chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Myalgia, Polymyalgia rheumatica
Clinical narrative: Seemed to reactivate my polymyalgia rheumatica autoimmune; Seemed to reactivate my polymyalgia rheumatica autoimmune; Muscle pain; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3180), via an unspecified route of administration, administered in right arm on 30Jul2021 18:30 (at 65 years old) as dose 1, single for COVID-19 immunization. Medical history included polymyalgia rheumatica, and allergies to fluorquinolone family of antibiotics. 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 has not been tested for COVID-19. There were no concomitant medications. The patient previously took erythromycin, sulfamethoxazole, and levofloxacin and experienced drug allergy. On 31Jul2021, the patient reported muscle pain and reported that the vaccine seemed to reactivate her polymyalgia rheumatica autoimmune. There were no treatments received for the events. The outcome of the events was not recovered.   Follow-up attempts are completed, No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Having really heavy menstral bleeding; Am not due for a period until the end of the month i had ended my last cycle on 28Jul; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself).   A 29-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA7485), dose 1 via an unspecified route of administration, administered in the right arm on 05Aug2021 18:30 (at the age of 29-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included known allergies to Latex. The patient's concomitant medications received within 2 weeks of vaccination included diclofenac sodium (SPRINTEX) taken birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no Covid prior to vaccination. The patient was not tested post vaccination. On 05Aug2021, the patient was vaccinated at 6:30 pm and at 7:30 (19:30) pm started having really heavy menstrual bleeding she was not due for a period until the end of the month she had ended her last cycle on 28Jul2021, and her cycles were never this heavy. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient not received treatment for the events. The outcome of the events was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: she felt her heart was squeezed really tight and had a similar feeling with anxiety attack; This is a spontaneous report from a contactable consumer. This 48-year-old female consumer reported for herself that.  A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 30Jul2021 as (At the age of 48-years) DOSE 1, SINGLE for covid-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced she felt her heart was squeezed really tight and had a similar feeling with anxiety attack. It was reported that Caller had the 1st dose of the Pfizer COVID 19 vaccine on 30Jul2021 the day after, she felt her heart was squeezed really tight and had a similar feeling with anxiety attack Asking if this is a reported side effects of the vaccine - She has been experiencing the symptoms until now. The outcome of evets was not recovered.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Breast pain, Lymphadenopathy, Mammogram, Ultrasound scan
Clinical narrative: enlarged lymph nodes/swollen lymphnodes; Pain especially under right side of my breast; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Feb2021 (lot number: EN9581) as dose 1, single and via an unspecified route of administration on 03Mar2021 (lot number: EN6205) as dose 2, single for COVID-19 immunization. Medical history included overweight from an unknown date and unknown if ongoing. Concomitant medications included vitamins NOS taken for an unspecified indication, start and stop date were not reported. The patient experienced enlarged lymph nodes/swollen lymphnodes on an unspecified date in Feb2021 and pain especially under right side of my breast on an unspecified date in 2021. It was reported that the patient developed swollen lymphnodes after the first dose. They continue to be swollen. She had an emerge lymph node and they said it was probably due to Pfizer. She had her second shot on 03Mar2021. They thought it was reaction of it because of the vaccine. Ever since then they had to call her every 8 week or every 6 weeks, the lymph nodes were still enlarged so she just need to see how during trial she should expect them to be enlarged. The exact date, she had to look it up it and said it was couple days after she got her first shot, she went for her mammogram she had to look that again and said it was probably around 15Feb roughly but she does not have the exact date. The patient added that she thought it got worse to be honest. She still has pain especially under right side of her breast. The patient underwent lab tests and procedures which included mammogram: unknown results on 15Feb2021 and ultrasound scan: unknown results on 2021. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy, Mammogram abnormal, Ultrasound scan
Clinical narrative: enlarged lymph nodes/swollen lymphnodes; Pain especially under right side of my breast; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Feb2021 (lot number: EN9581) as dose 1, single and via an unspecified route of administration on 03Mar2021 (lot number: EN6205) as dose 2, single for COVID-19 immunization. Medical history included overweight from an unknown date and unknown if ongoing. Concomitant medications included vitamins NOS taken for an unspecified indication, start and stop date were not reported. The patient experienced enlarged lymph nodes/swollen lymphnodes on an unspecified date in Feb2021 and pain especially under right side of my breast on an unspecified date in 2021. It was reported that the patient developed swollen lymphnodes after the first dose. They continue to be swollen. She had an emerge lymph node and they said it was probably due to Pfizer. She had her second shot on 03Mar2021. They thought it was reaction of it because of the vaccine. Ever since then they had to call her every 8 week or every 6 weeks, the lymph nodes were still enlarged so she just need to see how during trial she should expect them to be enlarged. The exact date, she had to look it up it and said it was couple days after she got her first shot, she went for her mammogram she had to look that again and said it was probably around 15Feb roughly but she does not have the exact date. The patient added that she thought it got worse to be honest. She still has pain especially under right side of her breast. The patient underwent lab tests and procedures which included mammogram: unknown results on 15Feb2021 and ultrasound scan: unknown results on 2021. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Heart rate, Memory impairment, Myalgia, Pharyngeal swelling
Clinical narrative: tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life; tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life; tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life; tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life; tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life; This is a spontaneous report from a contactable HCP (patient). A 34-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on left arm on 24Feb2021 at 01:00 PM (Lot Number: EL9263) at the age of 34-year-old as single dose for COVID-19 immunization. Medical history included asthma. Known allergies included erythromycin, shellfish and flu vaccine. No other vaccine in four weeks. COVID prior vaccination was none. COVID tested post vaccination was none. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously received flu vaccine, the erythromycin and experienced erythromycin allergies. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on left arm on 03Feb2021 at 02:00 PM (Lot Number: EL8982) at the age of 34-year-old as single dose for COVID-19 immunization. On 24Feb2021 at  01:30 AM, the patient experienced tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life. The events resulted in emergency room/department or urgent care. Treatment was received for events included epi, Benadryl, steroids and cardiac monitoring. The outcome of events was resolved with sequel.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events memory impairment, tachycardia, pharyngeal swelling, myalgia, arthralgia and the suspect drug "BNT162B2"  annot be completely excluded.  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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life; tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life; tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life; tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life; tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life; This is a spontaneous report from a contactable HCP (patient). A 34-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on left arm on 24Feb2021 at 01:00 PM (Lot Number: EL9263) at the age of 34-year-old as single dose for COVID-19 immunization. Medical history included asthma. Known allergies included erythromycin, shellfish and flu vaccine. No other vaccine in four weeks. COVID prior vaccination was none. COVID tested post vaccination was none. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously received flu vaccine, the erythromycin and experienced erythromycin allergies. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on left arm on 03Feb2021 at 02:00 PM (Lot Number: EL8982) at the age of 34-year-old as single dose for COVID-19 immunization. On 24Feb2021 at  01:30 AM, the patient experienced tachycardia, swelling of throat, sever muscle and joint pain, Lingering short term memory problems that affect daily life. The events resulted in emergency room/department or urgent care. Treatment was received for events included epi, Benadryl, steroids and cardiac monitoring. The outcome of events was resolved with sequel.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events memory impairment, tachycardia, pharyngeal swelling, myalgia, arthralgia and the suspect drug "BNT162B2"  annot be completely excluded.  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.
Sex: F
Vaccine: COVID19
Symptoms: Brain neoplasm, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: arm is still sore/would hurt/it is worse now with the hurting; arm is still sore, at first it was just red and swollen a bit; arm is still sore, at first it was just red and swollen a bit; brain tumor; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on May2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) on Apr2021 for COVID-19 immunization. On an unspecified date, patient experienced arm is still sore, at first it was just red and swollen a bit, but would hurt and it is worse now with the hurting. On Jun2021 patient had brain tumor and would be undergoing surgery. Outcome of event "arm is still sore/would hurt/it is worse now with the hurting" was not recovered while outcome of all other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Biopsy, Colonoscopy, Headache, Mammogram
Clinical narrative: The has been feeling non-stop pain at back of her neck, head, shoulder blades, and the arm; The has been feeling non-stop pain at back of her neck, head, shoulder blades, and the arm.; The has been feeling non-stop pain at shoulder blades/joint pain; Caller had developed a painful lump on her neck.; feeling strain and pain in the arm; She said she isn't bothered by the lump but instead of the pain.; feeling strain and pain in the arm; pain in the arm where she got the 2nd shot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm on Mar2021 as dose 2, single for covid-19 immunization. Previously on an unknown date, the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient has been feeling non-stop pain at back of her neck, head, shoulder blades and joint pain, the patient had developed a painful lump on her neck, feeling strain and pain in the arm. Patient stated she had both shots and noticed a side effect. Reportedly, soon after the vaccine, she had a lump on her neck, and went to the doctor. Patient does not know what the lump is. The patient reported she was not bothered by the lump but instead of the pain. She also had been feeling strain and pain in the arm where she got the 2nd shot. The patient had to visit the doctor due to painful lump in the neck and non-stop pain. There the doctor advised few tests which included biopsy, colonoscopy, mammogram and all the results were negative for cancer but lump was still there. Patient has every test possible. The patient took Advil and tried warm compress to relive the pain, but it still would not go away. The patient informed that this has been affecting her day to day in general and had concern if this was a lifelong pain. Patient asked if she can be on the clinical trial mentioned -How long side effects last from the paragraph which read "The safety evaluation of participants was still ongoing. The report was not related to a study or programme. Patient declined to complete a safety report. Patient questioned do other people have this, how long do they have it, was this a short term or long term effect. Treatment was received for the events. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Muscle strain, Neck mass, Neck pain, Pain, Pain in extremity
Clinical narrative: The has been feeling non-stop pain at back of her neck, head, shoulder blades, and the arm; The has been feeling non-stop pain at back of her neck, head, shoulder blades, and the arm.; The has been feeling non-stop pain at shoulder blades/joint pain; Caller had developed a painful lump on her neck.; feeling strain and pain in the arm; She said she isn't bothered by the lump but instead of the pain.; feeling strain and pain in the arm; pain in the arm where she got the 2nd shot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm on Mar2021 as dose 2, single for covid-19 immunization. Previously on an unknown date, the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient has been feeling non-stop pain at back of her neck, head, shoulder blades and joint pain, the patient had developed a painful lump on her neck, feeling strain and pain in the arm. Patient stated she had both shots and noticed a side effect. Reportedly, soon after the vaccine, she had a lump on her neck, and went to the doctor. Patient does not know what the lump is. The patient reported she was not bothered by the lump but instead of the pain. She also had been feeling strain and pain in the arm where she got the 2nd shot. The patient had to visit the doctor due to painful lump in the neck and non-stop pain. There the doctor advised few tests which included biopsy, colonoscopy, mammogram and all the results were negative for cancer but lump was still there. Patient has every test possible. The patient took Advil and tried warm compress to relive the pain, but it still would not go away. The patient informed that this has been affecting her day to day in general and had concern if this was a lifelong pain. Patient asked if she can be on the clinical trial mentioned -How long side effects last from the paragraph which read "The safety evaluation of participants was still ongoing. The report was not related to a study or programme. Patient declined to complete a safety report. Patient questioned do other people have this, how long do they have it, was this a short term or long term effect. Treatment was received for the events. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: The has been feeling non-stop pain at back of her neck, head, shoulder blades, and the arm; The has been feeling non-stop pain at back of her neck, head, shoulder blades, and the arm.; The has been feeling non-stop pain at shoulder blades/joint pain; Caller had developed a painful lump on her neck.; feeling strain and pain in the arm; She said she isn't bothered by the lump but instead of the pain.; feeling strain and pain in the arm; pain in the arm where she got the 2nd shot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm on Mar2021 as dose 2, single for covid-19 immunization. Previously on an unknown date, the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient has been feeling non-stop pain at back of her neck, head, shoulder blades and joint pain, the patient had developed a painful lump on her neck, feeling strain and pain in the arm. Patient stated she had both shots and noticed a side effect. Reportedly, soon after the vaccine, she had a lump on her neck, and went to the doctor. Patient does not know what the lump is. The patient reported she was not bothered by the lump but instead of the pain. She also had been feeling strain and pain in the arm where she got the 2nd shot. The patient had to visit the doctor due to painful lump in the neck and non-stop pain. There the doctor advised few tests which included biopsy, colonoscopy, mammogram and all the results were negative for cancer but lump was still there. Patient has every test possible. The patient took Advil and tried warm compress to relive the pain, but it still would not go away. The patient informed that this has been affecting her day to day in general and had concern if this was a lifelong pain. Patient asked if she can be on the clinical trial mentioned -How long side effects last from the paragraph which read "The safety evaluation of participants was still ongoing. The report was not related to a study or programme. Patient declined to complete a safety report. Patient questioned do other people have this, how long do they have it, was this a short term or long term effect. Treatment was received for the events. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Fast heart beat (100-135 bpm when sitting and not active).; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in the left arm on 20Mar2021 10:00 (at the age of 34-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Patient had no known allergies. Patient took birth control medication within 2 weeks of vaccination. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration, administered in the left arm on 20Mar2021 10:00 (at the age of 34-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Apr2021, the patient experienced fast heartbeat (100-135 bpm when sitting and not active). Patient Had not gone to doctor but was thinking of going. The patient underwent lab tests and procedures which included heart rate increased: 100-135 bpm on 26Apr2021. No treatment received as a result of events. The reporter considered the event as non-serious. The outcome of the event was not recovered.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Constipation, Dizziness, Dysstasia, Feeling abnormal
Clinical narrative: having unusual feelings and situations in his life; He has been a little unsteady when walking; needs assistance standing for more than a minute; constipation; speech trouble.; states that it  is getting worse.; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an 61 years age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported expiry date: unknown) via an unspecified route of administration on 24Mar2021 (at the age of 61-years-old) as a Dose 2,Single for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported expiry date:Unknown) via an unspecified route of administration on an unspecified date as a Dose 1,Single for  COVID-19 immunization. The patient had second shot on 24Mar2021 and was fine but had a little bit of dizziness, unsteady walking, trouble standing up and had pretty bad constipation. He had been a little unsteady when walking, needs assistance standing for more than a minute, he had to lean on something, he developed constipation and speech trouble. These began feeling this 3 months ago and can't relate this to the vaccine and stated that it was getting worse. Reporter stated that he had been having unusual feelings and situations in his life and wondering if people have had similar reactions. Outcome of the events was unknown.  Information about the Lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Speech disorder
Clinical narrative: having unusual feelings and situations in his life; He has been a little unsteady when walking; needs assistance standing for more than a minute; constipation; speech trouble.; states that it  is getting worse.; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an 61 years age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported expiry date: unknown) via an unspecified route of administration on 24Mar2021 (at the age of 61-years-old) as a Dose 2,Single for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported expiry date:Unknown) via an unspecified route of administration on an unspecified date as a Dose 1,Single for  COVID-19 immunization. The patient had second shot on 24Mar2021 and was fine but had a little bit of dizziness, unsteady walking, trouble standing up and had pretty bad constipation. He had been a little unsteady when walking, needs assistance standing for more than a minute, he had to lean on something, he developed constipation and speech trouble. These began feeling this 3 months ago and can't relate this to the vaccine and stated that it was getting worse. Reporter stated that he had been having unusual feelings and situations in his life and wondering if people have had similar reactions. Outcome of the events was unknown.  Information about the Lot/batch number has been requested.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient's parent) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 23-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: ER8735) via intramuscular route, administered in Left Arm on 05May2021(23-year-old at vaccination) as Dose 1, single and via intramuscular route, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0171), administered in Left Arm on 27May2021, (23-year-old at vaccination) as Dose 2, single, both doses for Covid-19 immunization. The patient's medical history was reported as none. The patient had no known allergies. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was reported as Other. 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 been tested for COVID-19. On 06Aug2021 at 10:00 AM, the reporter stated that, the patient had experienced a loss of smell today after attending a wedding this past weekend and tested positive for Covid this afternoon. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal swab): positive on 06Aug2021. No treatment received from the resulted events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Lung disorder
Clinical narrative: lung problem; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Feb2021 as single for COVID-19 immunisation. The patient experienced lung problem on an unspecified date. Reported as, "she already received her first and second of the Pfizer Covid-19 vaccine in February. Caller mentioned that she's been hearing news that Pfizer is providing a third dose or a booster shot and she wants to know if it's true. Also would like to know if it is necessary for her to get the third dose because she'll be going on a cruise in September and she also mentioned that she has a little bit of a lung problem. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Rash
Clinical narrative: The next day got a bit of a rash on arms.; Right away got like a sour metal kind of taste in mouth; This is a spontaneous report from a contactable other healthcare professional, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 05Aug2021 at 09:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Aug2021 at 09:45, the patient right away experienced like a sour metal kind of taste in mouth. On 06Aug2021, the patient experienced a bit of a rash on the arms. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sour metal kind of taste in mouth and a bit of a rash on the arms was not recovered at the time of this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Paraesthesia
Clinical narrative: Both arms and tops of hands were burning; Both arms and tops of hands appear reddened the day after vaccine; Showering the warm water felt like pins and needles; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 05Aug2021 at 16:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. The patient had known allergies to dust and shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient also took epinephrine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 06Aug2021 at 11:00, the patient experienced both arms and tops of hands were burning and reddened the day after vaccine. When she showering the warm water felt like pins and needles on her skin. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of events both arms and tops of hands were burning, both arms and tops of hands were reddened and showering the warm water felt like pins and needles were not resolved at the time of this report.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: Headache; Hearing impaired; Dizziness; Vomiting; Brain fog for several days; Vertigo; staggered walk/crawl; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration on the right arm on 07Jan2021 at 15:30 as a single dose for COVID-19 immunisation. Medical history included gynecomastia and testosterone low. The patient did not have any allergies to food, medications and other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 10:00 the patient experienced daily headaches and still ongoing. Intermittent hearing phenomenon - reduced, ringing, garbled, and/or amplification of low frequency sounds. Several instances of dizziness that became severe and resulted in staggered walk/crawl and vomiting, lasting several hours. Brain fog for several days after each vertigo incident. The events resulted in doctor or other healthcare professional office/clinic visit and also in emergency room/department or urgent care.     Therapeutic measures were taken as a result of headache, hearing impaired, dizziness, vomiting, brain freeze and vertigo and included treatment with Meclizine. The patient underwent CT(computerized tomography) scan of sinuses, MRI(Magnetic resonance imaging), and various exams on an unknown date and the result was unknown. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, hearing impaired, dizziness, vomiting, brain freeze and vertigo were not recovered at the time of this report.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Magnetic resonance imaging, Vertigo, Vomiting
Clinical narrative: Headache; Hearing impaired; Dizziness; Vomiting; Brain fog for several days; Vertigo; staggered walk/crawl; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration on the right arm on 07Jan2021 at 15:30 as a single dose for COVID-19 immunisation. Medical history included gynecomastia and testosterone low. The patient did not have any allergies to food, medications and other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 10:00 the patient experienced daily headaches and still ongoing. Intermittent hearing phenomenon - reduced, ringing, garbled, and/or amplification of low frequency sounds. Several instances of dizziness that became severe and resulted in staggered walk/crawl and vomiting, lasting several hours. Brain fog for several days after each vertigo incident. The events resulted in doctor or other healthcare professional office/clinic visit and also in emergency room/department or urgent care.     Therapeutic measures were taken as a result of headache, hearing impaired, dizziness, vomiting, brain freeze and vertigo and included treatment with Meclizine. The patient underwent CT(computerized tomography) scan of sinuses, MRI(Magnetic resonance imaging), and various exams on an unknown date and the result was unknown. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, hearing impaired, dizziness, vomiting, brain freeze and vertigo were not recovered at the time of this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema nummular
Clinical narrative: Diagnosed with nummular eczema; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. The patient had history of known allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and multivitamin from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 09Feb2021 at 18:45 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient also took erythromycin (MANUFACTURER UNKNOWN), tetracycline (MANUFACTURER UNKNOWN) and doxorubicin (ADRIAMYCIN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 01May2021, the patient had been diagnosed with nummular eczema about six weeks after the vaccination. She never had eczema before. Since the vaccination, the patient had not been tested for COVID-19. The adverse event resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures were taken as a result of reported events which included treatment with topical steroid cream (MANUFACTURER UNKNOWN). The clinical outcome of the event nummular eczema was not recovered at the time of this report.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Parosmia
Clinical narrative: Altered sense of smell. A lot of things smell very bad; received first dose/second dose on 06May2021; This is a spontaneous report from a contactable other hcp. A 20-year-old male patient received first dose of BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 (Batch/Lot Number: EW0167) as DOSE 1, SINGLE and second dose via an unspecified route of administration, administered in Arm Left on 06May2021 (Batch/Lot Number: ER8736) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient experienced altered sense of smell. a lot of things smell very bad Experiencing this for 3 months and received first dose/second dose on 06May2021. No treatment was received for the events. Outcome of the event altered sense of smell. a lot of things smell very bad was not recovered.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Parosmia cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Scab, Skin discolouration, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 22Jul2021 at 17:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy (allergy to sulfa). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. on 23Jul2021 at 17:30, 24 hours after the initial dose,  the patient upper left arm where the vaccine was injected broke out in large red hives. The patient stated, the hives went down as she took a Claritin and used Benadryl cream, but on an unknown date in Jul2021, she was left with a large red rash for about a week. On an unknown date in 2021, the patient had brown discoloration all over upper left arm that was beginning to scab off. Therapeutic measures were taken as a result of event hives and included treatment with CLARITIN and BENADRYL cream suggested by the pharma. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events upper left arm where the vaccine was injected broke out in large red hives and large red rash was resolved with sequelae on an unknown date in 2021. The clinical outcome of the events brown discoloration all over upper left arm and scab off was unknown at the time of this report.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Rash, Skin discolouration, Skin exfoliation, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 22Jul2021 at 17:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy (allergy to sulfa). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. on 23Jul2021 at 17:30, 24 hours after the initial dose,  the patient upper left arm where the vaccine was injected broke out in large red hives. The patient stated, the hives went down as she took a Claritin and used Benadryl cream, but on an unknown date in Jul2021, she was left with a large red rash for about a week. On an unknown date in 2021, the patient had brown discoloration all over upper left arm that was beginning to scab off. Therapeutic measures were taken as a result of event hives and included treatment with CLARITIN and BENADRYL cream suggested by the pharma. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events upper left arm where the vaccine was injected broke out in large red hives and large red rash was resolved with sequelae on an unknown date in 2021. The clinical outcome of the events brown discoloration all over upper left arm and scab off was unknown at the time of this report.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Scab, Skin discolouration, Urticaria
Clinical narrative: hives; rash; swirly snake redness; discoloration; skin peeling; This is a spontaneous report from contactable consumer (patient's mother).  A 39-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7984), via an unspecified route of administration, administered in left arm on 20Jul2021 (at the age of 39-years-old) at 16:30-17:00 as dose 1, single for COVID-19 immunisation. Medical history included difficult pregnancy (baby was born at the end of May2021). Family history included diabetes (some diabetes in grandparents). There were no concomitant medications.  The patient experienced hives on 21Jul2021 17:00. On 21Jul2021 (unspecified time) the patient experienced rash, "swirly snake redness" (as reported), discoloration and skin peeling. It was reported that it was exactly almost 24 hours after vaccination that patient developed a rash which she called "odd". The reporter described it as "swirly snake redness" on her arm to shoulder and in the back with some discoloration. She also added that her daughter had large hives on her arm and on her back. Reporter said that her daughter already took Benadryl and Benadryl cream on the hives and it calmed down but they were quite large when they came out. The patient still had discoloration and it was dark with skin peeling. She was at her house and she noticed getting huge hives on upper arms, shoulder and like near her back.  It was literally almost 24 hours, then right away, she called (Available) and they said to take Benadryl and if you have trouble breathing, to get to the ER, but she had no trouble breathing.  She then had a swirly snake redness on her arm to shoulder and is left with discoloration or darkness of skin and a little peeling. She was due to get second shot on Thursday and was really concerned this works out ok. The outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.