chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Vertigo
Clinical narrative: congestion in his chest; real deep coughing; hurting at the base of his neck/his shoulders were hurting from his neck down his arms to his elbow; dysentery; felt a little unwell; when he gets up, his back is giving him trouble; he can't stand up long because of the weakness; body also seemed to want to walk backward on his heels when he stands up and he is wanting to fall; he can't stand up that well; his head was hurting in the back of it; his shoulders were hurting from his neck down his arms to his elbow; his shoulders were hurting from his neck down his arms to his elbow; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 04Feb2021 (at the age of 84 years old) at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported he came home after getting his shot, and he felt a little unwell but it was no too bad (04Feb2021). Then, on 11Feb2021, he started having dysentery. On 12Feb2021, he got congestion in his chest and a real deep coughing, and then he started hurting at the base of his neck. The patient used a chest rub which helped break up some of the congestion, but he is still coughing. On unspecified date in Feb2021, the patient also experienced his head was hurting in the back of it, and his shoulders were hurting from his neck down his arms to his elbow; his shoulders had been hurting so bad, he thought they would come off. Now (Feb2021), when he gets up, his back is giving him trouble, and he can't stand up long because of the weakness. His body also seemed to want to walk backward on his heels when he stands up and he is wanting to fall (Feb2021). The patient has been taking his dog out every morning, but it is hard to do that now because he can't stand up that well (Feb2021). Therapeutic measure was taken as a result of the event congestion in his chest. Outcome of the event real deep coughing was not recovered while outcome of all the other events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: Very sore arm at the injection site; She had to lay down and sleep for a hour because of being very tired; Achy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for an unspecified indication. The patient medical history and concomitant medications were not reported. This patient received the Pfizer COVID-19 Vaccine 18 days ago, yesterday was day 18 or day 19 she guessed; and she had a very sore arm at the injection site again, which she had for about 1.5 days when she got the Pfizer COVID-19 Vaccine. She got very tired and achy. She had to lay down and sleep for an hour because of being very tired. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Breast engorgement, Breast induration, Breast pain
Clinical narrative: it is very painful; Right breast became like engorged almost, like very hard and heavy; Right breast became like engorged almost, like very hard and heavy; Chills; Fever/my fever at the highest point was 102; Joint ache; Muscle ache; Fatigue; Heavy feeling in chest; felt like drugged; felt like drugged as if I was almost intoxicated; Right eye was burning and watering; Right eye was burning and watering; Pain and numbness in lower legs below the knees; Pain and numbness in lower legs below the knees; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration on 11Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported "I am a teacher and we have received the first dosage of Pfizer COVID-19 vaccine on Thursday (11Feb2021) and I received mine early in the late afternoon, if that makes sense. And immediately after I had the shot, the best way I can describe it you is I almost felt like drugged as if I was almost intoxicated and my right eye was burning and watering and we were still teaching and then I came home and later that night, I had some pain and numbness in my lower legs below the knees and by that night, the next day, I was full blown with every side effects chills, fever, my fever at the highest point was 102 on 12Feb2021. I had joint aches, muscle aches, fatigue and a heavy feeling in my chest. But the reason I am calling is because most of those symptoms have subsided except for one. It's Tuesday which is five days after the inoculation and my right breast on Friday morning (16Feb2021) became like engorged almost, like very hard and heavy and that has not fully gone away, it is very painful and I read that there could be like a swelling of the lymph nodes but it was my entire breast. So that's not, I do not believe if that could be connected to the lymphatic but I am not sure and I called my Primary Care Physician first. They almost started almost immediately but then they continued to get worse. Friday was the worst, the 12th, 13th I was still experiencing symptoms. They were mostly subsided by the 14th except for the heavy feeling in my chest, that fatigue and this hardened breast. I am just trying to finding answers as to what I should do about this hardened tissue and if I should get the second inoculation." Outcome of fatigue, heavy feeling in chest, breast became like engorged almost, like very hard and heavy, it is very painful was not recovered; and of remaining events was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Eye irritation, Fatigue, Feeling drunk
Clinical narrative: it is very painful; Right breast became like engorged almost, like very hard and heavy; Right breast became like engorged almost, like very hard and heavy; Chills; Fever/my fever at the highest point was 102; Joint ache; Muscle ache; Fatigue; Heavy feeling in chest; felt like drugged; felt like drugged as if I was almost intoxicated; Right eye was burning and watering; Right eye was burning and watering; Pain and numbness in lower legs below the knees; Pain and numbness in lower legs below the knees; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration on 11Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported "I am a teacher and we have received the first dosage of Pfizer COVID-19 vaccine on Thursday (11Feb2021) and I received mine early in the late afternoon, if that makes sense. And immediately after I had the shot, the best way I can describe it you is I almost felt like drugged as if I was almost intoxicated and my right eye was burning and watering and we were still teaching and then I came home and later that night, I had some pain and numbness in my lower legs below the knees and by that night, the next day, I was full blown with every side effects chills, fever, my fever at the highest point was 102 on 12Feb2021. I had joint aches, muscle aches, fatigue and a heavy feeling in my chest. But the reason I am calling is because most of those symptoms have subsided except for one. It's Tuesday which is five days after the inoculation and my right breast on Friday morning (16Feb2021) became like engorged almost, like very hard and heavy and that has not fully gone away, it is very painful and I read that there could be like a swelling of the lymph nodes but it was my entire breast. So that's not, I do not believe if that could be connected to the lymphatic but I am not sure and I called my Primary Care Physician first. They almost started almost immediately but then they continued to get worse. Friday was the worst, the 12th, 13th I was still experiencing symptoms. They were mostly subsided by the 14th except for the heavy feeling in my chest, that fatigue and this hardened breast. I am just trying to finding answers as to what I should do about this hardened tissue and if I should get the second inoculation." Outcome of fatigue, heavy feeling in chest, breast became like engorged almost, like very hard and heavy, it is very painful was not recovered; and of remaining events was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lacrimation increased, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: it is very painful; Right breast became like engorged almost, like very hard and heavy; Right breast became like engorged almost, like very hard and heavy; Chills; Fever/my fever at the highest point was 102; Joint ache; Muscle ache; Fatigue; Heavy feeling in chest; felt like drugged; felt like drugged as if I was almost intoxicated; Right eye was burning and watering; Right eye was burning and watering; Pain and numbness in lower legs below the knees; Pain and numbness in lower legs below the knees; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration on 11Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported "I am a teacher and we have received the first dosage of Pfizer COVID-19 vaccine on Thursday (11Feb2021) and I received mine early in the late afternoon, if that makes sense. And immediately after I had the shot, the best way I can describe it you is I almost felt like drugged as if I was almost intoxicated and my right eye was burning and watering and we were still teaching and then I came home and later that night, I had some pain and numbness in my lower legs below the knees and by that night, the next day, I was full blown with every side effects chills, fever, my fever at the highest point was 102 on 12Feb2021. I had joint aches, muscle aches, fatigue and a heavy feeling in my chest. But the reason I am calling is because most of those symptoms have subsided except for one. It's Tuesday which is five days after the inoculation and my right breast on Friday morning (16Feb2021) became like engorged almost, like very hard and heavy and that has not fully gone away, it is very painful and I read that there could be like a swelling of the lymph nodes but it was my entire breast. So that's not, I do not believe if that could be connected to the lymphatic but I am not sure and I called my Primary Care Physician first. They almost started almost immediately but then they continued to get worse. Friday was the worst, the 12th, 13th I was still experiencing symptoms. They were mostly subsided by the 14th except for the heavy feeling in my chest, that fatigue and this hardened breast. I am just trying to finding answers as to what I should do about this hardened tissue and if I should get the second inoculation." Outcome of fatigue, heavy feeling in chest, breast became like engorged almost, like very hard and heavy, it is very painful was not recovered; and of remaining events was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Sedation
Clinical narrative: it is very painful; Right breast became like engorged almost, like very hard and heavy; Right breast became like engorged almost, like very hard and heavy; Chills; Fever/my fever at the highest point was 102; Joint ache; Muscle ache; Fatigue; Heavy feeling in chest; felt like drugged; felt like drugged as if I was almost intoxicated; Right eye was burning and watering; Right eye was burning and watering; Pain and numbness in lower legs below the knees; Pain and numbness in lower legs below the knees; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration on 11Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported "I am a teacher and we have received the first dosage of Pfizer COVID-19 vaccine on Thursday (11Feb2021) and I received mine early in the late afternoon, if that makes sense. And immediately after I had the shot, the best way I can describe it you is I almost felt like drugged as if I was almost intoxicated and my right eye was burning and watering and we were still teaching and then I came home and later that night, I had some pain and numbness in my lower legs below the knees and by that night, the next day, I was full blown with every side effects chills, fever, my fever at the highest point was 102 on 12Feb2021. I had joint aches, muscle aches, fatigue and a heavy feeling in my chest. But the reason I am calling is because most of those symptoms have subsided except for one. It's Tuesday which is five days after the inoculation and my right breast on Friday morning (16Feb2021) became like engorged almost, like very hard and heavy and that has not fully gone away, it is very painful and I read that there could be like a swelling of the lymph nodes but it was my entire breast. So that's not, I do not believe if that could be connected to the lymphatic but I am not sure and I called my Primary Care Physician first. They almost started almost immediately but then they continued to get worse. Friday was the worst, the 12th, 13th I was still experiencing symptoms. They were mostly subsided by the 14th except for the heavy feeling in my chest, that fatigue and this hardened breast. I am just trying to finding answers as to what I should do about this hardened tissue and if I should get the second inoculation." Outcome of fatigue, heavy feeling in chest, breast became like engorged almost, like very hard and heavy, it is very painful was not recovered; and of remaining events was recovering.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: Complete left sided deafness; This is a spontaneous report from a contactable physician. A 69-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), intramuscular, on 29Jan2021, at single dose, for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension and diverticulitis. Patient had no known allergies. Concomitant medications included several prescription medications. Patient did not receive other vaccine in four weeks. The patient experienced complete left sided deafness (disability, medically significant) on 29Jan2021 with outcome of not recovered. Therapeutic measures were taken as a result of the event and included treatment with steroids. The event required physician office visit. The reporting physician could not say that the vaccine definitely caused the event. But as the event happened shortly after the vaccine, the physician felt that it was reportable. The patient was not tested for COVID-19 after vaccination.  The information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event deafness unilateral cannot be excluded. 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Angioedema, Blood test, Investigation, Lip oedema
Clinical narrative: Angio-edema; Bottom lip locked badly; This is a spontaneous report from a contactable consumer (patient).   A 67-year-old patient of an unspecified gender received the 2nd dose of bnt162b2 (BNT162B2, lot # E19267) at single dose on 12Feb2021 for Covid-19 immunisation, as work in healthcare on the operational side (not clinical).  Medical history included blood pressure high. Concomitant medication included levothyroxine (LEVOTHYROXINE), nebivolol hydrochloride (BYSTOLIC), nifedipine (NIFEDIPINE), azilsartan kamedoxomil (EDARBI).  On 13Feb2021 the patient had to go directly to the emergency room because the bottom lip locked badly and they called (incomplete sentence), they said it was angio-edema and it was due to the injection. Patient went through a ton of lab work. All blood work and everything were fine, everything was perfect. All the last blood work patient had probably the last one was 26Jan2021, investigation: unknown results. The outcome of events was unknown. Patient wished to know if he/she could take vaccine ever again. That's a little scary, patient did not want to end up in a hospital, that he/she did.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Blood glucose, Chest pain, Hypoglycaemia, Impaired driving ability
Clinical narrative: severe hypoglycemic event (POC=38)/hypoglycemia; chest pain; He was found driving the wrong way down the highway; no memory of the event; This is a spontaneous report from a non-contactable pharmacist. A 70-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9265) intramuscular, on 01Feb2021 at 08:00 (at the age of 70 years old), for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 01Feb2021, after vaccination, the patient experienced severe hypoglycemic event (POC=38)/hypoglycemia and chest pain. He was found driving the wrong way down the highway with no memory of the event, once stopped by authorities. He was admitted to the hospital with hypoglycemia and chest pain. His home diabetes coverage was an insulin pump and there was denial of decreased PO intake. The insulin pump was stopped once the patient was admitted. His glucose improved and insulin regular SSI was initiated. He was brought for cardiac cath on 02Feb2021 with no new issues seen. The patient was stabilized, was set for follow-up with PCP and endocrinologist and discharged on 04Feb2021. The events resolved on an unspecified date in Feb2021.  No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, SARS-CoV-2 antibody test negative
Clinical narrative: tested for Covid 19 IgG and IgM antibodies, and the result was negative; This is a spontaneous report from a contactable Physician.  A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date, the patient tested for COVID 19 IGG and IGM antibodies, and the result was negative. The physician reported that the patient, after 2 doses of the covid vaccine the patient decided a month after to get a blood test, it was at a commercial lab, and tested for Covid 19 IgG and IgM antibodies, and the result was negative. The physician stated that it could be possible that the specific antibody was not part of the testing panel or if this is a concern that immunity was not generated with the vaccine. The patient was concern that immunity was not generated with the vaccine.  The patient had tests and procedures which included blood test: Negative a month after to get a blood test/ and tested for Covid 19 IgG and IgM antibodies, the result was negative. The clinical outcome of  tested for COVID 19 IGG and IGM antibodies, and the result was negative was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Death, Illness, Malaise
Clinical narrative: Was admitted and tested positive and put on ventilator; She felt slightly ill the day of vaccine; 2 days later patient become ill; tested negative 2 times over the following 10 day while deteriorating; Patient died 10 days later; This is a spontaneous report from a contactable consumer via Pfizer Sales Representative. This consumer (daughter) was reported for a female patient (mother). A 76-year-old female patient received first dose of bnt162b2 (Pfizer), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included lupus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient with lupus received 1st dose of vaccine. She felt slightly ill the day of vaccine. 2 days later patient become ill, tested negative 2 times over the following 10 day while deteriorating. Was admitted and tested positive and put on ventilator. Patient died 10 days later. Daughter thought she had COVID before vaccination. Event took place after use of product. The patient underwent lab tests and procedures which included COVID-19: negative (tested negative 2 times over the following 10 day while deteriorating), COVID-19: positive (Was admitted and tested positive and put on ventilator) all on an unspecified date. The patient died on an unspecified date.  It was not reported if an autopsy was performed. The outcome of other events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Patient died 10 days later
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Was admitted and tested positive and put on ventilator; She felt slightly ill the day of vaccine; 2 days later patient become ill; tested negative 2 times over the following 10 day while deteriorating; Patient died 10 days later; This is a spontaneous report from a contactable consumer via Pfizer Sales Representative. This consumer (daughter) was reported for a female patient (mother). A 76-year-old female patient received first dose of bnt162b2 (Pfizer), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included lupus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient with lupus received 1st dose of vaccine. She felt slightly ill the day of vaccine. 2 days later patient become ill, tested negative 2 times over the following 10 day while deteriorating. Was admitted and tested positive and put on ventilator. Patient died 10 days later. Daughter thought she had COVID before vaccination. Event took place after use of product. The patient underwent lab tests and procedures which included COVID-19: negative (tested negative 2 times over the following 10 day while deteriorating), COVID-19: positive (Was admitted and tested positive and put on ventilator) all on an unspecified date. The patient died on an unspecified date.  It was not reported if an autopsy was performed. The outcome of other events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Patient died 10 days later
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Near death experience, Pain
Clinical narrative: Chills; Fever; aches and pains; no appetite; felt weak as a kitten; injection site got swollen; having pain where the injection occurred; she had felt like she was at death's door; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose on BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN6200) solution for injection, via an unspecified route of administration in right arm on 15Feb2021 at a single dose for Covid-19 immunization. Medical history included allergies, hip surgery, and foot surgery three times. Concomitant medications included unspecified medications. Patient reported she has been so sick. She got the shot on Monday 15Feb2021, and that same day she got so sick, it was horrible. Patient had chills, fever, aches and pains, and if someone named it, it was there. She stated that before Monday she was 183 pounds, didn't know if it has changed as she has not been on a scale, but she was sure it has because hasn't eaten since Monday, as she has had no appetite. Her appointment was at 07:45, and she went right when she got up, so she did not really have anything to eat on Monday. Patient stated that on Tuesday, she did not eat anything until the evening when she had one piece of pizza. Today, patient has only had a yogurt. Today was the first time she has gotten out of bed and even felt like getting dressed and putting her contacts in, since Monday. The last few days, patient stated that after getting up and going to the bathroom she would walk downstairs and felt weak as a kitten (15Jan2021). Patient stated that she was at least 80% better, because she had felt like she was at death's door (Feb2021), and she was not a wimp, it was just horrible. Patient mentioned that she was on a lot of medicine, probably 10, but this was the first time she was receiving this vaccine. She stated that she was still having pain where the injection occurred (Feb2021), like when her shirt touches it, she can tell it was there. But patient stated that she had the nicest nurse and the injection itself did not hurt, it was just later, and the injection site got swollen (Feb2021). Outcome of the event she had felt like she was at death's door, chills, fever, aches and pains, felt weak as a kitten was recovering; no appetite was not recovered; while the other events was unknown.  No follow-up activities are needed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Chills; Fever; aches and pains; no appetite; felt weak as a kitten; injection site got swollen; having pain where the injection occurred; she had felt like she was at death's door; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose on BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN6200) solution for injection, via an unspecified route of administration in right arm on 15Feb2021 at a single dose for Covid-19 immunization. Medical history included allergies, hip surgery, and foot surgery three times. Concomitant medications included unspecified medications. Patient reported she has been so sick. She got the shot on Monday 15Feb2021, and that same day she got so sick, it was horrible. Patient had chills, fever, aches and pains, and if someone named it, it was there. She stated that before Monday she was 183 pounds, didn't know if it has changed as she has not been on a scale, but she was sure it has because hasn't eaten since Monday, as she has had no appetite. Her appointment was at 07:45, and she went right when she got up, so she did not really have anything to eat on Monday. Patient stated that on Tuesday, she did not eat anything until the evening when she had one piece of pizza. Today, patient has only had a yogurt. Today was the first time she has gotten out of bed and even felt like getting dressed and putting her contacts in, since Monday. The last few days, patient stated that after getting up and going to the bathroom she would walk downstairs and felt weak as a kitten (15Jan2021). Patient stated that she was at least 80% better, because she had felt like she was at death's door (Feb2021), and she was not a wimp, it was just horrible. Patient mentioned that she was on a lot of medicine, probably 10, but this was the first time she was receiving this vaccine. She stated that she was still having pain where the injection occurred (Feb2021), like when her shirt touches it, she can tell it was there. But patient stated that she had the nicest nurse and the injection itself did not hurt, it was just later, and the injection site got swollen (Feb2021). Outcome of the event she had felt like she was at death's door, chills, fever, aches and pains, felt weak as a kitten was recovering; no appetite was not recovered; while the other events was unknown.  No follow-up activities are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Gastric haemorrhage
Clinical narrative: bleeding stomach in the lower abdomen; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's wife) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The wife was asking for her husband who will get the second dose of the Covid-19 vaccine on 18Feb2021 however the husband had recent surgery and a bleeding stomach in the lower abdomen on an unspecified date. The wife wants to know if the husband can take the second shot of the vaccine after getting the surgery. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia supraventricular, Pericarditis, SARS-CoV-2 test
Clinical narrative: Acute pericarditis; Atrial arrhythmia; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on left arm, on 17Feb2021 10:45 (at the age of 74-year-old, not pregnant), at single dose, for Covid 19 (COVID-19 immunization). Medical history included allergies to alpha antibiotics. No COVID prior vaccination. Concomitant medications included atorvastatin, and bupropion. No other vaccine in four weeks. The patient previously took codeine and experienced allergies. The patient experienced acute pericarditis and atrial arrhythmia, both on 20Feb2021 15:00. Events resulted in emergency room/department or urgent care, and hospitalization (for 1 day). The patient underwent lab tests included COVID test (Nasal Swab/COVID 19 PCR) post vaccination on 21Feb2021, result was negative. Therapeutic measures were taken as a result of events and included treatment with multiple. The outcome of the events was recovering.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Face injury, Feeling hot, Head injury, Loss of consciousness
Clinical narrative: blacked out and loss consciousness twice; hit head and make a gauche on eyebrow needing stiches; hit head and make a gauche on eyebrow needing stiches; whole body was feverishly hot; This is a spontaneous report from a non-contactable consumer (patient). A 29-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201), via an unspecified route of administration on 13Feb2021 10:30 (at 29-years-old) at single dose (Left arm) for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262), on 23Jan2021 03:30 PM (at 29-years-old) on Left arm for COVID-19 immunization. Facility type vaccine was reported as Other. There were no other vaccine administered in four weeks. There were no other medications in two weeks. Approximately 12-24 hours after second dose, whole body was feverishly hot, blacked out and loss consciousness twice within 30mins of each other waking up on the floor from standing position, causing to hit head and make a gauche on eyebrow needing stiches. Events started on 14Feb2021 04:00. Events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of hit head and make a gauche on eyebrow needing stiches. The outcome of the events was recovering.    No follow-up attempts are possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Fear, Nightmare
Clinical narrative: bad dreams/ vivid and frightening; bad dreams/ vivid and frightening; afraid to go to sleep over fear that he would never wake up; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter's daughter said she spoke to some who have had bad dreams on an unspecified date from a COVID shot but the patient's were so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report from a contactable consumer reporting for a patient.  An 86-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 10Feb2021 at single dose for COVID-19 immunization. Concomitant medications were not reported. Relevant medical history included bacterial infection, the patient was being treated for bacterial infection and had spent 1 week in hospital within one month prior to being dosed with vaccine. On 17Feb2021 the patient died. The cause of death was unknown. It was unknown if an autopsy was performed.   Information on the lot/batch number has been requested.; Reported Cause(s) of Death: death
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Paraesthesia oral, Tachycardia, Urticaria
Clinical narrative: Tachycardic, hr 112; hives on both arms, chest, face.; Lips were tingly; This is a spontaneous report from a contactable other hcp. A 39-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021 16:00 at single dose, right arm for covid-19 immunization. Medical history included Anti Myelin oligodendrocyte glycoprotein(MOG) disease. Known allergies included prednisone, methyl prednisolone. Concomitant medication included cyclobenzaprine, celecoxib and duloxetine hydrochloride (CYMBALTA). There were no other vaccine in four weeks. The patient previously received first dose of bnt162b2 for covid-19 immunization. The patient had hives on both arms, chest, face. Lips were tingly. Tachycardic, HR 112. The patient took 75 mg diphenhydramine hydrochloride(BENADRYL) and became slightly better. Adverse events start date was 25Feb2021 16:30. Events resulted in [Life threatening illness (immediate risk of death from the event)]. The outcome of the events were recovering. The patient had no COVID prior vaccination. There was no COVID tested post vaccination.   Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be  completely excluded based on a compatible temporal relation. 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.
Sex: M
Vaccine: COVID19
Symptoms: Blue toe syndrome, Body temperature, Death, Feeling cold, Heart rate
Clinical narrative: heart attacks; Collapse of lung; pulse was in the 130s/140s; passed away; nose and fingers turned gray and were cold to the touch; nose and fingers turned gray and were cold to the touch; his big toe had turned gray; his right foot was swollen; low grade fever; Shaking; extremely cold; This is a spontaneous report from a contactable consumer. An elderly male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 18Feb2021, at single dose, for COVID-19 immunisation. Medical history included ongoing blood magnesium decreased (went to the hospital on 17Feb2021). Concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), on 27Jan2021, for COVID-19 immunisation and experienced arm soreness. The patient experienced passed away (death, hospitalization, medically significant) on 23Feb2021, heart attacks (caused hospitalization, medically significant) on 20Feb2021 with outcome of unknown, collapse of lung (caused hospitalization) on 20Feb2021 with outcome of unknown, pulse was in the 130s/140s (caused hospitalization) on 19Feb2021 with outcome of unknown, low grade fever on 18Feb2021 with outcome of recovered on 23Feb2021, shaking on 18Feb2021 with outcome of unknown, extremely cold on 18Feb2021 with outcome of unknown, nose and fingers turned gray and were cold to the touch on 19Feb2021 with outcome of unknown, his big toe had turned gray on 19Feb2021 with outcome of unknown, his right foot was swollen on 19Feb2021 with outcome of unknown. The events his big toe had turned gray and his right foot was swollen required physician visit on 19Feb2021. They were reported as a result of the magnesium deficiency. On 19Feb2021 evening his fever increased and his nose and fingers turned gray and were cold to the touch. On 20Feb2021 he collapsed at home and was taken to the hospital by ambulance. He had several heart attacks prior to the collapse. They decided to put him in a medically induced coma and reduce his body temperature that evening and started dialysis on 21Feb2021. They returned his body to normal temperature on 23Feb2021, his pulse was in the 130s/140s. They were starting to reduce the sedatives on 23Feb2021. The patient passed away on 23Feb2021. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: passed away
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Myocardial infarction, Nasopharyngitis, Peripheral swelling, Pneumothorax
Clinical narrative: heart attacks; Collapse of lung; pulse was in the 130s/140s; passed away; nose and fingers turned gray and were cold to the touch; nose and fingers turned gray and were cold to the touch; his big toe had turned gray; his right foot was swollen; low grade fever; Shaking; extremely cold; This is a spontaneous report from a contactable consumer. An elderly male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 18Feb2021, at single dose, for COVID-19 immunisation. Medical history included ongoing blood magnesium decreased (went to the hospital on 17Feb2021). Concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), on 27Jan2021, for COVID-19 immunisation and experienced arm soreness. The patient experienced passed away (death, hospitalization, medically significant) on 23Feb2021, heart attacks (caused hospitalization, medically significant) on 20Feb2021 with outcome of unknown, collapse of lung (caused hospitalization) on 20Feb2021 with outcome of unknown, pulse was in the 130s/140s (caused hospitalization) on 19Feb2021 with outcome of unknown, low grade fever on 18Feb2021 with outcome of recovered on 23Feb2021, shaking on 18Feb2021 with outcome of unknown, extremely cold on 18Feb2021 with outcome of unknown, nose and fingers turned gray and were cold to the touch on 19Feb2021 with outcome of unknown, his big toe had turned gray on 19Feb2021 with outcome of unknown, his right foot was swollen on 19Feb2021 with outcome of unknown. The events his big toe had turned gray and his right foot was swollen required physician visit on 19Feb2021. They were reported as a result of the magnesium deficiency. On 19Feb2021 evening his fever increased and his nose and fingers turned gray and were cold to the touch. On 20Feb2021 he collapsed at home and was taken to the hospital by ambulance. He had several heart attacks prior to the collapse. They decided to put him in a medically induced coma and reduce his body temperature that evening and started dialysis on 21Feb2021. They returned his body to normal temperature on 23Feb2021, his pulse was in the 130s/140s. They were starting to reduce the sedatives on 23Feb2021. The patient passed away on 23Feb2021. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: passed away
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Skin discolouration, Tremor
Clinical narrative: heart attacks; Collapse of lung; pulse was in the 130s/140s; passed away; nose and fingers turned gray and were cold to the touch; nose and fingers turned gray and were cold to the touch; his big toe had turned gray; his right foot was swollen; low grade fever; Shaking; extremely cold; This is a spontaneous report from a contactable consumer. An elderly male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 18Feb2021, at single dose, for COVID-19 immunisation. Medical history included ongoing blood magnesium decreased (went to the hospital on 17Feb2021). Concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), on 27Jan2021, for COVID-19 immunisation and experienced arm soreness. The patient experienced passed away (death, hospitalization, medically significant) on 23Feb2021, heart attacks (caused hospitalization, medically significant) on 20Feb2021 with outcome of unknown, collapse of lung (caused hospitalization) on 20Feb2021 with outcome of unknown, pulse was in the 130s/140s (caused hospitalization) on 19Feb2021 with outcome of unknown, low grade fever on 18Feb2021 with outcome of recovered on 23Feb2021, shaking on 18Feb2021 with outcome of unknown, extremely cold on 18Feb2021 with outcome of unknown, nose and fingers turned gray and were cold to the touch on 19Feb2021 with outcome of unknown, his big toe had turned gray on 19Feb2021 with outcome of unknown, his right foot was swollen on 19Feb2021 with outcome of unknown. The events his big toe had turned gray and his right foot was swollen required physician visit on 19Feb2021. They were reported as a result of the magnesium deficiency. On 19Feb2021 evening his fever increased and his nose and fingers turned gray and were cold to the touch. On 20Feb2021 he collapsed at home and was taken to the hospital by ambulance. He had several heart attacks prior to the collapse. They decided to put him in a medically induced coma and reduce his body temperature that evening and started dialysis on 21Feb2021. They returned his body to normal temperature on 23Feb2021, his pulse was in the 130s/140s. They were starting to reduce the sedatives on 23Feb2021. The patient passed away on 23Feb2021. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: passed away
Sex: U
Vaccine: COVID19
Symptoms: Death, Haemorrhage
Clinical narrative: died; bled out; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had bled out on an unspecified date with outcome of unknown. The patient died on an unspecified date. It was unknown if an autopsy was performed.  Information on the lot/batch number has been requested.; Sender's Comments: The limited information provided precludes a full clinical assessment of the case. As a cautionary measure and for reporting purposes, and assuming a drug-event temporal association, the Company cannot completely exclude a causal association between the reported events 'bled out' and 'died' (death of unknown cause) and BNT162B2 administration, until sufficient 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021210582 Same reporter/drug, different patient; Reported Cause(s) of Death: died