chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site cellulitis
Clinical narrative: left arm  was swelling from shoulder to elbow and got hot and red to touch/diagnosed as cellulitis; fever and chills; fever and chills; This is a spontaneous report from a contactable consumer (who is also the patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ep7533), via an unspecified route of administration in the left arm, on 27Apr2021 17:30, as 2nd dose, single, for COVID-19 immunisation, at a pharmacy/drug store. Medical history included psoriatic arthritis, strep cellulitis, known allergies to nightshade vegetables and dissolvable sutures. The patient was not pregnant at the time of vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and the patient was not tested for COVID-19 since the vaccination. Concomitant medications included ixekizumab (TALTZ); valproate semisodium (DEPAKOTE); diphenhydramine hydrochloride (BENADRYL); and unspecified birth control; all taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) received at age 33 years, on 30Mar2021 18:30, administered in the left arm, for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to BNT162B2. On 27Apr2021, immediately after the first dose, the patient experienced swelling and redness at injection site. On 28Apr2021, the following day, the patient had fever and chills. These resolved on 18Apr2021 15:00. On 30Apr2021 15:00, the patient's left arm was swelling from shoulder to elbow and got hot and red to touch. These symptoms continued the following day and required doctor's clinic visit. This was diagnosed as cellulitis. On 01May2021, the patient started a 10-day antibiotic treatment for cellulitis. The patient recovered from swelling and redness at injection site, fever and chills on 18Apr2021 15:00.  The outcome of cellulitis was not resolved.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Delirium, Dizziness, Dysarthria, Flushing, Headache
Clinical narrative: Delirium; swelling inside of throat; dizziness; Slurred speech; neck pain; flushed skin; Heart palpitations; Headache; worse throat itchiness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 28Apr2021 15:30 (Lot Number: ER8736) as 2nd dose, single for COVID-19 immunization. Medical history included myocarditis from COVID, elevated BP and known allergies: Cipro and IV contrast dye for CT scans; all from an unknown date and unknown if ongoing. The patient previously took BNT162B2 (lot number: EW0150), 1st dose, on 07Apr2021 04:00 PM in the left arm for COVID-19 Immunization and experienced swelling inside of throat, dizziness, slurred speech and delirium at 56 years old. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had other unspecified medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 07Apr2021 04:45 PM, the patient experienced swelling inside of throat, dizziness, slurred speech, delirium, immediate base of neck pain, flushed skin, heart palpitations, headache and worse throat itchiness. The patient did not received treatment for the events. The outcome of the events was recovered on unspecified date.  Information on lot/batch number is available; additional information has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Palpitations, Pharyngeal swelling, Throat irritation
Clinical narrative: Delirium; swelling inside of throat; dizziness; Slurred speech; neck pain; flushed skin; Heart palpitations; Headache; worse throat itchiness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 28Apr2021 15:30 (Lot Number: ER8736) as 2nd dose, single for COVID-19 immunization. Medical history included myocarditis from COVID, elevated BP and known allergies: Cipro and IV contrast dye for CT scans; all from an unknown date and unknown if ongoing. The patient previously took BNT162B2 (lot number: EW0150), 1st dose, on 07Apr2021 04:00 PM in the left arm for COVID-19 Immunization and experienced swelling inside of throat, dizziness, slurred speech and delirium at 56 years old. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had other unspecified medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 07Apr2021 04:45 PM, the patient experienced swelling inside of throat, dizziness, slurred speech, delirium, immediate base of neck pain, flushed skin, heart palpitations, headache and worse throat itchiness. The patient did not received treatment for the events. The outcome of the events was recovered on unspecified date.  Information on lot/batch number is available; additional information has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Dizziness, Heart rate, Heart rate irregular
Clinical narrative: chest flutter type feeling; irregular heart beat type feeling; dizzy; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on an unspecified date (Batch/Lot number was not reported) as 1 st dose, single then on an unspecified date (Batch/Lot Number: ER8732) (at the age of 35-years-old) as 2 nd dose, single; both via an unspecified route of administration for covid-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19 and since vaccination, patient was not tested for COVID-19. The patient had no medical history. The patient had no history of COVID or any health conditions. Concomitant medication was not reported. The patient reported that about 5 days after second dose (unspecified date), he developed a chest flutter type feeling/irregular heart beat type feeling. It was transient and went away after about 7 days. When he would get the weird heartbeat feeling he would feel dizzy. The patient had no treatment for the events. The outcome of the events was recovered on unspecified date.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Back pain, Chest discomfort, Chest pain, Pain
Clinical narrative: it is weird clot it is not that area where I got the shot; feeling like I was having heart pain; His left upper chest area has swelling and when he touches it he feels something hard. Pain when he touches; His left upper chest area has swelling and when he touches it he feels something hard. Pain when he touches; His left upper chest area has swelling and when he touches it he feels something hard. Pain when he touches; He feels pressure on his chest; It feels like pain on the heart. It's a sharp needle like pain in some spots; my left arm and also my back there is going to pain seems like needle anything from the back; my left arm and also my back there is going to pain seems like needle anything from the back; This is a spontaneous report from a contactable consumer (Patient) via a Pfizer sponsored program.  A male patient of an unspecified age received second dose of BNT162B2 (solution for injection, Lot number: ER8735) via an unspecified route of administration on 25Mar2020, as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient received first dose of BNT162B2 (solution for injection, Lot number: CVS8601) via an unspecified route of administration on an unspecified date, as 1st dose, single for COVID-19 immunization. It was stated that everything was fine on the first day after second dose and then from the second and third day the patient had a pain which was weird clot, and it was not that area where he got the shot.It was like between shoulder and neck, left shoulder, and neck. A kind of in deeper area there was lot of bone and just like where neck was connected to shoulder but it was in front of right. Patient had pain when he touched there in like size of the corn was like he could feel something hard inside and then just started day prior to this report further on the evening and started having chest pain like whole that spot felt like he was having heart pain and his left arm and his back there was going to pain seemed like needle anything from the back. The pain was constant. It was not on chest, it was not like that would come and go, would say it was bearable thing, but it was constant and breath that goes inside his body it was still there when touched, it was still paining. Patient upper left chest area had swelling and when touched it, he felt something hard. It would pain when touched. Patient felt pressure on his chest. It feels like pain on the heart. It was a sharp needle like pain in some spots. Patient took aspirin on the day and a day prior to this report. The outcome of the event of all the events was unknown.   Additional information about batch/lot has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Swelling, Thrombosis
Clinical narrative: it is weird clot it is not that area where I got the shot; feeling like I was having heart pain; His left upper chest area has swelling and when he touches it he feels something hard. Pain when he touches; His left upper chest area has swelling and when he touches it he feels something hard. Pain when he touches; His left upper chest area has swelling and when he touches it he feels something hard. Pain when he touches; He feels pressure on his chest; It feels like pain on the heart. It's a sharp needle like pain in some spots; my left arm and also my back there is going to pain seems like needle anything from the back; my left arm and also my back there is going to pain seems like needle anything from the back; This is a spontaneous report from a contactable consumer (Patient) via a Pfizer sponsored program.  A male patient of an unspecified age received second dose of BNT162B2 (solution for injection, Lot number: ER8735) via an unspecified route of administration on 25Mar2020, as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient received first dose of BNT162B2 (solution for injection, Lot number: CVS8601) via an unspecified route of administration on an unspecified date, as 1st dose, single for COVID-19 immunization. It was stated that everything was fine on the first day after second dose and then from the second and third day the patient had a pain which was weird clot, and it was not that area where he got the shot.It was like between shoulder and neck, left shoulder, and neck. A kind of in deeper area there was lot of bone and just like where neck was connected to shoulder but it was in front of right. Patient had pain when he touched there in like size of the corn was like he could feel something hard inside and then just started day prior to this report further on the evening and started having chest pain like whole that spot felt like he was having heart pain and his left arm and his back there was going to pain seemed like needle anything from the back. The pain was constant. It was not on chest, it was not like that would come and go, would say it was bearable thing, but it was constant and breath that goes inside his body it was still there when touched, it was still paining. Patient upper left chest area had swelling and when touched it, he felt something hard. It would pain when touched. Patient felt pressure on his chest. It feels like pain on the heart. It was a sharp needle like pain in some spots. Patient took aspirin on the day and a day prior to this report. The outcome of the event of all the events was unknown.   Additional information about batch/lot has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary oedema
Clinical narrative: Lungs filled up with fluid; could not breath after the second dose; This a spontaneous report from a contactable consumer via a Pfizer sales representative. An 89-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). The patient's concomitant medications were not reported. On an unspecified date, the patient died due to lungs filled with fluid and could not breath after the second dose. It was not reported if an autopsy was performed.  Information on the batch/lot number has been requested.; Reported Cause(s) of Death: Lung filled up with fluid; could not breath after the second dose
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test positive
Clinical narrative: patient contracted COVID and went to the hospital and got monoclonal antibodies; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on 13 Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 20Mar2021, patient contracted COVID and went to the hospital and got monoclonal antibodies. Lab test included SARS-CoV-2 antibody test positive on 20 Mar 2021. Outcome of the event was unknown.  Follow up #2(07May2021) This is a spontaneous report from a contactable consumer (patients wife) in response to trail mail sent included: the correct name for the wife provided over the call is withheld and the name for the husband (withheld) mentioned in the document was not spelled nor clarified.  Follow-up needed. Information about batch/lot number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Haematochezia, Swelling of eyelid
Clinical narrative: bloody stool; Yeast infection; swollen upper eyelid; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 17:00 at the age of 31 years old (Batch/Lot Number: Unknown) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. The patient experienced yeast infection, bloody stool, swollen upper eyelid on 13Apr2021. The patient did not receive treatment for the events. The outcome of the events was not recovered.  Information about Lot/Batch number is obtained. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Cardiac disorder, Chest pain, Fatigue, Flushing
Clinical narrative: They actually did admitted me to the hospital (further clarification unknown), did all cardiac stuff; Fatigue; Headache; Ringing in my ear; Flashed face; Fluctuation with my blood pressure and heart rate; Fluctuation with my blood pressure and heart rate; I have chest pressure; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 22Mar2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient had the typical fatigue, headache, ear ringing and flashed face that lasted a couple days. And about few days after (unspecified date), the patient had fluctuation with blood pressure and heart rate and chest pain. It was reported that the patent was actually admitted to the hospital (further clarification unknown), did all cardiac stuff and everything was okay. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Heart rate abnormal, Tinnitus
Clinical narrative: They actually did admitted me to the hospital (further clarification unknown), did all cardiac stuff; Fatigue; Headache; Ringing in my ear; Flashed face; Fluctuation with my blood pressure and heart rate; Fluctuation with my blood pressure and heart rate; I have chest pressure; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 22Mar2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient had the typical fatigue, headache, ear ringing and flashed face that lasted a couple days. And about few days after (unspecified date), the patient had fluctuation with blood pressure and heart rate and chest pain. It was reported that the patent was actually admitted to the hospital (further clarification unknown), did all cardiac stuff and everything was okay. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Influenza like illness, Myalgia, Myocarditis
Clinical narrative: Myocarditis; Pleuritic Chest Pain; Difficulty breathing; Myalgia; Headache; Flu-like symptoms; This is a spontaneous report from a contactable physician. A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 01May2021 as second dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2, on an unknown date, for COVID-19 immunization. The patient experienced myocarditis on 05May2021, and in May2021 (reported as started 2 and a half days after receiving the second dose) experienced pleuritic chest pain, difficulty breathing, myalgia, headache, and flu-like symptoms. The patient was hospitalized for the events from 05May2021 to an unknown date. The reporter assessed the events as life-threatening. The adverse events required a visit to Emergency Room. The reporter assessed that the patient's events were caused by the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on the limited information currently available, a possible association of the suspect drug administration with the reported events cannot be excluded, due to a plausible temporal relationship. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pleuritic pain
Clinical narrative: Myocarditis; Pleuritic Chest Pain; Difficulty breathing; Myalgia; Headache; Flu-like symptoms; This is a spontaneous report from a contactable physician. A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 01May2021 as second dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2, on an unknown date, for COVID-19 immunization. The patient experienced myocarditis on 05May2021, and in May2021 (reported as started 2 and a half days after receiving the second dose) experienced pleuritic chest pain, difficulty breathing, myalgia, headache, and flu-like symptoms. The patient was hospitalized for the events from 05May2021 to an unknown date. The reporter assessed the events as life-threatening. The adverse events required a visit to Emergency Room. The reporter assessed that the patient's events were caused by the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on the limited information currently available, a possible association of the suspect drug administration with the reported events cannot be excluded, due to a plausible temporal relationship. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure fluctuation, Blood pressure increased, Chest discomfort, Chest pain, Dizziness
Clinical narrative: Tunnel vision; Dizziness; Nausea; ringing in ears; Flushed face; chest pressure; my blood pressure up; fatigue; headache; fluctuation with blood pressure and heart rate; fluctuation with blood pressure and heart rate; chest pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient also received first dose of BNT162B2 on 22Mar2021 for COVID-19 immunization and experienced fatigue, headache, ear ringing, and flushed face that lasted a couple days; and fluctuation with blood pressure and heart rate and chest pain which resulted to hospital admission. The patient mentioned that with the second dose, the patient had just typical reaction with the first one (such as fatigue, headache, fluctuation with blood pressure and heart rate, and chest pain) on unspecified dates in 2021. The patient also mentioned that immediately like within 20 minutes following second dose on 21Apr2021, the patient had like tunnel vision, dizziness, nausea, ringing in ears, and flush face. The patient further stated, "Well here is my problem, I am having this, it will go away for a day and then it'll come back worst, and today is the worst it's been. I was fine this morning but for 10 hours now, my heart rate is up, it's just in the 90s, I have chest pressure, my blood pressure up. This morning when I got up and I didn't have any symptoms, my pressure was 107 over". Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Flushing, Headache, Heart rate abnormal, Nausea
Clinical narrative: Tunnel vision; Dizziness; Nausea; ringing in ears; Flushed face; chest pressure; my blood pressure up; fatigue; headache; fluctuation with blood pressure and heart rate; fluctuation with blood pressure and heart rate; chest pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient also received first dose of BNT162B2 on 22Mar2021 for COVID-19 immunization and experienced fatigue, headache, ear ringing, and flushed face that lasted a couple days; and fluctuation with blood pressure and heart rate and chest pain which resulted to hospital admission. The patient mentioned that with the second dose, the patient had just typical reaction with the first one (such as fatigue, headache, fluctuation with blood pressure and heart rate, and chest pain) on unspecified dates in 2021. The patient also mentioned that immediately like within 20 minutes following second dose on 21Apr2021, the patient had like tunnel vision, dizziness, nausea, ringing in ears, and flush face. The patient further stated, "Well here is my problem, I am having this, it will go away for a day and then it'll come back worst, and today is the worst it's been. I was fine this morning but for 10 hours now, my heart rate is up, it's just in the 90s, I have chest pressure, my blood pressure up. This morning when I got up and I didn't have any symptoms, my pressure was 107 over". Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Tunnel vision
Clinical narrative: Tunnel vision; Dizziness; Nausea; ringing in ears; Flushed face; chest pressure; my blood pressure up; fatigue; headache; fluctuation with blood pressure and heart rate; fluctuation with blood pressure and heart rate; chest pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient also received first dose of BNT162B2 on 22Mar2021 for COVID-19 immunization and experienced fatigue, headache, ear ringing, and flushed face that lasted a couple days; and fluctuation with blood pressure and heart rate and chest pain which resulted to hospital admission. The patient mentioned that with the second dose, the patient had just typical reaction with the first one (such as fatigue, headache, fluctuation with blood pressure and heart rate, and chest pain) on unspecified dates in 2021. The patient also mentioned that immediately like within 20 minutes following second dose on 21Apr2021, the patient had like tunnel vision, dizziness, nausea, ringing in ears, and flush face. The patient further stated, "Well here is my problem, I am having this, it will go away for a day and then it'll come back worst, and today is the worst it's been. I was fine this morning but for 10 hours now, my heart rate is up, it's just in the 90s, I have chest pressure, my blood pressure up. This morning when I got up and I didn't have any symptoms, my pressure was 107 over". Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Flushing, Heart rate
Clinical narrative: Tunnel vision; Dizziness; Nausea; ringing in ears; Flushed face; chest pressure; my blood pressure up; fatigue; headache; fluctuation with blood pressure and heart rate; fluctuation with blood pressure and heart rate; chest pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient also received first dose of BNT162B2 on 22Mar2021 for COVID-19 immunization and experienced fatigue, headache, ear ringing, and flushed face that lasted a couple days; and fluctuation with blood pressure and heart rate and chest pain which resulted to hospital admission. The patient mentioned that with the second dose, the patient had just typical reaction with the first one (such as fatigue, headache, fluctuation with blood pressure and heart rate, and chest pain) on unspecified dates in 2021. The patient also mentioned that immediately like within 20 minutes following second dose on 21Apr2021, the patient had like tunnel vision, dizziness, nausea, ringing in ears, and flush face. The patient further stated, "Well here is my problem, I am having this, it will go away for a day and then it'll come back worst, and today is the worst it's been. I was fine this morning but for 10 hours now, my heart rate is up, it's just in the 90s, I have chest pressure, my blood pressure up. This morning when I got up and I didn't have any symptoms, my pressure was 107 over". Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Nausea, Palpitations, Tinnitus
Clinical narrative: Tunnel vision; Dizziness; Nausea; ringing in ears; Flushed face; chest pressure; my blood pressure up; fatigue; headache; fluctuation with blood pressure and heart rate; fluctuation with blood pressure and heart rate; chest pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient also received first dose of BNT162B2 on 22Mar2021 for COVID-19 immunization and experienced fatigue, headache, ear ringing, and flushed face that lasted a couple days; and fluctuation with blood pressure and heart rate and chest pain which resulted to hospital admission. The patient mentioned that with the second dose, the patient had just typical reaction with the first one (such as fatigue, headache, fluctuation with blood pressure and heart rate, and chest pain) on unspecified dates in 2021. The patient also mentioned that immediately like within 20 minutes following second dose on 21Apr2021, the patient had like tunnel vision, dizziness, nausea, ringing in ears, and flush face. The patient further stated, "Well here is my problem, I am having this, it will go away for a day and then it'll come back worst, and today is the worst it's been. I was fine this morning but for 10 hours now, my heart rate is up, it's just in the 90s, I have chest pressure, my blood pressure up. This morning when I got up and I didn't have any symptoms, my pressure was 107 over". Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid virus after first Covid vaccine; Tested positive for Covid virus after first Covid vaccine; This is a spontaneous report from a Pfizer sponsored program. A contactable reporter reported for a patient (reporter's father). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter reported that the patient (reporter's father) tested positive for COVID virus after first of COVID vaccine on an unknown date. The patient's wife (reporter's mother) was also tested positive for COVID virus after the first dose of the COVID vaccine. The reporter asked that his father (patient) would like to make an appointment for his second COVID vaccine. The reporter notified that Pfizer did not participate in scheduling vaccinations. The reporter was referred back to healthcare provider, and/or local county and state resources that may possibly be of some assistance. The report was related to a study or programme. There was a Product Complaint and description of complaint was COVID 19 vaccine. Outcome of the events was unknown.  Reporter seriousness for At risk: needs to schedule second Covid vaccine: Unspecified  Information about lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Dizziness, Fatigue, Nasopharyngitis, Nausea
Clinical narrative: fluttering in chest; Nauseous; Dizzy; extreme fatigue; cold like symptoms; sore throat; slept on and off for 2 days; sinus drainage; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8733), via an unspecified route of administration, administered in arm right on 21Apr2021 at 12:45 (at the age of 56-years-old) as 2nd dose, single for COVID-19 immunisation. Concomitant medication included omeprazole taken for an unspecified indication, start and stop date were not reported. The patient previously took minocycline and had allergies. The patient also previously received the first dose of BNT162B2, administered in right arm on 31Mar2021 at 12:45 PM (at the age of 56-years-old) for COVID-19 immunisation. The patient experienced nauseous, dizzy, extreme fatigue, cold like symtoms with sore throat - sinus drainage, fluttering in chest and slept on and off for 2 days on 22Apr2021 at 04:00. The patient went to the doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 28Apr2021. There was no treatment received for nauseous, dizzy, extreme fatigue, sore throat, fluttering in chest and slept on and off for 2 days. The outcome of the events was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Paranasal sinus hypersecretion, SARS-CoV-2 test, Sleep disorder
Clinical narrative: fluttering in chest; Nauseous; Dizzy; extreme fatigue; cold like symptoms; sore throat; slept on and off for 2 days; sinus drainage; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8733), via an unspecified route of administration, administered in arm right on 21Apr2021 at 12:45 (at the age of 56-years-old) as 2nd dose, single for COVID-19 immunisation. Concomitant medication included omeprazole taken for an unspecified indication, start and stop date were not reported. The patient previously took minocycline and had allergies. The patient also previously received the first dose of BNT162B2, administered in right arm on 31Mar2021 at 12:45 PM (at the age of 56-years-old) for COVID-19 immunisation. The patient experienced nauseous, dizzy, extreme fatigue, cold like symtoms with sore throat - sinus drainage, fluttering in chest and slept on and off for 2 days on 22Apr2021 at 04:00. The patient went to the doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 28Apr2021. There was no treatment received for nauseous, dizzy, extreme fatigue, sore throat, fluttering in chest and slept on and off for 2 days. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Delirium, Heart rate increased, Pain, Sneezing
Clinical narrative: Delirious; felt like she had COVID; body ache; fast heart rate; Sneezing; Joint pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included Crohn's disease and synovial cyst (Verbatim: Ganglion cyst). The patient's concomitant medications were not reported. On an unspecified date, the patient experienced delirious, felt like she had COVID, body ache, fast heart rate, sneezing, and joint pain. It was further reported that for 7 days straight, her body ache and had joint pain for 12 days. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: Delirious; felt like she had COVID; body ache; fast heart rate; Sneezing; Joint pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included Crohn's disease and synovial cyst (Verbatim: Ganglion cyst). The patient's concomitant medications were not reported. On an unspecified date, the patient experienced delirious, felt like she had COVID, body ache, fast heart rate, sneezing, and joint pain. It was further reported that for 7 days straight, her body ache and had joint pain for 12 days. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea, Pain
Clinical narrative: Red hard hot itchy area around injection site; Extreme fatigue; body aches; joint pain; nausea; headache; Red hard hot itchy area around injection site; Red hard hot itchy area around injection site; This is a spontaneous report received from a  non- contactable consumer (patient). A 52-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 12:45 (at 52 years old, not pregnant) (Batch/Lot Number: ER8736) as 2nd dose, single for covid-19 immunisation. Medical history included Hashimoto Thyroiditis from an unknown date. The patient had her first dose of bnt162b2 (lot number -EL9263)  vaccine on 05Apr2021 11:00, on left arm for covid-19 immunisation. Concomitant medications included levothyroxine sodium (SYNTHROID); vitamin b complex (VITAMIN B); vitamin d [vitamin d nos]; magnesium.  After dose 2, patient experienced on 27Apr2021 08:00, Extreme fatigue, body aches, joint pain, nausea, headache, no treatments for these events. Red hard hot itchy area around injection site that she took Benadryl for. Patient had no reaction to dose 1. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow up possible. Follow up information can not be obtained
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Red hard hot itchy area around injection site; Extreme fatigue; body aches; joint pain; nausea; headache; Red hard hot itchy area around injection site; Red hard hot itchy area around injection site; This is a spontaneous report received from a  non- contactable consumer (patient). A 52-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 12:45 (at 52 years old, not pregnant) (Batch/Lot Number: ER8736) as 2nd dose, single for covid-19 immunisation. Medical history included Hashimoto Thyroiditis from an unknown date. The patient had her first dose of bnt162b2 (lot number -EL9263)  vaccine on 05Apr2021 11:00, on left arm for covid-19 immunisation. Concomitant medications included levothyroxine sodium (SYNTHROID); vitamin b complex (VITAMIN B); vitamin d [vitamin d nos]; magnesium.  After dose 2, patient experienced on 27Apr2021 08:00, Extreme fatigue, body aches, joint pain, nausea, headache, no treatments for these events. Red hard hot itchy area around injection site that she took Benadryl for. Patient had no reaction to dose 1. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow up possible. Follow up information can not be obtained
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Echocardiogram, Electrocardiogram, Myocardial necrosis marker, Myocarditis
Clinical narrative: myocarditis; Strange weird bilateral wrist pain severe; Pericarditis/inflammation around the heart; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar events for two patients (twins). This is the first of two reports.  A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0170), via an unspecified route of administration, administered in the left arm, on 26Apr2021 10:00, as 2nd dose, single, for COVID-19 immunization, at a pharmacy/drug store. Medical history included ongoing rare metabolic disorder. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8735) received at age 22 years, on 05Apr2021, for COVID-19 immunisation. On 26Apr2021, the patient received the second dose of BNT162B2. In the evening of the same day, 26Apr2021, the patient experienced tiredness/fatigue, and headache. In the morning of 27Apr2021, the patient was feeling really crappy and they though it was like the flu and it would pass. In the evening of 27Apr2021, the patient didn't sleep at all and was uncomfortable all night and pain. On the same day, 27Apr2021, the patient had severe chest pain, chest tightness, and lightheadedness. On 28Apr2021, the pain didn't go away, and the twins had elevated ST evaluation on the EKG (electrocardiograph). ST evaluation was done by the reporter's husband who is a retired firefighter emergency medical technician. The reporter decided to take the patient to hospital and said that the other twin had the same symptoms but kept saying his wasn't as bad as his brother's because he did not want to go to the hospital. The doctor advised the reporter to bring the other twin. The twins had the same echo cardiogram on 28Apr2021 (unknown results). On 28Apr2021, their troponin levels were elevated, and their cardiac enzymes continued to go up. On the same day, 28Apr2021, the patient had a strange weird bilateral wrist pain severe. It was reported that the twins were hospitalized on 28Apr2021 with myocarditis/pericarditis and inflammation around the heart. Treatment for myocarditis/pericarditis included ibuprofen and colchicine; and Toradol for breakthrough pain. The reporter stated that the twins are two identical males with the same DNA, had the vaccine at the same time, had the reactions at the same length of time, have the same lifestyle and live at the same house. The reporter said it would go a long way if they help her understand the complication. The patient recovered "strange weird bilateral wrist pain severe" on 29Apr2021. The outcome of the event myocarditis and pericarditis/inflammation around the heart was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021487544 same reporter, suspect drugs and events; different patients
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis, Troponin
Clinical narrative: myocarditis; Strange weird bilateral wrist pain severe; Pericarditis/inflammation around the heart; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar events for two patients (twins). This is the first of two reports.  A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0170), via an unspecified route of administration, administered in the left arm, on 26Apr2021 10:00, as 2nd dose, single, for COVID-19 immunization, at a pharmacy/drug store. Medical history included ongoing rare metabolic disorder. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8735) received at age 22 years, on 05Apr2021, for COVID-19 immunisation. On 26Apr2021, the patient received the second dose of BNT162B2. In the evening of the same day, 26Apr2021, the patient experienced tiredness/fatigue, and headache. In the morning of 27Apr2021, the patient was feeling really crappy and they though it was like the flu and it would pass. In the evening of 27Apr2021, the patient didn't sleep at all and was uncomfortable all night and pain. On the same day, 27Apr2021, the patient had severe chest pain, chest tightness, and lightheadedness. On 28Apr2021, the pain didn't go away, and the twins had elevated ST evaluation on the EKG (electrocardiograph). ST evaluation was done by the reporter's husband who is a retired firefighter emergency medical technician. The reporter decided to take the patient to hospital and said that the other twin had the same symptoms but kept saying his wasn't as bad as his brother's because he did not want to go to the hospital. The doctor advised the reporter to bring the other twin. The twins had the same echo cardiogram on 28Apr2021 (unknown results). On 28Apr2021, their troponin levels were elevated, and their cardiac enzymes continued to go up. On the same day, 28Apr2021, the patient had a strange weird bilateral wrist pain severe. It was reported that the twins were hospitalized on 28Apr2021 with myocarditis/pericarditis and inflammation around the heart. Treatment for myocarditis/pericarditis included ibuprofen and colchicine; and Toradol for breakthrough pain. The reporter stated that the twins are two identical males with the same DNA, had the vaccine at the same time, had the reactions at the same length of time, have the same lifestyle and live at the same house. The reporter said it would go a long way if they help her understand the complication. The patient recovered "strange weird bilateral wrist pain severe" on 29Apr2021. The outcome of the event myocarditis and pericarditis/inflammation around the heart was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021487544 same reporter, suspect drugs and events; different patients