chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immune system disorder
Clinical narrative: immune problem; extremely tired; This is a spontaneous report from a contactable consumer (Patient). A 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation:Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller was an 81-year-old consumer who has already gotten her first 2 doses of the Pfizer BioNTech COVID-19 vaccine, and she would like to get a booster. She has an immune problem and was a little compromised. She was scheduled for surgery, which has been postponed several times due to the pandemic, but she wanted that dose prior to that. She was 6 months out from her primary doses. She was asking when she can get that. She had very little trouble with her first two doses, aside from being extremely tired. She was asked what she should expect with the third. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Ischaemic stroke
Clinical narrative: acute ischemic stroke; This is a spontaneous report from a contactable consumer (brother and care giver). A 77-years-old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in arm left on 27Aug2021 (at the age of 77-years-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included high BP (blood pressure) and high cholesterol. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EWO178) via an unspecified route of administration in left arm on 06Aug2021 at 13:20 (at the age of 77-year-old) as single dose for COVID-19 immunization and followed by Right hip really hurt/sore right hip (last couple weeks) on 08Aug2021. The patient concerned about her high blood pressure and high cholesterol. She contacted her doctor to get this second shot. Doctor said ok via phone appointment call. 9 days later on 06Sep2021, the patient had a stroke 'Acute Ischemic Stroke' was hospitalize 2 days and reclosed. Follow up care was needed as she tried to recovered. The patient underwent lab test which included antibody test to platelet factor IV with unknown results. The outcome of the event was not recovered.      The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Heart rate increased, Myocardial infarction, Nausea
Clinical narrative: I was having a heart attack.; My heart rate was increased starting the night I got my second dose (my first dose as well).; I had trouble breathing; nausea; and struggled to sleep for days because it felt like my heart was beating out of my chest.; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3184), via an unspecified route of administration, administered in arm right on 03Sep2021 at 14:00 (at the age of 31-years-old) as dose 2, single for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: EW0167), administered in right arm on 04Aug2021 for COVID-19 immunisation and experienced 'My heart rate was increased starting the night I got my second dose (my first dose as well)'. The patient was hospitalized on an unspecified date, thinking he was having a heart attack on 03Sep2021 at 22:00. Also, on 03Sep2021 at 22:00, his heart rate was increased starting the night he got his second dose (his first dose as well). He had trouble breathing, nausea, and struggled to sleep for days because it felt like his heart was beating out of his chest. The patient was hospitalized all events on unspecified dates, for 1 day. The patient underwent lab tests and procedures which included echocardiogram and X-ray (What treatment received for the adverse event? heart ultrasounds, x-ray), both with an unknown result. Therapeutic measures were taken as a result of all events which included Saline solution, heart ultrasounds, X-ray. The adverse events resulted in emergency room/department or urgent care. The outcome of the events was recovered/resolved with sequel on Sep2021.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, X-ray
Clinical narrative: I was having a heart attack.; My heart rate was increased starting the night I got my second dose (my first dose as well).; I had trouble breathing; nausea; and struggled to sleep for days because it felt like my heart was beating out of my chest.; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3184), via an unspecified route of administration, administered in arm right on 03Sep2021 at 14:00 (at the age of 31-years-old) as dose 2, single for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: EW0167), administered in right arm on 04Aug2021 for COVID-19 immunisation and experienced 'My heart rate was increased starting the night I got my second dose (my first dose as well)'. The patient was hospitalized on an unspecified date, thinking he was having a heart attack on 03Sep2021 at 22:00. Also, on 03Sep2021 at 22:00, his heart rate was increased starting the night he got his second dose (his first dose as well). He had trouble breathing, nausea, and struggled to sleep for days because it felt like his heart was beating out of his chest. The patient was hospitalized all events on unspecified dates, for 1 day. The patient underwent lab tests and procedures which included echocardiogram and X-ray (What treatment received for the adverse event? heart ultrasounds, x-ray), both with an unknown result. Therapeutic measures were taken as a result of all events which included Saline solution, heart ultrasounds, X-ray. The adverse events resulted in emergency room/department or urgent care. The outcome of the events was recovered/resolved with sequel on Sep2021.  No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: then tested positive for Covid-19 the next day, 21SEP2021.; then tested positive for Covid-19 the next day, 21SEP2021.; She says her COVID symptoms are getting a little worse but they are not bad; This is a spontaneous report from a contactable consumer (patient) reported for herself. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 20Sep2021 (Lot Number: FC3182) as dose 2, single (at the age of 18 years) for COVID-19 immunisation and dose 1 via an unspecified route of administration, administered on 30Aug2021 (Lot Number: FC3181) as dose 1, single (at the age of 18 years) for COVID-19 immunisation. The patient medical history and concomitant medications were reported as none. She says that her COVID symptoms began right after she got her second dose of the vaccine. The patient had tested positive for Covid-19 the next day on 21Sep2021 and her COVID symptoms are getting a little worse, but they are not bad on Sep2021. She says that she has been taking Tylenol to treat her COVID symptoms, she doesn't have the Tylenol with her. The patient underwent lab tests and procedures which included covid-19: Positive on 21Sep2021 and body weight was: 120-130lbs on 21Sep2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Off label use
Clinical narrative: states he had his third booster yesterday and is on aspirin therapy 81mg and forgot to not take it before the vaccination 3 and a half hours before he received it; received BNT162B2 dose 3; received BNT162B2 dose 3; This is a spontaneous report from a Pfizer-sponsored program by contactable consumer (patient) reported himself. A male patient of an unknown age received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: unknown), via an unknown route of administration on an unknown date as dose 3, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included acetylsalicylic acid [ASPIRIN (E.C.)]. The patient received BNT162B2 on an unknown date as historical vaccine as dose 1 and dose 2, single for COVID-19 immunization. The patient stated that he just got his booster vaccine and was on 81 mg of aspirin therapy and forgot to not take it before the vaccination 3 and a half hours before he received it. He stated when he got his first two doses, he read something not to take it. He stated it was routine aspirin that he has been taking for a long time. The outcome of event was unknown.  No further information obtained. offered to email the information but the patient declined. Information about lot/batch number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: patient has been exposed to COVID-19 infection before getting their third dose; he was exposed to Covid before their 3rd dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program  Support. A contactable consumer reported for a male patient.   A male patient of an unspecified age received second dose of bnt162b2 (COMIRNATY, Solution injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. Medical history included that patient is immunocompromised. The patient's concomitant medications were not reported. Patient previously received first dose of bnt162b2 (COMIRNATY, Solution injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Caller is calling in behalf of a consumer, who received the third dose of the Pfizer (Comirnaty) vaccine. Caller states that a patient has been exposed to COVID-19 infection before getting their third dose. Caller is asking if an immunocompromised patient who have contracted COVID-19 before the third dose could be treated with monoclonal antibodies or not. Caller is asking if how long will the patient receive another monoclonal antibody after the vaccination. Caller noted that he knew that immunocompromised patients should defer vaccination if they received antibody therapy 90 days before vaccination.  The patient underwent lab test includes Covid-19 test with result positive 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: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: Grade 4 (above 104F) fever; severe chills; fatigue; This is a spontaneous report from a contactable consumer (patient). A 21-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in right arm, on 21Sep2021 at 16:30 (at the age of 21-years-old) at dose 2, single for COVID-19 immunisation. Medical history included gastric ulcer and COVID prior vaccination. COVID had not tested post vaccination. The patient had not known allergies. Concomitant medication included omeprazole taken for gastric ulcer, reported as other medication taken in two weeks. The patient received the first dose of BNT162B2 on 17Aug2021 at 16:00 (at the age of 21-years-old) administered in right arm for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. Patient had been experiencing severe chills, fatigue, and had been having a grade 4 (above 104F) fever since approximately 07:00 of 22Sep2021, so about 14 hours after he was vaccinated with the second dose. With fever reducing medication (TYLENOL), he had been able to reduce the fever to 101.3F, in Sep2021, but it kept creeping back up towards 104+F, in Sep2021. The patient had not recovered from the events.   The lot number for BNT162B2 was not provided and will be requested during follow-up.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: My heart rate was increased starting the night I got my second dose (my first dose as well).; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0167), via an unspecified route of administration, administered in right arm on 04Aug2021 at 11:00 (at the age of 31-year-old) as dose 1, single for COVID-19 immunisation. The patient did not have any medical history. There were no concomitant medications. The patient did not have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19 and 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. The patient mentioned that his heart rate was increased starting the night he got his second dose and after the first dose as well in 2021. The outcome was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Dizziness, Dyspnoea, Electrocardiogram abnormal
Clinical narrative: mental fogginess; Tired; waking up unable to catch breath/shortness of breath; bad anxiety; problems sleeping; vision not as clear; dizziness; irregular ekg; extreme joint pain and swelling; extreme joint pain and swelling; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; Lot Number: EN6207 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 19Mar2021 10:00 (at the age of 57-years-old) at dose 1, single for covid-19 immunization. Medical history included type 2 diabetes, hbp (high blood pressure), asthma and psoriasis. Concomitant medications included sitagliptin phosphate (JANUVIA); fluticasone propionate (FLOVENT); ramipril; alprazolam (XANAX), allergy nasal spray. Patient was not pregnant at the time of vaccination. The patient previously took codeine and experienced drug allergy. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient felt tired, shortness of breath, waking up unable to catch breath, bad anxiety, sleeping problems, mental fogginess, vision not as clear, dizziness, irregular EKG(electrocardiogram ), extreme joint pain and swelling on 20Mar2021 08:00. The patient was seeing a cardiologist. The most recent COVID-19 vaccine was administered at Hospital. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included electrocardiogram: irregular on 20Mar2021, sars-cov-2 test: negative on 03Aug2021. It was unknown if the patient had treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Joint swelling, Mental impairment, SARS-CoV-2 test negative
Clinical narrative: mental fogginess; Tired; waking up unable to catch breath/shortness of breath; bad anxiety; problems sleeping; vision not as clear; dizziness; irregular ekg; extreme joint pain and swelling; extreme joint pain and swelling; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; Lot Number: EN6207 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 19Mar2021 10:00 (at the age of 57-years-old) at dose 1, single for covid-19 immunization. Medical history included type 2 diabetes, hbp (high blood pressure), asthma and psoriasis. Concomitant medications included sitagliptin phosphate (JANUVIA); fluticasone propionate (FLOVENT); ramipril; alprazolam (XANAX), allergy nasal spray. Patient was not pregnant at the time of vaccination. The patient previously took codeine and experienced drug allergy. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient felt tired, shortness of breath, waking up unable to catch breath, bad anxiety, sleeping problems, mental fogginess, vision not as clear, dizziness, irregular EKG(electrocardiogram ), extreme joint pain and swelling on 20Mar2021 08:00. The patient was seeing a cardiologist. The most recent COVID-19 vaccine was administered at Hospital. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included electrocardiogram: irregular on 20Mar2021, sars-cov-2 test: negative on 03Aug2021. It was unknown if the patient had treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: mental fogginess; Tired; waking up unable to catch breath/shortness of breath; bad anxiety; problems sleeping; vision not as clear; dizziness; irregular ekg; extreme joint pain and swelling; extreme joint pain and swelling; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; Lot Number: EN6207 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 19Mar2021 10:00 (at the age of 57-years-old) at dose 1, single for covid-19 immunization. Medical history included type 2 diabetes, hbp (high blood pressure), asthma and psoriasis. Concomitant medications included sitagliptin phosphate (JANUVIA); fluticasone propionate (FLOVENT); ramipril; alprazolam (XANAX), allergy nasal spray. Patient was not pregnant at the time of vaccination. The patient previously took codeine and experienced drug allergy. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient felt tired, shortness of breath, waking up unable to catch breath, bad anxiety, sleeping problems, mental fogginess, vision not as clear, dizziness, irregular EKG(electrocardiogram ), extreme joint pain and swelling on 20Mar2021 08:00. The patient was seeing a cardiologist. The most recent COVID-19 vaccine was administered at Hospital. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included electrocardiogram: irregular on 20Mar2021, sars-cov-2 test: negative on 03Aug2021. It was unknown if the patient had treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Chest X-ray, Chest pain, Dyspnoea, Musculoskeletal chest pain
Clinical narrative: chest pain; breast lumps; pain in chest wall; covid like symptoms - shortness of breath; lung obstruction; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EW0191), via an unspecified route of administration on Jun2021 (at the age of 38-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included Penicillin allergy. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 15Jun2021, the patient experienced chest pain, breast lumps, pain in chest wall, covid like symptoms - shortness of breath and lung obstruction seen on chest xray. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has been tested for COVID-19- Nasal Swab with unknown result on unspecified date in 2021. The patient underwent lab tests and procedures which included chest x-ray on 15Jun2021 which shows lung obstruction. Therapeutic measures were taken as a result of the adverse events which included antibiotics, nebulizer, pump, albuterol, steroid. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive airways disorder, SARS-CoV-2 test
Clinical narrative: chest pain; breast lumps; pain in chest wall; covid like symptoms - shortness of breath; lung obstruction; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EW0191), via an unspecified route of administration on Jun2021 (at the age of 38-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included Penicillin allergy. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 15Jun2021, the patient experienced chest pain, breast lumps, pain in chest wall, covid like symptoms - shortness of breath and lung obstruction seen on chest xray. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has been tested for COVID-19- Nasal Swab with unknown result on unspecified date in 2021. The patient underwent lab tests and procedures which included chest x-ray on 15Jun2021 which shows lung obstruction. Therapeutic measures were taken as a result of the adverse events which included antibiotics, nebulizer, pump, albuterol, steroid. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clots/3 blood in the left leg; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included partial knee replacement in Dec2020 and developed 1 blood clot. The patient's concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for covid-19 immunisation. The reporter reported that her husband (patient) developed 3 blood clots on an unspecified date in 2021 after his second Pfizer vaccine in May2021. Now he did have a partial knee replacement last Dec2020 and developed 1 blood clot, but was cleared of any blood clots 07May2021 after having a dobler sonagram was done, the following week he had his second shot and on 07Jul2021 he was hospitalized with 3 blood in the left leg, odd how this happened 2 1/2 months after his second shot. The patient underwent lab tests and procedures which included dobler sonogram: cleared of any blood clots on 07May2021. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain
Clinical narrative: She got the Pfizer vaccine and told me it's kicking her butt; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that she got the Pfizer vaccine and told it's kicking her butt on an unspecified date. The clinical outcome of the event was unknown.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Breast mass, Breast pain, Daydreaming, Mental impairment
Clinical narrative: Lost in Daydream (Mental Fog); Lost in Daydream (Mental Fog); Lump in left armpit that gradually sent pain and lump into left breast; Lump in left armpit that gradually sent pain and lump into left breast; Lump in left armpit that gradually sent pain and lump into left breast; Change in taste of familiar foods; This is a spontaneous report from a non-contactable nurse (patient). A 39-years-old female patient received bnt162b2 (BNT162B2) (not pregnant), dose 2 administered in Arm Left on 10Sep2021 08:30 (Batch/Lot number was not reported) at age of 39-year-old as DOSE 2, SINGLE for covid-19 immunisation.  Facility where the most recent COVID-19 vaccine was administered was Workplace clinic.The patient medical history and the concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient previously received bnt162b2 dose 1 administered in Arm Left on 20Aug2021 13:00 at age of 39-year-old as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced Lump in left armpit that gradually sent pain and lump into left breast, Change in taste of familiar foods, Lost in Daydream (Mental Fog) on 10Sep2021. The outcome was Resolved with Sequel in Sep2021. No treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Covid test post vaccination (Nasal Swab): Negative.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported Lost in Daydream (Mental Fog) and the administration of the suspect, BNT162B2, based on the reasonable temporal association.   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 RA, Agency, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Taste disorder
Clinical narrative: Lost in Daydream (Mental Fog); Lost in Daydream (Mental Fog); Lump in left armpit that gradually sent pain and lump into left breast; Lump in left armpit that gradually sent pain and lump into left breast; Lump in left armpit that gradually sent pain and lump into left breast; Change in taste of familiar foods; This is a spontaneous report from a non-contactable nurse (patient). A 39-years-old female patient received bnt162b2 (BNT162B2) (not pregnant), dose 2 administered in Arm Left on 10Sep2021 08:30 (Batch/Lot number was not reported) at age of 39-year-old as DOSE 2, SINGLE for covid-19 immunisation.  Facility where the most recent COVID-19 vaccine was administered was Workplace clinic.The patient medical history and the concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient previously received bnt162b2 dose 1 administered in Arm Left on 20Aug2021 13:00 at age of 39-year-old as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced Lump in left armpit that gradually sent pain and lump into left breast, Change in taste of familiar foods, Lost in Daydream (Mental Fog) on 10Sep2021. The outcome was Resolved with Sequel in Sep2021. No treatment received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Covid test post vaccination (Nasal Swab): Negative.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported Lost in Daydream (Mental Fog) and the administration of the suspect, BNT162B2, based on the reasonable temporal association.   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 RA, Agency, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: have covid; have covid; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration  date were not reported), via an unspecified route of administration in Feb2021 at dose 1 single and via an unspecified route of administration in Mar2021 at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had covid (medically significant) in sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in Sep2021. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive
Clinical narrative: Congestive heart failure; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6200, Expiration date: Not reported), via an unspecified route of administration in right arm, on 03Mar2021 at 15:00 (at the age of 66-years-old) as dose 2, single for COVID-19 immunization in a facility reported as other. The patient's other medical history was reported as none. There were no known allergies reported. There were no concomitant medications/any other medications received within 2 weeks of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6200, Expiration date: Not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination and didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced congestive heart failure on 04Mar2021 at 00:00. The patient was in hospital for 7 days in 2021 and received unspecified treatment for heart failure. The patient didn't prolong the hospitalization. The event resulted in emergency room/department or urgent care. The event was considered as non-serious and the outcome of event was not recovered at the time of report.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Nausea, Postural orthostatic tachycardia syndrome
Clinical narrative: nausea; POTS flare ups not experienced for years. So bad over past months since May vaccine  that we have explored every gastro possibility to no avail.; POTS flare ups not experienced for years. So bad over past months since May vaccine  that we have explored every gastro possibility to no avail.; This is a spontaneous report from a contactable consumer. A non pregnant 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; Lot number and expiration date were not reported), via an unspecified route of administration, administered in Arm Right on 04May2021 14:45 (at the age of 19-years-old) at dose 2, single for covid-19 immunization. Medical history included known allergies to penicillins and POTS (Postural orthostatic tachycardia syndrome). The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; Lot number and expiration date were not reported), via an unspecified route of administration, administered on 13Apr2021 15:00 at dose 1, single for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. Patient did not receive any other vaccines in four weeks. Patient had POTS which was managed at time of Covid vaccine. After 2nd vaccine patient symptoms became much worse on 05May2021. She has not experienced POTS flare ups for years. It was so bad over past months since second vaccine that they have explored every gastro possibility to no avail. Nowshe has to withdrawfrom her first college classes due to this worsening of her POTS illness. The most recent covid-19 vaccine was administered at Pharmacy or Drug Store. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient was given Fluids in ER  and nausea prescriptions. The outcome of the event POTS was not recovered, outcome of nausea was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Cataract, Drug ineffective
Clinical narrative: COVID-19; COVID-19; Cataract; This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on the information received by Pfizer from Facilitating Company (MFR Control No.21K-163-4084340-00).  A contactable consumer reported that a 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 1, single, dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date at an unknown dose for rheumatoid arthritis. Medical history and concomitant medications were not reported. On unknown date in 2021, the patient experienced cataract and covid-19. The patient had cataract surgery. The action taken in response to the events for upadacitinib was unknown. The outcome of the events was recovering. Reporter causality was possible for the event covid-19, for the event cataract was not reported. She was still recovering from Covid 19 as of 16sep2021. She had a breakthrough case as she was fully Vaccinated. It was unknown if patient was enrolled in a covid-19 vaccine trial.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Extra dose administered, Gait disturbance, Insomnia
Clinical narrative: I got full on Sciatica with lower back, buttocks, hip and pain down my entire left leg; I got full on Sciatica with lower back, buttocks, hip and pain down my entire left leg; I got full on Sciatica with lower back, buttocks, hip and pain down my entire left leg; I cannot walk, move or sleep without pain; I cannot walk, move or sleep without pain; I cannot walk, move or sleep without pain; I started to feel lower back pain(on left side); I got full on Sciatica with lower back, buttocks, hip and pain down my entire left leg; I got a booster shot/I have received 3 doses of the Pfizer Vaccine.; I got a booster shot/I have received 3 doses of the Pfizer Vaccine.; This is a spontaneous report from a contactable consumer (patient) reported for himself that. A 48-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 3 intramuscular, administered in Arm Left on 07Sep2021 10:00 (Batch/Lot Number: FD8448) as DOSE 3, SINGLE for covid-19 immunization (Age at vaccination: 48 years). The patient medical history included Rheumatoid arthritis from an unknown date and unknown if ongoing I am immunocompromised as I have Rheum Arthritis and Sulfonamide allergy from an unknown date and unknown if ongoing. Concomitant medication(s) included celecoxib (CELEBREX, 200mg/Daily) taken for an unspecified indication, start and stop date were not reported; tofacitinib citrate (XELJANZ, 11mg/day) taken for an unspecified indication, start and stop date were not reported. Prior to the 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 vaccine within 4 weeks prior to covid-19 vaccination.  Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient reported 1 week after receiving the 3rd dose he started to feel lower back pain (on left side) on 14Sep2021, 10 days after the booster I got full on Sciatica with lower back, buttocks, hip and pain down my entire left leg. I cannot walk, move or sleep without pain on 17Sep2021.The event ae resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. The patient received a treatment with Physical therapy and an anti-inflammatory prescription. The event outcome was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Movement disorder, Musculoskeletal pain, Off label use, Pain in extremity, Sciatica
Clinical narrative: I got full on Sciatica with lower back, buttocks, hip and pain down my entire left leg; I got full on Sciatica with lower back, buttocks, hip and pain down my entire left leg; I got full on Sciatica with lower back, buttocks, hip and pain down my entire left leg; I cannot walk, move or sleep without pain; I cannot walk, move or sleep without pain; I cannot walk, move or sleep without pain; I started to feel lower back pain(on left side); I got full on Sciatica with lower back, buttocks, hip and pain down my entire left leg; I got a booster shot/I have received 3 doses of the Pfizer Vaccine.; I got a booster shot/I have received 3 doses of the Pfizer Vaccine.; This is a spontaneous report from a contactable consumer (patient) reported for himself that. A 48-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 3 intramuscular, administered in Arm Left on 07Sep2021 10:00 (Batch/Lot Number: FD8448) as DOSE 3, SINGLE for covid-19 immunization (Age at vaccination: 48 years). The patient medical history included Rheumatoid arthritis from an unknown date and unknown if ongoing I am immunocompromised as I have Rheum Arthritis and Sulfonamide allergy from an unknown date and unknown if ongoing. Concomitant medication(s) included celecoxib (CELEBREX, 200mg/Daily) taken for an unspecified indication, start and stop date were not reported; tofacitinib citrate (XELJANZ, 11mg/day) taken for an unspecified indication, start and stop date were not reported. Prior to the 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 vaccine within 4 weeks prior to covid-19 vaccination.  Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient reported 1 week after receiving the 3rd dose he started to feel lower back pain (on left side) on 14Sep2021, 10 days after the booster I got full on Sciatica with lower back, buttocks, hip and pain down my entire left leg. I cannot walk, move or sleep without pain on 17Sep2021.The event ae resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. The patient received a treatment with Physical therapy and an anti-inflammatory prescription. The event outcome was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Magnetic resonance imaging
Clinical narrative: Blackout; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: FD8448) as dose 1, single for COVID-19 immunisation. Medical history included Open heart surgery. Concomitant medications included pentoxifylline, atorvastatin, omeprazole, metoprolol, warfarin sodium (JANTOVEN), lisinopril and aspirin (ACETYLSALICYLIC ACID). No prior vaccination was given (within 4 weeks). The patient's doctor told her to call and report the side effects that she had. Ten (10) days after her first dose, on an unspecified date, she had a blackout and dizziness for about 4 hours. No treatment was given in response to the events. The patient had an MRI on an unspecified date to make sure she did not have any stroke when she blackout and she did not have one. The outcome of the events was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Vaccine ineffective (Lack of Efficacy); Vaccine ineffective (Lack of Efficacy); This is a spontaneous report from a contactable consumer (patient). A male patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included ocrelizumab (OCREVUS). On unknown date, it was reported that patient experienced: Vaccine ineffective (Lack of Efficacy). The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure increased, Feeling jittery
Clinical narrative: Blood pressure increased and bottomed out; Blood pressure increased and bottomed out; Jitters; This is a spontaneous report from a contactable consumer (patient's neighbor). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as unknown dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient's neighbor reported that she was older than him and his blood pressure increased and had bottomed out and also had the jitters on an unspecified date. The reporter declined to complete the safety report regrading her neighbor and reported that he'll be the one to call and report regarding his events. The outcome of the events was unknown at the time of report.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: Cancer; This is a spontaneous report from a contactable consumer (patient's son) via a Pfizer sponsored program  Support. A 91-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (unknown age at time of vacciantion) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. Event description: According to an article, Pfizer booster will be available on Sept2021 and will be upgraded to be against Delta. Patient's son wants to know more information about it. He mentioned that his father (the patient), 91-year-old and has cancer, wants to receive the booster shot. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Uterine haemorrhage, Uterine inflammation
Clinical narrative: Heavy bleeding and inflammation where IUD was; Heavy bleeding and inflammation where IUD was; Her period was very heavy, moreso than ever, and the next month and the month after was worse; This is a spontaneous report from a contactable consumer (patient).  A 48-year-old female patient received bnt162b2 (BNT162B2), intramuscular administered in Arm Left on 14Apr2021 15:00, at the age of 48-years-old, (Lot Number: ER8729; Expiration Date: 31Jul2021) as DOSE 2, 0.3 ML SINGLE for covid-19 immunisation; intrauterine contraceptive device (PARAGARD), via an unspecified route of administration from Oct2019 (Batch/Lot number was not reported) for Birth control. Historical vaccine includes dose 1 of Comirnaty, lot number: EP6955, expiration date: 30Jun2021, 30mcg, injected in left arm in the muscle. The patient also previously received flu vaccine in which her arm hurt and felt tired. The patient's medical history includes none. Concomitant medication is none. On 30Apr2021 12:00, the patient stated she started having Heavy bleeding and inflammation where IUD was.  It kept getting worse. The patient stated her Paraguard causes heavy bleeding anyway, so she really did not put it together at that time.  Her period was very heavy, moreso than ever, and the next month and the month after was worse.  In Aug 2021, she was only without a cycle for 5 days and it was horrible.  Her IDU was removed a week after the hurricane.  She had it done in the doctor's office and had no effects.  She is fine now.  She doesn't know if it had some sort of reaction with the copper.  She is healthy and has no issues now.  The events involved physician office visit and emergency room visit. The action taken for the event INTRAUTERINE CONTRACEPTIVE DEVICE (PARAGUARD) was unknown. The outcome of the events was recovered. Treatment was received for the events.  Follow-up attempts are completed. No further information is expected.