chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Fear, Feeling abnormal, Laboratory test, Lymphadenopathy
Clinical narrative: Muscle pain, joints pain in my hands and toes; Hands are like numb and they are getting like lazy and I can't touch paper; like shaking together; Muscle pain, joints pain in my hands and toes; Muscle pain, joints pain in my hands and toes; Hands are like numb and they are getting like lazy and I can't touch paper; Toes are not moving like they use to; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. This 30-year-old female consumer reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0172 and Expiry date: Aug2021), via an unspecified route of administration, administered in Left arm on 26Apr2021 (at the age of 32-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported.The patient's concomitant medications were not reported. On an unspecified date, the patient stated, "I called because I had side effects from this vaccine. Now I am having side effects that I never had before and the side effect that I had muscle pain, joints pain in my hands and toes, my hands are like numb and they were getting like lazy and I could not touch paper, now its my toes, my toe I am not moving, I got muscle pain and numbness and they were like shaking together, toes were not moving like they use to and I had muscle pain in my arm that I got the shot on 26th April, I had minor complications. Consumer further stated that I  still in pain right now. The patient underwent to emergency room and they gave Ibuprofen 600 mg tablet. The outcome of event was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder, Muscle tightness, Myalgia, Peripheral coldness, Tremor
Clinical narrative: Muscle pain, joints pain in my hands and toes; Hands are like numb and they are getting like lazy and I can't touch paper; like shaking together; Muscle pain, joints pain in my hands and toes; Muscle pain, joints pain in my hands and toes; Hands are like numb and they are getting like lazy and I can't touch paper; Toes are not moving like they use to; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. This 30-year-old female consumer reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0172 and Expiry date: Aug2021), via an unspecified route of administration, administered in Left arm on 26Apr2021 (at the age of 32-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported.The patient's concomitant medications were not reported. On an unspecified date, the patient stated, "I called because I had side effects from this vaccine. Now I am having side effects that I never had before and the side effect that I had muscle pain, joints pain in my hands and toes, my hands are like numb and they were getting like lazy and I could not touch paper, now its my toes, my toe I am not moving, I got muscle pain and numbness and they were like shaking together, toes were not moving like they use to and I had muscle pain in my arm that I got the shot on 26th April, I had minor complications. Consumer further stated that I  still in pain right now. The patient underwent to emergency room and they gave Ibuprofen 600 mg tablet. The outcome of event was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urinary retention
Clinical narrative: Muscle pain, joints pain in my hands and toes; Hands are like numb and they are getting like lazy and I can't touch paper; like shaking together; Muscle pain, joints pain in my hands and toes; Muscle pain, joints pain in my hands and toes; Hands are like numb and they are getting like lazy and I can't touch paper; Toes are not moving like they use to; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. This 30-year-old female consumer reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0172 and Expiry date: Aug2021), via an unspecified route of administration, administered in Left arm on 26Apr2021 (at the age of 32-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported.The patient's concomitant medications were not reported. On an unspecified date, the patient stated, "I called because I had side effects from this vaccine. Now I am having side effects that I never had before and the side effect that I had muscle pain, joints pain in my hands and toes, my hands are like numb and they were getting like lazy and I could not touch paper, now its my toes, my toe I am not moving, I got muscle pain and numbness and they were like shaking together, toes were not moving like they use to and I had muscle pain in my arm that I got the shot on 26th April, I had minor complications. Consumer further stated that I  still in pain right now. The patient underwent to emergency room and they gave Ibuprofen 600 mg tablet. The outcome of event was unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Intermittent SOB 5 days after the first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Apr2021 (at the age of 61-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 15May2021 (Saturday), the patient received the second dose of bnt162b2. On 29Apr2021, the patient experienced intermittent sob 5 days after the first dose. Shortness of breath started getting severe on the following monday (unspecified date), worsened on tuesday (unspecified date), went to ED on Wednesday. He was diagnosed with CHF and experienced being unable to breathe when laying back in a chair and having to stop 5-6 times during a 1 mile walk due to the shortness of breath. He had been referred to a cardiologist. Caller had told there was a Pfizer program that can underwrite the cost of his treatment since it is related to the adverse event. The clinical outcome of the intermittent SOB 5 days after the first dose was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer reported for his girlfriend (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0176) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified as dose 1, single for covid-19 immunisation. Reporter stated his girlfriend she took second dose of your Pfizer shot (clarified as Covid vaccine) on Friday she was in 103 fever right now and it was 5 days after she took the vaccine shot. Reporter seriousness for fever was unspecified. Outcome of the events was not unknown.  Information on the lot/batch number is available; further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: Since the first shot I've been experiencing some fatigue and oversleeping .; Since the first shot I've been experiencing some fatigue and oversleeping .; This is a spontaneous report from a contactable consumer (patient).   A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8730) dose 2 via an unspecified route of administration in Arm Left on 09Apr2021 14:00 (at the age of 59 years old) as single for COVID-19 immunisation at pharmacy or drug Store. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient received other medications within 2 weeks of vaccination. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0151) via an unspecified route of administration in Arm Right on an unspecified date as single for COVID-19 immunisation. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced as, since the first shot i've been experiencing some fatigue and oversleeping. I normally sleep 4-6 hours but now after the shot I sleep a lot more 14-18 hours daily intermittently  I thought I might sleep it off but it's taking longer than normal on 12Apr2021. Since the vaccination, the patient did not tested for COVID-19. No treatment was given. Outcome of the events were not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Eye contusion, Eye pain
Clinical narrative: Her eye is bruised in between the eyelid/ Black eye; Her eye was hurting; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 27May2021 (at the age of 54 year old) (Batch/Lot Number: EW0186) as single for covid-19 immunization. The patient's medical history and concomitant medications were reported as no. Historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 7May2021 (at the age of 54 year old) (Batch/Lot Number: EW0167) as single for covid-19 immunization and experienced no adverse event. Patient reported upon waking up this morning (28May2021) her eye was bruised in between the eyelid, also her eye was hurting. She was no Narcissistic so at first she didn't look in the mirror. She was trying to figure out why her eye would her. When she went to wash her face and get ready, that was when she saw the black eye. Investigation assessment was reported as no. The events were reported as non-serious. The outcome of both events was unknown.  Information on the batch/ lot number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Received 2nd vaccination on Monday and on Friday I broke out in Shingles on the back of my lower left thigh.; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0177 and expiration date was not reported), second dose via an unspecified route of administration, administered in arm Left on 24Apr2021(at the age of 59 years) as dose 2 single for covid-19 immunisation. Patient medical history included back surgeries, depression from an unknown date and unknown if ongoing along with known allergies to Latex, cipro, iodine, doxycylicine, codeine, sulfa, levaquin paper tape causing drug hypersensitivity. Patient concomitant medication(s) included plantago ovata (METAMUCIL), alprazolam, citalopram taken for an unspecified indication, start and stop date were not reported. Patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported), first dose via an unspecified route of administration, administered on an unspecified date dose 1 single for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On 28May2021 at 15:45 on Friday patient broke out in shingles on the back of his lower left thigh leading to emergency room. Already had those vaccinations 2 years ago. Patient received valacyclovir for the treatment of adverse event. The outcome of the event was not recovered.        Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Menstruation delayed
Clinical narrative: period is also late; Severe joint pain in my thumbs; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EW0183), dose 1 via an unspecified route of administration, administered in Arm Left on 24May2021 15:00 as dose 1, single for COVID-19 immunisation. Medical history included covid-19. The patient's concomitant medications were not reported. Severe joint pain in my thumbs a week after getting the first dose. My period is also late. I experienced both of these for five months after having Covid19. Things were just getting back to normal a month before I got the vaccine. The outcome of both the events was not recovered.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8730), dose 2 via an unspecified route of administration, administered in right arm on 01Apr2021 16:00 (at the age of 28-year-old) as single dose for covid-19 immunisation at doctors office/urgent care. The patient medical history included ongoing selective IgA deficient and ongoing IBS (irritable bowel syndrome). The was not patient diagnosed with COVID-19, prior to vaccination. The patient concomitant medication included amoxicillin, received within 2 weeks of vaccination. The patient previously took codeine phosphate (CODINEX) and experienced allergies. Historical vaccine included dose 1 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6204) via an unspecified route of administration, administered in right arm on 11Mar2021 at 16:00 as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shingles on 24May2021. Adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event with antiviral medications. The had not patient been tested for COVID-19 since the vaccination. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Pain
Clinical narrative: She is still having pain; is experiencing a flare; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received tofacitinib citrate (XELJANZ), oral from 2020 (Batch/Lot number was not reported) to 01Mar2021, at 10 mg, daily, oral from 15Apr2021 (Batch/Lot number was not reported) to an unspecified date, at 10 mg, daily for an unspecified indication; bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation (Age at vaccination: 72 years). The patient's medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient stated that she has been off the medication for 6 weeks since having the Covid vaccine. She is experiencing a flare on Apr2021, and is on pain medication. She had an appointment with her rheumatologist on 09Apr2021. The doctor gave her Prednisone as treatment for her flare reaction and pain. She went back on Xeljanz 15Apr2021. She is still having pain on an unspecified date. The action taken in response to the event for tofacitinib citrate was unknown. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Dissociation, Electric shock sensation, Fatigue
Clinical narrative: Brain zaps/Electric shock feeling; Constant, intense headaches with light sensitivity.; light sensitivity; Muscle weakness and trembling.; Pressure in head.; Nausea; Full body tremors; Fully body chills and shuddering; extreme Fatigue.; Disassociation.; Heavy period a week early.; Tinnitus.; It impacts her ability to function normally.; This is a spontaneous report from a contactable consumer (patient). A 26-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 11:00 (Batch/Lot Number: ER8734) as single dose for COVID-19 immunisation. Medical history included Anxiety, herniated disc. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included trazodone (TRAZODONE); fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported; birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since 12Apr2021, the patient experienced events: Constant, intense headaches with light sensitivity. Muscle weakness and trembling. Brain zaps. Pressure in head. Nausea. Full body tremors. Fully body chills and shuddering, lasting over an hour at a time. Extreme fatigue. Disassociation. Heavy period a week early. Tinnitus. It's been 2 months and the patient still had muscle weakness and electric shock feelings in most of her body, particularly upper body. It impacts her ability to function normally. Tinnitus had worsened and was now constant. Adverse event result to Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received treatment. Treatments for AE reported as Fluids, Cat of brain, bloodwork. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Heavy menstrual bleeding, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: Brain zaps/Electric shock feeling; Constant, intense headaches with light sensitivity.; light sensitivity; Muscle weakness and trembling.; Pressure in head.; Nausea; Full body tremors; Fully body chills and shuddering; extreme Fatigue.; Disassociation.; Heavy period a week early.; Tinnitus.; It impacts her ability to function normally.; This is a spontaneous report from a contactable consumer (patient). A 26-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 11:00 (Batch/Lot Number: ER8734) as single dose for COVID-19 immunisation. Medical history included Anxiety, herniated disc. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included trazodone (TRAZODONE); fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported; birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since 12Apr2021, the patient experienced events: Constant, intense headaches with light sensitivity. Muscle weakness and trembling. Brain zaps. Pressure in head. Nausea. Full body tremors. Fully body chills and shuddering, lasting over an hour at a time. Extreme fatigue. Disassociation. Heavy period a week early. Tinnitus. It's been 2 months and the patient still had muscle weakness and electric shock feelings in most of her body, particularly upper body. It impacts her ability to function normally. Tinnitus had worsened and was now constant. Adverse event result to Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received treatment. Treatments for AE reported as Fluids, Cat of brain, bloodwork. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Photophobia, Tinnitus, Tremor
Clinical narrative: Brain zaps/Electric shock feeling; Constant, intense headaches with light sensitivity.; light sensitivity; Muscle weakness and trembling.; Pressure in head.; Nausea; Full body tremors; Fully body chills and shuddering; extreme Fatigue.; Disassociation.; Heavy period a week early.; Tinnitus.; It impacts her ability to function normally.; This is a spontaneous report from a contactable consumer (patient). A 26-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 11:00 (Batch/Lot Number: ER8734) as single dose for COVID-19 immunisation. Medical history included Anxiety, herniated disc. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included trazodone (TRAZODONE); fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported; birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since 12Apr2021, the patient experienced events: Constant, intense headaches with light sensitivity. Muscle weakness and trembling. Brain zaps. Pressure in head. Nausea. Full body tremors. Fully body chills and shuddering, lasting over an hour at a time. Extreme fatigue. Disassociation. Heavy period a week early. Tinnitus. It's been 2 months and the patient still had muscle weakness and electric shock feelings in most of her body, particularly upper body. It impacts her ability to function normally. Tinnitus had worsened and was now constant. Adverse event result to Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received treatment. Treatments for AE reported as Fluids, Cat of brain, bloodwork. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration, Off label use, Premature labour
Clinical narrative: Premature contractions; Patient received first dose on 30Apr2021 and second dose received on 14May2021.; Patient received first dose on 30Apr2021 and second dose received on 14May2021.; Patient was received vaccine during pregnancy; This is a spontaneous report from a contactable nurse (patient, reported herself). This 34-year-old female pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in left arm, on 14May2021 at 12:00, as a single dose for COVID-19 immunisation and also received anti-D immunoglobulin (RHOGAM, formulation; unknown) via an unspecified route of administration, in left arm on 14May2021, as a single dose for immunisation; both were received at hospital. Patient's medical history included pregnancy. Patient had no known allergies. Concomitant medications included escitalopram oxalate (LEXAPRO), minerals nos, vitamins nos (PRENATAL VITAMINS), omeprazole and diphenhydramine hydrochloride (UNISOM) within two weeks of vaccination. Patient at Gestational period was 29 weeks at the time of report. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in left arm, on 30Apr2021 at 10:45 AM, as a single dose for COVID-19 immunisation. Patient received first dose on 30Apr2021, and second dose received on 14May2021. Patient did not receive any other vaccine in four weeks of vaccine. Patient was not diagnosed with COVID-19 prior to vaccine. The patient has not been tested for COVID-19, since vaccination. Patient was received vaccine during pregnancy. On 15May2021 (2 days after receiving 2nd dose of vaccine) at 10:00 AM, patient had Premature contractions; resulted in (Doctor or other healthcare professional office/clinic visit) and treatment (Medication to stop contractions) received. Outcome of the event Premature contractions was recovering and for other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, SARS-CoV-2 test
Clinical narrative: I received my second dose on Saturday Wednesday I was in the ER with a unexplained Cardiac event they could not determine what the cardiac issue was; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 42-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route , administered in Arm Right in Apr2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization.Medical history included depression, High blood pressure and covid-19. The patient had allergy to darvon [dextropropoxyphene hydrochloride]. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Left arm on 27Mar2021 10:00 AM as dose 1, single for covid-19 immunization and did not had reaction on previous exposure to drug. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19.On 21Apr2021 at 23:45 patient experienced Cardiac disorder. It was reported that she received her second dose on Saturday and on Wednesday (21Apr2021), she was in the ER (emergency room) with a unexplained cardiac event they could not determine what the cardiac issue. The patient was hospitalized for 6 days. The event resulted in emergency room/department or urgent care. The patient underwent lab tests which included sars-cov-2 test: negative on 24May2021 Nasal Swab. Therapeutic measures were taken as a result of event included heart attack measures were given. The patient recovered with sequelae.  Information on lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the cardiac event and the suspected vaccine 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: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: 5 days later, still have a fever; This is a spontaneous report from a contactable consumer, the patient. A 22-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0191), via an unspecified route of administration, administered in left arm on 19Jun2021 at 15:00, as dose 2, single (age at vaccination: 22 years), for covid-19 immunization. Medical history included lyme disease in the past from an unknown date and unknown if ongoing, biotoxic illness from an unknown date and unknown if ongoing. Concomitant medication included liothyronine sodium (CYTOMEL) taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfa [sulfanilamide] and experienced allergies (known allergies: Sulfa meds). Previously, the patient also received first dose of bnt162b2 (lot number: EW0191, age at vaccination: 22 years), as dose 1 single on 29May2021 at 14:00, administered in left arm. The patient stated that, on 20Jun2021, at 08:00 AM, he started experiencing fever and 5 days later, he still had a fever. Reportedly no other vaccine was administered on the same day of COVID vaccine and also no other vaccine within 4 weeks. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19, prior to vaccination. On 23Jun2021, the Nasal Swab sample was taken from the patient to test for COVID-19 and the test result was pending. No treatment was received for fever. The outcome of the event was recovered.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, X-ray
Clinical narrative: the patient was so excited after the first shot of the Covid-19 vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration in left arm on 12Jan2021 (age at vaccination 80-year-old) as 1st dose, single for Covid-19 immunisation. Patients medical history included stent placement from 2005, put in 5 stents, caller reported that the patient had a stent placed in his neck in nov2019, heart attack from 2017, sensitivity to bug bites if the patient went outside and got a mosquito bites, he looked like he had been beat with the knots on him, hypertension, contrast media allergy from 2005, high blood pressure and reaction to contrast dye on 2005. Concomitant medication included cetirizine taken for allergy problem, amlodipine besilate taken for hypertension, aspirin [acetylsalicylic acid] taken for antiplatelet therapy. The patient previously took codeine and experienced drug intolerance. Patient have sensitivity to codeine, goes way back, 40-50 years. The patient previously took tetanus vaccine, 20 years ago at least. The patient was so excited after the first shot of the covid-19 vaccine. The patient underwent lab tests and procedures which included x-ray: normal on 04Apr2021. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Facial shingles - developed 4 weeks after 2nd vaccine; This is a spontaneous report from a contactable other healthcare professional.   A 46-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 14Apr2021 09:30 (Batch/Lot Number: EK8731) (at age of 46-year-old) as DOSE 1, single for covid-19 immunisation at a facility. The patient medical history was not reported. Concomitant medications included cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC PLUS) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right arm on 24Mar2021 09:30 (Batch/Lot Number: ER8728) as single dose for covid-19 immunization and No reaction to reported (No reaction on previous exposure to vaccine). The 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, the patient has not been tested for COVID-19. On 20May2021 at 12:00 (4 weeks after 2nd vaccine), the patient developed facial shingles. Patient received treatment for the event included oral steroids, antiviral medications steroid oint and viral. The outcome of the event was reported as recovered on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Confusional state, Fatigue, Heart rate increased
Clinical narrative: received first dose on 01Mar2021 and second dose on 17Mar2021; my average BPM has gone from about 73 BPM to anywhere from 82 to 93 BPM often even when I am sedentary; struggling with sometimes identifying or saying the right words; being confused at things that shouldn't be; having more memory issues; panic; anxiety; often feel very tired; This is a spontaneous report from a contactable consumer. A 49-year-old female patient (non-pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on Left arm on 17Mar2021 05:00 PM (Age at Vaccination: 49 years) at single dose for COVID-19 immunisation. The patient medical history included High blood pressure taking meds since age 33 and had no known allergies. There was no covid prior vaccination and no covid tested post vaccination. The patient has not received other vaccine in four weeks and other vaccine in Two weeks (No new medications, Same one i have been on for years). The patient Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on Left arm on 01Mar2021 08:00 AM at single dose for COVID-19 immunisation. On an unspecified date in Mar2021, After her second dose, she noticed her heart rate feeling different, she figured it was just panic or anxiety, which typically does not increase her heart rate and her heart was tested and good prior to this and often feel very tired. Since then her average BPM has gone from about 73 BPM to anywhere from 82 to 93 BPM often even when she was sedentary, she just thought it was something weird, but when she read an article stating heart issues, she became concerned of the long term consequences of this. The patient experienced struggling with sometimes identifying or saying the right words and being confused at things that shouldn't be and had having more memory issues. The lab tests included test: Blood pressure, result: 82 to 93 BPM on an unspecified date. The patient did not receive any treatment for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Language disorder, Memory impairment, Panic attack
Clinical narrative: received first dose on 01Mar2021 and second dose on 17Mar2021; my average BPM has gone from about 73 BPM to anywhere from 82 to 93 BPM often even when I am sedentary; struggling with sometimes identifying or saying the right words; being confused at things that shouldn't be; having more memory issues; panic; anxiety; often feel very tired; This is a spontaneous report from a contactable consumer. A 49-year-old female patient (non-pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on Left arm on 17Mar2021 05:00 PM (Age at Vaccination: 49 years) at single dose for COVID-19 immunisation. The patient medical history included High blood pressure taking meds since age 33 and had no known allergies. There was no covid prior vaccination and no covid tested post vaccination. The patient has not received other vaccine in four weeks and other vaccine in Two weeks (No new medications, Same one i have been on for years). The patient Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on Left arm on 01Mar2021 08:00 AM at single dose for COVID-19 immunisation. On an unspecified date in Mar2021, After her second dose, she noticed her heart rate feeling different, she figured it was just panic or anxiety, which typically does not increase her heart rate and her heart was tested and good prior to this and often feel very tired. Since then her average BPM has gone from about 73 BPM to anywhere from 82 to 93 BPM often even when she was sedentary, she just thought it was something weird, but when she read an article stating heart issues, she became concerned of the long term consequences of this. The patient experienced struggling with sometimes identifying or saying the right words and being confused at things that shouldn't be and had having more memory issues. The lab tests included test: Blood pressure, result: 82 to 93 BPM on an unspecified date. The patient did not receive any treatment for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: feverish; tired; headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, lot number: EW0181) via unknown route of administration on 23Jun2021 06:00 PM in left arm as dose 2 single for COVID-19 immunization at Pharmacy or Drug Store. Medical history included hypertension, hyperthyroidism. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications received within 2 weeks of vaccination included losartan potassium at 100 mg, levothyroxine sodium at 75 ug. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, lot number: EW0180) on 02Jun2021 (at age of 36-year-old) in left arm for COVID-19 immunization and did not get many symptoms except sleep was disturbed for a while. After second dose it made me feverish on second day. I was tired and also headache all on 24Jun2021. No treatment received for adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperventilation, Palpitations, Somnolence, Tremor
Clinical narrative: Really worn down/wound up sleeping about 10 hours; chills; shaking; hyperventilating(gasping); chest pounding; This is a spontaneous report from a contactable consumer (patient). This 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on unspecified date in Jun2021 (at the age of 72 years old), as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunisation and no adverse event was reported. The patient was 72 years old while taking BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose. Patient reported that after receiving second dose, the next day (in Jun2021) he was really worn down, wound up sleeping about 10 hours that night (which was not normal) but then felt better the next day. He stated that after he received his 2nd COVID-19 shot, he had chills, shaking, was hyperventilating (gasping) and had chest pounding. Outcome of the event sleepy was recovered on an unknown date in Jun 2021 and for other events it was unknown.  Information on lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: I just starting having some this weird pain and discomfort in my heart; I just starting having some this weird pain and discomfort in my heart; This is a spontaneous report from a non-contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), dose 1 via an unspecified route of administration on 04Jun2021 as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient got the first dose of vaccine (Unspecified) on 04Jun2021 and shortly after that started having the information in the hard. Patient just started having some this weird pain and discomfort in heart in Jun2021 and presumed that is the information that started to come out and no one really mentioned it before. Patient would have never got it here now and heard they also recommended that we do not get the second dose if we are getting hard information after the first dose. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of personal independence in daily activities, Palpitations
Clinical narrative: I have been dizzy and sick for 3 months since I got the first vaccine; I am so dizzy, I can hardly function and I am having heart palpitations; I am so dizzy, I can hardly function and I am having heart palpitations; This is a spontaneous report from a contactable consumer (Patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EWO158), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 (70 years age at the time of vaccination) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer did not receive any other vaccine prior covid vaccine. It was reported that consumer have been dizzy and sick for 3 months since consumer got the first vaccine. So, consumer can't find any information on internet about all that. Consumer stated, she was having some horrific side effects. Consumer doctor told her that it would go away and not to worry about it but consumer was so dizzy, consumer can hardly function and having heart palpitations and consumer have been not go to the doctor. So consumer was pretty much just waiting to die from my vaccine. How do you like that? It should be on the card. First Pfizer dose something, EWO158. Consumer stated, No, consumer don't have anything like that and although consumer was 70. Consumer still have a full time job and have no medical condition. Consumer stated, Only took the first one because within week one, consumer was ill. So consumer did not take the second one. The outcome of events was unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Chills, Pain, Pyrexia, Swelling
Clinical narrative: Fever; Chills; Body aches; bump under skin in his armpit on right side was popped up and he described that as tennis ball cut in half, that was stuck under his arm and swollen; bump under skin in his armpit on right side was popped up and he described that as tennis ball cut in half, that was stuck under his arm and swollen; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and Expiry date: not reported), via an unspecified route of administration, on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. A day after the first vaccine shot, the patient experienced fever, chills and body aches and next day he was fine. And on second day, after his vaccine, a bump under skin in his armpit on right side was popped up and he described that as tennis ball cut in half, that was stuck under his arm and swollen which was not really sore. So, the patient was very concerned right now and also he was scheduled for his second dose on 12Jul2021, so was wandering if he should get the second vaccine or not. The outcome of events fever, chills and body aches were recovered on an unknown date and for remaining events it was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Cold-like symptoms; This is a spontaneous report from a contactable consumer (patient herself). A 7-decade old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date of 2021 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. Patient called in and said she is experiencing "cold-like symptoms". Patient received her first dose "several weeks ago" and guessed that this might just be "the flu" and "not related" to the vaccine. The outcome of event was unknown.  Information on Lot/Batch information has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Mitral valve disease, Palpitations
Clinical narrative: Heart palpitations; Premature contractions in the mitral valve; This is a spontaneous report from a contactable consumer (patient herself). A 32-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection and Lot Number: FW0181) via an unspecified route of administration, administered in Arm Right on 23Jun2021 09:45 (at the age of 32 years old) as single dose for COVID-19 immunization. Medical history included known Known allergies: Penicillin. Concomitant medications included ibuprofen taken for occasionally for headaches. It was reported that the patient had the vaccine on Wednesday and this morning on Friday on 25Jun2021 07:00, (two days later) started having heart palpitations which she never had before. They've been on and off. She went to the doctor this morning and had an EKG, she said she had premature contractions in the mitral valve. No treatment was received for the adverse events. The adverse event resulted in Doctor or other healthcare professional office/ or clinic visit. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included electrocardiogram: premature contractions in the mitral on 25Jun2021. The outcome of the events was unknown.  Follow-up attempts have been completed and no further information is expected.