chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Palpitations
Clinical narrative: irregular heart rhythm; Heart palpitations; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203 and expiration date not provided), via an unspecified route of administration, on 06Apr2021 15:30 (at the age of 43-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included allergies to penicillin. No other medical history. Patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 06Apr2021, the patient experienced heart palpations and irregular heart rhythm. Events result in doctor or other healthcare professional office/clinic visit. Since the vaccination, patient had not been tested for COVID-19. No treatment received for events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Lip discolouration, Nausea, Pallor, Physical examination, Product use issue
Clinical narrative: fainted; Nausea; lips white; Really pale; 12 year old daughter; This is a spontaneous report from a contactable consumer (patient's mother). A 12-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 got it closer to 12:00 (Batch/Lot number was reported: First letter was R, W or B, followed by A6256) at the age of 12-years-old as SINGLE DOSE for covid-19 immunization. The COVID-19 vaccine was administered at Pharmacy/Drug Store. Medical history reported as none. No family medical history relevant to adverse event, reporter who was the patients mother, is a fainter, who fainted a lot when she saw blood. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. As they were driving away, her daughter started feeling really nauseous, then fainted, was super pale, lips were white and she was really pale. It all occurred at the same time all started 10 minutes after vaccine on 14May2021. Then the ambulance came. Her daughter looked really bad and it freaked reporter out. Her daughter sat for a little while and was feeling better now. Her daughter was no longer pale, it went away. They checked her and everything was normal. No Emergency Room and no Physician Office visit required. Ambulance was called, they checked her and she was fine. Told her to keep any eye on her at home. The outcome of the events pale, lips were white was recovered on 14May2021, the outcome of the events nauseous, and fainted was recovering.  Information about Lot/Batch number has been requested.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: fainted; Nausea; lips white; Really pale; 12 year old daughter; This is a spontaneous report from a contactable consumer (patient's mother). A 12-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 got it closer to 12:00 (Batch/Lot number was reported: First letter was R, W or B, followed by A6256) at the age of 12-years-old as SINGLE DOSE for covid-19 immunization. The COVID-19 vaccine was administered at Pharmacy/Drug Store. Medical history reported as none. No family medical history relevant to adverse event, reporter who was the patients mother, is a fainter, who fainted a lot when she saw blood. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. As they were driving away, her daughter started feeling really nauseous, then fainted, was super pale, lips were white and she was really pale. It all occurred at the same time all started 10 minutes after vaccine on 14May2021. Then the ambulance came. Her daughter looked really bad and it freaked reporter out. Her daughter sat for a little while and was feeling better now. Her daughter was no longer pale, it went away. They checked her and everything was normal. No Emergency Room and no Physician Office visit required. Ambulance was called, they checked her and she was fine. Told her to keep any eye on her at home. The outcome of the events pale, lips were white was recovered on 14May2021, the outcome of the events nauseous, and fainted was recovering.  Information about Lot/Batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Portal vein thrombosis, SARS-CoV-2 test, Splenic vein thrombosis
Clinical narrative: 5/9/21 diagnosed with thrombus of proximal portal vein and in the splenic vein; 5/9/21 diagnosed with thrombus of proximal portal vein and in the splenic vein; Anemia diagnosed on 5/9/21; This is a spontaneous report from a contactable consumer (the patient). A 48-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6204) via an unspecified route of administration in left arm on 17Mar2021 at age of 48-year-old at single dose for COVID-19 immunisation. Medical history included known allergies: Azythromicine. Concomitant medication (within 2 weeks of vaccination) included ibuprofen (ADVIL 12 HOUR) taken for an unspecified indication from an unspecified date. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6202) via an unspecified route of administration in left arm on 24Feb2021 at age of 48-year-old for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Nasal swab was negative on 09May2021. On 09May2021, the patient was diagnosed with thrombus of proximal portal vein and in the splenic vein. No prior history of blood disorder or blood clots (the events onset date reported as "06May2021", pending clarification). The events were serious with seriousness criteria of "hospitalized". The events resulted in emergency room/department or urgent care. Treatment received for the events included Heparin. It also reported anemia diagnosed on 09May2021. The outcome of the events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Headache, Pain
Clinical narrative: breathing difficulties/shortness of breath that worsens with any activity; soreness/body aches; slight fever; intense headache; Dry cough; feel dizzy; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration in left arm on 12May2021 13:45 at age of 40-year-old at single dose for COVID-19 immunisation. Medical history included ongoing asthma, chronic migraine, known allergies: sulfa drugs, COVID-19 in Mar2020 (COVID test positive in Mar2021, confirmed by antibodies in May2020). Concomitant medications included nortriptyline, tizanidine, propranolol (PROPANOLOL) and zolpidem (ZOLPIDEM), all taken for an unspecified indication from an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 21Apr2021 13:45 at age of 40-year-old for COVID-19 immunisation. The patient had injection site pain with the first dose that cleared within a day. The second dose was when things became complicated. She had soreness, body aches, slight fever, and an intense headache as expected, but also, she experienced the same breathing difficulties she had when she had COVID. Dry cough and shortness of breath that worsens with any activity. She had preexisting asthma. It is not as bad as the shortness of breath she had with COVID, but it was similar (and different than her asthma symptoms - she didn't feel chest tightness, but she feel dizzy as if she was not getting oxygen when she move). She hadn't seen her primary care provider because it's not so bad that she needs medical attention, but she did want to report the adverse event since it's not a symptom she was warned about. The events onset date was reported as 13May2021 16:00. Treatment for the event (breathing difficulties/shortness of breath that worsens with any activity) included used albuterol rescue inhaler. The patient had not test COVID post vaccination. The outcome of the events was not recovered. The report considered non-serious.   Information on lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: breathing difficulties/shortness of breath that worsens with any activity; soreness/body aches; slight fever; intense headache; Dry cough; feel dizzy; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration in left arm on 12May2021 13:45 at age of 40-year-old at single dose for COVID-19 immunisation. Medical history included ongoing asthma, chronic migraine, known allergies: sulfa drugs, COVID-19 in Mar2020 (COVID test positive in Mar2021, confirmed by antibodies in May2020). Concomitant medications included nortriptyline, tizanidine, propranolol (PROPANOLOL) and zolpidem (ZOLPIDEM), all taken for an unspecified indication from an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 21Apr2021 13:45 at age of 40-year-old for COVID-19 immunisation. The patient had injection site pain with the first dose that cleared within a day. The second dose was when things became complicated. She had soreness, body aches, slight fever, and an intense headache as expected, but also, she experienced the same breathing difficulties she had when she had COVID. Dry cough and shortness of breath that worsens with any activity. She had preexisting asthma. It is not as bad as the shortness of breath she had with COVID, but it was similar (and different than her asthma symptoms - she didn't feel chest tightness, but she feel dizzy as if she was not getting oxygen when she move). She hadn't seen her primary care provider because it's not so bad that she needs medical attention, but she did want to report the adverse event since it's not a symptom she was warned about. The events onset date was reported as 13May2021 16:00. Treatment for the event (breathing difficulties/shortness of breath that worsens with any activity) included used albuterol rescue inhaler. The patient had not test COVID post vaccination. The outcome of the events was not recovered. The report considered non-serious.   Information on lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Malaise, Oropharyngeal pain, Pulmonary pain
Clinical narrative: Can't urinate; He was feeling tired/severe fatigue; He developed a fever up to 102; Extremely sore throat; Burning lungs; Feeling unwell; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 on an unspecified date for COVID-19 immunisation. Reporter stated that they have a family member that received the second shot of Pfizer Covid-19 vaccination on Saturday. On 13May2021, the patient experienced feeling tired and then today he developed a fever up to 102 and he has an extremely sore throat, burning lungs, severe fatigue, feeling unwell, and can't urinate. They were wondering if this was an adverse reaction or expected reaction or what the guidance might be as their concern right now was to make somebody feel better or determining what this was. Outcome of events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Urinary retention
Clinical narrative: Can't urinate; He was feeling tired/severe fatigue; He developed a fever up to 102; Extremely sore throat; Burning lungs; Feeling unwell; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 on an unspecified date for COVID-19 immunisation. Reporter stated that they have a family member that received the second shot of Pfizer Covid-19 vaccination on Saturday. On 13May2021, the patient experienced feeling tired and then today he developed a fever up to 102 and he has an extremely sore throat, burning lungs, severe fatigue, feeling unwell, and can't urinate. They were wondering if this was an adverse reaction or expected reaction or what the guidance might be as their concern right now was to make somebody feel better or determining what this was. Outcome of events was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain, Pyrexia, Swelling face
Clinical narrative: face swelled up really bad to where she could not open her eyes; allergic reaction; Fever; pain and aches; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose via an unspecified route of administration, administered in arm left on 03May2021 (at age of 32 years old) (lot number: ER8735, it also reported "the second dose lot number was either ER8735 or ER8235"), time the vaccination was given was between 15:00 and 15:30, as single dose for covid-19 immunisation. Patient's medical history was reported as no. Other products was reported as no. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Apr2021 (at age of 32 years old) (lot number: ER8N30) as single dose for covid-19 immunisation. Family medical history relevant to events was no. No relevant tests. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced face swelled up really bad to where she could not open her eyes on 05May2021, fever on 04May2021, pain and aches on 04May2021. The patient stated she was calling to make a report on the second shot since she had an allergic reaction. The patient clarified the second shot she was referring to was the COVID 19 vaccine. The patient stated the symptoms she had was the first day she had fever, aches, and pain then the next day her face swelled up really bad to where she could not open her eyes. The patient stated she went to urgent care and at urgent care she was given a steroid shot and then she took a steroid and allergy medication and also diphenhydramine hydrochloride (BENADRYL). The events did not require a visit to emergency room. When asked if went to physician office, the patient stated she went to urgent care for events fever, aches, pain, face swelled up really bad to where she could not open her eyes. History of all previous immunization with the Pfizer vaccine considered as suspect was no. Additional administered vaccines was no. The outcome for allergic reaction was recovered on 09May2021, for face swelled up really bad to where she could not open her eyes was recovered on 09May2021, for fever was recovered on 05May2021, for pain and aches was recovered on 07May2021.
Sex: U
Vaccine: COVID19
Symptoms: Pericardial effusion, Scan
Clinical narrative: pericardial effusion; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient, who was an echocardiographer had recently noticed more healthy patients coming in with small non-hemodynamically significant pericardial effusions (PE) on those who were vaccinated with the Pfizer vaccine. The patient scanned self before getting the first vaccine and had no effusion, but 7 days later, the patient did have one on an unspecified date. That was why he started asking patients which vaccine they got. The patient had not seen any PE's with the other vaccines and patient don't believe this was a coincidence and it deserves further investigation. Outcome of event was unknown.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Arthralgia, Chills, Diarrhoea
Clinical narrative: diarrhea with blood; Extreme fatigue; Severe gastrointestinal problems; severe body aches; joint pain; Painful diarrhea; bloating; abdominal pain; chills; soreness at injection site; This is a spontaneous report from a 49-years-old male contactable consumer (patient). A 49-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8729), intramuscularly administered in Arm Left on 20Apr2021 10:00 as single dose and dose 2 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8732) intramuscularly, administered in Arm Left on 11May2021 10:00 as single dose for covid-19 immunisation. Vaccine was administered: Workplace clinic. Concomitant medications included chlorthalidone for unknown indication and start stop date not reported. Medical history included drug allergies to Ibuprofen and codeine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Therapeutic measurements included Tylenol, rest, pepto bismol. On 12May2021 11:00, the patient experienced severe body aches, extreme fatigue, soreness at injection site, severe gastrointestinal problems, joint pain, painful diarrhea, diarrhea with blood, bloating, abdominal pain, chills. The outcome of events was not recovered.  On (17May2021) clarification was received from a Pfizer colleague with regards to the previous report received. The following was reported: Patient was self , Non- HCP, In sales.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.    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 Committees, and Investigators, as appropriate.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea haemorrhagic, Fatigue, Gastrointestinal disorder, Injection site pain, Pain
Clinical narrative: diarrhea with blood; Extreme fatigue; Severe gastrointestinal problems; severe body aches; joint pain; Painful diarrhea; bloating; abdominal pain; chills; soreness at injection site; This is a spontaneous report from a 49-years-old male contactable consumer (patient). A 49-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8729), intramuscularly administered in Arm Left on 20Apr2021 10:00 as single dose and dose 2 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8732) intramuscularly, administered in Arm Left on 11May2021 10:00 as single dose for covid-19 immunisation. Vaccine was administered: Workplace clinic. Concomitant medications included chlorthalidone for unknown indication and start stop date not reported. Medical history included drug allergies to Ibuprofen and codeine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Therapeutic measurements included Tylenol, rest, pepto bismol. On 12May2021 11:00, the patient experienced severe body aches, extreme fatigue, soreness at injection site, severe gastrointestinal problems, joint pain, painful diarrhea, diarrhea with blood, bloating, abdominal pain, chills. The outcome of events was not recovered.  On (17May2021) clarification was received from a Pfizer colleague with regards to the previous report received. The following was reported: Patient was self , Non- HCP, In sales.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.    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 Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive in covid-19; tested positive in covid-19; This is a spontaneous report from a Pfizer-sponsored program  from a contactable Pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. It was reported that the patient (the reporter don't know the name) got the 1st dose already and tested positive in covid-19. The patient asking if when he/she can take the 2nd dose. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 22-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 14May2021 11:00 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included asthma, rocky mt spotted fever, MRSA, sepsis x2, mono (monocytes) from an unknown date. The patient's concomitant medications were none. No other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. The patient received first dose of bnt162b2 on 23Apr2021 for covid-19 immunization at 22-year-old. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has been tested for COVID 19. The patient experienced Anaphylaxis, swollen closing throat,sob, wheezing, itching, dizziness on 14May2021 11:45. The adverse event result in Emergency room/department or urgent care. Therapeutic measures were taken as a result of all the events, treatment included Epi,Prednisone,Benedryl, IV. The outcome of the events was recovering.  Information about lot/batch number cannot be obtained. Additional information has been requested.; Sender's Comments: Based on the known safety profile of the drug and plausible temporal relationship, a causal association between the event of Anaphylactic reaction and suspect drug BNT162B2 cannot be excluded
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Influenza, Neuralgia, Pain in extremity, Pyrexia
Clinical narrative: severe pain down her both legs and the pain has not gone away; she also had back pain but it's a little bit better; she had nerve pain; I have the usual fever and you know feeling like I had the flu on Sunday the day after I had the flu on Sunday the day after I had the second vaccine.; I have the usual fever and you know feeling like I had the flu on Sunday the day after I had the flu on Sunday the day after I had the second vaccine.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on 17Apr2021 (at the age of 61-year-old) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot no.: EN6204) on 27Mar2021 (at the age of 61-year-old) as single dose for COVID-19 immunization and she experienced a slight pain (minimal) down in both of her legs, pain from the vaccine, nerve pain and could barely walk. Then she received the second dose on 17Apr2021 and the next day (18Apr2021), she started experiencing a severe pain down her both legs and the pain has not gone away, she also had back pain but it's a little bit better, during the call she mentioned that she didn't have muscle or joint pain, that she had nerve pain. She has gone to many doctors, her life is affected negatively, she said that they should care people better. She would like to know why she is experiencing this pain. The patient also had the usual fever and flu on Sunday (18Apr2021) after she had the second vaccine. Therapeutic measures were taken as a result of the events which included Advil and Tylenol. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic response; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for an unspecified indication.  The patient's medical history and concomitant medications were not reported.  The patient received a dose of the Pfizer COVID-19 vaccine and suffered an anaphylactic response. The patient had to be taken to the nearest hospital via ambulance and spent approximately 8 hours in the emergency room. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Pain; FACILITATED COLLECT  This is a non-interventional study report from the marketing program received from a Non-contactable consumer (patient) based on information received by Pfizer (manufacturer control number: 21K-163-3887413-00).  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), intramuscular on 26Mar2021 as single dose for COVID-19 immunisation. Medical history included alcohol (alcohol specify type social drinker two to three night during a week) from 1981, tobacco (tobacco specify type vape e cigarette) from 1983, and broken ankle from 20Jan2020. Concomitant medications included adalimumab (HUMIRA), from Jun2018 and ongoing for moderate to severe rheumatoid arthritis, atenolol (ATEROL) for attention deficit hyperactivity disorder (ADHD), progesterone for hormone, estrogen nos; testosterone for hormone, hydroxychloroquine phosphate (PLAQUENIL) for rheumatoid arthritis, and hydroxychloroquine for rheumatoid arthritis. The patient experienced rheumatoid arthritis flare up and pain on Apr2021. The outcome of the events was not recovered.  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 needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information currently available, there was not a reasonable possibility that the reported events of rheumatoid arthritis flare up and pain were related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE. The events are attributed to underlying medical conditions.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: her throat closed up and she could not breath; her throat closed up and she could not breath; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's husband) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced her throat closed up and she could not breath. The patient was hospitalized due to the events on an unspecified date. It was reported that ten minutes after her first covid vaccine, her throat closed up and she could not breath. Thankfully, paramedics were standing by to tend to her and rush her to the hospital. She was okay after a few hours and stated that their hospital bills were outrageous. Reporter stated that this was all due to that vaccine and believed that the company should pay the rest of what they owe. Outcome of events was recovering.  No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain, Pain assessment, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis aggravated; Pain; This is a solicited report based on the information. (manufacture control number: 21K-163-3895202-00).  A contactable consumer (patient) reported that a 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation; and upadacitinib (RINVOQ), oral from Feb2021 (Batch/Lot number was not reported) and ongoing, at 15 mg, once daily for moderate to severe rheumatoid arthritis/rheumatoid arthritis without rheumatoid/Rheumatoid Arthritis Without Rheumatoid Factor, Multiple Sites. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced rheumatoid arthritis aggravated and pain. It was further reported that patient had increase in bothersome rheumatoid arthritis symptoms/flares in hands after day of quilting and incredible pain with upadacitinib. The patient had rheumatoid arthritis flares in hands after day of quilting. After covid-19 vaccines (Pfizer) had reaction both times. She was still in incredible pain and had been for over a week since second covid-19 vaccine. She had pain in hands and feet for a few days but this second one pain was still on eight (pain scale: 8). She had called her physician. She had an increase in bothersome symptoms. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for upadacitinib was unknown. The patient was recovering from rheumatoid arthritis aggravated while outcome of pain was not yet recovered. The reporter's causality for the events with upadacitinib was no reasonable possibility.  The reporter's assessment of the causal relationship of the events with the bnt162b2 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 needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Rheumatoid arthritis 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Multiple sclerosis, Pain, Pruritus, Rash pruritic
Clinical narrative: I have Multiple sclerosis but never been this bad pain I don't want to get out of my bed; Itching/problem with itching; Multiple sclerosis but never been this bad pain I don't want to get out of my bed; have been taking Oxycodone for 20 years; this pain is indescribable because I actually feel it; Terrible weakness; itching in a rash/itch this is different very large rash; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: AR8727; Expiration Date: Jul2021), via an unspecified route of administration, administered in arm right on 01Apr2021 (at the age of 66-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included autoimmune thyroiditis (Hashimoto's thyroiditis), fibromyalgia, osteoarthritis and rheumatoid arthritis, all from an unknown date and unknown if ongoing. Concomitant medications included oxycodone taken for pain and levothyroxine sodium (SYNTHROID) taken for autoimmune thyroiditis, both start and stop date were not reported. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: AN762) on 03Mar2021 for COVID-19 immunisation. The patient stated, "I think I am having a reaction. I had my Pfizer first vaccine on 03Mar (not clarified) and second vaccine on 01Apr. The first one was I can't make it out and the second was initially. I don't have much, it started itching in a rash and now having nothing. I have been to the Hospital I told them that I had Pfizer vaccine with that reason now I am not really comfortable. I have multiple sclerosis but never been this bad pain I don't want to get out of my bed and I am taking oxycodone (treatment for pain) approximately 20 years." The outcome of the events was unknown.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis aggravated/ Psoriatic Arthritis Flare Up; This is a solicited report from a non-contactable female consumer (patient) based on the information received by Pfizer(MFR Control No. 21K-163-3890876-00).   A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation and adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at CF for Psoriatic Arthritis. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on an unspecified date. On an unknown date, the patient experienced Psoriatic Arthritis Flare Up with Humira (adalimumab). COVID-19 vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken for adalimumab was unknown. The outcome of the event was unknown.   The causality by the reporter to the event Psoriatic arthritis aggravated/ Psoriatic Arthritis Flare Up for Humira was no reasonable possibility and for PFIZER-BIONTECH COVID-19 VACCINE was not reported.   Information about Lot/Batch number is requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the Psoriatic Arthritis Flare Up and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Loss of consciousness, Malaise
Clinical narrative: her eyes were glazed over/eyes were cloudy, blurry, and then blacked out /passing out; headache; nauseous; feeling unwell; wobbly/ felt a little weird; her eyes were glazed over/eyes were cloudy, blurry, and then blacked out; she said she started feeling kind of dizzy; This is a spontaneous report from a contactable consumer. A 12-years-old female patient (daughter) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number and expiration date was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer COVID 19 vaccine around 11:30 yesterday. She states that she felt fine for the remainder of the day yesterday but that this morning she had a headache and was nauseous. She states that they had plans to attend a lunch with family but had delayed it due to her daughter feeling unwell so they waited for few hours just waiting to see if she would improve then after few hour she said okay the nausea was gone and after a few hours the daughter was feeling better and they proceeded to go to lunch. When the daughter got out of the car to go to lunch the mother states that she was wobbly and her eyes were glazed over. Then all of a sudden she said she started feeling kind of dizzy like she said her eyes kind of looked cloudy, she felt a little weird and she ended up passing out and had to catch her as she was falling. She reports that she then lost her footing and fell to the ground but that she was able to catch her somewhat. She states that she whole episode lasted about 15 seconds and then she came to. The daughter reports that her eyes were cloudy, blurry, and then blacked out. She states that she is not sitting and eating a banana and feeling okay. Should she get the second dose since she had side effects from the first dose. Response: As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. Outcome of the event nausea was recovered and outcome of the other events were unknown.  Information on the Lot/Batch number has been requested.  Follow-up (16May2021): This is a follow up-spontaneous report from a contactable consumer. This consumer Reported for 12-year-old female patient (daughter) that: outcome of the event was updated.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vision blurred
Clinical narrative: her eyes were glazed over/eyes were cloudy, blurry, and then blacked out /passing out; headache; nauseous; feeling unwell; wobbly/ felt a little weird; her eyes were glazed over/eyes were cloudy, blurry, and then blacked out; she said she started feeling kind of dizzy; This is a spontaneous report from a contactable consumer. A 12-years-old female patient (daughter) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number and expiration date was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer COVID 19 vaccine around 11:30 yesterday. She states that she felt fine for the remainder of the day yesterday but that this morning she had a headache and was nauseous. She states that they had plans to attend a lunch with family but had delayed it due to her daughter feeling unwell so they waited for few hours just waiting to see if she would improve then after few hour she said okay the nausea was gone and after a few hours the daughter was feeling better and they proceeded to go to lunch. When the daughter got out of the car to go to lunch the mother states that she was wobbly and her eyes were glazed over. Then all of a sudden she said she started feeling kind of dizzy like she said her eyes kind of looked cloudy, she felt a little weird and she ended up passing out and had to catch her as she was falling. She reports that she then lost her footing and fell to the ground but that she was able to catch her somewhat. She states that she whole episode lasted about 15 seconds and then she came to. The daughter reports that her eyes were cloudy, blurry, and then blacked out. She states that she is not sitting and eating a banana and feeling okay. Should she get the second dose since she had side effects from the first dose. Response: As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. Outcome of the event nausea was recovered and outcome of the other events were unknown.  Information on the Lot/Batch number has been requested.  Follow-up (16May2021): This is a follow up-spontaneous report from a contactable consumer. This consumer Reported for 12-year-old female patient (daughter) that: outcome of the event was updated.  Information on the Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Vaccination site swelling
Clinical narrative: Colitis ulcerative aggravated/ulcerative colitis flare ups; Vaccination site swelling; This is a solicited report based on the information received by Pfizer from. (MFR Control No. # 21K-163-3796877-00).   A contactable consumer reported that a 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for COVID-19 immunisation; The patient medical history included in Apr2019, the patient experienced ankle injury. In Feb2020, the patient experienced tore cartilage in shoulder. In Sep2020, the patient experienced back pain. Concomitant medications were not reported. The patient previously took adalimumab (HUMIRA), subcutaneous from Jun2020 to Jun2020, at citrate free, weekly for colitis ulcerative. The patient experienced ulcerative colitis flare ups (Colitis ulcerative aggravated) and swelling under arm (vaccination site swelling) after covid vaccine. The action taken in response to the events for adalimumab was unknown. The outcome of vaccination site swelling was recovered on an unspecified date and other event was unknown. The reporter's causality for the events of ankle injury, tore cartilage in shoulder, back pain and swelling under arm after covid vaccine with humira (adalimumab) was no reasonable possibility. the reporter's causality for the events of back injury and ulcerative colitis flare ups was not provided.; Sender's Comments: Based on known safety profile, the contribution of the suspect drug to the onset of event vaccination site swelling cannot be excluded. Based on information provided, the event ulcerative colitis flare up is secondary to the patient's underlying condition, thus unrelated to the suspect drug.  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.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Deep vein thrombosis, SARS-CoV-2 test
Clinical narrative: a DVT in his left calf after the second vaccine; This is a spontaneous report from a contactable consumer (patient). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 22Apr2021 18:15 (Batch/Lot Number: ER8735) at the age of 51-years-old as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications was none, patient did not received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (Lot number: ER8733) on 01Apr2021 16:00 at the age of 51-years-old in Left arm for covid-19 immunization and experienced a superficial blood clot in his left calf. The patient experienced a deep vein thrombosis (DVT) in his left calf after the second vaccine on 16Apr2021 6:30 PM. Event resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the events included had a shot of enoxaparin sodium (LOVENOX) and am taking rivaroxaban (XARELTO). The patient underwent lab tests and procedures which included blood test: negative on 06May2021, Nasal swab covid-19 test: negative on 27Apr2021. The outcome of the event was not recovered.