chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Hypopnoea, Nausea
Clinical narrative: felt tired; nausea; headache; short of breath; rapid/shallow breathing; rapid/shallow breathing; fast heart rate (100 bpm); low grade fever; felt very weak; pleuralpericardial effusion; pleuralpericardial effusion; This is a spontaneous report from a contactable consumer. A non-pregnant 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 16Jan2021 10:30 at a single dose for COVID-19 immunization.  Medical history included allergic to opioids, allergy to fish, cirrhosis with portal hypertension, parkinsonism, heart blockage, type 2 diabetes, depression, early dementia.  The patient previously took morphine and experienced drug hypersensitivity.  There was unspecified concomitant medication.  The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced allergic to morphine.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced felt tired, nausea, headache, short of breath, rapid/shallow breathing, fast heart rate (100 bpm), low grade fever, felt very weak, pleuralpericardial effusion on 16Jan2021.  All the events were reported with the seriousness criteria of disability, hospitalization and being life-threatening.  The patient was hospitalized for the events for 4 days.  After the injection, from 0 to 24 hours the patient felt tired, had nausea, a headache, short of breath then at about 24 hours post injection developed rapid/shallow breathing, fast heart rate (100 bpm) low grade fever and felt very weak. The patent was taken to the emergency room (ER) at 30 hours post injection and it was determined (Xray, CTA & EKG) that she had a pleuralpericardial effusion. She was flown by air life to another ER for treatment.  The patient underwent lab tests and procedures on 16Jan2021 which included angiogram (CTA): had a pleuralpericardial effusion; body temperature: low grade fever; electrocardiogram (EKG): had a pleuralpericardial effusion; heart rate: 100 beats per minute (bpm); X-ray: had a pleuralpericardial effusion.  The patient had a rapid nasal swab on 17Jan2021 which was negative.  Therapeutic measures were taken as a result of the events and included unspecified medications & oxygen therapy.  The outcome of the events was recovering.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pericardial effusion, Pleural effusion, Pyrexia, Respiratory rate increased, SARS-CoV-2 test negative
Clinical narrative: felt tired; nausea; headache; short of breath; rapid/shallow breathing; rapid/shallow breathing; fast heart rate (100 bpm); low grade fever; felt very weak; pleuralpericardial effusion; pleuralpericardial effusion; This is a spontaneous report from a contactable consumer. A non-pregnant 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 16Jan2021 10:30 at a single dose for COVID-19 immunization.  Medical history included allergic to opioids, allergy to fish, cirrhosis with portal hypertension, parkinsonism, heart blockage, type 2 diabetes, depression, early dementia.  The patient previously took morphine and experienced drug hypersensitivity.  There was unspecified concomitant medication.  The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced allergic to morphine.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced felt tired, nausea, headache, short of breath, rapid/shallow breathing, fast heart rate (100 bpm), low grade fever, felt very weak, pleuralpericardial effusion on 16Jan2021.  All the events were reported with the seriousness criteria of disability, hospitalization and being life-threatening.  The patient was hospitalized for the events for 4 days.  After the injection, from 0 to 24 hours the patient felt tired, had nausea, a headache, short of breath then at about 24 hours post injection developed rapid/shallow breathing, fast heart rate (100 bpm) low grade fever and felt very weak. The patent was taken to the emergency room (ER) at 30 hours post injection and it was determined (Xray, CTA & EKG) that she had a pleuralpericardial effusion. She was flown by air life to another ER for treatment.  The patient underwent lab tests and procedures on 16Jan2021 which included angiogram (CTA): had a pleuralpericardial effusion; body temperature: low grade fever; electrocardiogram (EKG): had a pleuralpericardial effusion; heart rate: 100 beats per minute (bpm); X-ray: had a pleuralpericardial effusion.  The patient had a rapid nasal swab on 17Jan2021 which was negative.  Therapeutic measures were taken as a result of the events and included unspecified medications & oxygen therapy.  The outcome of the events was recovering.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray abnormal
Clinical narrative: felt tired; nausea; headache; short of breath; rapid/shallow breathing; rapid/shallow breathing; fast heart rate (100 bpm); low grade fever; felt very weak; pleuralpericardial effusion; pleuralpericardial effusion; This is a spontaneous report from a contactable consumer. A non-pregnant 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 16Jan2021 10:30 at a single dose for COVID-19 immunization.  Medical history included allergic to opioids, allergy to fish, cirrhosis with portal hypertension, parkinsonism, heart blockage, type 2 diabetes, depression, early dementia.  The patient previously took morphine and experienced drug hypersensitivity.  There was unspecified concomitant medication.  The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced allergic to morphine.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced felt tired, nausea, headache, short of breath, rapid/shallow breathing, fast heart rate (100 bpm), low grade fever, felt very weak, pleuralpericardial effusion on 16Jan2021.  All the events were reported with the seriousness criteria of disability, hospitalization and being life-threatening.  The patient was hospitalized for the events for 4 days.  After the injection, from 0 to 24 hours the patient felt tired, had nausea, a headache, short of breath then at about 24 hours post injection developed rapid/shallow breathing, fast heart rate (100 bpm) low grade fever and felt very weak. The patent was taken to the emergency room (ER) at 30 hours post injection and it was determined (Xray, CTA & EKG) that she had a pleuralpericardial effusion. She was flown by air life to another ER for treatment.  The patient underwent lab tests and procedures on 16Jan2021 which included angiogram (CTA): had a pleuralpericardial effusion; body temperature: low grade fever; electrocardiogram (EKG): had a pleuralpericardial effusion; heart rate: 100 beats per minute (bpm); X-ray: had a pleuralpericardial effusion.  The patient had a rapid nasal swab on 17Jan2021 which was negative.  Therapeutic measures were taken as a result of the events and included unspecified medications & oxygen therapy.  The outcome of the events was recovering.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Cholecystitis, Death, Malaise, Respiratory arrest
Clinical narrative: Patient passed su hospital on 23Jan2021 stopped breathing; complained of not feeling well; had an inflamed gall bladder; This is a spontaneous report from a contactable consumer. A 98-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982 and expiry date unknown), via an unspecified route of administration on 16Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medication reported as has received other medications (unspecified) within 2 weeks. The patient passed in hospital on 23Jan2021 with stopped breathing. Day after vaccine on 17Jan2021, the patient complained of not feeling well, went to hospital where was told she had an inflamed gall bladder. The events caused patient hospitalization for 4 days. The cause of death reported as stopped breathing. It was unknown if autopsy done. Prior to vaccination, the patient not diagnosed with COVID-19. The outcome of the event breathing arrested was fatal, outcome of the other events was unknown.; Reported Cause(s) of Death: Stopped breathing
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Movement disorder, Muscle discomfort, Muscle tightness, Myalgia
Clinical narrative: Headache/Could not pick my head up; All the muscles in my shoulders and my back were tightened up/muscles are still tight and at all the way to my neck; Muscle pain; muscles in my neck are all tied up between my shoulder blades, my shoulders all was shrugging and I could never release the muscles back that is what I felt like.; Could never release the muscles back that is what I felt like/My muscles never acted this way; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Nurse reported that she had severe side effects but not an allergic reaction. She had the vaccine on Thursday (31Dec2020) and by Sunday (02Jan2021), she had a horrible headache, all the muscles in her shoulders and back were tightened up. And all the week long, she kept trying to keep care with hot packs and cold packs and Advil and Maxalt and all kind of things but could not. Yesterday morning (as reported), she lifted nothing heavy, did nothing different at all and she could not pick her head up. Patient had to seek for medical attention just at her doctor's office not at the hospital. She had to have somebody and take care of muscle pain. She still have the muscle pain she do have to go back but they did give a muscle relaxant. Patient reported that she never had a reaction ever like this. Nurse further stated that she didn't do anything as a precursor before the vaccine or after the vaccine. The muscles in her neck were all tied up between her shoulder blades, and her shoulders all was shrugging and could never release the muscles back that was what she felt like. Nurse stated that she just have to take the second shot, that was just the first one. Somebody told her that she have to report it because it took her off the work for two days. And her muscles were still tight and at all the way to my neck and still have headache. She had a shot on 31Dec2020, and symptoms started on the 2nd. Patient reported that she never had such kind of pain before and her muscles never acted this way. She was advised by her healthcare provider that there were side effects and this one she consider severe. She was advised to continue to take the second one. Outcome of the events headache/could not pick my head up and all the muscles in my shoulders and my back were tightened up/muscles are still tight and at all the way to my neck were not recovered; outcome of the rest of events was unknown.  Information on the Lot/Batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Got the COVID-19 vaccine shot and was COVID positive the day after; Got the COVID-19 vaccine shot and was COVID positive the day after; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program IBCC (Inbound Call Center for HCPs). A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248, expiration date not reported), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure and high cholesterol. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), atorvastatin. It was reported that the patient got the COVID-19 vaccine shot last Saturday (09Jan 2021) and was COVID positive on Sunday (10Jan2021), the day after. Outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Somnolence
Clinical narrative: Headache; weak; sleeping; tired/Fatigue; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. There were no medical history or concomitant medications. The patient experienced headache, weak, sleeping, and tired/fatigue on an unspecified date. Event details: first it was headache and that had gone away and he was like weak, sleeping, tired and all. He was all weak and was fatigued at time of reporting, but he was all better. The patient did not receive treatment for the events. The outcome of events headache and sleeping was resolved, outcome of other events was resolving.   Information about batch/lot number has been requested.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: Muscle ache and tenderness; Joint pain; I even ran a low fever like a 100.5; Chills; This is a spontaneous report from a contactable consumer reporting for himself. A 21-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not reported) on 14Jan2021 10:00 at single dose intramuscularly in right arm for COVID-19 immunization. There were no relevant medical history and no concomitant medications. The patient started experiencing muscle ache and joint pain around 21:00 or 22:00 on 14Jan2021 and then he ran a low fever like a 100.5, and had chills pretty much all throughout the night. The patient noticed that those are common side effects but he had main concern on his work that he was unsure if he was okay to work on 15Jan2021. The chills and fever were gone on 15Jan2021 but he still had the muscle ache and tenderness. He stated that on 15Jan2021 the muscle ache and joint pain was about the same, it'd gotten a little better compared to what it was throughout the night, mild. The patient took two ibuprofen (ADVIL). The patient was recovering from the muscle ache and joint pain. The events low fever, chills were resolved on 15Jan2021.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Circumstance or information capable of leading to device use error, Headache, Vomiting
Clinical narrative: Headache; Vomiting; Lower abdominal cramping; she scanned the bar code it said it was her first one but it really was her second one; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL1284), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunization. Medical history included systemic lupus, autoimmune disorder.  There were no concomitant medications.  The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunization and experienced headache. The patient stated that she had her second vaccine on Monday (11Jan2021) and when she scanned the bar code it said it was her first one but it really was her second one. She was not given the paper too for monitoring what she got at first one but ever since she got her first one she had a constant headache and that continued today and then at the middle of the night for whatever reason she had some vomiting and lower abdominal cramping and so to call out sick to work. She did have autoimmune disease, systemic lupus. She was not currently on any kind of suppressants or anything like that. She was advised to have a Covid test. The only criteria that she need according to her work was having the headache. Was it possible that this was just side effect from the immunization? The patient received Tylenol as treatment for the headache. The outcome of events was unknown.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Body temperature, Chills, Headache, Malaise
Clinical narrative: Not feeling good; Chills; Fever/it was a low grade fever of about 99.5; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 13Jan2021 19:40 at single dose for COVID-19 immunization. Medical history included blood pressure occasionally and it was high when the patient did not get much sleep. The patient's concomitant medications were not reported. The patient was a healthcare worker and the patient just got his second COVID Vaccine last night. The patient just started not feeling good about an hour and a half and then chills and then the patient checked a low grade fever. He had not had a fever in years. It looked like that it was one of the side effects, the patient was not (incomplete sentence), just trying to follow the process. The patient guessed within last couple hours he started not feeling good, headache, chills and then he just checked it half hour before and it was a low grade fever of about 99.5 (on 13Jan2021). The patient's body height just about 6 feet, just like 5'11", weight about 272 lbs. The outcome of the events was unknown.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Weight
Clinical narrative: Not feeling good; Chills; Fever/it was a low grade fever of about 99.5; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 13Jan2021 19:40 at single dose for COVID-19 immunization. Medical history included blood pressure occasionally and it was high when the patient did not get much sleep. The patient's concomitant medications were not reported. The patient was a healthcare worker and the patient just got his second COVID Vaccine last night. The patient just started not feeling good about an hour and a half and then chills and then the patient checked a low grade fever. He had not had a fever in years. It looked like that it was one of the side effects, the patient was not (incomplete sentence), just trying to follow the process. The patient guessed within last couple hours he started not feeling good, headache, chills and then he just checked it half hour before and it was a low grade fever of about 99.5 (on 13Jan2021). The patient's body height just about 6 feet, just like 5'11", weight about 272 lbs. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Dyspepsia
Clinical narrative: Heartburn; This is a spontaneous report from a contactable nurse (patient).  A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced heartburn on an unspecified date with outcome of unknown.  Information on Lot/Batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeding disorder, Gingival disorder, Gingival erythema, Gingival pain
Clinical narrative: Tiredness; mouth sores; it looked red and swollen and it hurt; patient cannot really eat; gum inside cheek have white spots on it; it looked red and swollen and it hurt; it looked red and swollen and it hurt; It was more of the cheek inside the mouth, that's painful; It was not open sore but it was just red; Tenderness of lymph nodes/Lymph node is kind of tender; swelling of the lymph node; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: not sure EL3249 or EU3249), via an unspecified route of administration on 11Jan2021 at single dose at left deltoid for covid-19 immunization. Medical history included hypertension, hypothyroidism, heartburn. Concomitant medications included levothyroxine for hypothyroidism, olmesartan, hydrochlorothiazide, amlodipine, omeprazole for heartburn, alprazolam. Patient had the tiredness, mouth sores or something like that in Jan2021. When patient look at her cheek, the gum inside cheek have white spots on it and it looked red and swollen and it hurt, especially the left side and that bothered patient because patient cannot really eat and it hurt. It was more of the cheek inside the mouth, that's painful. It's not open sore but it's just red and like tender. And also patient had a tenderness of lymph nodes on the left neck. For causality, the patient thought so because nothing has changed since before patient got the vaccine. Patient didn't have any of this, especially the sore in the mouth. Patient cannot eat on the left side because it hurt. But the rest of the symptoms which was the tiredness and the swelling of the lymph node, lymph node was kind of tender but it's only on the left side, that's listed as the side effects. But the sores in the mouth was not listed that's why patient was worried about that. Lab work: results were okay. The tiredness, it was like patient got it in the morning, so patient slept. Patient went straight after work, then patient slept. When patient started getting ready for work and the alarm went off, patient was extra tired so I called out sick, but patient was okay. For treatment, patient took naproxen sodium (ALEVE) and then, because patient was at work and yesterday it was really bothering patient because it was hurting. It started hurting really more when the evening was on. Then patient took paracetamol (TYLENOL), then the nystatin solution, patient tried to swish and it helped a little bit with the pain. Due date for the next dose was 08Feb2021. Outcome of events was unknown.   Information on the lot/ batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival swelling, Investigation, Lymph node pain, Lymphadenopathy, Oral mucosal erythema
Clinical narrative: Tiredness; mouth sores; it looked red and swollen and it hurt; patient cannot really eat; gum inside cheek have white spots on it; it looked red and swollen and it hurt; it looked red and swollen and it hurt; It was more of the cheek inside the mouth, that's painful; It was not open sore but it was just red; Tenderness of lymph nodes/Lymph node is kind of tender; swelling of the lymph node; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: not sure EL3249 or EU3249), via an unspecified route of administration on 11Jan2021 at single dose at left deltoid for covid-19 immunization. Medical history included hypertension, hypothyroidism, heartburn. Concomitant medications included levothyroxine for hypothyroidism, olmesartan, hydrochlorothiazide, amlodipine, omeprazole for heartburn, alprazolam. Patient had the tiredness, mouth sores or something like that in Jan2021. When patient look at her cheek, the gum inside cheek have white spots on it and it looked red and swollen and it hurt, especially the left side and that bothered patient because patient cannot really eat and it hurt. It was more of the cheek inside the mouth, that's painful. It's not open sore but it's just red and like tender. And also patient had a tenderness of lymph nodes on the left neck. For causality, the patient thought so because nothing has changed since before patient got the vaccine. Patient didn't have any of this, especially the sore in the mouth. Patient cannot eat on the left side because it hurt. But the rest of the symptoms which was the tiredness and the swelling of the lymph node, lymph node was kind of tender but it's only on the left side, that's listed as the side effects. But the sores in the mouth was not listed that's why patient was worried about that. Lab work: results were okay. The tiredness, it was like patient got it in the morning, so patient slept. Patient went straight after work, then patient slept. When patient started getting ready for work and the alarm went off, patient was extra tired so I called out sick, but patient was okay. For treatment, patient took naproxen sodium (ALEVE) and then, because patient was at work and yesterday it was really bothering patient because it was hurting. It started hurting really more when the evening was on. Then patient took paracetamol (TYLENOL), then the nystatin solution, patient tried to swish and it helped a little bit with the pain. Due date for the next dose was 08Feb2021. Outcome of events was unknown.   Information on the lot/ batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pain, Stomatitis
Clinical narrative: Tiredness; mouth sores; it looked red and swollen and it hurt; patient cannot really eat; gum inside cheek have white spots on it; it looked red and swollen and it hurt; it looked red and swollen and it hurt; It was more of the cheek inside the mouth, that's painful; It was not open sore but it was just red; Tenderness of lymph nodes/Lymph node is kind of tender; swelling of the lymph node; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: not sure EL3249 or EU3249), via an unspecified route of administration on 11Jan2021 at single dose at left deltoid for covid-19 immunization. Medical history included hypertension, hypothyroidism, heartburn. Concomitant medications included levothyroxine for hypothyroidism, olmesartan, hydrochlorothiazide, amlodipine, omeprazole for heartburn, alprazolam. Patient had the tiredness, mouth sores or something like that in Jan2021. When patient look at her cheek, the gum inside cheek have white spots on it and it looked red and swollen and it hurt, especially the left side and that bothered patient because patient cannot really eat and it hurt. It was more of the cheek inside the mouth, that's painful. It's not open sore but it's just red and like tender. And also patient had a tenderness of lymph nodes on the left neck. For causality, the patient thought so because nothing has changed since before patient got the vaccine. Patient didn't have any of this, especially the sore in the mouth. Patient cannot eat on the left side because it hurt. But the rest of the symptoms which was the tiredness and the swelling of the lymph node, lymph node was kind of tender but it's only on the left side, that's listed as the side effects. But the sores in the mouth was not listed that's why patient was worried about that. Lab work: results were okay. The tiredness, it was like patient got it in the morning, so patient slept. Patient went straight after work, then patient slept. When patient started getting ready for work and the alarm went off, patient was extra tired so I called out sick, but patient was okay. For treatment, patient took naproxen sodium (ALEVE) and then, because patient was at work and yesterday it was really bothering patient because it was hurting. It started hurting really more when the evening was on. Then patient took paracetamol (TYLENOL), then the nystatin solution, patient tried to swish and it helped a little bit with the pain. Due date for the next dose was 08Feb2021. Outcome of events was unknown.   Information on the lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis, Sinus disorder
Clinical narrative: Had a lot of sinus; Bloody nose; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3248), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Patient had the Covid vaccine shot last Friday (08Jan2021) and then Saturday patient started with symptoms and now patient had a lot of sinus and patient had a bloody nose in Jan2021. It was asked if people have been calling in with this as a side effect of the COVID. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: My whole body aches, it really aches; In every joint, my body seems to ache; My whole body aches, it really aches; In every joint, my body seems to ache; This is a spontaneous report from a contactable Consumer (patient). A patient of unspecified age and gender received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) , via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced whole body aches, it really aches; in every joint, body seems to ache. The outcome of events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Fatigue, Headache
Clinical narrative: Chills; Headache; Fatigue; Feel like I am burning; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated "I took the first dose of the Pfizer yesterday and I am experiencing like a (chills), headache and fatigue. I feel like I am burning. So, which kind of medication can I take? Can you take Tylenol or Ibuprofen (for treatment)." The outcome of the events was unknown.  Information on Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: it blocked the effect of vaccine; patient did not have antibodies; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable nurse. This nurse reported same events for two patients (patient's mother and her son). This is the second of two reports.   A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration first dose on 23Dec2020 at a single dose (lot number: EL1284) at a single dose and second dose on 11Jan2021 at a single dose (lot number: EL3246) for COVID-19 immunization; prednisone, via an unspecified route of administration from an unspecified date at 40 mg; famotidine (PEPCID), fexofenadine hydrochloride (ALLEGRA) and montelukast sodium (SINGULAIR), all via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. Medical history included psoriasis, severe allergies and anaphylactic reactions. There were no concomitant medications. The patient's mother and the patient had a history of anaphylactic reactions so their doctor recommended to take a series of prednisone 40 mg for 3 days along with famotidine, fexofenadine hydrochloride and montelukast sodium, to prevent an anaphylactic reaction. Around 2-3 weeks after the first shot, the patient did not have antibodies; maybe it was the steroid (unspecified medication) and he did not have a reaction. He took the second shot this week Monday but he still had no antibodies. The patient's mother was wondering if the reason might be from the pre-medications as the patient was not on any other medications. He received the vaccine in the hospital. The reporter considered that the event was related to the medications that the patient took (prednisone, famotidine, fexofenadine hydrochloride and montelukast sodium), she guessed that it blocked the effect of vaccine and that was why it was not going up yet. Outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021029933 Same reporter, product, events, different patient
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Inappropriate schedule of product administration, Malaise, Pyrexia
Clinical narrative: Fever; Injection site tenderness/ the injection site was tender; Chills; Feeling unwell; Her first shot of the COVID vaccine was 06Jan2021, she is coming up on 03Feb2021 for her second shot; This is a spontaneous report from a contactable pharmacist. A female patient in her middle of 20s received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 from Nov2020 (not ongoing), sick from Nov2020 (not ongoing). The patient had the COVID from Nov2020 during the Holiday and she was sick for about 10 days and then she was fine. There were no concomitant medications. Her first shot of the COVID vaccine was 06Jan2021 and she did okay with that. She did have some side effects which everybody has but she is coming up on 03Feb2021 for her second shot (onset date is Jan2021). The patient experienced fever, injection site tenderness, chills and feeling unwell all in Jan2021. The patient didn't have any strong side effects. She had fever, of course the injection site was tender and she had some chills and no nausea, just feeling unwell. She was okay there and that was about it. The outcome of the events was unknown. The reporter considered that the events was related to BNT162B2.  Information on Lot/ Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Fever; Injection site tenderness/ the injection site was tender; Chills; Feeling unwell; Her first shot of the COVID vaccine was 06Jan2021, she is coming up on 03Feb2021 for her second shot; This is a spontaneous report from a contactable pharmacist. A female patient in her middle of 20s received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 from Nov2020 (not ongoing), sick from Nov2020 (not ongoing). The patient had the COVID from Nov2020 during the Holiday and she was sick for about 10 days and then she was fine. There were no concomitant medications. Her first shot of the COVID vaccine was 06Jan2021 and she did okay with that. She did have some side effects which everybody has but she is coming up on 03Feb2021 for her second shot (onset date is Jan2021). The patient experienced fever, injection site tenderness, chills and feeling unwell all in Jan2021. The patient didn't have any strong side effects. She had fever, of course the injection site was tender and she had some chills and no nausea, just feeling unwell. She was okay there and that was about it. The outcome of the events was unknown. The reporter considered that the events was related to BNT162B2.  Information on Lot/ Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I did not clarify if the patient had shingles before the COVID Vaccine; This is a spontaneous report from a contactable pharmacist via a Pfizer sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist had a patient did the COVID vaccine the previous day and was being prescribed Valtrex (treatment) for shingles. The pharmacist clarified the patient has not started the Valtrex yet, but the pharmacist did not clarify if the patient had shingles before the COVID Vaccine. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: have been exposed with tested positive lady; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced have been exposed with tested positive lady. The patient had not got second shot yet. The outcome of event was unknown.    Information on the Batch/Lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dry mouth, Dysuria
Clinical narrative: Tried to urinate; cannot urinate; Felt my mouth was extremely dry; This is a spontaneous report from a contactable consumer reporting for her/him self. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated, "I got my vaccine, first vaccination shot yesterday, and I am having some problems. Everything worked fine, except this morning or very early in the morning (15Jan2021), I tried to urinate and I cannot urinate. And I felt my mouth was extremely dry." The outcome of the events were unknown.   Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Limb injury
Clinical narrative: her whole left arm was hurting with the first dose of the vaccine; This is a spontaneous report from a contactable consumer (patient herself). A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9599, expiration date: 31Mar2021), via an unspecified route of administration on 26Dec2020 in left arm at single dose for COVID-19 immunization. Medical history included overweight, diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient's concomitant medications were not reported.  The patient stated that her whole left arm was hurting with the first dose of the vaccine on 26Dec2020. She stated that she took a couple of ibuprofen (ADVIL) for event.  Outcome of event was recovered on 28Dec2020.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Viral test negative
Clinical narrative: Rught MCA Stroke; This is a spontaneous report from a contactable nurse (patient). A 39 years old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscular on 16Dec2020 10:15 at the first single dose at right arm for covid-19 immunisation.  Medical history included Hodgkin's disease.  Concomitant medication included colecalciferol (VITAMIN D3 1000).  The patient experienced rught MCA stroke on 25Dec2020 06:15. Seriousness criteria reported as hospitalization, life threatening. The patient was hospitalized for rught MCA stroke for 3 days.  The patient underwent lab tests and procedures which included Nasal Swab: negative on 25Dec2020.  The patient received unspecified treatment  for rught MCA stroke. The outcome of event was recovered.; Sender's Comments: The subject had medical history included Hodgkin's disease.  The reported stroke was more likely an intercurrent disease, and unlikely causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Atrial septal defect, Atrial septal defect repair, Cerebrovascular accident, Computerised tomogram
Clinical narrative: Rught MCA Stroke; This is a spontaneous report from a contactable nurse (patient). A 39 years old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscular on 16Dec2020 10:15 at the first single dose at right arm for covid-19 immunisation.  Medical history included Hodgkin's disease.  Concomitant medication included colecalciferol (VITAMIN D3 1000).  The patient experienced rught MCA stroke on 25Dec2020 06:15. Seriousness criteria reported as hospitalization, life threatening. The patient was hospitalized for rught MCA stroke for 3 days.  The patient underwent lab tests and procedures which included Nasal Swab: negative on 25Dec2020.  The patient received unspecified treatment  for rught MCA stroke. The outcome of event was recovered.; Sender's Comments: The subject had medical history included Hodgkin's disease.  The reported stroke was more likely an intercurrent disease, and unlikely causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disorganised speech, Echocardiogram, Electrocardiogram, Facial paralysis, Laboratory test
Clinical narrative: Rught MCA Stroke; This is a spontaneous report from a contactable nurse (patient). A 39 years old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscular on 16Dec2020 10:15 at the first single dose at right arm for covid-19 immunisation.  Medical history included Hodgkin's disease.  Concomitant medication included colecalciferol (VITAMIN D3 1000).  The patient experienced rught MCA stroke on 25Dec2020 06:15. Seriousness criteria reported as hospitalization, life threatening. The patient was hospitalized for rught MCA stroke for 3 days.  The patient underwent lab tests and procedures which included Nasal Swab: negative on 25Dec2020.  The patient received unspecified treatment  for rught MCA stroke. The outcome of event was recovered.; Sender's Comments: The subject had medical history included Hodgkin's disease.  The reported stroke was more likely an intercurrent disease, and unlikely causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Monoplegia, Thrombosis, Ultrasound Doppler
Clinical narrative: Rught MCA Stroke; This is a spontaneous report from a contactable nurse (patient). A 39 years old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscular on 16Dec2020 10:15 at the first single dose at right arm for covid-19 immunisation.  Medical history included Hodgkin's disease.  Concomitant medication included colecalciferol (VITAMIN D3 1000).  The patient experienced rught MCA stroke on 25Dec2020 06:15. Seriousness criteria reported as hospitalization, life threatening. The patient was hospitalized for rught MCA stroke for 3 days.  The patient underwent lab tests and procedures which included Nasal Swab: negative on 25Dec2020.  The patient received unspecified treatment  for rught MCA stroke. The outcome of event was recovered.; Sender's Comments: The subject had medical history included Hodgkin's disease.  The reported stroke was more likely an intercurrent disease, and unlikely causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This is a spontaneous report from a contactable consumer (patient's husband). A 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 (yesterday) at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not feeling well in Jan2021 with outcome of unknown.   Pfizer is a marketing authorization holder of [BNT162B2] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [BNT162B2] has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Soreness in the arm; This is Spontaneous report from a contactable other healthcare professional (patient). A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. Medical history included blood pressure (ongoing), cholesterol (ongoing) and heart issues. Ongoing concomitant medication included losartan for blood pressure, rosuvastatin calcium (CRESTOR) for cholesterol. The patient experienced soreness in the arm, nothing spectacular on an unspecified date. The patient is a dentist, dental surgeon.  For the soreness that was, just for an hour and two. There was no other consequences whatsoever. The patient did a COVID test a little over week ago in Jan2021, it came negative. The patient had no treatment for the event. The outcome of the event was unknown.