chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Malaise, Myalgia
Clinical narrative: joint pain; chills; tiredness; injection site pain; threw up all night; feeling unwell; muscle pain; nausea; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration Date: UNKNOWN) via an unspecified route of administration at left arm on 06Feb2021 08:30 (at the age of 74-year-old) as single dose for COVID-19 vaccination. The patient's medical history was not reported. There was no covid prior vaccination and no covid tested post vaccination. Concomitant medications were not reported. There were no known allergies. Patient did not receive any other vaccine in four weeks.   On 06Feb2021 21:00, the patient experienced joint pain, chills, tiredness, injection site pain, threw up all night, feeling unwell, muscle pain, nausea. Patient did not receive any treatment for adverse event. The outcome of event was recovered.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain, Vomiting
Clinical narrative: joint pain; chills; tiredness; injection site pain; threw up all night; feeling unwell; muscle pain; nausea; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration Date: UNKNOWN) via an unspecified route of administration at left arm on 06Feb2021 08:30 (at the age of 74-year-old) as single dose for COVID-19 vaccination. The patient's medical history was not reported. There was no covid prior vaccination and no covid tested post vaccination. Concomitant medications were not reported. There were no known allergies. Patient did not receive any other vaccine in four weeks.   On 06Feb2021 21:00, the patient experienced joint pain, chills, tiredness, injection site pain, threw up all night, feeling unwell, muscle pain, nausea. Patient did not receive any treatment for adverse event. The outcome of event was recovered.  Information on the lot/batch number has been requested.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: he had a itching sensation in the palm and fingers on the side that he received the vaccine; This is a spontaneous report from a contactable consumer. A 89-year-old male patient received bnt162b2 (Solution for injection, Lot Number: EL9262), dose 1 intramuscular, administered in Arm Right on 26Jan2021 14:30 (at the age 89-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included gastric cancer from 1989. Concomitant medication included cyanocobalamin (VIT B12) administered in left arm, from unspecified date of 1986 at 1 ml (monthly) for supplementation therapy from 1986 and ongoing. The patient experienced he had a itching sensation in the palm and fingers on the side that he received the vaccine (pruritus) on 26Jan2021. Caller reported that when his father took the shot, he had a itching sensation in the palm and fingers on the side that he received the vaccine. His father received the vaccine in the right arm. He did not touch it, it wouldn't itch, but if he touched it, it would itch. The action taken in response to the event(s) for bnt162b2 was not applicable. Outcome of the event was recovered on 27Jan2021.  No follow up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache
Clinical narrative: metal/odd taste in mouth; headache; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient received bnt162b2 (Solution for injection,Lot number was not reported), via an unspecified route of administration on 05Feb2021 to 05Feb2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced metal/odd taste in mouth and headache on 05Feb2021. The patient neither have Covid prior vaccination nor tested Covid post vaccination. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Dizziness, Headache, Hypoaesthesia oral
Clinical narrative: he felt very dizzy; his lips felt very swollen; My lips and mouth felt numb and swollen; My lips and mouth felt numb and swollen; headache; his blood sugar was down to 50; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that an 86-year-old male patient started to receive second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot# EN9581) via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunisation. The patient's medical history includes diabetes. The patient's concomitant medications include carvedilol (COREG), rosuvastatin calcium (CRESTOR), repaglinide (PRANDIN), adenosine (TRICOR), metformin and amlodipine besilate (NORVASC). On an unknown date, the patient reported that blood sugar was 130 on that morning. He had his normal breakfast and went to get his shot within about an hour after getting a shot he was home and he was having my lunch. He was halfway through lunch he answered his doorbell and he got extremely dizzy. His lips and mouth felt numb and swollen. On 04Feb2021, his blood sugar was down to 50. There was no reason and no explanation for precipitated drop in blood sugar other than the fact that he had the Covid shot. Subsequently he spoke to cousin of his who is physician to heard of someone who had an adverse reaction like low blood sugar and was hospitalized. Nowhere in the side effects warning doesn't say anything about diabetic with low sugar and with low population over 65 it seems to me that would great number of people who have diabetes and low blood sugar problem. In case indeed of indication of adverse effect of covid. The patient advised that a warning should be on leaf. At least people have sugar tablets or some form of counteracting low blood sugar especially since these are 5-7 have driven to and he was just very thankful but he had to get the shot in (city). He was driving from (city) on 95 for 70 miles an hour. He would have got dizzy and headache and low blood sugar reaction while he was in transit. He was thankful that he got home in time for this not be a tragedy. It was reported that no other treatment was taken by the patient other than consuming large amount of orange peels. The outcome of the events was unknown.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: he felt very dizzy; his lips felt very swollen; My lips and mouth felt numb and swollen; My lips and mouth felt numb and swollen; headache; his blood sugar was down to 50; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that an 86-year-old male patient started to receive second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot# EN9581) via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunisation. The patient's medical history includes diabetes. The patient's concomitant medications include carvedilol (COREG), rosuvastatin calcium (CRESTOR), repaglinide (PRANDIN), adenosine (TRICOR), metformin and amlodipine besilate (NORVASC). On an unknown date, the patient reported that blood sugar was 130 on that morning. He had his normal breakfast and went to get his shot within about an hour after getting a shot he was home and he was having my lunch. He was halfway through lunch he answered his doorbell and he got extremely dizzy. His lips and mouth felt numb and swollen. On 04Feb2021, his blood sugar was down to 50. There was no reason and no explanation for precipitated drop in blood sugar other than the fact that he had the Covid shot. Subsequently he spoke to cousin of his who is physician to heard of someone who had an adverse reaction like low blood sugar and was hospitalized. Nowhere in the side effects warning doesn't say anything about diabetic with low sugar and with low population over 65 it seems to me that would great number of people who have diabetes and low blood sugar problem. In case indeed of indication of adverse effect of covid. The patient advised that a warning should be on leaf. At least people have sugar tablets or some form of counteracting low blood sugar especially since these are 5-7 have driven to and he was just very thankful but he had to get the shot in (city). He was driving from (city) on 95 for 70 miles an hour. He would have got dizzy and headache and low blood sugar reaction while he was in transit. He was thankful that he got home in time for this not be a tragedy. It was reported that no other treatment was taken by the patient other than consuming large amount of orange peels. The outcome of the events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Body aches; headache; joint pain; sore arm; tiredness; This is a spontaneous report from a contactable consumer. A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation Solution for injection,lot number: EN9581, Expiration Date: not reported), via an unspecified route of administration in left arm on 05Feb2021 10:45 as single dose for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications included atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]), omeprazole (OMEPRAZOLE), clarithromycin (CLARITIN [CLARITHROMYCIN]), acetylsalicylic acid (BAYER ASPIRIN) taken for an unspecified indication, start and stop date were not reported. On 05Feb2021 the patient experienced body aches, headache, joint pain, sore arm and tiredness. The outcome of the events was reported as recovered on an unspecified date in Feb2021.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anosmia, Body temperature, COVID-19, Chest X-ray, Chills
Clinical narrative: body aches; fatigue; ill; Test: Covid Date:Result: Positive; Lost Sense of smell; chills; Fever reaching 100..8F; feeling sick; This is a spontaneous report received from a contactable nurse. A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EL8982) intramuscularly to left arm on 04Feb2021 1:30 at a single dose for COVID-19 Immunization. On 01 Jan2019, patient had started concomitant medications Metformin used for the indication Diabetes, Lovastatin used for the indication cholesterol and Montelukast used for the indication sinus allergy. past medical history pollen and bed bug allergies. On Jan 2021, patient had CXR, Hemoglobin resulted 11.2 and vitamin D. On 09 Feb2021, patient had Covid test and resulted positive On the 04Feb2021 22:30 the patient had experienced Fever and chills. The patient assessed the events as non-serious. She started feeling sick that evening. body aches, chills, and a fever reaching 100.8F. She is still experiencing fatigue. At the time of reporting the events chills, Fever reaching 100..8F were recovering and fatigue was not recovered and body aches, feeling sick, Lost Sense of smell and ill were unknown.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Haemoglobin, Illness, Malaise, Pain
Clinical narrative: body aches; fatigue; ill; Test: Covid Date:Result: Positive; Lost Sense of smell; chills; Fever reaching 100..8F; feeling sick; This is a spontaneous report received from a contactable nurse. A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EL8982) intramuscularly to left arm on 04Feb2021 1:30 at a single dose for COVID-19 Immunization. On 01 Jan2019, patient had started concomitant medications Metformin used for the indication Diabetes, Lovastatin used for the indication cholesterol and Montelukast used for the indication sinus allergy. past medical history pollen and bed bug allergies. On Jan 2021, patient had CXR, Hemoglobin resulted 11.2 and vitamin D. On 09 Feb2021, patient had Covid test and resulted positive On the 04Feb2021 22:30 the patient had experienced Fever and chills. The patient assessed the events as non-serious. She started feeling sick that evening. body aches, chills, and a fever reaching 100.8F. She is still experiencing fatigue. At the time of reporting the events chills, Fever reaching 100..8F were recovering and fatigue was not recovered and body aches, feeling sick, Lost Sense of smell and ill were unknown.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vitamin D
Clinical narrative: body aches; fatigue; ill; Test: Covid Date:Result: Positive; Lost Sense of smell; chills; Fever reaching 100..8F; feeling sick; This is a spontaneous report received from a contactable nurse. A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EL8982) intramuscularly to left arm on 04Feb2021 1:30 at a single dose for COVID-19 Immunization. On 01 Jan2019, patient had started concomitant medications Metformin used for the indication Diabetes, Lovastatin used for the indication cholesterol and Montelukast used for the indication sinus allergy. past medical history pollen and bed bug allergies. On Jan 2021, patient had CXR, Hemoglobin resulted 11.2 and vitamin D. On 09 Feb2021, patient had Covid test and resulted positive On the 04Feb2021 22:30 the patient had experienced Fever and chills. The patient assessed the events as non-serious. She started feeling sick that evening. body aches, chills, and a fever reaching 100.8F. She is still experiencing fatigue. At the time of reporting the events chills, Fever reaching 100..8F were recovering and fatigue was not recovered and body aches, feeling sick, Lost Sense of smell and ill were unknown.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergic sinusitis, Anosmia, Asthenia, Body temperature, Chills
Clinical narrative: body aches; fatigue; ill; Test: Covid Date:Result: Positive; Lost Sense of smell; chills; Fever reaching 100..8F; feeling sick; This is a spontaneous report received from a contactable nurse. A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EL8982) intramuscularly to left arm on 04Feb2021 1:30 at a single dose for COVID-19 Immunization. On 01 Jan2019, patient had started concomitant medications Metformin used for the indication Diabetes, Lovastatin used for the indication cholesterol and Montelukast used for the indication sinus allergy. past medical history pollen and bed bug allergies. On Jan 2021, patient had CXR, Hemoglobin resulted 11.2 and vitamin D. On 09 Feb2021, patient had Covid test and resulted positive On the 04Feb2021 22:30 the patient had experienced Fever and chills. The patient assessed the events as non-serious. She started feeling sick that evening. body aches, chills, and a fever reaching 100.8F. She is still experiencing fatigue. At the time of reporting the events chills, Fever reaching 100..8F were recovering and fatigue was not recovered and body aches, feeling sick, Lost Sense of smell and ill were unknown.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Freezing phenomenon, Headache, Illness
Clinical narrative: body aches; fatigue; ill; Test: Covid Date:Result: Positive; Lost Sense of smell; chills; Fever reaching 100..8F; feeling sick; This is a spontaneous report received from a contactable nurse. A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EL8982) intramuscularly to left arm on 04Feb2021 1:30 at a single dose for COVID-19 Immunization. On 01 Jan2019, patient had started concomitant medications Metformin used for the indication Diabetes, Lovastatin used for the indication cholesterol and Montelukast used for the indication sinus allergy. past medical history pollen and bed bug allergies. On Jan 2021, patient had CXR, Hemoglobin resulted 11.2 and vitamin D. On 09 Feb2021, patient had Covid test and resulted positive On the 04Feb2021 22:30 the patient had experienced Fever and chills. The patient assessed the events as non-serious. She started feeling sick that evening. body aches, chills, and a fever reaching 100.8F. She is still experiencing fatigue. At the time of reporting the events chills, Fever reaching 100..8F were recovering and fatigue was not recovered and body aches, feeling sick, Lost Sense of smell and ill were unknown.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Nasal congestion, Nasopharyngitis, Pyrexia, SARS-CoV-2 test
Clinical narrative: body aches; fatigue; ill; Test: Covid Date:Result: Positive; Lost Sense of smell; chills; Fever reaching 100..8F; feeling sick; This is a spontaneous report received from a contactable nurse. A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EL8982) intramuscularly to left arm on 04Feb2021 1:30 at a single dose for COVID-19 Immunization. On 01 Jan2019, patient had started concomitant medications Metformin used for the indication Diabetes, Lovastatin used for the indication cholesterol and Montelukast used for the indication sinus allergy. past medical history pollen and bed bug allergies. On Jan 2021, patient had CXR, Hemoglobin resulted 11.2 and vitamin D. On 09 Feb2021, patient had Covid test and resulted positive On the 04Feb2021 22:30 the patient had experienced Fever and chills. The patient assessed the events as non-serious. She started feeling sick that evening. body aches, chills, and a fever reaching 100.8F. She is still experiencing fatigue. At the time of reporting the events chills, Fever reaching 100..8F were recovering and fatigue was not recovered and body aches, feeling sick, Lost Sense of smell and ill were unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested Positive after the 1st dose; This is a spontaneous report from a Pfizer-sponsored program Pfizer. A contactable female consumer (patient) reported that female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Tested Positive after the 1st dose. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got her first dose last 26Jan2021, then she got tested positive today; This is a spontaneous report from a Pfizer Sponsored Program. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 26Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced got her first dose last 26Jan2021, then she got tested positive today (non-serious) on 05Feb2021. The caller got her first dose last 26Jan2021, then she got tested positive today. she will be done from her quarantine on the 15Feb2021, then scheduled for her 2nd dose on 16Feb2021. Caller stated that she received her first shot of Pfizer vaccination on 26Jan2021. Stated that she tested positive today and has to take second dose 16Feb2021. Stated that her the 10 day quarantine ends on 15Feb2021. Was wondering if she is able to get second shot if she had Covid that recently between shots. Clarified that it is the Pfizer Covid vaccine. Description of complaint: Pfizer Covid vaccine: Stated that she tested positive for Covid today. Has already received her first shot. The patient underwent lab tests and procedures which included covid-19: positive on 05Feb2021. The outcome of event was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Still joint pain with second dose, 13Jan2021 took 1 week to feel better; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 13Jan2021 07:30 (Batch/Lot Number: EK4176,EH9899) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 via an unspecified route of administration, on an unspecified date as single dose for covid-19 immunization. Still feel were first vaccine was given to the thouch (as reported). It was reported that, the patient still had joint pain with second dose on 13Jan2021. Took 1 week to feel better. The patient was not hospitalized. No treatment was received for the adverse event. Outcome of the event was recovering.  Follow-up attempts are completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Where that site was, it just discolored the skin and it is a little itchy; Where that site was, it just discolored the skin and it is a little itchy; injection swollen and red; injection swollen and red; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) dose 1 via an unspecified route of administration on 30Jan2021 (Batch/Lot Number: EL8982) as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, "I had a question. I had the Pfizer vaccine about nine days ago and the day after the vaccine, the injection site became swollen and red and then it took about a day and the swelling went down but the redness remained for quite a few days. And now, where that site was, it just discolored the skin and it was a little itchy and I wanted to know if that was a pretty common side effect from the vaccine and was it safe to get the second one". Consumer was informed about the role of Drug Safety and also informed about . In response to further probing, consumer stated, "No, not right now". Consumer further stated, "I am supposed to get the next one in nine days, and I wanted to make sure it was safe to do that" Further probing could not be initiated as consumer was unwilling to further answer the questions. Hence, further details were unknown and limited information was available over the call. The outcome of the event injection swollen and red was recovering, for other events outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Tooth injury
Clinical narrative: tooth extracted on Tuesday; This is a spontaneous report from a Pfizer sponsored program. A Contactable female consumer reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 06Feb2021, as a single dose for COVID-19 immunisation. The patient's medical history included knee replacement. Concomitant medications reported was amoxicillin (manufacturer unknown), for knee replacement. The caller ask if she could take her antibiotics that was prescribed to her because she will be having her tooth extracted on Tuesday. She had her first dose of the COVID-19 vaccine last Saturday. The reported event was considered as non-serious by the health authority. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Feeling a under the weather; This is a spontaneous report received from Pfizer sponsored Program. A contactable female consumer (patient herself) of 78-year-old received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9269), via an unspecified route of administration in left arm at 12:20pm on 06Feb2021 at single dose for covid-19 immunization. Medical history include needs a hip replacement and concomitant medications were not reported. On an unspecified date, patient felt like feeling under the weather and thought pain reliver might help. The patient took Tylenol prior to having the vaccine. It was further reported that she has heard a lot having to do with the use of Tylenol. It was reported that she takes 3000-4000mg of Tylenol for pain a day because she was waiting for a hip replacement. she cannot deal with the pain if she takes less than 1000mg a day. She wanted to know any recommendations with the use of any pain medication, Tylenol or Advil with the effectiveness of the vaccine conjunction, as she had no problem with the vaccine. The outcome of the event was unknown.   Follow up (09Feb2021): This is a follow up spontaneous report from a Contactable consumer. New information included relevant medical history, product details.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Body temperature, Diarrhoea, Fatigue
Clinical narrative: vasovagal response; nausea; stomach pains; vomited; diarrhea; severe headache; neck and shoulder aches; neck and shoulder aches; 100.5 fever; tired; slept all day next day; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN5318), via intramuscular route of administration in the right arm on 13Feb2021 09:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism. Concomitant medications included levothyroxine (manufacturer unknown), at 25 ug, daily, escitalopram (manufacturer unknown), 5 mg, daily, fish oil (manufacturer unknown) and calcium carbonate, colecalciferol (VITAMIN D 2000). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EL8982), via intramuscular in the right arm on 23Jan2021 at 10:30 AM After administration of 2nd vaccine, the patient developed nausea, stomach pains, vomited, diarrhea, severe headache, neck and shoulder aches, 100.5 fever, tired, slept on 14Feb2021. Also had vasovagal response 14Feb at 1:00 pm and almost passed out. The patient underwent lab tests and procedures which included Body temperature: 100.5 on an unspecified date. The reported events were considered as non-serious by the health authority. The outcome of the events were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Neck pain, Presyncope, Pyrexia
Clinical narrative: vasovagal response; nausea; stomach pains; vomited; diarrhea; severe headache; neck and shoulder aches; neck and shoulder aches; 100.5 fever; tired; slept all day next day; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN5318), via intramuscular route of administration in the right arm on 13Feb2021 09:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism. Concomitant medications included levothyroxine (manufacturer unknown), at 25 ug, daily, escitalopram (manufacturer unknown), 5 mg, daily, fish oil (manufacturer unknown) and calcium carbonate, colecalciferol (VITAMIN D 2000). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EL8982), via intramuscular in the right arm on 23Jan2021 at 10:30 AM After administration of 2nd vaccine, the patient developed nausea, stomach pains, vomited, diarrhea, severe headache, neck and shoulder aches, 100.5 fever, tired, slept on 14Feb2021. Also had vasovagal response 14Feb at 1:00 pm and almost passed out. The patient underwent lab tests and procedures which included Body temperature: 100.5 on an unspecified date. The reported events were considered as non-serious by the health authority. The outcome of the events were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Vomiting
Clinical narrative: vasovagal response; nausea; stomach pains; vomited; diarrhea; severe headache; neck and shoulder aches; neck and shoulder aches; 100.5 fever; tired; slept all day next day; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN5318), via intramuscular route of administration in the right arm on 13Feb2021 09:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism. Concomitant medications included levothyroxine (manufacturer unknown), at 25 ug, daily, escitalopram (manufacturer unknown), 5 mg, daily, fish oil (manufacturer unknown) and calcium carbonate, colecalciferol (VITAMIN D 2000). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EL8982), via intramuscular in the right arm on 23Jan2021 at 10:30 AM After administration of 2nd vaccine, the patient developed nausea, stomach pains, vomited, diarrhea, severe headache, neck and shoulder aches, 100.5 fever, tired, slept on 14Feb2021. Also had vasovagal response 14Feb at 1:00 pm and almost passed out. The patient underwent lab tests and procedures which included Body temperature: 100.5 on an unspecified date. The reported events were considered as non-serious by the health authority. The outcome of the events were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Back pain, Body temperature, Fatigue, Headache
Clinical narrative: fever up to 101 F; itching; severe head and spine pain; severe head and spine pain; Extreme fatigue; Erythematous; Loss of voice; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6201), via an unspecified route of administration in left arm on 12Feb2021 12:30 as single dose for covid-19 immunisation. Medical history included psoriatic arthropathy, basedow's disease, psoriasis. Concomitant medications included levothyroxine sodium (SYNTHROID) (MANUFACTURER UNKNOWN); estrogens conjugated, medroxyprogesterone acetate (PREMPRO) (MANUFACTURER UNKNOWN). The patient previously took fentanyl and experienced drug hypersensitivity and bnt162b2 (product=COVID 19, brand=Pfizer BioNTech, lot number=EL9262, administration date=21Jan2021, administration time=04:00 PM, vaccine location=Left arm, dose number=1).  On 13Feb2021 06:30 and experienced fever up to 101 f, itching, severe head and spine pain, severe head and spine pain, extreme fatigue, erythematous. On an unspecified date in Feb2021, patient experienced loss of voice. 18 hours post injection, severe head and spine pain, extreme fatigue, fever up to 101 F persisting 36 hours. Loss of voice 96 hours later, intermittent fever. Erythematous, hot area, raised (size of an orange) with itching in the area persists. On 13Feb2021, the patient underwent lab tests which included body temperature: up to 101 fahrenheit (intermittent fever). The patient did not receive any treatment for the events. The clinical outcomes of the fever up to 101 f, itching, severe head and spine pain, severe head and spine pain, extreme fatigue, erythematous, loss of voice were recovering. No follow-up attempts are possible.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash erythematous
Clinical narrative: fever up to 101 F; itching; severe head and spine pain; severe head and spine pain; Extreme fatigue; Erythematous; Loss of voice; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6201), via an unspecified route of administration in left arm on 12Feb2021 12:30 as single dose for covid-19 immunisation. Medical history included psoriatic arthropathy, basedow's disease, psoriasis. Concomitant medications included levothyroxine sodium (SYNTHROID) (MANUFACTURER UNKNOWN); estrogens conjugated, medroxyprogesterone acetate (PREMPRO) (MANUFACTURER UNKNOWN). The patient previously took fentanyl and experienced drug hypersensitivity and bnt162b2 (product=COVID 19, brand=Pfizer BioNTech, lot number=EL9262, administration date=21Jan2021, administration time=04:00 PM, vaccine location=Left arm, dose number=1).  On 13Feb2021 06:30 and experienced fever up to 101 f, itching, severe head and spine pain, severe head and spine pain, extreme fatigue, erythematous. On an unspecified date in Feb2021, patient experienced loss of voice. 18 hours post injection, severe head and spine pain, extreme fatigue, fever up to 101 F persisting 36 hours. Loss of voice 96 hours later, intermittent fever. Erythematous, hot area, raised (size of an orange) with itching in the area persists. On 13Feb2021, the patient underwent lab tests which included body temperature: up to 101 fahrenheit (intermittent fever). The patient did not receive any treatment for the events. The clinical outcomes of the fever up to 101 f, itching, severe head and spine pain, severe head and spine pain, extreme fatigue, erythematous, loss of voice were recovering. No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: 6hrs after taking the 1st dose her mom experienced hard time in breathing; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 14Jan2021 (Batch/Lot number: unknown) at single dose for covid-19 immunisation. Medical history included ongoing amyotrophic lateral sclerosis. The patient's concomitant medications was not reported. The patient stated 6hrs after taking the 1st dose her mom experienced hard time in breathing on 14Jan2021. Outcome of the event was unknown.   Information of lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: Headache; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache, chills and nausea; all (non-serious) on Feb2021. Consumer said that she had her Pfizer COVID-19 vaccine second shot on Saturday, and was calling today to find out how long she should expect the headaches, chills, and nausea feeling to last, or at what time should she be alarmed with these. Caller declined to complete a report. No further details captured, reported, or documented at this time. The outcome of events was unknown.    Information about Batch/Lot number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Right arm soreness; This is a spontaneous report from a contactable physician. A 32-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via intramuscular route, at the age of 32 years, administered in right arm on 23Dec2020 (Batch/Lot Number: EH9899) at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced right arm soreness. The event was considered as non-serious. The outcome of the event was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Tongue pruritus
Clinical narrative: Swollen and itchy tongue; Swollen and itchy tongue; This is a spontaneous report from a contactable Nurse (patient). A 50-Year-old non-pregnant female patient received first dose ofBNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN9581, Expiry date: unknown) via unspecified route of administration on 31Jan2021 at 10:45 AM (at the age of 50-years-old) at a single dose for covid-19 immunisation. Medical history included Known allergies, never had allergic reaction before. Concomitant medication patient received within 2 weeks of vaccination included 50 mcg  Levothyroxine, 10mg lisinopril, 67mg Fenofibrate. The patient experienced Swollen and itchy tongue on 31Jan2021 at 11:30 AM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of all the events was recovered in 2021.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Throat tightness
Clinical narrative: throat itching and tightness; throat itching and tightness; This is a spontaneous report from a contactable other healthcare professional. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose intramuscular on 06Mar2021 at 14:30 (batch/lot number: EN6204) as a single dose for COVID-19 immunization. Medical history included allergies to latex, eggs, dairy and wheat. The patient's concomitant medications were not reported. The patient previously took epinephrine (EPIPEN) (has been used in the past). Facility type vaccine was public health clinic/veterans administration facility. It was unknown if other vaccine in four weeks and unknown if other medications in two weeks. It was unknown if the patient had Covid prior to vaccination and unknown if Covid tested post vaccination. The patient experienced throat itching and tightness on 06Mar2021 at 14:30. The patient was hospitalized for throat itching and tightness from 06Mar2021 to Mar2021. Patient was given Benadryl 25 mg per oral (PO) by physician on duty. Patient's symptoms resolved and patient was discharged home with friends and boyfriend to watch over patient. The outcome of the events was recovered on Mar2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on a plausible temporal association, a causal association  between the reported events of throat itching and tightness cannot be excluded as the events followed the single dose of COVID-19 immunization.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dysphagia, Dyspnoea, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: chest congestion; My lymph nodes were swollen; my throat hurt; can't swallow; It affects the asthma; can't breathe; This is a spontaneous case received from a non-contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included asthma. Concomitant medications were not reported. The patient asked for information on the side effects with the vaccine for people with asthma because she had asthma and got sick from it. Her lymph nodes were swollen, throat hurt, she couldn't swallow and had chest congestion. It affected the asthma and she couldn't breathe. She was wondering if it was from the shot or not. She will have her second shot on Thursday. Outcome of the events was unknown.   No follow-up attempts are possible; information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary congestion
Clinical narrative: chest congestion; My lymph nodes were swollen; my throat hurt; can't swallow; It affects the asthma; can't breathe; This is a spontaneous case received from a non-contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included asthma. Concomitant medications were not reported. The patient asked for information on the side effects with the vaccine for people with asthma because she had asthma and got sick from it. Her lymph nodes were swollen, throat hurt, she couldn't swallow and had chest congestion. It affected the asthma and she couldn't breathe. She was wondering if it was from the shot or not. She will have her second shot on Thursday. Outcome of the events was unknown.   No follow-up attempts are possible; information about batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: Miscarriage; This is a spontaneous report from a contactable Other HCP (Nurse), reported for herself.  This 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route in the right arm, on 25Feb2021 at 17:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route in the right arm, on 19Mar2021 at 17:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation. The patient was pregnant at the time of vaccination and the last menstrual date was 02Sep2020. Gestational period 5 weeks and delivery date 19Nov2021. Relevant medical history included Hashimoto's thyroiditis. Past drug history included allergy to amoxicillin and omeprazole. Relevant concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. On 21Mar2021 (at 14:00), the patient had miscarriage. The event required physician office visit. The patient did not receive any treatment for the event. She was recovering from the event.   Information on the lot/batch number has been requested.; Sender's Comments: Pending the limited information on clinical course, the company does not attribute the event miscarriage to BNT162B2. The detailed document of pregnancy, relevant risk factors, status of Hashimoto's thyroiditis are missing for a medically meaningful assessment. 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.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Fall, Headache, Hyperhidrosis
Clinical narrative: Blackout; fell to the floor from a seated position; headache; abdominal pain; dizzy; sweat; This is a spontaneous report from a contactable consumer (patient).  A non-pregnant 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 19Mar2021 at 17:30 (Batch/Lot Number: EN6206) at 64-years-old as a single dose for COVID-19 immunization; administered in a hospital. The patient did not receive any other vaccine within four weeks of the suspect vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient's medical history included osteopenia, food sensitivities, seasonal allergy, allergy to molds; all from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks of the suspect vaccine. On 21Mar2021, the patient experienced: blackout (medically significant), fell to the floor from a seated position (non-serious), headache (non-serious), abdominal pain (non-serious), dizzy (non-serious), sweat (non-serious). Therapeutic measures were taken as a result of headache and abdominal pain. The clinical outcome of the events was unknown. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Blackout; fell to the floor from a seated position; headache; abdominal pain; dizzy; sweat; This is a spontaneous report from a contactable consumer (patient).  A non-pregnant 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 19Mar2021 at 17:30 (Batch/Lot Number: EN6206) at 64-years-old as a single dose for COVID-19 immunization; administered in a hospital. The patient did not receive any other vaccine within four weeks of the suspect vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient's medical history included osteopenia, food sensitivities, seasonal allergy, allergy to molds; all from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks of the suspect vaccine. On 21Mar2021, the patient experienced: blackout (medically significant), fell to the floor from a seated position (non-serious), headache (non-serious), abdominal pain (non-serious), dizzy (non-serious), sweat (non-serious). Therapeutic measures were taken as a result of headache and abdominal pain. The clinical outcome of the events was unknown. Since the vaccination, the patient had not been tested for COVID-19.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Skin infection
Clinical narrative: Infection, ended up being infection in it; This is a spontaneous report from a contactable consumer (patient's wife). A 74-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6199), via an unspecified route of administration on 05Mar2021 as a single dose for COVID-19 immunization. Medical history included heart transplant on an unspecified date, 20 years ago (as reported) and upper part of lung removed due to cancer, cancer spot on chest which was burned off on an unknown date. The patient has been on unspecified anti-rejection drugs for the heart transplant for the past 20 years. It was reported that prior to the first dose, the patient had a cancer spot on his chest, but they burned it off. After they burned it off, it got worse and so they sent him to an "MOH" doctor that had to go in there and remove the cancer. He was sent to this MOH doctor that goes more in depth, took it out, and patched him up, well it ended up being infection in it. The spot on the chest and the dermatologist burning the spot off occurred before the first dose. The infection was diagnosed on 22Mar2021. The doctor gave Cephalexin 500mg that the patient has not yet started. The outcome of the event infection was not recovered. The reporter wanted to know if the patient can receive the second shot while taking this medicine and if he can get the second dose while having an active infection. The second dose was scheduled on 26Mar2021.