chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head abnormal
Clinical narrative: My left foot felt very heavy then my left lower leg started to get numb.  We  all 911 by the time the ambulance came  my left arm was  getting numb.   I was transported in helicopter to  regional Hospital  I was having a stroke
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Condition aggravated, Feeling abnormal, Loss of personal independence in daily activities, Nausea
Clinical narrative: feeling bad & nauseous in morning during physical therapy.  Asthma flared up.  Used rescue inhaler AM, used again in 3 hours, then in two more hours used nebulizer.   Eventually falling asleep for about an hour.  Woke up and still needed rescue inhaler when trying to perform any tasks.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Syncope
Clinical narrative: Extreme Fatigue that led to multiple syncope. A police officer thought I had a heart attack and thus I ended up in the hospital. I did not have a heart attack but seemed to have fainted while walking or realizing it.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Vomiting
Clinical narrative: Vomiting, dizziness, flushing/sweating, vitals wnl. Known h/o of anxiety and vomiting with vaccines.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Basal ganglia infarction, Cerebrovascular accident, Computerised tomogram head abnormal, Drooling, Dysarthria
Clinical narrative: Patient started with left sided weakness and slurring of speech the evening of 1/16.   Symptoms improved after a little while so went to bed.  The next am he woke up with  worsened left arm and leg weakness, difficulty walking and slurred speech with drooling.    He was diagnosed with a right middle cerebral artery stroke.  Patient unable to return home due to dense left hemiparesis; was admitted to a nursing home for stroke rehab and PT/OT/ST.  Thankfully he is very gradually improving
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Hemiparesis, Lacunar infarction
Clinical narrative: Patient started with left sided weakness and slurring of speech the evening of 1/16.   Symptoms improved after a little while so went to bed.  The next am he woke up with  worsened left arm and leg weakness, difficulty walking and slurred speech with drooling.    He was diagnosed with a right middle cerebral artery stroke.  Patient unable to return home due to dense left hemiparesis; was admitted to a nursing home for stroke rehab and PT/OT/ST.  Thankfully he is very gradually improving
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: My arm is swollen and a lump can be felt at the sight of the vaccine.  Still very sore and tender a week later and lump seems bigger.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Pain, Pyrexia
Clinical narrative: Pt received J&J yesterday. Pt started having fever, bodyaches and chills. Pt was SOB last night, but not now.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: After my 1st vaccine, about 12 to 36 hours later I slowly started noticing rashes and hives on parts of my body. I already had a poison oak rash, so the timeline is a little rough as to when I was sure it wasn't a new poison oak rash (on a new part of my body), and was truly hives or a new rash. Then it became more obvious by 36 plus hours, due to hives on hands, feet, and lower torso/upper thigh areas, and my week-old poison oak rash was getting much better.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Nausea, Pain, Vomiting
Clinical narrative: Pt states he was vaccinated with J&J at 1500 yesterday. Pt c/o difficulty breathing, ha, body aches, and n/v. Pt went to  sick call which referred him to ED.Pt is able to drink water w/o issue.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Loss of personal independence in daily activities, Myalgia
Clinical narrative: 39-year-old female comes to the emergency room for flu-like symptoms after receiving the Johnson & Johnson vaccine.  Patient states that she receive the vaccine at approximately noon yesterday. starting at 1730-1800 last night she began developing fatigue and muscle aches.  Later in the evening the symptoms worsened and she developed a headache.  Overnight the headache resolved but the fatigue and muscle aches continued to worsen.  This morning she states that she was unable to make it to morning PT.  Here in the emergency room she states she has continued fatigue and muscle aches.  She denies any nausea, vomiting, diarrhea or abdominal pain.  She denies any hematuria or dysuria.  She denies any lightheadedness, diz
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pallor
Clinical narrative: Nausea, sweating, pallor. BPs 185/121 (pulse 110), 167/113 (pulse 80). Patient advised to take blood pressure medications.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Ear discomfort, Fatigue, Headache
Clinical narrative: I had the 2nd shot of Moderna vaccine Monday 5/3 at noon by 3 AM the next morning I had a fever measured 104.5 chills, headache, weak. I tool Tylenol as directed it would only reduce temps to 101 after 2 hours the fever 104 would return. This lasted until late morning the next day my temps started to fall off to 99. Tiredness and headaches still a problem been 3 days since the Moderna 2nd vaccine shot. I also feel some inner ear pressure like some inflammation in there.  The headaches seem to be getting somewhat worse causing me to feel nauseated I took 500 MG of Ibuprofen seems to reduce the headaches. I also developed a cough dry but almost like a flu cough which seems to be resolving.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: I had the 2nd shot of Moderna vaccine Monday 5/3 at noon by 3 AM the next morning I had a fever measured 104.5 chills, headache, weak. I tool Tylenol as directed it would only reduce temps to 101 after 2 hours the fever 104 would return. This lasted until late morning the next day my temps started to fall off to 99. Tiredness and headaches still a problem been 3 days since the Moderna 2nd vaccine shot. I also feel some inner ear pressure like some inflammation in there.  The headaches seem to be getting somewhat worse causing me to feel nauseated I took 500 MG of Ibuprofen seems to reduce the headaches. I also developed a cough dry but almost like a flu cough which seems to be resolving.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness postural, Fatigue, Headache, Illness, Loss of consciousness
Clinical narrative: 29-year-old female brought to the emergency room by EMS after syncopal episode at sick all this morning.  Patient states that she receive the Johnson and Johnson coronavirus vaccine yesterday at approximately 1500.  Throughout the evening and overnight she developed the expected side effects of myalgias, mild headache and fatigue.  She states because she was not feeling well this morning she was instructed to give us a call.  She is sick, she was sitting in a chair and when she was called to code forward she stood up, developed tunneling of her vision with spots in front of her eyes, felt dizzy and then passed out.  When she woke up the dizziness had resolved.  She states that she feels dizzy intermittently at basel
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Syncope, Tunnel vision, Visual impairment
Clinical narrative: 29-year-old female brought to the emergency room by EMS after syncopal episode at sick all this morning.  Patient states that she receive the Johnson and Johnson coronavirus vaccine yesterday at approximately 1500.  Throughout the evening and overnight she developed the expected side effects of myalgias, mild headache and fatigue.  She states because she was not feeling well this morning she was instructed to give us a call.  She is sick, she was sitting in a chair and when she was called to code forward she stood up, developed tunneling of her vision with spots in front of her eyes, felt dizzy and then passed out.  When she woke up the dizziness had resolved.  She states that she feels dizzy intermittently at basel
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Chest X-ray normal, Electrocardiogram, Laboratory test, Pyrexia
Clinical narrative: 24-year-old male brought in by EMS for multiple complaints.  On arrival vital signs stable with mild tachycardia and fever. on exam heart regular rate and rhythm.  Lungs clear to auscultation bilaterally.  EKG without evidence of STEMI.  Chest x-ray normal.  Labs with no actual abdomen bowel is.  Patient improved in ED with medications and pain control.  Suspect vaccine reaction.  Plan for discharge home with continued supportive care and follow up with primary care physician.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: 24-year-old male brought in by EMS for multiple complaints.  On arrival vital signs stable with mild tachycardia and fever. on exam heart regular rate and rhythm.  Lungs clear to auscultation bilaterally.  EKG without evidence of STEMI.  Chest x-ray normal.  Labs with no actual abdomen bowel is.  Patient improved in ED with medications and pain control.  Suspect vaccine reaction.  Plan for discharge home with continued supportive care and follow up with primary care physician.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Nausea, Tinea versicolour, Vaccination complication
Clinical narrative: Patient presents with chills and nausea without vomiting x 0230. Patient received J&J vaccine yesterday at 1630. Reports he took Tylenol at 0230. Patient also reports feeling achy to back but believes because he had ACFT yesterday.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Impaired work ability, Malaise, Nausea
Clinical narrative: 32 yo M, no known chronic medical conditions, p/w FLS since getting the J&J vaccine yesterday. Sx are improving, but pt was feeling sick at work so his supervisor told him to come to ED for eval. Only sx pt currently has are severe fatigue, mild frontal HA, and mild nausea.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Vision blurred
Clinical narrative: pt presents to the ED for migraines and blurred vision that began last night which he is concerned is a side effect from the J&J vaccine, pt received the vaccine on 5/3/21.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Pt c/o headaches, feverish, bodyaches x2hrs. Pt received the J&J covid vaccine at 1330 today. Pt has not taken any meds. Denies additional s/s. Denies anybody in area with similar s/s.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: pt presents to the ED for concerns of J&J vaccine reactions, states he received his vaccine on 5/5/21 and has had one episode of vomiting, nausea, headaches and chills, attempted to go to sick call yesterday but was unable
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: pt presents to the ED for concerns of J&J vaccine reactions, states he received his vaccine on 5/5/21 and has had one episode of vomiting, nausea, headaches and chills, attempted to go to sick call yesterday but was unable
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Eye pain, Headache, Pain
Clinical narrative: pt presents to the ED for "cold sweats, fever, headaches and soreness, and eye pain" that began yesterday after receiving the J&J COVID vaccine, has not attempted to take tylenol or motrin for fever and headaches
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: pt presents to the ED for "cold sweats, fever, headaches and soreness, and eye pain" that began yesterday after receiving the J&J COVID vaccine, has not attempted to take tylenol or motrin for fever and headaches
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Gait disturbance, Hypoaesthesia, Vasoconstriction
Clinical narrative: Seeing black, spotty eyesight, almost passing out but was able to make it back to bed to lay down twice. Cannot stand or walk for longer than a couple of minutes unassisted (holding onto something) without breathing becoming shallow and dizziness setting in. Intermittent dizziness and inability to focus eyesight occurred throughout the day even if sitting down. Issues have been consistent throughout entire day. Not sure if this is adverse but also started having circulation issues in toes/fingers turning white & numb when either standing, walking or lying down. Experienced chills but only until ceiling fan was turned off. Circulation slightly improved except in feet.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Seeing black, spotty eyesight, almost passing out but was able to make it back to bed to lay down twice. Cannot stand or walk for longer than a couple of minutes unassisted (holding onto something) without breathing becoming shallow and dizziness setting in. Intermittent dizziness and inability to focus eyesight occurred throughout the day even if sitting down. Issues have been consistent throughout entire day. Not sure if this is adverse but also started having circulation issues in toes/fingers turning white & numb when either standing, walking or lying down. Experienced chills but only until ceiling fan was turned off. Circulation slightly improved except in feet.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Nausea
Clinical narrative: pt presents to the ED for SOB/nasuea and dizziness that began yesterday evening after receiving the J&J vaccine on 5/6/21.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: As a patient with Asthma, Aspirin is a medicine that makes me short of breath. I do not think it is an allergy as such, but a hypersensitivity to Acetylsalysilic Acid. 1 hour after the application of the vaccine, I felt the same symptoms as when I used any component that contains acetylsalysilic acid. In those cases I must apply inhaler. So I did, in 1 hour, I was already better. I didn't need to go to a doctor or hospital.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: chest pain. Sharp, left sided CP with SOB x 3 hours; continuous, no radiation; mvmt increases pain, started while sitting today; HX PTX x 2 with VATS surgery 5 years ago.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Blindness, Coagulation test, Computerised tomogram head, Deafness, Feeling cold
Clinical narrative: Feeling cold goose bumps Numbness in hands and feet Cold skin  Syncope  Pupils dilated  long time to return to baseline Headache  Blacked out vision /trouble hearing hearing loss for several minutes  Tachycardia while asleep
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Fibrin D dimer increased, Full blood count, Headache, Hypoaesthesia, Liver function test
Clinical narrative: Feeling cold goose bumps Numbness in hands and feet Cold skin  Syncope  Pupils dilated  long time to return to baseline Headache  Blacked out vision /trouble hearing hearing loss for several minutes  Tachycardia while asleep
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Metabolic function test, Mydriasis, Pain, Peripheral coldness, Piloerection
Clinical narrative: Feeling cold goose bumps Numbness in hands and feet Cold skin  Syncope  Pupils dilated  long time to return to baseline Headache  Blacked out vision /trouble hearing hearing loss for several minutes  Tachycardia while asleep
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope, Tachycardia
Clinical narrative: Feeling cold goose bumps Numbness in hands and feet Cold skin  Syncope  Pupils dilated  long time to return to baseline Headache  Blacked out vision /trouble hearing hearing loss for several minutes  Tachycardia while asleep
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Costochondritis, Inflammation
Clinical narrative: Inflammation in ribs under left breast. Dr said it was costochondritis
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Blood lactic acid increased, Clonic convulsion, Computerised tomogram normal, Cyanosis, Dizziness
Clinical narrative: Had a severe colonic seizure and stopped breathing.  He said he felt funny after the shot, like he was light-headed and dizzy. Then out of nowhere I heard him moan and saw he was foaming at the mouth and violently convulsing and turning blue. I did cpr and the paramedics arrived and took him to the hospital. We are following up with a neurologist tomorrow.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram normal, Foaming at mouth, Moaning, Urine analysis normal
Clinical narrative: Had a severe colonic seizure and stopped breathing.  He said he felt funny after the shot, like he was light-headed and dizzy. Then out of nowhere I heard him moan and saw he was foaming at the mouth and violently convulsing and turning blue. I did cpr and the paramedics arrived and took him to the hospital. We are following up with a neurologist tomorrow.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Thrombosis
Clinical narrative: First shot 12/23, 2nd 1/12/21. A week after #2 my menstrual cycles (which have been clockwork all of my life-I have 4 children and track it monthly)  became much more frequent and heavy with excessive clotting. I thought perhaps I was going though early menopause (44) but then realized correlation with vaccine. My mood changed, I feel sad all of the time, I am dreading recommendation of additional shots.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Extremely heavy period
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Client received second dose COVID vaccine @ 10:10 am, complained of shortness of breath similar to asthma @ 10:23 am.  Client had rescue inhaler in car, self administered albuterol 5 puffs.  Observed and vital signs monitored.  Client reported shortness of breath improved with use of inhaler, left observation area @ 10:46 am once her symptoms improved and left with her husband,
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Nausea, Pain
Clinical narrative: Mild fever, chills, body aches, joint pain, nausea, headache.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Mild fever, chills, body aches, joint pain, nausea, headache.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood pressure fluctuation, Blood test normal, Chromaturia, Full blood count normal
Clinical narrative: Vasovagal Syncope starting five minutes after injection lasting about 20 minutes. BP fluctuated. Heart rate and O2 were normal. Monitored for approximately 30 minutes and then released. Abdominal pain started 3 hours after vaccination. Pain worsened and became severe over several hours, peaking with other flu-like symptoms and decreased over the next several days as other symptoms decreased. Pain was worse on left side about half way up rib cage and lasted for 5 days. Abdominal pain was worse and sharpened when twisting, rolling or bending torso.  I can still feel a pulling sensation under ribs on left side off and on.  Also starting about 15 hours after vaccination I had brownish colored urine that lasted about 36 hours.  Saw FNP 10 days after vaccination. CBC, liver & kidney function blood work & urine dip stick tests all normal.  They could not feel any enlargement on physical examination, but suspect spleen issue
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Liver function test normal, Renal function test normal, Syncope, Urine analysis normal
Clinical narrative: Vasovagal Syncope starting five minutes after injection lasting about 20 minutes. BP fluctuated. Heart rate and O2 were normal. Monitored for approximately 30 minutes and then released. Abdominal pain started 3 hours after vaccination. Pain worsened and became severe over several hours, peaking with other flu-like symptoms and decreased over the next several days as other symptoms decreased. Pain was worse on left side about half way up rib cage and lasted for 5 days. Abdominal pain was worse and sharpened when twisting, rolling or bending torso.  I can still feel a pulling sensation under ribs on left side off and on.  Also starting about 15 hours after vaccination I had brownish colored urine that lasted about 36 hours.  Saw FNP 10 days after vaccination. CBC, liver & kidney function blood work & urine dip stick tests all normal.  They could not feel any enlargement on physical examination, but suspect spleen issue
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood calcium, Chest pain
Clinical narrative: the day after the vaccine I had chest pains......never had them before......hope not to have them again.....very scarey
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Feeling hot, Pain, Pruritus
Clinical narrative: Fever and chills first first 24 hours. Red, swollen, hot, itchy large circle developed after the first 24 hours. Painful, hot, very itchy and uncomfortable.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: Fever and chills first first 24 hours. Red, swollen, hot, itchy large circle developed after the first 24 hours. Painful, hot, very itchy and uncomfortable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Hypoglycaemia
Clinical narrative: Flushing/sweating, vitals wnl. C/o hypoglycemia. Given 3 cups juice, 2 graham crackers.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Tremors; shortness of breath; Fever; Chills; profuse sweating. Headaches.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Tremors; shortness of breath; Fever; Chills; profuse sweating. Headaches.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting. BPs 87/54 (pulse 95), 98/63 (pulse 71).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Eructation, Fatigue, Headache, Pain
Clinical narrative: headache, fever(48 hours), stomach pain with constant burping, body aches, fatigue (still continues a week+  from onset)
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache, fever(48 hours), stomach pain with constant burping, body aches, fatigue (still continues a week+  from onset)
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Disorientation, Magnetic resonance imaging normal, Malaise
Clinical narrative: Malaise beginning ~10 hours after injection. Finally able to sleep at 8:00 next morning. Woke at 11:00 disoriented, blurred vision. EMT took me to stroke center. They determined probably not a stroke, sent me to the Hospital (cardiac) area. I was told the MRI there showed no evidence of stroke. I do not know the results of the other scans/tests. Felt better after 24 hours. Mostly recovered after 72 hours. Now (28 days later), have some residual problems with right eye, become out of breath after moderate exertion (%SpO2 95 or above). Health Department administers vaccinations at a local convention center but has no permanent offices/staff there.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Vision blurred, Vitamin supplementation
Clinical narrative: Malaise beginning ~10 hours after injection. Finally able to sleep at 8:00 next morning. Woke at 11:00 disoriented, blurred vision. EMT took me to stroke center. They determined probably not a stroke, sent me to the Hospital (cardiac) area. I was told the MRI there showed no evidence of stroke. I do not know the results of the other scans/tests. Felt better after 24 hours. Mostly recovered after 72 hours. Now (28 days later), have some residual problems with right eye, become out of breath after moderate exertion (%SpO2 95 or above). Health Department administers vaccinations at a local convention center but has no permanent offices/staff there.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: CHILLS; HEADACHE; MUSCLE ACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced headache. On MAY-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine  was not applicable. The outcome of the headache, chills and muscle aches was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Rash erythematous, Urticaria, Vital signs measurement
Clinical narrative: ITCHY HIVES; SWOLLEN LYMPH NODES NEAR THROAT; RED RASH ON LEG; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 04-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced swollen lymph nodes near throat. On 04-MAY-2021, the subject experienced red rash on leg. Laboratory data included: Vital signs measurement (NR: not provided) not reported. On 04-MAY-2021 17:00, the subject experienced itchy hives. The action taken with covid-19 vaccine  was not applicable. The patient recovered from itchy hives on 04-MAY-2021, was recovering from red rash on leg, and had not recovered from swollen lymph nodes near throat. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Lymphadenopathy, Myalgia, Palpitations, Rash
Clinical narrative: ITCHY HIVES; SWOLLEN LYMPH NODES NEAR THROAT; RED RASH ON LEG; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 04-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced swollen lymph nodes near throat. On 04-MAY-2021, the subject experienced red rash on leg. Laboratory data included: Vital signs measurement (NR: not provided) not reported. On 04-MAY-2021 17:00, the subject experienced itchy hives. The action taken with covid-19 vaccine  was not applicable. The patient recovered from itchy hives on 04-MAY-2021, was recovering from red rash on leg, and had not recovered from swollen lymph nodes near throat. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Pain in extremity
Clinical narrative: Cellulitis in the arm i received the shot; pain in my arm where i received the shot; This is a spontaneous report from a contactable other hcp. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot Number: EL1284), dose 1, via an unspecified route of administration on 30Dec2020 (at the age of 37-years-old) as a single dose for covid-19 immunisation. Medical history included was reported as none and the patient reported no known allergies. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. No other medications were received within 2 weeks of the vaccination. On 15Jan2021, the patient reported he started having pain in his arm where he received the shot. He went to the doctor and was diagnosed with cellulitis in the arm he received the shot. Therapeutic measures taken included unspecified antibiotics. Clinical outcome of the events cellulitis and pain in the arm he received the shot was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of cellulitis and pain in arm due to temporal relationship.  There is limited information provided in this report. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Infection, Nephrolithiasis
Clinical narrative: kidney stones; infection; This is a spontaneous report received from a Pfizer-sponsored program.  A 51-year-old male patient (husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose, dose 1 via an unspecified route of administration on an unspecified date for COVID--19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient was in the hospital for treatment of kidney stones on an unspecified date. Kidney stone symptoms started after his first dose. On an unknown date, he had a stent placed and had an infection. Treatment was received for kidney stones.The clinical outcome of kidney stones was unknown.  Information about the Lot/batch number has been requested.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Thrombosis
Clinical narrative: Blood clots on my legs; tired; This is a spontaneous report from a contactable consumer (the patient).   A 30-year-old patient of an unspecified gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number ER8737), via an unspecified route of administration, on 07Apr2021 at 12:30 (at the age of 30 years old) as a single dose in he left arm  for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient has no known allergies. The patient's concomitant medications were not reported. The patient had received no other vaccines within fourteen days prior to vaccination. The patient experienced "blood clots on my legs" on 07Apr2021 at 17:00 with outcome of unknown, and "feeling drained and tired for two weeks now" begining on 07Apr2021 at 17:00 with outcome of unknown. The patient has not been tested for COVID-19 since the vaccination .
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy lung, Organising pneumonia
Clinical narrative: Diagnosed with organized pneumonia; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: E1274) via an unspecified route of administration in the left arm on 03Jan2021 between 10:00 and 11:00 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history including any illness at time of vaccination was reported as none. Adverse events following prior vaccinations were reported as none. Family medical history relevant to the adverse event was reported as none. Concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine or on the same day as the COVID-19. On an unspecified date in Jan2021 (two weeks after dose 1 of the vaccine), the patient was diagnosed with organized pneumonia. The patient called to report that she received her first COVID-19 vaccine shot on 03Jan2021 and two weeks later she was diagnosed with pneumonia. As per the patient, the pneumonia progressively got worse and she was hospitalized for it for a total of three times. She stated that at her third hospitalization they performed a lung biopsy to determine the type of pneumonia she had. The biopsy diagnosed her with "oxidizing pneumonia" (also reported as organized pneumonia). The patient stated that it was a rare form of pneumonia.  The patient stated that she received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: L9269) via an unspecified route of administration in the left arm on 14Feb2021 (at the age of 75-years-old) as a single dose for COVID-19 immunization. She stated that she missed her original second dose appointment because she was in the hospital at the time of that appointment. She stated that her pneumonia was still bad at that time. The patient stated that she was hospitalized once in Jan2021; about 2 weeks after receiving the first vaccine. She was then hospitalized for a second time for pneumonia at the end of January or the beginning of February and her third hospitalization was at the end of February or beginning of March. During the third hospitalization was when they did the biopsy and diagnosed her type of pneumonia. The patient stated that they could not treat it with antibiotics, so she had to go on steroids. The patient stated that she was still taking the steroid medication. Otherwise, the patient denied any medications, medical conditions, labs, or treatments relevant to the adverse event. The patient stated that her internist wanted her to call and to report her adverse event. The patient inquired if anyone else had reported this or had a similar diagnosis after having received the COVID-19 vaccine. The clinical outcome of the event organized pneumonia was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Drug ineffective, Fatigue, SARS-CoV-2 test
Clinical narrative: I was hospitalized with covid; I was hospitalized with covid; kind of weak; tired; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 30Mar2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  Last week (unspecified date), she was hospitalized with COVID, just came home after a week in the hospital, just came home last night. She was asking whether she can get the second dose and if there is any guidance on timing of the second dose. She was in the hospital 2 weeks ago and they tested her, and she was negative and last Monday she didn't feel good and went to the hospital and she has COPD and she tested positive on Monday and they kept her. She already has 1 shot and is supposed to get the 2nd on the 24th and she doesn't know if she should wait 14 days. Stated she was kind of weak. She was starting to get tired and not able to complete report. Clarified it was the Pfizer Covid vaccine and she got the 1st dose 30Mar2021 and was due for the 2nd dose 24Apr2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on Apr2021 then positive on Apr2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Discomfort, Nerve injury, Peripheral swelling, Skin discolouration
Clinical narrative: three smallest toes on both feet (left/right) feel swollen; discomfort in wearing shoes and sleeping at night; balance is affected; nerve damage; discoloration; blood clots; This is a spontaneous report from a contactable consumer (patient). A 57-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 06Mar2021 11:00 as single dose for COVID-19 immunization. The patient had no medical history and known allergies. Patient did not have COVID prior vaccination. Patient was not tested for COVID post vaccination. Concomitant medications were not reported. It was reported that patient had three smallest toes on both feet (left/right) feel swollen. He had discomfort in wearing shoes and sleeping at night. He had movement of the toes but balance is affected. Just really troubling as nothing like this was affecting him before. He had been told it was COVID toe. He first thought it is was nerve damage. Could be blood clots small based on reading information. He never got sick. He was attempting to set a doctors appointment. There is a small amount of discoloration. He was hopeful with time this will get better. Events started on 09Mar2021 14:00 with outcome of not recovered. No treatment received. Events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Events were reported as serious due to disability. Patient had second dose of bnt162b2 (lot no.: ER2613) on 27Mar2021 on Left Arm.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: three smallest toes on both feet (left/right) feel swollen; discomfort in wearing shoes and sleeping at night; balance is affected; nerve damage; discoloration; blood clots; This is a spontaneous report from a contactable consumer (patient). A 57-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 06Mar2021 11:00 as single dose for COVID-19 immunization. The patient had no medical history and known allergies. Patient did not have COVID prior vaccination. Patient was not tested for COVID post vaccination. Concomitant medications were not reported. It was reported that patient had three smallest toes on both feet (left/right) feel swollen. He had discomfort in wearing shoes and sleeping at night. He had movement of the toes but balance is affected. Just really troubling as nothing like this was affecting him before. He had been told it was COVID toe. He first thought it is was nerve damage. Could be blood clots small based on reading information. He never got sick. He was attempting to set a doctors appointment. There is a small amount of discoloration. He was hopeful with time this will get better. Events started on 09Mar2021 14:00 with outcome of not recovered. No treatment received. Events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Events were reported as serious due to disability. Patient had second dose of bnt162b2 (lot no.: ER2613) on 27Mar2021 on Left Arm.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Disseminated varicella zoster vaccine virus infection
Clinical narrative: disseminated shingles; This is a spontaneous report from a contactable nurse (the patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899), via an unspecified route of administration in the left arm on 07Jan2021 (at the age of 45-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: Sjogren's syndrome, Hashimoto's thyroiditis, HBP (high blood pressure), Vit D deficiency, and Vit B deficiency. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications were reported as normal everyday medications, not specified. The patient previously took and had known allergies to hydroxychloroquine sulfate (PLAQUENIL) and BUPROPION HYDROCHLORIDE (WELLBUTRIN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899), via an unspecified route of administration in the left arm on 17Dec2020 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunization. On 23Mar2021, the patient was diagnosed with disseminated shingles. Treatment included valaciclovir hydrochloride (VALTREX) and steroids. The outcome of the event was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Reported event of Disseminated varicella zoster vaccine virus infection is most likely an intercurrent condition and unrelated to BNT162B2 vaccine. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received the first dose of the Pfizer COVID-19 vaccine and tested positive for COVID-19; Received the first dose of the Pfizer COVID-19 vaccine and tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 08Apr2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received the first dose of the Pfizer COVID-19 vaccine on 08Apr021 and next dose is due on 29Apr2021. In Apr2021, the patient tested positive for COVID-19 and wanted to know the timing of the second dose. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose, Blood glucose increased, Immobile, Platelet count
Clinical narrative: Decreased blood platelet counts; spiked up glucose; immobility; foot joint pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 43-years-old via an unspecified route of administration, administered in arm left on 12Apr2021 11:30 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. Medical history included blood cholesterol increased (other medical history: High cholesterol) from an unknown date and unknown if ongoing.  The patient has no covid prior to vaccination, has not been tested post vaccination and has no known allergies. There were no concomitant medications. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 43-years-old on 03Mar2021 11:00 (lot number: EN6204) on the left arm for covid-19 immunisation. The patient reported soon after his vaccination, he was in acute foot joint pain on 13Apr2021 03:45. Immobilized depending on she'll chair (for further clarification). His blood report on an unspecified date showed decreased blood platelet counts and spiked up glucose and so many other bio markers. He was on steroid and painkiller to manage the pain but he was not getting relief. New pains coming up. He was loosing lots of employment and fun actionable opportunities due this pain and immobility. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient underwent lab tests and procedure which included platelets: decreased and glucose: spiked up on an unspecified date. Therapeutic measures were taken as a result of foot joint pain and immobile which included steroid, Tylenol 3000 mg, Diclofenac 150 mg.  The patient did not recover from the events.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count decreased
Clinical narrative: Decreased blood platelet counts; spiked up glucose; immobility; foot joint pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 43-years-old via an unspecified route of administration, administered in arm left on 12Apr2021 11:30 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. Medical history included blood cholesterol increased (other medical history: High cholesterol) from an unknown date and unknown if ongoing.  The patient has no covid prior to vaccination, has not been tested post vaccination and has no known allergies. There were no concomitant medications. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 43-years-old on 03Mar2021 11:00 (lot number: EN6204) on the left arm for covid-19 immunisation. The patient reported soon after his vaccination, he was in acute foot joint pain on 13Apr2021 03:45. Immobilized depending on she'll chair (for further clarification). His blood report on an unspecified date showed decreased blood platelet counts and spiked up glucose and so many other bio markers. He was on steroid and painkiller to manage the pain but he was not getting relief. New pains coming up. He was loosing lots of employment and fun actionable opportunities due this pain and immobility. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient underwent lab tests and procedure which included platelets: decreased and glucose: spiked up on an unspecified date. Therapeutic measures were taken as a result of foot joint pain and immobile which included steroid, Tylenol 3000 mg, Diclofenac 150 mg.  The patient did not recover from the events.