chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, SARS-CoV-2 test
Clinical narrative: Fifty hours after injection I had a mild nosebleed; This is a spontaneous report received from a Pfizer sponsored program from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration in the right arm on 10Mar2021 10:00 (at the age of 67-years-old) as single dose for COVID-19 immunization. Medical history included breast cancer, high blood pressure and drug allergy to some medications, all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included lisinopril and tamoxifen. The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. The patient stated that fifty hours after injection (12Mar2021, 12 noon) she had a mild nosebleed. However, it was also reported that the mild nosebleed started on 12Mar2021 at 11:30 PM. At 11:30 (as reported), she was awakened with a gushing nosebleed. They couldn't get it stopped so they had to call the squad. The patient stayed in emergency room/department or urgent care for several hours to get it under control. The patient received some type of syringe medication reported as "Afrin packaging" as treatment for the event. The event of nosebleed was considered as non-serious by the reporter. The patient had no history of problems with nose bleeds. It just seems coincidental to receiving the vaccine. The patient wanted to make sure it was safe for her to get the second dose. The patient underwent COVID-19 test type post vaccination via nasal swab on 24Feb2021 which resulted to negative. The outcome of the event was recovered.  Follow up attempts are needed. Further information has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Fatigue, Intermenstrual bleeding, Pain in extremity
Clinical narrative: breakthrough bleeding period-wise/this has happened through years; breakthrough bleeding period-wise/this has happened through years; sore arm; extreme fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 42-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6198) via an unspecified route of administration administered on the left arm, on 23Feb2021 09:45, at a single dose, for covid-19 immunization. Medical history included breakthrough bleeding at times through years. There were no known allergies. Concomitant medication included hydromorphone hydrochloride (DILAUDID) and, alprazolam (XANAX) - both taken for unspecified indications, start and stop dates were not reported. Also as reported concomitant medications included "oxymoron" and "flexibility". The patient did not have Covid prior vaccination. The patient did not receive other vaccines in four weeks. The patient stated it was weird because she experienced a breakthrough bleeding period-wise 12 days after shot, on 07Mar2021 11:00. She stated this has happened through years and; a bunch of women on (social site name) were discussing it and majority had a breakthrough bleeding 1-2 weeks after shot and; that they will also be reporting. The patient stated she has no idea if this was a true side effect, but she considered it strange that so many experienced it too. She also experienced normal sore arm and extreme fatigue - both on 07Mar2021 11:00. Her next dose will be tomorrow, 16Mar2021. The patient recovered from the adverse events on Mar2021 with no treatment received. The patient was not Covid-tested post-vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: chills; fever; headache; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient wife) reported a male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route single dose for COVID-19 immunisation on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had reaction of chills, fever and headache after his first vaccine. Outcome of the events was unknown. ~ Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive COVID-19 test; Positive COVID-19 test; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient).   A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) single dose, on 24Feb2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. She is scheduled for the 2nd dose on 17Mar2021 (exactly 21 days apart). She is trying to reschedule the 2nd dose appointment because she went COVID-19 positive after the first dose (on an unspecified date, in 2021). Clinical outcome was unknown at time of this report.   The information on the lot number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Chronic obstructive pulmonary disease, Dyspnoea, Endoscopy, Illness
Clinical narrative: Pulmonary fibrosis; COPD; got sick; bloating; shortness of breath/ Even if lying down, he has difficulty breathing; ulcer; This is a spontaneous report from a contactable nurse (reporting for her husband). A male patient of an unspecified age (reported as Age: 67, unit: unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided) via an unspecified route of administration on 22Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter would like to know if the COVID vaccine is less effective if administered more than 21 days apart. She also reported that her husband (patient) received his first dose on 22Feb2021 and got sick on an unspecified date. Pulmonary fibrosis and COPD, for which he currently requires prednisolone. Last weeks, he had complaints of bloating and shortness of breath which was observed until Sunday (unspecified date). Even if lying down, he has difficulty breathing. He takes Symbicort. She rushed him to the emergency this morning (unspecified date) at 12:00. Although he has had similar complaints before, they still did an endoscopy and found ulcers. For his COPD exacerbation, he is taking prednisolone to lessen the inflammation. Now he's okay. She read on the Prednisolone information that it diminishes vaccine efficacy. The second dose of the COVID vaccine was supposed to be today but was moved on an unspecified date. The outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on the temporal gap between the vaccination and the event onset and considering the product's known safety profile, there was not a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the events pulmonary fibrosis and chronic obstructive pulmonary disease (COPD). The events were most likely due to the patient's underlying conditions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary fibrosis, Ulcer
Clinical narrative: Pulmonary fibrosis; COPD; got sick; bloating; shortness of breath/ Even if lying down, he has difficulty breathing; ulcer; This is a spontaneous report from a contactable nurse (reporting for her husband). A male patient of an unspecified age (reported as Age: 67, unit: unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided) via an unspecified route of administration on 22Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter would like to know if the COVID vaccine is less effective if administered more than 21 days apart. She also reported that her husband (patient) received his first dose on 22Feb2021 and got sick on an unspecified date. Pulmonary fibrosis and COPD, for which he currently requires prednisolone. Last weeks, he had complaints of bloating and shortness of breath which was observed until Sunday (unspecified date). Even if lying down, he has difficulty breathing. He takes Symbicort. She rushed him to the emergency this morning (unspecified date) at 12:00. Although he has had similar complaints before, they still did an endoscopy and found ulcers. For his COPD exacerbation, he is taking prednisolone to lessen the inflammation. Now he's okay. She read on the Prednisolone information that it diminishes vaccine efficacy. The second dose of the COVID vaccine was supposed to be today but was moved on an unspecified date. The outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on the temporal gap between the vaccination and the event onset and considering the product's known safety profile, there was not a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the events pulmonary fibrosis and chronic obstructive pulmonary disease (COPD). The events were most likely due to the patient's underlying conditions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Chronic obstructive pulmonary disease, Dyspnoea, Endoscopy, Gastrointestinal ulcer
Clinical narrative: Pulmonary fibrosis; COPD; got sick; bloating; shortness of breath/ Even if lying down, he has difficulty breathing; ulcer; This is a spontaneous report from a contactable nurse (reporting for her husband). A male patient of an unspecified age (reported as Age: 67, unit: unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided) via an unspecified route of administration on 22Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter would like to know if the COVID vaccine is less effective if administered more than 21 days apart. She also reported that her husband (patient) received his first dose on 22Feb2021 and got sick on an unspecified date. Pulmonary fibrosis and COPD, for which he currently requires prednisolone. Last weeks, he had complaints of bloating and shortness of breath which was observed until Sunday (unspecified date). Even if lying down, he has difficulty breathing. He takes Symbicort. She rushed him to the emergency this morning (unspecified date) at 12:00. Although he has had similar complaints before, they still did an endoscopy and found ulcers. For his COPD exacerbation, he is taking prednisolone to lessen the inflammation. Now he's okay. She read on the Prednisolone information that it diminishes vaccine efficacy. The second dose of the COVID vaccine was supposed to be today but was moved on an unspecified date. The outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on the temporal gap between the vaccination and the event onset and considering the product's known safety profile, there was not a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the events pulmonary fibrosis and chronic obstructive pulmonary disease (COPD). The events were most likely due to the patient's underlying conditions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Computerised tomogram, Dyspnoea, Fatigue, Magnetic resonance imaging
Clinical narrative: nauseous and vomited; nauseous and vomited; feeling weak; short of breath; I began seizing at the scene; tired; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302, expiration date: unknown), via an unspecified route of administration administered in left arm on 05Mar2021 at 00:30 as single dose for COVID-19 immunization. Medical history included hypertension (HTN), and known allergies to erythromycin. Concomitant medication included atenolol and furosemide, both for unspecified indication. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 12Feb2021 at 15:00 in left arm for COVID-19 immunization. Within a few hours after administration of the second vaccine on 05Mar2021, the patient became tired so went to bed early. Upon awakening the following morning (06Mar2021), the patient was nauseous and vomited. She got herself ready for work but noticed she was feeling weak, tired and had short of breath resulting in worsening of symptom. The patient then got in her car hoping to feel better with fresh air. However, her condition significantly worsened resulting in me calling number due to fear that she may expire. Upon arrival of emergency services, her condition significantly worsened, the patient was weak and unable to open car door. She was informed by medical personnel that she began seizing at the scene, in the ambulance and in the ED. Once she was stabilized in the ED, she was admitted for 3 days to continue tests and evaluations. The outcome of the events was recovering. The patient had no COVID-19 prior to vaccination. The patient was tested post vaccination via nasal swab on 06Mar2021 and was negative. The events resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage.; Sender's Comments: Considering the plausible temporal association and lacking any reported alternative explanation, a causative role of BNT162B2 vaccine for all reported SAEs 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.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, SARS-CoV-2 test, Seizure, Vomiting
Clinical narrative: nauseous and vomited; nauseous and vomited; feeling weak; short of breath; I began seizing at the scene; tired; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302, expiration date: unknown), via an unspecified route of administration administered in left arm on 05Mar2021 at 00:30 as single dose for COVID-19 immunization. Medical history included hypertension (HTN), and known allergies to erythromycin. Concomitant medication included atenolol and furosemide, both for unspecified indication. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 12Feb2021 at 15:00 in left arm for COVID-19 immunization. Within a few hours after administration of the second vaccine on 05Mar2021, the patient became tired so went to bed early. Upon awakening the following morning (06Mar2021), the patient was nauseous and vomited. She got herself ready for work but noticed she was feeling weak, tired and had short of breath resulting in worsening of symptom. The patient then got in her car hoping to feel better with fresh air. However, her condition significantly worsened resulting in me calling number due to fear that she may expire. Upon arrival of emergency services, her condition significantly worsened, the patient was weak and unable to open car door. She was informed by medical personnel that she began seizing at the scene, in the ambulance and in the ED. Once she was stabilized in the ED, she was admitted for 3 days to continue tests and evaluations. The outcome of the events was recovering. The patient had no COVID-19 prior to vaccination. The patient was tested post vaccination via nasal swab on 06Mar2021 and was negative. The events resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage.; Sender's Comments: Considering the plausible temporal association and lacking any reported alternative explanation, a causative role of BNT162B2 vaccine for all reported SAEs 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.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dyspnoea, Electroencephalogram, Headache, Loss of consciousness
Clinical narrative: nauseous and vomited; nauseous and vomited; feeling weak; short of breath; I began seizing at the scene; tired; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302, expiration date: unknown), via an unspecified route of administration administered in left arm on 05Mar2021 at 00:30 as single dose for COVID-19 immunization. Medical history included hypertension (HTN), and known allergies to erythromycin. Concomitant medication included atenolol and furosemide, both for unspecified indication. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 12Feb2021 at 15:00 in left arm for COVID-19 immunization. Within a few hours after administration of the second vaccine on 05Mar2021, the patient became tired so went to bed early. Upon awakening the following morning (06Mar2021), the patient was nauseous and vomited. She got herself ready for work but noticed she was feeling weak, tired and had short of breath resulting in worsening of symptom. The patient then got in her car hoping to feel better with fresh air. However, her condition significantly worsened resulting in me calling number due to fear that she may expire. Upon arrival of emergency services, her condition significantly worsened, the patient was weak and unable to open car door. She was informed by medical personnel that she began seizing at the scene, in the ambulance and in the ED. Once she was stabilized in the ED, she was admitted for 3 days to continue tests and evaluations. The outcome of the events was recovering. The patient had no COVID-19 prior to vaccination. The patient was tested post vaccination via nasal swab on 06Mar2021 and was negative. The events resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage.; Sender's Comments: Considering the plausible temporal association and lacking any reported alternative explanation, a causative role of BNT162B2 vaccine for all reported SAEs 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.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Seizure, Vomiting
Clinical narrative: nauseous and vomited; nauseous and vomited; feeling weak; short of breath; I began seizing at the scene; tired; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302, expiration date: unknown), via an unspecified route of administration administered in left arm on 05Mar2021 at 00:30 as single dose for COVID-19 immunization. Medical history included hypertension (HTN), and known allergies to erythromycin. Concomitant medication included atenolol and furosemide, both for unspecified indication. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 12Feb2021 at 15:00 in left arm for COVID-19 immunization. Within a few hours after administration of the second vaccine on 05Mar2021, the patient became tired so went to bed early. Upon awakening the following morning (06Mar2021), the patient was nauseous and vomited. She got herself ready for work but noticed she was feeling weak, tired and had short of breath resulting in worsening of symptom. The patient then got in her car hoping to feel better with fresh air. However, her condition significantly worsened resulting in me calling number due to fear that she may expire. Upon arrival of emergency services, her condition significantly worsened, the patient was weak and unable to open car door. She was informed by medical personnel that she began seizing at the scene, in the ambulance and in the ED. Once she was stabilized in the ED, she was admitted for 3 days to continue tests and evaluations. The outcome of the events was recovering. The patient had no COVID-19 prior to vaccination. The patient was tested post vaccination via nasal swab on 06Mar2021 and was negative. The events resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage.; Sender's Comments: Considering the plausible temporal association and lacking any reported alternative explanation, a causative role of BNT162B2 vaccine for all reported SAEs 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: M
Vaccine: COVID19
Symptoms: Drug ineffective, Laboratory test, Malaise, SARS-CoV-2 antibody test
Clinical narrative: Had zero effects after the second shot of Pfizer-BioNTech COVID-19 Vaccine; had an uneasy feeling all along on what level immunity; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number not provided), via an unspecified route of administration on 12Feb2021 (at unknown age) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer is patient who had second shot of Pfizer-BioNTech COVID-19 Vaccine. The patient was not satisfied with methodology of administrator of the Pfizer-BioNTech COVID-19 Vaccine. He had to bug his PCP for 2-3 weeks and order him to order a quantitative assessment of the effectiveness of the second shot of the Pfizer-BioNTech COVID-19 Vaccine. He does not have any confidence that the second shot of the Pfizer-BioNTech COVID-19 Vaccine is effective as it should be. He had zero effects after the second shot of Pfizer-BioNTech COVID-19 Vaccine and wanted to know if a certain percentage of people had zero effects as well after the Pfizer-BioNTech COVID-19 Vaccine. The results from the lab that did the quantitative test on him, they gave him a number but he does not have it in hand, but did give him the number; but it is unknown what it means without knowing what Pfizer measured to compare those numbers to. The patient initially reported that he had 2 questions: 1: he would like to know if Pfizer can provide him with the number or percentage of people who participated in the test program for Pfizer-BioNTech COVID-19 Vaccine that demonstrated zero effects after being administered the second shot of Pfizer-BioNTech COVID-19 Vaccine; 2: Caller is asking what is the antibody count after 1 month of receiving the second dose of Pfizer's COVID vaccine. The patient had a spike protein RBD test done with 250 measured antibodies and wants to compare these antibodies to the clinical study. Caller states: the person who gave shot was less than professional. The patient didn't feel it penetrate. The patient just had an uneasy feeling all along on what level immunity should had the patient gotten the 2 shots properly. His spike protein RBD antibody test had a measure of 250 antibodies. If it's less than 0.8' it is a negative result, and if it's 0.7 and above, it means you do have antibodies within you. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Came down with COVID between 1st and 2nd shot; Came down with COVID between 1st and 2nd shot; This is a spontaneous report from a contactable consumer. An adult male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient has no COVID prior to vaccination. The patient came down with COVID between 1st and 2nd shot on an unspecified date. The patient was tested for COVID post vaccination. The events were treated with Tylenol. The outcome of the events was recovered on an unspecified date.  Information about Lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased, Goitre, Headache, Odynophagia
Clinical narrative: I developed headaches; swelling of thyroid gland; tenderness; pain on swallowing; elevated TSH; low T3,T4 levels; low T3,T4 levels; subacute thyroiditis; This is a spontaneous report from a contactable physician (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ELO142), via intramuscular route of administration on 23Dec2020 (age at vaccination: 55-years) at a single dose in the left arm for COVID-19 immunization. Medical history included Diabetes mellitus (DM) and Hypertension (HTN). Concomitant medications were not specified. The patient previously took codeine and experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 27Dec2020, the patient developed headaches, swelling of thyroid gland,  tenderness, pain on swallowing, elevated TSH, low T3,T4 levels. Patient thought to have subacute thyroiditis. The events resulted to physician office visit. The patient did not receive any treatment for the reported events. The patient underwent nasal swab test on an unspecified date and showed negative result. The outcome of the events was recovered on an unspecified date.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tenderness, Thyroiditis subacute, Thyroxine, Thyroxine decreased
Clinical narrative: I developed headaches; swelling of thyroid gland; tenderness; pain on swallowing; elevated TSH; low T3,T4 levels; low T3,T4 levels; subacute thyroiditis; This is a spontaneous report from a contactable physician (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ELO142), via intramuscular route of administration on 23Dec2020 (age at vaccination: 55-years) at a single dose in the left arm for COVID-19 immunization. Medical history included Diabetes mellitus (DM) and Hypertension (HTN). Concomitant medications were not specified. The patient previously took codeine and experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 27Dec2020, the patient developed headaches, swelling of thyroid gland,  tenderness, pain on swallowing, elevated TSH, low T3,T4 levels. Patient thought to have subacute thyroiditis. The events resulted to physician office visit. The patient did not receive any treatment for the reported events. The patient underwent nasal swab test on an unspecified date and showed negative result. The outcome of the events was recovered on an unspecified date.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tri-iodothyronine, Tri-iodothyronine decreased
Clinical narrative: I developed headaches; swelling of thyroid gland; tenderness; pain on swallowing; elevated TSH; low T3,T4 levels; low T3,T4 levels; subacute thyroiditis; This is a spontaneous report from a contactable physician (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ELO142), via intramuscular route of administration on 23Dec2020 (age at vaccination: 55-years) at a single dose in the left arm for COVID-19 immunization. Medical history included Diabetes mellitus (DM) and Hypertension (HTN). Concomitant medications were not specified. The patient previously took codeine and experienced allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 27Dec2020, the patient developed headaches, swelling of thyroid gland,  tenderness, pain on swallowing, elevated TSH, low T3,T4 levels. Patient thought to have subacute thyroiditis. The events resulted to physician office visit. The patient did not receive any treatment for the reported events. The patient underwent nasal swab test on an unspecified date and showed negative result. The outcome of the events was recovered on an unspecified date.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Headache, Muscle spasms
Clinical narrative: Possibly a demyelinating neuropathy; I still have intermittent lumbar discomfort; started experiencing tingling sensation (paresthesia) in both legs without loss of sensitivity or strength/mild tingling sensation in my feet and sometimes legs depending on posture; I started having lumbar pain similar to a mild muscle cramp.; back and joint pain/I started having lumbar pain similar to a mild muscle cramp.; back and joint pain; shivers; headaches; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received second dose of bnt162b2 (lot number: el1283), via an unspecified route of administration, administered in Arm Left, on 09Jan2021 11:30 as single dose for COVID-19 immunisation. Medical history included mild asthma, allergies to fur, mites and olive tree pollen from an unknown date and unknown if ongoing. Concomitant medication(s) in two weeks included finasteride taken for an unspecified indication, start and stop date were not reported. The patient historical vaccine included first dose of bnt162b2 (Lot number: ek5730) at 30-year-old on 19Dec2020 08:00 PM at left arm for COVID-19 immunisation. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. A few hours after the second dose, the patient experienced back and joint pain, shivers and headaches for two days. On 19Jan2021 (reported as 10 days after the second dose), the patient started experiencing tingling sensation (paresthesia) in both legs without loss of sensitivity or strength. Also, the patient started having lumbar pain similar to a mild muscle cramp. The paresthesia was somewhat strong for a week and started to very slowly fade away, but the patient still has intermittent lumbar discomfort and mild tingling sensation in his feet and sometimes legs depending on posture. Possibly a demyelinating neuropathy. No treatment AE. The outcome of the events was recovering.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Neuropathy peripheral, Paraesthesia
Clinical narrative: Possibly a demyelinating neuropathy; I still have intermittent lumbar discomfort; started experiencing tingling sensation (paresthesia) in both legs without loss of sensitivity or strength/mild tingling sensation in my feet and sometimes legs depending on posture; I started having lumbar pain similar to a mild muscle cramp.; back and joint pain/I started having lumbar pain similar to a mild muscle cramp.; back and joint pain; shivers; headaches; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received second dose of bnt162b2 (lot number: el1283), via an unspecified route of administration, administered in Arm Left, on 09Jan2021 11:30 as single dose for COVID-19 immunisation. Medical history included mild asthma, allergies to fur, mites and olive tree pollen from an unknown date and unknown if ongoing. Concomitant medication(s) in two weeks included finasteride taken for an unspecified indication, start and stop date were not reported. The patient historical vaccine included first dose of bnt162b2 (Lot number: ek5730) at 30-year-old on 19Dec2020 08:00 PM at left arm for COVID-19 immunisation. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. A few hours after the second dose, the patient experienced back and joint pain, shivers and headaches for two days. On 19Jan2021 (reported as 10 days after the second dose), the patient started experiencing tingling sensation (paresthesia) in both legs without loss of sensitivity or strength. Also, the patient started having lumbar pain similar to a mild muscle cramp. The paresthesia was somewhat strong for a week and started to very slowly fade away, but the patient still has intermittent lumbar discomfort and mild tingling sensation in his feet and sometimes legs depending on posture. Possibly a demyelinating neuropathy. No treatment AE. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Mother tested positive for covid-19; This is a spontaneous report received from a contactable consumer via Pfizer Sponsored Program. A female patient (mother of reporter) of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) on 03Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. On 08Mar2021, the patient tested positive for covid-19. The reporter wanted to know if her mother should have her second dose of the vaccine on 24Mar2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: blurred vision; This is a spontaneous report from a contactable consumer (husband) from a Pfizer sponsored program. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 09Mar2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced blurred vision in Mar2021. The clinical outcome of blurred vision was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Osteomyelitis
Clinical narrative: bad bone infection; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A 57-year-old female patient (Wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Mar2021 (Lot number was not reported) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had a dental work with an implant placed either on the 08Mar2021 or 10Mar2021 of Mar2021 and she now had a "bad bone infection" in Mar2021. She was taking clindamycin hcl but it didn't work and now she was taking metronidazole and Flagyl (Was placed on heavy duty anti-biotics, wanted to know if taking anti-biotics would affect covid vaccine). Her second dose of the vaccine was due 25Mar2021 and she was very hesitant because of this infection and wanted to know if she should delay the second dose. Reporter stated he had not spoken to the oral surgeon since he's not an expert in vaccines and didn't trust what he would have to say. Not clarified if dental work was scheduled before or after vaccine. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Fatigue, Headache, Hypersensitivity, Vaccination site reaction
Clinical narrative: Anaphylaxis; hypersensitivity reactions; Injection site reactions; headache; feeling tired; This is a spontaneous case received from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER BIONTECH COVID 19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient experienced small rash after the first dose didn't itch, headache and feeling tired on an unspecified date. She treated her symptoms by taking 2 Tylenol. Spoke from fact sheet Adverse Reactions in Post Authorization Experience: Severe allergic reactions including anaphylaxis and other hypersensitivity reactions (e.g rash pruritus urticaria angioedema) had been reported following administration of the Pfizer BioNTech COVID 19 Vaccine during mass vaccination outside of clinical trials. Injection site reactions duration was 2.5 days. The outcome of the events headache, fatigue was recovered on an unspecified date, while other events were unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer-sponsored program. This consumer reported similar events for two patients. This is the second of two reports.  A 46-year-old male patient (consumer's husband) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 25Feb2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer's husband (patient) received the first dose the same time as her and he has Covid as well. The consumer (wife) and her husband (patient) received the covid vaccine at the end of Feb. Then recently tested positive for covid (in 2021), wanted to know when they will be able to receive the second dose of the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) :PFIZER-2021275214 same reporter/product/events, different patient
Sex: M
Vaccine: UNK
Symptoms: Endotracheal intubation, Medical induction of coma, Neurological symptom, Seizure
Clinical narrative: stroke like symptoms; seizures; the wellbutrin most likely interacted with the mRNA vaccine; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (Age: 38, Unit: Unknown) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization and bupropion hydrochloride (WELLBUTRIN), via an unspecified route of administration from an unspecified date to an unspecified date (reported as to approximately being taken for a year), at 150 mg for an unspecified indication. The patient's medical history and concomitant medications were not reported.  On an unspecified date, about 10 days after the vaccine the patient presented to the ER with stroke like symptoms and developed seizures.  The patient had to be put into a medically induced coma and intubated.  The patient had no previous history of seizures. His doctor told him that the wellbutrin most likely interacted with the mRNA vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Dizziness, Feeling hot, Palpitations, Tremor
Clinical narrative: feeling of extreme warmth or heat in the center of her chest /The warmth was not like a hot flash, nor was it like any kind of digestive issue, it was cardiac related.; feeling of extreme warmth or heat in the center of her chest /The warmth was not like a hot flash, nor was it like any kind of digestive issue, it was cardiac related.; heart rate started pounding; lightheaded and dizzy feeling; shaking all over; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205), via an unspecified route of administration, administered in arm left on 02Mar2021 12:45 as a single dose (at the age of 63-years-old) for covid-19 immunisation. Medical history included high blood pressure that was treated with metoprolol from an unknown date. The patient had known allergies to penicillin. The patient was not pregnant at the time of vaccination. Concomitant medications included metoprolol succinate taken for high blood pressure, start and stop date were not reported; escitalopram taken for an unspecified indication, start and stop date were not reported. The patient previously took prednisone and ciprofloxacin and experienced drug allergy. At about 25 minutes after receiving the vaccine (02Mar2021 13:15 as reported), the patient had a feeling of extreme warmth or heat in the center of her chest (about where her sternum was). It was a sudden feeling that started radiating outward, seemingly along her arteries and at the same time, her heart rate started pounding, accompanied by a lightheaded and dizzy feeling. The warmth was not like a hot flash, nor was it like any kind of digestive issue, it was cardiac related. It wasn't a panic attack either. The patient started shaking all over while was driving up and immediately looked for a place to pull over, and began texting someone close by (her brother) to let him know what was happening. No treatment was received for the reported events. The reported events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Swollen tongue
Clinical narrative: Tongue swelled a little; Headache; Felt dizzy 1 hour after vaccination, 7 hours later, she got really dizzy/Felt like she was going to faint; This is a spontaneous report from a contactable consumer. An female patient of an unspecified age (reported age: 78, no units reported) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration, administered in left arm on 11Mar2021 09:00 as single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient reported she felt dizzy 1 hour after vaccination on 11Mar2021. Then 7 hours later, she got really dizzy, then felt like she was going to faint. She woke up at 2 AM of 12Mar2021 with a really bad headache. Her tongue swelled a little at 4 AM. No treatment was received for the events. She reported that with this being the first shot, she is afraid to get the second. The patient has recovered from the events. The patient has no history of covid prior vaccination. He was not tested for covid post vaccination.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Asymptomatic - positive PCR test result; Asymptomatic - positive PCR test result; This is a spontaneous report from a contactable consumer. This consumer reported for herself that a 50-year-old female patient received first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) at the age of 50-years, via an unspecified route of administration in left arm on 24Feb2021 for COVID-19 immunisation, at workplace clinic. Medical history included breast cancer. No known allergies. No COVID prior vaccination. Patient was not pregnant at time of vaccination. Concomitant medications were not reported. The patient experienced asymptomatic - positive PCR test result on 15Mar2021. No treatment to AE. The patient underwent lab tests and procedures, which included PCR (Nasal Swab) tested positive on 15Mar2021. Outcome of the event was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Movement disorder, Polymerase chain reaction, Vaccination site pain
Clinical narrative: Asymptomatic - positive PCR test result; Asymptomatic - positive PCR test result; This is a spontaneous report from a contactable consumer. This consumer reported for herself that a 50-year-old female patient received first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) at the age of 50-years, via an unspecified route of administration in left arm on 24Feb2021 for COVID-19 immunisation, at workplace clinic. Medical history included breast cancer. No known allergies. No COVID prior vaccination. Patient was not pregnant at time of vaccination. Concomitant medications were not reported. The patient experienced asymptomatic - positive PCR test result on 15Mar2021. No treatment to AE. The patient underwent lab tests and procedures, which included PCR (Nasal Swab) tested positive on 15Mar2021. Outcome of the event was unknown.