chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site coldness, Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: Bruise; Covid antibody test and it came back negative; some bleeding that soaked the bandage; some significant soreness and stated that the injection site is still sore if he presses on it; a very cold sensation at the injection site; felt a chill on his arm; This is a spontaneous report from a contactable Consumer(patient). A 71-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249, Expiry Date: May2021), intramuscularly on 15Jan2021 at 0.3 mL, single, left arm for covid-19 vaccination. Medical history and concomitant medications reported as none. There was some/fair amount of bleeding that soaked/saturated the bandage after the shot and a bruise developed that was 3 inches around and was there for 10 days and he still had the bruise. He said that there was also a cold sensation at the injection site when it was administered and he felt a chill on his arm. He said that he was calling because he wanted to make sure the first dose was effective. He said that his 2nd dose was due next week. The bleeding resolved within the hour and soaked the band aid itself. He said that it was not persistent bleeding it was just immediately after the injection. He also had some significant soreness at the injection site and stated that the injection site was still sore if he presses on it.  He never bothered to look at his arm and stated that he noticed the bruise was there about 8 days later. It might have been there prior to that, but he did not know. He had blood work done on the 25Jan2021 and asked for a Covid antibody test and it came back negative. The patient asked should there be a positive antibody test at this point? The patient asked did this mean he didn't develop immunity? The bruise had diminished but still there. The soreness was still there. The soreness was not sore if pressure was not put on it and was never sore if he laid on it. The patient was asking if Pfizer considered the vaccine to be viable. He was not on a blood thinner. Onset date of events "some bleeding that soaked the bandage" was 15Jan2021, of bruise was unknown, "some significant soreness and stated that the injection site is still sore if he presses on it" was 15Jan2021, "a very cold sensation at the injection site" was 15Jan2021. The outcome of event "some bleeding that soaked the bandage" was recovered on 15Jan2021, of bruise and "some significant soreness and stated that the injection site is still sore if he presses on it" was recovering, of other events was unknown.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemorrhage, SARS-CoV-2 test, Vaccination site bruising, Vaccination site coldness, Vaccination site discomfort
Clinical narrative: Bruise; Covid antibody test and it came back negative; some bleeding that soaked the bandage; some significant soreness and stated that the injection site is still sore if he presses on it; a very cold sensation at the injection site; felt a chill on his arm; This is a spontaneous report from a contactable Consumer(patient). A 71-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249, Expiry Date: May2021), intramuscularly on 15Jan2021 at 0.3 mL, single, left arm for covid-19 vaccination. Medical history and concomitant medications reported as none. There was some/fair amount of bleeding that soaked/saturated the bandage after the shot and a bruise developed that was 3 inches around and was there for 10 days and he still had the bruise. He said that there was also a cold sensation at the injection site when it was administered and he felt a chill on his arm. He said that he was calling because he wanted to make sure the first dose was effective. He said that his 2nd dose was due next week. The bleeding resolved within the hour and soaked the band aid itself. He said that it was not persistent bleeding it was just immediately after the injection. He also had some significant soreness at the injection site and stated that the injection site was still sore if he presses on it.  He never bothered to look at his arm and stated that he noticed the bruise was there about 8 days later. It might have been there prior to that, but he did not know. He had blood work done on the 25Jan2021 and asked for a Covid antibody test and it came back negative. The patient asked should there be a positive antibody test at this point? The patient asked did this mean he didn't develop immunity? The bruise had diminished but still there. The soreness was still there. The soreness was not sore if pressure was not put on it and was never sore if he laid on it. The patient was asking if Pfizer considered the vaccine to be viable. He was not on a blood thinner. Onset date of events "some bleeding that soaked the bandage" was 15Jan2021, of bruise was unknown, "some significant soreness and stated that the injection site is still sore if he presses on it" was 15Jan2021, "a very cold sensation at the injection site" was 15Jan2021. The outcome of event "some bleeding that soaked the bandage" was recovered on 15Jan2021, of bruise and "some significant soreness and stated that the injection site is still sore if he presses on it" was recovering, of other events was unknown.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Bruise; Covid antibody test and it came back negative; some bleeding that soaked the bandage; some significant soreness and stated that the injection site is still sore if he presses on it; a very cold sensation at the injection site; felt a chill on his arm; This is a spontaneous report from a contactable Consumer(patient). A 71-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249, Expiry Date: May2021), intramuscularly on 15Jan2021 at 0.3 mL, single, left arm for covid-19 vaccination. Medical history and concomitant medications reported as none. There was some/fair amount of bleeding that soaked/saturated the bandage after the shot and a bruise developed that was 3 inches around and was there for 10 days and he still had the bruise. He said that there was also a cold sensation at the injection site when it was administered and he felt a chill on his arm. He said that he was calling because he wanted to make sure the first dose was effective. He said that his 2nd dose was due next week. The bleeding resolved within the hour and soaked the band aid itself. He said that it was not persistent bleeding it was just immediately after the injection. He also had some significant soreness at the injection site and stated that the injection site was still sore if he presses on it.  He never bothered to look at his arm and stated that he noticed the bruise was there about 8 days later. It might have been there prior to that, but he did not know. He had blood work done on the 25Jan2021 and asked for a Covid antibody test and it came back negative. The patient asked should there be a positive antibody test at this point? The patient asked did this mean he didn't develop immunity? The bruise had diminished but still there. The soreness was still there. The soreness was not sore if pressure was not put on it and was never sore if he laid on it. The patient was asking if Pfizer considered the vaccine to be viable. He was not on a blood thinner. Onset date of events "some bleeding that soaked the bandage" was 15Jan2021, of bruise was unknown, "some significant soreness and stated that the injection site is still sore if he presses on it" was 15Jan2021, "a very cold sensation at the injection site" was 15Jan2021. The outcome of event "some bleeding that soaked the bandage" was recovered on 15Jan2021, of bruise and "some significant soreness and stated that the injection site is still sore if he presses on it" was recovering, of other events was unknown.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Very slight, small area of tenderness yesterday morning at injection site; This is a spontaneous report from a contactable consumer (patient)  A 43-years-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) at left arm from lot# EL 3247, on 27Jan2021 (at 43 years old) 12:30 at SINGLE DOSE for covid-19 immunisation . Facility where the most recent COVID-19 vaccine was administered:Workplace clinic. Medical history included asthma, severe Osteoarthritis (OA) in right hip. The patient  didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR) 100/50, fluticasone (FLUTICASONE) OTC, montelukast sodium (SINGULAIR) 10 mg.  The patient previously took theophylline and experienced drug hypersensitivity.  The patient experienced very slight, small area of tenderness yesterday morning at injection site on 28Jan2021 07:00 with outcome of recovered. No treatment received. No Prior to vaccination, was the patient diagnosed with COVID 19 .Since the vaccination,  the patient hadn't been tested for COVID-19
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: Low grade fever; heart palpitations; This is a spontaneous report from a contactable consumer (patient) A 72-years-old no pregnant female patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from lot# El9262 on 27Jan2021 (at age of 72 years old ) in the right arm  08:30 at SINGLE DOSE for covid-19 immunisation .  First dose received on 06jan2021 (lot#EI3246) 10:30 in the right arm .The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered:Other. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient experienced low grade fever and heart palpitationson 28Jan2021 07:00 .Events were reported as non serious.No treatment received .Outcome of the events was recovered.No Prior to vaccination, was the patient diagnosed with COVID-19.Since the vaccination, the patient had been tested for COVID-19.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This is a spontaneous report from a contactable patient.  A 37-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unknown route, on 27Jan2021 (at 14:15) at single dose on the left arm for COVID-19 immunisation, administered at a clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have a relevant medical history and concomitant medications. No known allergies. On 28Jan2021, the patient developed soreness at the injection site. Post vaccination COVID-19 test was not performed. No treatment was given for the event. The patient recovered from the event on unknown date in 2021.   No follow up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Nausea, Pain in extremity, Vaccination site erythema
Clinical narrative: Naseau and vomiting commencing the following day and continuing for 24 hours; Naseau and vomiting commencing the following day and continuing for 24 hours; Redness and swelling and acute pain at site of injection Aches; Redness and swelling and acute pain at site of injection Aches; Redness and swelling and acute pain at site of injection Aches; Pains in arm radiating in back and shoulder; Pains in arm radiating in back and shoulder; Pains in arm radiating in back and shoulder; This is a spontaneous report from a contactable consumer (patient).   A 59-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)  on 27Jan2021 at 16:30 at single dose in Right arm for covid-19 immunisation. Patient was not pregnant.Medical history included allergies to cefalexin (KEFLEX), codeine and sulfa.Concomitant medication included escitalopram oxalate and omeprazole (PRILOSEC) . Patient experienced naseau and vomiting commencing on 28Jan2021 at 10:00 and continuing for 24 hours. On 28Jan2021 at 10:00 patient also had redness and swelling and acute pain at site of injection, aches and pains in arm radiating in back and shoulder.No treatment given. Final outcome of the events was recovering. Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vomiting
Clinical narrative: Naseau and vomiting commencing the following day and continuing for 24 hours; Naseau and vomiting commencing the following day and continuing for 24 hours; Redness and swelling and acute pain at site of injection Aches; Redness and swelling and acute pain at site of injection Aches; Redness and swelling and acute pain at site of injection Aches; Pains in arm radiating in back and shoulder; Pains in arm radiating in back and shoulder; Pains in arm radiating in back and shoulder; This is a spontaneous report from a contactable consumer (patient).   A 59-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)  on 27Jan2021 at 16:30 at single dose in Right arm for covid-19 immunisation. Patient was not pregnant.Medical history included allergies to cefalexin (KEFLEX), codeine and sulfa.Concomitant medication included escitalopram oxalate and omeprazole (PRILOSEC) . Patient experienced naseau and vomiting commencing on 28Jan2021 at 10:00 and continuing for 24 hours. On 28Jan2021 at 10:00 patient also had redness and swelling and acute pain at site of injection, aches and pains in arm radiating in back and shoulder.No treatment given. Final outcome of the events was recovering. Information on the lot/batch number has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Vaccination site erythema
Clinical narrative: a red mark the size of a silver dollar in the place I received the shot.; I ran a fever of 103 the day after I got the shot; body aches; chills; injection site pain; This is a spontaneous report from a contactable consumer (patient).   A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 at 17:00 at single dose in left arm for covid-19 immunisation .  The patient medical history and concomitant medications were not reported. The patient previously on 05Jan2021 at 18:00 received the  first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose in left arm for covid-19 immunisation. On 27Jan2021 at 07:00, the day after he got the vaccine, patient ran a fever of 103, with body aches ,chills and injection site pain. Three days after the shot, patient still had injection site pain and on 30Jan2021 he had a red mark the size of a silver dollar in the place he received the shot. The final outcome of the events was recovering. NO treatment given.Information on the lot/batch number has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: a red mark the size of a silver dollar in the place I received the shot.; I ran a fever of 103 the day after I got the shot; body aches; chills; injection site pain; This is a spontaneous report from a contactable consumer (patient).   A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 at 17:00 at single dose in left arm for covid-19 immunisation .  The patient medical history and concomitant medications were not reported. The patient previously on 05Jan2021 at 18:00 received the  first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose in left arm for covid-19 immunisation. On 27Jan2021 at 07:00, the day after he got the vaccine, patient ran a fever of 103, with body aches ,chills and injection site pain. Three days after the shot, patient still had injection site pain and on 30Jan2021 he had a red mark the size of a silver dollar in the place he received the shot. The final outcome of the events was recovering. NO treatment given.Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, COVID-19, Decreased appetite, Fatigue
Clinical narrative: diagnosed with Covid; diagnosed with Covid; sore arm; more tired/Very fatigue; overall unwell feeling; slept all day long/; poor appetite/No appetite; slept all day long/Had no energy; severe aches; woke up with 102° temperature; diagnosed with strep; This is a spontaneous report from a contactable health care professional nurse, the patient (patient).  A 57-years-old non-pregnant female patient (nurse) received  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), intramuscular in the left arm on 06Jan2021 at 16:30 as a single dose, Lot number Unknown for COVID-19 vaccination. The patient medical history was not reported. The patient has no know Allergies to medications, food, or other products. Concomitant medication included levothyroxine (LEVOTHYROXINE), alprazolam (XANAX). On 07-JAN-2021 at 12:00, the patient experienced diagnosed with Covid, sore arm, more tired/very fatigue, overall unwell feeling, slept all day long,  poor appetite/no appetite,  slept all day long/had no energy, severe aches, woke up with 102° temperature, diagnosed with strep. Adverse event start date was reported as 07JAN2021 at 12:00 PM However, the consumer reported the sequence of events as follows. Morning after the vaccination patients complaint was a  sore arm. As the day proceeding, She became more tired. The following day was Friday. Very fatigue overall unwell feeling. On the  weekend, Saturday and Sunday slept all day long. Had no energy. Very poor appetite. Once again overall unwell.  Was able to work approximately half days on Monday Tuesday and Wednesday. She work Hospice and did enter a facility with known positive cases but was in  Full PPE with every precaution as per my norm. On Thursday in the a.m. early she woke up with 102° temperature and severe aches. Was seen at the local urgent care and diagnosed with Covid.  The adverse event result in Emergency Room Visit and  Physician Office Visit  The patient underwent lab tests and procedures which included body temperature of 102 on 07Jan2021 and ,SARS-CoV-2 test ( Nasal Swab) Positive  on 14Jan2021. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19.  Treatment received for the events were unknown but it was also reported 'she is on second round of antibiotics And steroids. Numerous exposures over last 10 month'. The clinical outcome of the events Covid-19, sore arm, more tired/Very fatigue, overall unwell feeling,  Sleep excessive, poor appetite/No appetite, slept all day long/Had no energy, severe aches, fever was recovering; while Drug ineffective was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.         ,
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: diagnosed with Covid; diagnosed with Covid; sore arm; more tired/Very fatigue; overall unwell feeling; slept all day long/; poor appetite/No appetite; slept all day long/Had no energy; severe aches; woke up with 102° temperature; diagnosed with strep; This is a spontaneous report from a contactable health care professional nurse, the patient (patient).  A 57-years-old non-pregnant female patient (nurse) received  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), intramuscular in the left arm on 06Jan2021 at 16:30 as a single dose, Lot number Unknown for COVID-19 vaccination. The patient medical history was not reported. The patient has no know Allergies to medications, food, or other products. Concomitant medication included levothyroxine (LEVOTHYROXINE), alprazolam (XANAX). On 07-JAN-2021 at 12:00, the patient experienced diagnosed with Covid, sore arm, more tired/very fatigue, overall unwell feeling, slept all day long,  poor appetite/no appetite,  slept all day long/had no energy, severe aches, woke up with 102° temperature, diagnosed with strep. Adverse event start date was reported as 07JAN2021 at 12:00 PM However, the consumer reported the sequence of events as follows. Morning after the vaccination patients complaint was a  sore arm. As the day proceeding, She became more tired. The following day was Friday. Very fatigue overall unwell feeling. On the  weekend, Saturday and Sunday slept all day long. Had no energy. Very poor appetite. Once again overall unwell.  Was able to work approximately half days on Monday Tuesday and Wednesday. She work Hospice and did enter a facility with known positive cases but was in  Full PPE with every precaution as per my norm. On Thursday in the a.m. early she woke up with 102° temperature and severe aches. Was seen at the local urgent care and diagnosed with Covid.  The adverse event result in Emergency Room Visit and  Physician Office Visit  The patient underwent lab tests and procedures which included body temperature of 102 on 07Jan2021 and ,SARS-CoV-2 test ( Nasal Swab) Positive  on 14Jan2021. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19.  Treatment received for the events were unknown but it was also reported 'she is on second round of antibiotics And steroids. Numerous exposures over last 10 month'. The clinical outcome of the events Covid-19, sore arm, more tired/Very fatigue, overall unwell feeling,  Sleep excessive, poor appetite/No appetite, slept all day long/Had no energy, severe aches, fever was recovering; while Drug ineffective was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.         ,
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Streptococcal infection
Clinical narrative: diagnosed with Covid; diagnosed with Covid; sore arm; more tired/Very fatigue; overall unwell feeling; slept all day long/; poor appetite/No appetite; slept all day long/Had no energy; severe aches; woke up with 102° temperature; diagnosed with strep; This is a spontaneous report from a contactable health care professional nurse, the patient (patient).  A 57-years-old non-pregnant female patient (nurse) received  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), intramuscular in the left arm on 06Jan2021 at 16:30 as a single dose, Lot number Unknown for COVID-19 vaccination. The patient medical history was not reported. The patient has no know Allergies to medications, food, or other products. Concomitant medication included levothyroxine (LEVOTHYROXINE), alprazolam (XANAX). On 07-JAN-2021 at 12:00, the patient experienced diagnosed with Covid, sore arm, more tired/very fatigue, overall unwell feeling, slept all day long,  poor appetite/no appetite,  slept all day long/had no energy, severe aches, woke up with 102° temperature, diagnosed with strep. Adverse event start date was reported as 07JAN2021 at 12:00 PM However, the consumer reported the sequence of events as follows. Morning after the vaccination patients complaint was a  sore arm. As the day proceeding, She became more tired. The following day was Friday. Very fatigue overall unwell feeling. On the  weekend, Saturday and Sunday slept all day long. Had no energy. Very poor appetite. Once again overall unwell.  Was able to work approximately half days on Monday Tuesday and Wednesday. She work Hospice and did enter a facility with known positive cases but was in  Full PPE with every precaution as per my norm. On Thursday in the a.m. early she woke up with 102° temperature and severe aches. Was seen at the local urgent care and diagnosed with Covid.  The adverse event result in Emergency Room Visit and  Physician Office Visit  The patient underwent lab tests and procedures which included body temperature of 102 on 07Jan2021 and ,SARS-CoV-2 test ( Nasal Swab) Positive  on 14Jan2021. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19.  Treatment received for the events were unknown but it was also reported 'she is on second round of antibiotics And steroids. Numerous exposures over last 10 month'. The clinical outcome of the events Covid-19, sore arm, more tired/Very fatigue, overall unwell feeling,  Sleep excessive, poor appetite/No appetite, slept all day long/Had no energy, severe aches, fever was recovering; while Drug ineffective was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.         ,
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pneumonia
Clinical narrative: diagnosed with pneumonia; This is a Spontaneous report from a contactable consumer via a Pfizer sponsored program. A female patient (consumer) of an unspecified age received BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient medical history was not reported. Concomitant medication included cefalexin (CEPHALEXIN AMEL). Transferring agent stated, she got diagnosed with Pneumonia two days ago and she was also scheduled to have the second dose today. So, she wants to know if she can still have the second dose even though she got diagnosed with Pneumonia." When clarified the concern, consumer stated, "Yes, she wanted to know if she can still get her second dose today as now, she was on antibiotic, Cephalexin." It was reported that, she was due to receive the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine today. However, she said that 2 days ago, she was diagnosed with pneumonia on an unspecified date, but tested negative for Covid-19. She also mentioned that she was currently taking antibiotics. Consumer wants to know if it was still advisable for her to receive the 2nd dose despite this. Outcome of event was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood pressure measurement, Electrocardiogram, Feeling abnormal, Nervousness
Clinical narrative: I was in A Fib; feel strange; felt like my heart was racing; I felt shaky; This is a spontaneous report from a contactable consumer (patient). This 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL963), via an unspecified route of administration on 26Jan2021 12:00 at single dose in the left arm for COVID-19 immunization. The patient medical history included borderline high blood pressure, high cholesterol, Hashimoto's, hypothyroid. The patient's concomitant medications included rosuvastatin, levothyroxine sodium (LEVOXYL), hydrochlorothiazide and lisinpro received within 2 weeks of vaccination. The patient previously took ezetimibe (ZETIA) and experienced drug allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. After sitting in recovery room for about 10 minutes following injection patient began to feel strange. Patient called the nurse on duty and said she felt like her heart was racing. The nurse took her BP and pulseox and administered a mini EKG. Then the nurse called the EMT on duty who gave patient a six leader EKG and said patient was in A Fib. Asked if patient had ever had A fib before, patient said no. Then asked if patient wanted to go to the hospital, patient said no. After sitting with the EMT for five minutes or so another EKG showed patient was no longer in A Fib. Patient felt shaky for the rest of the day, but is normal now. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. Outcome of the events was recovering.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Palpitations
Clinical narrative: I was in A Fib; feel strange; felt like my heart was racing; I felt shaky; This is a spontaneous report from a contactable consumer (patient). This 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL963), via an unspecified route of administration on 26Jan2021 12:00 at single dose in the left arm for COVID-19 immunization. The patient medical history included borderline high blood pressure, high cholesterol, Hashimoto's, hypothyroid. The patient's concomitant medications included rosuvastatin, levothyroxine sodium (LEVOXYL), hydrochlorothiazide and lisinpro received within 2 weeks of vaccination. The patient previously took ezetimibe (ZETIA) and experienced drug allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. After sitting in recovery room for about 10 minutes following injection patient began to feel strange. Patient called the nurse on duty and said she felt like her heart was racing. The nurse took her BP and pulseox and administered a mini EKG. Then the nurse called the EMT on duty who gave patient a six leader EKG and said patient was in A Fib. Asked if patient had ever had A fib before, patient said no. Then asked if patient wanted to go to the hospital, patient said no. After sitting with the EMT for five minutes or so another EKG showed patient was no longer in A Fib. Patient felt shaky for the rest of the day, but is normal now. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. Outcome of the events was recovering.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test positive
Clinical narrative: COVID-19 antibody test positive; This is a spontaneous report from a Pfizer-sponsored program from (patient).  A female patient of an unspecified age received the two doses of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, both on an unspecified date, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, in Jan2021, she got her blood sample results as a part of community research. Blood sample results showed that the patient was exposed to COVID-19. Clinical outcome was unknown at time of this report.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus, Hypertension
Clinical narrative: diabetes; high blood pressure; This is a spontaneous report from a Pfizer Sponsored Program. A contactable male consumer reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) at single dose for COVID-19 immunisation on 16Jan2021. Relevant history and concomitant drugs were unknown. Relevant history and concomitant drugs were unknown.  The patient wanted to see his family doctor about his conditions like diabetes, high blood pressure and also about going to a urologist. Outcome of events was unknown.   Information about Lot/Batch has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Urinary retention
Clinical narrative: His urine retention is becoming worse; His urine retention is becoming worse; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A male patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL3247, on 21Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing urinary retention and taking medication. Concomitant medication included medication for urinary retention. The patient had his first shot 9 days ago. He had urinary retention and taking medication before receiving the vaccine. After taking the first shot, he said that his urine retention was becoming worse. The outcome of the events was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pruritus, Vaccination site erythema
Clinical narrative: Dose number 1 start of drug 08Jan2021/Dose number 2 start of drug 25Jan2021; Rash at injection site, upper back, back of knee on right leg; generalized itching all over; This is a spontaneous report from a contactable 40-year-old female other healthcare professional reporting for herself   A 40 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262) on an unspecified date at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medicao history included allergies to Latex, peniccillin, Tomatoes, and  Pineapple, diabetes mellitus and hypertension. The patient received first dose of BNT162B2 (Lot number:EJ1685) on 08Jan2021 intramuscular on left arm. Concomitant medications were not reported. On 26Jan2021 the patient experienced rash at injection site, upper back, back of knee on right leg and generalized itching all over. The patient did not received treatment for the events. The patient also experienced inappropriate schedule of vaccine administered as second dose was administered 17 days after first dose with outcome unknown. The patient had not yet recovered from other reported events.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Neck pain, Vaccination site pain
Clinical narrative: 1st dose: fatigue; muscle soreness in neck and shoulders excluding site of injection which was also sore.; muscle soreness in neck and shoulders excluding site of injection which was also sore.; muscle soreness in neck and shoulders excluding site of injection which was also sore.; This is a spontaneous report from a contactable Other Health Professional reporting for herself   A 37 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1686) on 30Dec2020 at 19:00 at single dose intramuscular on right arm  for COVID-19 immunization. The patient didn't have medical history. Concomitant medications included ibuprofen MIDOL [IBUPROFEN] and ibuprofen. On an unspecified date after vaccination the patient experienced fatigue and muscle soreness in neck and shoulders excluding site of injection which was also sore. The patient didn't received treatment for the reported events. At the time of the reporting the patient was recovering from the events.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, SARS-CoV-2 test
Clinical narrative: Headache; Chills; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318; Expiration date was not reported), intramuscularly on the right arm on 26Jan2021 (10:00) at a single dose for COVID-19 immunization at the hospital. The patient's medical history was not reported. Concomitant medications included omeprazole, metoprolol, methocarbamol, vitamin D3, pregabalin and levothyroxine. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported), intramuscularly on the right arm on 05Jan2021 (when the patient was 48 years old) for COVID-19 immunization, and had chills, headache, sore throat, nausea and loss of smell. The patient was not pregnant at the time of vaccination. In Jan2021, after the second dose of vaccination, the patient had headache and chills. The patient had resulted to going to the doctor/clinic visit due to the events. The patient did not receive any treatment for the events. The outcome of the events, headache and chills, was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had been tested post-vaccination. The patient's nasal swab test was negative on 11Jan2021.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Haemorrhage
Clinical narrative: bleed; big black bruise; TThis is a spontaneous report from a Pfizer-sponsored program. A contactable consumer consumer (Patient) reported a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown)), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bleed and big black bruise. The patient would like to know if the vaccine will still be effective after what happened. The outcome of the events was unknown.   Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site bruising
Clinical narrative: bleed; big black bruise; TThis is a spontaneous report from a Pfizer-sponsored program. A contactable consumer consumer (Patient) reported a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown)), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bleed and big black bruise. The patient would like to know if the vaccine will still be effective after what happened. The outcome of the events was unknown.   Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Nausea
Clinical narrative: severe dry mouth; Nausea; This is a spontaneous report received from a Pfizer-sponsored program. A contactable consumer (patient) reported that an unspecified aged female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 Vaccine immunization. Patient medical history and concomitant medications were not reported. On 28Jan2021 was her first dose of COVID vaccine. Seven and a half hours later she had a severe reaction had a severe dry mouth and had to go to the emergency room. Also had nausea. She was given steroids and BENADRYL. Second dose is scheduled 18Feb2021 and wondering if she can take BENADRYL before the next dose. Outcome of events was unknown.  Information regarding lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome; This is a spontaneous report from a non-contactable physician. A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, male 64 admitted at (Institution name) on 30Jan2021 with Guillain-Barre Syndrome after receiving Pfizer COVID vaccine. Event took place after use of product. It was shared on 30Jan2021 with physician by a doctor in town. They were in the doctors lounge this morning discussing the case. This was all of the information physician have. The event was considered as serious (hospitalization) by the physician. The outcome of the event was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Guillain-Barre Syndrome due to temporal relationship.  This case will be reassessed once additional information is 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Hyperhidrosis, Insomnia
Clinical narrative: Severe headaches; Heart palpitations; Severe joint pain/ right shoulder pain; Tremors to hands; Pain in feet; Chronic neck and right shoulder pain/mid upper back; Chronic neck and right shoulder pain/mid upper back; Severe sweats from lung region up-censation of passing out; Severe nerve pain; Insomnia; This is a spontaneous report from a contactable nurse reported for herself. A 50-years-old female patient (non pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 13Jan2021 at single dose for COVID -19 immunization. Medical history included allergies to morphine,demerol, codiene, dilaudid, golytle, adhesive tape. Concomitant medication included flecainide (FLECAINIDE). The patient received any other vaccines within 4 weeks prior to the COVID vaccine: product was GSK (as reported, lot number: hs75g) first dose, on 30Nov2020, in left arm. The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization on 23Dec2020 and experienced severe headache, lethargy, severe body aches,  high fevers, COVID positive. The patient experienced severe headaches, heart palpatations, severe joint pain, tremors to hands, pain in feet, chronic neck and r shoulder pain/mid upper back, severe sweats from lung region up-censation of passing out, severe nerve pain, insomnia in Jan2021. It was reported as serious report, seriousness criteria was disabling/incapacitating. The adverse events result in doctor or other healthcare professional office/clinic visit. The events outcome was not recovered.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Neuralgia, Pain in extremity, Palpitations, Tremor
Clinical narrative: Severe headaches; Heart palpitations; Severe joint pain/ right shoulder pain; Tremors to hands; Pain in feet; Chronic neck and right shoulder pain/mid upper back; Chronic neck and right shoulder pain/mid upper back; Severe sweats from lung region up-censation of passing out; Severe nerve pain; Insomnia; This is a spontaneous report from a contactable nurse reported for herself. A 50-years-old female patient (non pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 13Jan2021 at single dose for COVID -19 immunization. Medical history included allergies to morphine,demerol, codiene, dilaudid, golytle, adhesive tape. Concomitant medication included flecainide (FLECAINIDE). The patient received any other vaccines within 4 weeks prior to the COVID vaccine: product was GSK (as reported, lot number: hs75g) first dose, on 30Nov2020, in left arm. The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization on 23Dec2020 and experienced severe headache, lethargy, severe body aches,  high fevers, COVID positive. The patient experienced severe headaches, heart palpatations, severe joint pain, tremors to hands, pain in feet, chronic neck and r shoulder pain/mid upper back, severe sweats from lung region up-censation of passing out, severe nerve pain, insomnia in Jan2021. It was reported as serious report, seriousness criteria was disabling/incapacitating. The adverse events result in doctor or other healthcare professional office/clinic visit. The events outcome was not recovered.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Severe elevation of blood pressure as high as 180/100; This is a spontaneous report from a contactable physician reporting for himself. A 35-year-old male received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiry date unknown), intramuscular on 30Dec2020 16:00 at a single dose on the left arm for COVID-19 immunization. Patient has no medical history. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered at the hospital. Patient received the second dose on 21Jan2021 16:00 (lot number: EL1283) intramuscular on the left arm. After the second dose in left arm, after about 24 to 48 hours, vesicular pruritic erythematous patches in multiple locations of my left arm, left arm pit, left upper back, left chest occured, peaking on day three and still remain after ond week. The blisters have opened leaving behind painful ulcers. This is not a rash that disappears in a few days. It will take much longer than that to heal. There was no rash with the first dose. Also, with both doses, patient had severe elevation of blood pressure as high as 180/100 within 2 to 5 hours on 30Dec2020, requiring about 3 doses of clonidine over 7 days where blood pressure would cycle up and down. Patient has no history of allergic reactions to any medications in the past or other vaccines in childhood. Otherwise, young healthy male with no history of hypertension. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient was recovering from the event. Event reported as non-serious.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of blood pressure increased. 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: Chest discomfort, Lip pruritus, Lip swelling, Lymphadenopathy, Paraesthesia oral
Clinical narrative: Tingling lips; I thought maybe they (lips) were swollen just a little bit; Swelling in the left side of neck either in a lymph node or in that gland; Swelling in the left side of neck either in a lymph node or in that gland; Had some tightness when I was breathing deep, some tightness in lungs; Itching lips; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 11:45 AM at single dose for COVID-19 immunisation. The patient's medical history and patient's concomitant medications were not reported. In Jan2021 the patient had first Pfizer shot on Sunday at 11:45 AM. And then did not have any reaction to it that day. But later that night and early Monday morning had a little bit of tingling in lips and thought maybe they (lips) were swollen just a little bit. And had some swelling in the left side of neck either in a lymph node or in that gland. Then patient reported a little bit of swelling thought it was with the lymph node. And then had some tightness like when was breathing deep, some tightness in lungs. The patient asked if these are considered severe reactions or they just minor or what are they. The tingling in lips only lasted for just for itching or what, it only lasted only for a little while and the lymph node went back down after an hour or so. Outcome of other events was unknown.  Information on the lot/batch number has been requested.