chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: My hands are both swelled up really big and I find them difficult to use; Swelled up at the joint in my shoulder; My arm swelled up at the point of injection and it is hot and sore; My arm swelled up at the point of injection and it is hot and sore; My arm swelled up at the point of injection and it is hot and sore; Joint started to hurt in my left arm where I have the injection; Pain in my left lung same side as the injection and it felt like there is a blockage in my system; Pain in my wrist and in my hand on the left hand side where I had the injection and then it began to swell up on my right hand as well and the joints and the wrist and my hand; Pain and stiffness in my neck; Pain and stiffness in my neck; I am in great pain; 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 an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Paitent swelled up at the joint in the shoulder and it woke patient up at night. The arm swelled up at the point of injection and it is hot and sore and then the joint started to hurt in the left arm where the injection then developed pain in the left lung same side as the injection and it felt like there is a blockage in the system and it lasted for about two weeks and slowly went away. Patient got incredible pain in the wrist and in the hand on the left hand side where the injection and then it began to swell up on the right hand as well and the joints and the wrist and the hand. So, the hands are both swelled up really big and find them difficult to use even to pick up a cup of coffee and this is going on continuing from the last 8 weeks and then, developed pain and stiffness in the neck and also the feet is swelled up and its pretty swollen up.The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pulmonary pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: My hands are both swelled up really big and I find them difficult to use; Swelled up at the joint in my shoulder; My arm swelled up at the point of injection and it is hot and sore; My arm swelled up at the point of injection and it is hot and sore; My arm swelled up at the point of injection and it is hot and sore; Joint started to hurt in my left arm where I have the injection; Pain in my left lung same side as the injection and it felt like there is a blockage in my system; Pain in my wrist and in my hand on the left hand side where I had the injection and then it began to swell up on my right hand as well and the joints and the wrist and my hand; Pain and stiffness in my neck; Pain and stiffness in my neck; I am in great pain; 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 an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Paitent swelled up at the joint in the shoulder and it woke patient up at night. The arm swelled up at the point of injection and it is hot and sore and then the joint started to hurt in the left arm where the injection then developed pain in the left lung same side as the injection and it felt like there is a blockage in the system and it lasted for about two weeks and slowly went away. Patient got incredible pain in the wrist and in the hand on the left hand side where the injection and then it began to swell up on the right hand as well and the joints and the wrist and the hand. So, the hands are both swelled up really big and find them difficult to use even to pick up a cup of coffee and this is going on continuing from the last 8 weeks and then, developed pain and stiffness in the neck and also the feet is swelled up and its pretty swollen up.The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: My hands are both swelled up really big and I find them difficult to use; Swelled up at the joint in my shoulder; My arm swelled up at the point of injection and it is hot and sore; My arm swelled up at the point of injection and it is hot and sore; My arm swelled up at the point of injection and it is hot and sore; Joint started to hurt in my left arm where I have the injection; Pain in my left lung same side as the injection and it felt like there is a blockage in my system; Pain in my wrist and in my hand on the left hand side where I had the injection and then it began to swell up on my right hand as well and the joints and the wrist and my hand; Pain and stiffness in my neck; Pain and stiffness in my neck; I am in great pain; 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 an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Paitent swelled up at the joint in the shoulder and it woke patient up at night. The arm swelled up at the point of injection and it is hot and sore and then the joint started to hurt in the left arm where the injection then developed pain in the left lung same side as the injection and it felt like there is a blockage in the system and it lasted for about two weeks and slowly went away. Patient got incredible pain in the wrist and in the hand on the left hand side where the injection and then it began to swell up on the right hand as well and the joints and the wrist and the hand. So, the hands are both swelled up really big and find them difficult to use even to pick up a cup of coffee and this is going on continuing from the last 8 weeks and then, developed pain and stiffness in the neck and also the feet is swelled up and its pretty swollen up.The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Electrocardiogram, Feeling abnormal, Muscle strain
Clinical narrative: heart palpitations; fainted while using the restroom and woke on the bathroom floor; more like a sore or a strain; more like a sore or a strain; felt more strange; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11May2021 at 11:00 (Lot Number: EW0176, expiration date: Aug2021, at the age of 26-year-old) as 0.3 ml, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Apr2021 about 5:00pm (lot number: ER8731, expiration date: Jul2021, at the age of 26-year-old) as single dose for covid-19 immunisation. When he got the first one, he was fine. The day after he received the second shot, he fainted while using the restroom and woke on the bathroom floor on 12May2021 at 07:30, he was on the floor for a few minutes, 2 to 3 minutes. After that there was no other fainting. Patient had been having heart palpitations since the second dose on 13May2021. Did not particularly remember the time, just that it was in the middle of the day. The palpitations were going away and were less prevalent. He went to the Emergency room (ER) this past Sunday night because it was really working up and he couldn't wait to go to the doctor. Physician office was no. Electrocardiogram (EKG) and blood work were done in the emergency room on unspecified date in May2021 and came back normal. He was supposed to meet with a cardiologist next week. On unspecified date in May2021, he still felt kind of like he senses his heart beating but he didn't usually think about. It felt more strange, than soreness. This was all just so new. Thought it was a sign that he was going to recover and it was going to go away. The palpitations were coming on less and less. Was not so much of an irregular heart beat than last week. On unspecified date in May2021, felt like his heart was getting strong. Felt like his heart was making it's way back and was more like a sore or a strain. It had been going down and he was not feeling his heart in his chest. Treatment was no, not this far. There was not prior vaccinations within 4 weeks. The outcome of the event "fainted while using the restroom and woke on the bathroom floor" was unknown, for other events was recovering.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Syncope
Clinical narrative: heart palpitations; fainted while using the restroom and woke on the bathroom floor; more like a sore or a strain; more like a sore or a strain; felt more strange; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11May2021 at 11:00 (Lot Number: EW0176, expiration date: Aug2021, at the age of 26-year-old) as 0.3 ml, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Apr2021 about 5:00pm (lot number: ER8731, expiration date: Jul2021, at the age of 26-year-old) as single dose for covid-19 immunisation. When he got the first one, he was fine. The day after he received the second shot, he fainted while using the restroom and woke on the bathroom floor on 12May2021 at 07:30, he was on the floor for a few minutes, 2 to 3 minutes. After that there was no other fainting. Patient had been having heart palpitations since the second dose on 13May2021. Did not particularly remember the time, just that it was in the middle of the day. The palpitations were going away and were less prevalent. He went to the Emergency room (ER) this past Sunday night because it was really working up and he couldn't wait to go to the doctor. Physician office was no. Electrocardiogram (EKG) and blood work were done in the emergency room on unspecified date in May2021 and came back normal. He was supposed to meet with a cardiologist next week. On unspecified date in May2021, he still felt kind of like he senses his heart beating but he didn't usually think about. It felt more strange, than soreness. This was all just so new. Thought it was a sign that he was going to recover and it was going to go away. The palpitations were coming on less and less. Was not so much of an irregular heart beat than last week. On unspecified date in May2021, felt like his heart was getting strong. Felt like his heart was making it's way back and was more like a sore or a strain. It had been going down and he was not feeling his heart in his chest. Treatment was no, not this far. There was not prior vaccinations within 4 weeks. The outcome of the event "fainted while using the restroom and woke on the bathroom floor" was unknown, for other events was recovering.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood test, Cellulitis, Muscle spasms, Oropharyngeal pain
Clinical narrative: Sore throat; Numbing pain in the left leg; Little pain in his lower back on the left side; Muscle cramps; Cellulitis; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration in right arm, on 02May2021 at 02:00 PM (14:00) (at the age of 68 years), as first dose, single dose, for COVID-19 immunization. The patient's medical history included glaucoma from 2010. The patient's concomitant medications included dorzolamide, brimonidine, and travoprost (TRAVATAN); all for glaucoma. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient and his wife got the vaccine on 02May2021 and just wanted to report possible side effects. The patient did go online and reported this just in case he couldn't get through to the company. On 03May2021 at 08:00, the patient experienced sore throat after vaccination. About a week after that (May2021), the sore throat cleared up. Then after that (May2021), the patient started feeling some pain in his left leg, it's like a numbing pain in the left leg. The pain was still there, it's maybe about 4 on the scale of 1 to 10 (May2021), but it's kind of a numbing pain. The patient got a little pain in his lower back on the left side also in May2021; patient didn't know if it's muscle cramps over working. The patient just needed to report this. The patient and his wife are due to take another shot tomorrow (23May2021), so he didn't want things to be complicated before he reported this. Currently, for the pain in the left leg and the back, the patient talked to his nurse yesterday (21May2021) and the nurse said he might have cellulitis (May2021). It sounded like symptoms of cellulitis. And so, the nurse suggested antibiotics and the patient was thinking that he didn't know if he wanted to risk trying to get an antibiotic before he gets his next COVID-19 shot, things might get out of way and complicated. They didn't give the patient a name for antibiotics; they suggested the patient to go somewhere because he was thinking of postponing that after the next dose of the vaccine. Currently, treatment was not given for the events. The patient underwent laboratory tests and procedures on an unspecified date including blood test and physical check-up. Since the vaccination, the patient has not been tested for COVID-19. The patient considered the events as non-serious. The patient recovered from "Sore throat" in May2021. The patient had not recovered from "Numbing pain in the left leg". The outcome of the other events was unknown.  Information about lot or batch number for the suspect product will be requested in follow-up attempts.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain assessment, Pain in extremity, Physical examination
Clinical narrative: Sore throat; Numbing pain in the left leg; Little pain in his lower back on the left side; Muscle cramps; Cellulitis; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration in right arm, on 02May2021 at 02:00 PM (14:00) (at the age of 68 years), as first dose, single dose, for COVID-19 immunization. The patient's medical history included glaucoma from 2010. The patient's concomitant medications included dorzolamide, brimonidine, and travoprost (TRAVATAN); all for glaucoma. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient and his wife got the vaccine on 02May2021 and just wanted to report possible side effects. The patient did go online and reported this just in case he couldn't get through to the company. On 03May2021 at 08:00, the patient experienced sore throat after vaccination. About a week after that (May2021), the sore throat cleared up. Then after that (May2021), the patient started feeling some pain in his left leg, it's like a numbing pain in the left leg. The pain was still there, it's maybe about 4 on the scale of 1 to 10 (May2021), but it's kind of a numbing pain. The patient got a little pain in his lower back on the left side also in May2021; patient didn't know if it's muscle cramps over working. The patient just needed to report this. The patient and his wife are due to take another shot tomorrow (23May2021), so he didn't want things to be complicated before he reported this. Currently, for the pain in the left leg and the back, the patient talked to his nurse yesterday (21May2021) and the nurse said he might have cellulitis (May2021). It sounded like symptoms of cellulitis. And so, the nurse suggested antibiotics and the patient was thinking that he didn't know if he wanted to risk trying to get an antibiotic before he gets his next COVID-19 shot, things might get out of way and complicated. They didn't give the patient a name for antibiotics; they suggested the patient to go somewhere because he was thinking of postponing that after the next dose of the vaccine. Currently, treatment was not given for the events. The patient underwent laboratory tests and procedures on an unspecified date including blood test and physical check-up. Since the vaccination, the patient has not been tested for COVID-19. The patient considered the events as non-serious. The patient recovered from "Sore throat" in May2021. The patient had not recovered from "Numbing pain in the left leg". The outcome of the other events was unknown.  Information about lot or batch number for the suspect product will be requested in follow-up attempts.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Hypersensitivity, Pain, Pyrexia, Respiration abnormal
Clinical narrative: This is a spontaneous report from a non-contactable consumer.   A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Left Arm on 17Apr2021 09:15 (Batch/Lot Number: EW0169) as 1ST DOSE, SINGLE (at the age of 29 years) for covid-19 immunisation.  Medical history included gastritis from an unknown date and unknown if ongoing and covid-19 from an unknown date and unknown if ongoing.     The patient's concomitant medications were not reported.  The patient experienced hemorrhages for more than 1 month on 19Apr2021 with outcome of not recovered, allergies throughout the whole body on 19Apr2021 with outcome of not recovered, body pain on 19Apr2021 with outcome of not recovered, bad breathing on 19Apr2021 with outcome of not recovered and fever at night on 19Apr2021 with outcome of not recovered.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID 19 since the vaccination.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Her niece who received a dose and is pregnant; This is a spontaneous report from a contactable consumer or other non hcp.  This consumer or other non hcp reported information for both mother and fetus/baby. A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as an unknown dose, single for covid-19 immunization. The patient medical history and concomitant was not reported. On an unspecified date, it was reported that, Caller states she was scared for her niece who received a dose and is pregnant.  The reporter stated that she has heard about babies being stillborn and a breastfeeding mother whose child died one day after. She stated that she spoke to someone at a medical team. infection better have immunity than vaccination.  People who have had a previous infection do not need to be vaccinated. Not susceptible to malaria.  She knows genetically speaking some people are susceptible.  The spike protein could prevent women from developing a placenta. She was scared to death to get this thing and develop a blood clot. If there is anything Pfizer can say one hundred percent safe. Feel the more honest. People are going to become more violent. When daughter diagnosed with cancer stage 4 tumor in her stomach. The outcome of the event was unknown.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I have already had virus; I have already had virus; This is a spontaneous report received from a contactable consumer reporting for herself via medical information team. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for OVID-19 immunization. Medical history and concomitant medications were not reported. The patient stated "I have already had virus." The outcome of the event was unknown. Information on the lot/batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Cholecystitis
Clinical narrative: cholecystitis, a strange feeling in the abdomen which progressed to acute pain; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , first dose intramuscularly in Apr2021 (Batch/Lot number was not reported) (Age at Vaccination was reported as 41-year-old) as single dose for covid-19 immunisation. Medical history included covid-19 (diagnosed with COVID-19 prior to vaccination).  The patient's concomitant medications were not reported.  About two hours after vaccine administration, patient experienced a strange feeling in the abdomen which progressed to acute pain.  Patient was not sure how long this lasted.  The pain eventually resolved, but this was followed by two more attacks in the following week. The patient went to his doctor, and tests were run, which ultimately resulted in a diagnosis of cholecystitis. A fourth attack later occurred as of the time of this reporting. Since the vaccination, the patient hadn't been tested for COVID-19. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included. Patient had changed diet to avoid fatty foods, which had helped. The case reported as non-serious. The outcome of the event was recovered with sequel in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache, Musculoskeletal stiffness, Spinal cord disorder
Clinical narrative: really bad back pain down his spinal cord; really bad back pain down his spinal cord; headache; stiff neck; This is a spontaneous report from a contactable consumer (patient).  A 55-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16May2021 (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  Following receiving the vaccine, the patient experienced headache, really bad back pain down his spinal cord and stiff neck in May2021. He wanted to know if these were reported side effect of the vaccine and if he was having allergic reaction and if this was a medical emergency. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Disease recurrence, Pain, SARS-CoV-2 test, Seizure
Clinical narrative: 3 Violent seizures; 3 Violent seizures; body aches; chills; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 15:00 at the age of 57-years-old (Batch/Lot Number: EW0161) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included chronic kidney disease, atrial septal defect, essential tremors in both hands, seizures, currently taking blood thinners, known allergies: Ampicillin, Penicillin, grapes, raisins. The patient previously took ampicillin and experienced allergy. 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. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications within 2 weeks of vaccination. The patient experienced 3 violent seizures, body aches and chills on 30Apr2021 21:00. For 3 weeks non stop, she went to emergency room twice and was tested for COVID in one of those times at the ER, tested negative. Records of ER (Hospital name withheld) 03May2021 and 21May2021. There was no treatment received. The patient underwent lab tests and procedures which included Nasal Swab: negative on 21May2021. The outcome of the events was recovered with sequelae.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac disorder, Chest pain, Chills, Computerised tomogram
Clinical narrative: 3 Violent seizures; 3 Violent seizures; body aches; chills; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 15:00 at the age of 57-years-old (Batch/Lot Number: EW0161) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included chronic kidney disease, atrial septal defect, essential tremors in both hands, seizures, currently taking blood thinners, known allergies: Ampicillin, Penicillin, grapes, raisins. The patient previously took ampicillin and experienced allergy. 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. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications within 2 weeks of vaccination. The patient experienced 3 violent seizures, body aches and chills on 30Apr2021 21:00. For 3 weeks non stop, she went to emergency room twice and was tested for COVID in one of those times at the ER, tested negative. Records of ER (Hospital name withheld) 03May2021 and 21May2021. There was no treatment received. The patient underwent lab tests and procedures which included Nasal Swab: negative on 21May2021. The outcome of the events was recovered with sequelae.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Disability, Dyspnoea, Injected limb mobility decreased, Loss of personal independence in daily activities
Clinical narrative: 3 Violent seizures; 3 Violent seizures; body aches; chills; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 15:00 at the age of 57-years-old (Batch/Lot Number: EW0161) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included chronic kidney disease, atrial septal defect, essential tremors in both hands, seizures, currently taking blood thinners, known allergies: Ampicillin, Penicillin, grapes, raisins. The patient previously took ampicillin and experienced allergy. 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. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications within 2 weeks of vaccination. The patient experienced 3 violent seizures, body aches and chills on 30Apr2021 21:00. For 3 weeks non stop, she went to emergency room twice and was tested for COVID in one of those times at the ER, tested negative. Records of ER (Hospital name withheld) 03May2021 and 21May2021. There was no treatment received. The patient underwent lab tests and procedures which included Nasal Swab: negative on 21May2021. The outcome of the events was recovered with sequelae.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial strain, Pain, Pain in extremity, Pain in jaw, SARS-CoV-2 test
Clinical narrative: 3 Violent seizures; 3 Violent seizures; body aches; chills; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 15:00 at the age of 57-years-old (Batch/Lot Number: EW0161) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included chronic kidney disease, atrial septal defect, essential tremors in both hands, seizures, currently taking blood thinners, known allergies: Ampicillin, Penicillin, grapes, raisins. The patient previously took ampicillin and experienced allergy. 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. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications within 2 weeks of vaccination. The patient experienced 3 violent seizures, body aches and chills on 30Apr2021 21:00. For 3 weeks non stop, she went to emergency room twice and was tested for COVID in one of those times at the ER, tested negative. Records of ER (Hospital name withheld) 03May2021 and 21May2021. There was no treatment received. The patient underwent lab tests and procedures which included Nasal Swab: negative on 21May2021. The outcome of the events was recovered with sequelae.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast, Seizure, X-ray
Clinical narrative: 3 Violent seizures; 3 Violent seizures; body aches; chills; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 15:00 at the age of 57-years-old (Batch/Lot Number: EW0161) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included chronic kidney disease, atrial septal defect, essential tremors in both hands, seizures, currently taking blood thinners, known allergies: Ampicillin, Penicillin, grapes, raisins. The patient previously took ampicillin and experienced allergy. 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. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications within 2 weeks of vaccination. The patient experienced 3 violent seizures, body aches and chills on 30Apr2021 21:00. For 3 weeks non stop, she went to emergency room twice and was tested for COVID in one of those times at the ER, tested negative. Records of ER (Hospital name withheld) 03May2021 and 21May2021. There was no treatment received. The patient underwent lab tests and procedures which included Nasal Swab: negative on 21May2021. The outcome of the events was recovered with sequelae.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Palpitations, Thrombosis, Vaccination site discomfort
Clinical narrative: feel a constant and migrating thrombosis/palpitations on the right side of my head; palpations; mildly painful -not quite a headache; painful sensations in the lower left leg; a slight discomfort of the arm where the shot was administered; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right arm on 11May2021 10:30 (at the age of 56 years old) (Lot Number: EW0182) as 1st dose, single for COVID-19 immunization. Medical history included high blood pressure, allergies: contrast dye. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient reported that there was a slight discomfort of the arm where the shot was administered (11May2021) - not enough to worry about & expected.  The next morning (12May2021) he felt painful sensations in the lower left leg - sensations similar to stress fractures and palpations. It subsided and has not returned. About three/four days later (reported as 14May2021 18:00) continuing two weeks leading to the second dose - he felt a constant and migrating thrombosis/palpitations on the right side of his head. It was mildly painful - not quite a headache yet persistent and localized to the RT temporal lobe above the temple & slightly above that region. It became exacerbated by critical thinking when it occurred & persisted for long periods of time. The cognitive effect has become slightly debilitating & stressful. No treatment received. The outcome of the event 'a slight discomfort of the arm where the shot was administered' was unknown, of the event 'painful sensations in the lower left leg' was recovered, of the other events was not recovered.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: Myocarditis/pericarditis; Myocarditis/pericarditis; This is a spontaneous report from a contactable physician. A 18-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 18May2021 (at the age of 18-year-old) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in Arm Left on an unspecified date for COVID-19 Immunization. The patient experienced myocarditis/pericarditis on 21May2021 17:30. The adverse event result in emergency room/department or urgent care. The patient received treatment for the adverse event included anti-inflammatory medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  No follow up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of myocarditis/pericarditis due to temporal relationship.  Case will be re-assessed upon the additional information provided. 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Amyotrophic lateral sclerosis, Arthralgia, Asthenia, Dysstasia, Fatigue
Clinical narrative: ALS; Profound fatigue; weakness; joint pain; Difficulty getting up from a crouch position; This is a spontaneous report from a contactable nurse reported for herself.  A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 11:15 AM(Batch/Lot Number: EP7533) as 1ST DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 61 years old.  Medical history included  Damage from spinal cord tumor at C2, s/p resection, s/p ablations for cardiac arrhythmia, amyotrophic lateral sclerosis, Allergies. The patient's concomitant medications were not reported.  The patient experienced ALS, profound fatigue, weakness, joint pain and difficulty getting up from a crouch position, all on 03Apr2021 with outcome of recovering.  Reported Event: Profound fatigue, weakness and joint pain.  Difficulty getting up from a crouch position to the point that she googled 'how to get up off the floor'. She was worried she had Amyotrophic lateral sclerosis (ALS.)  This progressed to having difficulty getting both up and down, even from a chair. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The event ALS was serious as medically significant. No treatment received for events.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information, the Company considers the reported event ALS is unrelated to bnt162b2 vaccination, but more likely due to underlying or inter-current medical conditions. The patient has medical history of amyotrophic lateral sclerosis. 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: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Inappropriate schedule of product administration
Clinical narrative: arrhythmia; 1st and 2nd dose of BNT162B2 given on 17Mar2021; This is a spontaneous report from a contactable consumer or other non hcp.   A 35-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration, administered in the left arm on 17Mar2021 at 11:30 AM (pending clarification) as a single dose, and received the second dose (Lot Number: EP7534) via an unspecified route of administration, in the left arm on 17Mar2021 (pending clarification) as single dose for COVID-19 immunisation.  Medical history included long QT syndrome from an unknown date and unknown if ongoing. Relevant concomitant medications included diltiazem.  The patient previously took vancomycin. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced arrhythmia on 18Mar2021 at 16:30. The patient reported, Two days after first dose, I had multiple arrhythmias that were recorded via cardiac defibrillator. The readings were recorded and were printed.  The outcome of the events was unknown.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: fainted; This is a spontaneous report received from a contactable consumer. A 12 years old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 19May2021 (at age of 12 years old, Lot Number: EW0172) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient vaccinated after 4 minutes experienced fainted on 19May2021. The reporter asked if he qualifies for second dose or not recommended. The outcome of the event was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza, Lymph node pain, Syncope
Clinical narrative: This is a spontaneous report from a contactable consumer.   A 64-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 17May2021 at11:00 (at the age of 64 years-old), (Batch/Lot Number: ER8734) as a single dose, for covid-19 immunisation. Medical history included Hashimoto and total thyroidectomy on unspecified dates. Concomitant medications included levothyroxine sodium (SYNTHROID) and bupropion (BUPROPION) and unspecified HRT (hormone therapy).  The patient reported that on 18May2021 at 0100: "First 2 days just typical flu symptoms with bad headache. Then on 4th day fainting episode, 5th day pain in lymph node left side of neck. Hurts to turn my head." There was no treatment reported for the events. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Had covid; Covid and pneumonia; This is a spontaneous report received from Pfizer sponsored program via a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on 18Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient diagnosed with covid-19 on 31Mar2021. Patient was feeling so bad she had to go to the hospital. Patient had Covid and pneumonia, but they did not have to put her on a ventilator. Patient was weak and everything, but she came through it. The reporter states she is not sure which Covid vaccine patient got, but she got it at pharmacy and she thinks it was Moderna, she may have received both doses, she is not sure. She knows she had one dose. Reporter seriousness for Had covid was Hospitalization.  Information about lot/batch number has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, SARS-CoV-2 test, Vomiting
Clinical narrative: vomiting; dehydration; This is a spontaneous report from a contactable consumer (patient). A 21-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 01May2021 at 14:30 (Batch/Lot number was not reported) as a single dose for Covid-19 immunisation. Medical history included congenital hydrocephalus with ventriculoperitoneal (VP) shunt. The patient has no known allergies.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and patient was not pregnant. Concomitant medications included sertraline hydrochloride (ZOLOFT); bupropion; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and birth control (unspecified), all taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of bnt162b2 on an unspecified date (Batch/Lot number was not reported) on the left arm for Covid-19 immunization. On 06May2021, it was reported that the patient underwent a hospitalization for 2+ weeks due to uncontrollable vomiting and severe dehydration. No clear diagnosis for what prompted vomiting. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was hospitalized for vomiting and dehydration for 15 days. The patient was given treatment of fluids, medications, and electrolytes for the events. The patient underwent lab tests which included Covid-19 virus test (nasal swab): negative, on 13May2021. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Diarrhoea, Disorientation, Guillain-Barre syndrome, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).    A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6203, expiration date not provided),  2nd dose via an unspecified route of administration, administered in Arm Left on 05Mar2021 at age of 55 years old as a single dose for COVID-19 immunisation; mepivacaine hcl (manufacture unknown), via an unspecified route, date, dose for an unspecified indication. Medical history included Shingles. Concomitant medication included enalapril maleate (VASOTEC) taken for blood pressure. The patient previously took morphine and experienced allergies, BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9265, expiration date not provided),  1st dose via an unspecified route of administration, administered in Arm Left on 11Feb2021 as a single dose for COVID-19 immunisation. The patient experienced guillane-barre syndrome, tingling and numbness in the legs, arms and lower face, severe headache, imbalance, disorientation, muscle spasms, diarrhea, all on 16May2021.  The action taken in response to the events for mepivacaine hcl was unknown. The outcome of the events was not recovered. No treatment received for the events. The patient was not pregnancy at time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   Pfizer is a marketing authorization holder of [mepivacaine hcl] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [mepivacaine hcl] has submitted the same report to the regulatory authorities.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).    A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6203, expiration date not provided),  2nd dose via an unspecified route of administration, administered in Arm Left on 05Mar2021 at age of 55 years old as a single dose for COVID-19 immunisation; mepivacaine hcl (manufacture unknown), via an unspecified route, date, dose for an unspecified indication. Medical history included Shingles. Concomitant medication included enalapril maleate (VASOTEC) taken for blood pressure. The patient previously took morphine and experienced allergies, BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9265, expiration date not provided),  1st dose via an unspecified route of administration, administered in Arm Left on 11Feb2021 as a single dose for COVID-19 immunisation. The patient experienced guillane-barre syndrome, tingling and numbness in the legs, arms and lower face, severe headache, imbalance, disorientation, muscle spasms, diarrhea, all on 16May2021.  The action taken in response to the events for mepivacaine hcl was unknown. The outcome of the events was not recovered. No treatment received for the events. The patient was not pregnancy at time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   Pfizer is a marketing authorization holder of [mepivacaine hcl] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [mepivacaine hcl] has submitted the same report to the regulatory authorities.