescription the fluid was gone, but the ringing remained. I waited about a month to see if the ringing would subside and then scheduled an appointment with an ENT. The ENT stated that the COVID vaccine could be the cause as I have never had ear issues in the past. I was given a hearing test and told that I had hearing loss in my right ear. I was also diagnosed with Tinnitus and told that my best option would be managing this issue for the rest of my life.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered after the expiration date of 04/28/21. Patient reports no adverse events.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received the dose after manufacturer recommended freezer storage duration.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Oxygen saturation decreased, SARS-CoV-2 test positive
Clinical narrative: vaccinated 1/27/2021. Tested (+) COVID 5/22/2021. Admitted for 3 days into hospital for decreasing oxygen levels. Case completed initial case investigation but was unable to reach afterwards. Family disconnected my call 3x in attempts for follow up.  Person was not found in local obituaries.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Atrioventricular block, Continuous positive airway pressure, Dyspnoea, Echocardiogram normal, Fatigue
Clinical narrative: After a few days very fatigue, went to get a sleep study and doctor said he needed a sleep pap machine The sleep study was completed on 4/20/21. Also had shortness of breath on  after shot called pcp on 4/23/21  and told him to go to the ER. Went to ER pulse rate was high and showed signs of a heart attack. Stayed over night got a echocardiogram and he passed out as he was trying to walk on 4/24/21. 4/25 echocardiogram turned out good. 4/26 found blockage in heart and was told he needed bypass surgery.  He had surgery 4/28/21 during heart surgery they did and ultrasound on the artery between the lungs and he had a 4 inch saddle embolism which they removed and continued with the heart surgery. All his problems was actually caused by the embolism.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Loss of consciousness, Myocardial infarction, Pulmonary embolism, Sleep study abnormal
Clinical narrative: After a few days very fatigue, went to get a sleep study and doctor said he needed a sleep pap machine The sleep study was completed on 4/20/21. Also had shortness of breath on  after shot called pcp on 4/23/21  and told him to go to the ER. Went to ER pulse rate was high and showed signs of a heart attack. Stayed over night got a echocardiogram and he passed out as he was trying to walk on 4/24/21. 4/25 echocardiogram turned out good. 4/26 found blockage in heart and was told he needed bypass surgery.  He had surgery 4/28/21 during heart surgery they did and ultrasound on the artery between the lungs and he had a 4 inch saddle embolism which they removed and continued with the heart surgery. All his problems was actually caused by the embolism.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Thromboembolectomy, Ultrasound Doppler abnormal, Vascular graft
Clinical narrative: After a few days very fatigue, went to get a sleep study and doctor said he needed a sleep pap machine The sleep study was completed on 4/20/21. Also had shortness of breath on  after shot called pcp on 4/23/21  and told him to go to the ER. Went to ER pulse rate was high and showed signs of a heart attack. Stayed over night got a echocardiogram and he passed out as he was trying to walk on 4/24/21. 4/25 echocardiogram turned out good. 4/26 found blockage in heart and was told he needed bypass surgery.  He had surgery 4/28/21 during heart surgery they did and ultrasound on the artery between the lungs and he had a 4 inch saddle embolism which they removed and continued with the heart surgery. All his problems was actually caused by the embolism.
Sex: F
Vaccine: COVID19
Symptoms: Tooth impacted
Clinical narrative: impacted tooth; This is a spontaneous report from a contactable consumer a Pfizer sponsored program.  A female patient of an unspecified age received BNT162B2 (Pfizer COVID-19 Vaccine: Solution for injection; Batch/Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller was supposed to take her second shot yesterday. She is asking if she can still take it because she is taking Amoxicillin Clavulanate potassium for her impacted tooth for 4 to 5 days already. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Fatigue, Headache, Investigation
Clinical narrative: Feeling sick; Run a temperature; He still has been running a temperature of 102.3; Real bad headache; Little difficulty in breathing; Tired; This is a spontaneous report from a contactable consumer or other non hcp. A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot Number: EN6198), via an unspecified route of administration on 23Feb2021 12:00, unknown dose, as single dose for covid-19 immunization. The patient's medical history included congestive heart failure, diabetes mellitus and peripheral neuropathy. Concomitant medications included gabapentin taken for an unspecified indication, carvedilol (COREG) taken for an unspecified indication. Patient takes short and long-acting insulin for diabetes mellitus. On an unknown date, the patient experienced sickness, run a temperature; he has been running a temperature of 102.3, real bad headache, little difficulty in breathing and, fatigue. The patient underwent lab tests and procedures which included body temperature: 102.3. The reporter stated he had 15 to 20 percent ejection fraction and he takes insulin short acting and long acting, but there is no further information. Therapeutic measures were taken as a result of the events with Tylenol. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Feeling sick; Run a temperature; He still has been running a temperature of 102.3; Real bad headache; Little difficulty in breathing; Tired; This is a spontaneous report from a contactable consumer or other non hcp. A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot Number: EN6198), via an unspecified route of administration on 23Feb2021 12:00, unknown dose, as single dose for covid-19 immunization. The patient's medical history included congestive heart failure, diabetes mellitus and peripheral neuropathy. Concomitant medications included gabapentin taken for an unspecified indication, carvedilol (COREG) taken for an unspecified indication. Patient takes short and long-acting insulin for diabetes mellitus. On an unknown date, the patient experienced sickness, run a temperature; he has been running a temperature of 102.3, real bad headache, little difficulty in breathing and, fatigue. The patient underwent lab tests and procedures which included body temperature: 102.3. The reporter stated he had 15 to 20 percent ejection fraction and he takes insulin short acting and long acting, but there is no further information. Therapeutic measures were taken as a result of the events with Tylenol. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspepsia, Dyspnoea
Clinical narrative: Short of breath; Diarrhea; could not digest it very well; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program.   A male patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number not reported), via an unspecified route of administration on 01Feb2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Feb2021, the patient experienced Short of breath and on unspecified date on 2021, the patient experienced Diarrhea and the patient could not digest it very well. On 01Feb2021, patient took the vaccine and effect of vaccine was about 5 hours after the vaccine was put in the arm, he felt short of breath. The event didn't last too long, about 5 minutes. It didn't happen again. On an unspecified date of Feb2021, patient had diarrhea. On an unspecified date of Feb2021, about a week after the symptoms he felt when he was taking his evening meal, he could not digest it very well. It took a little longer and he took different things. He took one Omeprazole and another day something else. Then that disappeared. Patient was called to get an appointment for his second dose of Pfizer Covid-19 vaccine, patient was supposed to get his second dose of the vaccine on 22Feb2021 but the facility advised him to see his physician due to some adverse reactions he had during the hours after his first dose shot like shortness of breath, diarrhea and other things like in certain days he had some indigestions. Physician prescribed him medications like Claritin 10 mg and Tylenol 325 mg after the first dose of the vaccine. Patient asked that can he be sent to the same place that he went for the first one and said that hopefully they won't run out of the Pfizer second shot. Patient main concern was to have the second vaccine. The outcome of short of breath was resolved on 01Feb2021, diarrhea and could not digest it very well were resolved on 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Hypoaesthesia
Clinical narrative: tired; Nausea; weak; left arm hurts; dizzy; Headache; feels numb; This is a spontaneous report from a contactable consumer (patient herself). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6198), via an unspecified route of administration on 04Mar2021 (at the age of 71-years-old), as 2nd dose, single in left arm for COVID-19 immunization. The patient's medical history included irritable bowel syndrome which was diagnosed a few years ago, lost some weight last year in 2020, like 50 pounds, but now she was gaining weight. Concomitant medication included levothyroxine sodium (UNITHROID) 50mg, taken every day except one day of the week, for an unspecified indication, start and stop date were not reported and vitamins.  The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FL9269) via an unspecified route of administration on 11Feb2021 (at the age of 71-years-old), as single dose for COVID-19 immunization and experienced adverse reaction. The patient's past medication also included some vitamins, and cipro [CIPROFLOXACIN] from which she experienced adverse drug reaction. On 04Mar2021, after taking the second shot, the patient experienced, headache, she put ice on her head and the headache went away and it feels better, she didn't take Tylenol, but it feels numb. She felt, dizzy and her left arm hurts. On 05Mar2021, the patient woke up weak, nauseous and tired. Her arm hurt a little but she put ice on it. The patient said her nausea went away and that her weakness comes and goes. The patient's left arm hurt where the vaccine was, ice had helped. The patient also mentioned that after she had the vaccine, on the way home she felt dizzy but it went away. The patient stated that she knows there are some side effects for the vaccine, she had a general reaction with the first dose, she thinks today is a little bit stronger this time. The patient had ginger tea for nausea. The patient also wanted to know whether this was normal. The patient enquired about pain reliever use, multivitamin, walking/yoga. The clinical outcome of the event nausea and dizzy was resolved, the outcome of headache and left arm hurts was resolving. The outcome of the event weak and tired was not resolved and the outcome of event feels numb was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: tired; Nausea; weak; left arm hurts; dizzy; Headache; feels numb; This is a spontaneous report from a contactable consumer (patient herself). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6198), via an unspecified route of administration on 04Mar2021 (at the age of 71-years-old), as 2nd dose, single in left arm for COVID-19 immunization. The patient's medical history included irritable bowel syndrome which was diagnosed a few years ago, lost some weight last year in 2020, like 50 pounds, but now she was gaining weight. Concomitant medication included levothyroxine sodium (UNITHROID) 50mg, taken every day except one day of the week, for an unspecified indication, start and stop date were not reported and vitamins.  The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FL9269) via an unspecified route of administration on 11Feb2021 (at the age of 71-years-old), as single dose for COVID-19 immunization and experienced adverse reaction. The patient's past medication also included some vitamins, and cipro [CIPROFLOXACIN] from which she experienced adverse drug reaction. On 04Mar2021, after taking the second shot, the patient experienced, headache, she put ice on her head and the headache went away and it feels better, she didn't take Tylenol, but it feels numb. She felt, dizzy and her left arm hurts. On 05Mar2021, the patient woke up weak, nauseous and tired. Her arm hurt a little but she put ice on it. The patient said her nausea went away and that her weakness comes and goes. The patient's left arm hurt where the vaccine was, ice had helped. The patient also mentioned that after she had the vaccine, on the way home she felt dizzy but it went away. The patient stated that she knows there are some side effects for the vaccine, she had a general reaction with the first dose, she thinks today is a little bit stronger this time. The patient had ginger tea for nausea. The patient also wanted to know whether this was normal. The patient enquired about pain reliever use, multivitamin, walking/yoga. The clinical outcome of the event nausea and dizzy was resolved, the outcome of headache and left arm hurts was resolving. The outcome of the event weak and tired was not resolved and the outcome of event feels numb was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Urinary tract infection, Weight
Clinical narrative: she lost her sense of taste.; she had a bad UT infection; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 23Feb2021 (Batch/Lot Number: Pfizer6203) as 2nd dose, single for covid-19 immunisation. Medical history included blood pressure, diabetes type II from an unknown date. Concomitant medication(s) included ATORVASTATIN; acetylsalicylic acid (BAYER ASPIRIN); CLOPIDOGREL 75mg; ubidecarenone (COQ-10); FLUOXETINE; FISH OIL; GABAPENTIN taken for fibromyalgia,METFORMIN taken for diabetes mellitus; PANTOPRAZOLE; PRAMIPEXOLE taken for restless legs syndrome; VALSARTAN taken for blood pressure abnormal,VITAMIN D3; VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE] taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced she lost her sense of taste and she had a bad UT (urinary tract) infection. Caller stated patient received her first Pfizer Covid-19 vaccination bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03Feb2021 10:30 (Batch/Lot Number: EL9265) as 1st dose, single for covid-19 immunisation. On 04Feb2021 she lost her sense of taste. Caller stated, and still to this day patient didn't have it. Caller stated she received her second Pfizer Covid-19 vaccine on 23Feb2021. Caller asked, she want to know when will she get her taste back. How long would this last. She still can't taste anything. Is that a side effect and for how long. She went to the doctor yesterday. They said she had a bad UT infection. They gave her a shot. Caller doesn't know the name of the shot she was given. Maybe it was an antibiotic. She did ask the doctor about not being able to taste, but the doctor didn't know. She had asked lots of people and doctors, but no one knows. The patient underwent lab tests and procedures which included weight was 175 or 176 lbs on unknown date. Therapeutic measures were taken as a result of she had a bad UT (urinary tract) infection which include antibiotic. The clinical outcome for event she lost her sense of taste was not recovered while outcome for the event she had a bad UT infection was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Dry skin, Dyspnoea, Heart rate
Clinical narrative: SOB; Hypoglycemia; Hypotension; Dry skin; Diaphoresis; Lightheadedness; Generalized rash; This is a spontaneous report from a non-contactable other HCP. A 38-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6205 and expiration date was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. As per the description, it was reported that patient had eaten a turkey sandwich and had water prior to coming for vaccination. During 15 mins waiting period after the injection, the patient experienced lightheadedness, SOB and diaphoresis. Differential diagnosis was reported as systemic reaction (hypoglycaemia, hypotension and generalized rash). She had a hypotensive response to the vaccine and had dry skin. She denied rash, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. Treatment included water, snacks, body position and ice packs. Follow up response to treatment was excellent. She was discharged as she was stable and was advised to follow up with PCP. The patient underwent lab tests and procedures which included VS as stable, normotensive, normal heartrate and rhythm and a &O x 4. She was suggested to lay down for her next vaccine out of precaution. She was pleased with her care and walked out to the front with RN. The outcome of the event was recovered well after almost an hour of observation/intervention.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoglycaemia, Hypotension, Rash
Clinical narrative: SOB; Hypoglycemia; Hypotension; Dry skin; Diaphoresis; Lightheadedness; Generalized rash; This is a spontaneous report from a non-contactable other HCP. A 38-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6205 and expiration date was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. As per the description, it was reported that patient had eaten a turkey sandwich and had water prior to coming for vaccination. During 15 mins waiting period after the injection, the patient experienced lightheadedness, SOB and diaphoresis. Differential diagnosis was reported as systemic reaction (hypoglycaemia, hypotension and generalized rash). She had a hypotensive response to the vaccine and had dry skin. She denied rash, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. Treatment included water, snacks, body position and ice packs. Follow up response to treatment was excellent. She was discharged as she was stable and was advised to follow up with PCP. The patient underwent lab tests and procedures which included VS as stable, normotensive, normal heartrate and rhythm and a &O x 4. She was suggested to lay down for her next vaccine out of precaution. She was pleased with her care and walked out to the front with RN. The outcome of the event was recovered well after almost an hour of observation/intervention.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: difficulty breathing; heart racing; This is a spontaneous report from a non-contactable other healthcare professional. A 74-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6205, Expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single (at the age of 74-years-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, during her 15 minutes waiting period after the injection, patient began to experience difficulty breathing and heart racing. Patient denied rash, hives, welts, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Patient was monitored in bay for approximately 40 minutes. Patient received water and snacks, as a treatment for the events. Patient reported great improvement after snack and feels well. Suspect stress response to vaccine. Patient had no dizziness, lightheaded or palpitations/SOB with ambulation. Follow up response to treatment was good and at discharge, patient was stable to go home and follow up with PCP. Differential Diagnosis was Red flag symptoms (CP, SOB (shortness of breath), NVD, Visual/Neuro concerns). Patient would like to go home. Husband was with her today (08Mar2021) and was able to be with her. Patient left in her seated walker, pushed by husband. Accompanied out by staff member. Follow up with PCP if not improving. Discussed reasons for Emergency department (ED) visit. The outcome of both the events was resolving.  No follow-up attempts are possible. No further information is expected.