chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test, Computerised tomogram, X-ray
Clinical narrative: Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6200), dose 1 via an unspecified route of administration, administered in Arm Left on 22Feb2021 at 10:00 (at the age of 68-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included lisinopril 20 mg and atorvastatin 10 mg both were taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). Patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Had no known allergies. Facility type vaccine: Doctor's office/urgent care. Other vaccine same date product: Pfizer COVID 19 vaccine, on 22Feb2021, dose number: 2 administered in Left arm. On 25Jul2021 21:00, patient experienced bells palsy. Patient visited Emergency room/department or urgent care for event. The patient underwent lab tests and procedures which included blood work, Ct scan and x-rays with unknown results on unspecified date. Therapeutic measures were taken as a result of bells palsy. The outcome of event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Nausea, Pyrexia
Clinical narrative: My left arm went on full out shaking all over the place; but I can't eat anything.; nausea; fever; diarrhea; I was tired; This is a spontaneous report from a contactable consumer. An unspecified age female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for Covid 19 immunization. The patient medical history included diabetic, heart failure. The patient concomitant medications were not reported. It was reported that, After the first dose of the vaccine, on an unspecified date, the patient had experienced nausea, fever, diarrhea that lasted all night and day. She did not eat all day until 6:30 tonight. She supposed to eat breakfast lunch and dinner, but she can't eat anything. She was tired. The patient had a bad tremor in the left leg which was the side she got her vaccine. Her left arm went on full out shaking all over the place. She was diabetic and on blood thinners. I am oxygen. She wanted to know she can get the second shot. They cannot tell her if she should receive the second dose of the vaccine or not. The patient wanted to know she can get the vaccine if she has a medical conditions. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: My left arm went on full out shaking all over the place; but I can't eat anything.; nausea; fever; diarrhea; I was tired; This is a spontaneous report from a contactable consumer. An unspecified age female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for Covid 19 immunization. The patient medical history included diabetic, heart failure. The patient concomitant medications were not reported. It was reported that, After the first dose of the vaccine, on an unspecified date, the patient had experienced nausea, fever, diarrhea that lasted all night and day. She did not eat all day until 6:30 tonight. She supposed to eat breakfast lunch and dinner, but she can't eat anything. She was tired. The patient had a bad tremor in the left leg which was the side she got her vaccine. Her left arm went on full out shaking all over the place. She was diabetic and on blood thinners. I am oxygen. She wanted to know she can get the second shot. They cannot tell her if she should receive the second dose of the vaccine or not. The patient wanted to know she can get the vaccine if she has a medical conditions. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: confirmed covid-19 positive 7/26/21; confirmed covid-19 positive 7/26/21; This is a spontaneous report from a non-contactable consumer (patient).   A 31-year-old male patient received BNT162B2, (Lot Number: en6205/ep7533), via an unspecified route of administration on 01Apr2021 as dose number unknown, single, for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  Patient was not diagnosed with COVID-19 prior to vaccination. The patient confirmed COVID-19 positive on 24Jul2021. The events considered to be medically significant. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-COV-2 test, nasal swab: positive on 26Jul2021. It was unknown whether treatment was given for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Gait disturbance, Immune system disorder, Investigation
Clinical narrative: Terrible joint pain; Couldn't walk; Got worse after my second/ joint pain, couldn't walk and after 2nd dose 04Mar21 the s/s got much worst.; My immune system is freaking out!!; This is a spontaneous report received from a contactable consumer (patient). A 42-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206), via an unspecified route of administration on 04Mar2021 (at the age of 42-years) as single dose for covid-19 immunization. Medical history included joint pain from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Lot Number: EL9264) via an unspecified route of administration on 09Feb2021 (at the age of 42-years) as single dose for covid-19 immunization and experienced very sick and it started 2 weeks after first vaccine, joint pain and it has gotten worse, couldn't walk. On an unspecified in Mar2021, the patient experienced terrible joint pain, couldn't walk, got worse after second/ joint pain, couldn't walk and after 2nd dose 04mar21 the s/s got much worst and immune system is freaking out. Clinical course included: it was reported that she has been very sick, and it started 2 weeks after her first vaccine on 09Feb2021 and got worse after her second. The patient had terrible joint pain and has been on prednisone since her 2nd shot on 04Mar2021. She was a normal healthy person before all this, and she was suffering. The patient had a doctor and rheumatologist who would tell her this is an adverse reaction the vaccine. The patient's immune system was freaking out. It was reported that she was living in hell right now since she got her COVID vaccine and 2 weeks after she had it, she had joint pain and it has gotten worse. She spoke with her doctor who said to get the second dose and then the joint pain was even worse, so she had gone to urgent care and she has now been on 5 months of prednisone and done all kinds of lab tests and just has had so many prescriptions and doctor bills and she does not know what was going on, but it was all right after the COVID vaccine. When the patient was probed for outcome and she stated that she was on prednisone now and was trying to taper down which was causing the symptoms to become worse again, so the pain was definitely increasing. The events terrible joint pain, couldn't walk and condition worsened resulted in emergency room visit. Therapeutic measures were taken as a result of events terrible joint pain, couldn't walk and condition worsened. The patient underwent lab tests and procedures which included investigation: all kinds of lab tests - unknown on an unspecified date in 2021. The outcome of events was not resolved.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable other HCP.   This 23-year-old non-pregnant nurse reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 01Feb2021 at 08:30 as dose 2 on left arm, single for COVID-19 immunization. The medical history of the patient and medications received in last two weeks were reported as none. The patient had no known allergies, was not diagnosed with COVID-19 prior to vaccination, had not been tested for covid-19 since vaccination and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunization. On 10Apr2021 at 07:00 AM the patient experienced Bell's palsy. The event resulted in physician office and emergency room visit. Therapeutic measures were received with 14 day course of prednisone, valacyclovir and eyedrops. The patient recovered/resolved with sequel. The device date was 28Jul2021.  Information about Batch/Lot number was requested.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the event Bell's Palsy and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had symptomatic positive COVID test; had symptomatic positive COVID test; This is a spontaneous report from a contactable consumer. A contactable consumer reported similar events for 3 patients. This is one of 3 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER/BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior vaccinations were none. Patient had symptomatic positive COVID on an unspecified date. The patient underwent lab tests and procedures which included Symptomatic positive COVID test: positive on an unspecified date. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiomegaly, Chest pain
Clinical narrative: Severe abnormal chest pain (diagnosed as enlarged heart); Severe abnormal chest pain (diagnosed as enlarged heart); This is a spontaneous report from a contactable consumer (patient herself).   A 26-year-old non-pregnant female patient received bnt162b2 (formulation: solution for injection; Lot Number: EW0151), dose 1 via an unspecified route of administration administered in left arm on 18Apr2021 at 13:00 (at the age of 26 years) as dose 1, single for covid-19 immunisation. Medical history included allergy to peanuts from an unknown date. The patient's concomitant medications were not reported. The patient previously took bactrim and had allergies. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe abnormal chest pain (diagnosed as enlarged heart) on 24Apr2021.Event caused emergency room/department or urgent care. Device Date was 28Jul2021. Therapeutic measures were taken as a result of severe abnormal chest pain (diagnosed as enlarged heart) with imaging. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Nausea, Vomiting
Clinical narrative: nausea; vomiting; headache; felt really bad; This is a spontaneous report from a non-contactable Pfizer colleague (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. On unspecified date, the patient experienced nausea, vomiting, headache and felt really bad. Patient was going home, and she started to feel nausea, vomiting, and then felt she could not go any longer but then she felt she could still go, so she called her husband and she said that if he could help her. So, then she did not really feel bad and then she went on and on and on and she suddenly realized that she was feeling vomitish. Patient vomited and then she felt headache and so she laid down there and then. Later she called the doctor and the doctor arrived. So that was how sequence of events that occurred. It was reported that now she was feeling better, and she thought that she does not really need help. But She was still going ahead and calling, so that was the whole story. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test negative, Lymphocyte count, Lymphocyte count decreased, SARS-CoV-2 antibody test
Clinical narrative: 2 different antibody tests and both test showed 0 antibodies for the COVID19 virus; lymphocyte counts were at 0.40 and now it was down to 0.24; This is a spontaneous report. A contactable 67-year-old female consumer (patient) reported for herself that:  The 67-years-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. The patient had medical history of multiple sclerosis for which patient was taking Gilenya. The concomitant medications were not reported. Patient reported that she took 2 different antibody tests and both tests showed 0 antibodies for the COVID 19 virus. She also reported that prior getting the vaccine her lymphocyte counts were at 0.40 and now it was down to 0.24. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pain in extremity
Clinical narrative: Mild headache; sore arm; tired; he got light headed and dizzy that lasted for 30 minutes; This is a spontaneous report from a contactable consumer. This consumer (Patients wife) reported for a patient (Reporters husband). A 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FA7484), dose 1 via an unspecified route of administration, administered in left arm on 26Jul2021 14:00 (at the age of 49-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included high cholesterol. Concomitant medications were not reported. On unspecified date in Jul2021, the patient experienced mild headache, sore arm, tired and he got light headed and dizzy that lasted for 30 minutes. It was stated all these side effects are from the first dose and her husband right when he got injected he could feel the medication going through his blood stream, he got light headed and dizzy that lasted for 30 minutes, then he had a headache from that day, and he felt tired, and had a sore arm that still hurts today. The headache was the day of the vaccine and was relieved with motrin. Adds all his side effects were gone after about 30 minutes that day. The only thing he still has is a sore arm. The vaccination sites will monitor patients for at least 15min in case there is an allergic reaction, may refer to the vaccination site for more specific information. No specific statistical data is available but it's possible that severe reactions occurred, they may be reactions that were not in the clinical studies. Patient will get second dose on 16Aug2021. Treatment included motrin. Outcome of the event sore arm was recovering. Outcome of the other events was recovered on unspecified date in Jul2021.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations; This is a spontaneous report from a contactable consumer (patient reported for herself). A 69-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jan2021 (at the age of 69-year-old) (Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history included hypertension and blood cholesterol increased. The patient had no Covid prior vaccination. The patient had Known allergies to beta blockers. Concomitant medication(s) included TRIAMTERENE, DILTIAZEM, ATORVASTATIN, CALCIUM and colecalciferol (VITAMIN D), all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient had not been covid tested post vaccination. The patient experienced heart palpitations on 09Feb2021. The outcome of the event was not resolved at the time of this report.  Information on Lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging, Pain in extremity, Palpitations
Clinical narrative: headache; heart pounding; her arm was really sore; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old female patient received (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection,  (Lot number and expiry date was not reported) via an unspecified route of administration on 07Feb2021 as a  dose 1 single for covid-19 immunization. Medical history included brain neoplasm from 1995 to an unknown date Stated she has brain tumour and never experienced nothing this bad. Stated that she was diagnosed with a brain tumour malignant in 1995 and has an MRI every year for growth. The patient's concomitant medications were not reported. The patient reported that she had a couple of things happen since her Pfizer Covid vaccination on 07Feb2021.She stated that 10 minutes after the vaccination on the same day, her heart pounding and she dropped the paper with the side effects on the floor and for the time it took for her husband to pick it up that it was gone. The patient reported that heart pounding was short and It happened when she was waiting at the clinic for 15 minutes. The patient reported that it did not last long. The patient reported that she did not report while she was there. The patient came home, did the floors, went to bed and her arm was really sore. On an unspecified date (at 03:00), she had a horrible headache. The patient reported that it did not last all night, but she went to sleep. The patient reported that she tossed and turned. She got up the next morning and it was fine. The patient reported that it was not a severe reaction. The patient wanted to know if she could still get the second dose on 05Mar2021. Outcome of the events was recovered on an unspecified date in 2021.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Limb injury, Yellow skin
Clinical narrative: my fingers are tinlgy and sort of yellowishy; my fingers are tinlgy and sort of yellowishy; This is a spontaneous report from a Contactable Consumer (patient). A 49-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced my fingers are tinlgy and sort of yellowishy on an unspecified date. It was reported that, the patient received first dose of Pfizer-BioNTech COVID-19 Vaccine on 16Feb2021, and experienced "I waited for half an hour or so (after receipt of vaccine), it's freezing here, I took my gloves off and noticed my fingers are tinlgy and sort of yellowishy. Fingers were feeling tingly and turning yellow, looks like it is Dark, the skin, underneath my fingernails." Outcome of the event was unknown.    Information on the lot/ batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Palpitations, Peripheral swelling
Clinical narrative: Racing of heart; Swelling of hand/fingers & feet/toes; Burning sensation in veins; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm left on 19Feb2021 10:15 (Batch/Lot Number: EL9266) as single dose for COVID-19 immunisation. Medical history included diabetes and high blood pressure from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin, vitamin D3 and aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported. Prior and post to vaccination, the patient was not diagnosed with COVID-19. On 20Feb2021, the patient experienced swelling of hand/fingers & feet/toes, racing of heart; burning sensation in veins and dizziness. It was reported she felt better now. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 80-years-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Batch/Lot Number: EN5318) via an unspecified route of administration on 04Feb2021 at 14:00 as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 05Feb2021 at 06:00, the patient was awakened or woke up with heart palpitation which lasted less than a minute and then patient got up. Patient reported that last Thursday (2 weeks after administration), she was awakened by heart palpitations again, in which both times they have stopped by the time she was up on her feet. The outcome of the event was recovered on the same day.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring, Echocardiogram normal, Electrocardiogram normal, Palpitations
Clinical narrative: Heart palpitations; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 80-years-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Batch/Lot Number: EN5318) via an unspecified route of administration on 04Feb2021 at 14:00 as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 05Feb2021 at 06:00, the patient was awakened or woke up with heart palpitation which lasted less than a minute and then patient got up. Patient reported that last Thursday (2 weeks after administration), she was awakened by heart palpitations again, in which both times they have stopped by the time she was up on her feet. The outcome of the event was recovered on the same day.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain, Palpitations, Pyrexia
Clinical narrative: Heart palpitations; chills; fever; body aches; weakness; This is a spontaneous report from a contactable 66-year-old female Other HCP reported for herself (patient). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number was not reported) via an unspecified route of administration in right arm on 29Dec2020 05:00 (at the age of 66 years) as dose 1, single for COVID-19 immunisation at hospital. Medical history included heart disease from an unknown date and unknown if ongoing other medical history, known allergies to medications, food, or other products from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Dec2020, 20:00 the patient experienced heart palpitations, chills, fever, body aches, weakness. No treatment was received for events. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number was not reported) via an unspecified route of administration in right arm on 15Jan2021 04:30 as dose 2, single (at the age of 66-years-old) for COVID-19 immunisation at hospital. The case was reported as non-serious with no seriousness criteria (Results in death/ Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/ Congenital anomaly/birth defect). The clinical outcome of the events was not resolved.  Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Investigation, Palpitations, Paraesthesia
Clinical narrative: Heart palpitations; Little zinging feeling; This is a spontaneous report from a contactable consumer(patient). A 68-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EN6201; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left at the age of 68-year-old on 12Feb2021 11:30 as dose 1, single for covid-19 immunization. The patient's medical history included cholesterol. Concomitant medication included simvastatin taken for blood cholesterol. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. No other additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. AE(s) following prior vaccinations was reported as none. The patient stated that he had his first Pfizer shot on the 12Feb2021. He really did not have a reaction right that time. He had a little zinging feeling in the first hour or so. No feedback though. Heart palpitations started on 13Feb2021 in the afternoon. Caller clarified that it was more like 30 hours after receiving the injection, not 24 hours. He went to the Emergency Room. They did an EKG and blood work. The EKG and blood work were normal. All his enzymes were perfect. No indication of heart attack. They repeated EKG and blood work after several hours and there were no problems. They encouraged him to see his doctor. He went to the ER on 15Feb2021. By the evening of 17Feb2021 he had no palpitations and has felt fine ever since. He was scheduled to get second shot that week. He asked if he should have the shot. Caller clarified shot as COVID19 Vaccine. Caller clarified his question. Have other people had this symptom? Have they had this symptom and had the second one and been ok or do they avoid it? He knew this was new, but even after one shot there was quite a bit. He saw his physician on 16Feb2021, who has seen him for 20 years and he thought it was related to the shot. The patient underwent lab tests and procedures which included blood test: normal, electrocardiogram: normal, investigation: normal on an unspecified date. The outcome of event heart palpitations was recovered on 17Feb2021, while the other event little zinging feeling was unknown.    No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Axillary mass, Body temperature, Chills, Decreased appetite
Clinical narrative: Moderate to Severe joint pain; High temperature of 103.0; Moderate chills and shaking; Moderate chills and shaking; Severe fatigue; sore eyes and eye brows; moderate to severe headache; loss of apetite; moderate to severe swelling on upper back of neck with prominent lumps on both sides; moderate to severe swelling on upper back of neck with prominent lumps on both sides; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 81-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in arm left on Feb2021 at 10:45 as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in arm left on Feb2021 at 10:45 as dose 2, single for COVID-19 immunisation. Medical history was none. Concomitant medications included ibuprofen and daily vitamins. The patient previously took feldene and experienced drug hypersensitivity. Patient did not receive other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient was not tested for COVID tested post vaccination. The patient experienced moderate to severe joint pain, moderate to severe swelling on upper back of neck with prominent lumps on both sides, high temperature of 103.0, moderate chills and shaking, severe fatigue, sore eyes and eye brows and moderate to severe headache and loss of appetite. The patient underwent lab tests and procedures which included body temperature: high temperature of 103. Therapeutic measures were not taken as a result of the events. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Headache, Pyrexia, Swelling
Clinical narrative: Moderate to Severe joint pain; High temperature of 103.0; Moderate chills and shaking; Moderate chills and shaking; Severe fatigue; sore eyes and eye brows; moderate to severe headache; loss of apetite; moderate to severe swelling on upper back of neck with prominent lumps on both sides; moderate to severe swelling on upper back of neck with prominent lumps on both sides; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 81-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in arm left on Feb2021 at 10:45 as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in arm left on Feb2021 at 10:45 as dose 2, single for COVID-19 immunisation. Medical history was none. Concomitant medications included ibuprofen and daily vitamins. The patient previously took feldene and experienced drug hypersensitivity. Patient did not receive other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient was not tested for COVID tested post vaccination. The patient experienced moderate to severe joint pain, moderate to severe swelling on upper back of neck with prominent lumps on both sides, high temperature of 103.0, moderate chills and shaking, severe fatigue, sore eyes and eye brows and moderate to severe headache and loss of appetite. The patient underwent lab tests and procedures which included body temperature: high temperature of 103. Therapeutic measures were not taken as a result of the events. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Moderate to Severe joint pain; High temperature of 103.0; Moderate chills and shaking; Moderate chills and shaking; Severe fatigue; sore eyes and eye brows; moderate to severe headache; loss of apetite; moderate to severe swelling on upper back of neck with prominent lumps on both sides; moderate to severe swelling on upper back of neck with prominent lumps on both sides; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 81-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in arm left on Feb2021 at 10:45 as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in arm left on Feb2021 at 10:45 as dose 2, single for COVID-19 immunisation. Medical history was none. Concomitant medications included ibuprofen and daily vitamins. The patient previously took feldene and experienced drug hypersensitivity. Patient did not receive other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient was not tested for COVID tested post vaccination. The patient experienced moderate to severe joint pain, moderate to severe swelling on upper back of neck with prominent lumps on both sides, high temperature of 103.0, moderate chills and shaking, severe fatigue, sore eyes and eye brows and moderate to severe headache and loss of appetite. The patient underwent lab tests and procedures which included body temperature: high temperature of 103. Therapeutic measures were not taken as a result of the events. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Joint injury
Clinical narrative: has a bad ankle; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took ibuprofen. Caller asked if she can take ibuprofen after the first dose since she has a bad ankle.  She took ibuprofen before she took the vaccine. The outcome for all events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Insomnia, Pain, Palpitations, Pruritus
Clinical narrative: Itching and burning of my feet; Itching and burning of my feet; My body was painfully itchy and burning; My body was painfully itchy and burning; My body was painfully itchy and burning; Red blotches on various areas of my body, including chest, back, buttocks, thighs, knees, and feet; My heart was racing; Finally fell asleep about 4:00 AM on Friday/Interrupt my sleep; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809), via an unspecified route of administration in arm left on 23Feb2021 at 14:00 (at the age of 67-year-old) as a dose 1, single for COVID-19 immunisation. The patient's medical history included known allergies: some cosmetic or cleaning products, so she use only natural dye-free, fragrance-free, preservative-free products. The patient's concomitant medications in two weeks were reported as no. It was reported that, the patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. The patient stated that, prior to falling asleep on Thursday, 04Mar2021 at 11:45 PM, her heart was racing and she finally fell asleep about 4:00 AM on Friday. On Friday, 05Mar2021, the patient was awoke at 7:00AM. Stated that, her body was painfully itchy and burning. There were red blotches on various areas of her body, including chest, back, buttocks, thighs, knees and feet. It became so unbearable that she finally took an antihistamine and fell asleep. The same thing occurred Friday night into Saturday morning and Saturday night into Sunday morning, but to a much lesser degree. Stated that, the worst part of it on Saturday morning and Sunday morning was the itching and burning of her feet accompanied by a big red blotch. This passed after a couple of hours. Stated that, on Sunday night, the patient heart was racing and she took an antihistamine before sleeping for fear of experiencing the itching that might once again interrupt her sleep. Stated that, this morning upon awakening, the patient did not experience the severe itching and burning of her feet, just some light itching of her body. Treatment medication included was antihistamine. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Itching and burning of my feet; Itching and burning of my feet; My body was painfully itchy and burning; My body was painfully itchy and burning; My body was painfully itchy and burning; Red blotches on various areas of my body, including chest, back, buttocks, thighs, knees, and feet; My heart was racing; Finally fell asleep about 4:00 AM on Friday/Interrupt my sleep; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809), via an unspecified route of administration in arm left on 23Feb2021 at 14:00 (at the age of 67-year-old) as a dose 1, single for COVID-19 immunisation. The patient's medical history included known allergies: some cosmetic or cleaning products, so she use only natural dye-free, fragrance-free, preservative-free products. The patient's concomitant medications in two weeks were reported as no. It was reported that, the patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. The patient stated that, prior to falling asleep on Thursday, 04Mar2021 at 11:45 PM, her heart was racing and she finally fell asleep about 4:00 AM on Friday. On Friday, 05Mar2021, the patient was awoke at 7:00AM. Stated that, her body was painfully itchy and burning. There were red blotches on various areas of her body, including chest, back, buttocks, thighs, knees and feet. It became so unbearable that she finally took an antihistamine and fell asleep. The same thing occurred Friday night into Saturday morning and Saturday night into Sunday morning, but to a much lesser degree. Stated that, the worst part of it on Saturday morning and Sunday morning was the itching and burning of her feet accompanied by a big red blotch. This passed after a couple of hours. Stated that, on Sunday night, the patient heart was racing and she took an antihistamine before sleeping for fear of experiencing the itching that might once again interrupt her sleep. Stated that, this morning upon awakening, the patient did not experience the severe itching and burning of her feet, just some light itching of her body. Treatment medication included was antihistamine. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Heart racing and difficulty breathing after 12 hours of the first shot; Heart racing and difficulty breathing after 12 hours of the first shot; This is a spontaneous report from a non-contactable consumer (patient). A 33-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 07Mar2021 12:00 (age at the time of vaccination was 33-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced heart racing and difficulty breathing after 12 hours of the first shot on 07Mar2021. Seriousness Criteria-Persistent, AE required visit to: Physician office. The outcome of event was Recovering.    No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Malaise, Palpitations
Clinical narrative: heart racing; feeling a little uncomfortable; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 05Mar2021 (Lot number and Expiry date was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced Heart racing on, Feeling a little uncomfortable on Mar2021. The patient underwent lab tests and procedures which included heart rate: heart racing on Mar2021. He reports that afterwards he woke up in the middle of the night with his heart racing, heart rate: subsided on Mar2021, he mentioned that he hadn't taken his blood pressure medication yet, so he took it then, a few hours later his heart rate had subsided. Therapeutic measures were taken as a result of heart racing. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol increased, Hypersensitivity, Hypertension, Sinusitis
Clinical narrative: High blood pressure and cholesterol; High blood pressure and cholesterol; Sinusitis; allergy; This is a spontaneous report from a contactable consumer (patient). A 40- year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 11Mar2021 at 14:30 (40- year-old) as single dose for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19. Concomitant medication(s) included lisinopril taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (CETRIZINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. No prior covid vaccination was taken. Therapeutic measures were taken as no for all event. The patient experienced high blood pressure and cholesterol, sinusitis/ allergy on 18Sep2020 (as reported). The outcome of all event was recovering.     Information on Lot/Batch number was available. Additional information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Cardiovascular examination, Muscle tightness, Palpitations, SARS-CoV-2 test
Clinical narrative: Heart palpitations; Constant cranial head/neck muscle tension; This is a spontaneous report from a contactable nurse (patient). A 48-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EK5730), dose 1 intramuscular, administered in arm left on 21Dec2020 14:00 (at the age of 48-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Hospital. Medical history included hypothyroidism. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) included levothyroxine sodium (SYNTHROID), vitamins nos (DAILY VITAMINS). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Dec2020, the patient experienced heart palpitations, constant cranial head/neck muscle tension. Heart palpitations required ER visit and cardiac consult. Constant cranial head/neck muscle tension also required ER and physician visit. The patient underwent lab tests and procedures which included thyroid/hormone: unknown results and cardiac evaluation: unknown results on unspecified date, Covid test PCR (Nasal Swab): negative on 30Dec2020. Patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3249), dose 2 intramuscular, administered in arm left on 11Jan202112:00 PM as DOSE 2, SINGLE for covid-19 immunisation at Hospital. Therapeutic measures were taken as a result of heart palpitations, constant cranial head/neck muscle tension. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.