chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Death, Syncope
Clinical narrative: major stroke; This is a spontaneous report from a contactable consumer (patient's husband) via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was in the hospital due to a major stroke on an unspecified date. She can't move her right arm, right leg and she cannot talk. Patient's 2nd dose was due on 27Apr2021 and she can't continue to have the vaccine. Outcome of the event was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: mildly dizzy; heart palpitations; This is a spontaneous report from a non-contactable consumer (patient). A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0161), via an unspecified route of administration in the left arm, on 26Apr2021 at 10:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history or known allergies. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included estradiol (ESTROGEN) (reported as low dose), acetylsalicylic acid (BABY ASPIRIN), and omeprazole (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: ER8734), in the left arm, on 05Apr2021 at 10:15 (at the age of 51-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced heart palpitations on 26Apr2021 at 10:35 and mildly dizzy on 26Apr2021 at 10:40, which were reported as serious and medically significant. The clinical course was reported as: The patient experienced heart palpitations five minutes after receiving the vaccine, which went on for three minutes. Then, five minute later, she got mildly dizzy and was then fine for 10 minutes. This was reported to have repeated this cycle for two hours. The patient did not receive any treatment as a result of the events. The clinical outcome of heart palpitations and mildly dizzy was recovered on 26Apr2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: patient started her period the day of the vaccination and has not stopped bleeding since; This is a spontaneous report from a non-contactable consumer, reporting for herself. A 32-year-old non-pregnant female patient received the first dose of the bnt162b2 (BNT162B2), via an unspecified route of administration in the left arm on 09Apr2021 at 16:00 at a single dose for covid-19 immunisation. The patient received the vaccine in the hospital. The medical history was not reported. Concomitant medications included ergocalciferol/retinol palmitate (VITAMINS A & D) taken for an unspecified indication from 09Apr2021 to an unspecified stop date; cetirizine hydrochloride (ZYRTEC R) taken for an unspecified indication from 09Apr2021 to an unspecified stop date; rhamnus cathartica/rhamnus purshiana/senna spp. (HERBAL) taken for an unspecified indication start and stop date were not reported. No other vaccinations received in the last four weeks. On an unspecified date, the patient started her period the day of the vaccination and has not stopped bleeding since. It has been 18 days now. No therapeutic measures were taken as a result of the event. The clinical outcome of the event was unknown.   The batch/lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Computerised tomogram, Gait disturbance
Clinical narrative: Stated that she can hardly walk and she does not know what she has.; possibly having cellulitis; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 31Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer Covid-19 on 31Mar2021, and she is scheduled for the second dose today at 9:40, but she had CT scan yesterday and she is taking antibiotics for possibly having cellulitis. Stated that she went to see two doctors and one of them just told her that it was inflammation and the other one prescribed her the antibiotics. Stated that she can hardly walk on an unspecified date in Apr2021 and she does not know what she has. She would like to know if there are any similar reports for the vaccine. Patient would like to know if she should reschedule the second dose of the Pfizer Covid-19 if she is currently taking antibiotics for possibly having cellulitis. The outcome of the events was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Diagnosis of Bells Palsy on 14Apr2021; This is a spontaneous report from a contactable consumer.   A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), dose 1 via an unspecified route of administration, administered in the left arm  on 26Mar2021, at 11:00 as single dose for covid-19 immunization.  Medical history included hypertension from an unknown date . No known allergies were noted.  There were no concomitant medications.  The patient had diagnosis of Bells palsy on 14apr2021 on 14Apr2021, at 06:00. The event resulted in Emergency room/department or urgent care visit. Prior to vaccination, the patient  had not been diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of diagnosis of bells palsy on 14apr2021, and included treatment with predisone (x 5 days) and anti-viral (x 10 days). The outcome of diagnosis of Bells palsy on 14apr2021 was not recovered.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autonomic neuropathy, Hemiparesis, Hypotension, Orthostatic hypotension, Paraesthesia
Clinical narrative: Hypotension; weakness right side of the body, arm and leg; Paresthesia; Probably post vaccinal mild Brachial Neuritis; probably with autonomic neuropathy component, producing orthostatic hypotension; probably with autonomic neuropathy component, producing orthostatic hypotension; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in Arm Left on 06Apr2021 10:30 (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hypotension, weakness right side of the body, arm and leg; paresthesia, probably post vaccinal mild brachial neuritis, probably with autonomic neuropathy component, producing orthostatic hypotension on 13Apr2021 16:00. The patient was hospitalized for a day on unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 15Apr2021. The outcome of the event was recovering.  Information about lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Radiculitis brachial, SARS-CoV-2 test
Clinical narrative: Hypotension; weakness right side of the body, arm and leg; Paresthesia; Probably post vaccinal mild Brachial Neuritis; probably with autonomic neuropathy component, producing orthostatic hypotension; probably with autonomic neuropathy component, producing orthostatic hypotension; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in Arm Left on 06Apr2021 10:30 (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hypotension, weakness right side of the body, arm and leg; paresthesia, probably post vaccinal mild brachial neuritis, probably with autonomic neuropathy component, producing orthostatic hypotension on 13Apr2021 16:00. The patient was hospitalized for a day on unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 15Apr2021. The outcome of the event was recovering.  Information about lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autonomic neuropathy, Blood test normal, Cardiac stress test, Chest pain, Computerised tomogram aorta
Clinical narrative: Hypotension; weakness right side of the body, arm and leg; Paresthesia; Probably post vaccinal mild Brachial Neuritis; probably with autonomic neuropathy component, producing orthostatic hypotension; probably with autonomic neuropathy component, producing orthostatic hypotension; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in Arm Left on 06Apr2021 10:30 (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hypotension, weakness right side of the body, arm and leg; paresthesia, probably post vaccinal mild brachial neuritis, probably with autonomic neuropathy component, producing orthostatic hypotension on 13Apr2021 16:00. The patient was hospitalized for a day on unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 15Apr2021. The outcome of the event was recovering.  Information about lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head normal, Echocardiogram normal, Hemiparesis, Hypoaesthesia, Hypotension
Clinical narrative: Hypotension; weakness right side of the body, arm and leg; Paresthesia; Probably post vaccinal mild Brachial Neuritis; probably with autonomic neuropathy component, producing orthostatic hypotension; probably with autonomic neuropathy component, producing orthostatic hypotension; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in Arm Left on 06Apr2021 10:30 (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hypotension, weakness right side of the body, arm and leg; paresthesia, probably post vaccinal mild brachial neuritis, probably with autonomic neuropathy component, producing orthostatic hypotension on 13Apr2021 16:00. The patient was hospitalized for a day on unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 15Apr2021. The outcome of the event was recovering.  Information about lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, Nerve conduction studies abnormal, Neuralgic amyotrophy, Orthostatic hypotension, Radiculitis brachial
Clinical narrative: Hypotension; weakness right side of the body, arm and leg; Paresthesia; Probably post vaccinal mild Brachial Neuritis; probably with autonomic neuropathy component, producing orthostatic hypotension; probably with autonomic neuropathy component, producing orthostatic hypotension; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in Arm Left on 06Apr2021 10:30 (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hypotension, weakness right side of the body, arm and leg; paresthesia, probably post vaccinal mild brachial neuritis, probably with autonomic neuropathy component, producing orthostatic hypotension on 13Apr2021 16:00. The patient was hospitalized for a day on unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 15Apr2021. The outcome of the event was recovering.  Information about lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Eating disorder, Eosinophilic oesophagitis, Gastrooesophageal reflux disease
Clinical narrative: chills; sore arm; nausea; acid reflux causing extreme damage to the esophagus; cannot eat or sleep; cannot eat or sleep; rapid weight loss; Eosinophilic Esophagitis; cripeling upper back pain; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1283), via an unspecified route of administration on 01Mar2021 as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1283) on 08Feb2021 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was  clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications was received within 2 weeks of vaccination. On 15Mar2021, the patient experienced chills, sore arm, nausea, acid reflux causing extreme damage to the esophagus, cannot eat or sleep, rapid weight loss, eosinophilic esophagitis, cripeling upper back pain. Therapeutic measures were taken as a result of the events and included PPI's, diet and lifestyle changes. The events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events chills, sore arm, and nausea was unknown; and the outcome of the other events was unknown. Events were serious due to disability (as reported).  Information on lot/batch number was available. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Pain in extremity, Weight decreased
Clinical narrative: chills; sore arm; nausea; acid reflux causing extreme damage to the esophagus; cannot eat or sleep; cannot eat or sleep; rapid weight loss; Eosinophilic Esophagitis; cripeling upper back pain; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1283), via an unspecified route of administration on 01Mar2021 as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1283) on 08Feb2021 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was  clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications was received within 2 weeks of vaccination. On 15Mar2021, the patient experienced chills, sore arm, nausea, acid reflux causing extreme damage to the esophagus, cannot eat or sleep, rapid weight loss, eosinophilic esophagitis, cripeling upper back pain. Therapeutic measures were taken as a result of the events and included PPI's, diet and lifestyle changes. The events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events chills, sore arm, and nausea was unknown; and the outcome of the other events was unknown. Events were serious due to disability (as reported).  Information on lot/batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: Extreme swelling and pain in both hands; Extreme swelling and pain in both hands; numbness; Left eyelid swelling; Hives on head and stomach; not feeling well; headache; This is spontaneous report received from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on an unspecified date in 2021 (pending clarification) as 2ND DOSE, SINGLE for Covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient has no medical history. Concomitant medication included birth control (unspecified). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme swelling and pain in both hands, and numbness. The patient also experienced left eyelid swelling, hives on head and stomach, generally not feeling well, and non-stop headache. The event onset date was not reported (pending clarification). There was no treatment received for the adverse event. The adverse events resulted in disability or permanent damage. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered.  Information on lot/batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid, Urticaria
Clinical narrative: Extreme swelling and pain in both hands; Extreme swelling and pain in both hands; numbness; Left eyelid swelling; Hives on head and stomach; not feeling well; headache; This is spontaneous report received from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on an unspecified date in 2021 (pending clarification) as 2ND DOSE, SINGLE for Covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient has no medical history. Concomitant medication included birth control (unspecified). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme swelling and pain in both hands, and numbness. The patient also experienced left eyelid swelling, hives on head and stomach, generally not feeling well, and non-stop headache. The event onset date was not reported (pending clarification). There was no treatment received for the adverse event. The adverse events resulted in disability or permanent damage. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered.  Information on lot/batch number was available. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0151), via an unspecified route of administration, administered in Arm Right on 13Apr2021 12:30 as 2nd dose, single for COVID-19 immunization in a pharmacy/drugstore. Medical history included allergies: sulfa from unspecified date. Concomitant medications included hydrochlorothiazide and metoprolol succinate (TOPROL) both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (Lot number: ER8727) on 22Mar2021 9:00 AM at 42 years of age in the right arm for COVID-19 immunization. No COVID-19 prior to vaccination and not tested for COVID-19 post vaccination. On 25Apr2021 18:00 the patient had a stroke. The event required emergency room and physician's office visit and the patient was hospitalized for 1 day. The patient was treated with unspecified blood thinners. The outcome of the event was recovering.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Tinnitus - 24 hours a day, 7 days a week. I believe I have hearing loss and an scheduled for ent visit this week.; Tinnitus - 24 hours a day, 7 days a week. I believe I have hearing loss and an scheduled for ent visit this week.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (non-regnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration, administered in left leg on 06Apr2021 09:30 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Vaccine facility type was pharmacy/drug store. The patient did not received 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 has not been tested for COVID-19. The patient experienced tinnitus - 24 hours a day, 7 days a week. that started on 08Apr2021 at 09:00. The patient believed she had hearing loss and was scheduled for ENT visit this week. The patient will have a hearing test (do not know next steps). The outcome of the events was not recovered. Events were reported as non-serious.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Thrombosis
Clinical narrative: leg formed a blood clot above knee; Severe pain; Numbing in arm and leg; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 23Mar2021 10:00 (Batch/Lot Number: unknown) as 1ST DOSE, SINGLE for Covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included complications from bladder mesh and mitral valve prolapse. The patient's concomitant medications included Vitamins (unspecified). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 06:00, the patient experienced severe pain followed by numbing in arm and leg, and leg formed a blood clot above knee. The patient tried to make doctor appointment but 40 days out. The patient took aspirin daily for clot and will see doctor in 2 weeks. No treatment was received for severe pain and numbing in arm and leg. The patient has not been tested for COVID-19 since the vaccination. The outcome of events severe pain and numbing in arm and leg was recovering; outcome of event leg formed a blood clot above knee was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: the hives on her face; This is a spontaneous report received from a contactable consumer (patient herself). This female patient of unspecified age received first dose of bNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiry date was not reported) via unspecified route of administration as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced hives on her face. Caller would like to know whether the hives on her face will go away and what she can do to treat them. Caller stated now she wish she had not taken the shot. The clinical outcome of the event was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Sustained, rapid heart rate; This is spontaneous report from a contactable consumer (patient) . A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 23Mar2021 (Lot Number: ER8727) as single dose , dose 2 via an unspecified route of administration, administered in right arm on 13Apr2021 14:00 (Lot Number: EW0151) as SINGLE dose for covid-19 immunisation.   Medical history included high blood pressure from an unknown date and unknown if ongoing, arrhythmia many years ago from an unknown date and unknown if ongoing.  The patient's concomitant medications were unspecified. The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  Prior to the vaccination, the patient was not diagnosed with COVID-19. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The patient sustained, rapid heart rate in Apr2021 "02:00 PM". The event occurred after dose one and dose two. The event after dose one required treatment by Urgent Care Clinic, EMS, and hospital emergency department. Treatment included adenosine in hospital. Outcome of the event sustained, rapid heart rate was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Erythema, Thrombosis, Ultrasound scan
Clinical narrative: blood clot in one of his leg; leg became red; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 23Apr2021 (at the age of 73 years old) (Lot Number: EW0169, unknown expiration) as 1st dose, single for COVID-19 immunization.  Medical history and concomitant medications were reported as none.  The patient received his first dose of COVID-19 vaccine on 23Apr2021. In the night of 24Apr2021, his leg became red and he spoke to his doctor. The experienced a blood clot in one of his leg on 25Apr2021. The patient received Eliquis for the events to be taken for 45 days. He would like to consult if he should receive the second dose after the side effect from the first dose. Patient would like to know if there have been reports of blood clots after receiving the COVID-19 vaccine. The patient is scheduled to receive his second dose on 14May2021. The patient underwent lab tests and procedures which included blood test and ultrasound on leg: unknown results on 26Apr2021. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Thrombosis
Clinical narrative: Calf muscle pain since 1 week. Clots upto 1 inch near the knee area. Observed on both legs; Calf muscle pain since 1 week. Clots upto 1 inch near the knee area. Observed on both legs; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received BNT162B2 for COVID-19 immunization on 31Mar2021 (Lot unknown=True, Lot unknown reason=Unable to locate or read the details, Administration date=31Mar2021, Administration time=02:00 PM, Dose number=1, Vaccine location=Left arm, No reaction.) On 24Apr2021, Calf muscle pain since 1 week. Clots upto 1 inch near the knee area. Observed on both legs. The patient did not receive treatment for the events. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Cardiac dysfunction, Dyspnoea exertional, Echocardiogram, Lymphadenopathy
Clinical narrative: breathing labored while walking or doing activity; swollen lymph nodes/ lymph nodes were enlarged slightly; fluid built up around heart and lungs; fluid built up around heart and lungs; white blood count was elevated; heart was weak and only working at 29% percent; heart was weak and only working at 29% percent; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 13Feb2021 at 18:00 (at the age of 43 years old) (Lot Number: EM9809, unknown expiration) as 2nd dose, single for COVID-19 immunization.  Medical history included penicillin allergy.  There were no concomitant medications.  The patient also received first dose of BNT162B2 on 23Jan2021 at 18:00 (at the age of 43 years old) (lot number: EL3247, unknown expiration) in left arm for COVID-19 immunization. After the second shot, the patient did notice swollen lymph nodes on 02Apr2021 for several days.  She noticed her breathing labored while walking or doing activity on 02Apr2021 after getting the second shot. In 8 weeks, the patient went to the ER and found that she had fluid built up around heart and lungs which started on 02Apr2021.  They also found in a CT scan that lymph nodes were enlarged slightly and that the patient's white blood count was elevated on 02Apr2021. After an echocardiogram on 02Apr2021, they determined that the patient's heart was weak and only working at 29% percent.  The patient has had no prior history of heart problems or was taking any medications. The patient was given many heart medications to strengthen the heart and treatment for the events. The events resulted in emergency room/department or urgent care visit. The patient has no COVID and was not diagnosed with COVID prior to vaccination. The patient was tested for COVID via nasal swab on 10Apr2021 with negative result. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown. The events were assessed as serious (hospitalization) for 8 days.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pericardial effusion, Pulmonary oedema, SARS-CoV-2 test, White blood cell count, White blood cell count increased
Clinical narrative: breathing labored while walking or doing activity; swollen lymph nodes/ lymph nodes were enlarged slightly; fluid built up around heart and lungs; fluid built up around heart and lungs; white blood count was elevated; heart was weak and only working at 29% percent; heart was weak and only working at 29% percent; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 13Feb2021 at 18:00 (at the age of 43 years old) (Lot Number: EM9809, unknown expiration) as 2nd dose, single for COVID-19 immunization.  Medical history included penicillin allergy.  There were no concomitant medications.  The patient also received first dose of BNT162B2 on 23Jan2021 at 18:00 (at the age of 43 years old) (lot number: EL3247, unknown expiration) in left arm for COVID-19 immunization. After the second shot, the patient did notice swollen lymph nodes on 02Apr2021 for several days.  She noticed her breathing labored while walking or doing activity on 02Apr2021 after getting the second shot. In 8 weeks, the patient went to the ER and found that she had fluid built up around heart and lungs which started on 02Apr2021.  They also found in a CT scan that lymph nodes were enlarged slightly and that the patient's white blood count was elevated on 02Apr2021. After an echocardiogram on 02Apr2021, they determined that the patient's heart was weak and only working at 29% percent.  The patient has had no prior history of heart problems or was taking any medications. The patient was given many heart medications to strengthen the heart and treatment for the events. The events resulted in emergency room/department or urgent care visit. The patient has no COVID and was not diagnosed with COVID prior to vaccination. The patient was tested for COVID via nasal swab on 10Apr2021 with negative result. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown. The events were assessed as serious (hospitalization) for 8 days.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound scan
Clinical narrative: blood clot in her left calf; This is a spontaneous report from a contactable consumer, the patient. A female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 24Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN6203) on 02Feb2021 for COVID-19 immunization. On an unspecified date, the patient experienced pain and on 15Mar2021 it was confirmed that the patient had a blood clot in her left calf via ultrasound performed on 15Mar2021 with positive results. The patient was treated for the blood clot. The clinical outcome of "blood clot in her left calf" was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: developed 2 DVTs post Pfizer COVID vaccine; This is a spontaneous report from a non-contactable physician communicated to a Pfizer sales representative. A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) unknown dose number, via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient developed 2 DVTs post Pfizer COVID vaccine. Patient was put on apixaban (ELIQUIS). Event took place after use of product. Outcome of the event was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information expected.; Sender's Comments: The causal relationship between BNT162B2 and the reported deep vein thrombosis cannot be completely excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, SARS-CoV-2 antibody test
Clinical narrative: swab test and tested positive for Covid/symptoms such as chills, aching, headache and fatigue; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8733, expiry date not reported) via an unspecified route of administration, administered in right arm on 12Apr2021, as first dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. Patient had no prior vaccinations (within 4 weeks). Patient reported being exposed and testing positive for covid in between his first and second dose of the Pfizer COVID-19 vaccine. Patient wanted to know how he should proceed regarding his second dose of the Pfizer COVID-19 vaccine since he tested positive for COVID-19 before receiving his second dose. He stated that he had monoclonal antibody treatment when he tested positive for COVID-19. He would like to know the recommended interval of when he can receive the second dose of the Pfizer COVID-19 vaccine. COVID-19 antibody test on 17Apr2021 was positive. He received the first dose of the COVID vaccine by Pfizer. Before his second dose, he tested positive for COVID, 5 days later. He was positive for monoclonal antibodies in Apr2021. Patient asked if he should wait to get the second dose, or change the date of the second dose. It was then stated that he had the 1st dose of the vaccine on 12Apr2021 (also reported as 05Apr2021, pending clarification). Then last Apr2021 Wednesday, (also reported as 07Apr2021) he was experiencing symptoms such as chills, aching, headache and fatigue. His second dose was scheduled on 03May2021 (more than 3 weeks). He then was tested positive with Covid on 17Apr2021; he went for a swab test and tested positive for Covid (also reported as 10Apr2021, pending clarification). Therapeutic measures were taken as a result of the event which was reported as he had Monoclonal shot on 23Apr2021, and he asked how long he needs to wait before he could get the 2nd shot. Patient talked to physician at the clinic described his symptoms (also reported that no visit on the physician office; pending clarification) and he sent him to ER.  The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Lip swelling, Throat tightness
Clinical narrative: Anaphylaxis with swollen lips; Anaphylaxis with swollen lips; felt like throat was closing; difficulty breathing, could not take a deep breath; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 13Apr2021 at 12:00 (Lot Number: ER8B2) as SINGLE DOSE for COVID-19 immunization. Medical history included possible rheumatoid arthritis from an unknown date and allergy to poultry from an unknown date. There were no concomitant medications. No other medications were received by the patient within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 13Apr2021 at 23:00, the patient experienced anaphylaxis with swollen lips and reported that he felt like his throat was closing and had difficulty breathing, could not take a deep breath. The patient went to emergency room as well as the physician office for the reported events. As therapeutic measures multiple Intravenous (IVs), oral benadryl and steroids were taken by the patient for the reported events. The outcome was reported as recovered with sequel for the reported events.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pharyngeal swelling
Clinical narrative: Lip swelling; throat swelling; This is a spontaneous report from a contactable consumer reporting for herself. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number er8723 /expiration date: not provided), via an unspecified route of administration, on 27Mar2021 at 17:30 (at the age of 29 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included asthma, Triaminic allergy and requip allergy. 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 trazodone and alprazolam.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Apr2021, one week after vaccine was given, the patient experienced lip swelling and throat swelling which required a physician's office visit. The patient received treatment for the events lip swelling and throat swelling which included prednisolone injection. The outcome of the events lip swelling and throat swelling was recovering. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : same patient, different vaccine dose/event
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, SARS-CoV-2 test
Clinical narrative: Miscarriage; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), the second dose on 08Apr2021 at 07:30 (Lot Number: ER8729) and the first dose on 16Mar2021 at 07:30 (Lot Number: EN6207), both via an unspecified route of administration, administered in the left arm, as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included sertraline (manufacturer unknown); vitamin d3 (manufacturer unknown) and folic acid, iron (PRENATAL) all taken for an unspecified indication, start and stop date were not reported. The patient had a miscarriage on 20Apr2021 at 04:30. The patient did not receive any treatment for the event. The event resulted in a visit to the doctor or health care professional office/clinic visit and hospitalization on an unspecified date. The outcome of the event was recovering. The patient had a nasal swab Covid test on 23Apr2021 with a result of negative.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, SARS-CoV-2 test
Clinical narrative: Bells palsy; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration, at the age of 37 years, on 24Apr2021 09:00 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient experienced bells palsy on 24Apr2021 16:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25Apr2021. Therapeutic measures (Steroids and anti viral) were taken as a result of bells palsy. The outcome of the event was not recovered.  Information about batch/lot number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood pressure increased, COVID-19, Chills, Cough
Clinical narrative: Diagnosis of covid (despite negative test); Diagnosis of covid (despite negative test); Fever; Chills; Exhaustion; Body aches; Stomach ache; Diarrhea; Coughing; Headache; Short of breath; Elevated blood pressure; This is a spontaneous report from a contactable consumer (reporting for herself). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 at 08:45 (Batch/Lot Number: EN8730) as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Mar2021 (lot number: EN6206, administration time: 08:45 AM) for COVID-19 immunization. On 18Apr2021 at 12:00, the patient experienced fever, chills, exhaustion, body aches, stomach ache, diarrhea, coughing, headache, short of breath, elevated blood pressure.   The patient underwent lab tests and procedure which included 2 negative COVID tests on 19Apr2021 and 23Apr2021 respectively and flu test: negative on an unspecified date. The patient was diagnosis of COVID (despite negative test) received on 23Apr2021. The events resulted in emergency room/department visit or urgent care. The patient did not received treatment for the events. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Fatigue, Headache, Influenza virus test
Clinical narrative: Diagnosis of covid (despite negative test); Diagnosis of covid (despite negative test); Fever; Chills; Exhaustion; Body aches; Stomach ache; Diarrhea; Coughing; Headache; Short of breath; Elevated blood pressure; This is a spontaneous report from a contactable consumer (reporting for herself). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 at 08:45 (Batch/Lot Number: EN8730) as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Mar2021 (lot number: EN6206, administration time: 08:45 AM) for COVID-19 immunization. On 18Apr2021 at 12:00, the patient experienced fever, chills, exhaustion, body aches, stomach ache, diarrhea, coughing, headache, short of breath, elevated blood pressure.   The patient underwent lab tests and procedure which included 2 negative COVID tests on 19Apr2021 and 23Apr2021 respectively and flu test: negative on an unspecified date. The patient was diagnosis of COVID (despite negative test) received on 23Apr2021. The events resulted in emergency room/department visit or urgent care. The patient did not received treatment for the events. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.