chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intermenstrual bleeding, Menstruation irregular, Pain, Pyrexia, Vulvovaginal mycotic infection
Clinical narrative: I am a very regular person in my 28 day menstrual cycle.   After my first shot on march 31st. I had a sore for about 4 or 5 days. I was fine. But my period came unexpectedly 5 days early on April 15. It was a very light flow and only 3 days long. My regular period is about 7 days.  My next period came on May 8th. At first spotting, then full period. This was a more normal 7 days.  I had my second dose vaccine injection on May 17th at 11am.  I had a fever for 3 days with shivers and body pains. Suddenly the fevers and chills just stopped after 3rd day.  No one else in my family in our household got obvious side effects (all men).  I got a vaginal yeast infection which was treated at home with over the counter medication on May 27th.  Very rare to get for me.   My 3rd period started on June 2nd. Very heavy flow with a lot of back pain.   My periods are now random and just not normal.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Chills, Condition aggravated, Headache, Hyperhidrosis
Clinical narrative: Headache, body ache, drowsiness, sweats, chills,  and ACNE. All other symptoms except acne went away after 48 hours. Acne has been persistent for THREE MONTHS now and has spread from face to neck, back, and chest as well. Went to dermatologist and allergist in order to get rid of the acne and see what I am allergic to.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Somnolence
Clinical narrative: Headache, body ache, drowsiness, sweats, chills,  and ACNE. All other symptoms except acne went away after 48 hours. Acne has been persistent for THREE MONTHS now and has spread from face to neck, back, and chest as well. Went to dermatologist and allergist in order to get rid of the acne and see what I am allergic to.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Basilar artery thrombosis, Brain stem stroke, Computerised tomogram head abnormal, Lacunar stroke, Magnetic resonance imaging head abnormal
Clinical narrative: Pt admitted w/ respiratory distress, altered mental status due to basilar artery thrombosis causing brainstem and bilateral thalamic stroke.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Mental status changes, Respiratory distress
Clinical narrative: Pt admitted w/ respiratory distress, altered mental status due to basilar artery thrombosis causing brainstem and bilateral thalamic stroke.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Eye disorder, Vision blurred, Vitreous floaters
Clinical narrative: his vision was blurry/Felt like his vision was getting blurry in both eyes; with eye floaters that are catching the light more often/Eye floaters and they are catching the light more often which is creating a flashing light every now and then/The floaters are happening more in his left eye; with eye floaters that are catching the light more often/Eye floaters and they are catching the light more often which is creating a flashing light every now and then; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 36-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Left on 23May2021 12:40 (Batch/Lot Number: EW0178) as 1st dose, single for covid-19 immunisation. The patient medical history prior to vaccinations included headache, stomach ache and arm pain. Concomitant medications were not reported. History of all immunisation list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine or additional Vaccines Administered on Same Date of the Pfizer were reported as none. On 23May2021 after receiving a first dose of vaccination, a couple hours after the vaccine patient felt like his vision was getting blurry in both eyes and that had continued. He also had eye floaters before receiving the Covid 19 vaccine but now the eye floaters are catching the light more often which is creating a flashing light every now and then. It was happening in both eyes, the floaters are happening more in his left eye. He reported the ophthalmologist said his eyes were fine. He reported he was borderline on his eye prescription and according to the ophthalmologist the Covid 19 vaccine might impacted his eye muscles a little bit and pushed him over to the next prescription. The ophthalmologist said the blurred vision should go away in a few days. The ophthalmologist also said he had not heard of any vision side effects with the Covid 19 vaccine, and he should be fine a day or two. It was reported that patient was not visited to emergency room of physician office. At the time of report, patient was not recovered from the events. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: Complete loss of hearing in right ear; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via unspecified route of administration on an unspecified date (at the age of 63-year-old) in the hospital as single dose for COVID-19 immunisation. Patient had no relevant medical history, concurrent conditions or any known allergies. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since, the vaccination patient has not been the patient been tested for COVID-19. Patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. On 04May2021, at 10:00, patient experienced complete loss of hearing in right ear and visited doctor or other healthcare professional office/clinic visit. Reporter considered the events as non-serious. Therapeutic measures in response to the event included treatment with steroid injections in ear and oral steroids. Outcome of the event was recovered with lasting effects (resolved with sequalae) on an unspecified date in 2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Influenza like illness, Laboratory test
Clinical narrative: Shortness of breath; flu like symptoms; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 45-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 19Apr2021 (age at vaccination was unknown) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included diagnosis of asthma as an adult in 2013 and has an Autoimmune condition, Sjogren's syndrome. Concomitant medications were not reported. The patient took first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date in Apr2021 (age at vaccination was 45 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The caller received both doses of the Pfizer vaccine in April. After the 2nd vaccine dose, 19Apr2021, she experienced flu like symptoms and on the 3rd day those symptoms resolved. The caller then developed SOB and went to the ED where tests were completed and she was discharged home. The caller followed up with a Pulmonologist. She was placed on various medications, including steroids and inhalers. Nothing has helped one month Later. The caller asked whether these symptoms had been reported by other people and whether there was more information about SOB lasting for weeks after the pfizer vaccine. The outcome of event flu like symptoms was resolved on 21Apr2021. The outcome of event shortness of breath was unknown.  Information about lot/batch has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Near death experience
Clinical narrative: I almost die; I didn't build any response; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an unspecified route on unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced severe reaction to the Pfizer covid vaccine. Patient reported that immune compromised, didn't build any response and almost die on an unspecified date. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Magnetic resonance imaging, Synovial cyst, Ultrasound joint
Clinical narrative: experienced the same excruciating pain in my right knee this time; two Baker's Cysts were visible, one in each leg, only visible on the back of my right knee, but no trace of any blood clots; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: unknown) via an unspecified route of administration, administered in left arm on 13Apr2021 at 07:00 (at the age of 60-year-old) as 1st dose single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: unknown) via an unspecified route of administration on 04May2021 (at the age of 60-year-old) as 2nd dose, single both for covid-19 immunization. Medical history included undiagnosed arthritis. The patient did not receive any other concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID 19 prior to vaccination. On 13Apr2021 at 20:00, patient started experiencing the events. It was reported that, for twenty days, patient needed help to accomplish anything. On the 21st day, patient went out but the steps were extraordinarily painful in left knee. Her plan was to wait it out until she had the 2nd dose on 04May. Again, six days later, patient experienced the same excruciating pain in right knee this time. Two doses, both knees, unbelievable pain. The patient finally went the ER on Friday, 14May2021. After the first dose, patient suspected a Baker's Cyst. After the second dose, it measured the size of a golf ball cut in half. Trusted her research skills, she confirmed what she already knew, with an MRI scheduled and two ultrasounds done on both knees, two Baker's Cysts were visible, one in each leg, only visible on the back of right knee, but no trace of any blood clots. The patient underwent lab tests and procedures which included MRI: unknown and ultrasounds done on both knees: two baker's cysts were visible, one in each leg: size of a golf ball cut in half on an unspecified date. The adverse event resulted patient to visit the Physician Office Visit and Emergency Room Visit. The patient received treatment for the adverse event. Therapeutic measures were taken as a result of both events and treatment included with 10 mg Prednisone. Since the vaccination, patient has not been tested for COVID-19. The outcome of events was unknown.  Follow-up attempts are needed; information about lot/batch number can be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Major depression
Clinical narrative: it was four days after my second COVID-10 vaccination that this latest major depression hit; This is a spontaneous report from a contactable reporter.   A female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection; Lot Number and expiry date was unknown), via an unspecified route of administration on an unspecified date and second dose (lot number and expiry date was unknown) via an unspecified route of administration on 20Feb2021 as a single dose for COVID-19 immunization. The patients medical history included secondary progressive multiple sclerosis and Major Depressive Disorder. Concomitant medication included Lexapro (20mg) Wellbutrin (450mg). On an unknown date in February, the depression came back terribly. The patient worked with a psychologist, physician took her off Lexapro and put her on Trintellix (10 mg). After a month, with no success, she increased the Trintellix to 20mg and weaned of the Wellbutrin. The patient felt a little better for a couple of weeks, but the overwhelming black cloud had returned. Some interesting extra information she thought that much of the change may have been after changing from the Brand Name Lexapro to the generic drug. Also, it was four days after second COVID-10 vaccination that this latest major depression hit (2nd vaccine was February 20th and the horrid black cloud hit on February 24th). She did not know if there was any real drug interaction. The outcome of the events was unknown.  Follow-up attempts are needed; information about lot/batch number can be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: And had some symptoms on COVID after dose 1; And had some symptoms on COVID after dose 1; This is a spontaneous report received from a contactable consumer. A patient (reporter's sibling) of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced some with severe SOB (shortness of breath) ongoing, loss of taste and smell, and had some symptoms on COVID after dose 1. The outcome of the events was unknown.   Follow up needed, further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Chills, Fatigue
Clinical narrative: feeling tired; head hurts; legs hurt/feet pain; having chills; temp went up, to 101.9 lowest 100.3 F, 100.9 still has fever this morning; body aches; nausea; she states she couldn't open her eyes had photophobia due to the headache,  couldn't tolerate light due to extreme headache.; feeling cold; complaints of joint pain; back hurting; making humming sound during night; This is a spontaneous report from a contactable consumer (Patient). A 26-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: not reported), dose 2 via an unspecified route of administration, on 24May2021 at 08:30, as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date for COVID-19 immunization. On an unknown date in May2021, around 17:00-18:00, the patient started feeling tired, head hurts and legs hurt, by 21:00 started having chills temp went up, to 101.9 lowest 100.3 F, 100.9 still had fever this morning body aches, nausea, head kilting, last night she stated that she couldn't open her eyes had photophobia due to the headache, couldn't tolerate light due to extreme headache. She took Tylenol at 16:00, 12:00, and at 04:00 took Advil, still having fevers of 100.3, 101.9, 101.7 and complaints of chills throughout the night, was feeling cold, complaints of joint pain, feet pain, making humming sound during night. also, with c/o back hurting. The patient underwent lab tests and procedures which included body temperature: 101.9 Fahrenheit, lowest 100.3 Fahrenheit, 100.9 Fahrenheit, 100.3 Fahrenheit and 101.7 Fahrenheit on May2021. The outcome of event temp went up, to 101.9 lowest 100.3 F, 100.9 still has fever this morning was not recovered and for all rest events was unknown.  Information about lot/batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: feeling tired; head hurts; legs hurt/feet pain; having chills; temp went up, to 101.9 lowest 100.3 F, 100.9 still has fever this morning; body aches; nausea; she states she couldn't open her eyes had photophobia due to the headache,  couldn't tolerate light due to extreme headache.; feeling cold; complaints of joint pain; back hurting; making humming sound during night; This is a spontaneous report from a contactable consumer (Patient). A 26-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: not reported), dose 2 via an unspecified route of administration, on 24May2021 at 08:30, as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date for COVID-19 immunization. On an unknown date in May2021, around 17:00-18:00, the patient started feeling tired, head hurts and legs hurt, by 21:00 started having chills temp went up, to 101.9 lowest 100.3 F, 100.9 still had fever this morning body aches, nausea, head kilting, last night she stated that she couldn't open her eyes had photophobia due to the headache, couldn't tolerate light due to extreme headache. She took Tylenol at 16:00, 12:00, and at 04:00 took Advil, still having fevers of 100.3, 101.9, 101.7 and complaints of chills throughout the night, was feeling cold, complaints of joint pain, feet pain, making humming sound during night. also, with c/o back hurting. The patient underwent lab tests and procedures which included body temperature: 101.9 Fahrenheit, lowest 100.3 Fahrenheit, 100.9 Fahrenheit, 100.3 Fahrenheit and 101.7 Fahrenheit on May2021. The outcome of event temp went up, to 101.9 lowest 100.3 F, 100.9 still has fever this morning was not recovered and for all rest events was unknown.  Information about lot/batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Pyrexia, Tinnitus
Clinical narrative: feeling tired; head hurts; legs hurt/feet pain; having chills; temp went up, to 101.9 lowest 100.3 F, 100.9 still has fever this morning; body aches; nausea; she states she couldn't open her eyes had photophobia due to the headache,  couldn't tolerate light due to extreme headache.; feeling cold; complaints of joint pain; back hurting; making humming sound during night; This is a spontaneous report from a contactable consumer (Patient). A 26-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: not reported), dose 2 via an unspecified route of administration, on 24May2021 at 08:30, as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date for COVID-19 immunization. On an unknown date in May2021, around 17:00-18:00, the patient started feeling tired, head hurts and legs hurt, by 21:00 started having chills temp went up, to 101.9 lowest 100.3 F, 100.9 still had fever this morning body aches, nausea, head kilting, last night she stated that she couldn't open her eyes had photophobia due to the headache, couldn't tolerate light due to extreme headache. She took Tylenol at 16:00, 12:00, and at 04:00 took Advil, still having fevers of 100.3, 101.9, 101.7 and complaints of chills throughout the night, was feeling cold, complaints of joint pain, feet pain, making humming sound during night. also, with c/o back hurting. The patient underwent lab tests and procedures which included body temperature: 101.9 Fahrenheit, lowest 100.3 Fahrenheit, 100.9 Fahrenheit, 100.3 Fahrenheit and 101.7 Fahrenheit on May2021. The outcome of event temp went up, to 101.9 lowest 100.3 F, 100.9 still has fever this morning was not recovered and for all rest events was unknown.  Information about lot/batch has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: 2 stroke, on both sides of the brain; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A patient of unspecified age and gender received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced 2 stroke, on both sides of the brain (cerebrovascular accident) on an unspecified date with outcome of unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose abnormal, Dysuria, Inappropriate schedule of product administration, Sexually transmitted disease test
Clinical narrative: only thing out of range was his glucose; his second dose was 08APR2021/ his first dose was 21MAR2021; UTI-like symptoms (irritation and burning); UTI-like symptoms (irritation and burning); This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not provided) via unspecified route of administration in left arm on 08Apr2021 as single dose for COVID-19 immunization. The medical history and concomitant medication were not reported. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not provided) via unspecified route of administration in left arm on 21Mar2021 as single dose for COVID-19 immunization. On 28Apr2021 patient experienced UTI-like symptoms (irritation and burning). Patient stated that he had second dose of Pfizer COVID vaccine on 08Apr2021. He stated a couple weeks after the second dose he felt a twinge of urinary tract infection symptoms. At the end of April, clarified as 28Apr2021, he went to the doctor to see what was going on. He was prescribed "Ciproflaxin" to see if it was an infection. He confirmed the burning and irritation was still ongoing. Some days it was not bad, some days its annoying as all get out. Patient stated his urine had been tested and the test was negative. Patient stated he had blood tests and all the tests came back negative. Irritation and burning will be there for a day or so, then it quits, then it comes back. Some days it was not bad, some days its annoying as all get out. Patient required visit to physician Office. Patient confirmed full blood profile was completed on 28Apr2021 and the only thing out of range was his glucose because he didn't fast that morning and he didn't expect them to do the full blood profile. Patient stated he had every STI test done that one can think of and all came back negative. The patient underwent lab test and procedure which included Glucose 127 , STI Test negative and Urinalysis negative on 28Apr2021 The outcome of the event UTI-like symptoms (irritation and burning), dysuria was not recovered and only thing out of range was his glucose was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Urethritis noninfective, Urine analysis
Clinical narrative: only thing out of range was his glucose; his second dose was 08APR2021/ his first dose was 21MAR2021; UTI-like symptoms (irritation and burning); UTI-like symptoms (irritation and burning); This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not provided) via unspecified route of administration in left arm on 08Apr2021 as single dose for COVID-19 immunization. The medical history and concomitant medication were not reported. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not provided) via unspecified route of administration in left arm on 21Mar2021 as single dose for COVID-19 immunization. On 28Apr2021 patient experienced UTI-like symptoms (irritation and burning). Patient stated that he had second dose of Pfizer COVID vaccine on 08Apr2021. He stated a couple weeks after the second dose he felt a twinge of urinary tract infection symptoms. At the end of April, clarified as 28Apr2021, he went to the doctor to see what was going on. He was prescribed "Ciproflaxin" to see if it was an infection. He confirmed the burning and irritation was still ongoing. Some days it was not bad, some days its annoying as all get out. Patient stated his urine had been tested and the test was negative. Patient stated he had blood tests and all the tests came back negative. Irritation and burning will be there for a day or so, then it quits, then it comes back. Some days it was not bad, some days its annoying as all get out. Patient required visit to physician Office. Patient confirmed full blood profile was completed on 28Apr2021 and the only thing out of range was his glucose because he didn't fast that morning and he didn't expect them to do the full blood profile. Patient stated he had every STI test done that one can think of and all came back negative. The patient underwent lab test and procedure which included Glucose 127 , STI Test negative and Urinalysis negative on 28Apr2021 The outcome of the event UTI-like symptoms (irritation and burning), dysuria was not recovered and only thing out of range was his glucose was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Feeling abnormal, Respiratory rate
Clinical narrative: pain in her chest between her clavicle and top portion of her breast area/soreness in chest/fluttery sensation in her chest; She was feeling funny, never felt like that before; Experiencing shortness of breathe/rates her breathing as a 5; This is a spontaneous report from a contactable consumer (patient mother), who is a nurse. A 19-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, on 15May2021 at a single dose for Covid-19 immunization. Patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration, on an unspecified date at a single dose for Covid-19 immunization. On 25May2021, the patient experienced pain in her chest between her clavicle and top portion of her breast area/pain or soreness in her chest and describes a fluttery sensation in her chest that "feels funny, uncomfortable, weird, and not right. The patient had shortness of breath on an unspecified date in May2021. The patient woke up with a "funny sensation in her chest" and does not describe excruciating pain or difficulty breathing and "rates her breathing as a 5."The patient did not eat anything out of the ordinary or participated in any lifting or exercising of her chest muscles. Patient had never complained of anything like this before. The outcome of events was unknown.  Additional information has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, Dyspnea, chest pain, feeling uncomfortable cannot be completely ruled out. The impact of this report on 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, Ethic committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Myocardial infarction
Clinical narrative: I experienced 2 heart attacked within 3 days of receiving my second PFIZER vaccine; This is a spontaneous report from a contactable consumer (patient).  A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously took the first dose of  bnt162b2 on an unspecified date  (Batch/Lot number was not reported) for Covid-19 immunisation. It was reported that the patient needs to speak to someone around the covid vaccine. The purpose of this dialogue was that he would like an additional insight to side affects. He experienced 2 heart attacked within 3 days of receiving his second Pfizer vaccine. All his tests have come back normal as he is an extremely healthy 42yr old male that workouts 5 days per week and runs around 10-15 miles per week. Outcome of the event was unknown.  Information about batch/Lot number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pain, Vaccination site reaction
Clinical narrative: She was just joking with her kids that she was turning into a robot.; Can stick a magnet to her arm/now able to have a magnet stick to her vaccination site; she finds the spot that is a little sore; This is a spontaneous report from a Pfizer sponsored program COVAX support via contactable consumer (patient). A 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: Unknown), via unspecified route of administration in left arm on 20May2021 at 15:00 or 15:15 as 1st dose, single for COVID-19 immunisation. Medical history and concomitant medications or any other vaccinations within four weeks prior to the first administration date of the suspect vaccine were not reported. Previously patient received first dose of BNT162B2 in left arm on 26Apr2021 for COVID-19 immunisation. On 20May2021, same day when the patient had second shot, she had a spot that was a little sore. It was fading away and getting better. On 24May2021, at night for the first time, patient could stick a magnet to her arm and was now able to have a magnet stick to her vaccination site. The Medical Information document states that Pfizer was unaware of any properties that have a magnetic effect. There was a search done on 30Apr2021 and 19May2021, and it failed to identify related information on this topic. No relevant tests were performed. Outcome of the event she finds the spot that is a little sore was recovering and for other events were unknown.  Follow up needed, Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Cerebral haemorrhage, Chills, Culture
Clinical narrative: bleed on her brain; the infection had spread to her heart valves; she could not walk; legs went numb; sepsis; fever / fever went up over 103 F; chills; diarrhea; This is a spontaneous report received from a contactable consumer. A 61 years old female received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EP7533) on 30Mar2021 (at 61 years of age), in right arm, for COVID-19 immunisation. The patient received the first dose of BNT162B2 vaccine on 09Mar2021 (lot EN6202), at 61 years of age, in right arm. No other vaccines were given within 4 weeks prior to the COVID vaccine. Medical history included connective tissue disorder - scleroderma. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included methotrexate. On 30Mar2021, within a few hours of receiving the second vaccination, she had fever, chills and diarrhea. By 4:30 AM on 31Mar2021 she could not walk and her legs went numb. An ambulance was called and the EMTs had to carry her out of the house. She was taken to hospital where they started treating with antibiotics her for an infection but her fever went up over 103 F, so they ventilated her to try to control the fever. They did blood tests during that time and got the infections disease unit trying to figure out what was causing her symptoms. Doctors diagnosed sepsis. They continued to do blood test and cultures but could not determine the cause. They did Magnetic Resonance Imaging (MRIs) as follow-ups because she was not responding. The fever never went down. She was awake for a few days (ventilator still in) and then started getting worse again. They did an MRI and found a bleed on her brain and the infection had spread to her heart valves. She died on 14Apr2021 after 15 days of hospital care and Intensive Care Unit (ICU) care. The events were reported with a fatal outcome. It was unknown if autopsy was performed. Since the vaccination, the patient had not been tested for COVID-19.; Reported Cause(s) of Death: chills; diarrhea; she could not walk; legs went numb; sepsis; bleed on her brain; the infection had spread to her heart valves; fever / fever went up over 103 F
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Endocarditis, Gait disturbance, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: bleed on her brain; the infection had spread to her heart valves; she could not walk; legs went numb; sepsis; fever / fever went up over 103 F; chills; diarrhea; This is a spontaneous report received from a contactable consumer. A 61 years old female received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EP7533) on 30Mar2021 (at 61 years of age), in right arm, for COVID-19 immunisation. The patient received the first dose of BNT162B2 vaccine on 09Mar2021 (lot EN6202), at 61 years of age, in right arm. No other vaccines were given within 4 weeks prior to the COVID vaccine. Medical history included connective tissue disorder - scleroderma. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included methotrexate. On 30Mar2021, within a few hours of receiving the second vaccination, she had fever, chills and diarrhea. By 4:30 AM on 31Mar2021 she could not walk and her legs went numb. An ambulance was called and the EMTs had to carry her out of the house. She was taken to hospital where they started treating with antibiotics her for an infection but her fever went up over 103 F, so they ventilated her to try to control the fever. They did blood tests during that time and got the infections disease unit trying to figure out what was causing her symptoms. Doctors diagnosed sepsis. They continued to do blood test and cultures but could not determine the cause. They did Magnetic Resonance Imaging (MRIs) as follow-ups because she was not responding. The fever never went down. She was awake for a few days (ventilator still in) and then started getting worse again. They did an MRI and found a bleed on her brain and the infection had spread to her heart valves. She died on 14Apr2021 after 15 days of hospital care and Intensive Care Unit (ICU) care. The events were reported with a fatal outcome. It was unknown if autopsy was performed. Since the vaccination, the patient had not been tested for COVID-19.; Reported Cause(s) of Death: chills; diarrhea; she could not walk; legs went numb; sepsis; bleed on her brain; the infection had spread to her heart valves; fever / fever went up over 103 F
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sepsis
Clinical narrative: bleed on her brain; the infection had spread to her heart valves; she could not walk; legs went numb; sepsis; fever / fever went up over 103 F; chills; diarrhea; This is a spontaneous report received from a contactable consumer. A 61 years old female received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EP7533) on 30Mar2021 (at 61 years of age), in right arm, for COVID-19 immunisation. The patient received the first dose of BNT162B2 vaccine on 09Mar2021 (lot EN6202), at 61 years of age, in right arm. No other vaccines were given within 4 weeks prior to the COVID vaccine. Medical history included connective tissue disorder - scleroderma. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included methotrexate. On 30Mar2021, within a few hours of receiving the second vaccination, she had fever, chills and diarrhea. By 4:30 AM on 31Mar2021 she could not walk and her legs went numb. An ambulance was called and the EMTs had to carry her out of the house. She was taken to hospital where they started treating with antibiotics her for an infection but her fever went up over 103 F, so they ventilated her to try to control the fever. They did blood tests during that time and got the infections disease unit trying to figure out what was causing her symptoms. Doctors diagnosed sepsis. They continued to do blood test and cultures but could not determine the cause. They did Magnetic Resonance Imaging (MRIs) as follow-ups because she was not responding. The fever never went down. She was awake for a few days (ventilator still in) and then started getting worse again. They did an MRI and found a bleed on her brain and the infection had spread to her heart valves. She died on 14Apr2021 after 15 days of hospital care and Intensive Care Unit (ICU) care. The events were reported with a fatal outcome. It was unknown if autopsy was performed. Since the vaccination, the patient had not been tested for COVID-19.; Reported Cause(s) of Death: chills; diarrhea; she could not walk; legs went numb; sepsis; bleed on her brain; the infection had spread to her heart valves; fever / fever went up over 103 F
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsey; This is a spontaneous report from a contactable other health care professional (patient himself). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. Unknown if other vaccine in four weeks. It was reported that, patient developed Bells Palsey 4 days after second shot. No treatment for adverse event. It was unknown prior to vaccination, whether the patient diagnosed with COVID-19. It was unknown since the vaccination, if the patient been tested for COVID-19. The outcome for the event was reported as not resolved.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Bell's Palsy and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First shot: right arm pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EW0173), via an unspecified route of administration, administered in arm right on 30Apr2021 (at the age of 37-years-old), at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. After first shot, the patient developed right arm pain on an unspecified date in 2021. Outcome of the event was resolved on an unspecified date in 2021.  Information on the lot/batch number has been requested. Follow up needed, further information has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arterial occlusive disease, Dyspnoea, SARS-CoV-2 antibody test, Thrombosis
Clinical narrative: a blook clot; blockage in the Left Anterior Descending artery; symptoms of shortness of breath; This is a spontaneous report from a non-contactable consumer or other non hcp.   A 58-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 25Feb2021 17:30 (at the age of 57-years-old) as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 02Feb2021and experienced cardiac blockage. The patient did not take any other vaccines within 4 weeks prior to the COVID vaccine. On 15Apr2021 the patient experienced a blook clot, blockage in the left anterior descending artery and symptoms of shortness of breath. The events were reported as serious (life threatening). It was reported that 15Apr2021, emergency trip to ER, blockage in the Left Anterior Descending artery.  This blockage was only 40% blocked in Feb2021, and suddenly in April became 99% blocked. Dr suspected a blook clot when symptoms of shortness of breath appeared suddenly. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Blockage in the Left Anterior Descending artery was treated with cardiac stents. The patient underwent lab tests and procedures which included COVID-19 test tested performed on an unspecified date (result not reported). The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021600543 same patient, different vaccine dose/events
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: Miscarriage; This is a spontaneous report from a contactable consumer (patient). This is the mother case.   A 34-year-old female patient received the 1st single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in left arm on 18Apr2021 (Batch/Lot Number: Ew161), and the 2nd single dose, always in the left arm, on 02May2021 (Batch/Lot Number: Ew0171), for COVID-19 immunisation. First and second dose were administered at the age of 34 years old. Relevant medical history was reported as none. The patient's last menstrual period was on 18Feb2021 and pregnancy due date was 26Dec2021. Concomitant medications included unspecified pre-natal vitamins. Relevant past drug history included sulfa. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was never diagnosed with COVID-19, and since the vaccination the patient had not been tested for COVID-19. The patient reported having miscarriage on 13May2021, diagnosed after the 2nd shot of BNT162b2. A doctor or other healthcare professional office/clinic visit was needed. The fetus had died sometime between the 1st and 2nd shot based on gestational age. Gestation period when the event was observed was reported as 4 weeks. The patient had to undergo dilation and curettage from which the patient was recovering. The seriousness criterion was reported as 'Congenital anomaly/birth defect' (no further information reported about the congenital anomaly).  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021602308 mother/baby case
Sex: U
Vaccine: COVID19
Symptoms: Congenital anomaly, Maternal exposure during pregnancy
Clinical narrative: Miscarriage on 13May2021/seriousness criterion was reported as 'Congenital anomaly/birth defect'; Miscarriage on 13May2021/seriousness criterion was reported as 'Congenital anomaly/birth defect'; This is a spontaneous report from a contactable consumer (patient). This is the baby case.   A 34-year-old female patient received the 1st single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in left arm on 18Apr2021 (Batch/Lot Number: Ew161), and the 2nd single dose, always in the left arm, on 02May2021 (Batch/Lot Number: Ew0171), for COVID-19 immunisation. First and second dose were administered at the age of 34 years old. Relevant medical history was reported as none. The patient's last menstrual period was on 18Feb2021 and pregnancy due date was 26Dec2021. Concomitant medications included unspecified pre-natal vitamins. Relevant past drug history included sulfa. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was never diagnosed with COVID-19, and since the vaccination the patient had not been tested for COVID-19. The patient reported having miscarriage on 13May2021, diagnosed after the 2nd shot of BNT162b2. A doctor or other healthcare professional office/clinic visit was needed. The fetus had died sometime between the 1st and 2nd shot based on gestational age. Gestation period when the event was observed was reported as 4 weeks. The patient had to undergo dilation and curettage from which the patient was recovering. The seriousness criterion was reported as 'Congenital anomaly/birth defect' (no further information reported about the congenital anomaly).  No follow up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021602163 mother/baby case; Reported Cause(s) of Death: Miscarriage; Congenital anomaly; Miscarriage; Congenital anomaly
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Increased upper airway secretion
Clinical narrative: upper chest was tight; cough; He gets mucous build up after he eats something; This is a spontaneous report from a contactable consumer (patient himself). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration in Mar2021 as unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021 patient stated that the cough just started after he got his COVID-19 vaccine in March of this year. He gets mucous build up after he eats something and that was when he coughs.On an unspecified date, patient mentioned at one time his upper chest was tight and that lasted a few days and then it loosened up. The outcome of the events was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.