chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Hypoacusis, Vertigo
Clinical narrative: Less than 24 hours after receiving the second vaccine dose, I woke up in the middle of the night to go to the bathroom. I was fine getting out of bed, walking to the bathroom, using the toilet, and getting to the sink. As soon as I turned on the faucet to wash my hands, I was hit with vertigo. The entire room started to spin. I lost my vision and tried to make my way back to the bedroom to wake my husband. Once I got in the bedroom I not only could not see but my hearing became muffled like I was under water. My husband was speaking to me but sounded like he was far away. After about 30 seconds, my vision came back as did my hearing. The vertigo spinning lasted about half that amount of time (15 seconds). I have never had vertigo before in my entire life.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: patient was given Pfizer vaccine when it should have been Moderna dose two
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Communication disorder, Dysarthria, Fatigue, Vertigo
Clinical narrative: Fatigue, weakness for 7 days so far. Neurological symptoms began 2-3 days ago: unable to think of words, saying some things with slurred or mispronounced vowels, tried to scratch nose and stuck my finger in my eye, eyes aren't focusing  right or something like mild vertigo.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Fatigue, weakness for 7 days so far. Neurological symptoms began 2-3 days ago: unable to think of words, saying some things with slurred or mispronounced vowels, tried to scratch nose and stuck my finger in my eye, eyes aren't focusing  right or something like mild vertigo.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Dizziness, Feeling abnormal
Clinical narrative: Feeling of dizziness, lose of feeling and uncontrollable shaking in left leg.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Feeling of dizziness, lose of feeling and uncontrollable shaking in left leg.
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Arteriogram carotid abnormal, Cerebrovascular accident, Computerised tomogram head abnormal, Electrocardiogram abnormal
Clinical narrative: Mini stroke followed a few weeks later by inability to walk. Rapid onset. Hospitalized  for 2 weeks.  Extensive testing showed trace pericardial effusion and acute lacunae infarction involving the right thalamus.  Micro vascular ischemic changes.  Critical test result of acute stroke.
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait inability, Lacunar infarction, Pericardial effusion, Transient ischaemic attack, Vasculitis
Clinical narrative: Mini stroke followed a few weeks later by inability to walk. Rapid onset. Hospitalized  for 2 weeks.  Extensive testing showed trace pericardial effusion and acute lacunae infarction involving the right thalamus.  Micro vascular ischemic changes.  Critical test result of acute stroke.
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Venogram abnormal
Clinical narrative: Mini stroke followed a few weeks later by inability to walk. Rapid onset. Hospitalized  for 2 weeks.  Extensive testing showed trace pericardial effusion and acute lacunae infarction involving the right thalamus.  Micro vascular ischemic changes.  Critical test result of acute stroke.
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Immune thrombocytopenia
Clinical narrative: Mini stroke followed a few weeks later by inability to walk. Rapid onset. Hospitalized  for 2 weeks.  Extensive testing showed trace pericardial effusion and acute lacunae infarction involving the right thalamus.  Micro vascular ischemic changes.  Critical test result of acute stroke.
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Cardiac failure congestive, Cough, Death
Clinical narrative: Within 4-6 weeks of the second vaccine, patient started showing signs of shortness of breathe, swollen feet, cough, weak muscles, tired and no energy. patient had been walking with walker up to that point 5 times a week for 15-20 minutes. Since these symptoms began, he was not been able to walk more than a few feet without resting and being out of breath.  He had been put on a diuretic and inhaler which didn't seem to be doing much. He saw his primary and heart Dr since the beginning of June. On June 24th he was admitted into the Hospital with Congestive Heart Failure. After blood tests, he was also diagnosed with Leukemia. A week later, on July 1, 2021, patient passed away.
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Dyspnoea exertional, Echocardiogram, Fatigue, Laboratory test
Clinical narrative: Within 4-6 weeks of the second vaccine, patient started showing signs of shortness of breathe, swollen feet, cough, weak muscles, tired and no energy. patient had been walking with walker up to that point 5 times a week for 15-20 minutes. Since these symptoms began, he was not been able to walk more than a few feet without resting and being out of breath.  He had been put on a diuretic and inhaler which didn't seem to be doing much. He saw his primary and heart Dr since the beginning of June. On June 24th he was admitted into the Hospital with Congestive Heart Failure. After blood tests, he was also diagnosed with Leukemia. A week later, on July 1, 2021, patient passed away.
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Leukaemia, Muscular weakness, Peripheral swelling, Walking aid user
Clinical narrative: Within 4-6 weeks of the second vaccine, patient started showing signs of shortness of breathe, swollen feet, cough, weak muscles, tired and no energy. patient had been walking with walker up to that point 5 times a week for 15-20 minutes. Since these symptoms began, he was not been able to walk more than a few feet without resting and being out of breath.  He had been put on a diuretic and inhaler which didn't seem to be doing much. He saw his primary and heart Dr since the beginning of June. On June 24th he was admitted into the Hospital with Congestive Heart Failure. After blood tests, he was also diagnosed with Leukemia. A week later, on July 1, 2021, patient passed away.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Pain in extremity, Rash, Rash papular, Rash pruritic
Clinical narrative: Raised circular rash with excessive pain and itching approximately 1.5 weeks after vaccine. Arm pain and inflammation have not receded since shot
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Burning sensation, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Arm and shoulder pain, redness, burning, and bulging at site of injection that keeps growing larger the longer time passes. 2 months since vaccine with same symptoms. Tissue will be surgically removed under general anesthesia on 07/27/2021.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial flutter, Chest X-ray abnormal, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Rapid heart rate (atrial flutter), chest pain with elevated troponin, fever, fatigue, shortness of breath, lightheadedness
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Pyrexia, Troponin increased
Clinical narrative: Rapid heart rate (atrial flutter), chest pain with elevated troponin, fever, fatigue, shortness of breath, lightheadedness
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Full blood count, White blood cell count increased
Clinical narrative: White blood cell count almost doubled one month after the second vaccine and nearly tripled 6 weeks after the second vaccine.  Patient was placed on hospice on April 23rd and passed away on May 8th.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge
Clinical narrative: Same as 1st vaccine. Immediate dizziness and all over shaking  within 30 seconds of the shot.  Could not drive and it did not feel like cold chills, just shaking, but not panicking. Teeth chattering also . Symptoms lasted approx. 30-40 minutes after vaccine then eased off. EMT monitored me the whole time.  No  more shaking or dizziness after that. Had a driver with me  for this second vaccine that drove me home.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Headache, Oropharyngeal pain
Clinical narrative: patient developed sore throat, headache, and new loss of taste / smell on 07/14/21.  He tested positive for COVID on 07/18/21.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: patient developed sore throat, headache, and new loss of taste / smell on 07/14/21.  He tested positive for COVID on 07/18/21.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out for 30-45 seconds and came to after.  Now feeling fine.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo positional
Clinical narrative: Vertigo ongoing specifically when moving head left or right or up or down or changing from standing to seated or seated to standing or while laying down.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Cough, Dizziness, Fatigue
Clinical narrative: Severe cough lasting over a month, fatigue, headaches, muscle pain, congestion, sore throat, dizziness.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nasal congestion, Oropharyngeal pain
Clinical narrative: Severe cough lasting over a month, fatigue, headaches, muscle pain, congestion, sore throat, dizziness.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Fever; extreme weakness; extreme tiredness;  injection site warm, swollen, reddened, painful for 72 hrs
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Fever; extreme weakness; extreme tiredness;  injection site warm, swollen, reddened, painful for 72 hrs
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Bell's palsy, Blepharospasm, Bone pain, Ear pain
Clinical narrative: Bell?s palsy  Steroids and antiviral, eye drops gel eye patch eye mask Missing work to recover. Eyes are functioning properly or mouth. Ears and cheek bones hurts . Massive headaches
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Eyelid function disorder, Facial paralysis, Feeling abnormal, Headache
Clinical narrative: Bell?s palsy  Steroids and antiviral, eye drops gel eye patch eye mask Missing work to recover. Eyes are functioning properly or mouth. Ears and cheek bones hurts . Massive headaches
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Impaired work ability, Magnetic resonance imaging, Neurological symptom, Pain
Clinical narrative: Bell?s palsy  Steroids and antiviral, eye drops gel eye patch eye mask Missing work to recover. Eyes are functioning properly or mouth. Ears and cheek bones hurts . Massive headaches
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Bell?s palsy  Steroids and antiviral, eye drops gel eye patch eye mask Missing work to recover. Eyes are functioning properly or mouth. Ears and cheek bones hurts . Massive headaches
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation delayed, Menstruation irregular, Thrombosis
Clinical narrative: Approximately a week after I received the covid vaccine, I missed my period by 6 days. I then started to spot on may 15 for about a month. On June 12th I started to have extremely heavy menstrual cycle with large clots. I went to my doctor and they prescribed me progesterone to stop it. It slowed it down to spotting again and a week later I was back to extreme bleeding with large clots. I went to the ER on June 29 where they prescribed me a larger dose of progesterone to stop the bleeding. On July 3rd I was still spotting. I continued to spot until July 18 and began heavy bleeding with clots again. I have continued taking the progesterone to help stop the bleeding but it has not helped. I have alerted my doctor and the ER that it was shortly after I had the vaccine I started this problem. I have never had irregular bleeding during my menstrual cycle and my menstrual cycle has always been consistent.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Accelerated idioventricular rhythm, Angiogram, Cardiomegaly, Cardiomyopathy, Chest X-ray
Clinical narrative: On 6/1/21 Patient came in with shortness of breath; cardiomegaly; palpitations; marfanoid physique. Symptoms started soon after 03/18/2021 Covid Vaccine. ECHO showed significant RVR. I think trouble breathing is vaccine induced cardiomyopathy.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram abnormal, Electrocardiogram ambulatory, Marfan's syndrome, Palpitations
Clinical narrative: On 6/1/21 Patient came in with shortness of breath; cardiomegaly; palpitations; marfanoid physique. Symptoms started soon after 03/18/2021 Covid Vaccine. ECHO showed significant RVR. I think trouble breathing is vaccine induced cardiomyopathy.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Stress echocardiogram
Clinical narrative: On 6/1/21 Patient came in with shortness of breath; cardiomegaly; palpitations; marfanoid physique. Symptoms started soon after 03/18/2021 Covid Vaccine. ECHO showed significant RVR. I think trouble breathing is vaccine induced cardiomyopathy.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Facial paralysis, Fatigue, Headache, Magnetic resonance imaging
Clinical narrative: I came down with Bells Palsy and went to the ER; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), dose 1 via an unspecified route of administration on 04Jan2021, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After three days of first shot (on 07Jan2021), the patient came down with Bells Palsy and went to the emergency room. The two doctors had advised that it was a reaction from the shot. She was advised not to get the second shot because of this occurrence. Patient stated If she were to get the second shot what was the likely hood she would get the bells palsy again or something else. Something in the vaccine her body did not like. Outcome of the events was unknown.  Information on lot /batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Facial paralysis, Fatigue, Headache, Magnetic resonance imaging
Clinical narrative: I came down with Bells Palsy and went to the ER; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), dose 1 via an unspecified route of administration on 04Jan2021, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After three days of first shot (on 07Jan2021), the patient came down with Bells Palsy and went to the emergency room. The two doctors had advised that it was a reaction from the shot. She was advised not to get the second shot because of this occurrence. Patient stated If she were to get the second shot what was the likely hood she would get the bells palsy again or something else. Something in the vaccine her body did not like. Outcome of the events was unknown.  Information on lot /batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: I came down with Bells Palsy and went to the ER; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), dose 1 via an unspecified route of administration on 04Jan2021, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After three days of first shot (on 07Jan2021), the patient came down with Bells Palsy and went to the emergency room. The two doctors had advised that it was a reaction from the shot. She was advised not to get the second shot because of this occurrence. Patient stated If she were to get the second shot what was the likely hood she would get the bells palsy again or something else. Something in the vaccine her body did not like. Outcome of the events was unknown.  Information on lot /batch number has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Flushing, Lip swelling, Nasal congestion
Clinical narrative: First dose on January 14, 2021 - No adverse events.  Second dose on February 4, 2021 - Experienced Anaphylactic Shock. 10 minutes after second shot I experienced lip and tongue swelling, facial tingling, and throat tightening.   I was in the waiting room for observation.  Symptoms started while in the waiting room. The nurse who monitored the patients saw my reaction.  She had to hold me under my arm to help me walk back to the nurses who gave the vaccines.  When I arrived, my vision got black and I passed out.  I passed out from the reaction to the vaccine.  I have a history of Anaphylaxis,  I carried episode pens for years.  I forgot my episode pens that evening but I carried my own benadryl.  I stopped the reaction by drinking liquid Benadryl.  I was later transported to the ER via ambulance for monitoring and also for being groggy to the Benadryl.  My symptoms from the reactions were: lip swelling, tongue swelling, facial tingling, throat tightening, and sudden loss of consciousness for a few seconds.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic shock, Condition aggravated, Electrocardiogram normal, Lip swelling, Loss of consciousness
Clinical narrative: First dose on January 14, 2021 - No adverse events.  Second dose on February 4, 2021 - Experienced Anaphylactic Shock. 10 minutes after second shot I experienced lip and tongue swelling, facial tingling, and throat tightening.   I was in the waiting room for observation.  Symptoms started while in the waiting room. The nurse who monitored the patients saw my reaction.  She had to hold me under my arm to help me walk back to the nurses who gave the vaccines.  When I arrived, my vision got black and I passed out.  I passed out from the reaction to the vaccine.  I have a history of Anaphylaxis,  I carried episode pens for years.  I forgot my episode pens that evening but I carried my own benadryl.  I stopped the reaction by drinking liquid Benadryl.  I was later transported to the ER via ambulance for monitoring and also for being groggy to the Benadryl.  My symptoms from the reactions were: lip swelling, tongue swelling, facial tingling, throat tightening, and sudden loss of consciousness for a few seconds.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Swollen tongue, Throat tightness, Vaccination complication, Visual impairment
Clinical narrative: First dose on January 14, 2021 - No adverse events.  Second dose on February 4, 2021 - Experienced Anaphylactic Shock. 10 minutes after second shot I experienced lip and tongue swelling, facial tingling, and throat tightening.   I was in the waiting room for observation.  Symptoms started while in the waiting room. The nurse who monitored the patients saw my reaction.  She had to hold me under my arm to help me walk back to the nurses who gave the vaccines.  When I arrived, my vision got black and I passed out.  I passed out from the reaction to the vaccine.  I have a history of Anaphylaxis,  I carried episode pens for years.  I forgot my episode pens that evening but I carried my own benadryl.  I stopped the reaction by drinking liquid Benadryl.  I was later transported to the ER via ambulance for monitoring and also for being groggy to the Benadryl.  My symptoms from the reactions were: lip swelling, tongue swelling, facial tingling, throat tightening, and sudden loss of consciousness for a few seconds.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Heart rate increased
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EP7534), via unspecified route of administration in left arm on 22Mar2021 at 11:15 (at the age of 67-year-old), at single dose for COVID-19 immunisation. Medical history included arthritis, stenosis, seasonal allergies, hiatal hernia. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pregabalin (LYRICA), celecoxib (CELEBREX), omeprazole, loratadine (CLARITIN) and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6198), via unspecified route of administration in left arm on 01Mar2021 at 11:15 (at the age of 67-year-old), at single dose for COVID-19 immunisation; patient had known allergy with midazolam hydrochloride (VERSED), fentanyl, codeine, beta agonists and azithromycin (ZITHRO). On 22Mar2021 at 23:00, the patient experienced fatigue, headache, nausea, joint pain, severe chills, short of breath, increased heart rate, fever, redness at injection site and below on arm that had lasted past day 4. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive treatment for the events. The clinical outcome of the events was recovering. This report was reported as non-serious by reporter. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: patient's medical history and concomitant medications updated, event Localized erythema added.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EP7534), via unspecified route of administration in left arm on 22Mar2021 at 11:15 (at the age of 67-year-old), at single dose for COVID-19 immunisation. Medical history included arthritis, stenosis, seasonal allergies, hiatal hernia. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pregabalin (LYRICA), celecoxib (CELEBREX), omeprazole, loratadine (CLARITIN) and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6198), via unspecified route of administration in left arm on 01Mar2021 at 11:15 (at the age of 67-year-old), at single dose for COVID-19 immunisation; patient had known allergy with midazolam hydrochloride (VERSED), fentanyl, codeine, beta agonists and azithromycin (ZITHRO). On 22Mar2021 at 23:00, the patient experienced fatigue, headache, nausea, joint pain, severe chills, short of breath, increased heart rate, fever, redness at injection site and below on arm that had lasted past day 4. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive treatment for the events. The clinical outcome of the events was recovering. This report was reported as non-serious by reporter. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: patient's medical history and concomitant medications updated, event Localized erythema added.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EP7534), via unspecified route of administration in left arm on 22Mar2021 at 11:15 (at the age of 67-year-old), at single dose for COVID-19 immunisation. Medical history included arthritis, stenosis, seasonal allergies, hiatal hernia. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pregabalin (LYRICA), celecoxib (CELEBREX), omeprazole, loratadine (CLARITIN) and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6198), via unspecified route of administration in left arm on 01Mar2021 at 11:15 (at the age of 67-year-old), at single dose for COVID-19 immunisation; patient had known allergy with midazolam hydrochloride (VERSED), fentanyl, codeine, beta agonists and azithromycin (ZITHRO). On 22Mar2021 at 23:00, the patient experienced fatigue, headache, nausea, joint pain, severe chills, short of breath, increased heart rate, fever, redness at injection site and below on arm that had lasted past day 4. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive treatment for the events. The clinical outcome of the events was recovering. This report was reported as non-serious by reporter. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: patient's medical history and concomitant medications updated, event Localized erythema added.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Injection site erythema, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EP7534), via unspecified route of administration in left arm on 22Mar2021 at 11:15 (at the age of 67-year-old), at single dose for COVID-19 immunisation. Medical history included arthritis, stenosis, seasonal allergies, hiatal hernia. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pregabalin (LYRICA), celecoxib (CELEBREX), omeprazole, loratadine (CLARITIN) and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6198), via unspecified route of administration in left arm on 01Mar2021 at 11:15 (at the age of 67-year-old), at single dose for COVID-19 immunisation; patient had known allergy with midazolam hydrochloride (VERSED), fentanyl, codeine, beta agonists and azithromycin (ZITHRO). On 22Mar2021 at 23:00, the patient experienced fatigue, headache, nausea, joint pain, severe chills, short of breath, increased heart rate, fever, redness at injection site and below on arm that had lasted past day 4. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive treatment for the events. The clinical outcome of the events was recovering. This report was reported as non-serious by reporter. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: patient's medical history and concomitant medications updated, event Localized erythema added.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Muscle spasms, Nausea, Pyrexia, Vomiting
Clinical narrative: stomach cramps; fever 99.9; severe chills; medium nausea; mild vomiting, clear, no food; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 15:45 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), aneurysm (metal clips) in Dec1973 and COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), vit d nos (MANUFACTURER UNKNOWN) and probiotic received within 2 weeks of vaccination. The patient had known allergies to NSAIDs and caffeine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 05:10, the patient experienced severe chills, medium nausea, mild vomiting which was clear, no food in it and patient had no temperature. On 01Apr2021 at 07:30, the patient experienced mild vomiting of gastric juices, severe chills, stomach cramps and temperature at 99.9. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care (also reported as, the patient took tablets after conferring with doctor). Therapeutic measures were taken as a result of adverse events included treatment with omeprazole, tylenol once every 4 hours and lots of fluids. The clinical outcomes of severe chills, medium nausea, mild vomiting which was clear and no food, stomach cramps, fever and mild vomiting of gastric juices were recovering at the time of the report.  No follow up attempts are need; information about lot number can not be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Nausea, Pyrexia
Clinical narrative: stomach cramps; fever 99.9; severe chills; medium nausea; mild vomiting, clear, no food; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 15:45 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), aneurysm (metal clips) in Dec1973 and COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), vit d nos (MANUFACTURER UNKNOWN) and probiotic received within 2 weeks of vaccination. The patient had known allergies to NSAIDs and caffeine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 05:10, the patient experienced severe chills, medium nausea, mild vomiting which was clear, no food in it and patient had no temperature. On 01Apr2021 at 07:30, the patient experienced mild vomiting of gastric juices, severe chills, stomach cramps and temperature at 99.9. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care (also reported as, the patient took tablets after conferring with doctor). Therapeutic measures were taken as a result of adverse events included treatment with omeprazole, tylenol once every 4 hours and lots of fluids. The clinical outcomes of severe chills, medium nausea, mild vomiting which was clear and no food, stomach cramps, fever and mild vomiting of gastric juices were recovering at the time of the report.  No follow up attempts are need; information about lot number can not be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: stomach cramps; fever 99.9; severe chills; medium nausea; mild vomiting, clear, no food; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 15:45 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), aneurysm (metal clips) in Dec1973 and COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), vit d nos (MANUFACTURER UNKNOWN) and probiotic received within 2 weeks of vaccination. The patient had known allergies to NSAIDs and caffeine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 05:10, the patient experienced severe chills, medium nausea, mild vomiting which was clear, no food in it and patient had no temperature. On 01Apr2021 at 07:30, the patient experienced mild vomiting of gastric juices, severe chills, stomach cramps and temperature at 99.9. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care (also reported as, the patient took tablets after conferring with doctor). Therapeutic measures were taken as a result of adverse events included treatment with omeprazole, tylenol once every 4 hours and lots of fluids. The clinical outcomes of severe chills, medium nausea, mild vomiting which was clear and no food, stomach cramps, fever and mild vomiting of gastric juices were recovering at the time of the report.  No follow up attempts are need; information about lot number can not be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over the face; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 31Mar2021 at 12:00 PM (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy, allergy to nuts, chicken allergy, shrimps and tuna fish allergy. Concomitant medication included isotretinoin (CLARAVIS) for unknown indication and from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 08:00 AM, the patient experienced hives all over the face. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event hives all over the face. The clinical outcome of the event hives all over the face was recovered on 01April 2021.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Rash macular
Clinical narrative: bright red rash; sore area on right arm; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the right arm on 24Mar2021 at 20:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as "too long to list-can provide a list if contacted directly". The patient had history of known allergies to adhesives. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration on 03Mar2021 at 13:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation and cefprozil (CEFZIL) on an unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021, the patient firstly had noticed bright red rash and sore area on her right arm near the injection site, but it was very small and it became larger on 01Apr2021, measured approximately 17cm by 6cm in a parallelogram at the time of reporting. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of bright red rash and sore area on right arm were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Rash erythematous
Clinical narrative: bright red rash; sore area on right arm; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the right arm on 24Mar2021 at 20:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as "too long to list-can provide a list if contacted directly". The patient had history of known allergies to adhesives. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration on 03Mar2021 at 13:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation and cefprozil (CEFZIL) on an unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021, the patient firstly had noticed bright red rash and sore area on her right arm near the injection site, but it was very small and it became larger on 01Apr2021, measured approximately 17cm by 6cm in a parallelogram at the time of reporting. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of bright red rash and sore area on right arm were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling hot
Clinical narrative: Redness between the toes affecting the lower half of toes.  The toes feel very warm.; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on an unknown date (at the age of 64-years-old)  as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin, nickel, histamine in food and persimmon. The patient was allergic to neomycin. Concomitant medications included bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTICS), magnesium aspartate (MAGNESIUM), calcium carbonate, vitamin d nos (CALCIUM WITH VIT D) and dexpanthenol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B-COMP) used for unknown indication from an unspecified date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 27Feb2021 at 15:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021 at 18:00, the patient experienced redness between the toes affecting the lower half of toes. The toes felt very warm. The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit or urgent care. The clinical outcome of the event redness was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema
Clinical narrative: Redness between the toes affecting the lower half of toes.  The toes feel very warm.; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on an unknown date (at the age of 64-years-old)  as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin, nickel, histamine in food and persimmon. The patient was allergic to neomycin. Concomitant medications included bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTICS), magnesium aspartate (MAGNESIUM), calcium carbonate, vitamin d nos (CALCIUM WITH VIT D) and dexpanthenol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B-COMP) used for unknown indication from an unspecified date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 27Feb2021 at 15:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021 at 18:00, the patient experienced redness between the toes affecting the lower half of toes. The toes felt very warm. The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit or urgent care. The clinical outcome of the event redness was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 33-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734), via an unspecified route of administration in the left arm on 31Mar2021 at 12:15 (at the age of 33-years old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 31Mar2021 at 23:00, the patient experienced full body muscle spasms. It was reported that the episode lasted for thirty minutes, stopped briefly then started again for a couple hours and it felt like a shiver from the cold but then it never stops and 100x worse. It was reported that he was exhausted after the spasm event. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of full body muscle spasms and exhausted was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Muscle spasms
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 33-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734), via an unspecified route of administration in the left arm on 31Mar2021 at 12:15 (at the age of 33-years old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 31Mar2021 at 23:00, the patient experienced full body muscle spasms. It was reported that the episode lasted for thirty minutes, stopped briefly then started again for a couple hours and it felt like a shiver from the cold but then it never stops and 100x worse. It was reported that he was exhausted after the spasm event. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of full body muscle spasms and exhausted was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.