chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Syncope, Vomiting
Clinical narrative: fainted; At 3am I woke up feeling very sore; came to drenched in sweat; felt very heavy; having trouble moving my limbs and holding my head up; experienced palpitations band an elevated heart rate; experienced palpitations band an elevated heart rate; threw up; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0176, expiration date not provided), 2nd dose via an unspecified route of administration, administered in Arm Left on 18May2021 14:15 at age of 27 years old as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS). The patient's concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0176, expiration date not provided), 1st dose via an unspecified route of administration, administered in Arm Left on 27Apr2021 14:15 as a single dose for COVID-19 immunisation.  The patient experienced 'fainted, at 3am I woke up feeling very sore, came to drenched in sweat, felt very heavy, having trouble moving her limbs and holding her head up, experienced palpitations band an elevated heart rate, threw up, diarrhea', all on 19May2021 03:00.  At 3am she woke up feeling very sore so she got up and walked to the bathroom to take some Tylenol. Before she could take any she fainted. After it passed she tried to sit up with her back against the wall and fainted again. She came to drenched in sweat and felt very heavy. She was having trouble moving her limbs and holding her head up because they felt too heavy. She also experienced palpitations band an elevated heart rate during this. Then she threw up and had diarrhea. No treatment received. The outcome of the events was recovering. The report was reported as non-serious. The patient was not pregnancy at time of vaccination. The patient had no known allergies. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received within 2 weeks of vaccination included oral birth control. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event faint cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Neuropathy peripheral, Vasodilatation
Clinical narrative: peripheral neuropathy; had a burning sensation in dorsal aspect of her hands and feet; dilation of her veins; This is a spontaneous report from a contactable physician.   A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. As medical history was reported: patient had an iron deficiency, due to anemia she received IV iron infusion maybe 4-6 weeks before the vaccine, pre-diabetes, family history of hypothyroidism in parents and brother. The patient's concomitant medications were not reported. The physician reported that patient was experiencing peripheral neuropathy on an unspecified date. She also had a burning sensation in dorsal aspect of her hands and feet associated with dilation of her veins on an unspecified date. These symptoms were intermittent initially, but now they are more persistent. The physician is curious if this had been reported and what to expect about it in terms of a prognosis. The outcome of the events was unknown. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency. The physician confirmed that the patient was the physician's sister. Information on the lot/batch number has been requested.; Sender's Comments: Based on implied chronological connection to the vaccine, causality between event peripheral neuropathy and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely 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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: I'm curious about this condition called Myocarditis, and I think I'm experiencing symptoms of this conditions'; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: EN6208) as 2nd dose, single for covid-19 immunisation. No patient history. No other medical conditions. Concomitant medications included periodically thyroid medication. The patient received first dose of BNT162B2 on 11Mar2021 (lot number: EN6202) at age of 71 years old for covid-19 immunisation. Patient was curious about this condition called myocarditis and he think he was experiencing symptoms of this conditions, this kind brought on his Pfizer vaccine and so Pfizer was his first contact right now and there was couple of numbers on the sheet when he got his second vaccine shot. The outcome of event was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Eating disorder, Magnetic resonance imaging, Nausea, Pain
Clinical narrative: Acute pancreatitis/I had the pancreatic attack; in pain, she was hurting; Nausea; she was swollen; barely eat; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 05Mar2021 (Lot Number: EN6203) as 1st dose, single dose for covid-19 immunisation. Medical history included blood pressure high. Concomitant medications included losartan 100 mg, once a day taken for blood pressure high; metoprolol 25 mg, once a day. The patient had a side effect of vaccine so after that first dose in March and had been in emergency room at that time she did not realize that acute pancreatitis was one of the side effect of the vaccine. She had the vaccine and she got fits when she had the pancreatic attack and she could not go and get the other one. She had the first one on 05Mar2021, second was on the 18May2021 (lot number ET7533). She was supposed to go back was on the 26th and she already had some problems that didn't stopped (not clarified), so she got the shot for pain so she could not take on 26th, then she ended up going to the emergency room on the 29th. She was giving Tylenol with codeine for pain and she was given 'Oma' something for nausea. She was told not to eat anything solid for 2 days. They did blood work and they did an MRI. Then she had blood work done by 3 or 4 times. They tell she had pancreatitis. They wanted to put her in hospital but didn't because with the COVID and the lack of space. So she was at home with the clear instructions. She was given IV before she left the emergency room and she was given clear instructions no solid food for 2 days and make sure had hydrated, anything was not solid, she did that week she appear to be doing better, she had consultation with a nutritionist, the doctor said he could not understand what was causing the pancreatitis because she did not have a gall bladder problem, she was not a heavy drinker. Primary doctor did not know, she did not have any of those what was causing the pancreatitis. she had pain, she was swollen, she has to be careful what she eat, she was in constant pain. She never had a problem with her pancreas until now. She never had trouble with her pancreas and in the end she probably would not have reason that to call the problem with her pancreas but its ongoing pain, she was in pain, she was hurting, she barely eat. The outcome of events was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pancreatitis acute, Swelling
Clinical narrative: Acute pancreatitis/I had the pancreatic attack; in pain, she was hurting; Nausea; she was swollen; barely eat; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 05Mar2021 (Lot Number: EN6203) as 1st dose, single dose for covid-19 immunisation. Medical history included blood pressure high. Concomitant medications included losartan 100 mg, once a day taken for blood pressure high; metoprolol 25 mg, once a day. The patient had a side effect of vaccine so after that first dose in March and had been in emergency room at that time she did not realize that acute pancreatitis was one of the side effect of the vaccine. She had the vaccine and she got fits when she had the pancreatic attack and she could not go and get the other one. She had the first one on 05Mar2021, second was on the 18May2021 (lot number ET7533). She was supposed to go back was on the 26th and she already had some problems that didn't stopped (not clarified), so she got the shot for pain so she could not take on 26th, then she ended up going to the emergency room on the 29th. She was giving Tylenol with codeine for pain and she was given 'Oma' something for nausea. She was told not to eat anything solid for 2 days. They did blood work and they did an MRI. Then she had blood work done by 3 or 4 times. They tell she had pancreatitis. They wanted to put her in hospital but didn't because with the COVID and the lack of space. So she was at home with the clear instructions. She was given IV before she left the emergency room and she was given clear instructions no solid food for 2 days and make sure had hydrated, anything was not solid, she did that week she appear to be doing better, she had consultation with a nutritionist, the doctor said he could not understand what was causing the pancreatitis because she did not have a gall bladder problem, she was not a heavy drinker. Primary doctor did not know, she did not have any of those what was causing the pancreatitis. she had pain, she was swollen, she has to be careful what she eat, she was in constant pain. She never had a problem with her pancreas until now. She never had trouble with her pancreas and in the end she probably would not have reason that to call the problem with her pancreas but its ongoing pain, she was in pain, she was hurting, she barely eat. The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: I had the first vaccine on May 1st and got positive on May 10; This is a spontaneous report from a Pfizer sponsored Program form a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had the first vaccine on 01May2021 and tested positive on 10May2021 and patient was now (May2021) negative for Covid. Her second shot was scheduled to 24May2021. She would like to know if she could get the second dose or dose she had to wait. The outcome of events was recovered on an unspecified date in May2021.   Information on the lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pruritus, SARS-CoV-2 test, Urticaria
Clinical narrative: bad case of hives; its just annoying and really itchy; its just annoying and really itchy; This is a spontaneous report from a contactable Nurse (patient). A 71-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for Injection, Batch/Lot Number: EL3302; Expiration Date: May2021), (age at time of vaccination was 71 years) dose 1 intramuscularly, administered in Deltoid Left on 21Jan2021 07:30 as single dose and dose 2 (Batch/Lot Number was EN6201, Expiration Date: not reported) intramuscularly, administered in Deltoid Left on 16Feb2021 07:30 as single for covid-19 immunization. Patient had some allergies not provide any further details. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 2021. Patient did not receive any prior vaccinations within 4 weeks. The patient's concomitant medications were not reported. She knows the vaccine was a while ago but she wants to know if there have been people reporting any kind of delayed reaction to the Covid vaccine. She now has a bad case of hives, which is new for her. She mentions she is going to see her doctor next week. If the hives are still there, she will see her doctor. She doesn't think its worth going to the ER. The hives  are pretty bad on her left shoulder, and she has spots on her back and her trunk/body, kind of on her side. She adds they are itchy. She mentions she has been taking Benadryl and putting steroid cream/anti-itch cream on it. She confirms the hives have stayed the same. No further details provided. The outcome of the events was not recovered.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of  urticaria. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest pain, Dyspnoea, Feeling jittery, Hypersensitivity
Clinical narrative: Jittery; Allergic reaction - minor; left sided numbness; shortness of breath; chest pain; blood pressure elevated/ greater than 200; This is a spontaneous report from a contactable consumer (patient) and a physician. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22Apr2021 (Batch/Lot Number: EW0172; Expiration Date: Aug2021) as 1st dose, single for Covid-19 immunization. Medical history included lung cancer from Aug2008 (in remission), surgery to remove half of the upper lung (where the cancer mass was and also all of lymph nodes in upper left lung area), and allergies to pollen, bee sting, dust and dust mites. Concomitant medications included levocetirizine dihydrochloride (LEVOCETIRIZIN); losartan potassium; montelukast sodium. On 22Apr2021, the patient experienced jittery (1 hour after vaccination) and allergic reaction - minor, left sided numbness, shortness of breath, and chest pain. EMS was called vitals shown blood pressure elevated and greater than 200. patient was given famotidine (PEPCID) (oral, 20 mg, 2x/day for 3 days), diphenhydramine hydrochloride (BENADRYL) (oral, 25 mg, 1x/day every 6 hours for 5 days) and prednisone (oral, 20 mg, single for 2 days) for these vaccine reactions. Events required visit to Emergency Room. Patient got the vaccine because she was high risk for Covid 19 but now she does not plan on getting the 2nd vaccine for fear it would kill her. The outcome of events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Hypoaesthesia
Clinical narrative: Jittery; Allergic reaction - minor; left sided numbness; shortness of breath; chest pain; blood pressure elevated/ greater than 200; This is a spontaneous report from a contactable consumer (patient) and a physician. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22Apr2021 (Batch/Lot Number: EW0172; Expiration Date: Aug2021) as 1st dose, single for Covid-19 immunization. Medical history included lung cancer from Aug2008 (in remission), surgery to remove half of the upper lung (where the cancer mass was and also all of lymph nodes in upper left lung area), and allergies to pollen, bee sting, dust and dust mites. Concomitant medications included levocetirizine dihydrochloride (LEVOCETIRIZIN); losartan potassium; montelukast sodium. On 22Apr2021, the patient experienced jittery (1 hour after vaccination) and allergic reaction - minor, left sided numbness, shortness of breath, and chest pain. EMS was called vitals shown blood pressure elevated and greater than 200. patient was given famotidine (PEPCID) (oral, 20 mg, 2x/day for 3 days), diphenhydramine hydrochloride (BENADRYL) (oral, 25 mg, 1x/day every 6 hours for 5 days) and prednisone (oral, 20 mg, single for 2 days) for these vaccine reactions. Events required visit to Emergency Room. Patient got the vaccine because she was high risk for Covid 19 but now she does not plan on getting the 2nd vaccine for fear it would kill her. The outcome of events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Lower respiratory tract infection, Respiratory tract congestion
Clinical narrative: Chest cold; Chest congestion; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on an unspecified date (Lot Number: EW0179) as 2nd dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had 2nd shot of Pfizer vaccine a week ago and now patient had chest congestion and chest cold so was wondering if this was a normal reaction after a week. The patient just needed some advice. The outcome of events was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Erythema, Haemorrhage, Peripheral swelling, Rash
Clinical narrative: Xgeva: bleeding on her hands; redness; Xgeva: rash on both hands; Xgeva: swelling on right hand; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation; denosumab (XGEVA), via an unspecified route of administration from 07May2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. No other Products. No patient History. The patient medical history was not reported. There were no concomitant medications. The patient received first dose of BNT162B2 on an unspecified date for covid-19 immunization. Stated that patient started Xvega on 07May2021 and had a very bad rash on both hands, swelling on the top of her hands and swelling on right hand on 08May2021, and bleeding on the hands. 'Is going to the dermatology'. Stated that there was redness. Stated that patient had her second dose of the vaccine on that Wednesday the day before. Treatment included given Cortisone Cream for the rash. The outcome of rash on both hands, swelling on right hand was not recovered, of other events was unknown.   Information about lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Hypoaesthesia, Nausea, Near death experience
Clinical narrative: feel like I am going to die; felt dizzy; nauseous; The burning at the injection site lasted hours; itching all over my torso to my legs; get numbness and tingling in my lower left arm; get numbness and tingling in my lower left arm; right arm started shaking to the point I struggle to use my phone with my right hand; The pain in my upper arm is getting worse; I started getting hives on my left arm; The burning at the injection site lasted hours; This is a spontaneous report from a contactable consumer, the patient. A 34-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ev40177), via an unspecified route of administration, administered on left arm on 19May2021 16:45 (at the age of 34-years-old) as a single dose for covid-19 immunization. Medical history included seasonal allergies and had known allergies to penicillin. Concomitant medications in two weeks included loratadine (CLARITINE); diphenhydramine hydrochloride (BENADRYL); ethinylestradiol, etonogestrel (NUVARING). The patient had not received other vaccine within four weeks. 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 19May2021 16:00, The patient experienced "vaccine burned when it went in, immediately she felt dizzy and nauseous. The burning at the injection site lasted hours. About 3 hours after the injection she was started itching all over her torso and severe pain in her left arm muscle. About 16hours after the injection she started getting hives on my left arm and the itching spread from my torso to my legs. About 20 hours after the injection she started to get numbness and tingling in my lower left arm. My right arm started shaking to the point she struggled to use her phone with her right hand. The pain in her upper arm is getting worse. She stated that "I feel like I am going to die". The patient did not receive any treatment. Outcome of the events was not resolved.  Follow up needed, further information was requested
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Pruritus, Tremor, Urticaria
Clinical narrative: feel like I am going to die; felt dizzy; nauseous; The burning at the injection site lasted hours; itching all over my torso to my legs; get numbness and tingling in my lower left arm; get numbness and tingling in my lower left arm; right arm started shaking to the point I struggle to use my phone with my right hand; The pain in my upper arm is getting worse; I started getting hives on my left arm; The burning at the injection site lasted hours; This is a spontaneous report from a contactable consumer, the patient. A 34-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ev40177), via an unspecified route of administration, administered on left arm on 19May2021 16:45 (at the age of 34-years-old) as a single dose for covid-19 immunization. Medical history included seasonal allergies and had known allergies to penicillin. Concomitant medications in two weeks included loratadine (CLARITINE); diphenhydramine hydrochloride (BENADRYL); ethinylestradiol, etonogestrel (NUVARING). The patient had not received other vaccine within four weeks. 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 19May2021 16:00, The patient experienced "vaccine burned when it went in, immediately she felt dizzy and nauseous. The burning at the injection site lasted hours. About 3 hours after the injection she was started itching all over her torso and severe pain in her left arm muscle. About 16hours after the injection she started getting hives on my left arm and the itching spread from my torso to my legs. About 20 hours after the injection she started to get numbness and tingling in my lower left arm. My right arm started shaking to the point she struggled to use her phone with her right hand. The pain in her upper arm is getting worse. She stated that "I feel like I am going to die". The patient did not receive any treatment. Outcome of the events was not resolved.  Follow up needed, further information was requested
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: feel like I am going to die; felt dizzy; nauseous; The burning at the injection site lasted hours; itching all over my torso to my legs; get numbness and tingling in my lower left arm; get numbness and tingling in my lower left arm; right arm started shaking to the point I struggle to use my phone with my right hand; The pain in my upper arm is getting worse; I started getting hives on my left arm; The burning at the injection site lasted hours; This is a spontaneous report from a contactable consumer, the patient. A 34-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ev40177), via an unspecified route of administration, administered on left arm on 19May2021 16:45 (at the age of 34-years-old) as a single dose for covid-19 immunization. Medical history included seasonal allergies and had known allergies to penicillin. Concomitant medications in two weeks included loratadine (CLARITINE); diphenhydramine hydrochloride (BENADRYL); ethinylestradiol, etonogestrel (NUVARING). The patient had not received other vaccine within four weeks. 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 19May2021 16:00, The patient experienced "vaccine burned when it went in, immediately she felt dizzy and nauseous. The burning at the injection site lasted hours. About 3 hours after the injection she was started itching all over her torso and severe pain in her left arm muscle. About 16hours after the injection she started getting hives on my left arm and the itching spread from my torso to my legs. About 20 hours after the injection she started to get numbness and tingling in my lower left arm. My right arm started shaking to the point she struggled to use her phone with her right hand. The pain in her upper arm is getting worse. She stated that "I feel like I am going to die". The patient did not receive any treatment. Outcome of the events was not resolved.  Follow up needed, further information was requested
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: fainted immediately following vaccination; Mom described movements as tonic clonic with stiffening of muscles and jerking movements during fainting episode; This is a spontaneous report from a contactable pharmacist (parent). A 12-year-old male patient 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 DOSE for covid-19 immunisation. Medical history included fainting where the mother reports withheld has fainted in the past following administration of a vaccine. Unsure of the vaccine and exact date not known. The patient's concomitant medications were not reported. On an unspecified date, the patient fainted immediately following vaccination. The mother described movements as tonic clonic with stiffening of muscles and jerking movements during fainting episode. The outcome of the events was unknown.  Information about the lot/batch number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the events "fainted immediately" and "tonic clonic with stiffening muscles and jerking movements" with BNT162b2 can not be fully 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.
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Dizziness, Epistaxis, Headache
Clinical narrative: really bad bleeding nose; really bad bleeding nose; dizzy/lightheaded; light headache; This is a spontaneous report from a contactable consumer (patient's mother). A 13-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EW0185) as 1st dose, single for COVID-19 immunization. The patient's medical history included bleeding nose. The patient's concomitant medications were not reported. The patient experienced really really bad bleeding nose at about 2:30 and he was dizzy on 19May2021. Mother did not know that if that came with shot or he had not had bleeding nose in years. Patient with no other symptoms. He was dizzy and lightheaded and then that the bleeding nose. When probed ongoing for the adverse effect: Mother stated, Nose bleeding was almost gone but he felt light headache and dizzy. Events seriousness were provided as unspecified by reporter. No treatment received for events. Schedule date for the second shot was von 09Jun2021. The outcome of events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: severe difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization.  Medical history and concomitant medications were not reported.  The patient received the first dose of PFIZER BIONTECH COVID-19 VACCINE on an unspecified date (Batch/Lot number was not reported) for COVID-19 immunization and had vomiting on unknown date. Then, received the 2nd dose on unknown date. The patient experienced severe difficulty breathing on unknown date with unknown outcome.   Information regarding the lot/batch has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient) via a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of covid vaccine 3 weeks ago and recently diagnosed with covid on an unspecified date with outcome of unknown. The patient underwent lab tests included covid-19 positive on an unspecified date.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Immune system disorder
Clinical narrative: My immune system was compromised; the violent one where I thought I am going to die was on the second one; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05May2021 (Lot Number: EW0176) as second dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 14Apr2021 as first dose, single dose for COVID-19 immunization and experienced immune system was compromised. The patient reported "I had an adverse reaction to the first one and the violent one where I thought I am going to die was on the second one". The patient's doctor told the patient to report it and that patient have a severe reaction to both doses and advised the patient to not have the booster shot since it will exhaust him/her. The patient stated "My immune system was compromised.". The outcome of the events was unknown.   Information on lot/batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. On an unspecified date, It was reported that, she had a friend who experienced it, too". Her friend said "the shot was great" then a few days later she "encountered" the diarrhoea. She told her friend it may also be a stomach bug. Expressed she was glad she received the product she wanted. She states she's glad she got the Pfizer product, and she think Pfizer's been one of the better ones and heard people were having a much harder time with Moderna. The clinical outcome of the diarrhea was unknown.   No follow-up attempts are completed; information about batch/lot cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot disorder; This is a spontaneous report from Pfizer sponsored program. A contactable female consumer (patient) reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on an unspecified date and dose 2 on 19May2021, both via an unspecified route of administration (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller went on her 2nd dose today 19May2021, she was asked a question if she had a blood clot disorder, she was not asked about this on the 1st dose, and apparently, she was having a blood clot disorder on an unspecified date. She asked the people in the facility if she needed to be concerned, and they said that she didn't need to worry about it, however she wanted to make sure that everything was fine or should she watch out for something. Outcome of event was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Malaise
Clinical narrative: Flare-ups of ulcerative colitis; under the weather; This is a spontaneous report from a contactable healthcare professional and consumer. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for COVID-19 immunization. Medical history included ongoing ulcerative colitis. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on unspecified date as first dose, single dose for COVID-19 immunisation. On May2021, the patient was "under the weather" experiences flare-ups of ulcerative colitis symptoms were "pretty rough" which could be also due to him "loosen up" his diet and he received the second COVID-19 vaccine shot. The outcome the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the available information the reported events were  attributed to  an underlying or  an intercurrent medical condition and  it is assessed as unrelated to the  suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Nausea; fever; aches; chills; headache; This is a spontaneous report received from a non-contactable consumer (patient).  A 43-years-old non-pregnant female patient received unknown dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on 12Apr2021 (Batch/Lot number was not reported) as unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, it was unknown if patient has been tested for covid-19.On an unspecified date, the patient experienced nausea, fever, aches, chills and headache. Outcome of the events was resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased activity, Fatigue, Feeling abnormal, Headache, Muscular weakness
Clinical narrative: headaches that stopped her in her tracks; she felt like she had the flu; weakness in her muscles; She is tired; feels like she needs to lay her head down by lunch time; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7533 and Expiration date was not reported), via an unspecified route of administration in left arm on 08Apr2021 (at the age of 68-year-old), as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. Prior Vaccinations (within 4 weeks) and any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. The patient medical history included joint pain and arthritis. The patient historical vaccine she reports maybe a sore arm with the flu vaccine. She's had her shingles and pneumonia vaccines and never had any problems. NDC/Lot/Expiry for the flu vaccine not known. The sore arm is not even anything she would have been concerned about, there's no issue with a sore arm. The concomitant medications included levothyroxine sodium (SYNTHROID) and celecoxib (CELEBREX). The pharmacist told her to call Pfizer and report her symptoms and side effects. She and her husband both had their first Covid 19 vaccine on 08Apr2021 and she was fine for a few days. Then she noticed that she was getting headaches that stopped her in her tracks. The headaches would last a while then ease up. Then, in her muscles, she felt like she had the flu. She kept thinking her symptoms will work their way out of her system, but it's been constant. She hasn't received her second Covid 19 vaccine because honestly, she's afraid. She's still having headaches every day and weakness in her muscles. She's tired. She's usually energetic, she's a grandmother and she has many duties as a grandmother but now she feels like she needs to lay her head down by lunch time. She would like it known that her symptoms aren't debilitating or keeping her down or at home all the time. Sometimes she just has to stop in her tracks and rub her head a little bit. The napping and tiredness are not how she usually is but none of this is debilitating. Her symptoms haven't gotten worse or better, it's staying about the same. She has not taken anything different that would have affected the vaccine. She hasn't reported her symptoms to her primary healthcare provider. She thought her symptoms would go away. She hasn't been to the emergency room or any medical care facility. The outcome of the event was reported as not recovered.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Pruritus, Urticaria
Clinical narrative: hives that started on his foot and they moved up to his legs and his abdomen.; itching; This is a spontaneous report from a contactable consumer (patient) reporting himself. A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: EW0179) via an unspecified route of administration in Arm Left on 08May2021 as second dose, single dose for covid-19 immunization. Medical history included, high blood pressure, Allergy, kind of dry eye also have bulging disc at his back, squeezing out to the nerve that why he have to chair, phlebotomy. Patient had took first dose of BNT162B2. Concomitant medication included amlodipine besilate (NORVAS) taken for high blood pressure, atorvastatin (LIPITOR [ATORVASTATIN]), losartan (LOSARTAN), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an for heart, amlodipine (AMLODIPINE), verapamil (VERAPAMIL), hctz (HCTZ), cetirizine hydrochloride (ZYRTEC ALLERGY) taken for hypersensitivity, gabapentin (GABAPENTIN), oxycodone (OXYCODONE),metoprolol succinate (TOPROL XL), ascorbic acid (VITAMIN-C). The patient reported that he received his second dose of the vaccine on 08May2021 and later began noticing hives that started on his foot and they moved up to his legs and his abdomen he saw his primary care physician who prescribed a cream for the itching, but itching hasn't gone away and doesn't know if he should get checked out at the emergency room because the hives are still bothering him or if they will just go away. Upon follow-up (22May2021), event reported as he got reaction almost from this Pfizer vaccine, he was asking should he have to go to emergency room and he got hives popping up different places on his body and it like a really bad. He went to doctor yesterday they said they don't know what is going on, he thought what could be the vaccine, we don't know, past they told me hives is the side effects, then he have been on phone for a last couple of hours, and gotten anywhere, he is not getting anything from doctor or anybody. Last Saturday his foot broke out just once but now just same keep coming all over his body and he took to the doctor they said they don't know where it's coming from, so he think with that part of shot picks it up vaccine what led him to do. He still have concern about hives over his body, it is itching little bit. It was started last sunday on the 16th. This just started after he had the vaccine, he had not it before. Consumer stated, he just want to know if I need to to go to the emergency room, do he need to worry about it. The patient underwent lab tests and procedures which included blood test. Therapeutic measures were taken as a result of itching (pruritus) with Loratadine. The outcome of events was unknown.  Follow-up actions are required. Further information requested
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Skin discolouration
Clinical narrative: Yellow discoloration, like a bruise, over a week after the vaccine. No pain.; Yellow discoloration, like a bruise, over a week after the vaccine. No pain.; This is a spontaneous report from a contactable 23-year-old male consumer (patient himself). A 23-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0185) via an unspecified route of administration in left arm on 14May2021 13:30 as 2nd dose single and had previously received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8729) via an unspecified route of administration in left arm on 23Apr2021 13:30 as 1st single dose for COVID-19 immunization. Patient was 23-years-old at the time of vaccination. Patient medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has not been tested for COVID-19, since the vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23May2021 at 09:00, the patient experienced yellow discoloration, like a bruise, over a week after the vaccine with no pain. Patient did not receive any treatment for the adverse events. The outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Bad Headache, a worst Headache; got severe Headache; She is in pain; This is a spontaneous report from a contactable consumer (patient's mother) reported for the patient. A 16-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 21May2021 (age at vaccination was unknown) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The reporter stated that she was concerned about her 16 years old daughter who got her second dose of Pfizer yesterday, now she had really bad headache, got a worst headache ever. The reporter was informed about the Role of Pfizer Drug Safety. The reporter asked whether anyone could get her the answer to help her child. The reporter was requested to contact nearest Health Care Provider. The reporter stated that her child was in pain. She could have been searching for a Doctor. She was 16 years old and got a severe headache. The outcome of the events was unknown.   No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Swelling face, Throat tightness, Urticaria
Clinical narrative: trouble breathing; experiencing hives all over her body; swelling of the face; tightness of the throat; This is a spontaneous report from a contactable consumer or other non hcp.   A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date were not reported), dose 2 via an unknown route of administration on 20May2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date of May2021, the patient experienced hives all over her body and swelling of the face. She also experienced tightness of the throat and trouble breathing. The patient was at local hospital, who haven't provided her proper care, stating that Pfizer has not told them how to treat those reactions. Reporter would like to know if any treatment or a hospital recommended. Outcome of events hives all over her body and swelling face was not recovered while the outcome of events tightness of the throat and trouble breathing was unknown.   Information on Lot/Batch number was available. Additional information has been requested.