chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: Body aches/whole body is hurting; Running fever; Fatigued/tiredness; Arm hurting; This is a spontaneous report from a Pfizer Sponsored Program Covax US Support. A contactable 40-year-old female consumer (patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0198) via unspecified route of administration, on 12Jul2021 as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 13Jul2021 at 7:30 AM, the patient woke up with body aches and arm was hurting, running fever, tiredness fatigue and pains. The patient wanted to know if she can take Naproxen (ALEVE) or Paracetamol (TYLENOL) or aspirin for the pain. The outcome of the events unknown.   Information on the lot/batch number has been requested. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Cough, Dyspnoea
Clinical narrative: chills; loss of smell and taste; loss of smell and taste; had just little bit of cough but today I "breathe"; had just little bit of cough but today I "breathe"; This is a spontaneous report from a contactable consumer or other non hcp.     A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Expiry Date: unknown, Batch/Lot number: unknown), via an unspecified route of administration on 07Jul2021, as single dose for covid-19 immunization. Medical history and concomitant medications were not reported. It was stated that the patient stated took the Pfizer Vaccine on 07Jul2021 Wednesday (reported as last Wednesday) and had chills, a little bit "chills" (not clarified), he had just little bit of cough but on the day of this report (reported as today) he "breathe" (not clarified), here in last half hour he lost taste and smell on an unspecified date. It was stated that he lost taste and smell, it's been whole week almost. He wanted to know could he get covid 19 after first dose and before the second one, and that could he get covid 19 virus from the vaccine. The outcome of events was unknown.   Information on Lot/Batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Chills, Feeling of body temperature change, Nausea
Clinical narrative: lost of taste; chills (cold and hot); getting cold and hot; lack of energy; feeling nauseous; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Jun2021 (at the age of 53-years-old) as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus wife is diabetic. The patient's concomitant medications were not reported. On 28Jun2021, the patient experienced lost of taste, chills, getting hot and cold, lack of energy, feeling nauseous. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient).  A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported, expiration date not provided) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced stroke on 13Apr2021. The outcome of the event was unknown. Clinical course: the patient received a Pfizer covid vaccine in April a week later l had a stroke, he talked to someone at Pfizer the other day but didn't have all the information on hand, the reference # was withheld. The date of the first shot was 01Apr2021, the information from the card reads Pfizer 01Apr2021 withheld. He had the stroke on 13Apr2021 and was taken to the ER (emergency room) at (withheld) Medical Center. The doctor didn't know if the vaccine caused the stroke or if it was a coincidence. He wanted someone to be ware. He wasn't sure where else to turn to. Doctor recommended not getting the 2nd shot. He was wondering if any others have had the same issue.   Information on the Lot/Batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Arthralgia, Body temperature, Diarrhoea, Headache
Clinical narrative: high fever; joint pain; some weakness in her legs/severe muscle weakness; headache; nausea; she was very ill / She said she was pretty sick for 10 days; diarrhea; muscle pain; This is a spontaneous report from a contactable Nurse (patient). A 78-Year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0173, expiry: 31Aug2021), via an unspecified route of administration on 19May2021 (at the age of 78-year-old) as single for COVID-19 immunisation. Medical history of the patient included borderline multiple myeloma [had borderline multiple myeloma for 10-15 years], monoclonal gammopathy [MGUS, she had it for a while. there are periods of time when her protein was elevated making her borderline for myeloma], patient has had a couple rounds of prednisone to suppress the protein and has a positive ANC. Patient has a multitude of issues, severe allergies, COVID-19 in Mar2020 [had an antibody tested 3 months later and 6 months later that both showed no antibodies], diagnosed with sarcoidosis [in 1970 bust is in remission; tested regularly for sarcoidosis and patient thinks she might be having a gallbladder attack now], Russian flu [in 1988 and was in hospital for two weeks and almost died from that], was having a lot of immunology problems going on (immunocompromised patient), anaphylaxis (had 5 episodes of anaphylaxis), 9-10 episodes of total body hives, has been resuscitated twice, B-cell blood malignancy. Concomitant medications were not reported. Patient previously received hepatitis and tuberculosis vaccine and later discovered that she was a non-responder to hepatitis and TB. Patient previously received swine flu vaccination on an unspecified date in the 70s. Patient was having a lot of immunology problems going on and the doctor recommended her not get a flu vaccine. Patient has had no flu vaccine since swine flu in the 70s. Patient was allergic to over 30 drugs (unspecified). Immunologist did an immunology review of her allergies and prior vaccination problems before determining if patient could get the COVID vaccine. Physician wrote her a letter that said patient had to get the vaccine in a room with an IV ready and the defibrillator ready as well. On an unspecified date in 2021, after the first dose, patient was very ill, had a high fever, diarrhea for 6 days, severe muscle weakness/some weakness in her legs, muscle pain, joint pain, also had nausea and a headache that lasted about 2.5 weeks. She was reticent to get the second dose because she had barely recovered from the first dose when she was due for her second dose. Patient was pretty sick for 10 days. Outcome of the event nausea, headache (duration 2.5 weeks) and diarrhea (duration: six days) were resolved on an unspecified date in 2021 and for other events were unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Muscular weakness, Myalgia, Nausea, Pyrexia
Clinical narrative: high fever; joint pain; some weakness in her legs/severe muscle weakness; headache; nausea; she was very ill / She said she was pretty sick for 10 days; diarrhea; muscle pain; This is a spontaneous report from a contactable Nurse (patient). A 78-Year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0173, expiry: 31Aug2021), via an unspecified route of administration on 19May2021 (at the age of 78-year-old) as single for COVID-19 immunisation. Medical history of the patient included borderline multiple myeloma [had borderline multiple myeloma for 10-15 years], monoclonal gammopathy [MGUS, she had it for a while. there are periods of time when her protein was elevated making her borderline for myeloma], patient has had a couple rounds of prednisone to suppress the protein and has a positive ANC. Patient has a multitude of issues, severe allergies, COVID-19 in Mar2020 [had an antibody tested 3 months later and 6 months later that both showed no antibodies], diagnosed with sarcoidosis [in 1970 bust is in remission; tested regularly for sarcoidosis and patient thinks she might be having a gallbladder attack now], Russian flu [in 1988 and was in hospital for two weeks and almost died from that], was having a lot of immunology problems going on (immunocompromised patient), anaphylaxis (had 5 episodes of anaphylaxis), 9-10 episodes of total body hives, has been resuscitated twice, B-cell blood malignancy. Concomitant medications were not reported. Patient previously received hepatitis and tuberculosis vaccine and later discovered that she was a non-responder to hepatitis and TB. Patient previously received swine flu vaccination on an unspecified date in the 70s. Patient was having a lot of immunology problems going on and the doctor recommended her not get a flu vaccine. Patient has had no flu vaccine since swine flu in the 70s. Patient was allergic to over 30 drugs (unspecified). Immunologist did an immunology review of her allergies and prior vaccination problems before determining if patient could get the COVID vaccine. Physician wrote her a letter that said patient had to get the vaccine in a room with an IV ready and the defibrillator ready as well. On an unspecified date in 2021, after the first dose, patient was very ill, had a high fever, diarrhea for 6 days, severe muscle weakness/some weakness in her legs, muscle pain, joint pain, also had nausea and a headache that lasted about 2.5 weeks. She was reticent to get the second dose because she had barely recovered from the first dose when she was due for her second dose. Patient was pretty sick for 10 days. Outcome of the event nausea, headache (duration 2.5 weeks) and diarrhea (duration: six days) were resolved on an unspecified date in 2021 and for other events were unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Sarcoidosis
Clinical narrative: high fever; joint pain; some weakness in her legs/severe muscle weakness; headache; nausea; she was very ill / She said she was pretty sick for 10 days; diarrhea; muscle pain; This is a spontaneous report from a contactable Nurse (patient). A 78-Year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0173, expiry: 31Aug2021), via an unspecified route of administration on 19May2021 (at the age of 78-year-old) as single for COVID-19 immunisation. Medical history of the patient included borderline multiple myeloma [had borderline multiple myeloma for 10-15 years], monoclonal gammopathy [MGUS, she had it for a while. there are periods of time when her protein was elevated making her borderline for myeloma], patient has had a couple rounds of prednisone to suppress the protein and has a positive ANC. Patient has a multitude of issues, severe allergies, COVID-19 in Mar2020 [had an antibody tested 3 months later and 6 months later that both showed no antibodies], diagnosed with sarcoidosis [in 1970 bust is in remission; tested regularly for sarcoidosis and patient thinks she might be having a gallbladder attack now], Russian flu [in 1988 and was in hospital for two weeks and almost died from that], was having a lot of immunology problems going on (immunocompromised patient), anaphylaxis (had 5 episodes of anaphylaxis), 9-10 episodes of total body hives, has been resuscitated twice, B-cell blood malignancy. Concomitant medications were not reported. Patient previously received hepatitis and tuberculosis vaccine and later discovered that she was a non-responder to hepatitis and TB. Patient previously received swine flu vaccination on an unspecified date in the 70s. Patient was having a lot of immunology problems going on and the doctor recommended her not get a flu vaccine. Patient has had no flu vaccine since swine flu in the 70s. Patient was allergic to over 30 drugs (unspecified). Immunologist did an immunology review of her allergies and prior vaccination problems before determining if patient could get the COVID vaccine. Physician wrote her a letter that said patient had to get the vaccine in a room with an IV ready and the defibrillator ready as well. On an unspecified date in 2021, after the first dose, patient was very ill, had a high fever, diarrhea for 6 days, severe muscle weakness/some weakness in her legs, muscle pain, joint pain, also had nausea and a headache that lasted about 2.5 weeks. She was reticent to get the second dose because she had barely recovered from the first dose when she was due for her second dose. Patient was pretty sick for 10 days. Outcome of the event nausea, headache (duration 2.5 weeks) and diarrhea (duration: six days) were resolved on an unspecified date in 2021 and for other events were unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Fatigue, Insomnia, Pain
Clinical narrative: I have begun to experience covid symptoms, achy; Fever; Tired; No appetite; Cough; Cant sleep on 10Jul2021 for 3 days now; This is a spontaneous report from a contactable consumer or other non hcp. A 68-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 11May2021 17:30 (age at vaccination: 68-year-old) as single dose for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, skin cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient did not receive other vaccines within 4weeks prior to vaccination. Patient had received other medications within 2 weeks prior to vaccination. Patient had no allergies. Patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 21Apr2021 09:00 as (age at vaccination: 68-year-old), as single dose for COVID-19 immunisation. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested with COVID-19 to post vaccination. On 10Jul2021 the patient experienced I have begun to experience COVID symptoms, achy, fever, tired, no appetite, cough, can't sleep on 10Jul2021 for 3 days now. The outcome of the events pain, pyrexia, fatigue, decreased appetite, cough, insomnia was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I have begun to experience covid symptoms, achy; Fever; Tired; No appetite; Cough; Cant sleep on 10Jul2021 for 3 days now; This is a spontaneous report from a contactable consumer or other non hcp. A 68-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 11May2021 17:30 (age at vaccination: 68-year-old) as single dose for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, skin cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient did not receive other vaccines within 4weeks prior to vaccination. Patient had received other medications within 2 weeks prior to vaccination. Patient had no allergies. Patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 21Apr2021 09:00 as (age at vaccination: 68-year-old), as single dose for COVID-19 immunisation. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested with COVID-19 to post vaccination. On 10Jul2021 the patient experienced I have begun to experience COVID symptoms, achy, fever, tired, no appetite, cough, can't sleep on 10Jul2021 for 3 days now. The outcome of the events pain, pyrexia, fatigue, decreased appetite, cough, insomnia was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Caller stated that he "felt the dose"/when he got the first shot he felt pain; This is a spontaneous report from a Pfizer sponsored program COVAX Support. A non-contactable consumer(patient). A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller received the first dose of the Pfizer-BioNTech COVID-19 Vaccine, on his left shoulder. Caller stated that he felt the dose, and the Caller said the people in the vaccination centre were very nice. Caller got his second dose today (13JUL2021) on his right shoulder, 21 days after the first dose. Caller mentioned he did not have any response. He also expressed concern if the dose was properly administered. Caller said that the people where disinterested and only saw the syringe being thrown. Caller stated that, years ago, his right shoulder was injured and fell. It did not do any serious harm, but possibly the nerves may have been damaged. Caller mentioned he would check after 2 weeks if he did develop antibodies to see if the vaccine worked. patient was worried after he got the second shot of the Pfizer COVID-19 vaccine since he is not sure the vaccine was given. caller says he did not feel it when it was given, so he was worried nothing was injected when he got the second shot. Agent reports that the caller told him when he got the first shot, he felt pain, but for the second one he did not feel anything. caller was also wanting to get an antibody test to make sure he was already fully immune and has antibodies to COVID-19, which he will get it in the next two weeks to make sure. Caller says that for his first shot he felt the puncture, his second shot was not painful. He says when he looks online, he sees the big needle there, a big gauge online, a big needle, an inch and a half long. caller says maybe they did give the dose, and maybe it wasn't a coronavirus injection, or maybe they didn't give the dose at all, he didn't feel it, maybe wrong. He says he took a TB test a year ago and it was just like a scratch, he felt a little scratch, this shot he didn't feel. The outcome of the event caller stated that he felt the dose/when he got the first shot, he felt pain was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow up (PRD13Jul2021): This is a spontaneous report from a Pfizer sponsored program COVAX support. A non-contactable 72-year-old male patient reported that:  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced anaphylactic reaction to the vaccine shot on an unspecified date. The outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Dyspepsia
Clinical narrative: I couldn't even walk; had dizziness; Tiredness; Chills; Fever; Muscle pain; Joint Pain; I have stick to my stomach.; I was so sick and so weak.; It hit me like mouth break; I was so sick and so weak.; This is a spontaneous report from a contactable consumer (patient).   A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0177 expiration date: unknown), via an unspecified route of administration on 30Jun2021 15:00 (at the age of 74-year-old) as dose 1, single for covid-19 immunization. Medical history included hypertension, covid-19 in Mar2021 (had covid, back in March of this year). Concomitant medications included calcium, losartan, clonidine, hydrochlorothiazide triamterene (TRIAMTERENE HCTZ), vitamin d3, turmeric (curcuma longa rhizome). Patient did not take any other vaccination shot prior 4 weeks or during the covid vaccination period. The patient stated that when she got her shot, she got it at 15 O clock in the afternoon and 21 O Clock till next, she was fine, at 9 O Clock in the next morning, it hit her like mouth break. She was so sick and so weak. She could not even walk, her husband had to help her walk, she was feeling as if, she had dizziness, It was further stated that she had all the symptoms basically, she had stick to her stomach, had tiredness and had muscle pain, chills, joint pain and fever. She was supposed to be get-ting a shot on 21Jul2021 (reported as on the 21st of this month) and she was scared to get it, so she wanted somebody to tell her, that because she was having covid already, they were giving one shot. On an unknown date, before vaccination, the patient underwent lab test and was found to have covid-19. She wanted to know if one shot is sufficient or should she get another shot. Patient took Tylenol as treatment. The outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Myalgia, Oral pain, Pyrexia
Clinical narrative: I couldn't even walk; had dizziness; Tiredness; Chills; Fever; Muscle pain; Joint Pain; I have stick to my stomach.; I was so sick and so weak.; It hit me like mouth break; I was so sick and so weak.; This is a spontaneous report from a contactable consumer (patient).   A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0177 expiration date: unknown), via an unspecified route of administration on 30Jun2021 15:00 (at the age of 74-year-old) as dose 1, single for covid-19 immunization. Medical history included hypertension, covid-19 in Mar2021 (had covid, back in March of this year). Concomitant medications included calcium, losartan, clonidine, hydrochlorothiazide triamterene (TRIAMTERENE HCTZ), vitamin d3, turmeric (curcuma longa rhizome). Patient did not take any other vaccination shot prior 4 weeks or during the covid vaccination period. The patient stated that when she got her shot, she got it at 15 O clock in the afternoon and 21 O Clock till next, she was fine, at 9 O Clock in the next morning, it hit her like mouth break. She was so sick and so weak. She could not even walk, her husband had to help her walk, she was feeling as if, she had dizziness, It was further stated that she had all the symptoms basically, she had stick to her stomach, had tiredness and had muscle pain, chills, joint pain and fever. She was supposed to be get-ting a shot on 21Jul2021 (reported as on the 21st of this month) and she was scared to get it, so she wanted somebody to tell her, that because she was having covid already, they were giving one shot. On an unknown date, before vaccination, the patient underwent lab test and was found to have covid-19. She wanted to know if one shot is sufficient or should she get another shot. Patient took Tylenol as treatment. The outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Walking disability
Clinical narrative: I couldn't even walk; had dizziness; Tiredness; Chills; Fever; Muscle pain; Joint Pain; I have stick to my stomach.; I was so sick and so weak.; It hit me like mouth break; I was so sick and so weak.; This is a spontaneous report from a contactable consumer (patient).   A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0177 expiration date: unknown), via an unspecified route of administration on 30Jun2021 15:00 (at the age of 74-year-old) as dose 1, single for covid-19 immunization. Medical history included hypertension, covid-19 in Mar2021 (had covid, back in March of this year). Concomitant medications included calcium, losartan, clonidine, hydrochlorothiazide triamterene (TRIAMTERENE HCTZ), vitamin d3, turmeric (curcuma longa rhizome). Patient did not take any other vaccination shot prior 4 weeks or during the covid vaccination period. The patient stated that when she got her shot, she got it at 15 O clock in the afternoon and 21 O Clock till next, she was fine, at 9 O Clock in the next morning, it hit her like mouth break. She was so sick and so weak. She could not even walk, her husband had to help her walk, she was feeling as if, she had dizziness, It was further stated that she had all the symptoms basically, she had stick to her stomach, had tiredness and had muscle pain, chills, joint pain and fever. She was supposed to be get-ting a shot on 21Jul2021 (reported as on the 21st of this month) and she was scared to get it, so she wanted somebody to tell her, that because she was having covid already, they were giving one shot. On an unknown date, before vaccination, the patient underwent lab test and was found to have covid-19. She wanted to know if one shot is sufficient or should she get another shot. Patient took Tylenol as treatment. The outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Headache, Immune thrombocytopenia, Pain in extremity
Clinical narrative: headaches; fatigue; bruising all over body; undetectable platelets; Immune thrombocytopenia; petechiae; Arm pain at site; This is a spontaneous report received from a contactable consumer (patient). A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an unspecified route of administration, administered in arm left on 28Apr2021 (Lot Number: ER8735) at the age of 19 years old, at single dose for covid-19 immunisation. Medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. There was no other vaccine in four weeks or other medications in two weeks. The patient experienced arm pain at site in 2021, headaches in May2021, fatigue in May2021, bruising all over body in May2021, undetectable platelets in 2021, immune thrombocytopenia in 2021, petechiae in 2021. Arm pain at site, mid-May: headaches, fatigue, bruising all over body. Hospitalized with undetectable platelets and Immune thrombocytopenia and petechiae. The patient was hospitalized for all events for 3 days. All events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event).  The patient underwent lab tests and procedures which included Nasal Swab: negative on 23Jun2021. The outcome of the all events was recovering. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Petechiae, Platelet count, Platelet disorder, SARS-CoV-2 test
Clinical narrative: headaches; fatigue; bruising all over body; undetectable platelets; Immune thrombocytopenia; petechiae; Arm pain at site; This is a spontaneous report received from a contactable consumer (patient). A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an unspecified route of administration, administered in arm left on 28Apr2021 (Lot Number: ER8735) at the age of 19 years old, at single dose for covid-19 immunisation. Medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. There was no other vaccine in four weeks or other medications in two weeks. The patient experienced arm pain at site in 2021, headaches in May2021, fatigue in May2021, bruising all over body in May2021, undetectable platelets in 2021, immune thrombocytopenia in 2021, petechiae in 2021. Arm pain at site, mid-May: headaches, fatigue, bruising all over body. Hospitalized with undetectable platelets and Immune thrombocytopenia and petechiae. The patient was hospitalized for all events for 3 days. All events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event).  The patient underwent lab tests and procedures which included Nasal Swab: negative on 23Jun2021. The outcome of the all events was recovering. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Asthenia, Dizziness, Feeling abnormal
Clinical narrative: Lightheadedness, after first vaccine; Weakness, after first vaccine; Felt like she ran a marathon, after first vaccine; Stomach upset, after first vaccine; Bad stomach pains, after first vaccine; This is a spontaneous report from a contactable consumer (patient herself).   A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, lot number: unknown, expiry date: unknown), via unspecified route of administration on an unspecified date as DOSE 1, SINGLE for Covid-19 immunisation. She got her vaccine at her doctor's office. Patient s medical history and concomitant medications were not reported. Patient stated she got her first dose 3 weeks ago and was due for her second shot today. She asked if the second shot will make her react in the same way, when she got her first shot. Patient stated that after the first shot, she had light headedness, weakness, felt like she ran a marathon, stomach upset and bad stomach pains on an unspecified date. These effects lasted for over a week. She wanted to know whether her doctor could answer her question. Patient was due for her vaccination today (The consumer might miss her dose) and she want to know about will it make her feel the way she felt when she got the 1st one.The outcome of the events was recovered.   Information on the lot/batch number has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I eventually (30Jun2021) contracted symptomatic Covid (testing + for Covid on 02Jul2021); I eventually (30Jun2021) contracted symptomatic Covid (testing + for Covid on 02Jul2021); This is a spontaneous report from a contactable consumer (patient).     A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration, administered in Arm Left on 03Feb2021 (Batch/Lot number was not reported, expiration date not provided) at age of 57 years old as a single dose, 2nd dose via an unspecified route of administration, administered in Arm Left on 24Feb2021 (Batch/Lot number was not reported, expiration date not provided) at age of 57 years old as a single dose for covid-19 immunisation.  Medical history included systemic Lupus, prior CVA, seizure disorder, osteoporosis and known allergies: Yes. The patient eventually (30Jun2021) contracted symptomatic covid (testing + for covid on 02Jul2021) on 02Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): positive on 02Jul2021.  The outcome of the events was not recovered. The patient received Regeneron Covid Antibody cocktail as treatment. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The report was reported as serous for being disabling/incapacitating.   Information on the lot/batch number has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: diagnosed with GBS/ Symptoms started with tinglyness in hands and feet and proceeded to the point of hospitalization /in ability to walk, sit up un aided and affected involuntary functions.; This is a spontaneous report from a contactable consumer (patient). A 32-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left at age of 32 years on 29Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included diagnosed with COVID-19 prior vaccination. Since the vaccination, the patient has not been tested for COVID-19. No known allergies. No other medical history. The patient's concomitant medications were none.  The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Not any other medications the patient received within 2 weeks of vaccination. The patient was diagnosed with Guillain-Barre syndrome (GBS) within two weeks of receiving the first dose. Symptoms started with tinglyness in hands and feet and proceeded to the point of hospitalization that included in ability to walk, sit up un aided and affected involuntary functions. Still unable to function as he did prior to 29Mar2021. Adverse event started since 02Apr2021. The adverse event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and Hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient hospitalized for 6 days. Treatment received for the adverse event included (2) Rounds of IVIG. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Lymphadenopathy, Swelling, X-ray
Clinical narrative: swelling in the armpit area./swelling underneath his armpit; swelling underneath his armpit, his lymph nodes; This is a spontaneous report from a contactable (wife) and a non-contactable consumer (husband, patient). A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date in May2021 at single dose for COVID-19 immunisation. Medical history included the patient is a diabetic for years and he just take a pill for it, isn't that bad, high blood pressure from an unknown date and unknown if ongoing, he had a heart attack in 2005 (which the patient had and stand but he have been fine), he had COVID 19 back in Feb2021, bed sore, pneumonia due to COVID. Concomitant medications included lisinopril; glimepiride; pioglitazone; prazosin hydrochloride (PRAZOSIN); pravastatin; acetylsalicylic acid (BABY ASPIRIN); and pill for diabetic, he was taking something for his sugar and high blood pressure. The patient had COVID 19 and after 3 months he received the Pfizer COVID vaccine in May2021. He had bed sore, pneumonia due to COVID. After taking the first dose of the Pfizer COVID vaccine he experienced swelling in the armpit area. After the COVID virus he was feeling fine until he received the Pfizer COVID vaccine. He had COVID back in Feb he was hospitalized for about little over 2 weeks and he was released, with he had double pneumonia and that's why, he was in the hospital that long and he waited the 90 days because all the doctors said, he should get vaccinated for it. So, he had Pfizer vaccine, he had a first one, it wasn't terrible. The patient had been working since he just, she was working, he got the COVID attack after he got the attack and you know, his boss said came up and told him that, the boss didn't need him anymore, the boss was just afraid that, he was weak and he was gonna snatch from the attack and so there was nothing changed, after he came home for except for bed sore, he had and then after the first shot he had was in his right arm, and he got a swelling underneath his armpit, his lymph nodes, that went away, he had an x-ray, that went away.  He had tones of blood work. The outcome of the events was resolved in 2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Palpitations
Clinical narrative: electric shock on her left side; then palpitations; electric shock on her left side; then palpitations; This is a spontaneous report received from a contactable consumer (patient) reported for self that: A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient got the vaccine on a Thursday, on Saturday and Sunday she felt like an electric shock on her left side, then palpitations on an unspecified date. The patient reported that she tried to call everywhere for a consultation with a cardiologist. Asks if someone can help her, she called the Centers for Disease Control and Prevention (CDC), they gave her a number. She called that number, and they gave her another number. States she is calling because she was told to call this number and press option 3. Call handler asks caller to spell her name. She declines. Says she was going to press three when the options came up on this call, but it was talking about the ingredients of the vaccine and she doesn't need to know those because she already had the vaccines. States that she called before and spent 25 minutes reporting the way she felt after the second Covid Vaccine. The events outcome was unknown.  Information on the lot/batch number has been requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chills, Listless, Malaise
Clinical narrative: First dose 08JAN2021 and second 29JAN2021.  Husband tested positive 02JUL2021; Patient received both doses of the covid vaccine. Patient tested positive for covid.; not feeling too good; body aches; weak; chills; listless; restless; This is a spontaneous report from contactable consumer (Patient's wife). An 82-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 08:00 (Batch/Lot Number: EJ168) as dose 1, single, second dose on 29Jan2021 (Batch/Lot Number: EL9263) (at the age of 81-year-old) as dose 2, single, both administered in arm for covid-19 immunisation. Medical history included heart problems, leaky mitral valve, patient is waiting to do heart surgery, they are waiting for a new micro valve catheter. Concomitant medication(s) included amlodipine (AMLODIPINE) taken for Blood pressure; lisinopril (LISINOPRIL) taken for Blood pressure; simvastatin (SIMVASTATIN); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); ascorbic acid (VIT C); cyanocobalamin (VIT B12); finasteride (FINASTERIDE). None prior vaccinations within 4 weeks. Patient had Rapid covid test positive on 02Jul2021. Patient was not feeling too good, had body aches and was weak, and chills, listless, and felt weak. After a week of still not feeling great, and being restless. The events not required emergency room visit or physician office visit. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Restlessness, SARS-CoV-2 test, Vaccination failure
Clinical narrative: First dose 08JAN2021 and second 29JAN2021.  Husband tested positive 02JUL2021; Patient received both doses of the covid vaccine. Patient tested positive for covid.; not feeling too good; body aches; weak; chills; listless; restless; This is a spontaneous report from contactable consumer (Patient's wife). An 82-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 08:00 (Batch/Lot Number: EJ168) as dose 1, single, second dose on 29Jan2021 (Batch/Lot Number: EL9263) (at the age of 81-year-old) as dose 2, single, both administered in arm for covid-19 immunisation. Medical history included heart problems, leaky mitral valve, patient is waiting to do heart surgery, they are waiting for a new micro valve catheter. Concomitant medication(s) included amlodipine (AMLODIPINE) taken for Blood pressure; lisinopril (LISINOPRIL) taken for Blood pressure; simvastatin (SIMVASTATIN); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); ascorbic acid (VIT C); cyanocobalamin (VIT B12); finasteride (FINASTERIDE). None prior vaccinations within 4 weeks. Patient had Rapid covid test positive on 02Jul2021. Patient was not feeling too good, had body aches and was weak, and chills, listless, and felt weak. After a week of still not feeling great, and being restless. The events not required emergency room visit or physician office visit. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Erythema, Feeling hot, Rash, Skin fissures
Clinical narrative: her other ear was burning, red, felt hot and started cracking again; her other ear was burning, red, felt hot and started cracking again; her other ear was burning, red, felt hot and started cracking again; her other ear was burning, red, felt hot and started cracking again; getting a rash on her skin; This is a spontaneous report from a contactable consumer (patient reported for herself) communicated to Pfizer sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 30Jun2021, as dose 2, single for COVID-19 immunization. Medical history included autoimmune disorder from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single for COVID-19 immunization. It was about 10 days after the 1st dose of vaccine and it was the weirdest thing, the top of her, she believed, right ear at first it was itching and burning and then started to crack and that lasted 5 days. She Stated she applied Neosporin and Vaseline on it and did not think much of it. On an unspecified date, about a week after receiving the second dose, she reported that her other ear was burning, bright red and felt hot and started cracking again. She also had a rash on her skin after receiving the second dose. She stated she thought it was sunburn, but she wears hat and her ears were covered. Investigation Assessment was not Provided. The outcome of the events was unknown at the time of this report. She reported that 4 different people from 4 different locations have all experienced the exact same side effect after receiving the Pfizer COVID-19 vaccine.   Information on the Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pruritus, Erythema, Feeling hot, Skin fissures
Clinical narrative: right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack; her other ear was burning, red, felt hot and started cracking again; her other ear was burning, red, felt hot and started cracking again; This is a spontaneous report received from a contactable consumer or other non-health care professional. This is the report 2 of 5 regarding callers sons wife's father. A male patient of an unspecified age received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced right ear itching and burning and then the skin started to crack, burning, red, felt hot and started cracking again. The outcome of the events was reported as unknown.  Information on lot/Batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pruritus, Feeling hot, Skin fissures
Clinical narrative: right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack; top of ear burning and very hot; This is a spontaneous report from a contactable consumer or other non hcp. A female consumer reported for a patient (son's wife's grandfather). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported, expiration date unknown) via an unspecified route of administration on an unspecified date as first dose, single for covid-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient received first dose of vaccine and after that patient had right ear itching and burning and then the skin started to crack and top of ear burning and very hot. Reporter stated that the patient experienced the same adverse events like her. The outcome of the events was unknown.