chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Nephrotic syndrome, Peripheral swelling, Thrombosis, Urinary retention
Clinical narrative: A doctors office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; A doctors office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; A doctor's office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; no facilitated urination; Severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose; Severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose; This is a spontaneous report form a contactable consumer (patient) reported for herself. A 18-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection Batch/Lot Number: EW0158) via an unspecified route of administration in arm right on 18Apr2021 as dose 2, single for covid-19 immunisation. Medical history included none history. Concomitant medications include levocetirizine (LEVOCETIRIZINE Batch/Lot number was not reported) via an unspecified route of administration from an unspecified date, at 5 mg for an unspecified indication. Historical vaccine includes bnt162b2 (Dose 1 lot number=EP7534 vaccine location=Right arm) on 26Mar2021 for COVID-19 immunization. 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. Since the vaccination, the patient has not been tested for COVID-19. On 23Apr2021, the patient experienced a doctors office visit on 28Apr. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots). Started to take 20mg furosemide for 7 days from 28Apr and 20mg prednisone for 10 days and 20mg furosemide on 04May. Even after finishing medication, there were no changes in symptoms. Continued leg swelling and no facilitated urination. There was severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose. After finishing both, the swelling in legs subsided and weight returned to normal. About 10 days later, moderate swelling in legs returned and body weight increased by about 5 lbs. The patient visited nephrologist visit on 02Jun and was prescribed 20mg prednisone, 3 tablets every other am for 20 days. Currently, patient have been taking the medicine since 03Jun. As of now 12Jun2021, the leg swelling partially decreased and the body weight decreased by 1-1.5 lbs. The clinical outcome of all the events was not resolved.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: A doctors office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; A doctors office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; A doctor's office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; no facilitated urination; Severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose; Severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose; This is a spontaneous report form a contactable consumer (patient) reported for herself. A 18-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection Batch/Lot Number: EW0158) via an unspecified route of administration in arm right on 18Apr2021 as dose 2, single for covid-19 immunisation. Medical history included none history. Concomitant medications include levocetirizine (LEVOCETIRIZINE Batch/Lot number was not reported) via an unspecified route of administration from an unspecified date, at 5 mg for an unspecified indication. Historical vaccine includes bnt162b2 (Dose 1 lot number=EP7534 vaccine location=Right arm) on 26Mar2021 for COVID-19 immunization. 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. Since the vaccination, the patient has not been tested for COVID-19. On 23Apr2021, the patient experienced a doctors office visit on 28Apr. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots). Started to take 20mg furosemide for 7 days from 28Apr and 20mg prednisone for 10 days and 20mg furosemide on 04May. Even after finishing medication, there were no changes in symptoms. Continued leg swelling and no facilitated urination. There was severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose. After finishing both, the swelling in legs subsided and weight returned to normal. About 10 days later, moderate swelling in legs returned and body weight increased by about 5 lbs. The patient visited nephrologist visit on 02Jun and was prescribed 20mg prednisone, 3 tablets every other am for 20 days. Currently, patient have been taking the medicine since 03Jun. As of now 12Jun2021, the leg swelling partially decreased and the body weight decreased by 1-1.5 lbs. The clinical outcome of all the events was not resolved.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder; Constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder; Constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder; pain with any and all movement of left arm, pain at rest; This is a spontaneous report from a contactable physician (patient). A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: EL926L, Pfizer NTEC), via intramuscular route of administration in left arm on 01Feb2021 at 10:30 (at the age of 61-years-old) as 2nd dose, single for covid-19 immunization. The most recent COVID-19 vaccine was administered in the public health clinic/veteran's administration facility. The patient medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took naproxen for hypersensitivity and experienced periorbital oedema. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: EL2183, Pfizer NTEC), via intramuscular route of administration in left arm on 11Jan2021 at 14:00 as 1st dose, single for covid-19 immunization. On 02Feb2021 patient experienced constant left deltoid pain and stiffness that moderately limits range of motion of left shoulder, i.e., 40% reduction in range of motion, positive tenderness to palpation, pain with any and all movement of left arm, pain at rest, but no redness or swelling or bruising. Events resulted in disability or permanent damage. Treatment received for the events included NSAID and physical therapy. The clinical outcome for the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded   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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood test, Pain
Clinical narrative: They couldn't control my blood pressure; Pain; This is a spontaneous report from a contactable consumer. This 37-year-old female consumer (patient) reported for herself.   A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported; Expiration Date: 10Jun2021), intramuscular route of administration, administered in arm left on 28May2021 16:30 (age at the time of vaccination was 37-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included GERD (gastro oesophageal reflux disease). The patient previously took Atenolol 100 mg/daily for blood pressure. Concomitant medications included omeprazole (OMEPRAZOLE) taken at a dose of 20mg for gastro oesophageal reflux disease. On an unspecified date, the patient stated that she wanted to report that she had a reaction to the vaccine, and she do not know how to report it. I had to go to the emergency room, and I ended up with porosity (Not clarified) and then they could not control my blood pressure and then I had a reaction to the medication (Un-specified medication) that they gave me to control either my blood pressure or the porosity (Not clarified). The patient also experienced pain from an unspecified date. Treatment medication included Benadryl and some steroid for the event blood pressure and pain pills for the event pain. The patient underwent lab tests and procedures on an unspecified date which included blood test reported as normal. The patient further stated that she does not know they were checking for everything. They were checking for blood clot, they were checking for heart enzyme, they were checking for heart attack, they were checking for just to make sure that I was ok, and I did not have anything going out with my heart. The patient also stated, "it's gone better, they gave me some steroid medication. I had to take Benadryl, I had to take some steroid and I had to take they gave me like a pain pill and as long as I can control the pain, I don't have to take anymore steroids." The patient was recovering from the events.   Information on Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021696974 Pfizer
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Contracted COVID in April before they could receive the 2nd dose and were hospitalized for 2 weeks; Contracted COVID in April before they could receive the 2nd dose and were hospitalized for 2 weeks; Husband passed away; This is a spontaneous report from a contactable pharmacist. This pharmacist (Patient's wife) reported for a male patient (Reporter's husband).  A 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot number: unknown), dose 1 via an unspecified route of administration on 26Mar2021 as dose 1, single for COVID-19 immunization. No medical and concomitant medication history were reported. She and her husband (who also received the vaccine) contracted COVID in April 2021 before they could receive the second dose and were hospitalized for 2 weeks. The husband passed away on an unspecified date, while the patient recovered from a severe (not mild) COVID infection. She was asking if she can get the second dose and when should she receive the second dose.The patient underwent lab tests and procedures which included SARS-CoV-2 test contracted COVID-19 in Apr2021.It was not reported if an autopsy was performed. The outcome of the event death was fatal and rest on events was unknown.   information about lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.; Reported Cause(s) of Death: husband passed away
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Brain oedema, Dyspnoea
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 44-year-old non-pregnant female patient received her first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Batch/Lot number: EW0173), via an unspecified route of administration, administered into the left arm on May 26, 2021 12:00 pm (at the age of 44-year-old) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since vaccination the patient has not been tested for COVID-19. No relevant past drug history reported. Concomitant medication included paracetamol (Tylenol) the day after the shot. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. On May 27, 2021, at around 12:00, the patient experienced, (it felt like) the base of her brain swelled. She woke up breathing heavy and also started losing a lot of hair. She was still losing globs of hair. The patient did not receive any treatment for the events and there was no prolonged hospitalization. The outcome of the events was reported as not resolved. Information on Lot/Batch number was available. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Feeling abnormal, Gait disturbance, Muscle spasms
Clinical narrative: I think its like a cramp like a shock and pain and like it go through my knee; I think its like a cramp like a shock and pain and like it go through my knee; A cramp like a pain; There is anything is go out of here in my leg and pain in like in my thigh area,; Both my knees thats what I felt, each day it got worse/I notice the next day is like kind of pain going to my knee.; It stop me for walking its not good; Both my knees thats what I felt, each day it got worse/but its what I see every day its being worse; It is looking abnormal for me; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0217), via an unspecified route of administration on 07Jun2021 as dose number unknown, single for covid-19 immunization (at the age of 58-year-old). Medical history included blood pressure measurement -Verbatim: Blood pressure. Concomitant medication(s) included lisinopril (LISINOPRIL); atorvastatin (ATORVASTATIN); amlodipine (AMLODIPINE); pravastatin (PRAVASTATIN). On 08Jun2021, the patient experienced that she think its like a cramp like a shock and pain and like it go through her knee, a cramp like a pain, there is anything go out of here in her leg and pain in like in her thigh area, both her knees thats what she felt, each day it got worse/She notice the next day is like kind of pain going to her knee, it stop her for walking its not good but its what she see every day its being worse. It is looking abnormal for her. She had never feel anything like this. Treatment: Consumer stated, the day she went, she did not receive any treatment for this probably, going to use this, can noticeable today at work. The outcome of all events were not resolved.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Shock
Clinical narrative: I think its like a cramp like a shock and pain and like it go through my knee; I think its like a cramp like a shock and pain and like it go through my knee; A cramp like a pain; There is anything is go out of here in my leg and pain in like in my thigh area,; Both my knees thats what I felt, each day it got worse/I notice the next day is like kind of pain going to my knee.; It stop me for walking its not good; Both my knees thats what I felt, each day it got worse/but its what I see every day its being worse; It is looking abnormal for me; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0217), via an unspecified route of administration on 07Jun2021 as dose number unknown, single for covid-19 immunization (at the age of 58-year-old). Medical history included blood pressure measurement -Verbatim: Blood pressure. Concomitant medication(s) included lisinopril (LISINOPRIL); atorvastatin (ATORVASTATIN); amlodipine (AMLODIPINE); pravastatin (PRAVASTATIN). On 08Jun2021, the patient experienced that she think its like a cramp like a shock and pain and like it go through her knee, a cramp like a pain, there is anything go out of here in her leg and pain in like in her thigh area, both her knees thats what she felt, each day it got worse/She notice the next day is like kind of pain going to her knee, it stop her for walking its not good but its what she see every day its being worse. It is looking abnormal for her. She had never feel anything like this. Treatment: Consumer stated, the day she went, she did not receive any treatment for this probably, going to use this, can noticeable today at work. The outcome of all events were not resolved.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer. A 19-years-old female patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, Batch/Lot Number: EW0173, expiration date was not reported) via an unspecified route of administration, administered in arm right on Jun 11, 2021 16:00 (at the age of 19 years) as dose 2, single for COVID-19 immunization (reason: just to get it, everyone in my household got it, just to feel safe) at a medical facility. Medical history included depression (ongoing maybe 6 years ago), anxiety (ongoing maybe 6 years ago). The patient concomitant medications were not reported. No other products. No additional vaccines administered on same date of the Pfizer suspect. Family medical history relevant to adverse event was none. Patient previously received first dose of Pfizer-BioNTech COVID-19 vaccine (Batch/Lot Number: EW0179, expiration date: not reported) via an unspecified route of administration, administered in arm right on May 21, 2021 as dose 1, single for COVID-19 immunization. On Jun 11, 2021 16:00, the patient felt very dizzy and almost feels faint. On Jun 11, 2021 16:30 the patient got very nauseous. No emergency room and physician office visit. Relevant tests were none. The outcome for both events was not recovered. Clinical course was as follow: The patient just got the COVID-19 vaccine exactly 55 minutes before time of call and reported that she was not sure if it was a severe reaction, but she felt very dizzy and almost felt faint. The patient she was in her car and had to pull over. The patient reported that as soon as she got in the car, she felt very nauseous and started to feel dizzy. The patient she waited for 30 minutes after she got the COVID-19 vaccine. The patient began feeling dizzy when she stood up after receiving the COVID-19 vaccine and she had to sit right back down. The patient got some water and when she got the water she felt not as dizzy. The patient walked to her car after and sat there for a little. The patient was still feeling a little nauseous but wanted to get home to get settled. The patient was driving home, she felt herself drifting off, so she had to pull over. She was still feeling dizzy, and she was going to call her friend to pick her up. The patient was not sure what to do and inquired for any advice.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID after receiving the Pfizer Vaccine; Tested positive for COVID after receiving the Pfizer Vaccine; This is a spontaneous report received from a contactable consumer or other non HCP (patient, self-reporting). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on 12Apr2021 as dose 2, single for COVID-19 immunisation. Medical history included controlled hypertension. The concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation. On 11 Jun2021 the patient experienced tested positive for COVID after receiving the pfizer vaccine and tested positive for COVID after receiving the pfizer vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Jun2021. The outcome of both the events was unknown.   Information about batch/lot number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Headache, Muscle twitching, Uterine contractions abnormal
Clinical narrative: Experiencing contractions hours after vaccine administration, at regular intervals; Experiencing contractions hours after vaccine administration, at regular intervals; Arm twitching; Headache; This is a spontaneous report from a contactable consumer or other non HCP (patient herself).  A 35-years-old pregnant female patient (pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 11Jun2021 11:30 (at the age of 35-years-old) as 1st dose, single for covid-19 immunisation. The patient's medical history included COVID-19 prior to vaccination. The patient had no known allergies. The patient had no other medical history. The patient's concomitant medication received within 2 weeks of vaccination included ascorbic acid, biotin, folic acid, iodine, nicotinic acid, omega-3 fatty acids, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine, vitamin b12 nos, vitamin e nos (PRENATAL + DHA) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Jun2021 at 11:30 the 30 weeks pregnant (as reported) patient received vaccine and at 16:30, the patient started experiencing contractions hours after vaccine administration, at regular intervals. Arm twitching also noted, headache but not bothersome as much as the contractions. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient's last menstrual period date was 06Nov2020 and the due date is 15Aug2021. Since the vaccination, the patient has not been tested for COVID-19. The patient received treatment for events. The outcome of the event vaccine exposure during pregnancy was unknown and the other events were resolving.  No follow up attempts are possible. No further information expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Myocarditis, Pericarditis
Clinical narrative: After seeing reports of pericarditis/myocarditis, we contacted pediatrician and were advised that it sounded like a textbook reaction; After seeing reports of pericarditis/myocarditis, we contacted pediatrician and were advised that it sounded like a textbook reaction; Patient started complaining of chest pain on 4th day following 2nd vaccination. Pain made worse by certain movements.  (like leaning forward to pick something up.) It didn't bother him enough to seek; This is a spontaneous report from a contactable consumer (patient).   A 13-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection: Lot/Batch number: EW0178,) via an unspecified route of administration on 03Jun2021 at 03:30 pm (age at vaccination: 13 years) on the right arm as single dose for COVID-19 immunisation at Pharmacy or Drug Store. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection: Lot/Batch number: EW0185) via an unspecified route of administration on 13May2021 at 12:00 pm on the right arm as single dose for COVID-19 immunisation. On 4th day following the 2nd vaccination on 07Jun2021, the patient started complaining of chest pain. The patient stated that the Pain was made worse by certain movements (like leaning forward to pick something up). The patient stated that the chest pain didn't bother him enough to seek medical care and gradually resolved without treatment by 8th day. After seeing reports of pericarditis/myocarditis, the patient contacted pediatrician and was advised that it sounded like a textbook reaction and that we should report it here. The patient stated that he will have a checkup next week. Device Date was reported as 11Jun2021. The case was considered as serious (medically significant).  The patient did not receive any treatment for the events. The outcome of the events was resolved  Follow up needed, further information has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol increased, Blood pressure measurement, Diabetes mellitus, Fatigue, Myocardial infarction
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp.     A 49-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot Number: ED6955), dose 1 via an unspecified route of administration, administered in Arm Right on 03Apr2021 15:10 as 1st dose single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.Reporter stated on 03Apr2021 her husband had his first shot and on 28Apr2021 he had the second shot, then on 07May2021 he had a massive heart attack husband was hospitalized for three days and has not recovered completely also her husband is 49 years old with no heart issues or blood pressure and he had to have emergency surgery and has two stents in heart now to open his heart and was diagnosed with high blood pressure, diabetes, and high cholesterol. Reporter stated the doctor asked for her to call to make this report due to it being possible from the vaccination. Reporter stated her husband is now in the lower range because he went from taking no medication to taking 5 pills in the morning and 3 pills at night. Reporter stated the doctors are trying to adjust his blood pressure medication as it is a little low at this time and trying to see what will happen.  Reporter stated they do not know what this was caused, had a blood test that indicated he still was a diabetic but now they want to wait 3 months again and see what the numbers are since it was so high when he had the heart attack, couple of days after the second dose of the vaccine it stopped, and her husband was getting better each day and was not taking naps as often, slight pain where the shot was given in his arm: Reporter stated this was just a couple of days after the first dose and then it happened again after the second dose on 28Apr2021 but stopped a couple days after. On 7May2021,The patient experienced massive heart attack, high blood pressure was unknown, Diabetes, High cholesterol not recovered, extremely tired, achy and slight pain where the shot was given in his arm was resolved.  Follow-up attempts are needed. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp.     A 49-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot Number: ED6955), dose 1 via an unspecified route of administration, administered in Arm Right on 03Apr2021 15:10 as 1st dose single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.Reporter stated on 03Apr2021 her husband had his first shot and on 28Apr2021 he had the second shot, then on 07May2021 he had a massive heart attack husband was hospitalized for three days and has not recovered completely also her husband is 49 years old with no heart issues or blood pressure and he had to have emergency surgery and has two stents in heart now to open his heart and was diagnosed with high blood pressure, diabetes, and high cholesterol. Reporter stated the doctor asked for her to call to make this report due to it being possible from the vaccination. Reporter stated her husband is now in the lower range because he went from taking no medication to taking 5 pills in the morning and 3 pills at night. Reporter stated the doctors are trying to adjust his blood pressure medication as it is a little low at this time and trying to see what will happen.  Reporter stated they do not know what this was caused, had a blood test that indicated he still was a diabetic but now they want to wait 3 months again and see what the numbers are since it was so high when he had the heart attack, couple of days after the second dose of the vaccine it stopped, and her husband was getting better each day and was not taking naps as often, slight pain where the shot was given in his arm: Reporter stated this was just a couple of days after the first dose and then it happened again after the second dose on 28Apr2021 but stopped a couple days after. On 7May2021,The patient experienced massive heart attack, high blood pressure was unknown, Diabetes, High cholesterol not recovered, extremely tired, achy and slight pain where the shot was given in his arm was resolved.  Follow-up attempts are needed. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Seizure
Clinical narrative: She had a pass out instance and She ended up being diagnosed with seizures; This is a spontaneous report from a contactable nurse This nurse (patient's mother) reported.  A 18-year-old female patient (reporter's daughter) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration on 03May2021 (age at vaccination 18-year-old) at DOSE 2 SINGLE for covid-19 immunisation. The patients medical history was not provided and concomitant medications were not reported. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH covid-19 vaccine, formulation: solution for injection, lot number: unknown) on an unspecified date in Apr2021 (age at vaccination 18-year-old) via an unspecified route of administration as DOSE 1 SINGLE for covid-19 immunization. Reporter stated, her daughter received the second Pfizer vaccine on the 03May2021 and she had a pass out instance and she ended up being diagnosed with a seizures on at the morning at the 08May2021 and they, we took her to the hospital. patient was in the Emergency Room on the morning of 08May. Reporter asked that was there any reaction that have occurred from Pfizer related to that. Because it was within 5 days of her receiving the vaccine and she has never had any instance like this in her life. patient received treatment with Keppra, 500mg, twice a day. The patient underwent lab tests and procedures which included test Investigation which was all fine on an unspecified date.The outcome of event was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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 and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: My girlfriend's husband lost hearing in one ear after he got the vaccine; This is a spontaneous report from a contactable consumer. This is 3rd case out of 3 cases. This consumer reported for a male patient (reporter's girlfriend's husband) that, A patient received a dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as a Dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter Stated, that the patient lost hearing in one ear after he got the vaccine so, on an unspecified date. Reporter seriousness for the event was Unspecified. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021694995 Same reporter, different drug/patient/ AE
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Carpal tunnel syndrome, Drug ineffective, Nail disorder
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine, Formulation: solution for injection, Batch/Lot Number: EK5730, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on Dec 19, 2020 as dose 1, single dose, dose 2 via an unspecified route of administration, administered in left arm on Jan 9, 2021 08:45 (Batch/Lot Number: EJ16B6) as dose 2, single dose for COVID-19 immunization at hospital. Medical history included tennis elbow in both arms. Concomitant medications included fluoxetine hydrochloride (Prozac) taken for antidepressant, start and stop date were not reported; glyceryl trinitrate (Nitroglycerine) taken for an unspecified indication, start and stop date were not reported and clonazepam (Klonopin). When probed for dose of clonazepam, consumer stated, 0.5 mg. Consumer provided both Klonopin and clonazepam, it was not clarified if consumer was on generic or brand. The patient did not receive any other vaccines 4 weeks prior to COVID Vaccine. On an unspecified date, had a side effect she believed was COVID. Indentations in fingernails (on every finger and her thumbs). She stated it's a pretty deep indentation; the nails, the nail beds (the indentations are mid-nail until they grow out), tinnitus and carpal tunnel. She stated, where it is at on her finger would take her back to the timeline of something having happened when she got her COVID vaccine. Regarding lab tests, she stated, it was just blood test. He took it for routine and then for Gram staph (not clarified). When probed about the date and result of the tests, she doesn't know. It's been since January (this particular one) with no staph (not clarified further). She was (from what she can remember) just evaluated for her kidney (not clarified further). It had been a while back. When probed if she was still experiencing adverse events, she did not think so. She still has tinnitus and carpal tunnel, which was why she was given Prednisone (treatment for event). But Prozac was kind of like an extended thing. Klonopin goes with the antidepressant, so she did not take medications for them, and she did not have symptoms. Patient stated, once she starts taking medication it was better but that was from her mental (not clarified). She did not think it had anything to do with Pfizer. The patient underwent lab tests and procedures which included blood test: Gram staph on an unspecified date and no staph on an unspecified date. Therapeutic measures were taken as a result of tinnitus and carpal tunnel with prednisone 10 mg. The outcome of the events was unknown. Follow-up attempts are possible; further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine, Formulation: solution for injection, Batch/Lot Number: EK5730, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on Dec 19, 2020 as dose 1, single dose, dose 2 via an unspecified route of administration, administered in left arm on Jan 9, 2021 08:45 (Batch/Lot Number: EJ16B6) as dose 2, single dose for COVID-19 immunization at hospital. Medical history included tennis elbow in both arms. Concomitant medications included fluoxetine hydrochloride (Prozac) taken for antidepressant, start and stop date were not reported; glyceryl trinitrate (Nitroglycerine) taken for an unspecified indication, start and stop date were not reported and clonazepam (Klonopin). When probed for dose of clonazepam, consumer stated, 0.5 mg. Consumer provided both Klonopin and clonazepam, it was not clarified if consumer was on generic or brand. The patient did not receive any other vaccines 4 weeks prior to COVID Vaccine. On an unspecified date, had a side effect she believed was COVID. Indentations in fingernails (on every finger and her thumbs). She stated it's a pretty deep indentation; the nails, the nail beds (the indentations are mid-nail until they grow out), tinnitus and carpal tunnel. She stated, where it is at on her finger would take her back to the timeline of something having happened when she got her COVID vaccine. Regarding lab tests, she stated, it was just blood test. He took it for routine and then for Gram staph (not clarified). When probed about the date and result of the tests, she doesn't know. It's been since January (this particular one) with no staph (not clarified further). She was (from what she can remember) just evaluated for her kidney (not clarified further). It had been a while back. When probed if she was still experiencing adverse events, she did not think so. She still has tinnitus and carpal tunnel, which was why she was given Prednisone (treatment for event). But Prozac was kind of like an extended thing. Klonopin goes with the antidepressant, so she did not take medications for them, and she did not have symptoms. Patient stated, once she starts taking medication it was better but that was from her mental (not clarified). She did not think it had anything to do with Pfizer. The patient underwent lab tests and procedures which included blood test: Gram staph on an unspecified date and no staph on an unspecified date. Therapeutic measures were taken as a result of tinnitus and carpal tunnel with prednisone 10 mg. The outcome of the events was unknown. Follow-up attempts are possible; further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: went blind for two weeks after receiving the COVID vaccine; This is a spontaneous report from a contactable consumer or other non health care professional (Patient's friend). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as UKKNOWN DOSE, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient went blind for two weeks after receiving the covid vaccine. The event was medically significant. Reporter stated that her vision came back but the patient did lose it for two weeks. The outcome of the event was recovered on an unspecified date.  Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19 Vaccine is still being studied in clinical trials. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.  Information on the lot/batch number has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: About 2-3 minutes after vaccine administration patient had vasovagal episode lasting 1-2 seconds. Came to quickly.; This is a spontaneous report from a contactable other healthcare professional. A 15-year-old non-pregnant female patient received first dose of bnt162b2 (Solution for injection, Batch/Lot Number: EW0196), intramuscular, administered in arm left on 11Jun2021 15:30 (at the age of 15-years-old) as 1st dose, single for covid-19 immunisation at doctor's office/urgent care. The patient's medical history and concomitant medications were not reported. Patient had no known drug allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Any other medications the patient received within 2 weeks of vaccination was unknown. On 11Jun2021 15:30, the patient experienced about 2-3 minutes after vaccine administration patient had vasovagal episode lasting 1-2 seconds, came to quickly. The reported seriousness of the event was medically significant. Patient did not receive any treatment for the event. The clinical outcome of the event was recovered on an unspecified date in Jun2021.; Sender's Comments: Based on the information provided, the causal association between the suspect drug and the event cannot be excluded. 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 as appropriate.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Pyrexia, Rash
Clinical narrative: Tightness of chest; Severe headaches; Rashes on skin; Feverish ness; This is a spontaneous report from contactable consumer (patient). A 13-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0176), via an unspecified route on 04Jun2021 (at the age of 13-years) as dose number unknown, single in the left arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had known allergic to Aspirin and Ibuprofen. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Jun2021 at 13:15, the patient experienced tightness of chest for about 15 minutes. Happened again on 06Jun2021 for 5mins and on 07Jun2021 for about 3 minutes. Also experienced severe headaches, rashes on skin and feverish ness. The patient did not received treatment for events. The events was assessed as serious Life threatening illness. The outcome of the events was recovering.  Information on the lot/batch was available, further information has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Platelet count, Platelet count increased, Stomatitis, Vaccination site pruritus
Clinical narrative: platelet count was elevated above 400; sores on roof of mouth; immediate itching & rash on arm at site of injection; immediate itching & rash on arm at site of injection; mild asthma; This is a spontaneous report from a contactable consumer (Patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration, administered in left arm on 24Apr2021 at 05:00 PM (at the age of 49-years-old) as dose 2, single for COVID-19 immunization in a clinic. Medical history included known allergies to seseme seeds and codeine. 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 vaccination. Concomitant medication(s) included levothyroxine sodium (SYNTHROID, 100 mg); ergocalciferol (VIT D); tocopherol (VIT E), multivitamins and Tuna Oil; all were taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8732) via an unspecified route of administration, administered in left arm on 03Apr2021 at 05:00 PM, as dose 1, single for COVID-19 immunization. On 24Apr2021 at 5:00 PM (after second shot), patient experienced sores on roof of mouth, platelet count was elevated above 400, immediate itching & rash on arm at site of injection for 7 days, mild asthma for 24 hours. The event platelet count was elevated above 400 was Serious (Medically Significant). The patient underwent lab test which included platelet count: elevated above 400 on 24Apr2021. Patient did not receive any treatment for the events. The outcome of the events was recovered.