chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive last week for COVID; Tested positive last week for COVID; This is a spontaneous report from a Pfizer-sponsored programt. A contactable consumer (patient) reported that a 53-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 02Apr2021 (Batch/Lot number was not reported) (at the age of 53 years old) as single dose for COVID-19 immunisation.  There were no medical history and concomitant medications. The patient got his first shot of the vaccine and he was scheduled to get his second dose but he tested positive last week for COVID (Apr2021) and he wanted to know if he can get his second dose. He wanted to make sure about what he had to do because his second shot is supposed to be tomorrow but he was positive now, he was tested positive. The patient did his COVID test on Friday and Saturday night he was positive. Tomorrow is going to be his second shot on 23Apr2021 at 4:15 PM. No treatment for the event. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Hypersensitivity, Hypoaesthesia, Lymphadenopathy
Clinical narrative: severe allergic reaction; Swollen lymph nodes; unable to move her left side of her body; muscle and joint pain; muscle and joint pain; total numbness of her body; severe migraine; Headache / head pain; Injection site redness; Injection site swelling; arm was hurting a lot; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, first dose) solution for injection intramuscular in the left arm on 06Apr2021 at 13:30 (at the age of 89-years-old) as a single dose for COVID-19 vaccination. Medical history included seizures from 1970, serious migraines (would guess this was diagnosed about the same time as the seizures) from 1970, broken leg and ankle (diagnosed 4-5 years ago, she can't walk), severe arthritis (this was diagnosed about 5 years ago), Blood pressure high, and uses a walker and a wheelchair (prior to getting the vaccine). There were no concomitant medications. On 07Apr2021, the patient experienced severe allergic reaction, swollen lymph nodes, unable to move her left side of her body, muscle and joint pain, total numbness of her body, severe migraine, headache, injection site redness, and injection site swelling. In Apr2021, the patient experienced arm was hurting a lot. The patient went to the emergency room because she couldn't move the left side of her body, had a really bad migraine, and her head started hurting, but she didn't stay in the hospital. Treatment for the event migraine included acetaminophen (TYLENOL) but that was not doing anything. Shots of prednisone was offered for migraine but the patient refused. The outcome of the events allergic reaction, swollen lymph nodes, muscle and joint pain, total numbness of her body, severe migraine, headache, injection site redness, and arm was hurting was unknown. The outcome of the events unable to move her left side of her body and injection site swelling was recovering.  Information about lot/batch number has been requested.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Movement disorder, Myalgia, Pain in extremity, Vaccination site erythema
Clinical narrative: severe allergic reaction; Swollen lymph nodes; unable to move her left side of her body; muscle and joint pain; muscle and joint pain; total numbness of her body; severe migraine; Headache / head pain; Injection site redness; Injection site swelling; arm was hurting a lot; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, first dose) solution for injection intramuscular in the left arm on 06Apr2021 at 13:30 (at the age of 89-years-old) as a single dose for COVID-19 vaccination. Medical history included seizures from 1970, serious migraines (would guess this was diagnosed about the same time as the seizures) from 1970, broken leg and ankle (diagnosed 4-5 years ago, she can't walk), severe arthritis (this was diagnosed about 5 years ago), Blood pressure high, and uses a walker and a wheelchair (prior to getting the vaccine). There were no concomitant medications. On 07Apr2021, the patient experienced severe allergic reaction, swollen lymph nodes, unable to move her left side of her body, muscle and joint pain, total numbness of her body, severe migraine, headache, injection site redness, and injection site swelling. In Apr2021, the patient experienced arm was hurting a lot. The patient went to the emergency room because she couldn't move the left side of her body, had a really bad migraine, and her head started hurting, but she didn't stay in the hospital. Treatment for the event migraine included acetaminophen (TYLENOL) but that was not doing anything. Shots of prednisone was offered for migraine but the patient refused. The outcome of the events allergic reaction, swollen lymph nodes, muscle and joint pain, total numbness of her body, severe migraine, headache, injection site redness, and arm was hurting was unknown. The outcome of the events unable to move her left side of her body and injection site swelling was recovering.  Information about lot/batch number has been requested.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: severe allergic reaction; Swollen lymph nodes; unable to move her left side of her body; muscle and joint pain; muscle and joint pain; total numbness of her body; severe migraine; Headache / head pain; Injection site redness; Injection site swelling; arm was hurting a lot; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, first dose) solution for injection intramuscular in the left arm on 06Apr2021 at 13:30 (at the age of 89-years-old) as a single dose for COVID-19 vaccination. Medical history included seizures from 1970, serious migraines (would guess this was diagnosed about the same time as the seizures) from 1970, broken leg and ankle (diagnosed 4-5 years ago, she can't walk), severe arthritis (this was diagnosed about 5 years ago), Blood pressure high, and uses a walker and a wheelchair (prior to getting the vaccine). There were no concomitant medications. On 07Apr2021, the patient experienced severe allergic reaction, swollen lymph nodes, unable to move her left side of her body, muscle and joint pain, total numbness of her body, severe migraine, headache, injection site redness, and injection site swelling. In Apr2021, the patient experienced arm was hurting a lot. The patient went to the emergency room because she couldn't move the left side of her body, had a really bad migraine, and her head started hurting, but she didn't stay in the hospital. Treatment for the event migraine included acetaminophen (TYLENOL) but that was not doing anything. Shots of prednisone was offered for migraine but the patient refused. The outcome of the events allergic reaction, swollen lymph nodes, muscle and joint pain, total numbness of her body, severe migraine, headache, injection site redness, and arm was hurting was unknown. The outcome of the events unable to move her left side of her body and injection site swelling was recovering.  Information about lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, COVID-19, Chills, Colonoscopy, Drug ineffective
Clinical narrative: got COVID tested and they had COVID; got COVID tested and they had COVID; sore arm; stuffy nose; sinus infection; upset stomach and chills; chills/was so cold teeth were chattering; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the second of two reports.  A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 53-year-old, via an unspecified route of administration, administered in left arm on 18Mar2021 (Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included she had colonoscopy and anaesthesia. Concomitant medication included daily vitamins. The patient previously took oxytocin (PITOCIN) and experienced uncontrollable shaking. The patient got chills, was so cold teeth were chattering, sore arm, muscle aches, tired, and stuffy nose after the first dose on an unspecified date in 2021. She got it late in the day, but she didn't noticed symptoms until the next morning. It was complicated because her and her husband got the shot on 18Mar2021 and didn't feel well from it over the weekend. She thinks 18Mar2021 was on a Thursday. They knew they would be down for the weekend. They started to feel worse and worse. She went to a (institution name) because she thought she had a sinus infection on an unspecified date in 2021. She got some medication. The next day she lost the sense of smell and taste. Then her husband and her got COVID tested and they had COVID on an unspecified date in 2021. Somewhere around the time she got the first shot she had been exposed to COVID. She had COVID for 2 weeks. She didn't have to be hospitalized and her oxygen levels were fine on an unspecified date in 2021. She had all other symptoms except fever, diarrhea, and oxygen depletion. She called and the vaccine was scheduled out far enough and she was past COVID so she could come and get second dose. With the first dose, it was hard to tell what was a reaction to the shot when it was actually her coming down with COVID. She did have an upset stomach and chills and the worst headache of her life, she had no energy on an unspecified date in 2021. The sore arm was obviously was from the shot. The sore arm was clearly a side effect, but it was hard to tell when the side effects were ending and when it was COVID. It was a weird coincidence that they got exposed and she feels that it was not related to shot. The events got COVID tested and they had COVID and sinus infection resulted in physician office visit. The outcome of the event got COVID tested and they had COVID was recovered on an unspecified date in 2021 after two weeks and for the rest of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021460871 same reporter, drug , event; different patient
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oxygen saturation, Pain in extremity, SARS-CoV-2 antibody test, Sinusitis
Clinical narrative: got COVID tested and they had COVID; got COVID tested and they had COVID; sore arm; stuffy nose; sinus infection; upset stomach and chills; chills/was so cold teeth were chattering; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the second of two reports.  A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 53-year-old, via an unspecified route of administration, administered in left arm on 18Mar2021 (Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included she had colonoscopy and anaesthesia. Concomitant medication included daily vitamins. The patient previously took oxytocin (PITOCIN) and experienced uncontrollable shaking. The patient got chills, was so cold teeth were chattering, sore arm, muscle aches, tired, and stuffy nose after the first dose on an unspecified date in 2021. She got it late in the day, but she didn't noticed symptoms until the next morning. It was complicated because her and her husband got the shot on 18Mar2021 and didn't feel well from it over the weekend. She thinks 18Mar2021 was on a Thursday. They knew they would be down for the weekend. They started to feel worse and worse. She went to a (institution name) because she thought she had a sinus infection on an unspecified date in 2021. She got some medication. The next day she lost the sense of smell and taste. Then her husband and her got COVID tested and they had COVID on an unspecified date in 2021. Somewhere around the time she got the first shot she had been exposed to COVID. She had COVID for 2 weeks. She didn't have to be hospitalized and her oxygen levels were fine on an unspecified date in 2021. She had all other symptoms except fever, diarrhea, and oxygen depletion. She called and the vaccine was scheduled out far enough and she was past COVID so she could come and get second dose. With the first dose, it was hard to tell what was a reaction to the shot when it was actually her coming down with COVID. She did have an upset stomach and chills and the worst headache of her life, she had no energy on an unspecified date in 2021. The sore arm was obviously was from the shot. The sore arm was clearly a side effect, but it was hard to tell when the side effects were ending and when it was COVID. It was a weird coincidence that they got exposed and she feels that it was not related to shot. The events got COVID tested and they had COVID and sinus infection resulted in physician office visit. The outcome of the event got COVID tested and they had COVID was recovered on an unspecified date in 2021 after two weeks and for the rest of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021460871 same reporter, drug , event; different patient
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Infection, Myalgia, SARS-CoV-2 test
Clinical narrative: Myalgia; Fatigue; Chills; The reporter did not know if this is due to another infection or a viral infection; The reporter did not know if this is due to another infection or a viral infection; This is a spontaneous report from a contactable physician (patient's husband). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right deltoid on 08Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  Medical history and concomitant medications reported as none. The patient also received first dose of BNT162B2 via intramuscular injection in right deltoid on 11Mar2021 (unknown lot number and expiration) for COVID-19 immunization.  The patient experienced myalgia, fatigue and chills on 20Apr2021. The reporter asked if there have been any reports of delayed adverse events after receiving the second dose of the COVID vaccine. Clarified that by delayed adverse events he meant 12 days after receiving the second dose of the COVID vaccine, versus a few days after. The patient had a negative PCR COVID test on 22Apr2021. The reporter did not know if patient's myalgia, fatigue and chills is related to the COVID vaccine. That is why reporter called to find out if there have been any reports or delayed adverse reactions. The reporter did not know if this is due to another infection or a viral infection. The patient recovered from the events on 23Apr2021. The events were assessed as serious (medically significant).   Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events myalgia, fatigue and chills cannot be excluded. The events infection and viral infection are most likely intercurrent medical conditions and are assessed as unrelated to the suspect drug. 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.
Sex: F
Vaccine: COVID19
Symptoms: Viral infection
Clinical narrative: Myalgia; Fatigue; Chills; The reporter did not know if this is due to another infection or a viral infection; The reporter did not know if this is due to another infection or a viral infection; This is a spontaneous report from a contactable physician (patient's husband). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right deltoid on 08Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  Medical history and concomitant medications reported as none. The patient also received first dose of BNT162B2 via intramuscular injection in right deltoid on 11Mar2021 (unknown lot number and expiration) for COVID-19 immunization.  The patient experienced myalgia, fatigue and chills on 20Apr2021. The reporter asked if there have been any reports of delayed adverse events after receiving the second dose of the COVID vaccine. Clarified that by delayed adverse events he meant 12 days after receiving the second dose of the COVID vaccine, versus a few days after. The patient had a negative PCR COVID test on 22Apr2021. The reporter did not know if patient's myalgia, fatigue and chills is related to the COVID vaccine. That is why reporter called to find out if there have been any reports or delayed adverse reactions. The reporter did not know if this is due to another infection or a viral infection. The patient recovered from the events on 23Apr2021. The events were assessed as serious (medically significant).   Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events myalgia, fatigue and chills cannot be excluded. The events infection and viral infection are most likely intercurrent medical conditions and are assessed as unrelated to the suspect drug. 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.
Sex: U
Vaccine: COVID19
Symptoms: Conjunctivitis bacterial, Conjunctivitis viral, Upper respiratory tract infection
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had the first shot of the Pfizer vaccine and after three days, patient developed a very bad eye infection and got pus, bleeding out of the eyes. Also, in the last 24 hours, it has started turning in, patient thought he/she was getting an upper respiratory infection. Patient got this vaccine on Friday and by Monday, patient started noticing swelling in right eye and then it got worse and worse until patient finally ran down to the doctor on Tuesday because had a yellow pus leaking all out of the eyes. The doctor said that he/she have some kind of viral or bacterial conjunctivitis and got infected so he wanted patient to be on antibiotic (treatment) and started that. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Investigation, Limb discomfort, Muscular weakness, Nervousness
Clinical narrative: legs were heavy and numb; weakness in legs; bladder was now the problem/brain doesn't tell the body to go to the bathroom she is leaking because the bladder is filling up filling over; reason for hospitalization;her kidneys; totally became paralyzed from the waist down; legs were heavy and numb; Patient was a little nervous; painful tingling feeling she have that kind of feeling in her legs; This is a spontaneous report from a contactable consumer (patient's mother) from a Pfizer-sponsored program,. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 20Apr2021 at 19:30 (Batch/Lot number was not reported) as single dose for covid-19 immunization and pregabalin (LYRICA), via an unspecified route of administration from an unspecified date at 100 mg, 3x/day for neuropathy. Medical history included neuropathy from 2020 and ongoing. The patient's concomitant medications were not reported. It was reported that the patient got the vaccine and she was taking pregabalin as well and after vaccination, she experienced an adverse event, her legs were heavy and numb and also her bladder was now the problem she was actually now at the emergency room. Patient was a little nervous. The patient was still in the hospital and she was not getting any care. What happened at the beginning was that she totally became paralyzed from the waist down, when your foot fall asleep you get painful tingling feeling she have that kind of feeling in her legs not able to move any part of her anywhere from her waist down later on that night, after she took pregabalin, went to sleep about an hour she was able to move her left toes and able to drag one leg a little bit. She was supposed to take pregabalin 3 times a day and they were giving her a difficult time about it, she took one at 12 O' clock on Wednesday and the hospital they did not give another one until 11 o clock that evening because she was supposed to take 3 times a day. After she no longer feel from the waist down, she took a pregabalin and it didn't help her it didn't work and her physician told her to take 3 times a day and then at 10 O' clock yesterday morning she was still asking the hospital to give her another one. When asked to repeat the concern, patient stated "weakness in her legs that felt very heavy like she was dragging. The date of hospitalization was reported as 21Apr2021. The reason for hospitalization was reported as numbness in her legs and weakness in legs, became paralyzed from the waist down, and her kidneys. So her brain doesn't tell the body to go to the bathroom she is leaking because the bladder is filling up filling over and the body doesn't know to get it out its leaking because it is filling up it is so full. The patient underwent lab test in the hospital. The action taken with pregabalin in response to the events was unknown. Outcome of the events was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paralysis, Renal disorder, Urinary incontinence
Clinical narrative: legs were heavy and numb; weakness in legs; bladder was now the problem/brain doesn't tell the body to go to the bathroom she is leaking because the bladder is filling up filling over; reason for hospitalization;her kidneys; totally became paralyzed from the waist down; legs were heavy and numb; Patient was a little nervous; painful tingling feeling she have that kind of feeling in her legs; This is a spontaneous report from a contactable consumer (patient's mother) from a Pfizer-sponsored program,. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 20Apr2021 at 19:30 (Batch/Lot number was not reported) as single dose for covid-19 immunization and pregabalin (LYRICA), via an unspecified route of administration from an unspecified date at 100 mg, 3x/day for neuropathy. Medical history included neuropathy from 2020 and ongoing. The patient's concomitant medications were not reported. It was reported that the patient got the vaccine and she was taking pregabalin as well and after vaccination, she experienced an adverse event, her legs were heavy and numb and also her bladder was now the problem she was actually now at the emergency room. Patient was a little nervous. The patient was still in the hospital and she was not getting any care. What happened at the beginning was that she totally became paralyzed from the waist down, when your foot fall asleep you get painful tingling feeling she have that kind of feeling in her legs not able to move any part of her anywhere from her waist down later on that night, after she took pregabalin, went to sleep about an hour she was able to move her left toes and able to drag one leg a little bit. She was supposed to take pregabalin 3 times a day and they were giving her a difficult time about it, she took one at 12 O' clock on Wednesday and the hospital they did not give another one until 11 o clock that evening because she was supposed to take 3 times a day. After she no longer feel from the waist down, she took a pregabalin and it didn't help her it didn't work and her physician told her to take 3 times a day and then at 10 O' clock yesterday morning she was still asking the hospital to give her another one. When asked to repeat the concern, patient stated "weakness in her legs that felt very heavy like she was dragging. The date of hospitalization was reported as 21Apr2021. The reason for hospitalization was reported as numbness in her legs and weakness in legs, became paralyzed from the waist down, and her kidneys. So her brain doesn't tell the body to go to the bathroom she is leaking because the bladder is filling up filling over and the body doesn't know to get it out its leaking because it is filling up it is so full. The patient underwent lab test in the hospital. The action taken with pregabalin in response to the events was unknown. Outcome of the events was unknown.
Age: 48.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Abdominal pain upper, Arthralgia, Fatigue, Nausea, POEMS syndrome
Clinical narrative: Left arm sore improved after first shot as well as after second shot; He had 101.1 degree fever; Exhaustion and extremely tired; His stomach was hurting a lot; lungs felt like someone reach inside inside and punched him in the lungs; Achiness in joint in any place he had problems in the past in his body; nauseated; came right up on Pulmonary oil micro embolism or POEM; This is a spontaneous report from a contactable consumer, reporting for himself.   A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscular, administered in the left arm on 15Apr2021 at 12:00 (Batch/Lot Number: EN6204) as 2ND DOSE, SINGLE (at the age of 48 years old) for covid-19 immunisation; and testosterone cipionate (Perrigio manufacturer), via an unspecified route of administration from 2018 (Batch/Lot Number: 2005126.1; Expiration Date: Jul2023), at 200mg/ml. 100mg injected weekly for secondary hypogonadism .  Medical history included hypogonadism from 2018, diagnosed allergies from an unknown date, compromised immune status from an unknown date, respiratory illness from an unknown date, genetic /chromosomal abnormalities from an unknown date, endocrine abnormalities from an unknown date, diabetes from an unknown date, and obesity from an unknown date.  The patient's concomitant medications were not reported. Historical vaccine included flu vaccine over a year ago, and the first dose of BNT162B2 on 24Mar2021 at 12:30 injected intramuscularly in left arm for which he had a mild sore left arm. The patient experienced came right up on pulmonary oil micro embolism or poem  on 16Apr2021 with outcome of unknown, left arm sore improved after first shot as well as after second shot on 16Apr2021 at 13:30 with outcome of unknown, exhaustion and extremely tired on 16Apr2021 at 00:30 with outcome of recovering, his stomach was hurting a lot on 16Apr2021 with outcome of recovering, lungs felt like someone reach inside inside and punched him in the lungs on 16Apr2021 with outcome of recovering, he had 101.1 degree fever on 16Apr2021 at 01:00 with outcome of recovering, achiness in joint in any place he had problems in the past in his body on 16Apr2021 with outcome of recovering, and nauseated on 16Apr2021 with outcome of recovered on 18Apr2021.  Details were reported as follows: 16Apr2021 at 8-9 am he gave himself the testosterone injection and he felt that tickling, rough feeling in his wind pipe like he just had to cough hard. Caller states, "yesterday, 22Apr21, I  gave myself the testosterone injection like I have always done, my wind pipe started feeling like I had to cough, it tickled and felt just like it did on 16Apr21 following the 2nd vaccine dose. I looked my symptoms up on line and found  pome-(pulmonary oil micro embolism)."  The patient underwent lab tests and procedures which included pyrexia: 101.1 fahrenheit on 16Apr2021.  The action taken in response to the event(s) for bnt162b2 was not applicable, and for testosterone cipionate was unknown.
Age: 48.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, Pulmonary pain, Pyrexia
Clinical narrative: Left arm sore improved after first shot as well as after second shot; He had 101.1 degree fever; Exhaustion and extremely tired; His stomach was hurting a lot; lungs felt like someone reach inside inside and punched him in the lungs; Achiness in joint in any place he had problems in the past in his body; nauseated; came right up on Pulmonary oil micro embolism or POEM; This is a spontaneous report from a contactable consumer, reporting for himself.   A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscular, administered in the left arm on 15Apr2021 at 12:00 (Batch/Lot Number: EN6204) as 2ND DOSE, SINGLE (at the age of 48 years old) for covid-19 immunisation; and testosterone cipionate (Perrigio manufacturer), via an unspecified route of administration from 2018 (Batch/Lot Number: 2005126.1; Expiration Date: Jul2023), at 200mg/ml. 100mg injected weekly for secondary hypogonadism .  Medical history included hypogonadism from 2018, diagnosed allergies from an unknown date, compromised immune status from an unknown date, respiratory illness from an unknown date, genetic /chromosomal abnormalities from an unknown date, endocrine abnormalities from an unknown date, diabetes from an unknown date, and obesity from an unknown date.  The patient's concomitant medications were not reported. Historical vaccine included flu vaccine over a year ago, and the first dose of BNT162B2 on 24Mar2021 at 12:30 injected intramuscularly in left arm for which he had a mild sore left arm. The patient experienced came right up on pulmonary oil micro embolism or poem  on 16Apr2021 with outcome of unknown, left arm sore improved after first shot as well as after second shot on 16Apr2021 at 13:30 with outcome of unknown, exhaustion and extremely tired on 16Apr2021 at 00:30 with outcome of recovering, his stomach was hurting a lot on 16Apr2021 with outcome of recovering, lungs felt like someone reach inside inside and punched him in the lungs on 16Apr2021 with outcome of recovering, he had 101.1 degree fever on 16Apr2021 at 01:00 with outcome of recovering, achiness in joint in any place he had problems in the past in his body on 16Apr2021 with outcome of recovering, and nauseated on 16Apr2021 with outcome of recovered on 18Apr2021.  Details were reported as follows: 16Apr2021 at 8-9 am he gave himself the testosterone injection and he felt that tickling, rough feeling in his wind pipe like he just had to cough hard. Caller states, "yesterday, 22Apr21, I  gave myself the testosterone injection like I have always done, my wind pipe started feeling like I had to cough, it tickled and felt just like it did on 16Apr21 following the 2nd vaccine dose. I looked my symptoms up on line and found  pome-(pulmonary oil micro embolism)."  The patient underwent lab tests and procedures which included pyrexia: 101.1 fahrenheit on 16Apr2021.  The action taken in response to the event(s) for bnt162b2 was not applicable, and for testosterone cipionate was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 test
Clinical narrative: sore arm; positive COVID-19 test; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 08Jan2021 as a single dose for COVID-19 immunization. Medical history included arthritis and the patient could hardly walk because of the knee and body, in Jul2020 had the upper lung removed due to lung cancer, exposed to COVID-19 in Jan2021 (prior to the vaccination). Concomitant medications were not reported. The patient received the first vaccination on 08Jan2021 and prior in the week was exposed to COVID-19. On 15Jan2021, the patient tested positive for COVID-19. Per the patient, this was not from the vaccine. On 20Jan2021, the patient received an infusion of monoclonal antibodies as treatment for COVID-19. On an unspecified date after the first vaccination, the patient experienced a little sore arm. The clinical outcome of positive COVID-19 test and sore arm was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of COVID-19.  The reported event likely represent intercurrent medical condition.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. 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-2021461792 same patient/reporter/drug, different dose
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Ischaemic stroke, Road traffic accident, SARS-CoV-2 test
Clinical narrative: Ischemic stroke; Ischemic stroke causing car accident; This is a spontaneous report received a contactable consumer, the patient. This patient/consumer reported different events for different doses of the same product; this case refers to dose 2.An 84-year-old elderly [non-pregnant] female received the second dose of intramuscular BNT162b2 (solution for injection; Lot ER8731 and expiry information not provided) as a single dose in the left shoulder (deltoid) on 16Mar2021 at 12:00 (at 84-years-old) for COVID-19 immunization. Relevant medical history included ongoing atrial fibrillation, penicillin allergy, fractured tibia (09May2020; surgery to repair fractured tibia, plate and screws installed). The patient has a family history of strokes in maternal grandmother. Concomitant medications included oral rivaroxaban (XARELTO) 20mg once daily for atrial fibrillation ongoing from an unspecified date. The patient previously received COVID-19 immunization with the first dose of intramuscular BNT162b2 (Lot EN6200) in the left shoulder (deltoid) on 23Feb2021 at 12:10 (at 84-years-old) and experienced periods of dizziness like atrial fibrillation was acting up every few minutes all day, both days, left arm was sore for a day, and was fatigued and took two naps each day. The patient denied any COVID-19 prior to the vaccine and the patient was not pregnant at the time of vaccination. The patient denied receiving any other vaccine within four weeks prior to this vaccine. On 28Mar2021 the patient experienced an Ischemic stroke and car accident. The patient reported that the events resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient explained that she was hospitalized for thirty-two days, including seven days in the Intensive Care Unit. The patient assessed the events serious (life-threatening, hospitalization / prolongation of hosp., persistent / significant disability / incapacity, Important medical event). The patient was tested for COVID-19 post-vaccination via nasal swab PCR on 28Mar2021 which was negative. The patient received multiple treatments for the events including occupational therapy (OT), Speech/Swallowing therapy (ST) , Physical therapy (PT), gabapentin, acetaminophen (TYLENOL) twice daily (BID) and tramadol BID. The outcome of the events Ischemic stroke and car accident was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021216108 PFIZER (Same reporter/patient/product, different dose/events)
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Dysgeusia, Dysphagia, Loss of consciousness
Clinical narrative: almost passed out; Dizzy; heart started racing; Dry mouth; metal taste; hard to swallow; itchy on arm it is little bit blotchy; itchy on arm it is little bit blotchy; Migraine; This is a spontaneous report from a contactable consumer.   A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180), dose 1 via an unspecified route of administration, administered in left arm on 05Apr2021 as single dose for covid-19 immunisation. The patient medical history was not reported.   The patient had unspecified concomitant medications; unspecified allergy medicine and unspecified vitamins.  On 05Apr2021, the  patient experienced the following events:  almost passed out, dizzy, heart started racing, dry mouth, metal taste, hard to swallow, itchy on arm it is little bit blotchy, migraine. Details were as follows: patient had a reaction after the vaccination. She got really dizzy, almost passed out. Then her heart started racing. It took about 10 minutes to go normal and then she got like a super dry mouth and a metal taste after that, elaborated as like she had penny or something in her mouth like metal. After that,  it was little more hard to swallow and just started to get itchy on arm, it is little bit blotchy. Therapeutic measures were taken as a result of  migraine, and included treatment with sumatriptan (MANUFACTURER UNKNOWN), at 100 mg ( take half every time). The outcome of events, almost passed out, dizzy, heart started racing, dry mouth, metal taste, hard to swallow, itchy on arm it is little bit blotchy, migraine was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Palpitations, Pruritus, Rash macular
Clinical narrative: almost passed out; Dizzy; heart started racing; Dry mouth; metal taste; hard to swallow; itchy on arm it is little bit blotchy; itchy on arm it is little bit blotchy; Migraine; This is a spontaneous report from a contactable consumer.   A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180), dose 1 via an unspecified route of administration, administered in left arm on 05Apr2021 as single dose for covid-19 immunisation. The patient medical history was not reported.   The patient had unspecified concomitant medications; unspecified allergy medicine and unspecified vitamins.  On 05Apr2021, the  patient experienced the following events:  almost passed out, dizzy, heart started racing, dry mouth, metal taste, hard to swallow, itchy on arm it is little bit blotchy, migraine. Details were as follows: patient had a reaction after the vaccination. She got really dizzy, almost passed out. Then her heart started racing. It took about 10 minutes to go normal and then she got like a super dry mouth and a metal taste after that, elaborated as like she had penny or something in her mouth like metal. After that,  it was little more hard to swallow and just started to get itchy on arm, it is little bit blotchy. Therapeutic measures were taken as a result of  migraine, and included treatment with sumatriptan (MANUFACTURER UNKNOWN), at 100 mg ( take half every time). The outcome of events, almost passed out, dizzy, heart started racing, dry mouth, metal taste, hard to swallow, itchy on arm it is little bit blotchy, migraine was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose fluctuation, Bone contusion, Dizziness, Feeling cold, Feeling hot
Clinical narrative: little heart palpitations; felt really warm; felt like she was on fire; Nauseous; she was white as a ghost; felt cold; Dizzy; bruised her tailbone; Passed out; from when she fell she has a knot on the back of her head, and her back has a kink; from when she fell she has a knot on the back of her head, and her back has a kink; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in left arm on 22Apr2021 17:36 (Lot Number: EW0161) (at age 59 years old) as single dose for covid-19 immunisation. Medical history included diabetic from an unknown date and unknown if ongoing diagnosed in 2001-2002. The patient's concomitant medications were not reported. She did not get any other vaccinations yesterday or in the last four weeks. She says she has started no other new meds recently. The patient stated she got her first dose on 22Apr2021 and was perfectly fine, she didn't feel anything. She says when she went to bed a few hours later, she felt really really warm like she was sunburnt or something. She says she slept, then woke up around midnight and got up and thought maybe she had to go to the bathroom. She says she felt nauseous and thought she was going to be sick so she went back to the bathroom and she was white as a ghost, and felt cold and dizzy. She says she was feeling like she was gonna pass out, so she thought her sugar levels had dropped really low, so she went downstairs to check them then woke up on the floor, she had passed out. She says she came to, and checked her sugar and it was normal, 110, so she is assuming she passed out due to the shot. She says her first dose was injected around 17:36, and it was a few hours later when she went to bed around 09:00-9:30PM and got into bed when she kind of felt like she was on fire. She says she did no treatment; she went to sleep. She says from when she fell she has a knot on the back of her head, and her back has a kink in it. She says she is sure she has also bruised her tailbone. As of 23Apr2021, she doesn't feel warm or anything now, she just has little heart palpitations that is all, and those have stayed about the same. Outcome of the events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Nausea, Pallor, Palpitations
Clinical narrative: little heart palpitations; felt really warm; felt like she was on fire; Nauseous; she was white as a ghost; felt cold; Dizzy; bruised her tailbone; Passed out; from when she fell she has a knot on the back of her head, and her back has a kink; from when she fell she has a knot on the back of her head, and her back has a kink; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in left arm on 22Apr2021 17:36 (Lot Number: EW0161) (at age 59 years old) as single dose for covid-19 immunisation. Medical history included diabetic from an unknown date and unknown if ongoing diagnosed in 2001-2002. The patient's concomitant medications were not reported. She did not get any other vaccinations yesterday or in the last four weeks. She says she has started no other new meds recently. The patient stated she got her first dose on 22Apr2021 and was perfectly fine, she didn't feel anything. She says when she went to bed a few hours later, she felt really really warm like she was sunburnt or something. She says she slept, then woke up around midnight and got up and thought maybe she had to go to the bathroom. She says she felt nauseous and thought she was going to be sick so she went back to the bathroom and she was white as a ghost, and felt cold and dizzy. She says she was feeling like she was gonna pass out, so she thought her sugar levels had dropped really low, so she went downstairs to check them then woke up on the floor, she had passed out. She says she came to, and checked her sugar and it was normal, 110, so she is assuming she passed out due to the shot. She says her first dose was injected around 17:36, and it was a few hours later when she went to bed around 09:00-9:30PM and got into bed when she kind of felt like she was on fire. She says she did no treatment; she went to sleep. She says from when she fell she has a knot on the back of her head, and her back has a kink in it. She says she is sure she has also bruised her tailbone. As of 23Apr2021, she doesn't feel warm or anything now, she just has little heart palpitations that is all, and those have stayed about the same. Outcome of the events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: little heart palpitations; felt really warm; felt like she was on fire; Nauseous; she was white as a ghost; felt cold; Dizzy; bruised her tailbone; Passed out; from when she fell she has a knot on the back of her head, and her back has a kink; from when she fell she has a knot on the back of her head, and her back has a kink; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in left arm on 22Apr2021 17:36 (Lot Number: EW0161) (at age 59 years old) as single dose for covid-19 immunisation. Medical history included diabetic from an unknown date and unknown if ongoing diagnosed in 2001-2002. The patient's concomitant medications were not reported. She did not get any other vaccinations yesterday or in the last four weeks. She says she has started no other new meds recently. The patient stated she got her first dose on 22Apr2021 and was perfectly fine, she didn't feel anything. She says when she went to bed a few hours later, she felt really really warm like she was sunburnt or something. She says she slept, then woke up around midnight and got up and thought maybe she had to go to the bathroom. She says she felt nauseous and thought she was going to be sick so she went back to the bathroom and she was white as a ghost, and felt cold and dizzy. She says she was feeling like she was gonna pass out, so she thought her sugar levels had dropped really low, so she went downstairs to check them then woke up on the floor, she had passed out. She says she came to, and checked her sugar and it was normal, 110, so she is assuming she passed out due to the shot. She says her first dose was injected around 17:36, and it was a few hours later when she went to bed around 09:00-9:30PM and got into bed when she kind of felt like she was on fire. She says she did no treatment; she went to sleep. She says from when she fell she has a knot on the back of her head, and her back has a kink in it. She says she is sure she has also bruised her tailbone. As of 23Apr2021, she doesn't feel warm or anything now, she just has little heart palpitations that is all, and those have stayed about the same. Outcome of the events was unknown.