chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Dry throat, Pruritus
Clinical narrative: dry throat; itching; This is a spontaneous report from a contactable nurse. A 22-year-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced multiple spots where he was itching and reported a "dry throat or something like that." The patient's vital signs did not change and did not have any other anaphylaxis reaction. The outcome was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in jaw
Clinical narrative: chills/ shivering and chattering teeth; shivering and chattering teeth to point where jaw hurt; severe headache; nausea; This is a spontaneous report received from a contactable consumer (patient). A 35-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: pfizerep7533) via an unspecified route of administration at right arm on 25Mar2021 at 10:30 (35-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history was reported as none. There were no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications (other medications) the patient received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: pfizeren6199) at left arm on 04Mar2021 at 19:45 (35-year-old at time of vaccination) at single dose, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered in pharmacy or drug store. Patient experienced chills at 3 AM following the vaccine, shivering and chattering teeth to point where jaw hurt, severe headache and nausea (all from 26Mar2021 03:00) for four days following 2nd dose vaccine. Adverse events did not result in emergency room visit or physician office visit. Seriousness was reported as no. Since the vaccination, the patient has not been tested for COVID 19. No therapeutic measures were taken as a result of the event. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient and his wife took first dose of Pfizer Covid vaccine on 12Mar2021 and 2 weeks later both of them contracted COVID-19  infection/COVID-19 test positive; patient and his wife took first dose of Pfizer Covid vaccine on 12Mar2021 and 2 weeks later both of them contracted COVID-19  infection/COVID-19 test positive; This is a spontaneous report from a contactable consumer received from a Pfizer-sponsored program. A 79-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient and his wife took first dose of Pfizer COVID vaccine on 12Mar2021 and 2 weeks later both of them contracted COVID-19 infection/ COVID-19 test positive on an unspecified date in Mar2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: patient and his wife took first dose of Pfizer Covid vaccine on 12Mar2021 and 2 weeks later both of them contracted COVID-19  infection/COVID-19 test positive; patient and his wife took first dose of Pfizer Covid vaccine on 12Mar2021 and 2 weeks later both of them contracted COVID-19  infection/COVID-19 test positive; This is a spontaneous report from a contactable consumer received from a Pfizer-sponsored program. A 79-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient and his wife took first dose of Pfizer COVID vaccine on 12Mar2021 and 2 weeks later both of them contracted COVID-19 infection/ COVID-19 test positive on an unspecified date in Mar2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: her and her husband took first dose of pfizer covid vaccine on march 12th  and 2 weeks later both her and her husband contracted covid 19 infection.; contracted covid 19 infection; This is a spontaneous report from a contactable consumer via medical information team. A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 12Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient and her husband took first dose of pfizer covid vaccine on 12Mar21 and 2 weeks later both her and her husband contracted covid 19 infection (drug ineffective) (covid-19) (medically significant) on an unknown date in Mar2021. She was recovering at home and her husband was still in hospital due to covid infection. Her 2nd dose was due this friday. She was asking if she should get her 2nd shot this Friday. The patient lab test included covid-19: positive on an unspecified date. Outcome of the events was unknown.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: her and her husband took first dose of pfizer covid vaccine on march 12th  and 2 weeks later both her and her husband contracted covid 19 infection.; contracted covid 19 infection; This is a spontaneous report from a contactable consumer via medical information team. A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 12Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient and her husband took first dose of pfizer covid vaccine on 12Mar21 and 2 weeks later both her and her husband contracted covid 19 infection (drug ineffective) (covid-19) (medically significant) on an unknown date in Mar2021. She was recovering at home and her husband was still in hospital due to covid infection. Her 2nd dose was due this friday. She was asking if she should get her 2nd shot this Friday. The patient lab test included covid-19: positive on an unspecified date. Outcome of the events was unknown.  Information about Lot/Batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: blood pressure went up over 210/110; This is a spontaneous report from a contactable consumer reporting for herself. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6205/expiration date: not provided), via an unspecified route of administration, on 06Mar2021 at 13:45 (at the age of 63 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included high blood pressure. The patient had known allergies to sulfa drugs and  sulfamethoxazole and trimethoprim (BACTRIM). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included olmesartan medoxomil 20mg, naproxen, and fexofenadine.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Mar2021 at 03:00, the patient experienced blood pressure went up over 210/110. The clinical course was as follows: within 3 days of having the vaccine, her blood pressure went up over 210/110 (as measured by EMT).  The patient was on blood pressure medication but have never had a blood pressure reading that high before. One reading during that same day was 247/100 but dropped to 160/90 when she took a second reading.  The patient took blood pressure medicine but remained high. The event blood pressure went up over 210/110 was considered serious (medically significant). The event resulted in an Emergency Room visit. Treatment was received for the event blood pressure went up over 210/110, which included additional blood pressure medication and diazepam (VALIUM). The outcome of the event blood pressure went up over 210/110 was recovered on an unspecified date in Mar2021. Since the vaccination, the patient had not been tested for COVID-19.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Urticaria
Clinical narrative: broke out with hives on her face and hands; Swollen lymph nodes in throat; This is spontaneous report received from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in left arm on 25Mar2021 16:30 (Batch/Lot Number: ER8732) (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included benign brain tumor removal, seizures (previous seizures prior to surgery), penicillin (PCN) allergy and sulfa drugs allergy. Concomitant medications included topiramate (TOPAMAX), eletriptan hydrobromide (RELPAX), ergocalciferol (VITAMIN D) and ascorbic acid (VITAMIN C), all were taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient broke out with hives on her face and hands and had swollen lymph nodes in throat on 27Mar2021 08:00. The patient went to emergency room/ department or urgent care due to the events, broke out with hives on her face and hands and swollen lymph nodes in throat. The patient received antihistamine as the treatment for the events, broke out with hives on her face and hands and swollen lymph nodes in throat and the patient was also offered steroid but she declined it. The outcome of events, broke out with hives on her face and hands and swollen lymph nodes in throat, was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; pain in her back; This is a spontaneous report from a contactable other healthcare professional (patient) via the Pfizer-sponsored program. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received her first dose of the Pfizer BioNTech COVID-19 vaccine on 12Mar2021 and stated that 9 days after, on 21Mar2021, she tested positive for COVID-19. The patient added that today (unspecified date) is her 11th day of quarantine and was told by her doctor that she only needed to quarantine for 10 days. She would like to know if she will be able to get her second dose of the vaccine which is due on Friday 02Apr2021. She reported that she is feeling better but "not 100%" as she stated that yesterday (unspecified date) and today (unspecified date) she was experiencing pain in her back that she thinks is actually related to her lungs, and is thinking about going to get an X-ray for it. The outcome of event Covid-19 was recovering; outcome of event back pain was unknown.   Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, COVID-19, Frustration tolerance decreased, Malaise
Clinical narrative: still not feeling well; pressure was high; Frustration/frustration and dissatisfaction; diagnosed on March 8th with covid; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received her first shot on 01Mar2021, she was diagnosed on 08Mar2021 with covid. Her second shot was due on 21Mar2021, but she didn't take it because "she was still not feeling well. She rescheduled it for today at 6pm but her pressure was high", states "the hospital told her that once you get your first shot if you have covid you're supposed to get your next dose after 90 days and told her to call Pfizer". Caller vocalized frustration that she was being "talked around in circles" reporting that her doctor knows less than she does. The patient wanted to know what she should do about her second shot if she had covid after having my first dose. She also asked what is the timing that is recommended between the shots. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: still not feeling well; pressure was high; Frustration/frustration and dissatisfaction; diagnosed on March 8th with covid; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received her first shot on 01Mar2021, she was diagnosed on 08Mar2021 with covid. Her second shot was due on 21Mar2021, but she didn't take it because "she was still not feeling well. She rescheduled it for today at 6pm but her pressure was high", states "the hospital told her that once you get your first shot if you have covid you're supposed to get your next dose after 90 days and told her to call Pfizer". Caller vocalized frustration that she was being "talked around in circles" reporting that her doctor knows less than she does. The patient wanted to know what she should do about her second shot if she had covid after having my first dose. She also asked what is the timing that is recommended between the shots. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid 19; This is a spontaneous report received from a  non-contactable consumer (patient herself) via medical information team..A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 12MAR2021 and on 16MAR2021, she tested positive for COVID-19.  Patient was told it was ok for her to get the second dose but she wanted to make sure. She also said that she felt great compared to what she did before, she completed the 14 days quarantine and she will be taking the COVID test tomorrow or Friday from the time of report. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia, Dizziness, Nausea
Clinical narrative: Dizziness; Nauscious; fluorescent orange urine; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Mar2021 (Lot Number: ER8732) at the age of 52-year-old as single dose in arm left for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No allergy to medications, food, or other products. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and hasn't been tested for COVID-19 since the vaccination. The patient experienced Dizziness, Nauscious, fluorescent orange urine on 31Mar2021 09:45 AM. No treatment received for the events. The events were resolved on 31Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19 (nasal swab) test showed positive; COVID-19 (nasal swab) test showed positive; This is a spontaneous report received from a contactable Other HCP (patient). A 39-year-old non-pregnant female patient received first dose of BNT162B2 (LOT#: EL1283) intramuscularly administered in left arm on 12Jan2021 at single dose, and second dose of BNT162B2 (Lot Number: EL9265), via an unspecified route of administration, administered in left arm on 02Feb2021 at single dose for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD), depression, seasonal allergies. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was Hospital. Concomitant medications included bupropion hydrochloride (WELLBUTRIN XL), dextroamphetamine hydrochloride, amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), vitamin D3, loratadine (CLARITINE). On 27Mar2021 at 07:00, patient performed COVID-19 (nasal swab) test showed positive. The event resulted to doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse event. The outcome of event was reported as recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable pharmacist (patient) via medical information team. A 69-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 24Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported) administered via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunization. The patient experienced sore arm on an unspecified date. It was reported that the patient participated in a study where they did antibody testing after the being fully vaccinated and the patient's antibody test was negative for antibodies. The patient would like to know if there would be a chance that his antibodies wore off since it has been three months since he received the second dose of the vaccine. The patient would like to know should he receive a booster dose and stated that when he had the second dose, he did not have any side effects other than a sore arm. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer (patient's daughter) via medical information team and a Pfizer-sponsored program. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Mar2021 (lot number: EN6207) as single dose (at the age of 54-years-old) for COVID-19 immunization. Medical history included blood pressure high. Concomitant medications included an unspecified blood pressure medication. The patient received her first Pfizer COVID vaccine on 17Mar2021. She tested positive for COVID on 30Mar2021. The reporter wanted to know if she should keep her appointment on 07Apr2021 to receive the second Pfizer COVID vaccine and if the patient was allowed to go out in public to get the vaccine since the patient was supposed to be quarantining for 10 days. The outcome of the events was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chronic fatigue syndrome, Condition aggravated, Cough, Delirium
Clinical narrative: delirious; wheezing; fever up to 102.7; shortness of breath; coughing; slurring; body and face were swollen all over; body and face were swollen all over; new onset of widespread bodily pain; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the right arm on 10Mar2021 at 11:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history included hypersensitivity to iodine contrast, anaphylactic reaction, hypermobile Ehlers-Danlos Syndrome, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) being evaluated for mast cell activation syndrome. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), montelukast, estrogens esterified/ methyltestosterone (ESTROGEN/METHYLTES), and other unspecified medication. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 10Mar2021 at 14:00 the patient experienced a fever up to 102.7, extreme shortness of breath on standing, coughing and wheezing, delirious and slurring, body and face were swollen all over. The patient called the doctor on call at her primary care physicians office and treated the symptoms with diphenhydramine (BENADRYL), paracetamol (TYLENOL) and mast cell stabilizers. The patient had a bad flare of ME/CFS symptoms, in Mar2021, for about 7 days. She also experienced a new onset of widespread bodily pain in Mar2021 which didn't go away until the second vaccination. The patient received the second dose of BNT162B2 (Lot: ER8730) in the left arm on 31Mar2021 and had a better experience. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of delirious, wheezing, fever up to 102.7, shortness of breath, coughing, slurring, body and face were swollen all over was resolved with sequel on Mar2021; pain was resolved on 31Mar2021; bad flare of ME/CFS symptoms for about 7 days was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Dyspnoea, Pain, Post viral fatigue syndrome, Pyrexia
Clinical narrative: delirious; wheezing; fever up to 102.7; shortness of breath; coughing; slurring; body and face were swollen all over; body and face were swollen all over; new onset of widespread bodily pain; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the right arm on 10Mar2021 at 11:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history included hypersensitivity to iodine contrast, anaphylactic reaction, hypermobile Ehlers-Danlos Syndrome, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) being evaluated for mast cell activation syndrome. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), montelukast, estrogens esterified/ methyltestosterone (ESTROGEN/METHYLTES), and other unspecified medication. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 10Mar2021 at 14:00 the patient experienced a fever up to 102.7, extreme shortness of breath on standing, coughing and wheezing, delirious and slurring, body and face were swollen all over. The patient called the doctor on call at her primary care physicians office and treated the symptoms with diphenhydramine (BENADRYL), paracetamol (TYLENOL) and mast cell stabilizers. The patient had a bad flare of ME/CFS symptoms, in Mar2021, for about 7 days. She also experienced a new onset of widespread bodily pain in Mar2021 which didn't go away until the second vaccination. The patient received the second dose of BNT162B2 (Lot: ER8730) in the left arm on 31Mar2021 and had a better experience. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of delirious, wheezing, fever up to 102.7, shortness of breath, coughing, slurring, body and face were swollen all over was resolved with sequel on Mar2021; pain was resolved on 31Mar2021; bad flare of ME/CFS symptoms for about 7 days was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face, Wheezing
Clinical narrative: delirious; wheezing; fever up to 102.7; shortness of breath; coughing; slurring; body and face were swollen all over; body and face were swollen all over; new onset of widespread bodily pain; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the right arm on 10Mar2021 at 11:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history included hypersensitivity to iodine contrast, anaphylactic reaction, hypermobile Ehlers-Danlos Syndrome, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) being evaluated for mast cell activation syndrome. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), montelukast, estrogens esterified/ methyltestosterone (ESTROGEN/METHYLTES), and other unspecified medication. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 10Mar2021 at 14:00 the patient experienced a fever up to 102.7, extreme shortness of breath on standing, coughing and wheezing, delirious and slurring, body and face were swollen all over. The patient called the doctor on call at her primary care physicians office and treated the symptoms with diphenhydramine (BENADRYL), paracetamol (TYLENOL) and mast cell stabilizers. The patient had a bad flare of ME/CFS symptoms, in Mar2021, for about 7 days. She also experienced a new onset of widespread bodily pain in Mar2021 which didn't go away until the second vaccination. The patient received the second dose of BNT162B2 (Lot: ER8730) in the left arm on 31Mar2021 and had a better experience. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of delirious, wheezing, fever up to 102.7, shortness of breath, coughing, slurring, body and face were swollen all over was resolved with sequel on Mar2021; pain was resolved on 31Mar2021; bad flare of ME/CFS symptoms for about 7 days was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Nausea, Pyrexia, Syncope
Clinical narrative: Fainted; Fever 101.6; Vomiting; Nausea; Dizzy; This is a spontaneous report from a contactable consumer reporting for herself. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN 9581/expiration date: not provided), via an unspecified route of administration, on 31Mar2021 at 10:45 (at the age of 48 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included lupus, scleroderma, Mixed connective tissue disease (MCTD), and high blood pressure (HBP). The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydroxychloroquine 200 mg, and losartan 50mg.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021 at 19:00, the patient experienced fainted, fever 101.6, vomiting, nausea and dizzy. The patient did not receive any treatment for these events. The outcome of the events fainted, fever 101.6, vomiting, nausea and dizzy was unknown. Since the vaccination, the patient had not been tested for COVID-19.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fainted; Fever 101.6; Vomiting; Nausea; Dizzy; This is a spontaneous report from a contactable consumer reporting for herself. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN 9581/expiration date: not provided), via an unspecified route of administration, on 31Mar2021 at 10:45 (at the age of 48 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included lupus, scleroderma, Mixed connective tissue disease (MCTD), and high blood pressure (HBP). The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydroxychloroquine 200 mg, and losartan 50mg.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021 at 19:00, the patient experienced fainted, fever 101.6, vomiting, nausea and dizzy. The patient did not receive any treatment for these events. The outcome of the events fainted, fever 101.6, vomiting, nausea and dizzy was unknown. Since the vaccination, the patient had not been tested for COVID-19.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Computerised tomogram, Erythema, Pulmonary embolism, Rash
Clinical narrative: small peripheral right lower lobe pulmonary embolism; anaphylaxis; whole body rash and erythema; whole body rash and erythema; This is a spontaneous report received from a contactable physician. A 57-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 01Mar2021 (at the age of 57-year-old) as single dose for COVID-19 immunization. Medical history included joint pain and ongoing 45-packs per year smoker. The patient did not have any allergies to medications, food, or other products. Concomitant medications included salbutamol (ALBUTEROL), hydroxyzine (manufacturer unknown) and diclofenac sodium (manufacturer unknown). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The physician reported, "patient had anaphylaxis and whole-body rash and erythema on separate hospitalization (I was not involved for this but reviewed photos and this was reportedly attributed to the vaccine; I'm uncertain if that event was reported). On hospitalization, the patient was with small peripheral right lower lobe pulmonary embolism on a CT PE (CT scan for Pulmonary Embolus). Patient is an active smoker. No other obvious cause." As a result of the adverse events (unspecified), the patient was hospitalized for one day. The start date of the events was on 29Mar2021. The patient was treated with apixaban (for pulmonary embolism). The clinical outcome of "anaphylaxis and whole-body rash and erythema" and "small peripheral right lower lobe pulmonary embolism" was resolving.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events pulmonary embolism, anaphylactic reaction and associated generalized rash and generalized erythema. 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Dizziness, Feeling hot
Clinical narrative: Light-headed; Diarrhea; Puking; No appetite; Sweaty; Feet and legs got hot; Shaking uncontrollably so she put three blankets on and turned up the heat to 74°; Sick; Dying or having a panic attack; Heart was racing erratically; Bad headache; This is a spontaneous report from a contactable healthcare professional (patient). A 35-years-old non-pregnant female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose, via an unspecified route of administration, in the left arm on 29Mar2021 at 15:15 (Batch/Lot Number: ER8732) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient reported no known allergies. The patient did not received any other vaccine within four weeks of the BNT162B2 vaccine. The patient did not have COVID-19 prior to vaccination. Concomitant medications included diphenhydramine hydrochloride (BENADRYL), hydroxyzine 25mg, paracetamol (TYLENOL), pseudoephedrine hydrochloride (SUDAFED), ibuprofen; all taken for unspecified indications, start and stop dates were not reported. On 29Mar2021, about three and a half hours after the first dose of the vaccine, the patient experienced a really bad headache at about 6:30pm. The patient did yoga from 7:00 pm to 8:00 pm, had dinner at 8:30 pm,  had a shower at 9:00pm, then right around 10:00pm she was lying in bed and her feet and legs got really hot. She started to feel really sweaty and sick then pressure in her butt. She went to the bathroom a few times first it was normal then it was diarrhea. She threw up about six times. Her throat felt weird while puking. She was sitting on the bathroom floor between puking and pooping and her heart was racing erratically. She was trying to calm herself down. She felt like she was dying or having a panic attack. After about 2 hours she was able to go in her room and lay in bed and she could not stop shaking uncontrollably. She put three blankets on and turned up the heat to 74°. She finally fell asleep but woke up at 5am. She pooped a small bowel movement and had no appetite. She didn't eat until noon but it was small (meal). She still hardly has any appetite today (31Mar2021). She has been light-headed off and on for 2 days. No treatment was received for the events. The patient did not get tested for COVID-19 post vaccination. The outcome of the events dying or having a panic attack, headache, feet and legs got hot, sweaty, diarrhea, light-headed, sick, puking, shaking uncontrollably, no appetite, heart racing erratically was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Malaise, Palpitations, Panic attack
Clinical narrative: Light-headed; Diarrhea; Puking; No appetite; Sweaty; Feet and legs got hot; Shaking uncontrollably so she put three blankets on and turned up the heat to 74°; Sick; Dying or having a panic attack; Heart was racing erratically; Bad headache; This is a spontaneous report from a contactable healthcare professional (patient). A 35-years-old non-pregnant female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose, via an unspecified route of administration, in the left arm on 29Mar2021 at 15:15 (Batch/Lot Number: ER8732) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient reported no known allergies. The patient did not received any other vaccine within four weeks of the BNT162B2 vaccine. The patient did not have COVID-19 prior to vaccination. Concomitant medications included diphenhydramine hydrochloride (BENADRYL), hydroxyzine 25mg, paracetamol (TYLENOL), pseudoephedrine hydrochloride (SUDAFED), ibuprofen; all taken for unspecified indications, start and stop dates were not reported. On 29Mar2021, about three and a half hours after the first dose of the vaccine, the patient experienced a really bad headache at about 6:30pm. The patient did yoga from 7:00 pm to 8:00 pm, had dinner at 8:30 pm,  had a shower at 9:00pm, then right around 10:00pm she was lying in bed and her feet and legs got really hot. She started to feel really sweaty and sick then pressure in her butt. She went to the bathroom a few times first it was normal then it was diarrhea. She threw up about six times. Her throat felt weird while puking. She was sitting on the bathroom floor between puking and pooping and her heart was racing erratically. She was trying to calm herself down. She felt like she was dying or having a panic attack. After about 2 hours she was able to go in her room and lay in bed and she could not stop shaking uncontrollably. She put three blankets on and turned up the heat to 74°. She finally fell asleep but woke up at 5am. She pooped a small bowel movement and had no appetite. She didn't eat until noon but it was small (meal). She still hardly has any appetite today (31Mar2021). She has been light-headed off and on for 2 days. No treatment was received for the events. The patient did not get tested for COVID-19 post vaccination. The outcome of the events dying or having a panic attack, headache, feet and legs got hot, sweaty, diarrhea, light-headed, sick, puking, shaking uncontrollably, no appetite, heart racing erratically was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Light-headed; Diarrhea; Puking; No appetite; Sweaty; Feet and legs got hot; Shaking uncontrollably so she put three blankets on and turned up the heat to 74°; Sick; Dying or having a panic attack; Heart was racing erratically; Bad headache; This is a spontaneous report from a contactable healthcare professional (patient). A 35-years-old non-pregnant female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose, via an unspecified route of administration, in the left arm on 29Mar2021 at 15:15 (Batch/Lot Number: ER8732) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient reported no known allergies. The patient did not received any other vaccine within four weeks of the BNT162B2 vaccine. The patient did not have COVID-19 prior to vaccination. Concomitant medications included diphenhydramine hydrochloride (BENADRYL), hydroxyzine 25mg, paracetamol (TYLENOL), pseudoephedrine hydrochloride (SUDAFED), ibuprofen; all taken for unspecified indications, start and stop dates were not reported. On 29Mar2021, about three and a half hours after the first dose of the vaccine, the patient experienced a really bad headache at about 6:30pm. The patient did yoga from 7:00 pm to 8:00 pm, had dinner at 8:30 pm,  had a shower at 9:00pm, then right around 10:00pm she was lying in bed and her feet and legs got really hot. She started to feel really sweaty and sick then pressure in her butt. She went to the bathroom a few times first it was normal then it was diarrhea. She threw up about six times. Her throat felt weird while puking. She was sitting on the bathroom floor between puking and pooping and her heart was racing erratically. She was trying to calm herself down. She felt like she was dying or having a panic attack. After about 2 hours she was able to go in her room and lay in bed and she could not stop shaking uncontrollably. She put three blankets on and turned up the heat to 74°. She finally fell asleep but woke up at 5am. She pooped a small bowel movement and had no appetite. She didn't eat until noon but it was small (meal). She still hardly has any appetite today (31Mar2021). She has been light-headed off and on for 2 days. No treatment was received for the events. The patient did not get tested for COVID-19 post vaccination. The outcome of the events dying or having a panic attack, headache, feet and legs got hot, sweaty, diarrhea, light-headed, sick, puking, shaking uncontrollably, no appetite, heart racing erratically was recovering.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Lyme disease
Clinical narrative: knee flexibility was back to almost nothing; This is a spontaneous report from a contactable consumer.  A 46-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration the left arm on 24Mar2021 at 14:15 as a single dose for COVID-19 immunisation. Medical history included Lyme disease. There were no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient had not received other medications in the past two weeks. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 14:00, the patient experienced knee flexibility was back to almost nothing. Patient had just recovered from Lyme and took antibiotics in February. Lyme disease had impacted his knee joint, and he was fully flexible on the knee. Within 24 hours of the vaccine dose, his knee flexibility was back to almost nothing. Patient had another Lyme test that came back negative. The patient underwent lab tests and procedures which included laboratory test: negative. No treatment was given for knee flexibility was back to almost nothing. Clinical outcome of the event knee flexibility was back to almost nothing was not recovered.  Information on the lot/batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Feeling abnormal, Tremor
Clinical narrative: Vaccine- Related Anxiety; experience shaky, feeling like she "was seeing stars but not passing out; Lightheaded; experience shaky, feeling like she "was seeing stars but not passing out; This is a spontaneous report from a non-contactable other hcp. A 20-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 19Mar2021 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated that during her 15 minute waiting period after the injection, the patient began to experience shaky, Feeling like she "was seeing stars but not passing out". Lightheaded on 19Mar2021. She denied rash, hives, welts, difficulty Breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial Swelling, lip swelling and tongue swelling. Treatment included: water and snacks. The report considered as a non serious. Differential Diagnosis: Vaccine- Related Anxiety (include misc mental health) and Red flag symptoms. The outcome of the events experience shaky, feeling like she "was seeing stars but not passing out and Lightheaded was reported as recovered on 19Mar2021 and other event was reported as unknown.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Diarrhoea, Palpitations
Clinical narrative: bad diarrhea; heart racing for about an hour and a half; chills; temperature; This is a spontaneous report from a contactable consumer or other non-HCP. A male patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration on 17Mar2021 as single dose for covid-19 immunization. Medical history included arterial occlusive disease from an unknown date and unknown if ongoing. Concomitant medication(s) included acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, start and stop date were not reported.  The patient experienced bad diarrhea (diarrhoea) (non-serious) on an unspecified date, heart racing for about an hour and a half (palpitations) (non-serious) on an unspecified date, chills (chills) (non-serious) on an unspecified date, temperature (body temperature increased) (non-serious) on an unspecified date. The outcome of the events were unknown.