chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Loss of consciousness, Rash, Snoring
Clinical narrative: On 3/25/21 at 1220 Pt received her first Pfzier vaccine to the left deltoid and was sitting in the post vaccine observation site under 15 min observation.  Pt was witnessed slumping down in chair by nurse at 1225 and then became unconscious with eyes gazed and to the right with snoring respirations. Pt was assisted to the floor by two nurses without any trauma lying supine and legs elevated.  VS were taken 122/60,59,20 and SPO2 87%. Pt woke while BP was being taken and started talking and was A&OX4. Pt was placed on oxygen at 10LPM with NRB mask.  SPO2 increased to 99%, pt's skins were W/D with good color.  Pt denied any SOB, itchy throat or difficulty swallowing, rash or hives. Pt was feeling a bit better and oxygen was taken off.  Pt was then sat up with legs straight while on the floor to repeat VS at 1231  Pt's BP was 70 systolic, pluse of 58, SPO2 dropped again to 87% and pt became vere dizzy and vision blackening and was layed back down immediately with legs elevated and NRB mask at 10 LPM was placed back on with increased SPO2 of 99%.  Pt had positive orthostates. Pt also c/o tingling hands.  911 was contacted at 1234.  VS at 1241 were 106/60, 62, 20 and SPO2 of 100%.  Pt's husband was at her side.  1247 engine co 54 arrived onscene and report was given to paramedic.  AMR unit 460 arrived approx 2 min later.  Pt was assessed and transported to closest ER.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Urticaria, Visual impairment
Clinical narrative: On 3/25/21 at 1220 Pt received her first Pfzier vaccine to the left deltoid and was sitting in the post vaccine observation site under 15 min observation.  Pt was witnessed slumping down in chair by nurse at 1225 and then became unconscious with eyes gazed and to the right with snoring respirations. Pt was assisted to the floor by two nurses without any trauma lying supine and legs elevated.  VS were taken 122/60,59,20 and SPO2 87%. Pt woke while BP was being taken and started talking and was A&OX4. Pt was placed on oxygen at 10LPM with NRB mask.  SPO2 increased to 99%, pt's skins were W/D with good color.  Pt denied any SOB, itchy throat or difficulty swallowing, rash or hives. Pt was feeling a bit better and oxygen was taken off.  Pt was then sat up with legs straight while on the floor to repeat VS at 1231  Pt's BP was 70 systolic, pluse of 58, SPO2 dropped again to 87% and pt became vere dizzy and vision blackening and was layed back down immediately with legs elevated and NRB mask at 10 LPM was placed back on with increased SPO2 of 99%.  Pt had positive orthostates. Pt also c/o tingling hands.  911 was contacted at 1234.  VS at 1241 were 106/60, 62, 20 and SPO2 of 100%.  Pt's husband was at her side.  1247 engine co 54 arrived onscene and report was given to paramedic.  AMR unit 460 arrived approx 2 min later.  Pt was assessed and transported to closest ER.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: VACCINE ERROR: DOSE GIVEN OVER 6 HOURS AFTER VIAL PUNCTURED
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Bedtime 10pm started with chills, lasting 4 hours. Next morning woke with body aches , headache and fever, lasting until 3pm
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dry eye, Dry mouth, Dry throat, Hyperhidrosis
Clinical narrative: Approximately 12 hours after the vaccine i started to get very bad chills and body aches and also fever that reached 102. Every bone in the body felt like it was cracking. This lasted about 24 hours. I was also sweating a lot. The sweating at night lasted 3 days. I have the dry mouth and tongue with a thick layer of saliva and the mouth is swollen. I also have very dry eyes and nose/throat. These also are the after side effects of covid which i had in mid jan that i was getting better from. After taking the vaccine the symptoms of swollen mouth and thick saliva including dry eyes flared up again. Today is day number 6 after the vaccine and its a little better but not much.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Mouth swelling, Nasal dryness, Pain, Pyrexia, Tongue dry
Clinical narrative: Approximately 12 hours after the vaccine i started to get very bad chills and body aches and also fever that reached 102. Every bone in the body felt like it was cracking. This lasted about 24 hours. I was also sweating a lot. The sweating at night lasted 3 days. I have the dry mouth and tongue with a thick layer of saliva and the mouth is swollen. I also have very dry eyes and nose/throat. These also are the after side effects of covid which i had in mid jan that i was getting better from. After taking the vaccine the symptoms of swollen mouth and thick saliva including dry eyes flared up again. Today is day number 6 after the vaccine and its a little better but not much.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: covid 19 Pfizer biontech chills/ fever/ aches/ exhaustion mar 24 exhaustion mar 25
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Vomiting.nausea
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Red, Swollen, itchy, hard, painful, injection site x 2 weeks.   Not resolved after 2 weeks.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Feeling hot
Clinical narrative: Fever to 102.5, myalgias, arthralgias, fatigue started 8-10 hours post vaccine lasting for about 36 hours and mostly resolved at 48 hours post vaccine. Despite Tylenol, fever only decreased to 100.4 at best.  Worst symptoms were between  20 hours post vaccine until 40 hours post vaccine. After that only mild fever and chills persisted until around 48 hours post vaccine, then it resolved.  I noticed my upper arm was red just distal to the vaccine site about 3 days after the vaccine. It was a little warm and tender/itchy  but resolved after a couple days.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Pyrexia, Red blood cell abnormality, Tenderness
Clinical narrative: Fever to 102.5, myalgias, arthralgias, fatigue started 8-10 hours post vaccine lasting for about 36 hours and mostly resolved at 48 hours post vaccine. Despite Tylenol, fever only decreased to 100.4 at best.  Worst symptoms were between  20 hours post vaccine until 40 hours post vaccine. After that only mild fever and chills persisted until around 48 hours post vaccine, then it resolved.  I noticed my upper arm was red just distal to the vaccine site about 3 days after the vaccine. It was a little warm and tender/itchy  but resolved after a couple days.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Disorganised speech, Nausea, Pharyngeal swelling, Vomiting
Clinical narrative: Pt became nauseated and stated his throat was swelling able to speak in full sentences stats r/a 97% b/p 156/102 fsbs 117 rr 12 tempt 97.1 denies any pain was given a 25mg p.o. Benadryl about 10min vomited up water about 8oz of water, PA assessed pt lungs were clear, and after the vomiting felt he should be transported to the ED Mother transported to ED pt stable upon transport
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cataract nuclear, Macular oedema, Retinal artery occlusion, Retinal vein occlusion
Clinical narrative: Central retinal vein occlusion with macular edema of left; Central retinal vein occlusion with macular edema of left; ophthalmic and retinal artery occlusion left eye; nuclear sclerosis of both eyes; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: EL9262) via an unspecified route of administration in the left arm on 29Jan2021 14:45 (at the age of 72-year-old) as a single dose for COVID-19 immunization. Medical history included acid reflux and allergies to mollusks. The patient did not receive other vaccine in four weeks prior to vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included omeprazole (MANUFACTURER UNKNOWN). On 08Feb2021 at 06:00, the patent experienced central retinal vein occlusion with macular edema of left eye; ophthalmic and retinal artery occlusion, left eye and nuclear sclerosis of both eyes. The seriousness criteria were considered as disability. The event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with intraocular injection of anti-VEGF. The outcome of the events was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash
Clinical narrative: delayed allergic reaction - rash on upper arm
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: After less than five minutes after vaccine an excessive heart rate was noticeable. I have trouble checking it myself so after 15 minutes when I noticed it had not gotten better I asked the people available to check my vitals: Heart rate after sitting for 15 minutes was ~118 and blood pressure was 168/58. I otherwise felt fine so I left.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: The patient received the incorrect manufacturer for her second COVID vaccine dose. Patient did not have her card with her and she indicated she received Moderna for the first dose. When she got home and found her card she realized she received Pfizer COVID vaccine lot number EN 6198 for her first dose on 2/20/21 and called us with this information. The patient did not experience any adverse effects from either of the two vaccinations.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, IVth nerve paralysis
Clinical narrative: Sudden worsening of 4th cranial nerve palsy. Had surgery 2 years ago for it and had excellent correction but 2 days after vaccination started noticing recurrence of symptoms.  Coincidence versus reaction/side effect???
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Epstein-Barr virus test, Full blood count normal, Liver function test normal, Lymphadenopathy
Clinical narrative: Swollen lymph nodes left clavicular area
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Dizzy, fever, fatigue, chills, muscle aches, headache
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Dizzy, fever, fatigue, chills, muscle aches, headache
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Developed a headache 9 hours after I received vaccine. It's been 2 weeks and the headache has not subsided. It has been a persistent migraine feeling that is affecting my work and overall day to day activities.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Sleep disorder
Clinical narrative: Patient said had the Moderna vaccine at pharmacy yesterday 3/24/21 about 2:30. Technician administered the vaccine with supervising in the same room. Patient came in today around 1 pm stating he was sore and couldn't sleep last night and today he has limited movement in left arm. He can lift it up to almost horizontal position forward but difficulty moving it backwards. He took 2 of the 200 mg Ibuprofen as directed and still sore. Advised he can take 4 of the 200 mg Ibuprofen (800 mg) every 8 hours for a day and see if that relieves pain and motion. He can also put a cold compress to affected area for slight swelling. If not better in a day or so advised him to contact a doctor, because might need something stronger to treat reaction to vaccine.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Adverse event:  Chills (@ 12:45 a.m.) Treatment:   took 3 aspirin Time course:   lasted 3 hours. Outcome:  no current symptoms
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: tingling, slight numbness in pinky and left side of ring finger
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Mouth ulceration
Clinical narrative: Developed mouth ulcers on left incide cheek and left side of tongue; Dentist thinks shingles; This is a spontaneous report received from a contactable consumer (patient). A 47-year-old female patient (non-pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3302), via an unspecified route of administration on arm right on 19Feb2021 00:15 at single dose for COVID-19 immunisation in hospital. The patient medical history was not reported. Concomitant medications included piper methysticum (KAVA); vitamin D [vitamin D NOS]; cetirizine hydrochloride (ZYRTEC) and ashwaganda. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed mouth ulcers on left inside cheek and left side of tongue on 22Feb2021 15:00. Dentist thinks shingles. Ulcers increased in pain and amount over the three weeks since the first vaccine. The events result in doctor or other healthcare professional office/clinic visit. The patient received treatment with unspecified antiviral medication. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient has not been tested for COVID-19 Since the vaccination. Later the patient received her second dose of BNT162B2 (Lot number: En6208) on 11Mar2021, on right arm. The events were assessed as non-serious by the reporter. The outcome of the events was reported as unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: 73 year old female client told RN on 3/22 that on March 14th, after getting 2nd dose of Pfizer vaccine (EN 16203). On March 15th morning, she got Bell's Palsy on her R face. Her doctor sent her to ER and the doctor prescribed her Prednisone (20 mg tid) and Valacyclovir (1 g tid) for 7 days. After one week, client was slowly recovered.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Paraesthesia oral, Rash, Throat tightness
Clinical narrative: Mild throat tightness and discomfort beginning within 15 minutes after vaccine and lasting at least a week. Rash covering torso, arms, and legs the day after and lasting two days. Lip tingling beginning an hour after vaccine and lasting two days.  The day after vaccine, visited immediate care center and emergency room. They prescribed Benadryl. No change when taking benadryl. Throat discomfort persisted so saw doctor at employee health center a few days later. They prescribed Montelukast which provided some relief from throat discomfort and tightness. Throat still not back to normal.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Syncope, Urinary incontinence
Clinical narrative: 3/17/21   Chills from 12;30 am until 7:30 am.   7:30 am  felt very very ill.  had temp of 101.7.    All of a sudden I had Urinary incontinence.  I started peeing in my bed. Asked my husband to help me to bathroom because I felt so sick.  I fainted in his arms Got back into bed and had a horrible migraine.   had to have my eyes covered and dark room  I felt as though I was going to throw up for hours.  Did not eat anything until 8 pm.  some toast and tea. 3/18/21  Still sick but not as bad.  Stayed in bed for 1/2 day.  it was a slow go. 3/19/21   Still not myself.   3/20/21.  Felt more myself.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination error
Clinical narrative: VACCINE ERROR: DOSE GIVEN OVER 6 HOURS AFTER VIAL PUNCTURED
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Hypoacusis, Lethargy, Loss of consciousness, Nausea
Clinical narrative: Lethargic, Nausea, Difficulty with hearing, decreased LOC and Blurry vision
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Lethargic, Nausea, Difficulty with hearing, decreased LOC and Blurry vision
Sex: F
Vaccine: COVID19
Symptoms: Rib fracture
Clinical narrative: she had a broken rib after her first dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program  from a contactable consumer (patient). A female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Feb2021 as SINGLE DOSE for covid-19 immunisation, Lot Number: unknown. Medical history and concomitant medications were not provided. Patient asked if it was better to reschedule her second dose of the Covid-19 vaccine scheduled on 12Mar2021 since she had a broken rib on unknown date in 2021, after her first dose of the vaccine on 21Feb2021, and currently taking a pain medication ibuprofen (ADVIL), she wanted to know if the second dose of the vaccine will cause her any much pain given her situation. Outcome of the event was unknown. Information about Lot/Batch has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Anxiety, Throat irritation
Clinical narrative: Scratch in throat. Patient has history of anxiety and anaphylaxis. Patient states she feels nothing like previous allergic reactions. Patient is speaking in full sentences,  no signs of swelling/rash.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Full body rash
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test, Chest pain, Investigation, Nausea
Clinical narrative: hurting from her hand to her chest; stress; nausea and threw up that night; nausea and threw up that night; Bell's palsy; arm on the side she got her shot was hurting; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 34 years of age), dose 2 via an unspecified route of administration, administered in Arm Left on 26Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included asthma wherein she doesn't take medication, it was usually when she was cold; she had this diagnosis since her childhood. She was diabetic and was diagnosed when she was 16 years old (2002). Concomitant medication included insulin human injection, isophane (HUMULIN N) and insulin human (HUMULIN R), both for diabetes mellitus. Historical vaccine include PFIZER BIONTECH COVID 19 VACCINE first dose on 06Jan2021 for COVID-19 immunisation. She got the second dose and her arm on the side she got her shot was hurting from her hand to her chest for about 10 days. Then she got diagnosed with Bell's Palsy. The left side of her face has been twitching and droopy and not right. She got the second dose on 26Jan2021. Three days later was when she started experiencing the pain on left arm (29Jan2021). The shot was given in the left arm. It took 10 days to heal. Then after that was when she started to feel her face. She tried to call the doctor and they couldn't see her until 08Mar2021 to get diagnosed. She had been on medication for two days. She started one medication on Monday. There had been no improvement yet. One of the medication was Acyclovir 800mg tablet. She was taking it five times per day. She started it on 09Mar2021. The other medication she takes three at the time for the first six days. Then two at a time. It was a steroid. She started it on the 08Mar2021. She added that she was a diabetic and being on the steroid had her blood sugars high now. They said it was stress and not eating right. Investigations included blood work and checked her thyroid, both with unknown result. Then when she got in to the doctor she was diagnosed because it had been going on for five weeks. The arm pain started a couple of days after the vaccination (29Jan2021). It was after 10 days when she developed Bell's Palsy (Feb2021). The day that she got it she had nausea and threw up that night (Feb2021). She had gone to the emergency room for the arm pain as she was in bad pain and didn't go to work for 2 days. The ER told her it could take 10 days. She doesn't remember the exact date. It was sometime the first week of Feb2021. The outcome of vaccination site pain was recovered on 08Feb2021, chest pain was recovered on an unknown date; while unknown for other events. Therapeutic measures were taken as a result of Bell's palsy and vaccination site pain.  Information on the lot/ batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Stress, Vaccination site pain, Vomiting
Clinical narrative: hurting from her hand to her chest; stress; nausea and threw up that night; nausea and threw up that night; Bell's palsy; arm on the side she got her shot was hurting; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 34 years of age), dose 2 via an unspecified route of administration, administered in Arm Left on 26Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included asthma wherein she doesn't take medication, it was usually when she was cold; she had this diagnosis since her childhood. She was diabetic and was diagnosed when she was 16 years old (2002). Concomitant medication included insulin human injection, isophane (HUMULIN N) and insulin human (HUMULIN R), both for diabetes mellitus. Historical vaccine include PFIZER BIONTECH COVID 19 VACCINE first dose on 06Jan2021 for COVID-19 immunisation. She got the second dose and her arm on the side she got her shot was hurting from her hand to her chest for about 10 days. Then she got diagnosed with Bell's Palsy. The left side of her face has been twitching and droopy and not right. She got the second dose on 26Jan2021. Three days later was when she started experiencing the pain on left arm (29Jan2021). The shot was given in the left arm. It took 10 days to heal. Then after that was when she started to feel her face. She tried to call the doctor and they couldn't see her until 08Mar2021 to get diagnosed. She had been on medication for two days. She started one medication on Monday. There had been no improvement yet. One of the medication was Acyclovir 800mg tablet. She was taking it five times per day. She started it on 09Mar2021. The other medication she takes three at the time for the first six days. Then two at a time. It was a steroid. She started it on the 08Mar2021. She added that she was a diabetic and being on the steroid had her blood sugars high now. They said it was stress and not eating right. Investigations included blood work and checked her thyroid, both with unknown result. Then when she got in to the doctor she was diagnosed because it had been going on for five weeks. The arm pain started a couple of days after the vaccination (29Jan2021). It was after 10 days when she developed Bell's Palsy (Feb2021). The day that she got it she had nausea and threw up that night (Feb2021). She had gone to the emergency room for the arm pain as she was in bad pain and didn't go to work for 2 days. The ER told her it could take 10 days. She doesn't remember the exact date. It was sometime the first week of Feb2021. The outcome of vaccination site pain was recovered on 08Feb2021, chest pain was recovered on an unknown date; while unknown for other events. Therapeutic measures were taken as a result of Bell's palsy and vaccination site pain.  Information on the lot/ batch number has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiomyopathy, Echocardiogram, Electrocardiogram, Type V hyperlipidaemia
Clinical narrative: Atrial fibrillation; Cardiomyopathy; Mixed hyperlipidemia; This is a spontaneous report from a contactable consumer. This consumer reported the same events for himself and two other patients. This is the first of three cases.   An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 04Mar2021 and first dose on 27Jan2021 (batch/lot numbers not reported); both via unspecified routes of administration as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes. Concomitant medications were not specified and reported that they were too many to list, also he has quite a list of prescription. The patient stated since he has gotten both COVID shots and it was found out after going to the doctor and to a cardiologist that he was the third person that has been diagnosed with atrial fibrillation from taking the COVID shots and since he was the third person that they had recently after both shots, he thought he should call the toll number and report side effects after taking the vaccine. Consumer confirmed the date for diagnosis of atrial fibrillation as 08Mar2021 and stated primary care doctor, he went for his quarterly visit and she gave him an EKG and it showed this the fibrillation and he was immediately sent to a cardiologist who confirmed it after a second EKG and echocardiogram had both of those. Consumer stated it said atrial fibrillation, cardiomyopathy and mixed hyperlipidemia whatever that was, he has a print out of the diagnosis from the cardiologist in his hand. Consumer stated date of test was yesterday, 08Mar2021. Consumer stated he was given a new medicine Eliquis 5 mg twice a day as treatment. Consumer stated he just wanted to report this, since the doctor yesterday told him that he was the third patient that had both shots and came back with this. The outcome of the events was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021274387 Same reporter and drug, similar event, different patient;US-PFIZER INC-2021316269 Same reporter and drug, similar event, different patient
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DVT; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of BNT162B2, via an unspecified route of administration on 09Mar2021 10:00 at a single dose for Covid-19 immunization. The patient had no relevant medical history. No allergies to medications, food, or other products. No COVID prior to vaccination, he was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included evolocumab (REPATHA), levothyroxine, and unspecified vitamins. No other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar2021 03:00 PM (as reported), DVT occurred after receiving the first dose. Treatment received for the adverse event was blood thinner. The event resulted to doctor or other healthcare professional office/clinic visit. The event was reported as non-serious (did not result to death, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating, and not congenital anomaly/birth defect). No COVID test post vaccination. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal clotting factor, Adhesion, Back pain, Chest pain, Computerised tomogram
Clinical narrative: chest, back underarm pain; chest, back underarm pain; back pain; adhesions; Inflammation numbers were high; Clotting numbers were way high over 2000; pneumonia; This is a spontaneous report received from a contactable consumer. A 76-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration in right arm on 01Jan2021 11:45 at single dose for COVID-19 immunisation. Medical history included thyroid, pancreas, and known allergies: Sulfa, k-flex, macrobid, statins, and pork. Concomitant medications included levothyroxine sodium (L-THYROXINE CAMPUS), vitamin B3, magnesium sulfate, and unspecified blood thinners. The patient experienced chest, back underarm pain two week later and did not get better. Patient had some adhesions and thought maybe from that. Patient had surgery and did not help. Pain kept getting worse. ED visit. On 04Mar2021, patient was diagnosed with pneumonia and sent home. After antibiotic, patient was no better. Another ED visit on 08Mar2021, clotting numbers were way high over 2000. Inflammation numbers were high. Patient was admitted every test available. 3 days in hospital. Patient was no better. Pain was terrible. Chest underarms and upper back. Patient was in serious pain and afraid to get second shot. Patient had cancelled. These adverse events were result in emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. This case was reported as serious with seriousness criteria-caused/prolonged hospitalization. The patient underwent lab tests and procedures which included several computerised tomogram (CT scan): unknown results on an unspecified date, COVID test (nasal swab): negative on 08Mar2021, and X-ray: unknown results on an unspecified date. Patient was treatment for the adverse events. Outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pain in extremity, Pneumonia, SARS-CoV-2 test, X-ray
Clinical narrative: chest, back underarm pain; chest, back underarm pain; back pain; adhesions; Inflammation numbers were high; Clotting numbers were way high over 2000; pneumonia; This is a spontaneous report received from a contactable consumer. A 76-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration in right arm on 01Jan2021 11:45 at single dose for COVID-19 immunisation. Medical history included thyroid, pancreas, and known allergies: Sulfa, k-flex, macrobid, statins, and pork. Concomitant medications included levothyroxine sodium (L-THYROXINE CAMPUS), vitamin B3, magnesium sulfate, and unspecified blood thinners. The patient experienced chest, back underarm pain two week later and did not get better. Patient had some adhesions and thought maybe from that. Patient had surgery and did not help. Pain kept getting worse. ED visit. On 04Mar2021, patient was diagnosed with pneumonia and sent home. After antibiotic, patient was no better. Another ED visit on 08Mar2021, clotting numbers were way high over 2000. Inflammation numbers were high. Patient was admitted every test available. 3 days in hospital. Patient was no better. Pain was terrible. Chest underarms and upper back. Patient was in serious pain and afraid to get second shot. Patient had cancelled. These adverse events were result in emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. This case was reported as serious with seriousness criteria-caused/prolonged hospitalization. The patient underwent lab tests and procedures which included several computerised tomogram (CT scan): unknown results on an unspecified date, COVID test (nasal swab): negative on 08Mar2021, and X-ray: unknown results on an unspecified date. Patient was treatment for the adverse events. Outcome of the events was not resolved.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Heart rate, Tachycardia
Clinical narrative: she experienced tachycardia (157 BPM); warm sensation in her chest and ears; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date unknown), via an unspecified route of administration on 08Mar2021 at age of 49 years old at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient received her first Pfizer Covid vaccine on 08Mar2021. Within 15 minutes she experienced tachycardia (157 BPM) and a warm sensation in her chest and ears. The symptoms resolved in 45 minutes. She would like guidance on if she should receive the second dose. The outcome of events was recovered on 08Mar2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of tachycardia due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Heart rate, Heart rate increased
Clinical narrative: she experienced tachycardia (157 BPM); warm sensation in her chest and ears; This is a spontaneous report from a contactable Other HCP (patient). A 49-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date unknown), via an unspecified route of administration on 08Mar2021 at age of 49 years old at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient received her first Pfizer Covid vaccine on 08Mar2021. Within 15 minutes she experienced tachycardia (157 BPM) and a warm sensation in her chest and ears. The symptoms resolved in 45 minutes. She would like guidance on if she should receive the second dose. The outcome of events was recovered on 08Mar2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of tachycardia due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Neuropathy peripheral
Clinical narrative: neurothopy for 1-2 days; bone pain; Exhaustion; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via unspecified route of administration on unspecified date at age of 60 years old at single dose for COVID-19 immunisation. Patient had chemotherapy for ovarian cancer in 2020. Concomitant medications were not reported. Patient experienced exhaustion, bone pain, neurothopy for 1-2 days post first vaccine. Event took place after use of product. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Nausea, Seizure, Syncope
Clinical narrative: left arm is very sore, painful to touch and difficult to move; left arm is very sore, painful to touch and difficult to move; fainted /vasovagal syncope episode; might have convulsed on the floor; out of breath; nausea; dizziness; This is a spontaneous report from a non-contactable consumer (reported for herself). A 24-year-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in Arm Left on 11Mar2021 15:00 (Lot Number: EN6199) at the age of 24 years old as single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication received within 2 weeks of vaccination included levonorgestrel, ethinyl estradiol (reported as "Levonor-E Estrad"). Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Mar2021 15:15, Few minutes after vaccination patient fainted and might have convulsed on the floor. Patient became conscious after a couple min. Patient had spouts of nausea and dizziness. 2 hr after dose (11Mar2021) patient was out of breath and went to a hospital. Doctors suppose that the incident was a vasovagal syncope episode. After 18 hr (12Mar2021) patient's left arm was very sore, painful to touch and difficult to move. The events resulted in Emergency room/department or urgent care. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: left arm is very sore, painful to touch and difficult to move; left arm is very sore, painful to touch and difficult to move; fainted /vasovagal syncope episode; might have convulsed on the floor; out of breath; nausea; dizziness; This is a spontaneous report from a non-contactable consumer (reported for herself). A 24-year-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in Arm Left on 11Mar2021 15:00 (Lot Number: EN6199) at the age of 24 years old as single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication received within 2 weeks of vaccination included levonorgestrel, ethinyl estradiol (reported as "Levonor-E Estrad"). Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Mar2021 15:15, Few minutes after vaccination patient fainted and might have convulsed on the floor. Patient became conscious after a couple min. Patient had spouts of nausea and dizziness. 2 hr after dose (11Mar2021) patient was out of breath and went to a hospital. Doctors suppose that the incident was a vasovagal syncope episode. After 18 hr (12Mar2021) patient's left arm was very sore, painful to touch and difficult to move. The events resulted in Emergency room/department or urgent care. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: experienced symptoms similar to a heart attack; This is a spontaneous report from a Pfizer Sponsored Program received from a contactable consumer. A male patient of an unspecified age received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced symptoms similar to a heart attack on an unspecified date. The outcome of the event was unknown.    Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Atrial fibrillation; This is a spontaneous report from a contactable consumer. This consumer reported the same events for himself and two other patients. This is the second of three cases.   A patient of unspecified age and gender received the first and second doses of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that since the patient has been diagnosed with atrial fibrillation on an unspecified date after taking both COVID shots. The outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021269817 same reporter, drug and event, different patient;US-PFIZER INC-2021316269 same reporter, drug and event, different patient
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Tongue ulceration, Urticaria
Clinical narrative: cankers under her tongue; above her left kneecap it looked like a mushroom hard in the middle water around it; On right leg there was a big red welt the size of her calf.; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A 63-year-old female patient received bnt162b2 (BNT162B2) (at 63 years of age), dose 1 via an unspecified route of administration on 08Mar2021 14:20 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history included allergic reaction now and then to sulphur based medicines. The patient's concomitant medications were not reported. The patient received 1st shot 0220 pm yesterday (08Mar2021), she came home and she was fine, she worked around the house, she took a shower and above her left knee cap it looks like there was another knee cap and it looks like in the shape of a mushroom it was hard in the middle, water around it. On her right leg there was a big red welt that was the size of her cap, she had canker under her tongue. She went to the hospital and the hospital gave her an Epipen. She was curious if she should receive her second shot. Therapeutic measures were taken as a result of the events with Epipen which was given to her as a precaution. The patient was hospitalized due to the events. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dementia
Clinical narrative: Dementia has increased.; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration first dose on 08Jan2021 at single dose for Covid-19 immunization. The patient's medical history included Covid and ongoing dementia. The patient's concomitant medications were not reported.  It was reported that patient had the vaccine on 08Jan2021. Less than a month after patient had Covid and was aware of the 90 day waiting time during positive Covid. It was also reported that patient experienced dementia had increased. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Biopsy liver, Blood bilirubin, Blood bilirubin increased, Cholestasis, Fatigue
Clinical narrative: Bilirubin rose to 2.3; fatigue; malaise; Liver biopsy on 12Feb showed cholestasis; This is a spontaneous report from a contactable physician, received via a Pfizer sales representative. A 46-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 06Feb2021 at a single dose for COVID-19 immunization. Medical history included fatty liver and ulcerative colitis. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Jan2021 for COVID-19 immunization. On 12Feb2021, the patient had a liver biopsy which showed cholestasis. On an unknown date, the patient experienced fatigue and malaise, and bilirubin rose to 2.3. The events were resolving.   Information on the batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Bilirubin rose to 2.3; fatigue; malaise; Liver biopsy on 12Feb showed cholestasis; This is a spontaneous report from a contactable physician, received via a Pfizer sales representative. A 46-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 06Feb2021 at a single dose for COVID-19 immunization. Medical history included fatty liver and ulcerative colitis. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Jan2021 for COVID-19 immunization. On 12Feb2021, the patient had a liver biopsy which showed cholestasis. On an unknown date, the patient experienced fatigue and malaise, and bilirubin rose to 2.3. The events were resolving.   Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood bilirubin, Blood bilirubin increased, Cholestasis, Hepatic necrosis, Investigation
Clinical narrative: Liver bx severe cholestasis and some necrosis on 01Feb; Liver bx severe cholestasis and some necrosis on 01Feb; Bilirubin rose to 3.9; This is a spontaneous report from contactable Physician via Pfizer Sales Representative. A 61 -year-old female patient received her first dose on 29Dec2020, second dose on 19Jan2021, both of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, single dose for COVID-19 immunisation. Medical history included HTN (hypertension) and hyperlipidemia. Baseline labs from 2020 all WNL. Bilirubin rose to 3.9 (assessed 2021). Liver bx severe cholestasis and some necrosis on 01Feb2021. Hospitalized initially and now recovering at home. The events caused hospitalization. The events outcome was unknown.  Information on batch/lot number has been requested.; Sender's Comments: Information provided was so limited to prevent a meaningful medical assessment. A possible association of VACCINE in the reported Cholestasis, Hepatic necrosis, Blood bilirubin increased cannot be completely excluded due to temporal association, otherwise, there was not evidence or argument suggesting a causal relationship for BNT162B2 in development of serious hepatic events. 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.