chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 that same day; tested positive for COVID-19 that same day; This is a spontaneous report received from a contactable consumer, the patient reported a 54-year-old adult male received the first dose of BNT162b2 (solution for injection; batch/lot and expiry not provided) as a single dose via an unspecified route on 19Mar2021 for COVID-19 immunisation. There was no medical history, concomitant medications or past drug history reported. The patient reported that he got his first shot on 19Mar2021 and he was scheduled for his second shot on 09Apr2021 and also tested positive for COVID-19 on that same date. The patient reported that he was voluntarily tested at work. The patient wanted to know if he can get the second shot or does he need to wait. The outcome of the event tested positive for COVID-19 was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up
Sex: M
Vaccine: COVID19
Symptoms: Cerebral arteriosclerosis, Cerebral artery occlusion, Computerised tomogram, Headache, Magnetic resonance imaging
Clinical narrative: blocked artery in your brain; soft plaque; real bad headaches; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 11feb2021 as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were none. The patient received the first dose of vaccine on 24Jan2021 and experienced no adverse effect. The patient experienced blocked artery in brain on an unspecified date with outcome of unknow, soft plaque (cerebral arteriosclerosis) on an unspecified date with outcome of unknown, real bad headaches on an unspecified date with outcome of unknown.  The clinical course was as follows the patient was a disabled veteran. "A week after the second dose of vaccine the patient started having a real bad headaches and his head started hurting more and more the patient did a CAT scan with contrast for his ear because he had a problem on the side of his ear. The ear was ok, but the problem was on the left side of his head, he got a blocked artery in his brain which was called soft plaque, he never had this problem before till he had these shots."  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Decreased appetite, Dysgeusia
Clinical narrative: hallucenagetic type dreams repeating in constant loop; fever 101.5F; chills; uncontrollable shaking; sore / achy body and joints; achy body and joints; headache; no appetite; numb tongue; taste like metal; This is a spontaneous report from a non-contactable consumer, the patient. A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8732, first dose) solution for injection intramuscular on 21Apr2021 (at the age of 68-years-old) as a single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. The patient had no known allergies. 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. On 21Apr2021, the patient experienced fever 101.5F and chills, uncontrollable shaking, sore, achy body, and joints, headache, no appetite, numb tongue, taste like metal, hallucenagetic type dreams repeating in constant loop effects began approximately 10 hours after injection. There was no treatment for the events. The outcome of the events fever, chills, uncontrollable shaking, sore, achy body, and joints, headache, no appetite, numb tongue, taste like metal, and hallucenagetic type dreams was recovering. The patient was not tested post vaccination for COVID.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, Headache, Hypoaesthesia oral, Pain, Pyrexia
Clinical narrative: hallucenagetic type dreams repeating in constant loop; fever 101.5F; chills; uncontrollable shaking; sore / achy body and joints; achy body and joints; headache; no appetite; numb tongue; taste like metal; This is a spontaneous report from a non-contactable consumer, the patient. A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8732, first dose) solution for injection intramuscular on 21Apr2021 (at the age of 68-years-old) as a single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. The patient had no known allergies. 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. On 21Apr2021, the patient experienced fever 101.5F and chills, uncontrollable shaking, sore, achy body, and joints, headache, no appetite, numb tongue, taste like metal, hallucenagetic type dreams repeating in constant loop effects began approximately 10 hours after injection. There was no treatment for the events. The outcome of the events fever, chills, uncontrollable shaking, sore, achy body, and joints, headache, no appetite, numb tongue, taste like metal, and hallucenagetic type dreams was recovering. The patient was not tested post vaccination for COVID.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: hallucenagetic type dreams repeating in constant loop; fever 101.5F; chills; uncontrollable shaking; sore / achy body and joints; achy body and joints; headache; no appetite; numb tongue; taste like metal; This is a spontaneous report from a non-contactable consumer, the patient. A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8732, first dose) solution for injection intramuscular on 21Apr2021 (at the age of 68-years-old) as a single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. The patient had no known allergies. 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. On 21Apr2021, the patient experienced fever 101.5F and chills, uncontrollable shaking, sore, achy body, and joints, headache, no appetite, numb tongue, taste like metal, hallucenagetic type dreams repeating in constant loop effects began approximately 10 hours after injection. There was no treatment for the events. The outcome of the events fever, chills, uncontrollable shaking, sore, achy body, and joints, headache, no appetite, numb tongue, taste like metal, and hallucenagetic type dreams was recovering. The patient was not tested post vaccination for COVID.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Aggression, Anxiety, Confusional state, Fall
Clinical narrative: Rhabdomyolysis; violent; Two ER visits relating to falling; behavior; confusion; anxiety; This is a spontaneous report from a contactable consumer (patient).  A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 12:00 as single dose for COVID-19 immunization. Medical history included Severe traumatic brain injury, PNC (prenatal care). Patient had covid prior vaccination. Patient was not tested for covid post vaccination. Patient was not pregnant. Concomitant medications included allopurinol (ELAVIL); diazepam; clonidine; naproxen; diclofenac potassium (CAMBIA); Hum. It was reported that patient also took unspecified other vaccine on 05Mar2021 (other vaccine same date dose number=1, other vaccine same date  vaccine location=Right arm). It was reported that patient had two ER visits relating to falling (facility name) overnight visit Rhabdomyolysis 13 day stay in (facility name)- critical care unit in restraints for several days - violent, Behavior (abnormal), confusion, anxiety. Events started on 07Mar2021 12:00 with outcome of recovering. Events resulted in Emergency room/department or urgent care. Events were reported as serious due to Hospitalization and Disability or permanent damage. Number of days hospitalization was 14. Patient took second dose on 25Mar2021 05:00 AM on Right arm.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rhabdomyolysis
Clinical narrative: Rhabdomyolysis; violent; Two ER visits relating to falling; behavior; confusion; anxiety; This is a spontaneous report from a contactable consumer (patient).  A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 12:00 as single dose for COVID-19 immunization. Medical history included Severe traumatic brain injury, PNC (prenatal care). Patient had covid prior vaccination. Patient was not tested for covid post vaccination. Patient was not pregnant. Concomitant medications included allopurinol (ELAVIL); diazepam; clonidine; naproxen; diclofenac potassium (CAMBIA); Hum. It was reported that patient also took unspecified other vaccine on 05Mar2021 (other vaccine same date dose number=1, other vaccine same date  vaccine location=Right arm). It was reported that patient had two ER visits relating to falling (facility name) overnight visit Rhabdomyolysis 13 day stay in (facility name)- critical care unit in restraints for several days - violent, Behavior (abnormal), confusion, anxiety. Events started on 07Mar2021 12:00 with outcome of recovering. Events resulted in Emergency room/department or urgent care. Events were reported as serious due to Hospitalization and Disability or permanent damage. Number of days hospitalization was 14. Patient took second dose on 25Mar2021 05:00 AM on Right arm.   Information on the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: substantial hearing loss in his right ear; woke up with ringing in his right ear; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 31Mar2021 at 10:00 (lot number: ER8737) as single dose for covid-19 immunisation, administered at the hospital. The patient received the first dose of bnt162b2 in Mar2021 at 10:00 (lot number: EN6208) for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. The patient had no other vaccines in four weeks and no other medications in two weeks. The patient had no COVID prior vaccination and not COVID tested post vaccination. On 03Apr2021, patient woke up with ringing in his right ear at 5 AM and upon rising at 7:30 AM, he noticed substantial hearing loss in his right ear. The patient received treatment for the events. Outcome of the events were reported as recovered with lasting effects. The events resulted in doctor or other healthcare professional office/clinic visit and disability or permanent damage.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Blood glucose, Blood glucose increased, Body temperature, Chills
Clinical narrative: dehydration; anemia; neutropenia; thrombocytopenia; abnormal liver enzymes; increased blood sugar level; dysgeusia; developed severe throbbing headache; fever (102-103 F); chills; This is a spontaneous report from a contactable physician (patient). A 70-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6193), intramuscular, administered in Arm Left on 25Mar2021 08:30 as single dose for COVID-19 immunization in a hospital. Medical history included supraventricular tachycardia and NSTEMI (Non-ST Elevation Myocardial Infarction) both from an unknown date. No known allergies. No COVID-19 prior to vaccination. Concomitant medications included diltiazem hydrochloride (CARDIZEM CD) and asa (ASA) both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (lot number: EL9266) on 04Mar2021 in the left arm for COVID-19 immunization and experienced severe throbbing headache, fever and chills. On 25Mar2021 22:30, 14 hours after the second dose, the patient developed severe throbbing headache, fever, and chills lasting for 72 hours. On 08Apr2021, the patient was hospitalized for 1 day for dehydration, anemia, neutropenia, thrombocytopenia, abnormal liver enzymes, increased blood sugar level, dysgeusia. The patient again developed severe throbbing headache, fever (102-103 F), and chills. The patient underwent lab tests and procedures which included blood glucose: increased on 08Apr2021, body temperature: 102-103 fahrenheit on 08Apr2021, hepatic enzyme: abnormal on 08Apr2021, panel of lab tests: normal on 28Feb2021. The patient was tested for COVID-19 via nasal swab taken post vaccination with a negative result on an unspecified date. The patient was treated with IV fluids. The events required healthcare professional office/clinic and emergency room visit. The outcome of the events was recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Dysgeusia, Headache, Hepatic enzyme, Hepatic enzyme abnormal
Clinical narrative: dehydration; anemia; neutropenia; thrombocytopenia; abnormal liver enzymes; increased blood sugar level; dysgeusia; developed severe throbbing headache; fever (102-103 F); chills; This is a spontaneous report from a contactable physician (patient). A 70-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6193), intramuscular, administered in Arm Left on 25Mar2021 08:30 as single dose for COVID-19 immunization in a hospital. Medical history included supraventricular tachycardia and NSTEMI (Non-ST Elevation Myocardial Infarction) both from an unknown date. No known allergies. No COVID-19 prior to vaccination. Concomitant medications included diltiazem hydrochloride (CARDIZEM CD) and asa (ASA) both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (lot number: EL9266) on 04Mar2021 in the left arm for COVID-19 immunization and experienced severe throbbing headache, fever and chills. On 25Mar2021 22:30, 14 hours after the second dose, the patient developed severe throbbing headache, fever, and chills lasting for 72 hours. On 08Apr2021, the patient was hospitalized for 1 day for dehydration, anemia, neutropenia, thrombocytopenia, abnormal liver enzymes, increased blood sugar level, dysgeusia. The patient again developed severe throbbing headache, fever (102-103 F), and chills. The patient underwent lab tests and procedures which included blood glucose: increased on 08Apr2021, body temperature: 102-103 fahrenheit on 08Apr2021, hepatic enzyme: abnormal on 08Apr2021, panel of lab tests: normal on 28Feb2021. The patient was tested for COVID-19 via nasal swab taken post vaccination with a negative result on an unspecified date. The patient was treated with IV fluids. The events required healthcare professional office/clinic and emergency room visit. The outcome of the events was recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Neutropenia, Pyrexia, SARS-CoV-2 test, Thrombocytopenia
Clinical narrative: dehydration; anemia; neutropenia; thrombocytopenia; abnormal liver enzymes; increased blood sugar level; dysgeusia; developed severe throbbing headache; fever (102-103 F); chills; This is a spontaneous report from a contactable physician (patient). A 70-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6193), intramuscular, administered in Arm Left on 25Mar2021 08:30 as single dose for COVID-19 immunization in a hospital. Medical history included supraventricular tachycardia and NSTEMI (Non-ST Elevation Myocardial Infarction) both from an unknown date. No known allergies. No COVID-19 prior to vaccination. Concomitant medications included diltiazem hydrochloride (CARDIZEM CD) and asa (ASA) both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (lot number: EL9266) on 04Mar2021 in the left arm for COVID-19 immunization and experienced severe throbbing headache, fever and chills. On 25Mar2021 22:30, 14 hours after the second dose, the patient developed severe throbbing headache, fever, and chills lasting for 72 hours. On 08Apr2021, the patient was hospitalized for 1 day for dehydration, anemia, neutropenia, thrombocytopenia, abnormal liver enzymes, increased blood sugar level, dysgeusia. The patient again developed severe throbbing headache, fever (102-103 F), and chills. The patient underwent lab tests and procedures which included blood glucose: increased on 08Apr2021, body temperature: 102-103 fahrenheit on 08Apr2021, hepatic enzyme: abnormal on 08Apr2021, panel of lab tests: normal on 28Feb2021. The patient was tested for COVID-19 via nasal swab taken post vaccination with a negative result on an unspecified date. The patient was treated with IV fluids. The events required healthcare professional office/clinic and emergency room visit. The outcome of the events was recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: testing positive for Covid-19 after they got their first dose of the vaccine; testing positive for Covid-19 after they got their first dose of the vaccine; This is a spontaneous report from a contactable pharmacist received from a Pfizer-sponsored program. This pharmacist reported same events for 2 patients. This is the first of two reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that two patients who have been testing positive for Covid-19 after they got their first dose of the vaccine. The outcome of the events was unknown.   Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) :PFIZER INC-2021460993 same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Cerebrovascular accident, Chest pain, Dyspepsia, Feeling abnormal
Clinical narrative: I never had chest pain or this feeling in my heart like I am going die; feeling like I was having a stroke or something; heart pain; headache; chest pain; where your lungs are, it's pain; heartburn; My arm was still sore a week after, I could not lay on it or touch it; I can't sleep; I am nervous; I feel it in my body and something is just taking over me.  Something is happening and I could feel; This is a spontaneous report from a contactable consumer. A 58-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 09Apr2021 (Batch/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 previously took first dose of bnt162b2 on 18Mar2021 for covid-19 immunisation it went pretty well, no problems and tylenol and experienced drug ineffective. On an unspecified date, it was reported "I can tell the drug was inside me and can feel it taking over, and going through my body. I had headache, chest pain, heart pain, and feeling like I was having a stroke or something. On my right side there is pain, where your lungs are, it's pain. I've been having symptoms every single day. I took some Tylenol one day, but that did not help.  I took some Tums, thinking maybe it is heartburn, but it has not gone away. I feel it in my body and something is just taking over me. Something is happening and I could feel.  I never had chest pain or this feeling in my heart like I am going die. My arm was still sore a week after, I could not lay on it or touch it and then other symptoms came on more and more. I have pain in my chest and head constantly, all day all night. I can't sleep because I am nervous and I don't know what is going on." Therapeutic measures were taken as a result of headache, chest pain, where your lungs are, it's pain, my arm was still sore a week after, i could not lay on it or touch it (pain in extremity). The events I never had chest pain or this feeling in my heart like I am going die, feeling like I was having a stroke or something, and heart pain were considered as serious (medically significant). The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Insomnia, Near death experience, Nervousness, Pain in extremity
Clinical narrative: I never had chest pain or this feeling in my heart like I am going die; feeling like I was having a stroke or something; heart pain; headache; chest pain; where your lungs are, it's pain; heartburn; My arm was still sore a week after, I could not lay on it or touch it; I can't sleep; I am nervous; I feel it in my body and something is just taking over me.  Something is happening and I could feel; This is a spontaneous report from a contactable consumer. A 58-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 09Apr2021 (Batch/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 previously took first dose of bnt162b2 on 18Mar2021 for covid-19 immunisation it went pretty well, no problems and tylenol and experienced drug ineffective. On an unspecified date, it was reported "I can tell the drug was inside me and can feel it taking over, and going through my body. I had headache, chest pain, heart pain, and feeling like I was having a stroke or something. On my right side there is pain, where your lungs are, it's pain. I've been having symptoms every single day. I took some Tylenol one day, but that did not help.  I took some Tums, thinking maybe it is heartburn, but it has not gone away. I feel it in my body and something is just taking over me. Something is happening and I could feel.  I never had chest pain or this feeling in my heart like I am going die. My arm was still sore a week after, I could not lay on it or touch it and then other symptoms came on more and more. I have pain in my chest and head constantly, all day all night. I can't sleep because I am nervous and I don't know what is going on." Therapeutic measures were taken as a result of headache, chest pain, where your lungs are, it's pain, my arm was still sore a week after, i could not lay on it or touch it (pain in extremity). The events I never had chest pain or this feeling in my heart like I am going die, feeling like I was having a stroke or something, and heart pain were considered as serious (medically significant). The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary pain
Clinical narrative: I never had chest pain or this feeling in my heart like I am going die; feeling like I was having a stroke or something; heart pain; headache; chest pain; where your lungs are, it's pain; heartburn; My arm was still sore a week after, I could not lay on it or touch it; I can't sleep; I am nervous; I feel it in my body and something is just taking over me.  Something is happening and I could feel; This is a spontaneous report from a contactable consumer. A 58-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 09Apr2021 (Batch/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 previously took first dose of bnt162b2 on 18Mar2021 for covid-19 immunisation it went pretty well, no problems and tylenol and experienced drug ineffective. On an unspecified date, it was reported "I can tell the drug was inside me and can feel it taking over, and going through my body. I had headache, chest pain, heart pain, and feeling like I was having a stroke or something. On my right side there is pain, where your lungs are, it's pain. I've been having symptoms every single day. I took some Tylenol one day, but that did not help.  I took some Tums, thinking maybe it is heartburn, but it has not gone away. I feel it in my body and something is just taking over me. Something is happening and I could feel.  I never had chest pain or this feeling in my heart like I am going die. My arm was still sore a week after, I could not lay on it or touch it and then other symptoms came on more and more. I have pain in my chest and head constantly, all day all night. I can't sleep because I am nervous and I don't know what is going on." Therapeutic measures were taken as a result of headache, chest pain, where your lungs are, it's pain, my arm was still sore a week after, i could not lay on it or touch it (pain in extremity). The events I never had chest pain or this feeling in my heart like I am going die, feeling like I was having a stroke or something, and heart pain were considered as serious (medically significant). The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: paralysis; rapid heartbeat; heart palpitations; cold sweats; chills; muscle pain; in arm; nausea; difficulty breathing; This is a spontaneous report from a Contactable Consumer (patient). An 88-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613), first dose via an unspecified route of administration, administered in Arm Left on 05Apr2021 (at 88 years old) for covid-19 immunisation. Medical history included breast cancer. She had breast cancer surgery on that side previously. She had chills on and off before the Covid vaccine also. Says it started after her Pneumonia and Flu shots that she believes were in Nov2020; possibly 12Nov2020. Concomitant medications included spironolactone  and other unspecified medicines. She had them go over her medications to see if any of them would interact with the vaccine. They said that all of her medications were okay. On Apr2021, patient experienced heart palpitations, paralysis, cold sweats, chills, muscle pain, in arm, nausea and difficulty breathing about three weeks after the vaccine. She noticed that it mentioned concerns if you experience a rapid heartbeat. States she did, and is wondering about getting her second vaccine. Her rapid heartbeat became so bad this past Tuesday night she thought she was having a stroke. It came over her and she could not move. She went to an urgent care center. They did a Covid 19 Test and it was negative on Apr2021. Also states she has been having lots of chills. The outcome of the events Heartbeats increased, palpitations, Chills was not recovered, other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Palpitations, Paralysis
Clinical narrative: paralysis; rapid heartbeat; heart palpitations; cold sweats; chills; muscle pain; in arm; nausea; difficulty breathing; This is a spontaneous report from a Contactable Consumer (patient). An 88-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613), first dose via an unspecified route of administration, administered in Arm Left on 05Apr2021 (at 88 years old) for covid-19 immunisation. Medical history included breast cancer. She had breast cancer surgery on that side previously. She had chills on and off before the Covid vaccine also. Says it started after her Pneumonia and Flu shots that she believes were in Nov2020; possibly 12Nov2020. Concomitant medications included spironolactone  and other unspecified medicines. She had them go over her medications to see if any of them would interact with the vaccine. They said that all of her medications were okay. On Apr2021, patient experienced heart palpitations, paralysis, cold sweats, chills, muscle pain, in arm, nausea and difficulty breathing about three weeks after the vaccine. She noticed that it mentioned concerns if you experience a rapid heartbeat. States she did, and is wondering about getting her second vaccine. Her rapid heartbeat became so bad this past Tuesday night she thought she was having a stroke. It came over her and she could not move. She went to an urgent care center. They did a Covid 19 Test and it was negative on Apr2021. Also states she has been having lots of chills. The outcome of the events Heartbeats increased, palpitations, Chills was not recovered, other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: paralysis; rapid heartbeat; heart palpitations; cold sweats; chills; muscle pain; in arm; nausea; difficulty breathing; This is a spontaneous report from a Contactable Consumer (patient). An 88-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613), first dose via an unspecified route of administration, administered in Arm Left on 05Apr2021 (at 88 years old) for covid-19 immunisation. Medical history included breast cancer. She had breast cancer surgery on that side previously. She had chills on and off before the Covid vaccine also. Says it started after her Pneumonia and Flu shots that she believes were in Nov2020; possibly 12Nov2020. Concomitant medications included spironolactone  and other unspecified medicines. She had them go over her medications to see if any of them would interact with the vaccine. They said that all of her medications were okay. On Apr2021, patient experienced heart palpitations, paralysis, cold sweats, chills, muscle pain, in arm, nausea and difficulty breathing about three weeks after the vaccine. She noticed that it mentioned concerns if you experience a rapid heartbeat. States she did, and is wondering about getting her second vaccine. Her rapid heartbeat became so bad this past Tuesday night she thought she was having a stroke. It came over her and she could not move. She went to an urgent care center. They did a Covid 19 Test and it was negative on Apr2021. Also states she has been having lots of chills. The outcome of the events Heartbeats increased, palpitations, Chills was not recovered, other events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Post-acute COVID-19 syndrome
Clinical narrative: In late Feb2021 I started to develop symptoms which increased substantially in March and April was diagnosed with Long Haul reaction; In late Feb2021 I started to develop symptoms which increased substantially in March and April was diagnosed with Long Haul reaction; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE, and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination was unknown. The patient medical history and concomitant medications were not reported. In late Feb2021, patient started to develop symptoms which increased substantially in March and April and was diagnosed with Long Haul reaction in late March which patient stated are now presenting a significant problem. Patient wanted to know if there is a blood test available to verify this diagnose. Patient stated he is also interested in knowing and obtaining any medication to cure this problem. Treatment was not received. Patient was not on medication and no other treatments going on. He stated he has no idea what to do. Outcome of the events was unknown.  Information on the Batch/Lot number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Nausea, Thrombosis
Clinical narrative: Blood clot, inner right upper leg; Chills; stomach upset; nausea; headache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 11:30 (Batch/Lot Number: Er8735) as single dose for covid-19 immunisation. Medical history included covid-19 prior to vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient has no other vaccine in four weeks. The patient experienced blood clot in inner right upper leg, chills, stomach upset, nausea, and headache on 01Apr2021 at 20:00. The events were not treated. The patient was not tested for covid post vaccination. The patient had the second dose on 22Apr2021 at 11:30 AM in the left arm (lot: Er8731). The outcome of the events was recovered with sequel.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, CSF pressure, Intracranial pressure increased, SARS-CoV-2 test
Clinical narrative: Increased intracranial pressure with vision loss requiring VP shunt placement; Increased intracranial pressure with vision loss requiring VP shunt placement; This is a spontaneous report from a contactable nurse (patient).  A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 23Jan2021 at 12:00 (Lot Number: EK9231)(at the age of 41-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included hypertension (HTN), obstructive sleep apnea syndrome (OSA) and hypothyroidism, all from an unknown date and unknown if ongoing. Known allergies: KEFLEX, LEVAQUIN, Penicillin. Concomitant medication included levothyroxine; lisinopril; trazodone and HCTZ, all concomitants were taken for an unspecified indication, start and stop date were not reported.  The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 04Jan2021 at 15:00 (Lot Number: EL0140) (at the age of 40-year-old) as single dose for COVID-19 immunisation. On 26Jan2021 at 14:00, the patient experienced increased intracranial pressure with vision loss requiring VP shunt placement. The events required emergency room visit and physician office visit.  The patient was hospitalized due to the events for 2 days.  The patient underwent lab tests and procedures which included intracranial pressure (CSF pressure): increased on 26Jan2021, SARS-COV-2 test (Nasal Swab): negative on an unspecified date.  Therapeutic measures were taken as a result of the events and included 3 lumbar punctures and surgery for VP shunt. The patient outcome of the events was recovering.; Sender's Comments: The 41-year-old patient had medical history included hypertension (HTN), obstructive sleep apnea syndrome (OSA) and hypothyroidism, and was on multiple concomitant medications.  Intracranial pressure increased and blindness were most likely due to concurrent disease, and unlikely related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram thorax, Pain in extremity, Thrombosis, Ultrasound scan
Clinical narrative: I had an ultrasound done on my leg where a blood clot was found. I had a chest CT performed where several clots were found; Two days after my vaccine I began having severe pain in my right leg in the calf area and pain in my chest when I took a deep breath or coughed.  Over the weekend it got worse and worse, on Tuesday th; Pain in my chest; This is a spontaneous report from a contactable consumer (patient).  A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 14Apr2021 13:00 (Batch/Lot Number: Ew0153) (at the age of 51 years old) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included duloxetine; trazodone; pregabalin (LYRICA); oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]); and meloxicam, all taken for an unspecified indication, start and stop date were not reported. The patient previously took vancomycin and daptomycin and experienced drug allergy to these medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  On 16Apr2021 09:00, two days after the vaccine, the patient began having severe pain in his right leg in the calf area and pain in his chest when he took a deep breath or coughed. Over the weekend, it got worse and worse, on Tuesday 20Apr2021, the patient had an ultrasound done on his leg where a blood clot was found. He had a chest computerized tomography (CT) performed where several clots were found. The event resulted in doctor or other healthcare professional office/clinic visit. The treatment included blood thinners. No COVID prior vaccination and not COVID tested post vaccination.  The case was assessed as non-serious by the reporter. The outcome of the event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: bloody stool; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported as 42; unit unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 21Apr2021 (batch/lot number and expiry date not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced blood in his stool for 2 days since getting the vaccine, not just a little bit or a spot of blood but a lot. The patient would like to know whether his side effect; bloody stool, is related to the COVID vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion threatened, Blood glucose abnormal, Dizziness, Foetal death, Ultrasound scan
Clinical narrative: absence of heartbeat and estimated the embryo stopped growing at 7 weeks; had a very difficult time keeping her glucose levels; lightheaded; possible threatened miscarriage; persistent vertigo; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 at 11:00 (Lot Number: EN6204) as single dose for covid-19 immunisation, administered at the hospital. No other vaccine received in four weeks. Medical history included type 2 diabetes, fatty liver disease, high cholesterol, and known allergies: Pineapples and Zoloft. Concomitant medications included metformin; glipizide; escitalopram oxalate (LEXAPRO); and meclozine hydrochloride (MECLIZINE [MECLOZINE HYDROCHLORIDE]).  The patient was pregnant at the time of vaccination. The patient's last menstrual period was on 03Feb2021. On 25Mar2021, 03:00 PM, patient sought treatment for persistent vertigo at a hospital and was given meclizine. On 03Apr2021, patient went to the emergency room to be assessed for a possible threatened miscarriage. They found her embryo sac and determined she was pregnant. She was released and told to go home. Patient is a type 2 diabetic and was ordered to go on insulin. On 05Apr2021, she had another threatened miscarriage and returned to the hospital. She was given an ultrasound and her due date changed from 10Nov2021 to 28Nov2021. Ultrasound discovered a heartbeat at 132 bpm. On 23Apr2021, at a routine ultrasound and OB visit, doctor discovered absence of heartbeat and estimated the embryo stopped growing at 7 weeks. She was electing for a D&C surgical procedure and requesting pathology testing to investigate the cause of death. She had a very difficult time keeping her glucose levels within the recommended pregnancy range of 90-150. She had persistent lightheaded still. Outcome of events vertigo, possible threatened miscarriage, and lightheaded was not recovered. The patient received treatment for vertigo and did not receive treatment for other events.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: absence of heartbeat and estimated the embryo stopped growing at 7 weeks; had a very difficult time keeping her glucose levels; lightheaded; possible threatened miscarriage; persistent vertigo; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 at 11:00 (Lot Number: EN6204) as single dose for covid-19 immunisation, administered at the hospital. No other vaccine received in four weeks. Medical history included type 2 diabetes, fatty liver disease, high cholesterol, and known allergies: Pineapples and Zoloft. Concomitant medications included metformin; glipizide; escitalopram oxalate (LEXAPRO); and meclozine hydrochloride (MECLIZINE [MECLOZINE HYDROCHLORIDE]).  The patient was pregnant at the time of vaccination. The patient's last menstrual period was on 03Feb2021. On 25Mar2021, 03:00 PM, patient sought treatment for persistent vertigo at a hospital and was given meclizine. On 03Apr2021, patient went to the emergency room to be assessed for a possible threatened miscarriage. They found her embryo sac and determined she was pregnant. She was released and told to go home. Patient is a type 2 diabetic and was ordered to go on insulin. On 05Apr2021, she had another threatened miscarriage and returned to the hospital. She was given an ultrasound and her due date changed from 10Nov2021 to 28Nov2021. Ultrasound discovered a heartbeat at 132 bpm. On 23Apr2021, at a routine ultrasound and OB visit, doctor discovered absence of heartbeat and estimated the embryo stopped growing at 7 weeks. She was electing for a D&C surgical procedure and requesting pathology testing to investigate the cause of death. She had a very difficult time keeping her glucose levels within the recommended pregnancy range of 90-150. She had persistent lightheaded still. Outcome of events vertigo, possible threatened miscarriage, and lightheaded was not recovered. The patient received treatment for vertigo and did not receive treatment for other events.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Gait inability, Gout, Urine analysis
Clinical narrative: could not walk; episode of the gout; extremely tired; This is a spontaneous report from two contactable consumers (one of which is the patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Lot Number: EB6204, unknown expiration) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on 18Feb2021 (Lot: EN6201, unknown expiration) for COVID-19 immunization and experienced sore arm. Upon receiving the second dosage on 11Mar2021, the patient was extremely tired for about 10 days in Mar2021. The two-week period after vaccination was 25Mar2021. On 28Mar2021, the patient had an episode of gout. The patient had to go to the hospital because the patient could not walk. The patient was diagnosed with gout and given medication which took care of it. The patient had never had any episodes of gout, so it was a surprise to the patient that suddenly would have an episode of gout. Since then on 13Apr2021, the patient has seen the primary care doctor. The patient had urine and blood test and the numbers were normal on unspecified dates. The patient was asked if this could have been a reaction to the vaccine. The patient recovered from extreme fatigue on unspecified date in Mar2021. Outcome of the remaining events was unknown. The events could not walk, and gout were assessed as serious (hospitalization). The event fatigue was assessed as non-serious.  No follow-up attempts are possible. No further information is expected.