chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: labs are abnormal; blood pressure dropping; Then 8 days later i developed throbbing pain head to toe; low grade temp; sweats; swelling of joints, especially my fingers, hands and feet; swelling of joints, especially my fingers, hands and feet; diarrhea; dizziness; problems thinking; anxiety; About 4 hours after receiving my Covid vaccine I started to feel fatigue/severe fatigue; This is a spontaneous report from a contactable Nurse (Patient). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 08Apr2021 16:00 (Batch/Lot Number: EK8734) at the age of 43-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Pharmacy or Drug Store. Patient was not pregnant. Medical history included Rheumatoid Arthritis, fibromyalgia, anxiety/depression, Known allergies: Sulfa, Covid-19 prior vaccination. Post the vaccination, the patient was not been tested for COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported; lorazepam (ATIVAN) taken for an unspecified indication, start and stop date were not reported. About 4 hours on 08Apr2021 after receiving her Covid vaccine she started to feel fatigue. Then 8 days later on 16Apr2021 08:00 AM, patient developed throbbing pain from head to toe, severe fatigue, low grade temp, sweats, swelling of joints, especially her fingers, hands and feet, diarrhea, blood pressure dropping, dizziness, problems thinking, and anxiety. His symptoms have progressively gotten worse and she had seen her family doctor, and her rheumatologist. Events resulted in: Doctor or other healthcare professional office/clinic visit. Leflunomide (ARAVA) and ibuprofen (MOTRIN) to help with inflammation and swelling. Her labs were abnormal, but chest X-ray normal on an unknown date. She have been off work since 26Apr2021. The outcome of the events was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Arthralgia, Chest X-ray, Chest pain, Condition aggravated
Clinical narrative: labs are abnormal; blood pressure dropping; Then 8 days later i developed throbbing pain head to toe; low grade temp; sweats; swelling of joints, especially my fingers, hands and feet; swelling of joints, especially my fingers, hands and feet; diarrhea; dizziness; problems thinking; anxiety; About 4 hours after receiving my Covid vaccine I started to feel fatigue/severe fatigue; This is a spontaneous report from a contactable Nurse (Patient). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 08Apr2021 16:00 (Batch/Lot Number: EK8734) at the age of 43-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Pharmacy or Drug Store. Patient was not pregnant. Medical history included Rheumatoid Arthritis, fibromyalgia, anxiety/depression, Known allergies: Sulfa, Covid-19 prior vaccination. Post the vaccination, the patient was not been tested for COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported; lorazepam (ATIVAN) taken for an unspecified indication, start and stop date were not reported. About 4 hours on 08Apr2021 after receiving her Covid vaccine she started to feel fatigue. Then 8 days later on 16Apr2021 08:00 AM, patient developed throbbing pain from head to toe, severe fatigue, low grade temp, sweats, swelling of joints, especially her fingers, hands and feet, diarrhea, blood pressure dropping, dizziness, problems thinking, and anxiety. His symptoms have progressively gotten worse and she had seen her family doctor, and her rheumatologist. Events resulted in: Doctor or other healthcare professional office/clinic visit. Leflunomide (ARAVA) and ibuprofen (MOTRIN) to help with inflammation and swelling. Her labs were abnormal, but chest X-ray normal on an unknown date. She have been off work since 26Apr2021. The outcome of the events was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Deafness unilateral, Diarrhoea, Fatigue, Full blood count
Clinical narrative: labs are abnormal; blood pressure dropping; Then 8 days later i developed throbbing pain head to toe; low grade temp; sweats; swelling of joints, especially my fingers, hands and feet; swelling of joints, especially my fingers, hands and feet; diarrhea; dizziness; problems thinking; anxiety; About 4 hours after receiving my Covid vaccine I started to feel fatigue/severe fatigue; This is a spontaneous report from a contactable Nurse (Patient). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 08Apr2021 16:00 (Batch/Lot Number: EK8734) at the age of 43-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Pharmacy or Drug Store. Patient was not pregnant. Medical history included Rheumatoid Arthritis, fibromyalgia, anxiety/depression, Known allergies: Sulfa, Covid-19 prior vaccination. Post the vaccination, the patient was not been tested for COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported; lorazepam (ATIVAN) taken for an unspecified indication, start and stop date were not reported. About 4 hours on 08Apr2021 after receiving her Covid vaccine she started to feel fatigue. Then 8 days later on 16Apr2021 08:00 AM, patient developed throbbing pain from head to toe, severe fatigue, low grade temp, sweats, swelling of joints, especially her fingers, hands and feet, diarrhea, blood pressure dropping, dizziness, problems thinking, and anxiety. His symptoms have progressively gotten worse and she had seen her family doctor, and her rheumatologist. Events resulted in: Doctor or other healthcare professional office/clinic visit. Leflunomide (ARAVA) and ibuprofen (MOTRIN) to help with inflammation and swelling. Her labs were abnormal, but chest X-ray normal on an unknown date. She have been off work since 26Apr2021. The outcome of the events was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Insomnia, Joint swelling, Myalgia, Neutrophil count abnormal
Clinical narrative: labs are abnormal; blood pressure dropping; Then 8 days later i developed throbbing pain head to toe; low grade temp; sweats; swelling of joints, especially my fingers, hands and feet; swelling of joints, especially my fingers, hands and feet; diarrhea; dizziness; problems thinking; anxiety; About 4 hours after receiving my Covid vaccine I started to feel fatigue/severe fatigue; This is a spontaneous report from a contactable Nurse (Patient). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 08Apr2021 16:00 (Batch/Lot Number: EK8734) at the age of 43-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Pharmacy or Drug Store. Patient was not pregnant. Medical history included Rheumatoid Arthritis, fibromyalgia, anxiety/depression, Known allergies: Sulfa, Covid-19 prior vaccination. Post the vaccination, the patient was not been tested for COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported; lorazepam (ATIVAN) taken for an unspecified indication, start and stop date were not reported. About 4 hours on 08Apr2021 after receiving her Covid vaccine she started to feel fatigue. Then 8 days later on 16Apr2021 08:00 AM, patient developed throbbing pain from head to toe, severe fatigue, low grade temp, sweats, swelling of joints, especially her fingers, hands and feet, diarrhea, blood pressure dropping, dizziness, problems thinking, and anxiety. His symptoms have progressively gotten worse and she had seen her family doctor, and her rheumatologist. Events resulted in: Doctor or other healthcare professional office/clinic visit. Leflunomide (ARAVA) and ibuprofen (MOTRIN) to help with inflammation and swelling. Her labs were abnormal, but chest X-ray normal on an unknown date. She have been off work since 26Apr2021. The outcome of the events was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet disorder, Pyrexia, Red blood cell sedimentation rate, Thinking abnormal, Weight decreased
Clinical narrative: labs are abnormal; blood pressure dropping; Then 8 days later i developed throbbing pain head to toe; low grade temp; sweats; swelling of joints, especially my fingers, hands and feet; swelling of joints, especially my fingers, hands and feet; diarrhea; dizziness; problems thinking; anxiety; About 4 hours after receiving my Covid vaccine I started to feel fatigue/severe fatigue; This is a spontaneous report from a contactable Nurse (Patient). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 08Apr2021 16:00 (Batch/Lot Number: EK8734) at the age of 43-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Pharmacy or Drug Store. Patient was not pregnant. Medical history included Rheumatoid Arthritis, fibromyalgia, anxiety/depression, Known allergies: Sulfa, Covid-19 prior vaccination. Post the vaccination, the patient was not been tested for COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported; lorazepam (ATIVAN) taken for an unspecified indication, start and stop date were not reported. About 4 hours on 08Apr2021 after receiving her Covid vaccine she started to feel fatigue. Then 8 days later on 16Apr2021 08:00 AM, patient developed throbbing pain from head to toe, severe fatigue, low grade temp, sweats, swelling of joints, especially her fingers, hands and feet, diarrhea, blood pressure dropping, dizziness, problems thinking, and anxiety. His symptoms have progressively gotten worse and she had seen her family doctor, and her rheumatologist. Events resulted in: Doctor or other healthcare professional office/clinic visit. Leflunomide (ARAVA) and ibuprofen (MOTRIN) to help with inflammation and swelling. Her labs were abnormal, but chest X-ray normal on an unknown date. She have been off work since 26Apr2021. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Eye pain, Myalgia, Pain in extremity
Clinical narrative: This is a spontaneous from a Pfizer sponsored program from a contactable consumer (patient). 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 05May2021 at first dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain in both shoulders and arms, burning muscles and painful eyes on 07May2021. Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Malaise
Clinical narrative: the patient experienced the event of not feeling well (malaise).; This is a spontaneous report received from a non-contactable consumer. A 50-year-old female consumer (patient) reported for a herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Other co-suspect included treprostinil diethanolamine (TREPROSTINIL DIETHANOLAMINE), oral from 30Nov2018 (ongoing), (Extended release tablet) taken for pulmonary arterial hypertension and treprostinil diolamin (ORENITRAM), oral from an unspecified date (Batch/Lot Number: 2101650; Expiration Date: 31Jan2022) ongoing, at 5 mg (every 8 hours (q8h)) (Extended release tablet,) for pulmonary arterial hypertension. Medical history included ongoing pulmonary arterial hypertension. Concomitant medication included tadalafil. It was reported that, the patient was not feeling well after getting her COVID vaccine on an unspecified date. The patient did not elaborate it any further. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on my neck and my head and my shoulders; This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 06May2021 11:15 am (Lot Number: EW0182; Expiration Date: Aug2021) as UNKNOWN, SINGLE for covid-19 immunisation. Medical history included mouth surgery. Concomitant medication included omeprazole (PRILOSEC [OMEPRAZOLE]) taken for an unspecified indication, start and stop date were not reported. The patient stated "I had the Pfizer shot (Covid-19 Shot) yesterday at 11 o'clock (06May2021) and then I woke up this morning with a rash on my neck and my head and my shoulders (on 07May2021). So, I was wondering if that is something that I need to go to (sentence incomplete), I tried to take a Benadryl, but it didn't help. So, is it something that is going to pass?". Patient stated "I got the shot at 11 o' clock like 11.15 in the morning and then I started feeling it about 5:00 or 6:00." Therapeutic measures were taken as a result of the event. The outcome of the event was not recovered.  Information about lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: a little rash on my arm and it won't stop itching; a little rash on my arm and it won't stop itching; This is a spontaneous report from a contactable consumer reporting for himself. A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 10Mar2021 (Batch/Lot Number: EW6208) as a single dose (at the age of 61 years old), and dose 2 via an unspecified route of administration on 31Mar2021 (Batch/Lot Number: ERB731) as a single dose (at the age of 61 years old) for COVID-19 immunisation. Relevant medical history was not provided. Concomitant medication included a lot of unspecified medication. On an unspecified date, the patient experienced a little rash on my arm and it won't stop itching. Therapeutic measures were taken as a result of a little rash on my arm and it won't stop itching included diphenhydramine (BENADRYL). The patient reported that he took diphenhydramine to stop it but it's still right there. The outcome of the event a little rash on my arm and it won't stop itching was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: they both got sick and tested positive for Covid-19; they both got sick and tested positive for Covid-19; they both got sick and tested positive for Covid-19; This is a spontaneous report from a Pfizer Sponsored Program. A non-contactable female consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient got sick and tested positive for covid-19 on an unspecified date.The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of sick and tested positive for covid-19  was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: drug ineffective; they both got sick and tested positive for Covid-19; This is a spontaneous report from a Pfizer sponsored program via a non-contactable consumer (wife of patient).   A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number and expiration date unknown), via an unspecified route of administration, on 23Mar2021 as a single dose for COVID-19 vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller and her husband received first dose 23Mar however, they both got sick and tested positive for Covid-19. After being in the hospital for a while they were told to quarantine. The clinical outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021531128 Original Case : 2021531128
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: And today I had a stool, that was kind of had blood in it not much.; just a little diarrhea with a little blood in it; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown) via an unspecified route of administration on 07May2021 as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient mentioned that she just finished her 2nd shot of the COVID Vaccine on Friday and today she had a stool, that was kind of had blood in it not much. The patient experienced a stool, that was kind of had blood in it not much on 10May2021 with outcome of unknown and just a little diarrhea with a little blood in it on 10May2021 with outcome of unknown.  The patient was wondering is that some form of side effect. Therapeutic measures, if any, were not reported.   Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: as we vaccinated a week later we both my wife and I both got COVID; This is a spontaneous report from a contactable consumer (patient's husband). This consumer reported similar event for two patients.  This is the second of two reports.  A female patient (wife) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 27Jan2021 as 1 st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The husband stated that, "as we vaccinated a week later we both my wife and I both got COVID" on 03Feb2021. The seriousness was unspecified. They were told that they couldn't go back for our second shot for 90 days which they just completed on this morning for the shot. The husband asked if that should be their second shot or should they stop the process over again with the first shot. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021530683 same reporter/drug/event, different patients
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Body temperature, Cardiovascular disorder, Chills, Gait disturbance
Clinical narrative: Chills; sick; Fever; hard for me to walk; Atrial fibrillation; blood clot in her finger; thumb right now is real cold; the tip of my thumb is numb; tip was numb and real cold- there was no circulation going on; Irregular heartbeat; Blood pressure high; Headache; Muscle ache; This is a spontaneous report from a contactable consumer, the patient, via the Pfizer-sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: Unknown), via an unspecified route of administration on 19Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 19Mar2021 for COVID-19 immunization and felt fine (no adverse event). On an unspecified date in Apr2021, four days after the second vaccination, the patient was sick for seven days with chills. On an unspecified date in 2021, the patient had terrible side effects such as muscle ache and fever ("99 something") for 7 days. On an unspecified date in 2021, the patient experienced headache, blood pressure high, irregular heartbeat, atrial fibrillation and the calf was "real bad"- it was hard for the patient to walk. The patient called her doctor and got tested for COVID-19 two weeks after the vaccination, in May2021, with negative results. The doctor stated that the patient got so sick from the shot. On an unspecified date in 2021, the patient's thumb was like a blood clot to the thumb (blood clot in her finger), the tip was numb and real cold- there was no circulation going on. The patient went to the emergency room where an ultrasound was performed on the arm to see if there were any blood clots in there, with unknown results. The patient was treated with an unspecified "pill" for irregular heartbeat. The patient was scheduled for an echocardiogram and heart monitor. The clinical outcome of atrial fibrillation, blood clot in her finger, thumb right now is real cold, the tip of my thumb is numb, "tip was numb and real cold- there was no circulation going on", irregular heartbeat, blood pressure high, headache, muscle ache, chills, sick, fever, "hard for me to walk" was unknown.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate irregular, Hypertension, Hypoaesthesia, Illness
Clinical narrative: Chills; sick; Fever; hard for me to walk; Atrial fibrillation; blood clot in her finger; thumb right now is real cold; the tip of my thumb is numb; tip was numb and real cold- there was no circulation going on; Irregular heartbeat; Blood pressure high; Headache; Muscle ache; This is a spontaneous report from a contactable consumer, the patient, via the Pfizer-sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: Unknown), via an unspecified route of administration on 19Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 19Mar2021 for COVID-19 immunization and felt fine (no adverse event). On an unspecified date in Apr2021, four days after the second vaccination, the patient was sick for seven days with chills. On an unspecified date in 2021, the patient had terrible side effects such as muscle ache and fever ("99 something") for 7 days. On an unspecified date in 2021, the patient experienced headache, blood pressure high, irregular heartbeat, atrial fibrillation and the calf was "real bad"- it was hard for the patient to walk. The patient called her doctor and got tested for COVID-19 two weeks after the vaccination, in May2021, with negative results. The doctor stated that the patient got so sick from the shot. On an unspecified date in 2021, the patient's thumb was like a blood clot to the thumb (blood clot in her finger), the tip was numb and real cold- there was no circulation going on. The patient went to the emergency room where an ultrasound was performed on the arm to see if there were any blood clots in there, with unknown results. The patient was treated with an unspecified "pill" for irregular heartbeat. The patient was scheduled for an echocardiogram and heart monitor. The clinical outcome of atrial fibrillation, blood clot in her finger, thumb right now is real cold, the tip of my thumb is numb, "tip was numb and real cold- there was no circulation going on", irregular heartbeat, blood pressure high, headache, muscle ache, chills, sick, fever, "hard for me to walk" was unknown.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Peripheral coldness, Pyrexia, SARS-CoV-2 test, Thrombosis
Clinical narrative: Chills; sick; Fever; hard for me to walk; Atrial fibrillation; blood clot in her finger; thumb right now is real cold; the tip of my thumb is numb; tip was numb and real cold- there was no circulation going on; Irregular heartbeat; Blood pressure high; Headache; Muscle ache; This is a spontaneous report from a contactable consumer, the patient, via the Pfizer-sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: Unknown), via an unspecified route of administration on 19Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 19Mar2021 for COVID-19 immunization and felt fine (no adverse event). On an unspecified date in Apr2021, four days after the second vaccination, the patient was sick for seven days with chills. On an unspecified date in 2021, the patient had terrible side effects such as muscle ache and fever ("99 something") for 7 days. On an unspecified date in 2021, the patient experienced headache, blood pressure high, irregular heartbeat, atrial fibrillation and the calf was "real bad"- it was hard for the patient to walk. The patient called her doctor and got tested for COVID-19 two weeks after the vaccination, in May2021, with negative results. The doctor stated that the patient got so sick from the shot. On an unspecified date in 2021, the patient's thumb was like a blood clot to the thumb (blood clot in her finger), the tip was numb and real cold- there was no circulation going on. The patient went to the emergency room where an ultrasound was performed on the arm to see if there were any blood clots in there, with unknown results. The patient was treated with an unspecified "pill" for irregular heartbeat. The patient was scheduled for an echocardiogram and heart monitor. The clinical outcome of atrial fibrillation, blood clot in her finger, thumb right now is real cold, the tip of my thumb is numb, "tip was numb and real cold- there was no circulation going on", irregular heartbeat, blood pressure high, headache, muscle ache, chills, sick, fever, "hard for me to walk" was unknown.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Chills; sick; Fever; hard for me to walk; Atrial fibrillation; blood clot in her finger; thumb right now is real cold; the tip of my thumb is numb; tip was numb and real cold- there was no circulation going on; Irregular heartbeat; Blood pressure high; Headache; Muscle ache; This is a spontaneous report from a contactable consumer, the patient, via the Pfizer-sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: Unknown), via an unspecified route of administration on 19Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 19Mar2021 for COVID-19 immunization and felt fine (no adverse event). On an unspecified date in Apr2021, four days after the second vaccination, the patient was sick for seven days with chills. On an unspecified date in 2021, the patient had terrible side effects such as muscle ache and fever ("99 something") for 7 days. On an unspecified date in 2021, the patient experienced headache, blood pressure high, irregular heartbeat, atrial fibrillation and the calf was "real bad"- it was hard for the patient to walk. The patient called her doctor and got tested for COVID-19 two weeks after the vaccination, in May2021, with negative results. The doctor stated that the patient got so sick from the shot. On an unspecified date in 2021, the patient's thumb was like a blood clot to the thumb (blood clot in her finger), the tip was numb and real cold- there was no circulation going on. The patient went to the emergency room where an ultrasound was performed on the arm to see if there were any blood clots in there, with unknown results. The patient was treated with an unspecified "pill" for irregular heartbeat. The patient was scheduled for an echocardiogram and heart monitor. The clinical outcome of atrial fibrillation, blood clot in her finger, thumb right now is real cold, the tip of my thumb is numb, "tip was numb and real cold- there was no circulation going on", irregular heartbeat, blood pressure high, headache, muscle ache, chills, sick, fever, "hard for me to walk" was unknown.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills two different times kind of week; fever; This is a spontaneous report from a contactable consumer (Patient brother). A female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: unknown and Expire Date: unknown), via an unspecified route of administration on an unspecified date as an unknown, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, patient had chills two different times kind of week, and fever. The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Pyrexia
Clinical narrative: lost consciousness/fainted; Feeling feverish; feeling lightheaded/dizzy; drenched in sweat; This is a spontaneous report received from a contactable consumer (the patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the right arm on 06May2021 16:30 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included: ethinylestradiol/ norethisterone acetate (LARIN 1.5/30) and multivitamin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the right arm on 15Apr2021 16:30 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient woke up at 03:00 on 07May2021 (also reported as 03:05), the night after receiving her second dose of COVID-19 vaccine, feeling feverish and dizzy. She got up to urinate. While she was on the toilet, she started feeling lightheaded and lost consciousness (07May2021 03:00). The next thing she remembered was coming to on the bathroom floor, drenched in sweat (07May2021 03:00). She had been unconscious for two minutes. This was the first time that she had ever fainted. A doctor or other healthcare professional office/clinic visit was involved. No treatment was received. The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   Information about lot number has been requested.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dyspnoea, Laboratory test, Oedema peripheral
Clinical narrative: shortness of breath; temperature; I had edema and swelling in my lower extremities, my feet and my legs; soreness in my arm; diarrhea/ frequent and loose bowels; body aches and pains; a bit gastro intestinal upset, distress; This is a spontaneous report from a contactable consumer (patient). A 62-year-old patient of an unspecified gender received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCCINE), dose 1 via an unspecified route of administration on 24Apr2021 (Batch/Lot Number: ER873U) as a single dose in the Left arm/ left shoulder (at 62 years of age) for COVID-19 immunization and dexamethasone sodium phosphate (DEXAMETASON), unspecified route, dates, dose and indication. Medical history included gastrointestinal (GI) bleed, ulcer, glaucoma and allergies. Concomitant medications included enteric coated acetylsalicylic acid (BABY ASPIRIN) 81mg, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]), cetirizine hydrochloride (ZYRTEC ALLERGY) and 3 medications for glaucoma. The patient had significant soreness in the arm later that evening, initially they had nothing. About nighttime, it was very sore and they had body aches and pains. The patient did not take anything for it. The patient had quite a bit GI upset and distress right after taking the vaccine. They had diarrhea and some frequent and loose bowels. The GI upset started before the patient even left the pharmacy. They stayed there for a good hour. The patient had was shortness of breath that was intermittent. On 28Apr2021, they had edema and swelling in the lower extremities, feet and legs. The patient's legs started swelling when they had edema, food retention and swelling after having taken the vaccine. Although the patient did not have a temperature, they went to the ER. Because of their history of GI bleed, they were not able to take anything so they were administered an IV infusion of Dexamethasone on 28Apr2021. They tested and the patient's heart was fine. The patient was concerned whether taking the dexamethasone after the first dose would diminish the efficacy of the vaccine or the efficacy of the second dose and will that interfere with the upcoming administration. The patient was not going to take another dose of the Dexamethasone. It had to be given because they could not take aspirin for temperature so they had an infusion of dexamethasone. The outcome of soreness in the arm, body aches and pains, GI upset/ distress, diarrhea/ frequent and loose bowels, shortness of breath, edema lowere extremities, feet, legs, food retention and temperature was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: shortness of breath; temperature; I had edema and swelling in my lower extremities, my feet and my legs; soreness in my arm; diarrhea/ frequent and loose bowels; body aches and pains; a bit gastro intestinal upset, distress; This is a spontaneous report from a contactable consumer (patient). A 62-year-old patient of an unspecified gender received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCCINE), dose 1 via an unspecified route of administration on 24Apr2021 (Batch/Lot Number: ER873U) as a single dose in the Left arm/ left shoulder (at 62 years of age) for COVID-19 immunization and dexamethasone sodium phosphate (DEXAMETASON), unspecified route, dates, dose and indication. Medical history included gastrointestinal (GI) bleed, ulcer, glaucoma and allergies. Concomitant medications included enteric coated acetylsalicylic acid (BABY ASPIRIN) 81mg, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]), cetirizine hydrochloride (ZYRTEC ALLERGY) and 3 medications for glaucoma. The patient had significant soreness in the arm later that evening, initially they had nothing. About nighttime, it was very sore and they had body aches and pains. The patient did not take anything for it. The patient had quite a bit GI upset and distress right after taking the vaccine. They had diarrhea and some frequent and loose bowels. The GI upset started before the patient even left the pharmacy. They stayed there for a good hour. The patient had was shortness of breath that was intermittent. On 28Apr2021, they had edema and swelling in the lower extremities, feet and legs. The patient's legs started swelling when they had edema, food retention and swelling after having taken the vaccine. Although the patient did not have a temperature, they went to the ER. Because of their history of GI bleed, they were not able to take anything so they were administered an IV infusion of Dexamethasone on 28Apr2021. They tested and the patient's heart was fine. The patient was concerned whether taking the dexamethasone after the first dose would diminish the efficacy of the vaccine or the efficacy of the second dose and will that interfere with the upcoming administration. The patient was not going to take another dose of the Dexamethasone. It had to be given because they could not take aspirin for temperature so they had an infusion of dexamethasone. The outcome of soreness in the arm, body aches and pains, GI upset/ distress, diarrhea/ frequent and loose bowels, shortness of breath, edema lowere extremities, feet, legs, food retention and temperature was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Palpitations, Rash, Rectal haemorrhage
Clinical narrative: uncommon rectal bleeding and extreme diahrrea; Heart palpitations; lightheaded; uncommon rectal bleeding and extreme diahrrea; vomiting; legs and arms rash; This is a spontaneous report from contactable consumer (patient). A 62-year-old non-pregnant female patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration, administered in the left arm (deltoid) on 19Apr2021 at 09:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included lisinopril for an unspecified indication, start and stop date were not reported; levothyroxine sodium for an unspecified indication, start and stop date were not reported; furosemide for an unspecified indication, start and stop date were not reported; valproate semisodium (DIVALPROEX) for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration, administered in the left arm (deltoid) on 22Mar2021 at 09:00  (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 01 :00 AM, the patient experienced uncommon rectal bleeding (medically significant) and extreme diahrrea, heart palpitations, lightheaded, vomiting, and legs and arms rash. The events resulted in Emergency room/department or urgent care visit. The patient was given unspecified I.V. drip, and unspecified meds and underwent CAT scan, specimens, and EKG, no results provided. The outcome of the events, uncommon rectal bleeding and extreme diahrrea, heart palpitations, lightheaded, vomiting, and legs and arms rash was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: uncommon rectal bleeding and extreme diahrrea; Heart palpitations; lightheaded; uncommon rectal bleeding and extreme diahrrea; vomiting; legs and arms rash; This is a spontaneous report from contactable consumer (patient). A 62-year-old non-pregnant female patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration, administered in the left arm (deltoid) on 19Apr2021 at 09:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included lisinopril for an unspecified indication, start and stop date were not reported; levothyroxine sodium for an unspecified indication, start and stop date were not reported; furosemide for an unspecified indication, start and stop date were not reported; valproate semisodium (DIVALPROEX) for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration, administered in the left arm (deltoid) on 22Mar2021 at 09:00  (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 01 :00 AM, the patient experienced uncommon rectal bleeding (medically significant) and extreme diahrrea, heart palpitations, lightheaded, vomiting, and legs and arms rash. The events resulted in Emergency room/department or urgent care visit. The patient was given unspecified I.V. drip, and unspecified meds and underwent CAT scan, specimens, and EKG, no results provided. The outcome of the events, uncommon rectal bleeding and extreme diahrrea, heart palpitations, lightheaded, vomiting, and legs and arms rash was unknown.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Accident, Anxiety, Atrial fibrillation, Computerised tomogram, Dysphemia
Clinical narrative: She fell and had an accident; She fell and had an accident; The hospital was going to send her home, but her A-Fib went off suddenly; she couldn't breathe; they treated her lungs for inflammation; to see if she had pneumonia. She was put on antibiotics; Anxiety; fatigue / She is very fatigued; She has memory issues since hospitalization; She is now stuttering; This is a spontaneous report from a contactable consumer (daughter) An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunisation and started to receive palbociclib (IBRANCE) via an unspecified route of administration on an unspecified date to an unspecified date at 100mg, unspecified frequency and via an unspecified route of administration on an unspecified date to an unspecified date at 75mg, unspecified frequency, for an unspecified indication. Medical history included atrial fibrillation (A-Fib) from an unspecified date and unspecified if ongoing. Concomitant medications were not reported. On unspecified dates the patient experienced she fell and had an accident, the hospital was going to send her home, but her A-Fib went off suddenly, she could not breathe, they treated her lungs for inflammation, to see if she had pneumonia. She was put on antibiotics, anxiety, fatigue / she is very fatigued, she has memory issues since hospitalization, and she is now stuttering. The clinical course was reported as follows: "My mother has anxiety and fatigue as her main symptoms. She did go into the hospital recently. She fell and had an accident. My mother got the vaccine a day before the event happened, so not sure if that contributed to the accident. The hospital was going to send her home, but her atrial fibrillation (A-Fib) went off suddenly and she could not breathe. They almost sent her to the intensive care unit (ICU). They got her and her heart rate stabilized. She had difficulty breathing, so they treated her lungs for inflammation. They did a computerized axial tomography (cat) scan of her lungs to see if she had pneumonia. She was put on antibiotics. She went down on the dose of palbociclib from 100mg to 75mg. She was very fatigued. She had adverse events to the antibiotics. She became psychotic on them. She had memory issues since hospitalization. She was now stuttering."  The action taken in response to the events for palbociblib was dose reduced. The clinical outcomes of the events she fell and had an accident, the hospital was going to send her home, but her A-Fib went off suddenly, she could not breathe, they treated her lungs for inflammation, to see if she had pneumonia. She was put on antibiotics, anxiety, fatigue / she is very fatigued, she has memory issues since hospitalization, and she is now stuttering were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.