chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Arthralgia, Arthritis, Body temperature, Diarrhoea
Clinical narrative: heart pain; Fever 100.9; (L) arm pain down to fingers and back up to shoulder and neck; (L) arm pain down to fingers and back up to shoulder and neck; (L) arm pain down to fingers and back up to shoulder and neck; Increased (L) lymph node, grape size; Muscle aches; fatigue; diarrhea; Chest palpitations; Arthritis flare; This is a spontaneous report from a non-contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot Number: ew0183) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced fever 100.9, left (L) arm pain down to fingers and back up to shoulder and neck. Increased (L) lymph node, grape size. Called PCP and was told to see a surgeon for removal. Muscle aches, fatigue, diarrhea, heart pain, chest palpitations, arthritis flare. The patient had not COVID and she was non COVID tested post vaccination. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Myalgia, Neck pain, Pain in extremity
Clinical narrative: heart pain; Fever 100.9; (L) arm pain down to fingers and back up to shoulder and neck; (L) arm pain down to fingers and back up to shoulder and neck; (L) arm pain down to fingers and back up to shoulder and neck; Increased (L) lymph node, grape size; Muscle aches; fatigue; diarrhea; Chest palpitations; Arthritis flare; This is a spontaneous report from a non-contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot Number: ew0183) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced fever 100.9, left (L) arm pain down to fingers and back up to shoulder and neck. Increased (L) lymph node, grape size. Called PCP and was told to see a surgeon for removal. Muscle aches, fatigue, diarrhea, heart pain, chest palpitations, arthritis flare. The patient had not COVID and she was non COVID tested post vaccination. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: heart pain; Fever 100.9; (L) arm pain down to fingers and back up to shoulder and neck; (L) arm pain down to fingers and back up to shoulder and neck; (L) arm pain down to fingers and back up to shoulder and neck; Increased (L) lymph node, grape size; Muscle aches; fatigue; diarrhea; Chest palpitations; Arthritis flare; This is a spontaneous report from a non-contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot Number: ew0183) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced fever 100.9, left (L) arm pain down to fingers and back up to shoulder and neck. Increased (L) lymph node, grape size. Called PCP and was told to see a surgeon for removal. Muscle aches, fatigue, diarrhea, heart pain, chest palpitations, arthritis flare. The patient had not COVID and she was non COVID tested post vaccination. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I was diagnosed with a breakthrough case several days ago and am on my way to a full recovery; I was diagnosed with a breakthrough case several days ago and am on my way to a full recovery; This is a spontaneous report from a Pfizer sponsored program Pfizer.com - General Company Information.  A contactable consumer (patient) reported he/she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient experienced as reported "I was diagnosed with a breakthrough case several days ago and am on my way to a full recovery" on an unspecified date.   The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, Hyperhidrosis, Illness, Off label use, Pyrexia
Clinical narrative: I got the Booster vaccine (Pfizer COVID 19 Vaccine); I got the Booster vaccine (Pfizer COVID 19 Vaccine); I have been sick; I ran out Fever; I ran out Fever and have sweat; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on Aug2021 as dose 3, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose and second dose of bnt162b2 both for COVID-19 immunization. On Aug2021, the patient experienced been sick, ran out fever, had sweat. Outcome of the events was unknown.  F/U #1 (PRD/SRD 08Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test, Sneezing
Clinical narrative: he is coughing; sneezing; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother) from a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that the patient received the first dose of vaccine and after that he was tested negative for Covid-19, but on an unspecified date he was coughing and sneezing. The reporter also mentioned that the patient was scheduled to receive the second dose of vaccine on tomorrow (unspecified date) and wanted to know if it is okay for him to receive the vaccine as scheduled or if they need to re-schedule it. The patient underwent lab tests and procedures which included Covid-19 test which was negative on an unspecified date. Reporter declined to provide further contact information or verify her contact information as she was short on time. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration in arm left on 16Mar2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant and was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient's concomitant medications were not reported. The patient experienced covid-19 (medically significant) on 19Aug2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab): positive on 19Aug2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Patient had a seizure when had this (vaccine) and did not feel comfortable getting it; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a seizure when had this (vaccine) and did not feel comfortable getting it (seizure) (non-serious) on an unspecified date. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 30.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: experienced COVID; experienced COVID; This is a non-interventional study report received from a contactable consumer (patient) based on information received by Pfizer (manufacturer control number:(21K-163-4049584-00) that: A 30-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), intramuscular on an unspecified date (Batch/Lot number was not reported, at age 30-year-old) as dose number unknown, single for covid-19 immunization and adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at citrate free 1 in 1 once for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced covid -19 on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: experienced covid on an unspecified date. The action taken in response to the event for adalimumab was unknown. The outcome of event was not recovered. Causality by reporter not provided.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Muscle spasms, Paraesthesia
Clinical narrative: numbness; cramping in her legs; heaviness in her legs; feels a pinch sensation; This is a spontaneous report from a contactable consumer (Patient). A 57-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on 21Jul2021 (at the age of 56 years old) as DOSE 2, Single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on unspecified date for covid-19 immunisation. On Jul2021 the patient experienced About 6 to 7 days after, consumer experienced numbness and cramping in her legs. consumer didn't think it was the vaccine that caused this because she researched the side effects and what she was experiencing was not listed. She was provided patient information from the pharmacy and is experiencing all the symptoms that were listed on that form. consumer feels a heaviness in her legs like after sitting for too long and sometimes feels a pinch sensation and then it goes away. It is moving around her legs. consumer saw a new allergist yesterday and feels the symptoms have moved to her right arm. The outcome of the event pinch sensation was recovered on unspecified date in 2021 while other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up activities closed. Batch/lot number not available.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Cardiac flutter, Electrocardiogram, Heart alternation
Clinical narrative: Fluttering; Increased heart beat; Heart beating out of my chest; Anxiety; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot number was not reported), via an unspecified route of administration on 06Aug2021 as dose 1, single for covid-19 immunisation. Medical history included anxiety (She has had anxiety in the past related to perimenopause and this felt nothing like anxiety) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced fluttering, increased heart beat, heart beating out of my chest, anxiety. The patient stated that 2 days after her first dose, she started getting an increased heart beat, it started out with a fluttering and then she could feel her heart beating out of her chest. She was resting on the couch. She said that this lasted continuously for about 2 weeks and then it improved slightly, however, it was still occurring on and off at times and her heart rate was higher than usual at times. She stated that she did see her doctor about this reaction and he told her that he felt like it was anxiety. The patient reported that she has had anxiety in the past related to perimenopause and this felt nothing like anxiety. She stated she know what anxiety feels like, she was not anxious or nervous. She was sitting on the couch resting and then all of the sudden her heart was fluttering and then beating out of her chest and she couldn't control it. With anxiety she can control it and calm down. This was totally different. She felt like her doctor just wrote her off. It was reported that her doctor performed an EKG and did blood work that was normal. Her doctor told her to proceed with the second dose. The patient stated that, she went back to the pharmacy on Friday 27Aug2021 to get her second dose and the pharmacist told her that based on her reaction to the first dose that she should not receive the second dose as it was not safe. The pharmacist told her that this reaction would happen again with the second dose and probably be more severe, therefore, the pharmacist did not feel safe administering the vaccine to her. The patient wanted to know if what she experienced could potentially happen again with the second dose and if it could be worse. The patient asked if she has any protection from receiving one dose of the Pfizer COVID-19 vaccine -Comirnaty. The AE required a visit to physician office. On an unspecified date in Aug2021, the patient underwent lab tests and procedures which included blood test: normal, electrocardiogram: normal, heart rate: increased (heart beat). Outcome of the 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: Heart rate, Heart rate increased
Clinical narrative: Fluttering; Increased heart beat; Heart beating out of my chest; Anxiety; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot number was not reported), via an unspecified route of administration on 06Aug2021 as dose 1, single for covid-19 immunisation. Medical history included anxiety (She has had anxiety in the past related to perimenopause and this felt nothing like anxiety) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced fluttering, increased heart beat, heart beating out of my chest, anxiety. The patient stated that 2 days after her first dose, she started getting an increased heart beat, it started out with a fluttering and then she could feel her heart beating out of her chest. She was resting on the couch. She said that this lasted continuously for about 2 weeks and then it improved slightly, however, it was still occurring on and off at times and her heart rate was higher than usual at times. She stated that she did see her doctor about this reaction and he told her that he felt like it was anxiety. The patient reported that she has had anxiety in the past related to perimenopause and this felt nothing like anxiety. She stated she know what anxiety feels like, she was not anxious or nervous. She was sitting on the couch resting and then all of the sudden her heart was fluttering and then beating out of her chest and she couldn't control it. With anxiety she can control it and calm down. This was totally different. She felt like her doctor just wrote her off. It was reported that her doctor performed an EKG and did blood work that was normal. Her doctor told her to proceed with the second dose. The patient stated that, she went back to the pharmacy on Friday 27Aug2021 to get her second dose and the pharmacist told her that based on her reaction to the first dose that she should not receive the second dose as it was not safe. The pharmacist told her that this reaction would happen again with the second dose and probably be more severe, therefore, the pharmacist did not feel safe administering the vaccine to her. The patient wanted to know if what she experienced could potentially happen again with the second dose and if it could be worse. The patient asked if she has any protection from receiving one dose of the Pfizer COVID-19 vaccine -Comirnaty. The AE required a visit to physician office. On an unspecified date in Aug2021, the patient underwent lab tests and procedures which included blood test: normal, electrocardiogram: normal, heart rate: increased (heart beat). Outcome of the events was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Pemphigoid, SARS-CoV-2 test
Clinical narrative: PA had biopsy of blister on chest, histology = Bullus Pemphigoid; skin blisters; This is a spontaneous report from a contactable physician (patient). A 75-year-old male patient received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 13Mar2021 at 12:00 (Lot Number: EN6206) at the age of 74-year-old as single dose for COVID-19 immunization. Medical history included hypertension benign. Covid prior vaccination was none. The patient performed Covid tested post vaccination. Known allergy included sulfa. The patient didn't received other vaccine whit in four weeks. Concomitant medications included apixaban (ELIQUIS), valsartan, metoprolol, colecalciferol (D3), ubidecarenone (COQ10 [UBIDECARENONE]) and ch 14.18. On 23Mar2021 at 13:30, the patient experienced skin blisters (two or three after first dose) then 10 to total leg blisters after second dose. Treated by (name), referred to Dermatology center in (name) had biopsy of blister on chest, histology = Bullus Pemphigoid. On 17Aug2021, the patient performed Covid test post vaccination. The type was blood test, the name was antibody and the result was negative. Treatment was received. The outcome of events was recovering.; Sender's Comments: Based on the narrative information provided, a causal association between the reported event Pemphigoid and  BNT162B2 vaccine cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Sister-in-law and nephew have all gotten covid 19 after being fully vaccinated.; Her Sister-in-law and nephew have all gotten covid 19 after being fully vaccinated; This is a spontaneous report from a Pfizer sponsored program via Medical Information team. A contactable consumer reported that a female patient (reporter's sister-in law) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Not Reported), Dose 1 and dose 2, both via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter's sister in law gotten covid 19 after being fully vaccinated on an unspecified date. She had problems and just got out of the hospital. The outcome of event was unknown.  No follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Fatigue, Glomerulonephritis, Oedema, Swelling of eyelid
Clinical narrative: Glomerulonephritis (inflammation of filters in kidneys); Blood in urine; fatigue; edema; swollen left eyelid; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER/BIONTECH) via an unspecified route of administration on the left arm in Feb2021 at 01:45 PM (Lot Number: EN6201) as single dose for COVID-19 immunizaiton. Medical history included inflammation, immunity, profound deafness and have familial hypertension. COVID prior vaccination was none. COVID tested post vaccination was none. Known allergy was none. The patient was a Congenital Rubella Baby w/lifetime immunity. The patient didn't received other vaccine in four weeks. Concomitant medications included amitriptyline, atenolol and hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), all taken for Congenital Rubella Baby w/lifetime immunity. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm in Jan2021 at 01:30 PM (Lot Number: EL9261) as single dose for COVID-19 immunizaiton. In Apr2021, the patient experienced glomerulonephritis (inflammation of filters in kidneys), blood in urine, fatigue, edema and had swollen left eyelid. The event resulted in doctor or other healthcare professional office/clinic visit. Treatment was received included 2 antibiotics, neither worked; ultrasound lower ab. The outcome of events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound abdomen
Clinical narrative: Glomerulonephritis (inflammation of filters in kidneys); Blood in urine; fatigue; edema; swollen left eyelid; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER/BIONTECH) via an unspecified route of administration on the left arm in Feb2021 at 01:45 PM (Lot Number: EN6201) as single dose for COVID-19 immunizaiton. Medical history included inflammation, immunity, profound deafness and have familial hypertension. COVID prior vaccination was none. COVID tested post vaccination was none. Known allergy was none. The patient was a Congenital Rubella Baby w/lifetime immunity. The patient didn't received other vaccine in four weeks. Concomitant medications included amitriptyline, atenolol and hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), all taken for Congenital Rubella Baby w/lifetime immunity. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm in Jan2021 at 01:30 PM (Lot Number: EL9261) as single dose for COVID-19 immunizaiton. In Apr2021, the patient experienced glomerulonephritis (inflammation of filters in kidneys), blood in urine, fatigue, edema and had swollen left eyelid. The event resulted in doctor or other healthcare professional office/clinic visit. Treatment was received included 2 antibiotics, neither worked; ultrasound lower ab. The outcome of events was not recovered.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Drug ineffective, Joint injury, Suspected COVID-19
Clinical narrative: Lack of drug effect; Lack of drug effect; lot of damage to elbows and was in a lot of pain; Pain in elbow; This is a solicited report (Mfr. Control No.: 21K-163-4053360-00). This female consumer (patient) reported for herself.   A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via  unknown route on 20Feb2021 (Batch/Lot number was not reported), dose 2 intramuscular in 2021 (Batch/Lot number was not reported) both as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose for an unspecified indication. Medical history was none.  The patient's concomitant medications were not reported. The patient experienced Lack of drug effect, Humira was not helping elbows and lot of damage to elbows and was in a lot of pain, pain in elbow on unknown dates. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The action taken in response to the events for adalimumab was unknown.  Causality for HUMIRA(ADALIMUMAB): The reporters causality for the events of lot of damage to elbows and was in a lot of pain, Humira was not helping elbows and lot of damage to elbows and was in a lot of pain was not provided.   The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the events elbow injury, arthralgia and other reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Chest pain, Dizziness, Heart rate
Clinical narrative: nausea; Chest pain; dizziness; drop in Blood Pressure; increase in pulse; palpitations/heart racing; This is a spontaneous report from a contactable consumer or other non-health professional (patient). A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number FF2588 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 28Aug2021 16:00 (vaccination at the age of 46 years) as dose 1, single for covid-19 immunisation. Medical history included Anxiety, depression, allergies, asthma, pericarditis, Chronic Systolic Heart Failure, mixed connective tissue disease (MCTD) all from an unknown date and unknown if ongoing. The patient previously took erythromycin and experienced drug hypersensitivity. The concomitant therapy was reported as yes. On 30Aug2021 15:00, the patient experienced nausea, chest pain, dizziness, drop in blood pressure, increase in pulse, palpitations, heart racing. The patient underwent lab tests and procedures which included drop in blood pressure: drop on 30Aug2021, pulse: increase on 30Aug2021 increase in pulse. The patient had physician office visit for adverse event. Therapeutic measures were taken as a result of adverse events. The outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Nausea, Palpitations
Clinical narrative: nausea; Chest pain; dizziness; drop in Blood Pressure; increase in pulse; palpitations/heart racing; This is a spontaneous report from a contactable consumer or other non-health professional (patient). A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number FF2588 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 28Aug2021 16:00 (vaccination at the age of 46 years) as dose 1, single for covid-19 immunisation. Medical history included Anxiety, depression, allergies, asthma, pericarditis, Chronic Systolic Heart Failure, mixed connective tissue disease (MCTD) all from an unknown date and unknown if ongoing. The patient previously took erythromycin and experienced drug hypersensitivity. The concomitant therapy was reported as yes. On 30Aug2021 15:00, the patient experienced nausea, chest pain, dizziness, drop in blood pressure, increase in pulse, palpitations, heart racing. The patient underwent lab tests and procedures which included drop in blood pressure: drop on 30Aug2021, pulse: increase on 30Aug2021 increase in pulse. The patient had physician office visit for adverse event. Therapeutic measures were taken as a result of adverse events. The outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Feeling abnormal, Malaise, Pain
Clinical narrative: not feeling good; Diarrhea; Feels sore; shortness of breath; he isn't feeling well; This is a spontaneous report from a Pfizer sponsored program Support. A contactable male consumer (patient) reported that. A male patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: was not reported) dose 1 via an unspecified route of administration on unspecified date in Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 29Aug2021 the patient experienced shortness of breath, diarrhea and feels sore. On 30Aug2021 the patient experienced not feeling good. On an unspecified date in Aug2021 patient experienced he isn't feeling well. Consumer was supposed to take his 2nd dose of the Pfizer COVID 19 vaccine today and he is not feeling good. States he is asking for advice on when to take the 2nd dose. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be re-quested during follow up.  Follow-up activities closed. Batch /lot number not available.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I have COVID; I have COVID; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer Program.  A 85-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) and  dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) both as single dose for covid-19 immunisation  .  The patient medical history was not reported. Concomitant medications included tofacitinib citrate (XELJANZ XR - 11mg tablet) taken for an unspecified indication, start and stop date were not reported.  The patient stated I have covid  on 22Aug2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive   on 22Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Uterine haemorrhage
Clinical narrative: Uterine bleeding; This is a spontaneous report from a contactable consumer (Patient)   A 37-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 07Aug2021 (at the age of 37-year-ol)  (Batch/Lot Number: FA7485) as single dose, dose 2 via an unspecified route of administration, administered in arm left on 28Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history was not reported. The concomitant medications in two weeks included Levothyroxine 0.75 mcg. The patient was not pregnant. No other vaccine in four weeks. No COVID prior vaccination. The patient experienced uterine bleeding (medically significant) on 09Aug2021 with outcome of not recovered. The course of events was as follows: Uterine bleeding started after receiving the 1st dose of the vaccine on 07Aug2021. Bleeding started on 09Aug2021 and lasted until 24Aug2021. Uterine bleeding started few hours after receiving second dose on 28Aug2021. No treatment received. COVID was not tested post vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough Covid infection. Positive covid test on Sunday 29Aug.; Breakthrough Covid infection. Positive covid test on Sunday 29Aug.; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3248), dose 2 intramuscular, administered in left arm on 23Mar2021 as DOSE 2, SINGLE (at the age of 42-years-old) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3248), dose 1 intramuscular, administered in left arm on 02Mar2021 as DOSE 1, SINGLE (at the age of 42-years-old) for COVID-19 immunisation. On 29Aug2021 at 13:00 hours, the patient experienced breakthrough COVID infection. positive COVID test on Sunday 29Aug. The patient's symptoms were fever, chest congestion, runny nose, tiredness, and loose stools. The patient underwent lab tests and procedures which included Bivax: positive on 29Aug2021 Nasal Swab. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested positive for COVID-19. The patient has not recovered from the event.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive Covid test on 01Sep2021; Positive Covid test on 01Sep2021; This is a spontaneous report from a contactable consumer via Pfizer Colleague. A 39-years-old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8735, via intramuscular route of administration on 22Apr2021 (at the age of 39-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included Benign heart murmur. Concomitant medication(s) included valacyclovir [valaciclovir] (VALACYCLOVIR [VALACICLOVIR]) taken for an unspecified indication within two weeks of vaccination, start and stop date were not reported. The patient previously took Demerol and experienced known allergy. On 01Sep2021, the patient experienced positive covid test. No seriousness criteria were reported. No treatment received for AE. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Sep2021. No other vaccine received in four weeks. No covid prior vaccination, it was unknown if covid tested post vaccination. The outcomes of event was recovering
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Panic attack, Rash
Clinical narrative: shortness of breath/difficulty breathing; panic attacks; rash on arms and legs; This is a spontaneous report from a contactable nurse, from a Pfizer-sponsored program.  A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 10Aug2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the reporter was reporting a female patient had first dose of Pfizer Covid 19 vaccine on 10Aug2021 and then developed rash on arms and legs three days later. The nurse who is the vaccine provider explained that the patient also experienced shortness of breath/difficulty breathing but it was attributed to her baseline panic attacks and not the vaccine. Nurse further explained that the patient's HCP advised her not to get the second dose of the vaccine. Vaccine provider would like to know if her patient would be able to get the second dose given the side effects previously experienced. Nurse would like to know if there is an exemption form that can be provided for medical clearance. The outcome of the 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: Thrombosis, Vaginal haemorrhage
Clinical narrative: blood clots; non-stop vaginal bleeding for 23 days straight; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 41-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number and expiration date was not reported), second dose via an unspecified route of administration on an unspecified date single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical dose included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot number and expiration date was not reported) first dose via an unspecified route of administration on an unspecified date single for covid-19 immunization. On an unspecified date the patient experienced non-stop vaginal bleeding for 23 days straight and blood clots. The outcome of the events was unknown.   The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation, Pruritus, Skin exfoliation
Clinical narrative: Atrial fibrillation; Daily itching; Flaky skin; This is a spontaneous report received from a contactable consumer (patient) based on information received by Pfizer. (Manufacturer Control Number 20210823000368). A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on 19Jan2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced atrial fibrillation (caused hospitalization) on 10Mar2021 with outcome of unknown, daily itching (non-serious) on 2021 with outcome of recovering, flaky skin (non-serious) on 2021 with outcome of recovering. Therapeutic measures were taken as a result of the events and included treatment with cardioversion and long-term use of medications (for atrial fibrillation), Dupixent (for daily itching and flaky skin).  The lot number for bnt162b2 was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous solicited report from a contactable healthcare professional and a consumer (patient) based on the information received by Pfizer (Manufactuter control number 20210339257) and via PPSPHNO02327 SP Services Theracon (no farther information specified).  A 75-year-old male patient received two single doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both on unspecified dates in 2021, for COVID-19 immunization. Co-suspect drug included macitentan (OPSUMIT; 10 mg tablet) oral, from 2017, 10 mg, 1x/day, for an unspecified indication. Medical history and concomitant medications were not reported. On an unspecified date in 2021 the patient teste positive for COVID-19. The event required hospitalization from 04Mar2021 to 19Mar2021. The patient recovered from COVID-19 on an unspecified date in 2021. Clinical course was reported as follows. On an unspecified date, the patient experienced flu. On follow up it was reported patient was diagnosed with COVID-19, 2 days after receiving his second dose of COVID vaccine. He was admitted into the hospital on 04Mar2021. The dose of macitatan was not changed. The reporter considered the causality between Macitentan and COVID-19 not related. Company causality between macitetan and COVID-19 was not related. Additional information was received from the health care professional and patient on 11Aug2021. The following information was updated and incorporated into the case narrative: Patient demography. reporter details, event flu was updated to COVID-19, cosuspect and suspect dose details and narrative information was updated. Company Remarks (sender's comments): V2 Follow up pertained to patient demography, event of flu was updated to COVID-19), co-suspect and suspect dose details and reporter details. This report concerned an 8 decade old male patient who had COVID-19 infection while on macitentan. Considering the current COVID-19 pandemic and given the novel status of this disease and limited understanding of COVID-19 pathogenesis, the causality for the event was considered as not related to macitentan. The company will continue to monitor and the potential relationship between maitentan treatment and COVID-19 cases. Protocol relatedness was also reported unknown both for reporter and for company.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the event, a possible contribution of the drug to the event cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid 30Aug2021; Tested positive for Covid 30Aug2021; This is a spontaneous report from a contactable consumer. This consumer reported that a Non-pregnant 36-Year-Old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Apr2021 at the age of 35-Year-Old (Lot number: ER8735) as single dose for COVID-19 immunisation. No COVID prior vaccination. Medical history and concomitant medications were not reported. No other vaccine in four weeks. The patient experienced tested positive for COVID 30Aug2021. Adverse event start date was 31Aug2021. It was Unknown If patient COVID tested post vaccination. No treatment for AE. The outcome of the event was Recovering.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Appendicitis perforated
Clinical narrative: Appendicitis attack; Appendix ruptured; This is a spontaneous report from a contactable consumer. This report was received via a sales representative. A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 25Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 25Feb2021 as dose 1, single for covid-19 immunisation. The patient reported the appendicitis attack on 09May2021 where her appendix ruptured. This was being reported as she noticed that there were SAEs in similar nature with the vaccine on the CDC website and she did not attribute it to the vaccine but wanted to report, event took place after use of product. The clinical outcome of the events were unknown.  Follow-up activities closed. Batch/lot number not available for [vaccine/BNT162B2].; Sender's Comments: Based on the available information the reported events appendicitis and appendicitis perforated may not be related to suspect product BNT162B2.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough case/covid test result = Positive; Breakthrough case/covid test result = Positive; This is a spontaneous report from a contactable consumer (Patient). A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: En6206 and Expiry date was not reported), via unspecified route of administration on 15Mar2021 (at the age of 37-years-old) in Arm Left as dose 1, single for COVID-19 immunization and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Er8730 and Expiry date was not reported), via unspecified route of administration on 05Apr2021 (at the age of 37-years-old) in Arm Left as dose 2, single for COVID-19 immunization. The Patient Medical history included none from an unknown date and unknown if ongoing other medical history: None. The patient concomitant medications was not reported. The Patient had no known allergies. The patient had received other vaccine in 4 weeks. The Patient had not diagnosed with COVID-19 prior to vaccination and the patient had tested for COVID-19 post vaccination. On 09Jul2021 08:00, the patient experienced breakthrough case/COVID-19 test result positive. The Patient did not received treatment. Patient visited emergency room. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Jul2021 Nasal Swab. The outcome for the events was recovered in 2021.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Decreased appetite, Weight, Weight decreased
Clinical narrative: Lost 33 lbs to date; Lost appetite; noted hair loss; This is a spontaneous report from a contactable consumer via Pfizer colleague. An elderly non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose via an unspecified route of administration on 2021 (Batch/Lot number and expiration date were not reported) as a single dose for covid-19 immunisation. The patient was not pregnancy at time of vaccination. Medical history included COVID-19. The patient previously received 1st dose of BNT162B2 in 2021 (lot number and expiration date were unknown) and experienced runny nose, sore throat, cough, fever, headache.  The patient's concomitant medications were not reported. After second dose, patient lost appetite, noted hair loss, and had lost 33 lbs to date, all on an unspecified date. The patient underwent lab tests and procedures which included weight: lost 33 lbs to date on an unknown date. The outcome of the events was unknown. Treatment received was unknown. The events were resulted in Doctor or other healthcare professional office/clinic visit.   The lot number for BNT162b2 was not provided and will be requested during follow up.