chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Serum ferritin decreased, Ultrasound scan
Clinical narrative: Dyssynchronous contraction of IV septum; Elevated IgA; low ferritin; Cardiac MRI showed focal myocardits; Recieved second dose and worsened still/Cardiac MRI showed focal myocardits; ejection fraction down to 33/37% (58% 6 months prior); This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER2613), via an unspecified route of administration, administered in left arm on 22Mar2021 (at the age of 53-year-old) at single dose for COVID-19 immunization. Medical history included previous to vaccine had exposure to A. flavus in 2014 with development of fungal ball in sphenoid cavity causing brain injury from 2014 and all body damage; autonomic disorder developed causing tachycardia. Prior to vaccination, patient was not diagnosed with COVID-19. No known allergy. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6202), administered in left arm on 01Mar2021 (at the age of 53-year-old) at single dose for COVID-19 immunization and developed focal myocarditis, Echo in Nov2020 showed no abnormalities, 12 days after first dose on 13Mar2021 vomited clotted blood, hospitalized, cleared and discharged after a day unknown cause of bleeding, elevated HR and BP, now on ivabradine 2.5mg to lower HR to hope to allow heart to heal; difficulty breathing, chest tightness and extreme fatigue to the point of barely being able to walk continued for several weeks. The patient received second dose and worsened still. After about a month began to normalize. Cardiac MRI on 22Mar2021 showed focal myocardits; ejection fraction down to 33/37% (58% 6 months prior in Sep2020). Dyssynchronous contraction of IV septum not previously present either. Elevated IgA and low ferritin on unspecified dates; awaiting hematologist appt. Events were resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Since the vaccination, patient had been tested for COVID-19 which included Nasal swab: Negative on 22Mar2021 and Negative on 10Apr2021. No treatment was received for the events. The outcome of the events was not recovered. Events were reported as serious due to disabling.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive with COVID; tested positive with COVID; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. This male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 01Feb2021 (Lot Number: not reported) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The patient was not able to get the second dose because he tested positive with COVID in Feb2021. The patient wanted to know if it was still okay for him to take the second dose. The outcome of event was unknown.   Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Drug screen, Eye movement disorder, Fall, Foaming at mouth, Seizure
Clinical narrative: As we discussed my 22 year old son got the Pfizer vaccine last week and 24 hours later he had a seizure; He fell over and was foaming at the mouth; He fell over and was foaming at the mouth; Eyes rolled up; This is a spontaneous report from a contactable consumer (patient's parent) and another consumer. A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization; and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at  for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient got the Pfizer vaccine last week and 24 hours later he had a seizure. He fell over, eyes rolled up, and was foaming at the mouth, his roommate rolled him over and called. He went to the hospital and was screened for different possible drugs which all came back negative. He did say he took an Adderall that day to help study. Very odd and no history of seizures. ER documented it as a likely seizure. He recovered fully within several hours of the episode. They are trying to decide whether or not he should get the second shot and also asked if there have been any other issues like this. The events occurred in 2021. The outcome of the events was recovered in 2021.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, Bone pain, Dyspnoea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0153), via an unspecified route of administration, administered in left arm on 15Apr2021 at 14:30 (at the age of 56-year-old) at single dose for COVID-19 immunization. No other vaccine received in four weeks. Medical history included hypertension, thyroid disorder, prior to vaccination, patient was diagnosed with COVID-19. No known allergy. Concomitant medications included levothyroxine sodium (SYNTHROID); azilsartan medoxomil, chlortalidone (EDARBYCLOR); nebivolol hydrochloride (BYSTOLIC); cetirizine hydrochloride (ZYRTEC) and antibodies. The patient experienced fever 104.2 fahrenheit for 3 days, sore arm 10 days, hot arm, bones hurt. Loss taste and smell for 10 days (30% better). Pulse ox dropped down to 92 and shortness of breath 3 days. Because she had Covid and was in a long haulers study, patient still had antibodies 11 months post Covid and when she took the 1 vaccine. It was like her body knew this and it rallied. She could not get out of bed for 24 hours. Symptoms began 12 post vaccine on 16Apr2021 at 02:30 AM. She had antibodies drawn 4 weeks after 1 dose and was at the highest limit. The patient also underwent lab tests which included sars-cov-2 test: negative on an unspecified date. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events fever and shortness of breath was recovered on 19Apr2021 for 3 days; sore arm was recovered on 26Apr2021 for 10 days; could not get out of bed was recovered on 17Apr2021 02:30 for 24 hours; outcome of the other events was recovering. This report was reported as non-serious by reporter, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Heart rate, Heart rate decreased, Mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0153), via an unspecified route of administration, administered in left arm on 15Apr2021 at 14:30 (at the age of 56-year-old) at single dose for COVID-19 immunization. No other vaccine received in four weeks. Medical history included hypertension, thyroid disorder, prior to vaccination, patient was diagnosed with COVID-19. No known allergy. Concomitant medications included levothyroxine sodium (SYNTHROID); azilsartan medoxomil, chlortalidone (EDARBYCLOR); nebivolol hydrochloride (BYSTOLIC); cetirizine hydrochloride (ZYRTEC) and antibodies. The patient experienced fever 104.2 fahrenheit for 3 days, sore arm 10 days, hot arm, bones hurt. Loss taste and smell for 10 days (30% better). Pulse ox dropped down to 92 and shortness of breath 3 days. Because she had Covid and was in a long haulers study, patient still had antibodies 11 months post Covid and when she took the 1 vaccine. It was like her body knew this and it rallied. She could not get out of bed for 24 hours. Symptoms began 12 post vaccine on 16Apr2021 at 02:30 AM. She had antibodies drawn 4 weeks after 1 dose and was at the highest limit. The patient also underwent lab tests which included sars-cov-2 test: negative on an unspecified date. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events fever and shortness of breath was recovered on 19Apr2021 for 3 days; sore arm was recovered on 26Apr2021 for 10 days; could not get out of bed was recovered on 17Apr2021 02:30 for 24 hours; outcome of the other events was recovering. This report was reported as non-serious by reporter, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0153), via an unspecified route of administration, administered in left arm on 15Apr2021 at 14:30 (at the age of 56-year-old) at single dose for COVID-19 immunization. No other vaccine received in four weeks. Medical history included hypertension, thyroid disorder, prior to vaccination, patient was diagnosed with COVID-19. No known allergy. Concomitant medications included levothyroxine sodium (SYNTHROID); azilsartan medoxomil, chlortalidone (EDARBYCLOR); nebivolol hydrochloride (BYSTOLIC); cetirizine hydrochloride (ZYRTEC) and antibodies. The patient experienced fever 104.2 fahrenheit for 3 days, sore arm 10 days, hot arm, bones hurt. Loss taste and smell for 10 days (30% better). Pulse ox dropped down to 92 and shortness of breath 3 days. Because she had Covid and was in a long haulers study, patient still had antibodies 11 months post Covid and when she took the 1 vaccine. It was like her body knew this and it rallied. She could not get out of bed for 24 hours. Symptoms began 12 post vaccine on 16Apr2021 at 02:30 AM. She had antibodies drawn 4 weeks after 1 dose and was at the highest limit. The patient also underwent lab tests which included sars-cov-2 test: negative on an unspecified date. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events fever and shortness of breath was recovered on 19Apr2021 for 3 days; sore arm was recovered on 26Apr2021 for 10 days; could not get out of bed was recovered on 17Apr2021 02:30 for 24 hours; outcome of the other events was recovering. This report was reported as non-serious by reporter, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, SARS-CoV-2 test
Clinical narrative: I started to have a severe anxiety until now today; This is a spontaneous report from a contactable other HCP (patient). A 50-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration, administered in left arm on 05May2021 at 15:00 (at the age of 50-year-old) at single dose for COVID-19 immunization. No other vaccine received in four weeks. Medical history included bipolar disorder; prior to vaccination, patient was diagnosed with COVID-19; had known allergies. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 50-year-old at single dose for COVID-19 immunization and got a little anxiety. After patient received a second one of Pfizer's vaccine on 05May2021, he started to have a severe anxiety from 07May2021 until now 23May2021. Some medications won't help him out as enough. Event was resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 3 days. The patient underwent lab tests which included Nasal swab: Positive on 11Dec2020; since the vaccination, patient had been tested for COVID-19 with unknown result on an unspecified date. Therapeutic measures were taken as a result of the event included Lorazepam. The outcome of the event was not recovered. This report was reported as serious with seriousness criteria-Caused hospitalization.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Joint swelling, Malaise, Peripheral swelling, Suspected COVID-19
Clinical narrative: She is feeling like she really has COVID; She is feeling like she really has COVID; Not feeling well; I'm not feeling good; I feel like anything that makes me feel this bad cannot be good for me; Experiencing side effects, her arm is swelling up to the elbow; not feeling well about the whole arm; Experiencing side effects, her arm is swelling up to the elbow; not feeling well about the whole arm; This is a spontaneous report from a Pfizer sponsored program support. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. After having the first dose of Pfizer COVID-19 Vaccine the patient she was not feeling well, she was experiencing side effects, her arm was swelling up to the elbow, her whole arm was (incomplete sentence), she was not feeling well about the whole arm. She was experiencing like she was feeling like she really has COVID, that's what she felt.  She asked if she allergic to something, and if she can still going to receive the second dose. She not feeling good, don't feel like doing this and just not getting it. She feel like anything that makes her feel this bad cannot be good for her. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bronchitis, Dysgeusia, Dyspnoea, Ear congestion, Haemoptysis
Clinical narrative: Pneumonia; congestion in one side of her head or in the upper front side, similar like a sinus infection; She had her ears going plugged, she had a bloody flavor and blood was coming little portion of her coughing; arm swollen; Rash; lot of stuffy nose; really bad runny nose; she can't breathe to sleep; ears going plugged; she had a bloody flavor and blood was coming little portion of her coughing; bronchitis symptoms; congestion in one side of my head or in the upper front side, similar like a sinus infection; This is a spontaneous report from two contactable consumers (patient and patient's husband). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose via an unspecified route of administration, administered in right arm on 17May2021 (Batch/Lot number was not reported) (at age 51 years old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date at age 51 years old for COVID-19 immunization. The patient reported she had the second shot for the vaccine (confirmed as Pfizer COVID vaccine) on 17May2021 almost at midnight and she had been really sick since Wednesday. She clarified that it was really bad from Monday (17May2021) but on the Tuesday (18May2021) she has her arm swollen and the rash but she thought it was normal and then from the 17May2021 up to the time of report she has been really, really sick, like bronchitis symptoms something like that and she had a lot of stuffy nose and she had congestion in one side of her head or in the upper front side, similar like a sinus infection. She had her ears going plugged, she had a bloody flavor and blood was coming little portion of her coughing, really bad runny nose and she can't breathe to sleep, she had to use (incomplete sentence). The patient's husband stated she got no treatment she did not go to the doctor. They wanted to know if she can take cold medicine because she was up with pneumonia. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, Peripheral swelling, Pneumonia, Rash, Rhinorrhoea
Clinical narrative: Pneumonia; congestion in one side of her head or in the upper front side, similar like a sinus infection; She had her ears going plugged, she had a bloody flavor and blood was coming little portion of her coughing; arm swollen; Rash; lot of stuffy nose; really bad runny nose; she can't breathe to sleep; ears going plugged; she had a bloody flavor and blood was coming little portion of her coughing; bronchitis symptoms; congestion in one side of my head or in the upper front side, similar like a sinus infection; This is a spontaneous report from two contactable consumers (patient and patient's husband). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose via an unspecified route of administration, administered in right arm on 17May2021 (Batch/Lot number was not reported) (at age 51 years old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date at age 51 years old for COVID-19 immunization. The patient reported she had the second shot for the vaccine (confirmed as Pfizer COVID vaccine) on 17May2021 almost at midnight and she had been really sick since Wednesday. She clarified that it was really bad from Monday (17May2021) but on the Tuesday (18May2021) she has her arm swollen and the rash but she thought it was normal and then from the 17May2021 up to the time of report she has been really, really sick, like bronchitis symptoms something like that and she had a lot of stuffy nose and she had congestion in one side of her head or in the upper front side, similar like a sinus infection. She had her ears going plugged, she had a bloody flavor and blood was coming little portion of her coughing, really bad runny nose and she can't breathe to sleep, she had to use (incomplete sentence). The patient's husband stated she got no treatment she did not go to the doctor. They wanted to know if she can take cold medicine because she was up with pneumonia. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sinusitis, Upper respiratory tract congestion
Clinical narrative: Pneumonia; congestion in one side of her head or in the upper front side, similar like a sinus infection; She had her ears going plugged, she had a bloody flavor and blood was coming little portion of her coughing; arm swollen; Rash; lot of stuffy nose; really bad runny nose; she can't breathe to sleep; ears going plugged; she had a bloody flavor and blood was coming little portion of her coughing; bronchitis symptoms; congestion in one side of my head or in the upper front side, similar like a sinus infection; This is a spontaneous report from two contactable consumers (patient and patient's husband). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose via an unspecified route of administration, administered in right arm on 17May2021 (Batch/Lot number was not reported) (at age 51 years old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date at age 51 years old for COVID-19 immunization. The patient reported she had the second shot for the vaccine (confirmed as Pfizer COVID vaccine) on 17May2021 almost at midnight and she had been really sick since Wednesday. She clarified that it was really bad from Monday (17May2021) but on the Tuesday (18May2021) she has her arm swollen and the rash but she thought it was normal and then from the 17May2021 up to the time of report she has been really, really sick, like bronchitis symptoms something like that and she had a lot of stuffy nose and she had congestion in one side of her head or in the upper front side, similar like a sinus infection. She had her ears going plugged, she had a bloody flavor and blood was coming little portion of her coughing, really bad runny nose and she can't breathe to sleep, she had to use (incomplete sentence). The patient's husband stated she got no treatment she did not go to the doctor. They wanted to know if she can take cold medicine because she was up with pneumonia. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site rash, Injection site swelling, Rhinorrhoea, Sinus congestion
Clinical narrative: Pneumonia; congestion in one side of her head or in the upper front side, similar like a sinus infection; She had her ears going plugged, she had a bloody flavor and blood was coming little portion of her coughing; arm swollen; Rash; lot of stuffy nose; really bad runny nose; she can't breathe to sleep; ears going plugged; she had a bloody flavor and blood was coming little portion of her coughing; bronchitis symptoms; congestion in one side of my head or in the upper front side, similar like a sinus infection; This is a spontaneous report from two contactable consumers (patient and patient's husband). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose via an unspecified route of administration, administered in right arm on 17May2021 (Batch/Lot number was not reported) (at age 51 years old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date at age 51 years old for COVID-19 immunization. The patient reported she had the second shot for the vaccine (confirmed as Pfizer COVID vaccine) on 17May2021 almost at midnight and she had been really sick since Wednesday. She clarified that it was really bad from Monday (17May2021) but on the Tuesday (18May2021) she has her arm swollen and the rash but she thought it was normal and then from the 17May2021 up to the time of report she has been really, really sick, like bronchitis symptoms something like that and she had a lot of stuffy nose and she had congestion in one side of her head or in the upper front side, similar like a sinus infection. She had her ears going plugged, she had a bloody flavor and blood was coming little portion of her coughing, really bad runny nose and she can't breathe to sleep, she had to use (incomplete sentence). The patient's husband stated she got no treatment she did not go to the doctor. They wanted to know if she can take cold medicine because she was up with pneumonia. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sneezing
Clinical narrative: Pneumonia; congestion in one side of her head or in the upper front side, similar like a sinus infection; She had her ears going plugged, she had a bloody flavor and blood was coming little portion of her coughing; arm swollen; Rash; lot of stuffy nose; really bad runny nose; she can't breathe to sleep; ears going plugged; she had a bloody flavor and blood was coming little portion of her coughing; bronchitis symptoms; congestion in one side of my head or in the upper front side, similar like a sinus infection; This is a spontaneous report from two contactable consumers (patient and patient's husband). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose via an unspecified route of administration, administered in right arm on 17May2021 (Batch/Lot number was not reported) (at age 51 years old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date at age 51 years old for COVID-19 immunization. The patient reported she had the second shot for the vaccine (confirmed as Pfizer COVID vaccine) on 17May2021 almost at midnight and she had been really sick since Wednesday. She clarified that it was really bad from Monday (17May2021) but on the Tuesday (18May2021) she has her arm swollen and the rash but she thought it was normal and then from the 17May2021 up to the time of report she has been really, really sick, like bronchitis symptoms something like that and she had a lot of stuffy nose and she had congestion in one side of her head or in the upper front side, similar like a sinus infection. She had her ears going plugged, she had a bloody flavor and blood was coming little portion of her coughing, really bad runny nose and she can't breathe to sleep, she had to use (incomplete sentence). The patient's husband stated she got no treatment she did not go to the doctor. They wanted to know if she can take cold medicine because she was up with pneumonia. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: developed Bell's palsy; This is a spontaneous report from a non-contactable consumer via a sales representative. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, for Covid-19 immunisation. The patient medical history and concomitant medications were not reported.  It was reported that "I wasn't sure if this was reportable or not because wasn't sure if this was identifiable patient. Reporter told me he had heard of a teenage patient that was related to someone he knew who developed Bell's palsy after receiving vaccine. If I receive any more information will keep you posted. He did not officially say it was Pfizer vaccine they received, but am reporting just in case as I am not aware of other Covid vaccines being given to teenagers." Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction, Incorrect route of product administration, Vaccination site pain, Vaccination site swelling
Clinical narrative: had not experienced an erection after the last shot; the left arm that they shot him in the vein had swollen up and was burning; the left arm that they shot him in the vein had swollen up and was burning; the left arm that they shot him in the vein had swollen up and was burning; This is a spontaneous report from a non-contactable consumer (patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intravenously, administered in the left arm on an unspecified date (Batch/Lot number and Expiration date were unknown) as the 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that women had no clue what he was talking about, but he just heard about children and young  adult having problem with heart and heart was connected to the penis. On an unspecified date, on the 20th, the patient took the shot and he went woken up or he had not experienced an erection after the last shot. He further described that the first shot he took, it didn't do any thing for like 3 hours. The patient woke up and the left arm that they shot him in the vein had swollen up and was burning on an unspecified date and he would have to rub and it went down; it still didn't do anything, it kept coming up and going back down. The patient thought that "it must be the time release, that's the only reason what it's doing." 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.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Fatigue, Movement disorder
Clinical narrative: felt like she could not move it and then she felt like paralyzed for less than three second; right arm little bit hurting/pain in her hand like she couldn't grab something; pain in her hand like she couldn't grab something, and it's twitching; felt short breath/felt like she need to grab air to breathe, she can't breathe/it was hard to breathe; chest kept hurting/short pain in chest; felt like she could not move it; body felt super tired; Chills; little fever; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18May2021 (at the age of 36 years old; Lot Number: EW0182, unknown expiration) as 1st dose, single for COVID-19 immunisation.  Medical history and concomitant medications reported as none. The patient reported that she received her first shot on 18May2021. She came home with her right arm little bit hurting, felt pain in her hand like she couldn't grab something, and it's twitching. As soon as she received the vaccine, she felt short breath, she called the place where she received the vaccine, she was there for 20 minutes. In her aid, she walked out as she needed air and her chest kept hurting and hurting on 18May2021. Every time she breathes, she felt like she need to grab air to breathe, she can't breathe/it was hard to breathe. Since 18May2021 to today, she felt short pain in chest and right hand and in the morning it was like twitch, she felt like she could not move it and then she felt like paralyzed for less than three second and then the shortening went to exactly to her chest and felt like she was losing air. She mentioned she need air to breathe and her body felt super tired on 18May2021. She is a very active person; she feels so tired. She also experienced chills, little fever, and her chest was hurting more on 18May2021. Due date of second shot is on 08Jun2021. The patient did not receive treatment for the events. The patient had not yet recovered from the events.   No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Pain in extremity, Paralysis, Pyrexia
Clinical narrative: felt like she could not move it and then she felt like paralyzed for less than three second; right arm little bit hurting/pain in her hand like she couldn't grab something; pain in her hand like she couldn't grab something, and it's twitching; felt short breath/felt like she need to grab air to breathe, she can't breathe/it was hard to breathe; chest kept hurting/short pain in chest; felt like she could not move it; body felt super tired; Chills; little fever; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18May2021 (at the age of 36 years old; Lot Number: EW0182, unknown expiration) as 1st dose, single for COVID-19 immunisation.  Medical history and concomitant medications reported as none. The patient reported that she received her first shot on 18May2021. She came home with her right arm little bit hurting, felt pain in her hand like she couldn't grab something, and it's twitching. As soon as she received the vaccine, she felt short breath, she called the place where she received the vaccine, she was there for 20 minutes. In her aid, she walked out as she needed air and her chest kept hurting and hurting on 18May2021. Every time she breathes, she felt like she need to grab air to breathe, she can't breathe/it was hard to breathe. Since 18May2021 to today, she felt short pain in chest and right hand and in the morning it was like twitch, she felt like she could not move it and then she felt like paralyzed for less than three second and then the shortening went to exactly to her chest and felt like she was losing air. She mentioned she need air to breathe and her body felt super tired on 18May2021. She is a very active person; she feels so tired. She also experienced chills, little fever, and her chest was hurting more on 18May2021. Due date of second shot is on 08Jun2021. The patient did not receive treatment for the events. The patient had not yet recovered from the events.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Headache, SARS-CoV-2 test, Tinnitus, Type 2 diabetes mellitus
Clinical narrative: Higher blood sugar levels noted within one week of Vaccine indicated Type II diabetes levels when I had not previously had diabetes-level blood sugar. Constant high pitched ringing in ears X 6 weeks a; Higher blood sugar levels noted within one week of Vaccine indicated Type II diabetes levels when I had not previously had diabetes-level blood sugar. Constant high pitched ringing in ears X 6 weeks a; headache X 3 days after 1st and 2nd vaccines; Higher blood sugar levels noted within one week of Vaccine indicated Type II diabetes levels when I had not previously had diabetes-level blood sugar. Constant high pitched ringing in ears X 6 weeks a; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female non- pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left at the age of 59-year-old on 01Apr2021 16:00 (Lot Number: EN6202) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included perennial allergies. Concomitant medications included oxymetazoline hydrochloride (CLARITIN ALLERGIC); fluticasone propionate (FLONASE ALLERGY RELIEF); amoxicillin trihydrate, clarithromycin, esomeprazole magnesium (NEXIUM 1-2-3), multi- vitamin, all taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) via an unspecified route of administration administered in arm left at the age of 59-year-old on 04Mar2021 16:00 for covid-19 immunisation and experienced ringing in ears and headache; seldane and experienced drug hypersensitivity, horseradish and experienced drug hypersensitivity.  The patient experienced higher blood sugar levels noted within one week of vaccine indicated type ii diabetes levels when the patient had not previously had diabetes-level blood sugar (on an unknown date); constant high pitched ringing in ears for 6 weeks and headache for 3 days after 1st and 2nd vaccines, both occurred on 01Apr2021 16:00. Events all resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 10May2021. Therapeutic measures were taken as a result of all events. It is reported as high blood sugar noted routine check, 3 months recheck. The outcome of the events was unknown.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Severe chest pain at heart. Was taken to ER and given Morphing for pain. Was diagnosed with Myocarditis.; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN6205), via an unspecified route of administration on 26Feb2021 at 07:00 am on the left arm as a single dose for COVID-19 immunisation. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EN6201), via an unspecified route of administration on 05Feb2021 at 07:00 am on the left arm as a single dose for COVID-19 immunisation. The patient had no known allergy. The patient's medical history included IGA. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient medications two weeks prior vaccination included Losartan, Atorvastatin, Atenolol. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. On 28Feb2021 at 06:00 pm, the patient experienced Severe chest pain in the heart. The patient was taken to ER was and given Morphine for pain. Patient was diagnosed with Myocarditis. The case was assessed as Serious (Myocarditis). The patient visited the emergency room for the events. The patient was treated with morphine and inflammation drugs for the events. The outcome of the events was resolved.
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Eye pain, Retinal detachment
Clinical narrative: detachment of the retina; having problems with the left eye; she feels a line a curved line on the left side that moves and it is very painful; having problems with the left eye;  it is very painful; This is a spontaneous report from a non-contactable physician. A female patient (physician's wife) of an unspecified age received BNT162B2 (Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot number was not reported), on an unspecified date as single dose for COVID-19 immunization. The patient experienced detachment of the retina and having problems with the left eye; she feels a line a curved line on the left side that moves and it is very painful, all on an unspecified date. The patient received the second dose of Pfizer Vaccine she was having symptoms. She had problems with the left eye. The physician measured the pressure of the eyes and they are equal, so it is not a glaucoma and she feels a line a curved line on the left side that moves and it is very painful like they hear and it moves permanently and does not disappear and when she closes the eye, she feels that line. The physician had seen the detachment of the retina. The outcome of the events was unknown.  No Follow-up attempts are possible. Information on lot/batch number cannot be obtained.; Sender's Comments: The information provided is limited and does not allow a full medically meaningful assessment. Considering temporal relationship, a possible contribution role of BNT162B2 to the onset of the eye events cannot be completely excluded. The case will be reassessed should additional information become 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: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Asthenia, Back pain, Blood pressure measurement, Blood sodium decreased
Clinical narrative: downward spiral after 2nd vaccine; high blood pressure; extreme back pain; swelled feet; pain was arthritis; vomiting a lot; very weak; sodium was low; arm is blue; vision is decreasing; This is a spontaneous report from a contactable consumer (Patient's daughter) communicated to a Pfizer Colleague. An 83-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 10Mar2021 (Batch/Lot Number: EN6206) as 2ND DOSE, SINGLE, vaccinated at the age of 83 years old for covid-19 immunisation. Patient received the first dose of bnt162b2 (lot number: EN6201, at the age of 83 years old) on 17Feb2021. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient had no previous health issues, then from 12Mar2021 downward spiral after 2nd vaccine. Within days of shot, on 12Mar2021 had high blood pressure(178/86) extreme back pain, swelled feet.  Dr then said pain was arthritis and presribed blood pressure med for high bp. Pt was getting worse and in a couple of weeks ago she was vomiting a lot and was very week.  Went to ER and was kept overnight.  Was told sodium was low and she was sent home.  Now her arm is blue and her vision is decreasing.  Reporter reported her mother never had any health issues prior to getting vaccine. Events feeling abnormal, hypertension, back pain, swelled feet, pain was arthritis, vomiting, very weak and sodium was low resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care and hospitalized. Outcome of events was not recovered.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypertension, Peripheral swelling, Skin discolouration, Visual impairment
Clinical narrative: downward spiral after 2nd vaccine; high blood pressure; extreme back pain; swelled feet; pain was arthritis; vomiting a lot; very weak; sodium was low; arm is blue; vision is decreasing; This is a spontaneous report from a contactable consumer (Patient's daughter) communicated to a Pfizer Colleague. An 83-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 10Mar2021 (Batch/Lot Number: EN6206) as 2ND DOSE, SINGLE, vaccinated at the age of 83 years old for covid-19 immunisation. Patient received the first dose of bnt162b2 (lot number: EN6201, at the age of 83 years old) on 17Feb2021. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient had no previous health issues, then from 12Mar2021 downward spiral after 2nd vaccine. Within days of shot, on 12Mar2021 had high blood pressure(178/86) extreme back pain, swelled feet.  Dr then said pain was arthritis and presribed blood pressure med for high bp. Pt was getting worse and in a couple of weeks ago she was vomiting a lot and was very week.  Went to ER and was kept overnight.  Was told sodium was low and she was sent home.  Now her arm is blue and her vision is decreasing.  Reporter reported her mother never had any health issues prior to getting vaccine. Events feeling abnormal, hypertension, back pain, swelled feet, pain was arthritis, vomiting, very weak and sodium was low resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care and hospitalized. Outcome of events was not recovered.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: downward spiral after 2nd vaccine; high blood pressure; extreme back pain; swelled feet; pain was arthritis; vomiting a lot; very weak; sodium was low; arm is blue; vision is decreasing; This is a spontaneous report from a contactable consumer (Patient's daughter) communicated to a Pfizer Colleague. An 83-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 10Mar2021 (Batch/Lot Number: EN6206) as 2ND DOSE, SINGLE, vaccinated at the age of 83 years old for covid-19 immunisation. Patient received the first dose of bnt162b2 (lot number: EN6201, at the age of 83 years old) on 17Feb2021. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient had no previous health issues, then from 12Mar2021 downward spiral after 2nd vaccine. Within days of shot, on 12Mar2021 had high blood pressure(178/86) extreme back pain, swelled feet.  Dr then said pain was arthritis and presribed blood pressure med for high bp. Pt was getting worse and in a couple of weeks ago she was vomiting a lot and was very week.  Went to ER and was kept overnight.  Was told sodium was low and she was sent home.  Now her arm is blue and her vision is decreasing.  Reporter reported her mother never had any health issues prior to getting vaccine. Events feeling abnormal, hypertension, back pain, swelled feet, pain was arthritis, vomiting, very weak and sodium was low resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care and hospitalized. Outcome of events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest pain, Heart rate, Heart rate increased
Clinical narrative: Heart attack related symptoms; Severe chest pain; Numbness and tingling in the left arm, face, and legs; Numbness and tingling in the left arm, face, and legs; Very elevated heart rate and blood pressure; Very elevated heart rate and blood pressure; This is a spontaneous report from a Pfizer sponsored program.. A contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 02May2021, as second dose, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the vaccine on 02May2021. The patient had sickness 12 hours after (May2021) with very elevated heart rate and blood pressure. 2 weeks after the vaccine (16May2021) when the patient was fully immunized, the patient began to experience severe chest pain, and numbness and tingling in the left arm, face, and legs. The patient was fearing that he/she was having heart attack related symptoms and was rushed to the emergency room (ER) for all events. The patient was wondering if he/she could speak to anyone in regard of billing for the hospitals bills from this. The outcome of the events was unknown.  Information about lot or batch number for the suspect product will be requested in follow-up attempts.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myocardial infarction, Paraesthesia
Clinical narrative: Heart attack related symptoms; Severe chest pain; Numbness and tingling in the left arm, face, and legs; Numbness and tingling in the left arm, face, and legs; Very elevated heart rate and blood pressure; Very elevated heart rate and blood pressure; This is a spontaneous report from a Pfizer sponsored program.. A contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 02May2021, as second dose, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the vaccine on 02May2021. The patient had sickness 12 hours after (May2021) with very elevated heart rate and blood pressure. 2 weeks after the vaccine (16May2021) when the patient was fully immunized, the patient began to experience severe chest pain, and numbness and tingling in the left arm, face, and legs. The patient was fearing that he/she was having heart attack related symptoms and was rushed to the emergency room (ER) for all events. The patient was wondering if he/she could speak to anyone in regard of billing for the hospitals bills from this. The outcome of the events was unknown.  Information about lot or batch number for the suspect product will be requested in follow-up attempts.