chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Malaise, Nausea, Pyrexia
Clinical narrative: shakes; chills; headaches; body aches; general malaise; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not provided) via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included Crohn's disease. The patient's concomitant medications were not reported. The patient previously took pneumococcal vaccine in 2020 (reported as last year) and she got a flu shot every year with no issues. She had no issues with vaccines in the past. Patient stated that she was calling about the Pfizer BioNtech Vaccine EUA. Patient stated that she had 1st dose 21Dec2020 and then she had reaction on 22Dec2020 23Dec2020 and part of 24Dec2020, she was scared to death, she was having shakes, chills, headaches, body aches. Due to this she would like to know if it is okay to get the second dose. Her second dose is schedule for 11Jan2021. On 22Dec2020 she had the general malaise, like she was punk'ed. She was home that night and got the shakes. All side effects ended on 24Dec2020 by dinner time. Patient stated that they didn't give her anything after getting the vaccine, they just gave information like this phone number, and websites. They gave stuff to read. She got the vaccine at (Hospital name). She has had no positive tests for Covid prior to the vaccine. She had 1 negative test at the end of Aug2020, and that was because she went to hospital for a total knee and they did Covid test then. She has had no antibody tests. Patient stated that she did vaccine reaction reporting on the website provided, she did the online reporting. The outcome of the events was recovered on 24Dec2020.   Information on lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Malaise, Pain, SARS-CoV-2 antibody test
Clinical narrative: shakes; chills; headaches; body aches; general malaise; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not provided) via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included Crohn's disease. The patient's concomitant medications were not reported. The patient previously took pneumococcal vaccine in 2020 (reported as last year) and she got a flu shot every year with no issues. She had no issues with vaccines in the past. Patient stated that she was calling about the Pfizer BioNtech Vaccine EUA. Patient stated that she had 1st dose 21Dec2020 and then she had reaction on 22Dec2020 23Dec2020 and part of 24Dec2020, she was scared to death, she was having shakes, chills, headaches, body aches. Due to this she would like to know if it is okay to get the second dose. Her second dose is schedule for 11Jan2021. On 22Dec2020 she had the general malaise, like she was punk'ed. She was home that night and got the shakes. All side effects ended on 24Dec2020 by dinner time. Patient stated that they didn't give her anything after getting the vaccine, they just gave information like this phone number, and websites. They gave stuff to read. She got the vaccine at (Hospital name). She has had no positive tests for Covid prior to the vaccine. She had 1 negative test at the end of Aug2020, and that was because she went to hospital for a total knee and they did Covid test then. She has had no antibody tests. Patient stated that she did vaccine reaction reporting on the website provided, she did the online reporting. The outcome of the events was recovered on 24Dec2020.   Information on lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: shakes; chills; headaches; body aches; general malaise; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not provided) via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included Crohn's disease. The patient's concomitant medications were not reported. The patient previously took pneumococcal vaccine in 2020 (reported as last year) and she got a flu shot every year with no issues. She had no issues with vaccines in the past. Patient stated that she was calling about the Pfizer BioNtech Vaccine EUA. Patient stated that she had 1st dose 21Dec2020 and then she had reaction on 22Dec2020 23Dec2020 and part of 24Dec2020, she was scared to death, she was having shakes, chills, headaches, body aches. Due to this she would like to know if it is okay to get the second dose. Her second dose is schedule for 11Jan2021. On 22Dec2020 she had the general malaise, like she was punk'ed. She was home that night and got the shakes. All side effects ended on 24Dec2020 by dinner time. Patient stated that they didn't give her anything after getting the vaccine, they just gave information like this phone number, and websites. They gave stuff to read. She got the vaccine at (Hospital name). She has had no positive tests for Covid prior to the vaccine. She had 1 negative test at the end of Aug2020, and that was because she went to hospital for a total knee and they did Covid test then. She has had no antibody tests. Patient stated that she did vaccine reaction reporting on the website provided, she did the online reporting. The outcome of the events was recovered on 24Dec2020.   Information on lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: 25 minutes after injection numbness of throat and tingling/prickling at back of tongue. Another 10 minutes later entire tongue tingling/prickling. Another 5 minutes lips began tingling/prickling. Epi-pen administered by military staff present for vaccination. Taken to ER and received a dose of Benadryl and prednisone.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia, Throat irritation
Clinical narrative: 25 minutes after injection numbness of throat and tingling/prickling at back of tongue. Another 10 minutes later entire tongue tingling/prickling. Another 5 minutes lips began tingling/prickling. Epi-pen administered by military staff present for vaccination. Taken to ER and received a dose of Benadryl and prednisone.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Rash with itching. 01/04/2021 prednisone 60mg, 40mg, 20mg-3 day taper.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic
Clinical narrative: Rash with itching. 01/04/2021 prednisone 60mg, 40mg, 20mg-3 day taper.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Cold sweat, Fatigue, Nausea, Paraesthesia
Clinical narrative: extremities were still cold with occasional tingling; hands and feet were very cold and arms and legs were cold and clammy; hands and feet were very cold and arms and legs were cold and clammy; feeling tired with some chills; feeling tired with some chills; nausea; vomiting; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration on 02Jan2021 08:00 at single dose at left arm for covid-19 immunization. Medical history included arthritis, hip replacement, calcified DVT. Concomitant medication within 2 weeks of vaccination included colecalciferol (VITAMIN D, gummies). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took acetylsalicylic acid (ASPRIN) and experienced allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient received the first dose on 02Jan2021 at 08: 00. At 14: 30, patient started feeling tired with some chills. By 0500 (as reported), patient was having nausea with vomiting. The next morning on 03Jan2021, patient woke at 07:00, patient still had nausea, but also, hands and feet were very cold and arms and legs were cold and clammy. It was 05Jan2021 now and patient still had nausea and extremities were still cold with occasional tingling. Patient didn't receive treatment for events. The report is considered non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of events nausea and extremities were still cold with occasional tingling was not recovered, and outcome of other events was recovering.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral coldness, Vomiting
Clinical narrative: extremities were still cold with occasional tingling; hands and feet were very cold and arms and legs were cold and clammy; hands and feet were very cold and arms and legs were cold and clammy; feeling tired with some chills; feeling tired with some chills; nausea; vomiting; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration on 02Jan2021 08:00 at single dose at left arm for covid-19 immunization. Medical history included arthritis, hip replacement, calcified DVT. Concomitant medication within 2 weeks of vaccination included colecalciferol (VITAMIN D, gummies). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took acetylsalicylic acid (ASPRIN) and experienced allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient received the first dose on 02Jan2021 at 08: 00. At 14: 30, patient started feeling tired with some chills. By 0500 (as reported), patient was having nausea with vomiting. The next morning on 03Jan2021, patient woke at 07:00, patient still had nausea, but also, hands and feet were very cold and arms and legs were cold and clammy. It was 05Jan2021 now and patient still had nausea and extremities were still cold with occasional tingling. Patient didn't receive treatment for events. The report is considered non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of events nausea and extremities were still cold with occasional tingling was not recovered, and outcome of other events was recovering.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Injection site swelling
Clinical narrative: sore left arm swelling at injection site; 15 hours after injection:Sore left arm swelling at injection site; Nausea; joint pain; specifically hands wrists and neck; muscle pain; headache; fever between 102.8 and 101.3; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 04Jan2021 11:45 am at single dose at left arm for covid-19 immunization. The patient medical history was not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient previously took codeine and zolpidem and experienced allergies. Prior to vaccination, patient was not diagnosed with COVID-19. 15 hours after injection, patient experienced sore left arm swelling at injection site, nausea, joint pain, specifically hands wrists and neck, muscle pain, headache, fever between 102.8 and 101.3, chills on 05Jan2021 03:00 AM. Patient took covid test /Nasal Swab on 04Jan2021 and on 05Jan2021 with unknown results. Patient didn't receive treatment for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Outcome of events was not recovered. The report is considered non-serious.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Myalgia, Neck pain, Pyrexia
Clinical narrative: sore left arm swelling at injection site; 15 hours after injection:Sore left arm swelling at injection site; Nausea; joint pain; specifically hands wrists and neck; muscle pain; headache; fever between 102.8 and 101.3; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 04Jan2021 11:45 am at single dose at left arm for covid-19 immunization. The patient medical history was not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient previously took codeine and zolpidem and experienced allergies. Prior to vaccination, patient was not diagnosed with COVID-19. 15 hours after injection, patient experienced sore left arm swelling at injection site, nausea, joint pain, specifically hands wrists and neck, muscle pain, headache, fever between 102.8 and 101.3, chills on 05Jan2021 03:00 AM. Patient took covid test /Nasal Swab on 04Jan2021 and on 05Jan2021 with unknown results. Patient didn't receive treatment for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Outcome of events was not recovered. The report is considered non-serious.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Myalgia
Clinical narrative: sore left arm swelling at injection site; 15 hours after injection:Sore left arm swelling at injection site; Nausea; joint pain; specifically hands wrists and neck; muscle pain; headache; fever between 102.8 and 101.3; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 04Jan2021 11:45 am at single dose at left arm for covid-19 immunization. The patient medical history was not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient previously took codeine and zolpidem and experienced allergies. Prior to vaccination, patient was not diagnosed with COVID-19. 15 hours after injection, patient experienced sore left arm swelling at injection site, nausea, joint pain, specifically hands wrists and neck, muscle pain, headache, fever between 102.8 and 101.3, chills on 05Jan2021 03:00 AM. Patient took covid test /Nasal Swab on 04Jan2021 and on 05Jan2021 with unknown results. Patient didn't receive treatment for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Outcome of events was not recovered. The report is considered non-serious.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test, Vaccination site pain, Vaccination site swelling
Clinical narrative: sore left arm swelling at injection site; 15 hours after injection:Sore left arm swelling at injection site; Nausea; joint pain; specifically hands wrists and neck; muscle pain; headache; fever between 102.8 and 101.3; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 04Jan2021 11:45 am at single dose at left arm for covid-19 immunization. The patient medical history was not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient previously took codeine and zolpidem and experienced allergies. Prior to vaccination, patient was not diagnosed with COVID-19. 15 hours after injection, patient experienced sore left arm swelling at injection site, nausea, joint pain, specifically hands wrists and neck, muscle pain, headache, fever between 102.8 and 101.3, chills on 05Jan2021 03:00 AM. Patient took covid test /Nasal Swab on 04Jan2021 and on 05Jan2021 with unknown results. Patient didn't receive treatment for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Outcome of events was not recovered. The report is considered non-serious.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Swelling face
Clinical narrative: sand paper face rash and full swollen face; sand paper face rash and full swollen face; This is a spontaneous report from a contactable other healthcare professional (HCP). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EH9899) via intramuscular on arm left as the first dose on 19Dec2020 at single dose for COVID-19 immunization. The patient had Botox and facial fillers on 15Dec2020. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. And it was unknown whether the patient had been tested for COVID-19 since the vaccination. The patient had sand paper face rash and full swollen face that started on 01Jan2021 (also reported as 3 days after receiving the vaccine). The events were reported as non-serious. It was unknown whether treatment was received for the events. The outcome of the events was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Feeling hot, Hyperhidrosis, Hypertension, Pruritus
Clinical narrative: itching, hot, high blood pressure Blood pressure has gone down but is still high.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Hypertension, Pruritus
Clinical narrative: itching, hot, high blood pressure Blood pressure has gone down but is still high.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Paraesthesia oral
Clinical narrative: About 5 min after the vax I was at the recovery/triage at the vaccine place and I started to get tingling and numbness on the right side of my tongue, so I did not actually reported as a concern but after my 15 min observation I left but then the numbness and tingliness got worse in my tongue and now lower lip and then I decided to return to the vaccine area to report my symptoms and they brought me over and took my vitals and they were stable BP/HR were normal and the numbness and tingling did not get any worse but because of the reaction they gave me 25mg of oral Benadryl probably around 40 min after the vaccine they kept monitoring me for abot 2 hours but my vitals remained very stable and the numbness and tingling have resolved. My tongue was still numb but not getting any worse so i felt it was ok to leave. I decided to go home after those 2 hours and i took 10 min of zyrtec and about 5 hours later i still had a little numbness and tingling on the right side of the tongue but the rest of the tongue and lip had resolvedf. Had fatigue and myalgia for the rest of the day.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Hypoaesthesia oral, Myalgia, Paraesthesia oral
Clinical narrative: About 5 min after the vax I was at the recovery/triage at the vaccine place and I started to get tingling and numbness on the right side of my tongue, so I did not actually reported as a concern but after my 15 min observation I left but then the numbness and tingliness got worse in my tongue and now lower lip and then I decided to return to the vaccine area to report my symptoms and they brought me over and took my vitals and they were stable BP/HR were normal and the numbness and tingling did not get any worse but because of the reaction they gave me 25mg of oral Benadryl probably around 40 min after the vaccine they kept monitoring me for abot 2 hours but my vitals remained very stable and the numbness and tingling have resolved. My tongue was still numb but not getting any worse so i felt it was ok to leave. I decided to go home after those 2 hours and i took 10 min of zyrtec and about 5 hours later i still had a little numbness and tingling on the right side of the tongue but the rest of the tongue and lip had resolvedf. Had fatigue and myalgia for the rest of the day.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Disturbance in attention, Dizziness, Fatigue, Nausea
Clinical narrative: Jan 5, 2021 - Fatigue, nausea, diarrhea, headache, unable to get out of bed.  Sore arm.    Jan 6, 2021 - Very dizzy, nausea, headache.  Seen at clinic.  Blood pressure elevated.  Normal heart rate.  Prescribed extra dose of Lisinopril for the high blood pressure and Zofran for the nausea.  Sore arm. Jan 7, 2021 - Fatigued, no longer dizzy but feeling lightheaded.  Mild headache, mild nausea.  Arm pain resolved.  Jan 8, 20214 - All symptoms resolved except for mild to moderate fatigue.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Jan 5, 2021 - Fatigue, nausea, diarrhea, headache, unable to get out of bed.  Sore arm.    Jan 6, 2021 - Very dizzy, nausea, headache.  Seen at clinic.  Blood pressure elevated.  Normal heart rate.  Prescribed extra dose of Lisinopril for the high blood pressure and Zofran for the nausea.  Sore arm. Jan 7, 2021 - Fatigued, no longer dizzy but feeling lightheaded.  Mild headache, mild nausea.  Arm pain resolved.  Jan 8, 20214 - All symptoms resolved except for mild to moderate fatigue.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Jan 5, 2021 - Fatigue, nausea, diarrhea, headache, unable to get out of bed.  Sore arm.    Jan 6, 2021 - Very dizzy, nausea, headache.  Seen at clinic.  Blood pressure elevated.  Normal heart rate.  Prescribed extra dose of Lisinopril for the high blood pressure and Zofran for the nausea.  Sore arm. Jan 7, 2021 - Fatigued, no longer dizzy but feeling lightheaded.  Mild headache, mild nausea.  Arm pain resolved.  Jan 8, 20214 - All symptoms resolved except for mild to moderate fatigue.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling over entire body.  Settled to left side.  Still present 9 days post vaccination.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Impaired work ability, Muscular weakness, Paraesthesia
Clinical narrative: Numbness and tingling over entire body.  Settled to left side.  Still present 9 days post vaccination.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleeds; she had allergies; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), Batch/lot number: EJ1685, via an unspecified route of administration on 04Jan2021 15:30 at single dose in right deltoid for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient received the Covid-19 vaccine on 04Jan2021 at 3:30pm. They monitored her for 30 minutes after she received it because she had allergies. After she got home she had a nose bleed on 04Jan2021. This morning (05Jan2021) at 5:00am she went downstairs to fix herself some food. She felt her nose running. She touched her nose with a paper towel and saw that it was bleeding. It was bleeding now. She had never had a nose bleed before. The patient had no lab tests. The outcome of the event "nose bleed" was not recovered, and of "she had allergies" was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Epistaxis
Clinical narrative: Nose bleeds; she had allergies; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), Batch/lot number: EJ1685, via an unspecified route of administration on 04Jan2021 15:30 at single dose in right deltoid for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient received the Covid-19 vaccine on 04Jan2021 at 3:30pm. They monitored her for 30 minutes after she received it because she had allergies. After she got home she had a nose bleed on 04Jan2021. This morning (05Jan2021) at 5:00am she went downstairs to fix herself some food. She felt her nose running. She touched her nose with a paper towel and saw that it was bleeding. It was bleeding now. She had never had a nose bleed before. The patient had no lab tests. The outcome of the event "nose bleed" was not recovered, and of "she had allergies" was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug hypersensitivity, Erythema, Food allergy, Pruritus
Clinical narrative: itching to lower left arm; redness noted in the size of about a half dollar on lower left arm; This is a spontaneous report from a contactable nurse.  A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899) intramuscular in the left arm on 29Dec2020 at single dose for COVID-19 immunisation. Relevant medical history included hives and allergy to coconut and acetylsalicylic acid (ASA). Concomitant medications were not reported. The patient had been observed and released but she returned at 15:21 on 29Dec2020 with itching to lower left arm and redness was noted in the size of about a half dollar on lower left arm. Corrective treatment taken as a result of the events included 25mg of diphenhydramine orally. Patients vitals were taken (results unknown) and additional observation was done. The patient was left with supervising nurse. The patient was called the following day, 30Dec2020, and she reported that she was doing fine; she recovered from the events on 30Dec2020.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Investigation, Pruritus
Clinical narrative: itching to lower left arm; redness noted in the size of about a half dollar on lower left arm; This is a spontaneous report from a contactable nurse.  A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899) intramuscular in the left arm on 29Dec2020 at single dose for COVID-19 immunisation. Relevant medical history included hives and allergy to coconut and acetylsalicylic acid (ASA). Concomitant medications were not reported. The patient had been observed and released but she returned at 15:21 on 29Dec2020 with itching to lower left arm and redness was noted in the size of about a half dollar on lower left arm. Corrective treatment taken as a result of the events included 25mg of diphenhydramine orally. Patients vitals were taken (results unknown) and additional observation was done. The patient was left with supervising nurse. The patient was called the following day, 30Dec2020, and she reported that she was doing fine; she recovered from the events on 30Dec2020.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphonia, Nodule
Clinical narrative: Feeling of lump in throat and lightheadedness. Benadryl 50 mg IM given. Symptoms resolved within 2-3 hours.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Sensation of foreign body
Clinical narrative: Feeling of lump in throat and lightheadedness. Benadryl 50 mg IM given. Symptoms resolved within 2-3 hours.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Swelling face, Urticaria
Clinical narrative: after 15 minutes developed rash on face and chest .Became dizzy and felt like she was going to pass out
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Rash
Clinical narrative: after 15 minutes developed rash on face and chest .Became dizzy and felt like she was going to pass out
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Dyspnoea, Heart rate increased, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: I was having trouble clearing my throat, felt like it was closing up; high heart rate/rapid heart rate agai; uncontrollable rigors; numb lips and hands; numb lips and hands; nausea; shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable Other Health Professional (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, intramuscular in the left arm, on 30Dec2020 09:15 at a single dose for COVID-19 immunization. Medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had her gall bladder and tonsils removed. Concomitant medication included rizatriptan and paracetamol (TYLENOL). The patient had no known allergies but mentioned that she cannot take the NSAIDs eventhough she was not allergic to them. She had no allergies to food or to other products. It was reported that within about 10 minutes of the injection of the vaccine, she had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea on 30Dec2020 at 09:30 AM. She was discharged from the ED (emergency department), went home and took a nap. Later that evening, she began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath and she was admitted to the emergency department again and given more IV medications. The onset of the events was reported to be 30Dec2020 at 09:30 AM with outcome of recovering. As a result of the events, the patient visited that Emergency room/department or urgent care. Treatment received with IV medications (unspecified), breathing treatment, and epinephrine injection. The patient had no covid prior vaccination. She had not had Covid test post vaccination.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events throat tightness, heart rate increased, chills, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Oropharyngeal discomfort, Throat clearing, Throat tightness
Clinical narrative: I was having trouble clearing my throat, felt like it was closing up; high heart rate/rapid heart rate agai; uncontrollable rigors; numb lips and hands; numb lips and hands; nausea; shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable Other Health Professional (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, intramuscular in the left arm, on 30Dec2020 09:15 at a single dose for COVID-19 immunization. Medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had her gall bladder and tonsils removed. Concomitant medication included rizatriptan and paracetamol (TYLENOL). The patient had no known allergies but mentioned that she cannot take the NSAIDs eventhough she was not allergic to them. She had no allergies to food or to other products. It was reported that within about 10 minutes of the injection of the vaccine, she had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea on 30Dec2020 at 09:30 AM. She was discharged from the ED (emergency department), went home and took a nap. Later that evening, she began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath and she was admitted to the emergency department again and given more IV medications. The onset of the events was reported to be 30Dec2020 at 09:30 AM with outcome of recovering. As a result of the events, the patient visited that Emergency room/department or urgent care. Treatment received with IV medications (unspecified), breathing treatment, and epinephrine injection. The patient had no covid prior vaccination. She had not had Covid test post vaccination.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events throat tightness, heart rate increased, chills, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Throat clearing, Throat tightness
Clinical narrative: I was having trouble clearing my throat, felt like it was closing up; high heart rate/rapid heart rate agai; uncontrollable rigors; numb lips and hands; numb lips and hands; nausea; shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable Other Health Professional (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, intramuscular in the left arm, on 30Dec2020 09:15 at a single dose for COVID-19 immunization. Medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had her gall bladder and tonsils removed. Concomitant medication included rizatriptan and paracetamol (TYLENOL). The patient had no known allergies but mentioned that she cannot take the NSAIDs eventhough she was not allergic to them. She had no allergies to food or to other products. It was reported that within about 10 minutes of the injection of the vaccine, she had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea on 30Dec2020 at 09:30 AM. She was discharged from the ED (emergency department), went home and took a nap. Later that evening, she began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath and she was admitted to the emergency department again and given more IV medications. The onset of the events was reported to be 30Dec2020 at 09:30 AM with outcome of recovering. As a result of the events, the patient visited that Emergency room/department or urgent care. Treatment received with IV medications (unspecified), breathing treatment, and epinephrine injection. The patient had no covid prior vaccination. She had not had Covid test post vaccination.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events throat tightness, heart rate increased, chills, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Anxiety, Chest X-ray normal, Condition aggravated, Electrocardiogram P wave abnormal
Clinical narrative: I was having trouble clearing my throat, felt like it was closing up; high heart rate/rapid heart rate agai; uncontrollable rigors; numb lips and hands; numb lips and hands; nausea; shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable Other Health Professional (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, intramuscular in the left arm, on 30Dec2020 09:15 at a single dose for COVID-19 immunization. Medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had her gall bladder and tonsils removed. Concomitant medication included rizatriptan and paracetamol (TYLENOL). The patient had no known allergies but mentioned that she cannot take the NSAIDs eventhough she was not allergic to them. She had no allergies to food or to other products. It was reported that within about 10 minutes of the injection of the vaccine, she had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea on 30Dec2020 at 09:30 AM. She was discharged from the ED (emergency department), went home and took a nap. Later that evening, she began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath and she was admitted to the emergency department again and given more IV medications. The onset of the events was reported to be 30Dec2020 at 09:30 AM with outcome of recovering. As a result of the events, the patient visited that Emergency room/department or urgent care. Treatment received with IV medications (unspecified), breathing treatment, and epinephrine injection. The patient had no covid prior vaccination. She had not had Covid test post vaccination.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events throat tightness, heart rate increased, chills, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram QRS complex normal, Electrocardiogram QT prolonged, Fibrin D dimer normal, Heart rate increased, Hypersensitivity
Clinical narrative: I was having trouble clearing my throat, felt like it was closing up; high heart rate/rapid heart rate agai; uncontrollable rigors; numb lips and hands; numb lips and hands; nausea; shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable Other Health Professional (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, intramuscular in the left arm, on 30Dec2020 09:15 at a single dose for COVID-19 immunization. Medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had her gall bladder and tonsils removed. Concomitant medication included rizatriptan and paracetamol (TYLENOL). The patient had no known allergies but mentioned that she cannot take the NSAIDs eventhough she was not allergic to them. She had no allergies to food or to other products. It was reported that within about 10 minutes of the injection of the vaccine, she had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea on 30Dec2020 at 09:30 AM. She was discharged from the ED (emergency department), went home and took a nap. Later that evening, she began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath and she was admitted to the emergency department again and given more IV medications. The onset of the events was reported to be 30Dec2020 at 09:30 AM with outcome of recovering. As a result of the events, the patient visited that Emergency room/department or urgent care. Treatment received with IV medications (unspecified), breathing treatment, and epinephrine injection. The patient had no covid prior vaccination. She had not had Covid test post vaccination.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events throat tightness, heart rate increased, chills, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Panic attack, Sinus tachycardia, Tachycardia, Throat tightness, Troponin normal
Clinical narrative: I was having trouble clearing my throat, felt like it was closing up; high heart rate/rapid heart rate agai; uncontrollable rigors; numb lips and hands; numb lips and hands; nausea; shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable Other Health Professional (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, intramuscular in the left arm, on 30Dec2020 09:15 at a single dose for COVID-19 immunization. Medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had her gall bladder and tonsils removed. Concomitant medication included rizatriptan and paracetamol (TYLENOL). The patient had no known allergies but mentioned that she cannot take the NSAIDs eventhough she was not allergic to them. She had no allergies to food or to other products. It was reported that within about 10 minutes of the injection of the vaccine, she had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea on 30Dec2020 at 09:30 AM. She was discharged from the ED (emergency department), went home and took a nap. Later that evening, she began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath and she was admitted to the emergency department again and given more IV medications. The onset of the events was reported to be 30Dec2020 at 09:30 AM with outcome of recovering. As a result of the events, the patient visited that Emergency room/department or urgent care. Treatment received with IV medications (unspecified), breathing treatment, and epinephrine injection. The patient had no covid prior vaccination. She had not had Covid test post vaccination.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events throat tightness, heart rate increased, chills, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone, Disturbance in attention, Fatigue, Feeling abnormal, Full blood count normal
Clinical narrative: Sxs at injx site and fatigue. 12/22/2020 paraesthesias to upper/lower extremities, now becoming more consistent; headaches.  Persistent sxs.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Haemoglobin, Headache, Limb discomfort, Metabolic function test normal, Neurological examination normal
Clinical narrative: Sxs at injx site and fatigue. 12/22/2020 paraesthesias to upper/lower extremities, now becoming more consistent; headaches.  Persistent sxs.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Red blood cell sedimentation rate normal, Type III immune complex mediated reaction, Vitamin B12
Clinical narrative: Sxs at injx site and fatigue. 12/22/2020 paraesthesias to upper/lower extremities, now becoming more consistent; headaches.  Persistent sxs.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Disturbance in attention, Fatigue, Feeling abnormal, Headache, Hypoaesthesia
Clinical narrative: Sxs at injx site and fatigue. 12/22/2020 paraesthesias to upper/lower extremities, now becoming more consistent; headaches.  Persistent sxs.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Sxs at injx site and fatigue. 12/22/2020 paraesthesias to upper/lower extremities, now becoming more consistent; headaches.  Persistent sxs.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Injection site paraesthesia, Paraesthesia
Clinical narrative: Sxs at injx site and fatigue. 12/22/2020 paraesthesias to upper/lower extremities, now becoming more consistent; headaches.  Persistent sxs.