chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: Muscle soreness at injection site. Chills starting 18 hours after injection & lasting for several hours.; Muscle soreness at injection site. Chills starting 18 hours after injection & lasting for several hours.; This is a spontaneous report from a non-contactable consumer (patient).  A 51-year-old female patient received the second dose of bnt162b2 (BNT162B2 also reported as COVID 19 vaccine brand Pfizer, lot EL3248), via an unspecified route of administration in the right arm 02Feb2021 08:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included high blood pressure. She had her first dose of bnt162b2 (lot EL3248) in the right arm and she had muscle soreness at injection site. Concomitant medications included lisinopril, amlodipine and potassium. The patient experienced muscle soreness at injection site and chills starting 18 hours after injection & lasting for several hours on 02Feb2021, no treatment reported. The outcome of events recovered.    No follow up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Loss of personal independence in daily activities
Clinical narrative: As the needle was being inserted and while the vaccine was being injected, I immediately felt intense pain like none I've had during any prior vaccine administration . The needle was inserted very high on the arm about 1/2 inch below the shoulder.  About 4:00 pm that afternoon, new pain developed in the same shoulder, along with very limited range of motion, gradually worsening during next few hours. By 9:00pm the pain was excruciating, like there were multiple knives in all directions in my shoulder. By then I could not lift or move my arm any amount in any direction without excruciating pain.  I suspected a severe inflammatory response. This pain level continued for the next 2 days.  On the 3rd day the pain was a little less severe and I had slightly more range of motion, but was still unable to lift my arm without pain. On the 4th day (Feb. 18) the pain was a little better but I still had severe sharp pain if I lifted my arm in certain directions. I began to suspect a torn muscle or tendon. Today (March 5, almost 3 weeks after the vaccine), the pain and limited range of motion are the same as Feb. 18.  It is relieved only by complete rest of the arm, and easily aggravated by any basic activity (grocery shopping, dressing, etc.)  I believe my shoulder was injured by improper administration.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Product administered at inappropriate site
Clinical narrative: As the needle was being inserted and while the vaccine was being injected, I immediately felt intense pain like none I've had during any prior vaccine administration . The needle was inserted very high on the arm about 1/2 inch below the shoulder.  About 4:00 pm that afternoon, new pain developed in the same shoulder, along with very limited range of motion, gradually worsening during next few hours. By 9:00pm the pain was excruciating, like there were multiple knives in all directions in my shoulder. By then I could not lift or move my arm any amount in any direction without excruciating pain.  I suspected a severe inflammatory response. This pain level continued for the next 2 days.  On the 3rd day the pain was a little less severe and I had slightly more range of motion, but was still unable to lift my arm without pain. On the 4th day (Feb. 18) the pain was a little better but I still had severe sharp pain if I lifted my arm in certain directions. I began to suspect a torn muscle or tendon. Today (March 5, almost 3 weeks after the vaccine), the pain and limited range of motion are the same as Feb. 18.  It is relieved only by complete rest of the arm, and easily aggravated by any basic activity (grocery shopping, dressing, etc.)  I believe my shoulder was injured by improper administration.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal haemorrhage, Intensive care, Transfusion
Clinical narrative: Acute GI bleed requiring ICU care and transfusion
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient inadvertently administered 1st dose of Moderna cov 19 vaccine to person under the age of 18. Patient administered 2nd dose of Moderna cov 19 vaccine on 3/3/2021 with approval of health officials,
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine pt has history of migraines and pressure started 1407 and then continued to get worse.   pt instructed to rest a bit longer in observation  area and started feeling better 1500
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Asthenia, Chest discomfort, Chills, Cough
Clinical narrative: Immediately following the injection soreness and muscle pain in arm. Headache began to worsen overnight. 2pm throbbing headache, muscle pain throughout body, tightness in chest, coughing. Very lathargic and severe headache. Unable to talk due to fatigue(Asthenia). 6pm severe symptoms including, headache, body ache, fatigue, tight chest, muscle pain, nausea, chills, sweats, unable to call for help. Unable to control bowels...soiled self. Attempted to get to bathroom fell against walls and furniture. Feces everywhere in home, dehydration has been a big problem. Low blood pressure 107/40. Disoriented, lathargic and pale. Trouble keeping fluid down or in..forgetful and unable to keep a thought. Blacked out .etc.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Disorientation, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Immediately following the injection soreness and muscle pain in arm. Headache began to worsen overnight. 2pm throbbing headache, muscle pain throughout body, tightness in chest, coughing. Very lathargic and severe headache. Unable to talk due to fatigue(Asthenia). 6pm severe symptoms including, headache, body ache, fatigue, tight chest, muscle pain, nausea, chills, sweats, unable to call for help. Unable to control bowels...soiled self. Attempted to get to bathroom fell against walls and furniture. Feces everywhere in home, dehydration has been a big problem. Low blood pressure 107/40. Disoriented, lathargic and pale. Trouble keeping fluid down or in..forgetful and unable to keep a thought. Blacked out .etc.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Lethargy, Loss of consciousness, Memory impairment, Mobility decreased
Clinical narrative: Immediately following the injection soreness and muscle pain in arm. Headache began to worsen overnight. 2pm throbbing headache, muscle pain throughout body, tightness in chest, coughing. Very lathargic and severe headache. Unable to talk due to fatigue(Asthenia). 6pm severe symptoms including, headache, body ache, fatigue, tight chest, muscle pain, nausea, chills, sweats, unable to call for help. Unable to control bowels...soiled self. Attempted to get to bathroom fell against walls and furniture. Feces everywhere in home, dehydration has been a big problem. Low blood pressure 107/40. Disoriented, lathargic and pale. Trouble keeping fluid down or in..forgetful and unable to keep a thought. Blacked out .etc.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pain in extremity, Pallor
Clinical narrative: Immediately following the injection soreness and muscle pain in arm. Headache began to worsen overnight. 2pm throbbing headache, muscle pain throughout body, tightness in chest, coughing. Very lathargic and severe headache. Unable to talk due to fatigue(Asthenia). 6pm severe symptoms including, headache, body ache, fatigue, tight chest, muscle pain, nausea, chills, sweats, unable to call for help. Unable to control bowels...soiled self. Attempted to get to bathroom fell against walls and furniture. Feces everywhere in home, dehydration has been a big problem. Low blood pressure 107/40. Disoriented, lathargic and pale. Trouble keeping fluid down or in..forgetful and unable to keep a thought. Blacked out .etc.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Aching pain in right arm
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Diplopia, Vision blurred
Clinical narrative: Pt c/o blurry vision. Pt waited 60 minutes following vaccine and double vision is now occurring. BP elevated at 160/90 and 150/96. Co-worker to transport pt to ER. Patient was seen and discharged from the ED. Concern for anaphylaxis.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Vaccination site pain
Clinical narrative: Severe body ache; ache at the injection site; headache; chills; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL3247) via an unspecified route of administration in the left arm on 18Feb2021 at 12:00 (at the age of 33-years-old) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was not aware of allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient previously took first dose of BNT162B2 (Lot number: EL3247 and left arm) on 28Jan2021 at 12:30 (at the age of 33-years-old) for COVID-19 immunization. On 18Feb2021 at 23:00 severe body ache, ache at the injection site, headache and chills. The seriousness criteria were considered as non-serious. The patient did not receive any treatment of the events. The outcome of the events was not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Injection site swelling, Lacrimation increased, Nausea
Clinical narrative: patient stated she developed a fever of 101 degrees for more than 24 hours, severe chills, runny, watery eyes, mild cough, nausea, severe body aches, and a large red lump at the injection site
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: patient stated she developed a fever of 101 degrees for more than 24 hours, severe chills, runny, watery eyes, mild cough, nausea, severe body aches, and a large red lump at the injection site
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: My mother had the COVID vaccine at 9 am. By 7:30 pm she felt weak, had muscles aches and severe headache. As the night continued on she had fever chills that would come and go all night causing her not to get much sleep.  Day two the chills were gone but still very achey, weak, tired and headache.  Day three she is still tired and weak with headache.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: My mother had the COVID vaccine at 9 am. By 7:30 pm she felt weak, had muscles aches and severe headache. As the night continued on she had fever chills that would come and go all night causing her not to get much sleep.  Day two the chills were gone but still very achey, weak, tired and headache.  Day three she is still tired and weak with headache.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension
Clinical narrative: Hypertension and lightheadedness. No other symptoms. Likely not related.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pruritus, Lip swelling
Clinical narrative: Upper lip itched and was slightly puffy. Next day it returned to normal but bottom lip became itchy and felt 2 little bumps underneath. I assume it was hives.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Eczema, Fatigue, Headache
Clinical narrative: Day of and following day of first shot was fatigue, slight chills, intermittant headache. After 48 hrs severe joint pain in my shoulders, predominantly the left - sites of previous and ongoing damage. Also severe swelling and joint pain in the toes of my right foot, also a site of a previous and ongoing issue. Excema: a skin rash, that is an autoimmune  reaction to stress, returned around my mouth These side effects lasted for most of the first week following the first shot. Abating considerably by day 6
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Day of and following day of first shot was fatigue, slight chills, intermittant headache. After 48 hrs severe joint pain in my shoulders, predominantly the left - sites of previous and ongoing damage. Also severe swelling and joint pain in the toes of my right foot, also a site of a previous and ongoing issue. Excema: a skin rash, that is an autoimmune  reaction to stress, returned around my mouth These side effects lasted for most of the first week following the first shot. Abating considerably by day 6
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain
Clinical narrative: Pt reported feeling faint approx 10 min after receiving vaccine. He disclosed that he had not eaten anything before the vaccination. Monitoring revealed BP of 150/74, HR 52, O2 93%. He felt better after 10 min and was released to self. In follow-up he stated he went home and had something to eat and felt much better. Only sequela was pain at site if injection.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Multiple fractures, Pyrexia, Vaccination site pain
Clinical narrative: Broken bones; Fever 102.2; General weakness; Injection site pain; This is a spontaneous report from a contactable other health professional reported for himself. A 62-year-old male received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Feb2021 08:15 on Arm left at single dose (Lot # EL9267) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products. He experienced Fever 102.2, broken bones, general weakness and injection site pain on 17Feb2021, which were non serious. Tylenol were received for the events. The patient had not been tested for COVID-19. Outcome of the events was recovered.; Sender's Comments: The event broken bones was considered as an intercurrent condition and unrelated to the use of BNT162B2. 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Feeling hot, Flushing, Heart rate increased
Clinical narrative: Pt reported rapid heart rate to EMT at 1410. EMT assessed pt. HR: 82 and no SOB. Pt reported hx of hypertension, allergies to PCN, and severe allergic reaction to flue vaccine 2 years ago. Pt offered adult dose of diphenhydramine. Pt refused diphenhydramine. Pt offered EMS. Pt denied EMS. Pt advised to wait 15 extra minutes. At 1417 pt reported dry throat and feeling hot. Flushing was observed by RN. Pt was moved outside. Pt was offered EMS for a second time. Pt agreed to EMS. EMS was activated at 1420. EMS arrived at 1430 and assumed care. Pt left vaccination site at 1435 and transported to ER.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given outside of manufacturer's age parameters.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Sensory disturbance
Clinical narrative: 4 Days following the second Moderna shot, I began to feel a tingling, mostly buzzing sensation in the area below my abdomen. The intensity was not very strong and would come and go. Now, several weeks later, the buzzing has intensified, is constant and has spread to my chest. Prior to receiving this does, I have never experienced this sort of sensation in my body.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure decreased, Blood test, Chills, Diarrhoea
Clinical narrative: 2am woke up with severe chills and a severe migraine. At 10am severe migraine progressed to skin on scalp feeling like it was pulled too tight. From there I began to feel an internal tremor in my head, almost like if you ran a jack hammer all day and then stopped, that shaky, off-kilter feeling.  I used the bathroom that morning and had massive diarrhea, experience a vaso/syncope episode and passed out.  All week I felt like this and experienced nausea, dizziness, heart palpitations, severe migraine, internal tremor, severe anxiety and severe thirst.  By Friday, 2/26/21, it got so bad and my blood pressure dropped to 112/50, that I was taken via ambulance to the ER.  They gave me IV fluids, ran labs, EKG, etc.  Blood pressure went up to 137/91.  Released to rehab at home.  2nd ER visit to Hospital on Sunday where they repeated labs, EKG, gave me fluids and treated symptoms. Both trips I was labeled Tachy.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Head titubation, Laboratory test, Loss of consciousness
Clinical narrative: 2am woke up with severe chills and a severe migraine. At 10am severe migraine progressed to skin on scalp feeling like it was pulled too tight. From there I began to feel an internal tremor in my head, almost like if you ran a jack hammer all day and then stopped, that shaky, off-kilter feeling.  I used the bathroom that morning and had massive diarrhea, experience a vaso/syncope episode and passed out.  All week I felt like this and experienced nausea, dizziness, heart palpitations, severe migraine, internal tremor, severe anxiety and severe thirst.  By Friday, 2/26/21, it got so bad and my blood pressure dropped to 112/50, that I was taken via ambulance to the ER.  They gave me IV fluids, ran labs, EKG, etc.  Blood pressure went up to 137/91.  Released to rehab at home.  2nd ER visit to Hospital on Sunday where they repeated labs, EKG, gave me fluids and treated symptoms. Both trips I was labeled Tachy.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Palpitations, Syncope, Tachycardia
Clinical narrative: 2am woke up with severe chills and a severe migraine. At 10am severe migraine progressed to skin on scalp feeling like it was pulled too tight. From there I began to feel an internal tremor in my head, almost like if you ran a jack hammer all day and then stopped, that shaky, off-kilter feeling.  I used the bathroom that morning and had massive diarrhea, experience a vaso/syncope episode and passed out.  All week I felt like this and experienced nausea, dizziness, heart palpitations, severe migraine, internal tremor, severe anxiety and severe thirst.  By Friday, 2/26/21, it got so bad and my blood pressure dropped to 112/50, that I was taken via ambulance to the ER.  They gave me IV fluids, ran labs, EKG, etc.  Blood pressure went up to 137/91.  Released to rehab at home.  2nd ER visit to Hospital on Sunday where they repeated labs, EKG, gave me fluids and treated symptoms. Both trips I was labeled Tachy.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Tension headache, Thirst
Clinical narrative: 2am woke up with severe chills and a severe migraine. At 10am severe migraine progressed to skin on scalp feeling like it was pulled too tight. From there I began to feel an internal tremor in my head, almost like if you ran a jack hammer all day and then stopped, that shaky, off-kilter feeling.  I used the bathroom that morning and had massive diarrhea, experience a vaso/syncope episode and passed out.  All week I felt like this and experienced nausea, dizziness, heart palpitations, severe migraine, internal tremor, severe anxiety and severe thirst.  By Friday, 2/26/21, it got so bad and my blood pressure dropped to 112/50, that I was taken via ambulance to the ER.  They gave me IV fluids, ran labs, EKG, etc.  Blood pressure went up to 137/91.  Released to rehab at home.  2nd ER visit to Hospital on Sunday where they repeated labs, EKG, gave me fluids and treated symptoms. Both trips I was labeled Tachy.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Wrong Covid vaccine brand was administered for dose #2.  No signs or symptoms of distress.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Dizziness, Feeling abnormal, Nausea, Presyncope
Clinical narrative: Patient received his Pfizer vaccine at 08:10 and at 08:25 he started feeling light headed and nauseated and had a vagal response. Episode lasted about 40 seconds but he did not  become cyanotic or stop breathing. Pt denies any chest pain but was diaphoretic after episode. Called EMS for transport to CPH. Pt had syncopal episode with persistent Bradycardia. Current VS are P=40 R=22 BP 101/63 Pt A&O x4 with no focal neural deficits. Pulse ox is 100% on RA and pt states still feels a little "foggy". No rash or evidence of an allergic reaction.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient was given the Pfizer Covid vaccine at 10:10 AM. At noon I was informed that the facility had conducted a rapid covid test and the patient had tested positive. The patient was given the vaccine before the results of the covid test were known.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Decreased appetite, Fatigue, Induration, Lymphadenopathy
Clinical narrative: The day after my second vaccine I experienced extreme fatigue, lack of appetite, and nausea, lasting  all day. No fever and no soreness in my arm, and I did not contact my doctor. A few days later I noticed a firm lump or swollen lymph gland in my left armpit. After a few days it gradually began to improve over a 10 day to 2 week period.  I am reporting in order to assist vaccine knowledge.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: The day after my second vaccine I experienced extreme fatigue, lack of appetite, and nausea, lasting  all day. No fever and no soreness in my arm, and I did not contact my doctor. A few days later I noticed a firm lump or swollen lymph gland in my left armpit. After a few days it gradually began to improve over a 10 day to 2 week period.  I am reporting in order to assist vaccine knowledge.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Fifty cent piece size red slightly swollen and a little itch on the injection site.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Paraesthesia, Pyrexia
Clinical narrative: Mar. 1, Day of injection- sore arm, fever up to 100.8; significant chills; Mar 2, Day after injection, arm very sore, fatigue, highest fever 101.8;  Mar. 3, fatigue, tongue & mouth started to tingle, rash on trunk of body & arms; highest temperature, 99.8; Mar. 4, fatigue tongue & mouth tingling more pronounced, Mar. 5, Fatigue, tingling in tongue, mouth & lips
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Colitis microscopic, Colonoscopy, Diarrhoea, Malaise
Clinical narrative: Developed watery diarrhea; malaise; weight loss; collagenous colitis on colonoscopy biopsies; This is a spontaneous report from a contactable physician (patient). An 81-years-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included was none. No covid prior vaccination. No known allergies. Concomitant medication included allopurinol (ALLOPURINOL), losartan potassium (COZAAR), tadalafil (TADALAFIL), acetylsalicylic acid (ASPRIN), simvastatin (ZOCOR). Historical vaccine included BNT162B2 details: (Product= COVID 19) for covid-19 immunisation, Lot number= EL1284, Administration date= 31Dec2020, administration time= 11:00 AM, vaccine location: Left arm, dose number= 1, Developed watery diarrhea about 5 days after the dose. No other vaccine in four weeks. Adverse event: watery diarrhea improved somewhat but worsened again after the second dose of vaccine, along with some malaise and weight loss, since 05Jan2021. Extensive investigations eventually revealed collagenous colitis on colonoscopy biopsies in Jan2021. May well be coincidence, but interested to know if others have been reported. AE resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Anti-diarrheals, budesonide. The event outcome of collagenous colitis was recovering, watery diarrhea was  not recovered, outcome of other event was unknown. Covid test post vaccination covid test date=19Jan2021, which was negative.; Sender's Comments: Based on the available information, the company considers that a causal relationship between collagenous colitis on colonoscopy biopsies and bnt162b2 cannot be excluded due to plausible temporal association. 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.,Linked Report(s) : US-PFIZER INC-2021229604 same  patient/reporter, different AE/first dose
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Weight, Weight decreased
Clinical narrative: Developed watery diarrhea; malaise; weight loss; collagenous colitis on colonoscopy biopsies; This is a spontaneous report from a contactable physician (patient). An 81-years-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included was none. No covid prior vaccination. No known allergies. Concomitant medication included allopurinol (ALLOPURINOL), losartan potassium (COZAAR), tadalafil (TADALAFIL), acetylsalicylic acid (ASPRIN), simvastatin (ZOCOR). Historical vaccine included BNT162B2 details: (Product= COVID 19) for covid-19 immunisation, Lot number= EL1284, Administration date= 31Dec2020, administration time= 11:00 AM, vaccine location: Left arm, dose number= 1, Developed watery diarrhea about 5 days after the dose. No other vaccine in four weeks. Adverse event: watery diarrhea improved somewhat but worsened again after the second dose of vaccine, along with some malaise and weight loss, since 05Jan2021. Extensive investigations eventually revealed collagenous colitis on colonoscopy biopsies in Jan2021. May well be coincidence, but interested to know if others have been reported. AE resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Anti-diarrheals, budesonide. The event outcome of collagenous colitis was recovering, watery diarrhea was  not recovered, outcome of other event was unknown. Covid test post vaccination covid test date=19Jan2021, which was negative.; Sender's Comments: Based on the available information, the company considers that a causal relationship between collagenous colitis on colonoscopy biopsies and bnt162b2 cannot be excluded due to plausible temporal association. 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.,Linked Report(s) : US-PFIZER INC-2021229604 same  patient/reporter, different AE/first dose
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Strong body aches, headaches, fever, sore and tenderness in arm
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity, Rash
Clinical narrative: Rash, nausea, sore arm, tired
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Received 1st dose COVID-19 vaccine Pfizer Received 2nd dose  COVID-19 vaccine Moderna
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Exposure during pregnancy, Fatigue, Injection site swelling, Nausea
Clinical narrative: Light-headness within forty five minutes - a little dizzy; tiredness; nauseous; swelling on injection site - it was a little worse then on the first dose (I forgot to mention that I had swelling on the injection site after the first dose, too). These symptoms lasted for about two weeks. I took Benadryl to help with the symptoms - it helped  the symptoms to let me to sleep. A week and a half before I took the second COVID vaccine, I had a TB test done. Exhaustion is still there and I still have nausea. Dizziness has been gone since second week of the 2nd dose of vaccine. Swelling on the injection site is gone. I had a doctor visit - Video visit with clinic and the dr recommended bedrest - February 11th or 12th - no meds given.  I'm due Sept 26, 2021. This is my fourth pregnancy - I had my daughter who is eight years old; an abortion; had my son who is five and he was born pre-term due to lack of fluids in the stomach - 4 lbs 5 oz. and now this pregnancy.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Paraesthesia oral, Swelling face, Throat tightness
Clinical narrative: The patient had tightness in the throat. Then her lips started to tingle and her face looked red and swollen.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Left arm tingling after vaccination that did not go away after 30min. Evaluated by EMS. ST elevation in screening lead 2, 12 lead performed but revealed only enlarged QRS, no ST change. No resp distress, no chest pain, given aspiring by EMS and transferred to hospital for continued monitoring and observation.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given outside age parameters.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: During post-vaccination observation period, patient developed hives. The patient was attended to by EMS but refused treatment.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Facial discomfort, Nervousness, Oropharyngeal discomfort, Pain
Clinical narrative: Within a few minutes of getting the injection my face began tingling.  A few minutes after that the tingling turned into a burning feeling.  My cheeks were slightly flushed but felt like I had a bad sunburn.  At the same time my throat felt thick.  I could talk and breathe but it definitely felt like it had swelled inside my throat.  I also felt shaky.  My hands were not shaky but I felt shaky on the inside.  I didn't report this to the people working the vaccine clinic (but in retrospect I should have) The thick throat feeling resolved within one hour and the face burning feeling was gone by the next morning.  Then I just had the typical sore arm, a few body aches and nothing else. Note: never a vaccine reaction but I had an anaphylactic reaction requiring treatment when receiving a 2nd dose of chemotherapy
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Within a few minutes of getting the injection my face began tingling.  A few minutes after that the tingling turned into a burning feeling.  My cheeks were slightly flushed but felt like I had a bad sunburn.  At the same time my throat felt thick.  I could talk and breathe but it definitely felt like it had swelled inside my throat.  I also felt shaky.  My hands were not shaky but I felt shaky on the inside.  I didn't report this to the people working the vaccine clinic (but in retrospect I should have) The thick throat feeling resolved within one hour and the face burning feeling was gone by the next morning.  Then I just had the typical sore arm, a few body aches and nothing else. Note: never a vaccine reaction but I had an anaphylactic reaction requiring treatment when receiving a 2nd dose of chemotherapy
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria
Clinical narrative: Hives in the injection area a week after the vaccine was administered
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Rash erythematous, Rash pruritic
Clinical narrative: Red, swelling, itchy rash at injection site nine days after injection. The rash spread rapidly but was gone within 48 hours
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Delirium, Fatigue, Pain
Clinical narrative: patient 's daughter reports client very tired, body pain and confusion (delirium)
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: around 5 to 10 minutes after her vaccination, patient reported feeling dizzy/lightheaded, "seeing stars" and  reported that the symptoms "comes and goes".  Patient reported eating lunch that day.  Paramedics were called and came to examine patient
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Impaired driving ability, Impaired work ability, Incorrect route of product administration, Mobility decreased
Clinical narrative: I developed extreme shoulder pain and weakness in my arm with limited mobility  the evening of my Covid vaccine. I kept trying to move my arm since I thought it was pain from the vaccine dose, but the pain continued to get worse over the week even with ibuprofen. I went to my primary care physician a week after the vaccine and he examined me and said the placement of the injection was much too high and it missed my deltoid muscle. I completed lab work to rule out infection, and I am scheduled to have imaging of my left shoulder to determine the extent of the shoulder injury from the misplaced injection. It has been 2 weeks and the pain is continuing to increase with very limited mobility. I have had to miss work, can't drive my stick shift car, and my sleep is poor because the pain wakes me up during the night.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Poor quality sleep, Sleep disorder
Clinical narrative: I developed extreme shoulder pain and weakness in my arm with limited mobility  the evening of my Covid vaccine. I kept trying to move my arm since I thought it was pain from the vaccine dose, but the pain continued to get worse over the week even with ibuprofen. I went to my primary care physician a week after the vaccine and he examined me and said the placement of the injection was much too high and it missed my deltoid muscle. I completed lab work to rule out infection, and I am scheduled to have imaging of my left shoulder to determine the extent of the shoulder injury from the misplaced injection. It has been 2 weeks and the pain is continuing to increase with very limited mobility. I have had to miss work, can't drive my stick shift car, and my sleep is poor because the pain wakes me up during the night.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient inadvertently administered 1st dose of Moderna covid 19 vaccine to person under 18 years of age. Patient administered 2nd dose of Moderna covid 19 vaccine on 3/3/2021 with approval of Chief and Medical Director.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient under 16 years of age who received 1st dose of COVID19 vaccine on 12FEB21.  patient was 15 years and 9 months at time of vaccination.    NOTE: ample information available to patient/guardian on vaccine including  FACT SHEET FOR RECIPIENTS AND CAREGIVERS; as well as local screening  form which has patient/caregiver sign the following statement: "I have read or had explained to me the information in the Coronavirus Vaccine Emergency Use Authorization (EUA) Fact Sheet. I have also had a chance to ask questions, and they were answered to my satisfaction".   Patient/Guardian attempted to make an appointment for 2nd dose;  Appointment line clerk was able to screen patient and advice that patient was not eligible for vaccination per manufacturer recommendation and EUA authorization.   Officer in charge of site attempted to contact parent/guardian but upon attempts only was able to leave voice messages.  Parent/guardian given a  number for callback.  at the time of this report no callback was received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: mosquito like bump, itching, redness
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia
Clinical narrative: Numbness in left arm 4 minutes after receiving the vaccine, improved after observation for 30 minutes
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Feeling cold, Feeling hot, Micturition urgency
Clinical narrative: Body gets hot then cold, with constant urination, and I am not a Diabetic, no energy.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Decreased appetite, Eating disorder, Memory impairment
Clinical narrative: he violently threw up/vomiting; lost control of all of his extremities; acute pancreatitis; had no strength; affected his memory; barely moving; balance was horrible/his whole balance everything was off; lost his appetite right away; not eat; This is a spontaneous report from a contactable consumer reporting for the husband. A 76-year-old male patient received the first dose of bnt162b2 (Batch/lot number: EL3302), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunisation. Medical history included Allergy from an unknown date, blood pressure abnormal from an unknown date, ongoing kidney patient and was on dialysis three times a week. Concomitant medication included insulin aspart (NOVOLOG), insulin glargine, vitamin b complex (SUPER B COMPLEX), acetylsalicylic acid (BABY ASPIRIN), vitamin d3, ascorbic acid, biotin, folic acid, mecobalamin, nicotinic acid, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine (DIALYVITE), atorvastatin, cetirizine for Allergy, fish oil, docusate, amlodipine besilate for Blood pressure and other medications as the patient was kidney patient. For Concomitant medication amlodipine besilate, the consumer stated, Right now at this time he was not supposed to take them on his dialysis days. So, he took one tablet on Saturday & Sunday, Tuesday & Thursday. The patient had his first shot of the Pfizer on 21Jan2021, he lost his appetite right away and wasn't eating. And then on 29Jan2021 he took 2 bites of a meal, and had extremely volatile vomiting and lost control of all of his extremities. He violently threw up on the 29Jan2021 and from that's when on he had no appetite, she couldn't get him to eat anything. Her daughter had to help her pick him up of the floor, the Friday night 24 hours it was just horrible. The consumer stated, Saturday morning (30Jan2021) he had gotten use of extremities back but barely moving and still very, his whole balance everything was off. He was able stand up and use the restroom by himself. This had all affected his memory, he couldn't do his medications alone anymore and he couldn't take care of himself. And then on the 12Feb2021 the consumer took him over to the hospital because after when he vomited on the 29Jan2021 he lost all use of his extremities. They diagnosed him with acute pancreatitis, but he still, he was in the hospital from Friday 12Feb2021 and they released him on the 17Feb2021. And he still had no strength. His balance was horrible. It was affecting, whatever it was affecting his memory. The consumer stated they had no idea why he came down with acute pancreatitis and he never had any pain with it. They said they were amazed that he was not in severe pain, never any pain. The outcome of events had no strength and balance was horrible was not recovered. The outcome of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021187441 Same reporter/patient/product, Different dose/AE
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Movement disorder, Muscle disorder, Pancreatitis acute, Vomiting
Clinical narrative: he violently threw up/vomiting; lost control of all of his extremities; acute pancreatitis; had no strength; affected his memory; barely moving; balance was horrible/his whole balance everything was off; lost his appetite right away; not eat; This is a spontaneous report from a contactable consumer reporting for the husband. A 76-year-old male patient received the first dose of bnt162b2 (Batch/lot number: EL3302), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunisation. Medical history included Allergy from an unknown date, blood pressure abnormal from an unknown date, ongoing kidney patient and was on dialysis three times a week. Concomitant medication included insulin aspart (NOVOLOG), insulin glargine, vitamin b complex (SUPER B COMPLEX), acetylsalicylic acid (BABY ASPIRIN), vitamin d3, ascorbic acid, biotin, folic acid, mecobalamin, nicotinic acid, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine (DIALYVITE), atorvastatin, cetirizine for Allergy, fish oil, docusate, amlodipine besilate for Blood pressure and other medications as the patient was kidney patient. For Concomitant medication amlodipine besilate, the consumer stated, Right now at this time he was not supposed to take them on his dialysis days. So, he took one tablet on Saturday & Sunday, Tuesday & Thursday. The patient had his first shot of the Pfizer on 21Jan2021, he lost his appetite right away and wasn't eating. And then on 29Jan2021 he took 2 bites of a meal, and had extremely volatile vomiting and lost control of all of his extremities. He violently threw up on the 29Jan2021 and from that's when on he had no appetite, she couldn't get him to eat anything. Her daughter had to help her pick him up of the floor, the Friday night 24 hours it was just horrible. The consumer stated, Saturday morning (30Jan2021) he had gotten use of extremities back but barely moving and still very, his whole balance everything was off. He was able stand up and use the restroom by himself. This had all affected his memory, he couldn't do his medications alone anymore and he couldn't take care of himself. And then on the 12Feb2021 the consumer took him over to the hospital because after when he vomited on the 29Jan2021 he lost all use of his extremities. They diagnosed him with acute pancreatitis, but he still, he was in the hospital from Friday 12Feb2021 and they released him on the 17Feb2021. And he still had no strength. His balance was horrible. It was affecting, whatever it was affecting his memory. The consumer stated they had no idea why he came down with acute pancreatitis and he never had any pain with it. They said they were amazed that he was not in severe pain, never any pain. The outcome of events had no strength and balance was horrible was not recovered. The outcome of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021187441 Same reporter/patient/product, Different dose/AE
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Glossodynia
Clinical narrative: Sores/Canker sores on the side of the patients tongue were reported 3 days after administration of her 1st dose of Moderna COVID-19. Pt stated that she noticed a sore tongue in the evening after getting the vaccine and it appears that the next day she realized they were like canker sores. They continue to persist
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Nausea, Pain
Clinical narrative: Fever, body aches, headache, nausea, upset stomach, overall body fatigue..  Most adverse effects lasted about 10 hours and all gradually wore off on their own within 24 hours onset.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, body aches, headache, nausea, upset stomach, overall body fatigue..  Most adverse effects lasted about 10 hours and all gradually wore off on their own within 24 hours onset.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Hypoaesthesia, Injection site pain, Muscular weakness, SARS-CoV-2 test positive
Clinical narrative: Prolonged pain, tenderness and weakness in left shoulder to elbow. Numbness in left arm.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Secretion discharge
Clinical narrative: EVENT: increased mucus discharge from lungs through tracheotomy cannula of a thicker than usual consistency. TREATMENT: increased fluid intake, sterile water droplets in trach, increased suction, nebulized sterile water. OUTCOME:  4 days out - resolving slowly
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Sinus rhythm
Clinical narrative: Pt had second dose of Pfizer vaccine at 09:20. Stated she had headache on left side and left-sided chest pain at 09:25. Not associated with other symptoms.  Vitals taken BP=165/101 Resp=24 O2=100%RA,. Reported to EMS. Established IV, 4 81mg aspirin given. Pt placed on telemetry monitor. Pt states CP resolved prior to transport to hospital.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: Approximately 7 hours after immunization, I experienced a change in orientation.  I did not remember getting a vaccination, day of week, month, color of my car, president.  However, I knew my name, birthdate, people who were with me at the time of the event.  I experienced no speech or mobility impairment.  I was able to walk with no difficulty in my gate.  My grasp was strong and equal.  No facial muscle weakness was noted.   45 minutes later I had total recall of the day's activities. I am not a smoker, no consumption of alcohol or illegal drugs.  Called primary care physician on 3/5/21 at approximately 4:30 pm.  Primary physician was not available, spoke to a nurse.