chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use, Peripheral swelling, Pruritus, Rash
Clinical narrative: get a rash all over; swelling of the extremities; very itchy; DOSE 3 (BOOSTER) SINGLE; DOSE 3 (BOOSTER) SINGLE; This is a spontaneous report from a contactable other hcp (patient). A 19-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2), dose 3 intramuscular, administered in Arm Right on 07Oct2021 10:00 (Batch/Lot Number: 301308A) at the 19-years-old as DOSE 3 (BOOSTER) SINGLE, for covid-19 immunisation. Medical history included Covid-19. Concomitant medication included influenza vaccine (FLU) taken for immunisation on 27Sep2021; medroxyprogesterone acetate (DEPO PROVERA) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included BNT162B2 on 05Feb2021 at the age of 19-year-old for Covid-19 Immunization (Dose Number: 2, Batch/Lot No: EN5318, Location of injection: Right Arm, Vaccine Administration Time: 03:00 PM, Route of Administration: Intramuscular); and BNT162B2 on 15Jan2021 at the age of 19-year-old for Covid-19 Immunization (Dose Number: 1, Batch/Lot No: EL3249, Location of injection: Right Arm, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular). The most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. The patient experienced get a rash all over, swelling of the extremities, very itchy on 07Oct2021 10:30 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19: diagnosed with covid-19 on an unknown date (Prior to vaccination). The patient started to get a rash all over and had swelling of the extremities. The patient became very itchy, was given 25mg of Benadryl to try and reverse the itching and rash. She was still feeling itchy and have some. No hospitalization Prolonged. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Rash, Peripheral swelling, Pruritus and the suspect drug BNT162B2 cannot be excluded. The case will be re-assessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 19.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: get a rash all over; swelling of the extremities; very itchy; DOSE 3 (BOOSTER) SINGLE; DOSE 3 (BOOSTER) SINGLE; This is a spontaneous report from a contactable other hcp (patient). A 19-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2), dose 3 intramuscular, administered in Arm Right on 07Oct2021 10:00 (Batch/Lot Number: 301308A) at the 19-years-old as DOSE 3 (BOOSTER) SINGLE, for covid-19 immunisation. Medical history included Covid-19. Concomitant medication included influenza vaccine (FLU) taken for immunisation on 27Sep2021; medroxyprogesterone acetate (DEPO PROVERA) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included BNT162B2 on 05Feb2021 at the age of 19-year-old for Covid-19 Immunization (Dose Number: 2, Batch/Lot No: EN5318, Location of injection: Right Arm, Vaccine Administration Time: 03:00 PM, Route of Administration: Intramuscular); and BNT162B2 on 15Jan2021 at the age of 19-year-old for Covid-19 Immunization (Dose Number: 1, Batch/Lot No: EL3249, Location of injection: Right Arm, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular). The most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. The patient experienced get a rash all over, swelling of the extremities, very itchy on 07Oct2021 10:30 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19: diagnosed with covid-19 on an unknown date (Prior to vaccination). The patient started to get a rash all over and had swelling of the extremities. The patient became very itchy, was given 25mg of Benadryl to try and reverse the itching and rash. She was still feeling itchy and have some. No hospitalization Prolonged. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Rash, Peripheral swelling, Pruritus and the suspect drug BNT162B2 cannot be excluded. The case will be re-assessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Gait inability, Headache
Clinical narrative: rheumatoid like pain (extreme) in all joints; shakes; swollen hands/ swelling under left arm; weakness in the legs; muscle spasm; Stomach upset; unable to walk with body upright; chills; fever; extreme headache; Pain in muscles and joints; nausea; extreme muscle pain/ pain in muscles and joints; This is a spontaneous report from a contactable pharmacist. This pharmacist (patient) reported for herself that a 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ff2589) at the age of 45-years, via an unspecified route of administration in left arm on 07Oct2021 at 18:00 at single dose for COVID-19 immunization, at pharmacy/drug store. Medical history included high blood pressure. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Concomitant medications included olmesartan medoxomil (BENICAR) and gabapentin (GRALISE). The patient historically received first single dose of BNT162B2 (lot number: 301308a) at the age of 45-years via an unspecified route of administration in left arm on 15Sep2021 at 12:00 PM for COVID-19 immunization. On 08Oct2021 at 12:00, the patient had extreme muscle pain, shakes, chills and fever, swollen hands, weakness in the legs, extreme headache, muscle spasm that feels like she was beaten. Swelling under left arm. Pain in muscles and joints. Stomach upset and nausea. Unable to walk with her body upright and rheumatoid like pain (extreme) in all joints. AE treatment included paracetamol (TYLENOL) 500 mg. Outcome of the events was recovered with lasting effects. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event rheumatic disorder 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.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscular weakness, Myalgia, Nausea, Peripheral swelling
Clinical narrative: rheumatoid like pain (extreme) in all joints; shakes; swollen hands/ swelling under left arm; weakness in the legs; muscle spasm; Stomach upset; unable to walk with body upright; chills; fever; extreme headache; Pain in muscles and joints; nausea; extreme muscle pain/ pain in muscles and joints; This is a spontaneous report from a contactable pharmacist. This pharmacist (patient) reported for herself that a 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ff2589) at the age of 45-years, via an unspecified route of administration in left arm on 07Oct2021 at 18:00 at single dose for COVID-19 immunization, at pharmacy/drug store. Medical history included high blood pressure. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Concomitant medications included olmesartan medoxomil (BENICAR) and gabapentin (GRALISE). The patient historically received first single dose of BNT162B2 (lot number: 301308a) at the age of 45-years via an unspecified route of administration in left arm on 15Sep2021 at 12:00 PM for COVID-19 immunization. On 08Oct2021 at 12:00, the patient had extreme muscle pain, shakes, chills and fever, swollen hands, weakness in the legs, extreme headache, muscle spasm that feels like she was beaten. Swelling under left arm. Pain in muscles and joints. Stomach upset and nausea. Unable to walk with her body upright and rheumatoid like pain (extreme) in all joints. AE treatment included paracetamol (TYLENOL) 500 mg. Outcome of the events was recovered with lasting effects. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event rheumatic disorder 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.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rheumatic disorder, Tremor
Clinical narrative: rheumatoid like pain (extreme) in all joints; shakes; swollen hands/ swelling under left arm; weakness in the legs; muscle spasm; Stomach upset; unable to walk with body upright; chills; fever; extreme headache; Pain in muscles and joints; nausea; extreme muscle pain/ pain in muscles and joints; This is a spontaneous report from a contactable pharmacist. This pharmacist (patient) reported for herself that a 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ff2589) at the age of 45-years, via an unspecified route of administration in left arm on 07Oct2021 at 18:00 at single dose for COVID-19 immunization, at pharmacy/drug store. Medical history included high blood pressure. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Concomitant medications included olmesartan medoxomil (BENICAR) and gabapentin (GRALISE). The patient historically received first single dose of BNT162B2 (lot number: 301308a) at the age of 45-years via an unspecified route of administration in left arm on 15Sep2021 at 12:00 PM for COVID-19 immunization. On 08Oct2021 at 12:00, the patient had extreme muscle pain, shakes, chills and fever, swollen hands, weakness in the legs, extreme headache, muscle spasm that feels like she was beaten. Swelling under left arm. Pain in muscles and joints. Stomach upset and nausea. Unable to walk with her body upright and rheumatoid like pain (extreme) in all joints. AE treatment included paracetamol (TYLENOL) 500 mg. Outcome of the events was recovered with lasting effects. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event rheumatic disorder 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.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cardiac flutter, Chest discomfort, Fatigue, Headache
Clinical narrative: heart fluttering; chest discomfort; irregular heartbeat; Severe headache; joint pain; nausea; fatigue; pain and redness at injection site lasting two days; pain and redness at injection site lasting two days; This is a spontaneous report from contactable consumer (patient). A 78-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 3 via an unspecified route of administration, administered in Arm Left on 05Oct2021 13:00 (Lot Number: FE3592) as dose 3 (booster), single (at age of 78-years-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included MGUS, Barritts, Ventricular Fibrillation. No known allergies. Concomitant medications included apixaban (ELIQUIS); omeprazole; atorvastatin. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot No: EL9262, Location of injection: Arm Left) on 19Feb2021 10:00 AM (at age of 77-years-old) for COVID-19 Immunization; the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot No: EL9269, Location of injection: Arm Left) on 09Mar2021 09:30 AM (at age of 77-years-old) for COVID-19 Immunization. On 06Oct2021 03:30, the patient experienced Severe headache, joint pain, nausea, fatigue, pain and redness at injection site lasting two days. On 07Oct2021 (third day), he experienced heart fluttering, chest discomfort, and irregular heartbeat. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment received. Outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular, Nausea, Vaccination site erythema, Vaccination site pain
Clinical narrative: heart fluttering; chest discomfort; irregular heartbeat; Severe headache; joint pain; nausea; fatigue; pain and redness at injection site lasting two days; pain and redness at injection site lasting two days; This is a spontaneous report from contactable consumer (patient). A 78-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 3 via an unspecified route of administration, administered in Arm Left on 05Oct2021 13:00 (Lot Number: FE3592) as dose 3 (booster), single (at age of 78-years-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included MGUS, Barritts, Ventricular Fibrillation. No known allergies. Concomitant medications included apixaban (ELIQUIS); omeprazole; atorvastatin. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot No: EL9262, Location of injection: Arm Left) on 19Feb2021 10:00 AM (at age of 77-years-old) for COVID-19 Immunization; the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot No: EL9269, Location of injection: Arm Left) on 09Mar2021 09:30 AM (at age of 77-years-old) for COVID-19 Immunization. On 06Oct2021 03:30, the patient experienced Severe headache, joint pain, nausea, fatigue, pain and redness at injection site lasting two days. On 07Oct2021 (third day), he experienced heart fluttering, chest discomfort, and irregular heartbeat. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment received. Outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypotension, Immunisation, Loss of consciousness, Off label use
Clinical narrative: loss of consciousness; severe hypotension; two episodes of emesis and LOC; severe chills; received the third dose of BNT162B2; received the third dose of BNT162B2; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient (not pregnant) received the third dose of BNT162B2 (PFIZER BIONTECH COVID 19) via intramuscular on the left arm on 08Oct2021 at 09:00 AM (Lot Number: EW0183) at the age of 32-year-old as single dose for COVID-19 immunization. Medical history was none. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. Known allergy was none. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Concomitant medication was none. The patient previously received the first dose and the second dose of BNT162B2, the second dose on 15Jan2021 at 12:00 PM (Lot Number: EL1283) on the left arm, the first dose on 24Dec2020 at 01:15 PM (Lot Number: EK5730) on the right arm, both via intramuscular at the age of 31-year-old as single dose for COVID-19 immunization. On 09Oct2021 at 12:15 PM, the patient experienced severe hypotension and loss of consciousness. Hypotension lasting about 60 min with two episodes of emesis and LOC. followed by severe chills. No treatment was received. The outcome of booster and off label use was unknown. The outcome of other events was recovered with sequel in 2021.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development loss of consciousness cannot be totally excluded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: loss of consciousness; severe hypotension; two episodes of emesis and LOC; severe chills; received the third dose of BNT162B2; received the third dose of BNT162B2; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient (not pregnant) received the third dose of BNT162B2 (PFIZER BIONTECH COVID 19) via intramuscular on the left arm on 08Oct2021 at 09:00 AM (Lot Number: EW0183) at the age of 32-year-old as single dose for COVID-19 immunization. Medical history was none. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. Known allergy was none. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Concomitant medication was none. The patient previously received the first dose and the second dose of BNT162B2, the second dose on 15Jan2021 at 12:00 PM (Lot Number: EL1283) on the left arm, the first dose on 24Dec2020 at 01:15 PM (Lot Number: EK5730) on the right arm, both via intramuscular at the age of 31-year-old as single dose for COVID-19 immunization. On 09Oct2021 at 12:15 PM, the patient experienced severe hypotension and loss of consciousness. Hypotension lasting about 60 min with two episodes of emesis and LOC. followed by severe chills. No treatment was received. The outcome of booster and off label use was unknown. The outcome of other events was recovered with sequel in 2021.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development loss of consciousness cannot be totally excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eyelid ptosis, Feeling cold, SARS-CoV-2 test
Clinical narrative: my right eye felt droopy lid; severe chills; felt so cold despite blankets and sweater; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 27Sep2021 at 13:30 at the age of 53-year-old as single dose for COVID-19 immunization. Medical history included lupus, HX antiphospholipid antibodies, pulmonic stenosis and sjogren's. The patient didn't receive other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 (Nasal Swab) on 07Oct2021 and result was negative. Concomitant medication included warfarin and hydroxychloroquine. The patient previously received dilaudid and experienced allergy. On 27Sep2021 at 18:30, the patient experienced severe chills, felt so cold despite blankets and sweater. Then about 6hrs later the right eye felt droopy lid. Since patient was feeling to cold he stayed under covers for hours until I felt warm. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was received included steroid eye drops. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Application site bruise, Nerve injury
Clinical narrative: Forearm of injection arm developed two small bruises with nerve type discomfort; Forearm of injection arm developed two small bruises with nerve type discomfort. At times it feels like there is tearing or pulling apart inside.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FF8841), via an unspecified route of administration in left arm on 03Oct2021 at 15:00 (at the age of 61 years old, not pregnant at the time of vaccination) as dose 2, single for covid-19 immunisation. Medical history included patient had known allergies pennecilin. Concomitant medication in two weeks included levothyroxine sodium. Other vaccine within 4 weeks included influenza vaccine as DOSE NUMBER UNKNOWN, SINGLE from 08Sep2021 to 08Sep2021. Historical vaccine included first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injectio n, Lot number: FC3183), via an unspecified route of administration in left arm on 12Sep2021 at 03:00 PM (at the age of 61 years old,) for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Oct2021 patient experienced forearm of injection arm developed two small bruises with nerve type discomfort. At times it feels like there was tearing or pulling apart inside. Bruises did not appear at same time but few days apart. This happened approx. 2 days after 2nd dose injection. It was not going away. No hospitalization required. The patient did not received treatment due to the events. Reporter considered events as non-serious. The outcome of events was not recovered.  Follow up attempts completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Tenderness, Vaccination site mass, Vaccination site swelling
Clinical narrative: Lump/swelling at injection site; Lump/swelling at injection site; swollen tender left clavicular lymph node; swollen tender left clavicular lymph node; This is a spontaneous report from a contactable nurse. This 32-year-old female nurse (patient) reported for herself. A 32-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 intramuscular, administered in Arm Left on 08Oct2021 11:45 (at the age of 32 years) (Batch/Lot Number: EW018S) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation at hospital. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) dose 1, administered in Arm Left on 26Dec2020 (at the age of 31 years) (Batch/Lot Number: EK5730) and dose 2, administered in left leg on 14Jan2021 (at the age of 31 years) (Batch/Lot Number: EL8982) for COVID-19 Immunization. On 09Oct2021 12:00 the patient experienced Lump/swelling at injection site, swollen tender left clavicular lymph node. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was recovering at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: Everytime i have a bowel movement i bleed; This is a spontaneous report received from a contactable consumer (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number FF2588), administered in left arm on 07Oct2021 at 05:45 PM (at the age of 26-year-old) as dose 2, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug store. The patient's medical history was reported as none. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications included other unspecified vaccine (lot number Wag4161) administered in left arm on 07Oct2021 as dose number 2 (as reported). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ff2587), administered in left arm on 15Sep2021 at 01:00 PM as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine (as reported). On 08Oct2021 at 09:15 AM the patient experienced that every time she had a bowel movement she bled. The event was reported as non-serious, and no treatment was received due to the event. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event was not resolved.  Follow-up (13Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cardiac flutter, Chills, Fatigue, Headache
Clinical narrative: Feelings of having a fast beating, fluttering, pounding heart; Thought I was having an heart attack.; pounding heart; injection site pain/really bad arm pain on arm that injection was given; Feelings of having a fast beating; tiredness; severe headaches; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; This is a spontaneous report from a contactable consumer. A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; Lot Number: Ff2587 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 20Sep2021 (at the age of 49-years-old) at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took morphine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19. The patient had feelings of having a fast beating, fluttering, pounding heart, thought he was having an heart attack, had injection site pain/really bad arm pain on arm that injection was given, tiredness, severe headaches, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell on 20Sep2021. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. No treatment was given for the events. The outcome of the event feeling unwell was recovered and outcome of rest of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Malaise, Myalgia, Myocardial infarction, Nausea
Clinical narrative: Feelings of having a fast beating, fluttering, pounding heart; Thought I was having an heart attack.; pounding heart; injection site pain/really bad arm pain on arm that injection was given; Feelings of having a fast beating; tiredness; severe headaches; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; This is a spontaneous report from a contactable consumer. A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; Lot Number: Ff2587 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 20Sep2021 (at the age of 49-years-old) at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took morphine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19. The patient had feelings of having a fast beating, fluttering, pounding heart, thought he was having an heart attack, had injection site pain/really bad arm pain on arm that injection was given, tiredness, severe headaches, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell on 20Sep2021. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. No treatment was given for the events. The outcome of the event feeling unwell was recovered and outcome of rest of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Feelings of having a fast beating, fluttering, pounding heart; Thought I was having an heart attack.; pounding heart; injection site pain/really bad arm pain on arm that injection was given; Feelings of having a fast beating; tiredness; severe headaches; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; This is a spontaneous report from a contactable consumer. A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; Lot Number: Ff2587 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 20Sep2021 (at the age of 49-years-old) at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took morphine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19. The patient had feelings of having a fast beating, fluttering, pounding heart, thought he was having an heart attack, had injection site pain/really bad arm pain on arm that injection was given, tiredness, severe headaches, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell on 20Sep2021. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. No treatment was given for the events. The outcome of the event feeling unwell was recovered and outcome of rest of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Chills, Fatigue, Heart rate
Clinical narrative: swollen armpit (lymph nodes?); overnight sweats; elevated heartrate; chest pain; burning sensation throughout the day; fatigue; overnight chills; injection-site pain; This is a spontaneous report from a contactable consumer or other non-HCP. A 33-years-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FF8841), via an unspecified route of administration, administered in left arm on 08Oct2021 at 10:20 (at the age of 33-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution injection, lot number: EL3247) on 14Jan2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution injection, lot number: EL3247) on 04Feb2021 for COVID-19 immunization. Medical history included cholesterol, hypothyroidism and Hashimoto's Thyroiditis. Concomitant medications included levothyroxine sodium (LEVOXYL), colecalciferol, fish oil (OMEGASAN 3) and Multi-vitamins. On 08Oct2021 10:20 the patient experienced overnight chills and injection-site pain. On 09Oct2021 13:00 the patient experienced fatigue, elevated heartrate, chest pain, burning sensation throughout the day, overnight sweats. On 09Oct2021 19:00 the patient noticed swollen armpit (lymph nodes?). Facility type vaccine mentioned as Workplace clinic. No other vaccine in four weeks has been administered. Other medications in two weeks mentioned as Levoxyl, Omegas, Multi-vitamins, Other medical history: Cholesterol, Hypothyroidism, Hashimoto's Thyroiditis. The patient did not had COVID prior vaccination and post vaccination, patient had not tested with covid 19. No known allergies reported for the patient. The patient underwent lab tests and procedures which included Nasal Swab (SARS-CoV-2 test): Negative on 31Mar2021 COVID 19 Antigen/Rapid; heart rate: elevated on 09Oct2021. Therapeutic measures were taken as a result of overnight chills, injection-site pain, fatigue, elevated heartrate, chest pain, burning sensation throughout the day, swollen armpit (lymph nodes), overnight sweats. On 08Oct2021 at around 20:00 took two Tylenol PM tablets. On 09Oct2021 at around 9am took two Tylenol Gelcaps. May plan to visit Primary Care Physician this coming week reporter stated. The outcome of event overnight chills, injection-site pain was recovered on an unspecified date of Oct2021 while outcome of event fatigue recovered on 09Oct2021. The events were reported non-serious. The outcome of event overnight sweats was outcome of recovering while outcome of rest all event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Lymphadenopathy, Night sweats, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: swollen armpit (lymph nodes?); overnight sweats; elevated heartrate; chest pain; burning sensation throughout the day; fatigue; overnight chills; injection-site pain; This is a spontaneous report from a contactable consumer or other non-HCP. A 33-years-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FF8841), via an unspecified route of administration, administered in left arm on 08Oct2021 at 10:20 (at the age of 33-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution injection, lot number: EL3247) on 14Jan2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution injection, lot number: EL3247) on 04Feb2021 for COVID-19 immunization. Medical history included cholesterol, hypothyroidism and Hashimoto's Thyroiditis. Concomitant medications included levothyroxine sodium (LEVOXYL), colecalciferol, fish oil (OMEGASAN 3) and Multi-vitamins. On 08Oct2021 10:20 the patient experienced overnight chills and injection-site pain. On 09Oct2021 13:00 the patient experienced fatigue, elevated heartrate, chest pain, burning sensation throughout the day, overnight sweats. On 09Oct2021 19:00 the patient noticed swollen armpit (lymph nodes?). Facility type vaccine mentioned as Workplace clinic. No other vaccine in four weeks has been administered. Other medications in two weeks mentioned as Levoxyl, Omegas, Multi-vitamins, Other medical history: Cholesterol, Hypothyroidism, Hashimoto's Thyroiditis. The patient did not had COVID prior vaccination and post vaccination, patient had not tested with covid 19. No known allergies reported for the patient. The patient underwent lab tests and procedures which included Nasal Swab (SARS-CoV-2 test): Negative on 31Mar2021 COVID 19 Antigen/Rapid; heart rate: elevated on 09Oct2021. Therapeutic measures were taken as a result of overnight chills, injection-site pain, fatigue, elevated heartrate, chest pain, burning sensation throughout the day, swollen armpit (lymph nodes), overnight sweats. On 08Oct2021 at around 20:00 took two Tylenol PM tablets. On 09Oct2021 at around 9am took two Tylenol Gelcaps. May plan to visit Primary Care Physician this coming week reporter stated. The outcome of event overnight chills, injection-site pain was recovered on an unspecified date of Oct2021 while outcome of event fatigue recovered on 09Oct2021. The events were reported non-serious. The outcome of event overnight sweats was outcome of recovering while outcome of rest all event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abscess of salivary gland, Feeding disorder, Lymph node pain, Lymphadenopathy, Swelling face
Clinical narrative: Salivary gland to abscess; swollen lymph nodes around my jaw; It is swollen and sore; they are on my jaw more so then my neck/ Jaw was swollen, sore and tender; Jaw was swollen; couldn't eat; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on 20Oct2021, this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report from a contactable consumer (reporting or self).   A patient of unspecified age and gender received BNT162b2 (COMIRNATY), dose 2 via an unspecified route of administration in Oct2021 (Batch/Lot Number: FF8839) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient previously received dose 1 of BNT162b2 (COMIRNATY), Lot # FF2588, on an unspecified date for COVID-19 immunization and experienced foggy brain. The patient reported having had their second COVID vaccine "on this last Wednesday" (Oct2021). The patient reported swollen lymph nodes, which seem to be around the patient's jaw. It was swollen and sore. The reporter clarified they were on the patient's jaw moreso than neck. Jaw was swollen, sore and tender. Salivary gland to abscess. There was a lot of swelling and pain, and she couldn't eat. When it burst, it all went down. Swelling and pain 6 hours after her shot. Following Monday, around five days. The patient received ibuprofen for treatment. The patient recovered from the events on an unspecified date in Oct2021.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Hot flush, Menometrorrhagia
Clinical narrative: having hot flash things; she started her period little bit, and it didn't stop since then. It's been still going on and on 08Oct2021 she started bleeding a lot; maybe on 04Sep2021, she started her period little bit, and it didn't stop since then. It's been still going on and on 08Oct2021 she started bleeding a lot; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 3 via an unspecified route of administration, administered in Arm Left on Aug2021 (Lot Number: FC3181) as dose 3 (booster), single (at age of 40-years-old) for covid-19 immunisation. Medical history included Lupus; pain associated with severe back spine issues, immune compromised. Concomitant medications included hydroxychloroquine taken for Lupus; duloxetine hydrochloride (CYMBALTA) taken for pain associated with severe back spine issues. Historical Vaccine included the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation on an unspecified date. The patient got the booster vaccine (Covid-19 Vaccine) probably 6 weeks ago and after a week, maybe on 04Sep2021, she started her period little bit, and it didn't stop since then. It's been still going on and on 08Oct2021 she started bleeding a lot, she was having hot flash things. The patient will call her OB-GYN (further not clarified) on Monday. She was assuring if it was all brought on by booster vaccine. Which happened about 5 weeks ago, maybe 04Sep2021. The event was not worsening. When probed if any doctor prescribed the vaccine, the patient stated doctor didn't prescribe her. She got vaccine because she was immune compromised (further not clarified the word). No treatment received. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Fatigue, Headache
Clinical narrative: Very tired; She took my bp and it was 218/92./Kept me for about an hour re-checking bp readings of 201/81, 186/78 & 172/66/My bp was 185/78, 192/80,180/73 & 174/78; My heart suddenly started pounding rapidly and would not slow down.; Headache; Dizziness; This is a spontaneous report from a contactable consumer. A 59-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF2588), via an unspecified route on 06Oct2021 at 16:00 (at the age of 59-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included Hypertension, Carotid stenosis, Hyperlipidemia & spasmodic dysphonia and had known allergies: Naproxen, Ezetimibe, Benzonatate & NSAID. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received other prescribed medications in two weeks. The patient experienced and stated within 10 minutes after receiving injection my heart suddenly started pounding rapidly and would not slow down. I told nurse, she took my bp and it was 218/92. They quickly took me to an exam room with a doctor following me in. Kept me for about an hour re-checking bp readings of 201/81, 186/78 & 172/66 then discharging me at 5:10 pm. Later that evening had headache and dizziness. My bp was 185/78, 192/80,180/73 & 174/78. Next day was very tired but bp was normal at 117/69 on 06Oct2021 at 16:30. AE resulted in: Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered on unspecified date of 2021.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Palpitations
Clinical narrative: Very tired; She took my bp and it was 218/92./Kept me for about an hour re-checking bp readings of 201/81, 186/78 & 172/66/My bp was 185/78, 192/80,180/73 & 174/78; My heart suddenly started pounding rapidly and would not slow down.; Headache; Dizziness; This is a spontaneous report from a contactable consumer. A 59-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF2588), via an unspecified route on 06Oct2021 at 16:00 (at the age of 59-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included Hypertension, Carotid stenosis, Hyperlipidemia & spasmodic dysphonia and had known allergies: Naproxen, Ezetimibe, Benzonatate & NSAID. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received other prescribed medications in two weeks. The patient experienced and stated within 10 minutes after receiving injection my heart suddenly started pounding rapidly and would not slow down. I told nurse, she took my bp and it was 218/92. They quickly took me to an exam room with a doctor following me in. Kept me for about an hour re-checking bp readings of 201/81, 186/78 & 172/66 then discharging me at 5:10 pm. Later that evening had headache and dizziness. My bp was 185/78, 192/80,180/73 & 174/78. Next day was very tired but bp was normal at 117/69 on 06Oct2021 at 16:30. AE resulted in: Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered on unspecified date of 2021.  Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive on 30-Sep-2021 by PCR.; Tested positive on 30-Sep-2021 by PCR.; This is a spontaneous report from a contactable consumer.   A 17-year-old male patient received two doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot numbers not reported), on 02May2021  (first dose, at 17 years) and on 23May2021 (second dose, at 17 years), both at single doses for covid-19 immunisation .  The patient medical history included allergy. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported.  Symptoms initiated on 28Sep2021 and included nasal congestion, cough. He was tested positive on 30Sep2021 by PCR (Nasal Swab). Symptoms began to subside about "2Sep2021" (as reported).  Patient attended on 25Sep2021 (as reported). No treatment given. Patient recovered on an unknown date in 2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient started symptoms on 01Oct2021, tested positive via home test on 03Oct2021; Patient started symptoms on 01Oct2021, tested positive via home test on 03Oct2021; This is a spontaneous report from a contactable consumer.    A 15-year-old female patient (not pregnant) received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot numbers not reported), on 20May2021 (first dose, at 15 years) and on 12Jun2021 (second dose, at 15 years) , both as single doses for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19.Patient's brother tested positive via PCR test on 30Sep2021. Patient started symptoms on 01Oct2021, tested positive via home test on 03Oct2021. Symptoms of nasal congestion and headache subsided within a few days. No treatment given. Patient recovered on an unknown date in Oct2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up