chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Haematochezia, Occult blood positive, Renal pain
Clinical narrative: she is positive for blood in her stool; left hip/back/kidney pain; left hip/back/kidney pain; left hip/back/kidney pain; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date unknown) 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 patient received the vaccine on 28Dec2020 (reported on 05Jan2021 as 'a week ago Monday'). After getting the vaccine (2-3 days after getting the vaccine) she started to have some events happen that she was not sure were side effects from the vaccine. She mentioned she started to experience blood in her stool - following a test at her doctor's she was positive for blood in her stool. Also, the left side of her lower back and hip started hurting. She was experiencing left hip/back/kidney pain, as reported. She took hydrochlorothiazide. The outcome of the events was unknown. She wanted to know if this had anything to do with the vaccine and if this could be a side effect. These events did not start happening until after she got the vaccine.   Information on the lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Presyncope
Clinical narrative: difficulty of breathing; chest pain; nearly passing out/fainting; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter called in behalf of her friend that has been experiencing serious adverse event. The patient experienced difficulty of breathing, chest pain, nearly passing out/fainting on unspecified date. They felt that the vaccination provider did not provide enough support about the adverse event that happened.  Follow-up activities are possible, information on the batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Immediate post-injection reaction, Impaired work ability, Injected limb mobility decreased
Clinical narrative: believed it was injected incorrectly because she didn't have pain in her deltoid but she did have all the pain inside her shoulder, like in the bursa; received the first dose 17DEC2020 / received the second dose 4JAN2021; anterior medial shoulder joint/shoulder pain/pain in shoulder after second dose of COVID 19 vaccine; can't actively use shoulder / can't move her arm; weakness in her hand; bone pain; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself.  A 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685, expiry date not provided) via an unspecified route of administration in the left arm on 17Dec2020 13:30, and the second dose (lot number EK9231, expiry date not provided)via an unspecified route of administration in the left arm on 04Jan2021 13:30, for COVID-19 immunization. There was no relevant medical history. The patient's concomitant medications were not reported. The patient experienced anterior medial shoulder joint/shoulder pain/pain in shoulder after second dose of the vaccine on 04Jan2021, and couldn't actively use shoulder. She believed it was injected incorrectly because she didn't have pain in her deltoid but she did have all the pain inside her shoulder, like in the bursa, and she couldn't move her arm and felt weakness in her hand. She noticed the pain and all other symptoms immediately when they were injecting it. She told the nurse who said she was tensing up. The events were considered medically significant by the patient. She also reported experiencing bone pain, unable to put in sutures at work.  She was taking 600mg Ibuprofen and 1000mg paracetamol (TYLENOL) every 6-8 hours. The events were not resolved. The pain had gotten worse. The other symptoms were persisting.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site joint pain, Injection site pain, Muscle tightness, Muscular weakness
Clinical narrative: believed it was injected incorrectly because she didn't have pain in her deltoid but she did have all the pain inside her shoulder, like in the bursa; received the first dose 17DEC2020 / received the second dose 4JAN2021; anterior medial shoulder joint/shoulder pain/pain in shoulder after second dose of COVID 19 vaccine; can't actively use shoulder / can't move her arm; weakness in her hand; bone pain; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself.  A 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685, expiry date not provided) via an unspecified route of administration in the left arm on 17Dec2020 13:30, and the second dose (lot number EK9231, expiry date not provided)via an unspecified route of administration in the left arm on 04Jan2021 13:30, for COVID-19 immunization. There was no relevant medical history. The patient's concomitant medications were not reported. The patient experienced anterior medial shoulder joint/shoulder pain/pain in shoulder after second dose of the vaccine on 04Jan2021, and couldn't actively use shoulder. She believed it was injected incorrectly because she didn't have pain in her deltoid but she did have all the pain inside her shoulder, like in the bursa, and she couldn't move her arm and felt weakness in her hand. She noticed the pain and all other symptoms immediately when they were injecting it. She told the nurse who said she was tensing up. The events were considered medically significant by the patient. She also reported experiencing bone pain, unable to put in sutures at work.  She was taking 600mg Ibuprofen and 1000mg paracetamol (TYLENOL) every 6-8 hours. The events were not resolved. The pain had gotten worse. The other symptoms were persisting.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. 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: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: SEVERE ABDOMINAL PAIN
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Flushing, Hot flush, Injection site erythema, Injection site pain
Clinical narrative: tongue not swollen but felt sluggish/tongue felt strange, it was sluggish to swallow; tongue felt strange like hard to swallow/tongue felt strange, it was sluggish to swallow/Her tongue felt strange; tongue felt strange like hard to swallow/tongue felt strange, it was sluggish to swallow/felt hard to swallow; hot flash; flush feeling all over her face/flush all over her face/she felt flush; arm was sore; arm was sore and heavy; drowsiness; pain and redness at injection site; pain and redness at injection site; This is a spontaneous report from a contactable nurse reporting for herself.  A 36-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284, expiry date not provided) on 23Dec2020 09:15 intramuscularly in the left arm for COVID-19 immunisation (reported as preventive). There was no relevant medical history and no concomitant medications. The nurse (patient) received her first dose of the vaccine on 23Dec2020 at the hospital that she worked at. She was kept there for 15 min for monitoring and she felt fine. About 30 minutes post vaccination she got a hot flash, a flush over her face, she does not know if she was red but she felt flush. Her tongue felt strange, nothing swelled that she could tell, it felt hard to swallow, to make the motion to swallow it felt kind of sluggish. She felt weird swallowing which lasted for only a few minutes. She never struggled to breathe. She went back to park in the hospital parking lot since she was not sure if she was experiencing a anaphylactic reaction and then after a few minutes it went away. Her arm was sore and heavy feeling for that day. She had drowsiness for a couple of hours and pain and redness at the injection site for a couple of days that was not bothersome, it was mild. No relevant test. She wanted to know if she should get the second dose of the vaccine due to the symptoms she had after the first dose. The pain and redness at injection site was resolved on an unspecified date in Dec2020, while the other events were resolved on 23Dec2020.  The reporting nurse considered the events hot flash, flush all over her face, arm was sore and heavy, drowsiness, pain and redness at injection site were non-serious, while the events "tongue felt strange, it was sluggish to swallow" were serious that she drove back to the hospital (no emergency room/phycian office visit). She considered the events were related to the vaccine.; Sender's Comments: A possible contributory effect of suspect BNT162Bw on the 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Paraesthesia oral, Somnolence, Tongue movement disturbance
Clinical narrative: tongue not swollen but felt sluggish/tongue felt strange, it was sluggish to swallow; tongue felt strange like hard to swallow/tongue felt strange, it was sluggish to swallow/Her tongue felt strange; tongue felt strange like hard to swallow/tongue felt strange, it was sluggish to swallow/felt hard to swallow; hot flash; flush feeling all over her face/flush all over her face/she felt flush; arm was sore; arm was sore and heavy; drowsiness; pain and redness at injection site; pain and redness at injection site; This is a spontaneous report from a contactable nurse reporting for herself.  A 36-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284, expiry date not provided) on 23Dec2020 09:15 intramuscularly in the left arm for COVID-19 immunisation (reported as preventive). There was no relevant medical history and no concomitant medications. The nurse (patient) received her first dose of the vaccine on 23Dec2020 at the hospital that she worked at. She was kept there for 15 min for monitoring and she felt fine. About 30 minutes post vaccination she got a hot flash, a flush over her face, she does not know if she was red but she felt flush. Her tongue felt strange, nothing swelled that she could tell, it felt hard to swallow, to make the motion to swallow it felt kind of sluggish. She felt weird swallowing which lasted for only a few minutes. She never struggled to breathe. She went back to park in the hospital parking lot since she was not sure if she was experiencing a anaphylactic reaction and then after a few minutes it went away. Her arm was sore and heavy feeling for that day. She had drowsiness for a couple of hours and pain and redness at the injection site for a couple of days that was not bothersome, it was mild. No relevant test. She wanted to know if she should get the second dose of the vaccine due to the symptoms she had after the first dose. The pain and redness at injection site was resolved on an unspecified date in Dec2020, while the other events were resolved on 23Dec2020.  The reporting nurse considered the events hot flash, flush all over her face, arm was sore and heavy, drowsiness, pain and redness at injection site were non-serious, while the events "tongue felt strange, it was sluggish to swallow" were serious that she drove back to the hospital (no emergency room/phycian office visit). She considered the events were related to the vaccine.; Sender's Comments: A possible contributory effect of suspect BNT162Bw on the 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: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: DEVELOPED RASH, ITCH AND WARMTH AT INJECTION SITE DAY 14 POST VACCINATION
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Aphasia, Blood pressure increased, Computerised tomogram, Confusional state
Clinical narrative: experienced symptoms of TIA; Severe aphasia; blurred vision; confusion; short term memory loss; elevated blood pressure; This is a spontaneous report from a contactable Other-HCP(Patient). A 57-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right arm, on 22Dec2020 08:15 at single dose for COVID-19 immunization. The patient was not pregnant. Medical history included herpes simplex on lips, post menopause, elevated cholesterol w/lifestyle changes. Known allergies reported as no. Concomitant medication included varicella zoster vaccine rge (cho) (SHINGRIX) for immunization. On 04Jan2021 08:30, the patient experienced symptoms of transient ischaemic attack(TIA), severe aphasia, blurred vision, confusion, short term memory loss, elevated blood pressure. The patient admitted to (Hospital name) (still here, hospitalization days reported as 2). Symptoms resolved except very mild aphasia. The patient had very few risk factors for TIA but did have family history of cardiovascular(CV) disease at young age, low density lipoprotein(LDL) was 192. The patient did not have diabetes, HTN, or known heart disease. She did not have severe anxiety. She did not smoke or use any substances. She walked about five miles 4x a week. Weigh reported as 157. Events reported as serious due to hospitalization. The patient had no Covid prior vaccination. Covid(nasal swab) was tested post vaccination on 04Jan2021, Covid test result was Negative. The event resulted in emergency room/department or urgent care. Treatment received for the adverse event included clopidogrel bisulfate(PLAVIX), acetylsalicylic acid (ASPIRIN), statin; potassium, CT, MRI, "telemet". The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported  symptoms of transient ischaemic attack(TIA), severe aphasia, blurred vision, confusion, short term memory loss, elevated blood pressure and the administration of BNT162B2, based on the reasonable temporal association.   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 RA, Agency, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Low density lipoprotein increased, Magnetic resonance imaging, SARS-CoV-2 test negative, Transient ischaemic attack, Vision blurred
Clinical narrative: experienced symptoms of TIA; Severe aphasia; blurred vision; confusion; short term memory loss; elevated blood pressure; This is a spontaneous report from a contactable Other-HCP(Patient). A 57-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right arm, on 22Dec2020 08:15 at single dose for COVID-19 immunization. The patient was not pregnant. Medical history included herpes simplex on lips, post menopause, elevated cholesterol w/lifestyle changes. Known allergies reported as no. Concomitant medication included varicella zoster vaccine rge (cho) (SHINGRIX) for immunization. On 04Jan2021 08:30, the patient experienced symptoms of transient ischaemic attack(TIA), severe aphasia, blurred vision, confusion, short term memory loss, elevated blood pressure. The patient admitted to (Hospital name) (still here, hospitalization days reported as 2). Symptoms resolved except very mild aphasia. The patient had very few risk factors for TIA but did have family history of cardiovascular(CV) disease at young age, low density lipoprotein(LDL) was 192. The patient did not have diabetes, HTN, or known heart disease. She did not have severe anxiety. She did not smoke or use any substances. She walked about five miles 4x a week. Weigh reported as 157. Events reported as serious due to hospitalization. The patient had no Covid prior vaccination. Covid(nasal swab) was tested post vaccination on 04Jan2021, Covid test result was Negative. The event resulted in emergency room/department or urgent care. Treatment received for the adverse event included clopidogrel bisulfate(PLAVIX), acetylsalicylic acid (ASPIRIN), statin; potassium, CT, MRI, "telemet". The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported  symptoms of transient ischaemic attack(TIA), severe aphasia, blurred vision, confusion, short term memory loss, elevated blood pressure and the administration of BNT162B2, based on the reasonable temporal association.   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 RA, Agency, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coagulopathy, Computerised tomogram, Condition aggravated, Epistaxis, Haemorrhage
Clinical narrative: two skin procedures performed in his surgeons office the day before- one on his nose and one on his arm; nose was still slightly bleeding; This is a spontaneous report from a contactable consumer(patient).  A 72-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. Medical history included phlebotomy in Sep2020 because his blood was "too thick" and he had no history of a clotting problem until the time of the report. The patient's concomitant medications were not reported. He reported having two skin procedures performed in his surgeons office the day before- one on his nose and one on his arm. The surgeon nicked a vein on his arm and it began bleeding again last night. The arm was addressed in the emergency deportment(ED) and was fine at time of the report. His nose was still slightly bleeding. This morning his blood was drawn for a CT scan and it took a little while to get the bleeding to stop. He had a "phlebotomy" in Sep2020 because his blood was "too thick" and he had no history of a clotting problem until the time of the report. The patient asked if the Covid vaccine act as an anticoagulant. He had not spoken to this HCP yet. He was not on a blood thinner. The reporter considered that the event was non-serious. The outcome of the event arm bleeding/bleeding was recovered, of event "nose was still slightly bleeding" was not recovered.    Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, Blood test, Coagulopathy, Computerised tomogram, Post procedural haemorrhage
Clinical narrative: two skin procedures performed in his surgeons office the day before- one on his nose and one on his arm; nose was still slightly bleeding; This is a spontaneous report from a contactable consumer(patient).  A 72-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. Medical history included phlebotomy in Sep2020 because his blood was "too thick" and he had no history of a clotting problem until the time of the report. The patient's concomitant medications were not reported. He reported having two skin procedures performed in his surgeons office the day before- one on his nose and one on his arm. The surgeon nicked a vein on his arm and it began bleeding again last night. The arm was addressed in the emergency deportment(ED) and was fine at time of the report. His nose was still slightly bleeding. This morning his blood was drawn for a CT scan and it took a little while to get the bleeding to stop. He had a "phlebotomy" in Sep2020 because his blood was "too thick" and he had no history of a clotting problem until the time of the report. The patient asked if the Covid vaccine act as an anticoagulant. He had not spoken to this HCP yet. He was not on a blood thinner. The reporter considered that the event was non-serious. The outcome of the event arm bleeding/bleeding was recovered, of event "nose was still slightly bleeding" was not recovered.    Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin haemorrhage
Clinical narrative: two skin procedures performed in his surgeons office the day before- one on his nose and one on his arm; nose was still slightly bleeding; This is a spontaneous report from a contactable consumer(patient).  A 72-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. Medical history included phlebotomy in Sep2020 because his blood was "too thick" and he had no history of a clotting problem until the time of the report. The patient's concomitant medications were not reported. He reported having two skin procedures performed in his surgeons office the day before- one on his nose and one on his arm. The surgeon nicked a vein on his arm and it began bleeding again last night. The arm was addressed in the emergency deportment(ED) and was fine at time of the report. His nose was still slightly bleeding. This morning his blood was drawn for a CT scan and it took a little while to get the bleeding to stop. He had a "phlebotomy" in Sep2020 because his blood was "too thick" and he had no history of a clotting problem until the time of the report. The patient asked if the Covid vaccine act as an anticoagulant. He had not spoken to this HCP yet. He was not on a blood thinner. The reporter considered that the event was non-serious. The outcome of the event arm bleeding/bleeding was recovered, of event "nose was still slightly bleeding" was not recovered.    Information about lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coagulopathy, Computerised tomogram, Condition aggravated, Epistaxis, Haemorrhage
Clinical narrative: one of those biopsies was bleeding pretty heavy/looked at the incision/The one on his nose is still dripping blood and its coming up on 24 hours now; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: E70124), Intramuscular in arm on 30Dec2020 at single dose for COVID-19 vaccination. Medical history included ongoing blood pressure high and he had been treated for that for a number of years, diabetes from 2009 and ongoing, COPD (chronic obstructive pulmonary disease) issues from 2020 and ongoing and his issues began within the last year, ongoing kidney failure and this started occurring within the last 2 or 3 years, had a urostomy done, had bladder cancer and he had had phlebotomy performed around 3-4 months ago in 2020 and he knew his blood was thick at the time. There were no concomitant medications. The patient received the first vaccine on Wednesday, 30Dec2020. He had noticed something. He had a couple of things happen that basically involved a couple of skin biopsies. He had some lab work drawn for a CT scan, and he didn't clot right away on 05Jan2021. Last night 04Jan2021, he went to the emergency room because one of those biopsies was bleeding pretty heavy. He wanted to know if there is any known connection with the COVID vaccine and anti-clogging. He was going to follow up with the surgeon that did the biopsies. He stated its weird. He had had phlebotomy performed around 3-4 months ago in 2020 and he knew his blood was thick at the time. There had been 2 or 3 incidents where he was not clogging up. He clarified they were skin cancer biopsies, which was something diagnosed prior to receiving the vaccine. It was a follow-up because they didn't get it all the first time and they had to go back in. His skin biopsies were done yesterday, 04Jan2021. He verified when he went to the emergency room last night 04Jan2021 he was not admitted into the hospital. It was outpatient and they looked at the incision and put a little clotting tape (or whatever it is) on him and wrapped it up. He hadn't been bleeding. He knew the doctor nicked a vein. There were 2 biopsies done- one was on his nose. The one on his nose was still dripping blood and its coming up on 24 hours now. The blood drawn for the CT scan was drawn early this morning 05Jan2021 around 7:30 AM. The outcome of the event was not resolved.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, Blood test, Coagulopathy, Computerised tomogram, Post procedural haemorrhage
Clinical narrative: one of those biopsies was bleeding pretty heavy/looked at the incision/The one on his nose is still dripping blood and its coming up on 24 hours now; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: E70124), Intramuscular in arm on 30Dec2020 at single dose for COVID-19 vaccination. Medical history included ongoing blood pressure high and he had been treated for that for a number of years, diabetes from 2009 and ongoing, COPD (chronic obstructive pulmonary disease) issues from 2020 and ongoing and his issues began within the last year, ongoing kidney failure and this started occurring within the last 2 or 3 years, had a urostomy done, had bladder cancer and he had had phlebotomy performed around 3-4 months ago in 2020 and he knew his blood was thick at the time. There were no concomitant medications. The patient received the first vaccine on Wednesday, 30Dec2020. He had noticed something. He had a couple of things happen that basically involved a couple of skin biopsies. He had some lab work drawn for a CT scan, and he didn't clot right away on 05Jan2021. Last night 04Jan2021, he went to the emergency room because one of those biopsies was bleeding pretty heavy. He wanted to know if there is any known connection with the COVID vaccine and anti-clogging. He was going to follow up with the surgeon that did the biopsies. He stated its weird. He had had phlebotomy performed around 3-4 months ago in 2020 and he knew his blood was thick at the time. There had been 2 or 3 incidents where he was not clogging up. He clarified they were skin cancer biopsies, which was something diagnosed prior to receiving the vaccine. It was a follow-up because they didn't get it all the first time and they had to go back in. His skin biopsies were done yesterday, 04Jan2021. He verified when he went to the emergency room last night 04Jan2021 he was not admitted into the hospital. It was outpatient and they looked at the incision and put a little clotting tape (or whatever it is) on him and wrapped it up. He hadn't been bleeding. He knew the doctor nicked a vein. There were 2 biopsies done- one was on his nose. The one on his nose was still dripping blood and its coming up on 24 hours now. The blood drawn for the CT scan was drawn early this morning 05Jan2021 around 7:30 AM. The outcome of the event was not resolved.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin haemorrhage
Clinical narrative: one of those biopsies was bleeding pretty heavy/looked at the incision/The one on his nose is still dripping blood and its coming up on 24 hours now; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: E70124), Intramuscular in arm on 30Dec2020 at single dose for COVID-19 vaccination. Medical history included ongoing blood pressure high and he had been treated for that for a number of years, diabetes from 2009 and ongoing, COPD (chronic obstructive pulmonary disease) issues from 2020 and ongoing and his issues began within the last year, ongoing kidney failure and this started occurring within the last 2 or 3 years, had a urostomy done, had bladder cancer and he had had phlebotomy performed around 3-4 months ago in 2020 and he knew his blood was thick at the time. There were no concomitant medications. The patient received the first vaccine on Wednesday, 30Dec2020. He had noticed something. He had a couple of things happen that basically involved a couple of skin biopsies. He had some lab work drawn for a CT scan, and he didn't clot right away on 05Jan2021. Last night 04Jan2021, he went to the emergency room because one of those biopsies was bleeding pretty heavy. He wanted to know if there is any known connection with the COVID vaccine and anti-clogging. He was going to follow up with the surgeon that did the biopsies. He stated its weird. He had had phlebotomy performed around 3-4 months ago in 2020 and he knew his blood was thick at the time. There had been 2 or 3 incidents where he was not clogging up. He clarified they were skin cancer biopsies, which was something diagnosed prior to receiving the vaccine. It was a follow-up because they didn't get it all the first time and they had to go back in. His skin biopsies were done yesterday, 04Jan2021. He verified when he went to the emergency room last night 04Jan2021 he was not admitted into the hospital. It was outpatient and they looked at the incision and put a little clotting tape (or whatever it is) on him and wrapped it up. He hadn't been bleeding. He knew the doctor nicked a vein. There were 2 biopsies done- one was on his nose. The one on his nose was still dripping blood and its coming up on 24 hours now. The blood drawn for the CT scan was drawn early this morning 05Jan2021 around 7:30 AM. The outcome of the event was not resolved.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy, Tenderness
Clinical narrative: Erythema and tenderness with reactive lymph nodes left axillary area The size of erythema is 18x8 cm
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Palpitations, Peripheral swelling
Clinical narrative: Heart racing and hands swelling, redness/swelling at injection site
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Echocardiogram, Pain, Pelvic venous thrombosis, Ultrasound Doppler
Clinical narrative: DVT; have pain in same site where DVT is; This is a spontaneous report from a contactable consumer. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9291), via an unspecified route of administration in left deltoid on 24Dec2020 10:00 at first single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. Caller was calling to report a possible adverse reaction to the Pfizer Covid-19 vaccine. The patient was currently at hospital, she was admitted for deep vein thrombosis (DVT) of left iliac vein, the patient had no past history as to why this would happen, that she is only 28 years old. Received the vaccine on 24Dec2020, the following day she did have pain in same site where DVT was. Took ibuprofen for the pain. The patient was admitted yesterday 04Jan2020 for the DVT, they were currently treating her with Lovenox injections and prescribing dose for discharge is Eliquis. CT scans and three shots of Lovenox for it, doing a doppler of bilateral legs and echocardiogram (echo) of her heart to make sure there is nothing else. The AEs require a visit to emergency room. The patient was asking if she can still get the 2nd dose based off the adverse event she experienced. Outcome of DVT was not recovered, of pain was unknown.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Laboratory test, Thrombosis, Ultrasound scan
Clinical narrative: DVT; have pain in same site where DVT is; This is a spontaneous report from a contactable consumer. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9291), via an unspecified route of administration in left deltoid on 24Dec2020 10:00 at first single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. Caller was calling to report a possible adverse reaction to the Pfizer Covid-19 vaccine. The patient was currently at hospital, she was admitted for deep vein thrombosis (DVT) of left iliac vein, the patient had no past history as to why this would happen, that she is only 28 years old. Received the vaccine on 24Dec2020, the following day she did have pain in same site where DVT was. Took ibuprofen for the pain. The patient was admitted yesterday 04Jan2020 for the DVT, they were currently treating her with Lovenox injections and prescribing dose for discharge is Eliquis. CT scans and three shots of Lovenox for it, doing a doppler of bilateral legs and echocardiogram (echo) of her heart to make sure there is nothing else. The AEs require a visit to emergency room. The patient was asking if she can still get the 2nd dose based off the adverse event she experienced. Outcome of DVT was not recovered, of pain was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hyperhidrosis, Pruritus
Clinical narrative: palms of hands started to swell and itch.  diaphoretic, then neck started to itch.  extended to throat leading to difficulty swallowing
Sex: F
Vaccine: COVID19
Symptoms: Mycobacterium tuberculosis complex test
Clinical narrative: TB test; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported that received received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. Certified Nursing Assistant got the first dose of the covid vaccine on January 2nd and also she needs to get her TB test. She was told to wait 2weeks between the application and the TB test but the 2 weeks period ends on January 15th and she needs to have the test before that day, so she was wondering if she could get the test done a couple of days early. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Chills, Dysstasia, Headache
Clinical narrative: Extremely severe body aches, sweating, headache, back ache and chills.  I also experienced a low grade fever and chest pain.  The aches were so intense that standing on my own was almost impossible for 24hours.  At the 24 hour mark, my symptoms reduced significantly.  Day 2 after the injection was mainly mild body ache and moderate arm pain at the injection site.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Injection site pain, Pain, Pyrexia
Clinical narrative: Extremely severe body aches, sweating, headache, back ache and chills.  I also experienced a low grade fever and chest pain.  The aches were so intense that standing on my own was almost impossible for 24hours.  At the 24 hour mark, my symptoms reduced significantly.  Day 2 after the injection was mainly mild body ache and moderate arm pain at the injection site.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Hyperhidrosis, Syncope, Vision blurred
Clinical narrative: syncope; diaphoresis; varying HR; blurred vision; This is a spontaneous report from a contactable physician (patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 05Jan2021 as single dose for COVID -19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced syncope, diaphoresis, varying HR (heart rate) and blurred vision in Jan2021.  The patient underwent lab tests and procedures which included heart rate: varying in Jan2021. Details were as follows:   Patient received the vaccine in the morning.  He reported diaphoresis, syncope, varying HR, and blurred vision within 10 minutes of receiving the vaccine.  He was taken to the emergency room and therapeutic measures were taken as a result of the events; he was given fluids. The patient generally tolerated vaccines and has recovered from the episode. The events, syncope, diaphoresis, varying HR (heart rate) and blurred vision recovered in Jan2021.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event due to temporal association.  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: 41.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Throat tightness
Clinical narrative: Pateint reports feeling tightness in throat  she did take Benadryl, was talking in full complete sentences Denies hives, denies swelling on mouth or SOB SHe called 911 no epi provided
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Gait inability
Clinical narrative: Patient received her second dose of shingrix and later developed severe joint pain across many joints.  The pain was severe enough that she was unable to walk.  She went to the ER for evaluation where she was given pain meds and discharged.  The pain continued and she went back to the ER the next day where she was treated again. 3 days after the injection, patient reports joint pain is subsiding and she is now able to walk again.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Fatigue
Clinical narrative: tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head on wall, head just hurts; hit head on wall, head just hurts; Chills; she was very cold; could not sleep good; site of vaccine was sore; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer. A 58-year-old female patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EK9231) by injection once to left arm, via an unspecified route of administration on 04Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included thyroid disorder. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder; patient started it after she had her son, and her son is 18 years old. The patient had her vaccine yesterday (04Jan2021) at 12:30, and at nighttime, around 22:00, she started having chills, she was very cold, so she went to bed, she could not sleep good, she kept waking up, and the site of vaccine was sore, she had muscle pain, joint pain, she didn't have fever, but she got up late today (05Jan2021), around 11:00, and had breakfast and felt nauseated, so she stopped eating, and she went to the bathroom and passed out on the toilet, when she woke up, she had her nightgown inside the toilet, it was all wet, she felt better, so she stood up and then she woke up again, and was inside the tub, her legs were inside the basin, she was lying down with her back inside the tub, she thinks she hit her head on the wall, and it just hurts, it didn't bleed or nothing.  The patient stated she had the paper she was given. Again stated she can not even function. Patient still feels Chills a little bit, not as bad as last night. She is awake now, but she feels very very tired, like she has no energy, she is laying down on couch right now. She kept waking up and noticed this morning, she had low back pain, in the muscles, even her fingers are hurting. Regarding hitting her head on the wall, states she has a terrible headache, not a little pain, she thinks it is because she hurt her head. The patient is supposed to get second vaccination on 25Jan2021. The outcome of events Chills, Joint pain and nauseated was recovering; of events site of vaccine was sore and muscle pain was not recovered; of other events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Head injury, Headache, Loss of consciousness, Myalgia
Clinical narrative: tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head on wall, head just hurts; hit head on wall, head just hurts; Chills; she was very cold; could not sleep good; site of vaccine was sore; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer. A 58-year-old female patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EK9231) by injection once to left arm, via an unspecified route of administration on 04Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included thyroid disorder. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder; patient started it after she had her son, and her son is 18 years old. The patient had her vaccine yesterday (04Jan2021) at 12:30, and at nighttime, around 22:00, she started having chills, she was very cold, so she went to bed, she could not sleep good, she kept waking up, and the site of vaccine was sore, she had muscle pain, joint pain, she didn't have fever, but she got up late today (05Jan2021), around 11:00, and had breakfast and felt nauseated, so she stopped eating, and she went to the bathroom and passed out on the toilet, when she woke up, she had her nightgown inside the toilet, it was all wet, she felt better, so she stood up and then she woke up again, and was inside the tub, her legs were inside the basin, she was lying down with her back inside the tub, she thinks she hit her head on the wall, and it just hurts, it didn't bleed or nothing.  The patient stated she had the paper she was given. Again stated she can not even function. Patient still feels Chills a little bit, not as bad as last night. She is awake now, but she feels very very tired, like she has no energy, she is laying down on couch right now. She kept waking up and noticed this morning, she had low back pain, in the muscles, even her fingers are hurting. Regarding hitting her head on the wall, states she has a terrible headache, not a little pain, she thinks it is because she hurt her head. The patient is supposed to get second vaccination on 25Jan2021. The outcome of events Chills, Joint pain and nauseated was recovering; of events site of vaccine was sore and muscle pain was not recovered; of other events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Sleep disorder, Vaccination site pain
Clinical narrative: tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head on wall, head just hurts; hit head on wall, head just hurts; Chills; she was very cold; could not sleep good; site of vaccine was sore; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer. A 58-year-old female patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EK9231) by injection once to left arm, via an unspecified route of administration on 04Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included thyroid disorder. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder; patient started it after she had her son, and her son is 18 years old. The patient had her vaccine yesterday (04Jan2021) at 12:30, and at nighttime, around 22:00, she started having chills, she was very cold, so she went to bed, she could not sleep good, she kept waking up, and the site of vaccine was sore, she had muscle pain, joint pain, she didn't have fever, but she got up late today (05Jan2021), around 11:00, and had breakfast and felt nauseated, so she stopped eating, and she went to the bathroom and passed out on the toilet, when she woke up, she had her nightgown inside the toilet, it was all wet, she felt better, so she stood up and then she woke up again, and was inside the tub, her legs were inside the basin, she was lying down with her back inside the tub, she thinks she hit her head on the wall, and it just hurts, it didn't bleed or nothing.  The patient stated she had the paper she was given. Again stated she can not even function. Patient still feels Chills a little bit, not as bad as last night. She is awake now, but she feels very very tired, like she has no energy, she is laying down on couch right now. She kept waking up and noticed this morning, she had low back pain, in the muscles, even her fingers are hurting. Regarding hitting her head on the wall, states she has a terrible headache, not a little pain, she thinks it is because she hurt her head. The patient is supposed to get second vaccination on 25Jan2021. The outcome of events Chills, Joint pain and nauseated was recovering; of events site of vaccine was sore and muscle pain was not recovered; of other events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainting; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 2 patients. This is 2nd of 2 reports.   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 experienced fainting on an unspecified date with outcome of unknown.  The action taken in response to the event for bnt162b2 was not applicable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006219 same reporter/drug/event, different patient
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Diarrhoea, Pyrexia
Clinical narrative: fever chills diarhea