chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin
Clinical narrative: Severe pain where the shot was given. Unable to raise arm, unable to sleep on the left arm. 05/26 Fever of 101. 3  05/26 Skin sensitive to touch on whole body, restless body, upper back pain.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes left side
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Saline diluent used a second time for a second pfizer vial . No adverse events reported
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests normal, Computerised tomogram, Nausea, Parosmia, Tinnitus
Clinical narrative: started to smell things not present to others - initially I thought something was burning. occasionally it will make me a little nauseous. It was happening once or twice a day. I was given essential oils to smell twice a day for one minute for 12 weeks. I am in week 8. Now I rarely smell the smell. Also I now have a constant ringing in my head. sounds like a TV was left on after the broadcasting stopped.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: NURSE GAVE A .6CC INJECTION INSTEAD OF .3CC
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Saline diluent used a second time for a second pfizer vial . No adverse events reported
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Muscle strain
Clinical narrative: Presented as a pulled muscle in the left chest/lung area.  No SOB, just pain and tightness in the chest.  Began after the second vaccine and occurred on and off for about 2-3 weeks.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: NURSE GAVE .6CC INJECTION, SHOULD HAVE BEEN .3CC
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Saline diluent used a second time for a second pfizer vial . No adverse events reported
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Inflammation, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Warm, itchy red skin at the site of injection. Noticeable at 9 pm two days after the vaccine. The skin around the injection looks inflamed and slightly bubbly. Skin hurts, with a burning-like pain, when touched.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Tenderness
Clinical narrative: Warm, itchy red skin at the site of injection. Noticeable at 9 pm two days after the vaccine. The skin around the injection looks inflamed and slightly bubbly. Skin hurts, with a burning-like pain, when touched.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Saline diluent used a second time for a second pfizer vial . No adverse events reported
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Peripheral swelling, Rash, Rash macular, Skin haemorrhage
Clinical narrative: Patient report to have developed red blotches all over both lower extremities a few weeks after receiving first covid vaccine. Leg began to swell with bleeding and open sores. Required hospitalization 4/22/21.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin ulcer
Clinical narrative: Patient report to have developed red blotches all over both lower extremities a few weeks after receiving first covid vaccine. Leg began to swell with bleeding and open sores. Required hospitalization 4/22/21.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Lip swelling, Swelling face
Clinical narrative: Patient states about 1 hour after receiving pfizer  Covid-19 vaccine she had left-sided facial swelling  and a numbing sensation of the face along with lip  swelling . she complains of Left upper extremity and  injection site pain .
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: - Swollen arm - Pain at the site oF injection  - Arm is warm. - Entire arm hurts.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Malaise, Nausea
Clinical narrative: Patient got 2nd shot and 10 minutes after started feeling sick, nausea, chills and sweating said fell like blood pressure dropping. Paramedics were called in and she left with them.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Peripheral swelling, X-ray
Clinical narrative: Right upper arm swelling
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Urticaria
Clinical narrative: hives across chest, both arms and upper back-hot flashes (not related to menopause)
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Affective disorder, Angina pectoris, Antinuclear antibody negative, Arthralgia
Clinical narrative: swollen and painful hands, extreme exhaustion, eye floaters, blurred vision, fever, then hypothermia, trembling, confusion, widespread myalgia and joint issues of hips, feet, back, both legs, shoulders, new costochondritis, new chronic tachacardia, new angina, new mental and mood disorders, new suicidal thoughts, new excessive mobility issues still ongoing, beginning of kidney failure, left hip extreme pain, loss of freedom, driving, all coming and going for 12 weeks plus. No labs can determine any distinct reason for disabilities, everything is from Covid vaccine. SEVERE adverse reaction, also happening to my Father no end in sight, new allergies to routine medications skin reactions to routine procedures, rash
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Blood test, Borrelia test negative, Computerised tomogram thorax normal, Confusional state
Clinical narrative: swollen and painful hands, extreme exhaustion, eye floaters, blurred vision, fever, then hypothermia, trembling, confusion, widespread myalgia and joint issues of hips, feet, back, both legs, shoulders, new costochondritis, new chronic tachacardia, new angina, new mental and mood disorders, new suicidal thoughts, new excessive mobility issues still ongoing, beginning of kidney failure, left hip extreme pain, loss of freedom, driving, all coming and going for 12 weeks plus. No labs can determine any distinct reason for disabilities, everything is from Covid vaccine. SEVERE adverse reaction, also happening to my Father no end in sight, new allergies to routine medications skin reactions to routine procedures, rash
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Costochondritis, Disability, Drug hypersensitivity, Electrocardiogram abnormal, Electrocardiogram ambulatory normal
Clinical narrative: swollen and painful hands, extreme exhaustion, eye floaters, blurred vision, fever, then hypothermia, trembling, confusion, widespread myalgia and joint issues of hips, feet, back, both legs, shoulders, new costochondritis, new chronic tachacardia, new angina, new mental and mood disorders, new suicidal thoughts, new excessive mobility issues still ongoing, beginning of kidney failure, left hip extreme pain, loss of freedom, driving, all coming and going for 12 weeks plus. No labs can determine any distinct reason for disabilities, everything is from Covid vaccine. SEVERE adverse reaction, also happening to my Father no end in sight, new allergies to routine medications skin reactions to routine procedures, rash
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypothermia, Impaired driving ability, Laboratory test normal, Loss of personal independence in daily activities
Clinical narrative: swollen and painful hands, extreme exhaustion, eye floaters, blurred vision, fever, then hypothermia, trembling, confusion, widespread myalgia and joint issues of hips, feet, back, both legs, shoulders, new costochondritis, new chronic tachacardia, new angina, new mental and mood disorders, new suicidal thoughts, new excessive mobility issues still ongoing, beginning of kidney failure, left hip extreme pain, loss of freedom, driving, all coming and going for 12 weeks plus. No labs can determine any distinct reason for disabilities, everything is from Covid vaccine. SEVERE adverse reaction, also happening to my Father no end in sight, new allergies to routine medications skin reactions to routine procedures, rash
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Mental disorder, Mobility decreased, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: swollen and painful hands, extreme exhaustion, eye floaters, blurred vision, fever, then hypothermia, trembling, confusion, widespread myalgia and joint issues of hips, feet, back, both legs, shoulders, new costochondritis, new chronic tachacardia, new angina, new mental and mood disorders, new suicidal thoughts, new excessive mobility issues still ongoing, beginning of kidney failure, left hip extreme pain, loss of freedom, driving, all coming and going for 12 weeks plus. No labs can determine any distinct reason for disabilities, everything is from Covid vaccine. SEVERE adverse reaction, also happening to my Father no end in sight, new allergies to routine medications skin reactions to routine procedures, rash
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Renal failure, Rheumatoid factor increased, Skin reaction
Clinical narrative: swollen and painful hands, extreme exhaustion, eye floaters, blurred vision, fever, then hypothermia, trembling, confusion, widespread myalgia and joint issues of hips, feet, back, both legs, shoulders, new costochondritis, new chronic tachacardia, new angina, new mental and mood disorders, new suicidal thoughts, new excessive mobility issues still ongoing, beginning of kidney failure, left hip extreme pain, loss of freedom, driving, all coming and going for 12 weeks plus. No labs can determine any distinct reason for disabilities, everything is from Covid vaccine. SEVERE adverse reaction, also happening to my Father no end in sight, new allergies to routine medications skin reactions to routine procedures, rash
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Suicidal ideation, Tachycardia, Tremor, Vision blurred, Vitreous floaters
Clinical narrative: swollen and painful hands, extreme exhaustion, eye floaters, blurred vision, fever, then hypothermia, trembling, confusion, widespread myalgia and joint issues of hips, feet, back, both legs, shoulders, new costochondritis, new chronic tachacardia, new angina, new mental and mood disorders, new suicidal thoughts, new excessive mobility issues still ongoing, beginning of kidney failure, left hip extreme pain, loss of freedom, driving, all coming and going for 12 weeks plus. No labs can determine any distinct reason for disabilities, everything is from Covid vaccine. SEVERE adverse reaction, also happening to my Father no end in sight, new allergies to routine medications skin reactions to routine procedures, rash
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Asthenia, Back pain, Chest pain, Dyspnoea
Clinical narrative: Insomnia, muscle aches and weakness. Back pain, severe headaches, fatigue. Abnormal D-Dimer levels. Shortness of breathe and chest pain.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Fibrin D dimer increased, Headache, Insomnia, Myalgia
Clinical narrative: Insomnia, muscle aches and weakness. Back pain, severe headaches, fatigue. Abnormal D-Dimer levels. Shortness of breathe and chest pain.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: Insomnia, muscle aches and weakness. Back pain, severe headaches, fatigue. Abnormal D-Dimer levels. Shortness of breathe and chest pain.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated
Clinical narrative: Joint pain and arthralgia
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Beginning around date/time listed in #5, felt and to some extent since (severity varying) felt diziness and vertigo-style-consiousness I have not experienced anything resembling since at least the second half of 2005 when I sustained a massive blunt-force-concussion & post concussion syndrome which didn't dissipate for a couple of years.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Feeling abnormal, Fibrin D dimer increased, Genital rash
Clinical narrative: Violently Ill, bodyaches, brain fog, rash in the left groin to knee area. Raised D-dimer test.  Muscle aches and weakness.  Joint pain and frequent headaches. Bladder leakage and her blood pressure has been elevated since vaccine.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain, Rash, Urinary incontinence
Clinical narrative: Violently Ill, bodyaches, brain fog, rash in the left groin to knee area. Raised D-dimer test.  Muscle aches and weakness.  Joint pain and frequent headaches. Bladder leakage and her blood pressure has been elevated since vaccine.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Irritability, Pyrexia
Clinical narrative: fever and fussy for 5 days.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Discomfort, Headache, Hyperhidrosis
Clinical narrative: Terrible pain, heachace, worst flu like symptoms, chills, fever, sweats, loss of energy, 24 hours, slept all day, very uncomfortable, 2nd day 30% better, still headache, achy
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Influenza like illness, Pain, Pyrexia
Clinical narrative: Terrible pain, heachace, worst flu like symptoms, chills, fever, sweats, loss of energy, 24 hours, slept all day, very uncomfortable, 2nd day 30% better, still headache, achy
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pain in extremity
Clinical narrative: Left arm pain inflammation.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Blood test, Chest pain, Chest scan abnormal, Fibrin D dimer
Clinical narrative: No symptoms for first two weeks post-vaccine. After ~16 days, I began having chest pain on the left side (later determined pleurisy denoting something underlying). I waited 24 hours and was still having chest pain, so went to the ER. After several tests/scans, they determined I had multiple PEs (pulmonary embolisms/blood clots in both lungs). I was hospitalized for two nights/three days while they gave me blood thinners through IV (argatroban). To note, no shortness-of-breath, oxygen at 99-100% throughout this experience. I was released on Day 3 with direction to take Eliquis/blood thinner pills (5mg 2x/day) and follow up with a hematologist, who recommended a blood coagulation work-up to determine if I had something underlying aside from the vaccine which may have caused the clots. My chest pain/pleurisy went away within a week after hospitalization. After seeing the hematologist (three weeks post-hospitalization,) all tests showed negative (no underlying trait causing clots,) so doctor recommending thinners for six months, then will re-evaluate. I will also add that I have had one other experience with blood clots ~ 15 years ago when I took birth control pills (multiple PEs that time, too.) I was put on blood thinners at that time as well for nine months, and was simply told I could not/should not take birth control pills thereafter, and I have not had any clotting issues since then until this vaccine experience. (I now also have tingling feet/ankles which began in the hospital, so not sure if this is due to the vaccine or the blood thinners. This occurs on and off throughout every day now. I plan to inquire with a PCP soon if it persists.)
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Haematology test normal, Paraesthesia, Platelet count decreased, Pleurisy, Pulmonary embolism
Clinical narrative: No symptoms for first two weeks post-vaccine. After ~16 days, I began having chest pain on the left side (later determined pleurisy denoting something underlying). I waited 24 hours and was still having chest pain, so went to the ER. After several tests/scans, they determined I had multiple PEs (pulmonary embolisms/blood clots in both lungs). I was hospitalized for two nights/three days while they gave me blood thinners through IV (argatroban). To note, no shortness-of-breath, oxygen at 99-100% throughout this experience. I was released on Day 3 with direction to take Eliquis/blood thinner pills (5mg 2x/day) and follow up with a hematologist, who recommended a blood coagulation work-up to determine if I had something underlying aside from the vaccine which may have caused the clots. My chest pain/pleurisy went away within a week after hospitalization. After seeing the hematologist (three weeks post-hospitalization,) all tests showed negative (no underlying trait causing clots,) so doctor recommending thinners for six months, then will re-evaluate. I will also add that I have had one other experience with blood clots ~ 15 years ago when I took birth control pills (multiple PEs that time, too.) I was put on blood thinners at that time as well for nine months, and was simply told I could not/should not take birth control pills thereafter, and I have not had any clotting issues since then until this vaccine experience. (I now also have tingling feet/ankles which began in the hospital, so not sure if this is due to the vaccine or the blood thinners. This occurs on and off throughout every day now. I plan to inquire with a PCP soon if it persists.)
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Scan normal, Ultrasound Doppler normal
Clinical narrative: No symptoms for first two weeks post-vaccine. After ~16 days, I began having chest pain on the left side (later determined pleurisy denoting something underlying). I waited 24 hours and was still having chest pain, so went to the ER. After several tests/scans, they determined I had multiple PEs (pulmonary embolisms/blood clots in both lungs). I was hospitalized for two nights/three days while they gave me blood thinners through IV (argatroban). To note, no shortness-of-breath, oxygen at 99-100% throughout this experience. I was released on Day 3 with direction to take Eliquis/blood thinner pills (5mg 2x/day) and follow up with a hematologist, who recommended a blood coagulation work-up to determine if I had something underlying aside from the vaccine which may have caused the clots. My chest pain/pleurisy went away within a week after hospitalization. After seeing the hematologist (three weeks post-hospitalization,) all tests showed negative (no underlying trait causing clots,) so doctor recommending thinners for six months, then will re-evaluate. I will also add that I have had one other experience with blood clots ~ 15 years ago when I took birth control pills (multiple PEs that time, too.) I was put on blood thinners at that time as well for nine months, and was simply told I could not/should not take birth control pills thereafter, and I have not had any clotting issues since then until this vaccine experience. (I now also have tingling feet/ankles which began in the hospital, so not sure if this is due to the vaccine or the blood thinners. This occurs on and off throughout every day now. I plan to inquire with a PCP soon if it persists.)
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Livedo reticularis, Paraesthesia
Clinical narrative: The IM injection was given very high on the Left  Arm/shoulder area. I immediately felt a shock when it was injected then arm started to burn, tingle, pins and needles  started swelling. Notified Nurse
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Electric shock sensation, Neurological symptom, Paraesthesia, Peripheral swelling
Clinical narrative: The IM injection was given very high on the Left  Arm/shoulder area. I immediately felt a shock when it was injected then arm started to burn, tingle, pins and needles  started swelling. Notified Nurse
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: The IM injection was given very high on the Left  Arm/shoulder area. I immediately felt a shock when it was injected then arm started to burn, tingle, pins and needles  started swelling. Notified Nurse
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Myocardial infarction
Clinical narrative: Death
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Injection site swelling
Clinical narrative: Death
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Confusional state, Erythema, Feeling hot, Urticaria
Clinical narrative: Approximately 30 minutes after administration of vaccine, I started to feel like I couldn't concentrate or think properly. Shortly after that, I started feeling very hot. It was an immediate hot feeling all over my body and was I started sweating. Then I was told that I was red and checked myself out and was bright red all over my body.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disturbance in attention, Erythema, Fatigue, Feeding disorder, Feeling hot
Clinical narrative: Approximately 30 minutes after administration of vaccine, I started to feel like I couldn't concentrate or think properly. Shortly after that, I started feeling very hot. It was an immediate hot feeling all over my body and was I started sweating. Then I was told that I was red and checked myself out and was bright red all over my body.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Impaired work ability, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Approximately 30 minutes after administration of vaccine, I started to feel like I couldn't concentrate or think properly. Shortly after that, I started feeling very hot. It was an immediate hot feeling all over my body and was I started sweating. Then I was told that I was red and checked myself out and was bright red all over my body.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Mobility decreased, Nausea, Pyrexia, Thinking abnormal
Clinical narrative: Approximately 30 minutes after administration of vaccine, I started to feel like I couldn't concentrate or think properly. Shortly after that, I started feeling very hot. It was an immediate hot feeling all over my body and was I started sweating. Then I was told that I was red and checked myself out and was bright red all over my body.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Dizziness, Electrocardiogram, Gastrointestinal disorder
Clinical narrative: Labile BP; Rapid heart rate; Migraines; Body aches; Chest pain and tightness; Chest pain and tightness; Inflammation; This is a spontaneous report from a contactable other hcp (parent). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), dose 1 intramuscular, administered in right arm on 22Dec2020 15:00 as 1st dose, single for covid-19 immunisation. Medical history included covid-19. The patient's concomitant medications were not reported. There is no other vaccine in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, covid test type post vaccination was Nasal Swab on 29Dec2020, covid test result was negative. Starting 5 days post vaccine (26Dec2020 18:00), ongoing symptoms of labile BP; rapid heart rate; migraines; body aches; chest pain and tightness; inflammation. Now going on 6 months of ongoing issues that have resulted in 4 ED visits, multiple tests and numerous doctor's office visits. There is some treatment (Medication) for AE. The adverse event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of the events was resolving.; Sender's Comments: Based on known safety  profile it  is unlikely that the reported events were causally related to  bnt162b2.  These are probably  intercurrent  medical conditions. Case will be reassessed if additional information is received.   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 Committees and Investigators, as appropriate.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hypertension, Palpitations, Ultrasound scan
Clinical narrative: Labile BP; Rapid heart rate; Migraines; Body aches; Chest pain and tightness; Chest pain and tightness; Inflammation; This is a spontaneous report from a contactable other hcp (parent). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), dose 1 intramuscular, administered in right arm on 22Dec2020 15:00 as 1st dose, single for covid-19 immunisation. Medical history included covid-19. The patient's concomitant medications were not reported. There is no other vaccine in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, covid test type post vaccination was Nasal Swab on 29Dec2020, covid test result was negative. Starting 5 days post vaccine (26Dec2020 18:00), ongoing symptoms of labile BP; rapid heart rate; migraines; body aches; chest pain and tightness; inflammation. Now going on 6 months of ongoing issues that have resulted in 4 ED visits, multiple tests and numerous doctor's office visits. There is some treatment (Medication) for AE. The adverse event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of the events was resolving.; Sender's Comments: Based on known safety  profile it  is unlikely that the reported events were causally related to  bnt162b2.  These are probably  intercurrent  medical conditions. Case will be reassessed if additional information is received.   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 Committees and Investigators, as appropriate.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Heart rate increased, Inflammation, Labile blood pressure
Clinical narrative: Labile BP; Rapid heart rate; Migraines; Body aches; Chest pain and tightness; Chest pain and tightness; Inflammation; This is a spontaneous report from a contactable other hcp (parent). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), dose 1 intramuscular, administered in right arm on 22Dec2020 15:00 as 1st dose, single for covid-19 immunisation. Medical history included covid-19. The patient's concomitant medications were not reported. There is no other vaccine in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, covid test type post vaccination was Nasal Swab on 29Dec2020, covid test result was negative. Starting 5 days post vaccine (26Dec2020 18:00), ongoing symptoms of labile BP; rapid heart rate; migraines; body aches; chest pain and tightness; inflammation. Now going on 6 months of ongoing issues that have resulted in 4 ED visits, multiple tests and numerous doctor's office visits. There is some treatment (Medication) for AE. The adverse event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of the events was resolving.; Sender's Comments: Based on known safety  profile it  is unlikely that the reported events were causally related to  bnt162b2.  These are probably  intercurrent  medical conditions. Case will be reassessed if additional information is received.   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 Committees and Investigators, as appropriate.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Migraine, Pain, SARS-CoV-2 test
Clinical narrative: Labile BP; Rapid heart rate; Migraines; Body aches; Chest pain and tightness; Chest pain and tightness; Inflammation; This is a spontaneous report from a contactable other hcp (parent). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), dose 1 intramuscular, administered in right arm on 22Dec2020 15:00 as 1st dose, single for covid-19 immunisation. Medical history included covid-19. The patient's concomitant medications were not reported. There is no other vaccine in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, covid test type post vaccination was Nasal Swab on 29Dec2020, covid test result was negative. Starting 5 days post vaccine (26Dec2020 18:00), ongoing symptoms of labile BP; rapid heart rate; migraines; body aches; chest pain and tightness; inflammation. Now going on 6 months of ongoing issues that have resulted in 4 ED visits, multiple tests and numerous doctor's office visits. There is some treatment (Medication) for AE. The adverse event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of the events was resolving.; Sender's Comments: Based on known safety  profile it  is unlikely that the reported events were causally related to  bnt162b2.  These are probably  intercurrent  medical conditions. Case will be reassessed if additional information is received.   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 Committees and Investigators, as appropriate.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure decreased, Blood pressure increased, Headache, Nausea, SARS-CoV-2 test negative
Clinical narrative: Labile BP; Rapid heart rate; Migraines; Body aches; Chest pain and tightness; Chest pain and tightness; Inflammation; This is a spontaneous report from a contactable other hcp (parent). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), dose 1 intramuscular, administered in right arm on 22Dec2020 15:00 as 1st dose, single for covid-19 immunisation. Medical history included covid-19. The patient's concomitant medications were not reported. There is no other vaccine in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, covid test type post vaccination was Nasal Swab on 29Dec2020, covid test result was negative. Starting 5 days post vaccine (26Dec2020 18:00), ongoing symptoms of labile BP; rapid heart rate; migraines; body aches; chest pain and tightness; inflammation. Now going on 6 months of ongoing issues that have resulted in 4 ED visits, multiple tests and numerous doctor's office visits. There is some treatment (Medication) for AE. The adverse event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of the events was resolving.; Sender's Comments: Based on known safety  profile it  is unlikely that the reported events were causally related to  bnt162b2.  These are probably  intercurrent  medical conditions. Case will be reassessed if additional information is received.   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 Committees and Investigators, as appropriate.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Labile BP; Rapid heart rate; Migraines; Body aches; Chest pain and tightness; Chest pain and tightness; Inflammation; This is a spontaneous report from a contactable other hcp (parent). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), dose 1 intramuscular, administered in right arm on 22Dec2020 15:00 as 1st dose, single for covid-19 immunisation. Medical history included covid-19. The patient's concomitant medications were not reported. There is no other vaccine in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19, covid test type post vaccination was Nasal Swab on 29Dec2020, covid test result was negative. Starting 5 days post vaccine (26Dec2020 18:00), ongoing symptoms of labile BP; rapid heart rate; migraines; body aches; chest pain and tightness; inflammation. Now going on 6 months of ongoing issues that have resulted in 4 ED visits, multiple tests and numerous doctor's office visits. There is some treatment (Medication) for AE. The adverse event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of the events was resolving.; Sender's Comments: Based on known safety  profile it  is unlikely that the reported events were causally related to  bnt162b2.  These are probably  intercurrent  medical conditions. Case will be reassessed if additional information is received.   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 Committees and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Low grade fever; Chills; Achy; Swollen lymph nodes; Headache; Blisters on my tongue; Tired; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: not reported), via an unspecified route of administration, administered on left on 27Jan2021 (at age of 58-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient has not received vaccine in four weeks. The patient has not received other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19 .The patient concomitant medications were not reported. The patient had known allergies and had Reaction to Codeine 30 years ago. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: not reported) via an unspecified route of administration 06Jan2021 at 08:30 AM (at age of 58-year-old) on right arm at single dose for COVID-19 immunization. On 28Jan2021 at 01:00 PM, the patient experienced Low grade fever, chills, achy, swollen lymph nodes, headache, tired and blisters on tongue. Th events resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The outcome of the events was recovered.   Information about lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no fur-ther information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative, Tongue blistering
Clinical narrative: Low grade fever; Chills; Achy; Swollen lymph nodes; Headache; Blisters on my tongue; Tired; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: not reported), via an unspecified route of administration, administered on left on 27Jan2021 (at age of 58-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient has not received vaccine in four weeks. The patient has not received other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19 .The patient concomitant medications were not reported. The patient had known allergies and had Reaction to Codeine 30 years ago. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: not reported) via an unspecified route of administration 06Jan2021 at 08:30 AM (at age of 58-year-old) on right arm at single dose for COVID-19 immunization. On 28Jan2021 at 01:00 PM, the patient experienced Low grade fever, chills, achy, swollen lymph nodes, headache, tired and blisters on tongue. Th events resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The outcome of the events was recovered.   Information about lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no fur-ther information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Pain
Clinical narrative: Low grade fever; Chills; Achy; Swollen lymph nodes; Headache; Blisters on my tongue; Tired; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: not reported), via an unspecified route of administration, administered on left on 27Jan2021 (at age of 58-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient has not received vaccine in four weeks. The patient has not received other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19 .The patient concomitant medications were not reported. The patient had known allergies and had Reaction to Codeine 30 years ago. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: not reported) via an unspecified route of administration 06Jan2021 at 08:30 AM (at age of 58-year-old) on right arm at single dose for COVID-19 immunization. On 28Jan2021 at 01:00 PM, the patient experienced Low grade fever, chills, achy, swollen lymph nodes, headache, tired and blisters on tongue. Th events resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The outcome of the events was recovered.   Information about lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no fur-ther information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tongue blistering
Clinical narrative: Low grade fever; Chills; Achy; Swollen lymph nodes; Headache; Blisters on my tongue; Tired; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: not reported), via an unspecified route of administration, administered on left on 27Jan2021 (at age of 58-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient has not received vaccine in four weeks. The patient has not received other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19 .The patient concomitant medications were not reported. The patient had known allergies and had Reaction to Codeine 30 years ago. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: not reported) via an unspecified route of administration 06Jan2021 at 08:30 AM (at age of 58-year-old) on right arm at single dose for COVID-19 immunization. On 28Jan2021 at 01:00 PM, the patient experienced Low grade fever, chills, achy, swollen lymph nodes, headache, tired and blisters on tongue. Th events resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The outcome of the events was recovered.   Information about lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no fur-ther information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chills, Diarrhoea, Dizziness
Clinical narrative: 101 temp for two days.; Chills; sweats; muscle aches and joint all over; muscle aches and joint; headache; severe fatigue; diarrhea; Dizziness; weakness; This is a spontaneous report from a contactable consumer or other non hcp. A 70-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3302; Expiration Date: unknown), via an unspecified route of administration, administered in left right on 29Jan2021 02:15 pm at the age of 70 years old as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no allergies to medications, food, or other products. On 30Jan2021, at 03:00am, the patient experienced 101 temp for two days, Chills, sweats, muscle aches and joint all over, headache, severe fatigue, diarrhea, Dizziness and it my weakness. Reporter considered the events as non-serious. No treatment was received for the adverse event. The patient was diagnosed with COVID-19 prior to vaccination. The patient underwent lab tests and procedures which included body temperature: 101 on 30Jan2021 and result was 101 temp for two days. The outcome of the events was recovered on 30Jan2021.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: 101 temp for two days.; Chills; sweats; muscle aches and joint all over; muscle aches and joint; headache; severe fatigue; diarrhea; Dizziness; weakness; This is a spontaneous report from a contactable consumer or other non hcp. A 70-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3302; Expiration Date: unknown), via an unspecified route of administration, administered in left right on 29Jan2021 02:15 pm at the age of 70 years old as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no allergies to medications, food, or other products. On 30Jan2021, at 03:00am, the patient experienced 101 temp for two days, Chills, sweats, muscle aches and joint all over, headache, severe fatigue, diarrhea, Dizziness and it my weakness. Reporter considered the events as non-serious. No treatment was received for the adverse event. The patient was diagnosed with COVID-19 prior to vaccination. The patient underwent lab tests and procedures which included body temperature: 101 on 30Jan2021 and result was 101 temp for two days. The outcome of the events was recovered on 30Jan2021.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Diarrhoea
Clinical narrative: 101 temp for two days.; Chills; sweats; muscle aches and joint all over; muscle aches and joint; headache; severe fatigue; diarrhea; Dizziness; weakness; This is a spontaneous report from a contactable consumer or other non hcp. A 70-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3302; Expiration Date: unknown), via an unspecified route of administration, administered in left right on 29Jan2021 02:15 pm at the age of 70 years old as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no allergies to medications, food, or other products. On 30Jan2021, at 03:00am, the patient experienced 101 temp for two days, Chills, sweats, muscle aches and joint all over, headache, severe fatigue, diarrhea, Dizziness and it my weakness. Reporter considered the events as non-serious. No treatment was received for the adverse event. The patient was diagnosed with COVID-19 prior to vaccination. The patient underwent lab tests and procedures which included body temperature: 101 on 30Jan2021 and result was 101 temp for two days. The outcome of the events was recovered on 30Jan2021.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: 101 temp for two days.; Chills; sweats; muscle aches and joint all over; muscle aches and joint; headache; severe fatigue; diarrhea; Dizziness; weakness; This is a spontaneous report from a contactable consumer or other non hcp. A 70-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3302; Expiration Date: unknown), via an unspecified route of administration, administered in left right on 29Jan2021 02:15 pm at the age of 70 years old as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no allergies to medications, food, or other products. On 30Jan2021, at 03:00am, the patient experienced 101 temp for two days, Chills, sweats, muscle aches and joint all over, headache, severe fatigue, diarrhea, Dizziness and it my weakness. Reporter considered the events as non-serious. No treatment was received for the adverse event. The patient was diagnosed with COVID-19 prior to vaccination. The patient underwent lab tests and procedures which included body temperature: 101 on 30Jan2021 and result was 101 temp for two days. The outcome of the events was recovered on 30Jan2021.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.