chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Mobility decreased, Pain in extremity, SARS-CoV-2 test, Speech disorder
Clinical narrative: dizzy; not in her "right mind"; weakness; speech impairment; Covid positive at one point; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration, on 27Aug2021, 3:30PM (age at vaccination: 68), as dose 2, single for COVID-19 immunization. The patient medical history included very weak immune system. The patient's concomitant medications were not reported. Historical vaccine reported as BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration, on unspecified date as dose 1, single for COVID-19 immunization and had different reactions to both. The patient experienced dizzy, not in right mind, weakness and speech impairment and covid positive at one point . The patient underwent lab tests and procedures which included sars-cov-2 test: positive at one point. Outcome of all events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: dizzy; not in her "right mind"; weakness; speech impairment; Covid positive at one point; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration, on 27Aug2021, 3:30PM (age at vaccination: 68), as dose 2, single for COVID-19 immunization. The patient medical history included very weak immune system. The patient's concomitant medications were not reported. Historical vaccine reported as BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration, on unspecified date as dose 1, single for COVID-19 immunization and had different reactions to both. The patient experienced dizzy, not in right mind, weakness and speech impairment and covid positive at one point . The patient underwent lab tests and procedures which included sars-cov-2 test: positive at one point. Outcome of all events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Influenza like illness, Malaise, Pain
Clinical narrative: feels like she might be back in bed again today; whole body aches/whole body was hurting like someone beat her up/hurting all over; had a bad case of the flu.; Her head felt like "migraine  headache/headache from hell; vomiting last night; felt weird; arm is sore; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 66-years-old female patient received BNT162B2 (Pfizer covid 19 vaccine, formulation: solution for injection, Batch/Lot Number: FC3180), via an unspecified route of administration, administered in Arm Left on 28Aug2021 (at the age of 66-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included myocardial infarction from an unknown date and unknown if ongoing Verbatim: massive heart attack, hypertension from an unknown date and unknown if ongoing Verbatim: Hypertension. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included verapamil (VERAPAMIL) taken for an unspecified indication, start and stop date were not reported. On 29Aug2021, the patient experienced whole body aches/whole body was hurting like someone beat her up/hurting all over, had a bad case of the flu, her head felt like "migraine headache/headache from hell, vomiting last night, felt weird, arm is sore, feels like she might be back in bed again today. The outcome of the events was unknown.  PSCC Communication: Report 1 of 2. Caller advised to follow up with PCP if she feels it is necessary.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: feels like she might be back in bed again today; whole body aches/whole body was hurting like someone beat her up/hurting all over; had a bad case of the flu.; Her head felt like "migraine  headache/headache from hell; vomiting last night; felt weird; arm is sore; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 66-years-old female patient received BNT162B2 (Pfizer covid 19 vaccine, formulation: solution for injection, Batch/Lot Number: FC3180), via an unspecified route of administration, administered in Arm Left on 28Aug2021 (at the age of 66-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included myocardial infarction from an unknown date and unknown if ongoing Verbatim: massive heart attack, hypertension from an unknown date and unknown if ongoing Verbatim: Hypertension. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included verapamil (VERAPAMIL) taken for an unspecified indication, start and stop date were not reported. On 29Aug2021, the patient experienced whole body aches/whole body was hurting like someone beat her up/hurting all over, had a bad case of the flu, her head felt like "migraine headache/headache from hell, vomiting last night, felt weird, arm is sore, feels like she might be back in bed again today. The outcome of the events was unknown.  PSCC Communication: Report 1 of 2. Caller advised to follow up with PCP if she feels it is necessary.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness and pins sticking bottom of his foot; This is a spontaneous report from a contactable nurse reported for her son. A 15-year-old male received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and batch no: not reported/lot number: not reported) via an unspecified route of administration, on Wednesday 25Aug2021 (at the age of 15-years-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 27Aug2021 the patient experienced numbness and pins sticking bottom of his foot. It was reported that RN calling about the Pfizer COVID-19 vaccine who says she was wondering because her son got the vaccine two days ago and was now having some numbness and pins sticking in the bottom of his foot if that was a normal side effect. The outcome of the event was unknown.   No follow-up attempts are needed. Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Blood pressure measurement, Blood test, Body temperature, Fatigue
Clinical narrative: has a temperature of 100.5 degrees Fahrenheit; spinal issues; Arthritic issues; I do feel very fatigue and achy like I am getting a flu; Tingling on my right lowest foot; being lethargic; I do feel very fatigue and achy like I am getting a flu; Kind of like a flu/I do feel very fatigue and achy like I am getting a flu; This is a spontaneous report from a contactable consumer or other non hcp.     A 65-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: FC3183), dose 2 via an unspecified route of administration, administered in Arm Right on 29Aug2021 as dose 2, single for covid-19 immunisation. Medical history included, hypertension, blood pressure measurement, multiple sclerosis. Concomitant medication(s) included metoprolol (METOPROLOL) taken for blood pressure measurement; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) .It was Reported that, The patient experienced tingling on my right lowest foot on Aug2021 with outcome of recovered , being lethargic on Aug2021, do feel very fatigue and achy like am getting a flu on Aug2021 with outcome of unknown, kind of like a flu/i do feel very fatigue and achy like am getting a flu, has a temperature of 100.5 degrees Fahrenheit on 30Aug2021 with outcome of unknown , spinal issues , arthritic issues, do feel very fatigue and achy like iam getting a flu  on Aug2021 with outcome of unknown.  The patient underwent lab tests and procedures which included blood pressure measurement: unknown results on He also said it would be okay, blood test: unknown results  on ,body temperature: 100.5 Fahrenheit on 30Aug2021 degrees , magnetic resonance imaging: no change on it said there was no change.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lethargy, Magnetic resonance imaging, Pain, Paraesthesia
Clinical narrative: has a temperature of 100.5 degrees Fahrenheit; spinal issues; Arthritic issues; I do feel very fatigue and achy like I am getting a flu; Tingling on my right lowest foot; being lethargic; I do feel very fatigue and achy like I am getting a flu; Kind of like a flu/I do feel very fatigue and achy like I am getting a flu; This is a spontaneous report from a contactable consumer or other non hcp.     A 65-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: FC3183), dose 2 via an unspecified route of administration, administered in Arm Right on 29Aug2021 as dose 2, single for covid-19 immunisation. Medical history included, hypertension, blood pressure measurement, multiple sclerosis. Concomitant medication(s) included metoprolol (METOPROLOL) taken for blood pressure measurement; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) .It was Reported that, The patient experienced tingling on my right lowest foot on Aug2021 with outcome of recovered , being lethargic on Aug2021, do feel very fatigue and achy like am getting a flu on Aug2021 with outcome of unknown, kind of like a flu/i do feel very fatigue and achy like am getting a flu, has a temperature of 100.5 degrees Fahrenheit on 30Aug2021 with outcome of unknown , spinal issues , arthritic issues, do feel very fatigue and achy like iam getting a flu  on Aug2021 with outcome of unknown.  The patient underwent lab tests and procedures which included blood pressure measurement: unknown results on He also said it would be okay, blood test: unknown results  on ,body temperature: 100.5 Fahrenheit on 30Aug2021 degrees , magnetic resonance imaging: no change on it said there was no change.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Spinal disorder
Clinical narrative: has a temperature of 100.5 degrees Fahrenheit; spinal issues; Arthritic issues; I do feel very fatigue and achy like I am getting a flu; Tingling on my right lowest foot; being lethargic; I do feel very fatigue and achy like I am getting a flu; Kind of like a flu/I do feel very fatigue and achy like I am getting a flu; This is a spontaneous report from a contactable consumer or other non hcp.     A 65-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: FC3183), dose 2 via an unspecified route of administration, administered in Arm Right on 29Aug2021 as dose 2, single for covid-19 immunisation. Medical history included, hypertension, blood pressure measurement, multiple sclerosis. Concomitant medication(s) included metoprolol (METOPROLOL) taken for blood pressure measurement; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) .It was Reported that, The patient experienced tingling on my right lowest foot on Aug2021 with outcome of recovered , being lethargic on Aug2021, do feel very fatigue and achy like am getting a flu on Aug2021 with outcome of unknown, kind of like a flu/i do feel very fatigue and achy like am getting a flu, has a temperature of 100.5 degrees Fahrenheit on 30Aug2021 with outcome of unknown , spinal issues , arthritic issues, do feel very fatigue and achy like iam getting a flu  on Aug2021 with outcome of unknown.  The patient underwent lab tests and procedures which included blood pressure measurement: unknown results on He also said it would be okay, blood test: unknown results  on ,body temperature: 100.5 Fahrenheit on 30Aug2021 degrees , magnetic resonance imaging: no change on it said there was no change.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is little sore; This is a spontaneous report from a contactable consumer (Patient's husband). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FA7485; Expiration Date: Oct2021), via an unspecified route of administration, administered in arm on 05Aug2021 (at the age of 36-years-old) as dose 1, single for covid-19 immunization.  Medical history included asthma. The patient had no concomitant medication.  The patient after her 1st dose had little sore in the injection area. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dementia
Clinical narrative: he has dementia; This is a spontaneous report from a Pfizer Sponsored Program via a non-contactable consumer (patient's wife) reported for a patient (reporter's husband). A male patient of an unspecified age 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 an unspecified date in Feb2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first 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 an unspecified date in Jan2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient had both doses of the Pfizer COVID-19 vaccine. The 1st dose was last Jan2021 and the 2nd dose was last Feb2021. On an unspecified date of 2021, the patient had dementia. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Eating disorder, Gingival pain, Gingival swelling, Oral disorder, Oral mucosal eruption
Clinical narrative: sores all in her mouth; there was some patches and streaks/the patches that some are white while some are yellowish which are also present in the back of her throat; there was some patches and streaks/the patches that some are white while some are yellowish which are also present in the back of her throat; gums are swollen; oral lesion through out my mouth; teeth is hurting as well as her gums/pain in my teeth and in my gums; teeth is hurting as well as her gums/pain in my teeth and in my gums; everything hurts; can hardly talk; I cannot even eat/barely eat; her teeth are throbbing; This is a spontaneous report from a contactable nurse (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EWQ175) via an unspecified route of administration on 25Aug2021 (at the age of 64-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Aug2021, the patient experienced teeth was hurting as well as her gums/pain in my teeth and in my gums. On 29Aug2021, she developed sores all in her mouth and there were some patches and streaks. She described the patches that some was white while some were yellowish which was also present in the back of her throat. On Aug2021 she can hardly talk and barely eat/ I cannot even eat and that everything hurts. Her teeth are throbbing and on 28Aug2021 her gums were swollen. She feels her teeth will out since her gums was swollen. She also mentioned that she has developed this oral lesions. Nurse stated, "I had the vaccine on Wednesday, the Pfizer vaccine the first dose and yesterday 3 days after I started feeling pain in my teeth and in my gums and I have oral lesion through out my mouth and my gums were swollen." Nurse stated that she was scheduled for endoscopy and colonoscopy. The outcome of all events was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pain, Oropharyngeal discomfort, Pain, Speech disorder, Tooth disorder
Clinical narrative: sores all in her mouth; there was some patches and streaks/the patches that some are white while some are yellowish which are also present in the back of her throat; there was some patches and streaks/the patches that some are white while some are yellowish which are also present in the back of her throat; gums are swollen; oral lesion through out my mouth; teeth is hurting as well as her gums/pain in my teeth and in my gums; teeth is hurting as well as her gums/pain in my teeth and in my gums; everything hurts; can hardly talk; I cannot even eat/barely eat; her teeth are throbbing; This is a spontaneous report from a contactable nurse (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EWQ175) via an unspecified route of administration on 25Aug2021 (at the age of 64-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Aug2021, the patient experienced teeth was hurting as well as her gums/pain in my teeth and in my gums. On 29Aug2021, she developed sores all in her mouth and there were some patches and streaks. She described the patches that some was white while some were yellowish which was also present in the back of her throat. On Aug2021 she can hardly talk and barely eat/ I cannot even eat and that everything hurts. Her teeth are throbbing and on 28Aug2021 her gums were swollen. She feels her teeth will out since her gums was swollen. She also mentioned that she has developed this oral lesions. Nurse stated, "I had the vaccine on Wednesday, the Pfizer vaccine the first dose and yesterday 3 days after I started feeling pain in my teeth and in my gums and I have oral lesion through out my mouth and my gums were swollen." Nurse stated that she was scheduled for endoscopy and colonoscopy. The outcome of all events was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: sores all in her mouth; there was some patches and streaks/the patches that some are white while some are yellowish which are also present in the back of her throat; there was some patches and streaks/the patches that some are white while some are yellowish which are also present in the back of her throat; gums are swollen; oral lesion through out my mouth; teeth is hurting as well as her gums/pain in my teeth and in my gums; teeth is hurting as well as her gums/pain in my teeth and in my gums; everything hurts; can hardly talk; I cannot even eat/barely eat; her teeth are throbbing; This is a spontaneous report from a contactable nurse (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EWQ175) via an unspecified route of administration on 25Aug2021 (at the age of 64-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Aug2021, the patient experienced teeth was hurting as well as her gums/pain in my teeth and in my gums. On 29Aug2021, she developed sores all in her mouth and there were some patches and streaks. She described the patches that some was white while some were yellowish which was also present in the back of her throat. On Aug2021 she can hardly talk and barely eat/ I cannot even eat and that everything hurts. Her teeth are throbbing and on 28Aug2021 her gums were swollen. She feels her teeth will out since her gums was swollen. She also mentioned that she has developed this oral lesions. Nurse stated, "I had the vaccine on Wednesday, the Pfizer vaccine the first dose and yesterday 3 days after I started feeling pain in my teeth and in my gums and I have oral lesion through out my mouth and my gums were swollen." Nurse stated that she was scheduled for endoscopy and colonoscopy. The outcome of all events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Eye inflammation, Iritis
Clinical narrative: she has a friend with irisitis since getting a dose of the vaccine; inflammation of the eye; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced she has a friend with irisitis since getting a dose of the vaccine and inflammation of the eye on an unspecified date. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Overdose, SARS-CoV-2 test positive
Clinical narrative: I received 2 doses of Pfizer's Covid vaccine.  I tested positive for Covid on August 28th, 2021.; I received 2 doses of Pfizer's Covid vaccine.  I tested positive for Covid on August 28th, 2021.; Other vaccine same date vaccine date=12Mar2021, Other vaccine same date dose number=2; This is a spontaneous report from a contactable consumer or other non hcp.   A 41-years-old non pregnant female patient received (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN6204), via an unspecified route of administration, administered in Arm Left on 12Mar2021 12:00 as dose 1, single and dose 2 via an unspecified route of administration, administered in Arm Left on 12Mar2021 (Batch/Lot Number: EW0150) as dose 2 single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine 75 mcg tablet (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Aug2021 13:00, the patient stated I received 2 doses of Pfizer's Covid vaccine. Other vaccine same date vaccine date=12Mar2021, Other vaccine same date dose number=2. On 27Aug2021, the patient had laboratory investigation on nasal Swab which results in positive. I tested positive for Covid on August 28th, 2021.  This is a breakthrough case.  I'm fully vaccinated and still got Covid. No treatment was received in response to the adverse events. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. At the time of reporting, the outcome of the events were recovering and the event other vaccine same date vaccine date=12Mar2021, other vaccine same date dose number=2 was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Laboratory test, Memory impairment, Screaming, Walking disability
Clinical narrative: She began not to be able to walk; She would scream whenever I touched her; she does not even know who I am right now; This is a spontaneous report from a contactable consumer via medical information team. An 80-year-old female patient received bnt162b2 (COMIRNATY, Solution for Injection) via an unspecified route of administration on 28May2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 on 05May2021 as dose 1, single for COVID-19 immunisation. It was reported that, patient did very well with the 1st dose, but after the second dose reporter began to notice a change in patient. On an unspecified date in 2021, patient was not able to walk and then patient would scream whenever reporter touched patient. It was reported that patient was hospitalized. They did tests at the hospital, and the CT showed nothing was wrong. Patient was currently in a withheld facility because patient did not even know who reporter was right now. The patient underwent lab tests which included computerised tomogram: nothing was wrong in 2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Herpes zoster
Clinical narrative: Shingles of Ear with Bells Palsy; Shingles of Ear with Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via intramuscular, administered in Arm Left on 31Mar2021 (Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included gadolinium deposition disease (GAD). Concomitant medication which the patient received within 2 weeks of vaccination included sertraline taken for an unspecified indication, start and stop date were not reported. 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. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took cefaclor (CECLOR) and experienced known allergies, augmentine (amoxicillin;clavulanic acid) and experienced known allergies. The patient previously took the historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Left arm on 10Mar2021 (Lot Number: EL3247) as single dose for covid-19 immunisation. The patient experienced symptoms of shingles of ear with bells palsy on 28Jun2021 symptoms started. The events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received the treatment of Antiviral, steroids. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Death, Myocardial infarction
Clinical narrative: Found him dead while he was sleeping; Heart attack; This is a spontaneous report from a contactable consumer. This consumer (patients brother) reported for a 66-year-old male patient (reporters brother). A 66-year-old male had received BNT162B2 (Pfizer-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number and expiration date: not reported) via an unspecified route of administration on 08jun2021 as DOSE 2, SINGLE for covid-19 immunization (At the age of 66 years).The patient medical history had included High blood pressure, Diabetes, and Continuous positive airway pressure. It was reported that, patients brother son had brain cancer. He was on high blood pressure medication and was diabetic but, does not know what medication he was on. He is not sure of the name and can't say.The patient concomitant medication He was on high blood pressure medication. It was reported that there was no idea that patient took any vaccination within 4 weeks of vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: PHURCR8735) on 18May2021 as DOSE 1, SINGLE for COVID-19 Immunization. On 25Aug2021 the patient found while he was sleeping. It was reported that, received Comirnaty second dose and died in his sleep 6 weeks later and was found dead last Wednesday when he was sleeping. He reports he was cremated so an autopsy was unable to be performed so they are unable to determine if there is a connection between the vaccine and his death. He wants to know if deaths after the vaccine have been reported. As cause of death was unknown, Caller figured he just had a heart attack. He still had his CPAP machine on and had copabilities. They figured he would outlast all of them. The patient was on a CPAP machine, had diabetes that wasn't too bad, and was overweight, probably about 250 pounds, and had been taking blood pressure medications for years. The patient had not visited any emergency room and physician office. The clinical outcome of the event Found him dead while he was sleeping and heart attack was fatal.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: Found him dead while he was sleeping
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeding disorder, Headache, Pyrexia, Speech disorder
Clinical narrative: hard to eat; hard to talk; excruciating headache which she had to get an icepack, but it still hurts; fever; chills; This is a spontaneous report from a contactable consumer (patient). This female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for covid-19 immunisation. Medical history included ongoing lung disease. The patient's concomitant medications were not reported. Previously, the patient had first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation and didn't have any reaction at first and noticed after 3 day she had difficulty of breathing and 4 days after it got worse. She had the second dose in 2021 (Saturday) and in 2021 experienced fever, chills, and excruciating headache which she had to get an icepack, but it still hurt. She did have lung disease but had never experienced that. On 30Aug2021 (today), it was hard for her to talk and it was hard to eat. She said that she did not have COVID symptoms. She also mentioned that the hospitals were full of COVID patients and they could not help her. She had oxygen on her house. She wanted to let Pfizer know that she had these side effects and wanted to know if anybody had reported these. Therapeutic measures were taken as a result of excruciating headache. The outcome of all events was unknown.  Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus/my hubby did also but his just comes and goes; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a male patient (reporter's husband).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 03Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included 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 dose 1, single for COVID-19 immunization. It was reported that the patient experienced tinnitus/my hubby did also but his just comes and goes on 03Mar2021. Outcome of the event was reported as recovered on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Pityriasis rosea
Clinical narrative: pityriasis rosea; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 67-years-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on Mar2021 (at the age of 67-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via unspecified route of administration on Mar2021 (at the age of 67-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient reported that she/he received the Pfizer vaccine (both doses) in Mar2021. A couple of weeks later patient developed what his/her dermatologist believed was pityriasis rosea. Patient still had it and will be returning for his/her third appointment to follow up. He/she was also concerned about who was at greatest risk for myocarditis. The clinical outcome of event was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Mobility decreased, Pain, Product administered at inappropriate site
Clinical narrative: The doctor stated the location of administration was absolutely not in the deltoid/vaccine administered in the top of the shoulder; The caller states she is 9 months pregnant; Lost mobility in the left arm completely for a few days; Unbelievable amount of pain; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 31-years-old female patient received first dose of BNT162B2, Solution for injection, Batch/Lot Number: EW0180, Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 06Aug2021 (at the age of 31-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included pregnancy. She stated that she was 9 months pregnant. History: Besides being pregnant, probably not. There were no concomitant medications. Clinical course:  She received her first dose Pfizer Covid Vaccine three weeks ago. Vaccine administered in the top of the shoulder: The patient stated the first dose Pfizer Covid Vaccine was incorrectly administered. The person who administered the first dose Pfizer Covid Vaccine, administered the first dose Pfizer Covid Vaccine in the top of the shoulder. This caused lose mobility in the left arm completely for a few days and an unbelievable amount of pain ( on unspecified date in Aug2021). The patient went to the urgent care the next morning because she thought this was not a normal reaction and something went wrong. She told the doctor she was just sitting in the (withheld) chair when the first dose Pfizer Covid Vaccine was administered. The doctor stated the location of administration was absolutely not in the deltoid(Left top of shoulder)(on 06Aug2021), the first dose Pfizer Covid Vaccine was administered in-between the bones and likely hit a nerve or bursa area. Could cause bursitis or whatever. Lost mobility in the left arm completely for a few days/unbelievable amount of pain: She stated that she was still in pain three weeks later and did not have full range of motion in the arm. This was annoying because it was avoidable. The patient was 33 Weeks pregnant at the onset of the event. The outcome of lose mobility in the left arm completely for a few days and an unbelievable amount of pain was not recovered. The outcome of other events was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive for Covid on 8/30/2021; I tested positive for Covid on 8/30/2021; This is a spontaneous report from a contactable Consumer (patient, self-reported). A 38-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247 and expiry date was not reported), via intramuscular, in Arm Left, on 10Mar2021, as unknown, single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included chronic sinusitis. Concomitant medications included montelukast sodi-um (SINGULAIR), magnesium, and ascorbic acid, betacarotene, biotin, calcium lactate, choline bitartrate, chromium nicotinate, colecalciferol, cyanocobalamin, dexpanthenol, dl-selenomethionine, folic acid, inositol, magnesium lactate, manganese gluconate, nicotinamide, potassium citrate, potassium iodide, pyridoxine hydrochloride, retinol palmitate, riboflavin phosphate, thiamine hydrochloride, tocopheryl acetate, zinc gluconate (MULTI VITAMIN). Past drug included Reglan and was allergic to Reglan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. On 30Aug2021, the patient was tested positive for Covid on 30Aug2021. The patient underwent lab tests and procedure included Covid-19 test with positive result on 30Aug2021. The patient did not receive any treatment for the events. Outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Disturbance in attention, Feeling abnormal, Headache
Clinical narrative: within 20 minutes she felt a sensation up her nose and down her lungs; Caller stated it was not tightening or wheezing but felt like when she has a mild asthma attack; allergic reaction; Headache; pain at the site; Caller stated she saw a rapid chest rise; breathing is still shallow and is taking effort; could not focus or do anything; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received BNT162b2 (Comirnaty, Formulation: Solution for injection, Batch/Lot number: not provided, expiration date not provided), via an unspecified route of administration, administered on 30Aug2021 as (at the age of 36-year-old) DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medication were not provided. The patient reported, within 20 minutes of vaccination she felt a sensation up her nose and down her lungs which was not tightening or wheezing but felt like when she had a mild asthma attack. The patient thought her asthma was acting up and also thought she had an allergic reaction. The patient's headache was bad previous day from the day of report which was describing as pounding. She also experienced pain at the site. The patient had to use accessory muscles to take deeper breaths. The patient saw a rapid chest rose. The patient could not focus or do anything previous day. Symptoms not severe and she curled up and went to bed previous day. The patient reported that symptoms were more than before she got the shot. On 31Aug2021 her breathing was still shallow and was taking effort. The patient reported she was not normally how she was, but she was better the day of reporting. On 31Aug2021 her headache was mild. The patient thought she was better today as she drunk water previous day. The patient also reported that she was scared to take the second dose noting she did not want to put herself through it. She stated work making her get the vaccine. The patient's hands were tied because she was forced to get it. The patient wanted to guide about getting the second shot. The outcome of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypopnoea, Vaccination site pain
Clinical narrative: within 20 minutes she felt a sensation up her nose and down her lungs; Caller stated it was not tightening or wheezing but felt like when she has a mild asthma attack; allergic reaction; Headache; pain at the site; Caller stated she saw a rapid chest rise; breathing is still shallow and is taking effort; could not focus or do anything; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received BNT162b2 (Comirnaty, Formulation: Solution for injection, Batch/Lot number: not provided, expiration date not provided), via an unspecified route of administration, administered on 30Aug2021 as (at the age of 36-year-old) DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medication were not provided. The patient reported, within 20 minutes of vaccination she felt a sensation up her nose and down her lungs which was not tightening or wheezing but felt like when she had a mild asthma attack. The patient thought her asthma was acting up and also thought she had an allergic reaction. The patient's headache was bad previous day from the day of report which was describing as pounding. She also experienced pain at the site. The patient had to use accessory muscles to take deeper breaths. The patient saw a rapid chest rose. The patient could not focus or do anything previous day. Symptoms not severe and she curled up and went to bed previous day. The patient reported that symptoms were more than before she got the shot. On 31Aug2021 her breathing was still shallow and was taking effort. The patient reported she was not normally how she was, but she was better the day of reporting. On 31Aug2021 her headache was mild. The patient thought she was better today as she drunk water previous day. The patient also reported that she was scared to take the second dose noting she did not want to put herself through it. She stated work making her get the vaccine. The patient's hands were tied because she was forced to get it. The patient wanted to guide about getting the second shot. The outcome of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: felt the pain in the same arm where she got the vaccine; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional from a Pfizer sponsored program  Support. A 67-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported) as dose 2 single, via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included Dose 1 of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported) on an unspecified date for COVID 19 immunisation. On an unspecified date the patient felt the pain in the same arm where she got the vaccine. The patient wanted to know if she can put ice pack on the affected area as she described it to be hurting a lot. She also reported that she knew or heard someone passed away due to inflammation of the heart as an adverse event post-vaccination. She questioned how long after taking the vaccine was the myocarditis is observed. Outcome of the event was unknown.   The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm for 12 hours; This is a spontaneous report from COVAX SUPPORT. A contactable male consumer (patient) reported for his self. A 62 years-old male patient received first dose of BNT162B2 (Pfizer BioNTech Covid 19 vaccine, formulation: Solution for injection, batch/lot number: unknown) via unknown route of administration, 22 days ago as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. After the vaccine the patient had a sore arm for 12 hours. The patient's daughter suggested he drink a lot of water and taking a tylenol before the vaccine and it was a non-issue the first time around. The patient was to get his second dose today but was wondering what would happen if he was asymptomatic and receives the second dose of the vaccine. What adverse effects could occur between having the actual covid virus and then receiving the vaccine? Aren't you supposed to wait 90 days after having covid to get the vaccine? What if you're asymptomatic and don't know? The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2 was not provided and would be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hypertension
Clinical narrative: high blood pressure; high pulse for a day; This is a spontaneous report received from a contactable consumer (reporter's wife).  A female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on 06Aug2021 as dose 1, single for covid-19 immunization. The patient medical history was not reported.. The patient concomitant medications were not reported. The reporter stated that after received her first dose of Pfizer BioNtech covid 19 vaccine on 06Aug2021, she experienced high blood pressure and high pulse for a day. The outcome of events was resolved on Aug2021.   No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia, Pain, Pain in extremity, Rhabdomyolysis
Clinical narrative: Rhabdomyolysis/his muscles are deteriorating and he has high levels of protein that are developing into his body and are seeping into his bloodstream; Got a cola colored urine/his pee was the color of Pepsi- Cola; Excruciating pain/his body was achy but he thought that maybe that was possibly a regular side effect; At some time during that night he had pain and aches but they said that he might feel that in his arm; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 23-year-old male patient (reporter' son).   A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 24Aug2021 (age at the time of vaccination was 23-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that at some time during that night on 24Aug2021, the patient had pain and aches, but they said that the patient might feel that in his arm, that was Tuesday. Then on Wednesday, 25Aug2021, the patient body was achy, but the patient thought that maybe that was possibly a regular side effect and then by Thursday, 26Aug2021, the patient was having excruciating pain. On Friday, 27Aug2021, the patient thought that he had blood in his urine because his pee was the color of Pepsi- Cola but he still had the pain. The patient was told that this was a result of the COVID vaccine and that he had rhabdomyolysis on 28Aug2021. Then on Saturday, 28Aug2021, the patient went to the emergency room and was hospitalized on 28Aug2021. The patient was an otherwise healthy young man and now the patient muscles were deteriorating, and the patient had high levels of protein that were developed into his body and were seeping into the patient bloodstream. The patient was told that this could have caused renal failure if the patient had not gone to the emergency room when he did. They were currently flushing the patient. They said that the numbers were so high, they were like 300 something either in the millions or the thousands. It was reported that the patient was kept in the hospital and he now had circumstance that the patient did not have before he took the COVID vaccine.The patient had his own apartment, the patient worked every day, and his baby was due in November. The patient insurance just kicked in with his job, but the caller (patient's mother) was unsure about any long-term care for him. The patient IVs had been changed and were flushing this stuff out of the patient system. The doctor said that the numbers were not going higher, but they were also not going down fast. The patient was recommended for her son to not take the second dose. Outcome of all the events was reported as Unknown at this time of the report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.