chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache, Muscle spasms, Myalgia
Clinical narrative: raised/bruised baseball marking at injection site; day 2: headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point; day 2: headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; baseball size red warm to touch welt; baseball size red warm to touch welt; temp; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; This is a spontaneous report from a contactable nurse, , the patient. A 31 -year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot_number: unknown), via an unspecified route of administration on 29Dec2020 at 11:30 AM, (at the age of 31 years-old) for COVID-19 vaccination.  Medical history included Crohn's. The patient was allergic to adalimumab (HUMIRA). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not  receive  any other vaccine within 4 weeks prior to the vaccine. On 29Dec2020 at 08:00 PM, the patient had a baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills. On 30Dec2020 (reported as day 2), the patient experienced headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site. The patient was not treated for baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills, headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site. The clinical outcome of baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills, headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site was recovering. It was also reported that since the vaccination, the patient was been tested for COVID-19 (nasal swab) on 02Jan2021.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-1 test, Vaccination site bruising, Vaccination site erythema, Vaccination site urticaria
Clinical narrative: raised/bruised baseball marking at injection site; day 2: headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point; day 2: headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; baseball size red warm to touch welt; baseball size red warm to touch welt; temp; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; This is a spontaneous report from a contactable nurse, , the patient. A 31 -year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot_number: unknown), via an unspecified route of administration on 29Dec2020 at 11:30 AM, (at the age of 31 years-old) for COVID-19 vaccination.  Medical history included Crohn's. The patient was allergic to adalimumab (HUMIRA). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not  receive  any other vaccine within 4 weeks prior to the vaccine. On 29Dec2020 at 08:00 PM, the patient had a baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills. On 30Dec2020 (reported as day 2), the patient experienced headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site. The patient was not treated for baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills, headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site. The clinical outcome of baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills, headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site was recovering. It was also reported that since the vaccination, the patient was been tested for COVID-19 (nasal swab) on 02Jan2021.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: raised/bruised baseball marking at injection site; day 2: headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point; day 2: headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; baseball size red warm to touch welt; baseball size red warm to touch welt; temp; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; This is a spontaneous report from a contactable nurse, , the patient. A 31 -year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot_number: unknown), via an unspecified route of administration on 29Dec2020 at 11:30 AM, (at the age of 31 years-old) for COVID-19 vaccination.  Medical history included Crohn's. The patient was allergic to adalimumab (HUMIRA). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not  receive  any other vaccine within 4 weeks prior to the vaccine. On 29Dec2020 at 08:00 PM, the patient had a baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills. On 30Dec2020 (reported as day 2), the patient experienced headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site. The patient was not treated for baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills, headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site. The clinical outcome of baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills, headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site was recovering. It was also reported that since the vaccination, the patient was been tested for COVID-19 (nasal swab) on 02Jan2021.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Nausea, Peripheral swelling, Pruritus
Clinical narrative: Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; This is a spontaneous report from a contactable consumer, the patient.  A 68 -year-old elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0142), via an unspecified route of administration in the left arm on 29Dec2020 at 02:30 PM, (at the age of 68 -years-old) as a single dose, dose number=1 for COVID-19 vaccination.  Medical history included hypothyroidism and osteopenia. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included levothyroxin and citalopram within 2 weeks of the vaccination.  The patient did not  receive  any other vaccine within 4 weeks prior to the vaccine. On 02Jan2021, the patient woke up with a red and swollen, slightly itchy, left 4th finger, redness progressed to left hand, and arm, generalized red rash noted in groin and abdomen, slight headache and nausea. The patient was treated for red and swollen, slightly itchy, left 4th finger, redness progressed to left hand, and arm, generalized red rash noted in groin and abdomen, slight headache and nausea with diphenhydramine (BENADRYL) 50 mg x 1. The clinical outcome of red and swollen, slightly itchy, left 4th finger, redness progressed to left hand, and arm, generalized red rash noted in groin and abdomen, slight headache and nausea was recovering.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; Woke up on 02Jan with a red and swollen, slightly itchy, left 4th finger. Redness progressed to left hand, and arm. Generalized red rash noted in groin and abdomen. Slight headache and nausea.; This is a spontaneous report from a contactable consumer, the patient.  A 68 -year-old elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0142), via an unspecified route of administration in the left arm on 29Dec2020 at 02:30 PM, (at the age of 68 -years-old) as a single dose, dose number=1 for COVID-19 vaccination.  Medical history included hypothyroidism and osteopenia. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included levothyroxin and citalopram within 2 weeks of the vaccination.  The patient did not  receive  any other vaccine within 4 weeks prior to the vaccine. On 02Jan2021, the patient woke up with a red and swollen, slightly itchy, left 4th finger, redness progressed to left hand, and arm, generalized red rash noted in groin and abdomen, slight headache and nausea. The patient was treated for red and swollen, slightly itchy, left 4th finger, redness progressed to left hand, and arm, generalized red rash noted in groin and abdomen, slight headache and nausea with diphenhydramine (BENADRYL) 50 mg x 1. The clinical outcome of red and swollen, slightly itchy, left 4th finger, redness progressed to left hand, and arm, generalized red rash noted in groin and abdomen, slight headache and nausea was recovering.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I tested positive for COVID today; I tested positive for COVID today; This is a spontaneous report from a contactable other Health Care Professional (HCP).  A female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date unknown) via an unspecified route of administration on 24Dec2020 (at an unknown age) at an unknown dose for COVID-19 vaccination.  The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive for COVID on 01Jan2021. The patient was inquiring as to if she can still get the second dose since she has tested positive in between. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 01Jan2021. The clinical outcome of COVID-19 virus test positive was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cough, Electrocardiogram, Head discomfort
Clinical narrative: 48 hours after the vaccine , I awoke from a sleep with chills; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; I still felt a little weak in my legs; This is a spontaneous report from a contactable nurses. A 56-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot EK9231, expiration date unspecified), via an unspecified route of administration on 31Dec2020 at 13:00 at single dose at right arm for COVID-19 immunization. Medical history included hypertension, cholesterol (abnormal) and hypothyroid which were well managed. The patient was not pregnant at the time of vaccination and had no allergies to medications, food or other products. Concomitant medications were not reported. On 31Dec2020 at 13:30, approximately 5-10 minutes after receiving the Pfizer covid-19 vaccine, patient's heart rate became elevated at 110-120, chest was irritated, head felt full and started to cough. Patient was taken to the emergency room (ER) and was placed on a monitor/EKG was obtained. Patient was released to home that same day, however she still felt a little weak in her legs. It was reported that 48 hours after the vaccine, the patient awoke from a sleep with chills, all her vitals were within normal limits, but the dry cough had returned. The patient was treated with fluids, vitals, EKG closely monitored and rapid cov (as reported). The events resulted to a doctor or healthcare professional office/ clinic visit. The patient was vaccinated at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and there were other medications the patient received within 2 weeks of vaccination. The patient underwent lab tests and procedures which included a nasal swab was negative on 31Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of events was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Muscular weakness, SARS-CoV-2 test, Vital signs measurement
Clinical narrative: 48 hours after the vaccine , I awoke from a sleep with chills; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; I still felt a little weak in my legs; This is a spontaneous report from a contactable nurses. A 56-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot EK9231, expiration date unspecified), via an unspecified route of administration on 31Dec2020 at 13:00 at single dose at right arm for COVID-19 immunization. Medical history included hypertension, cholesterol (abnormal) and hypothyroid which were well managed. The patient was not pregnant at the time of vaccination and had no allergies to medications, food or other products. Concomitant medications were not reported. On 31Dec2020 at 13:30, approximately 5-10 minutes after receiving the Pfizer covid-19 vaccine, patient's heart rate became elevated at 110-120, chest was irritated, head felt full and started to cough. Patient was taken to the emergency room (ER) and was placed on a monitor/EKG was obtained. Patient was released to home that same day, however she still felt a little weak in her legs. It was reported that 48 hours after the vaccine, the patient awoke from a sleep with chills, all her vitals were within normal limits, but the dry cough had returned. The patient was treated with fluids, vitals, EKG closely monitored and rapid cov (as reported). The events resulted to a doctor or healthcare professional office/ clinic visit. The patient was vaccinated at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and there were other medications the patient received within 2 weeks of vaccination. The patient underwent lab tests and procedures which included a nasal swab was negative on 31Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of events was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, SARS-CoV-2 test
Clinical narrative: Diarrhea; Nausea; This is a spontaneous report from a contactable nurse. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 29Dec2020 at 17:00 (at the age of 52-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none, and the patient had no known allergies. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 31Dec2020 at 12:30, the patient experienced diarrhea and nausea. The patient did not receive any treatment for the events. Since the vaccination, the patient had been tested for COVID-19 on 23Dec2020 (as reported) via nasal swab and the result was negative. The clinical outcome of the diarrhea and nausea was not resolved.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Headache, SARS-CoV-2 test positive
Clinical narrative: experienced loss of smell, taste and a headache/she came down with signs and symptoms/she got tested and got the results on Thursday that she was positive for covid 19 virus; experienced loss of smell, taste and a headache/she came down with signs and symptoms/she got tested and got the results on Thursday that she was positive for covid 19 virus; This is a spontaneous report from a contactable Other Health Professional (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection, lot number, via an unspecified route of administration from 14Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first dose of COVID vaccine on 14Dec2020. Eleven days following first dose, she experienced loss of smell, taste and a headache. She stated that she came down with signs and symptoms on 25Dec2020 and she got tested and got the results on Thursday that she was positive for Covid 19 virus. She was due for the 2nd dose of the COVID vaccine on the 6th of January. She asked what she should do about the second dose. She mentioned that her symptoms and positive test results were reported where she works in (State name). She wanted to know information as to whether she should get the second dose. Her second dose's scheduled was 6Jan2021. The event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of suspected LOE and COVID 19 infection due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available. 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: Adverse event, SARS-CoV-2 test positive
Clinical narrative: had a positive covid test results; had a positive covid test results; This is a spontaneous report from a contactable physician.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization.On 22Dec2020 he started to experience COVID like symptoms. On 26Dec2020, he had a positive COVID test results. On 28Dec2020, he received the Regeneron antibody infusion. Patient wants to know more about receiving the 2nd dose based on his positive diagnosis/antibody treatment. Outcome of the event was unknown.    Information on batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of SARS-CoV-2 test positive and suspected LOE due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available.  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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Blood pressure increased, Chills, Condition aggravated, Dizziness
Clinical narrative: Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asthma attack; Difficulty sleeping; Light headed and dizzy; Nausea; high BP 140's; HR 110's to 120s; Nasal congestion; Swelling of the face; Sore throat; This is a spontaneous report from a contactable nurse.  A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), intramuscular on the right arm on 31Dec2020 at 10:15 AM, at a single dose for Covid-19 immunization.  Medical history included asthma, allergy, hypothyroidism, and some fish allergy. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Patient previously took ibuprofen and experienced allergy. The patient is not pregnant. On 31Dec2020, after ten-15 minutes (10:30 AM) of receiving the vaccine, she was light headed and dizzy with some nausea. Monitored in the emergency room (ER) with high BP 140's and heart rate (HR) 110s to 120s. After an hour of saline bolus, she was better but she got nasal congestion and swelling of the face with sore throat. On 01Jan2021, after 24 hours, she got some soreness at the injection site with generalized body aches. Also she got some shortness of breath which lead to her asthma attack and difficulty sleeping. On 02Jan2021, after 48hours, she was feeling still light headed with some sore throat, chills, body aches and severe headache which lead her to go to the ER and got herself tested for flu, covid and strep, which came back all negative but her signs and symptoms (s/sx )still after discharge was getting worst especially the headache and generalized body aches. As well as congestion and sore throat. The patient had given "Ivf" for the events. The patient was not diagnosed with Covid prior to vaccination and was not Covid tested post vaccination. The outcome of the events was not recovered. The reporter assessed the events as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Heart rate increased, Influenza virus test negative, Injection site pain
Clinical narrative: Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asthma attack; Difficulty sleeping; Light headed and dizzy; Nausea; high BP 140's; HR 110's to 120s; Nasal congestion; Swelling of the face; Sore throat; This is a spontaneous report from a contactable nurse.  A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), intramuscular on the right arm on 31Dec2020 at 10:15 AM, at a single dose for Covid-19 immunization.  Medical history included asthma, allergy, hypothyroidism, and some fish allergy. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Patient previously took ibuprofen and experienced allergy. The patient is not pregnant. On 31Dec2020, after ten-15 minutes (10:30 AM) of receiving the vaccine, she was light headed and dizzy with some nausea. Monitored in the emergency room (ER) with high BP 140's and heart rate (HR) 110s to 120s. After an hour of saline bolus, she was better but she got nasal congestion and swelling of the face with sore throat. On 01Jan2021, after 24 hours, she got some soreness at the injection site with generalized body aches. Also she got some shortness of breath which lead to her asthma attack and difficulty sleeping. On 02Jan2021, after 48hours, she was feeling still light headed with some sore throat, chills, body aches and severe headache which lead her to go to the ER and got herself tested for flu, covid and strep, which came back all negative but her signs and symptoms (s/sx )still after discharge was getting worst especially the headache and generalized body aches. As well as congestion and sore throat. The patient had given "Ivf" for the events. The patient was not diagnosed with Covid prior to vaccination and was not Covid tested post vaccination. The outcome of the events was not recovered. The reporter assessed the events as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nasal congestion, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asthma attack; Difficulty sleeping; Light headed and dizzy; Nausea; high BP 140's; HR 110's to 120s; Nasal congestion; Swelling of the face; Sore throat; This is a spontaneous report from a contactable nurse.  A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), intramuscular on the right arm on 31Dec2020 at 10:15 AM, at a single dose for Covid-19 immunization.  Medical history included asthma, allergy, hypothyroidism, and some fish allergy. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Patient previously took ibuprofen and experienced allergy. The patient is not pregnant. On 31Dec2020, after ten-15 minutes (10:30 AM) of receiving the vaccine, she was light headed and dizzy with some nausea. Monitored in the emergency room (ER) with high BP 140's and heart rate (HR) 110s to 120s. After an hour of saline bolus, she was better but she got nasal congestion and swelling of the face with sore throat. On 01Jan2021, after 24 hours, she got some soreness at the injection site with generalized body aches. Also she got some shortness of breath which lead to her asthma attack and difficulty sleeping. On 02Jan2021, after 48hours, she was feeling still light headed with some sore throat, chills, body aches and severe headache which lead her to go to the ER and got herself tested for flu, covid and strep, which came back all negative but her signs and symptoms (s/sx )still after discharge was getting worst especially the headache and generalized body aches. As well as congestion and sore throat. The patient had given "Ivf" for the events. The patient was not diagnosed with Covid prior to vaccination and was not Covid tested post vaccination. The outcome of the events was not recovered. The reporter assessed the events as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Streptococcus test negative, Swelling face
Clinical narrative: Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asthma attack; Difficulty sleeping; Light headed and dizzy; Nausea; high BP 140's; HR 110's to 120s; Nasal congestion; Swelling of the face; Sore throat; This is a spontaneous report from a contactable nurse.  A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), intramuscular on the right arm on 31Dec2020 at 10:15 AM, at a single dose for Covid-19 immunization.  Medical history included asthma, allergy, hypothyroidism, and some fish allergy. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Patient previously took ibuprofen and experienced allergy. The patient is not pregnant. On 31Dec2020, after ten-15 minutes (10:30 AM) of receiving the vaccine, she was light headed and dizzy with some nausea. Monitored in the emergency room (ER) with high BP 140's and heart rate (HR) 110s to 120s. After an hour of saline bolus, she was better but she got nasal congestion and swelling of the face with sore throat. On 01Jan2021, after 24 hours, she got some soreness at the injection site with generalized body aches. Also she got some shortness of breath which lead to her asthma attack and difficulty sleeping. On 02Jan2021, after 48hours, she was feeling still light headed with some sore throat, chills, body aches and severe headache which lead her to go to the ER and got herself tested for flu, covid and strep, which came back all negative but her signs and symptoms (s/sx )still after discharge was getting worst especially the headache and generalized body aches. As well as congestion and sore throat. The patient had given "Ivf" for the events. The patient was not diagnosed with Covid prior to vaccination and was not Covid tested post vaccination. The outcome of the events was not recovered. The reporter assessed the events as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Diarrhoea, Dizziness, Electrocardiogram, Headache
Clinical narrative: diarrhea; headache (HA); I felt light headed when I went to stand up and I was taken by wheelchair to the ED; my heart started racing; high blood pressure; Sinus tachycardia at 105 bpm; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EJ1685), via an unspecified route of administration on 28Dec2020 09:00 at a single dose for covid-19 immunization. The patient's medical history included allergy to fish but patient had a type of fish she was not allergic to on 01Jan2021. Concomitant medications were not reported. The patient received first vaccine on 28Dec2020 at 9:00 am. After about 5-15 minutes her heart started racing, she felt light headed when she went to stand up and patient was taken by wheelchair to the emergency department (ED). The procedures done in ED included Stat EKG which showed sinus tachycardia at 105 bpm and high blood pressure. Patient was normotensive normally. ED gave her Benedryl and pepcid. It took about 3 hours for my heartrate and BP to go back to normal in ED for 3 1/2 hours. Patient takes allergy meds everyday, allegra. The patient stated she went to bed and woke with headache (HA), (tylenol and ibuprofen were taken) lasted for 2 hours and returned the next day and patient took more ibuprofen and then it went away. The patient was allergic to fish, but she had a type of fish she was not allergic to on 01Jan2021 and had diarrhea within 30 minutes (one time occurrence). It was reported that the patient wishes to take the 2nd vaccine and has had no further adverse events. The outcome of the event was Headache (HA), heart rate increased  and high blood pressure was recovered on an unknown date and unknown outcome for the remaining events.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hypertension, Sinus tachycardia
Clinical narrative: diarrhea; headache (HA); I felt light headed when I went to stand up and I was taken by wheelchair to the ED; my heart started racing; high blood pressure; Sinus tachycardia at 105 bpm; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EJ1685), via an unspecified route of administration on 28Dec2020 09:00 at a single dose for covid-19 immunization. The patient's medical history included allergy to fish but patient had a type of fish she was not allergic to on 01Jan2021. Concomitant medications were not reported. The patient received first vaccine on 28Dec2020 at 9:00 am. After about 5-15 minutes her heart started racing, she felt light headed when she went to stand up and patient was taken by wheelchair to the emergency department (ED). The procedures done in ED included Stat EKG which showed sinus tachycardia at 105 bpm and high blood pressure. Patient was normotensive normally. ED gave her Benedryl and pepcid. It took about 3 hours for my heartrate and BP to go back to normal in ED for 3 1/2 hours. Patient takes allergy meds everyday, allegra. The patient stated she went to bed and woke with headache (HA), (tylenol and ibuprofen were taken) lasted for 2 hours and returned the next day and patient took more ibuprofen and then it went away. The patient was allergic to fish, but she had a type of fish she was not allergic to on 01Jan2021 and had diarrhea within 30 minutes (one time occurrence). It was reported that the patient wishes to take the 2nd vaccine and has had no further adverse events. The outcome of the event was Headache (HA), heart rate increased  and high blood pressure was recovered on an unknown date and unknown outcome for the remaining events.
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Disorganised speech, Electrocardiogram normal, Incoherent, Laboratory test normal
Clinical narrative: becoming incoherent and talking nonsense; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Physician calling about whether or not she should receive the second dose of vaccine. She received dose on 23Dec2020. On 26Dec2020 she started experiencing several side effects including becoming incoherent and talking nonsense. Her daughter who is an EMT suggested that she go to the ER. While in the ER she received TPA but it was later decided she did not have a stroke. Her EKG, bloodwork and other testing came back negative. She otherwise healthy and has no comorbidities. She already spoke with agency. She has also already spoken with an infectious disease doctor and her neurologist. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the event incoherent is conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. 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 agencys, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram head, Fatigue, Full blood count, Headache
Clinical narrative: Chills and body aches approximately 8 hours vision changes approximately 30 minutes, headache ongoing for several days now, fatigue
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Metabolic function test, Pain, Visual impairment
Clinical narrative: Chills and body aches approximately 8 hours vision changes approximately 30 minutes, headache ongoing for several days now, fatigue
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Muscle tightness, Nausea, Pain in extremity
Clinical narrative: My arm hurt severely and the muscles in my arm would not contract to allow for motion until 11:00am on 1/8/21, but the pain was so severe that I could not sleep.  I have also had severe chills, nausea, vomited twice, generalized weakness and shakiness.  It is currently 12:10pm on 1/8/21 and these symptoms continue.  Two of my other co-workers were at this same facility at the same time on 1/7 and have had very similar symptoms as well as severe headache which prevented them to work today.  We are all physical therapists, healthy young individuals, no co-comorbidities and were very surprised by these negative reactions and concerned.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tremor, Vomiting
Clinical narrative: My arm hurt severely and the muscles in my arm would not contract to allow for motion until 11:00am on 1/8/21, but the pain was so severe that I could not sleep.  I have also had severe chills, nausea, vomited twice, generalized weakness and shakiness.  It is currently 12:10pm on 1/8/21 and these symptoms continue.  Two of my other co-workers were at this same facility at the same time on 1/7 and have had very similar symptoms as well as severe headache which prevented them to work today.  We are all physical therapists, healthy young individuals, no co-comorbidities and were very surprised by these negative reactions and concerned.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Lip swelling, Oropharyngeal pain, Palpitations, Speech disorder
Clinical narrative: About 15 minutes after receiving the vaccine she felt palpitations. She was monitored for another 15 minutes and while she was walking to her car se started noticing sore throat associated with inability to talk, unable to swallow secretions,  and swelling the lips. Patient presented to the emergency room where she received EpiPen dose. Received diphenhydramine, famotidine, and prednisone.  Lip swelling and sore throat began improving in ED.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: About 15 minutes after receiving the vaccine she felt palpitations. She was monitored for another 15 minutes and while she was walking to her car se started noticing sore throat associated with inability to talk, unable to swallow secretions,  and swelling the lips. Patient presented to the emergency room where she received EpiPen dose. Received diphenhydramine, famotidine, and prednisone.  Lip swelling and sore throat began improving in ED.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac flutter, Dizziness, Lip swelling, Throat tightness
Clinical narrative: About 15 minutes after receiving the vaccine she felt palpitations. She was monitored for another 15 minutes and while she was walking to her car se started noticing sore throat associated with inability to talk, unable to swallow secretions,  and swelling the lips. Patient presented to the emergency room where she received EpiPen dose. Received diphenhydramine, famotidine, and prednisone.  Lip swelling and sore throat began improving in ED.