chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Dizziness, Hypotension
Clinical narrative: collapse/rapid progression of symptoms; hypotension/rapid progression of symptoms; respiratory distress with stridor; respiratory distress with stridor; dizziness/rapid progression of symptoms; not limited to abdominal pain/rapid progression of symptoms; blood pressure abnormality/rapid progression of symptoms; chest pain/rapid progression of symptoms; drooling/rapid progression of symptoms; increased swelling/rapid progression of symptoms; wheezing; dyspnea and increased work of breathing; skin changes; tongue swelling and vomiting; tongue swelling and vomiting; This is a spontaneous report from a non-contactable other health professional. A 35-year-old female patient (Age at vaccination: 35) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. During her 15 minute waiting period after the injection, the patient began to experience dizziness. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality, chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea and increased work of breathing, skin changes, tongue swelling and vomiting. Treatment included: no therapy. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the collapse, hypotension, respiratory distress and other reported events due to temporal relationship.  There is very limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including BP measurements, chest x-ray, EKG and chemistry panel, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Escherichia infection
Clinical narrative: Escherichia Coli infection; This is a spontaneous report from a non-contactable consumer (daughter) from a Pfizer sponsored program Pfizer First Connect. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter's mother has Escherichia Coli infection and is taking Nitrofurantoin antibiotic (Macrodantin). Asked if it is safe to take the second dose of the vaccine while on antibiotic. Caller asking if we could update info regarding antibiotic as even her doctor does not have info on this. Saying that even her doctor is unsure as Pfizer should know information regarding this more than her doctor. Treatment for event was Nitrofurantoin antibiotic (Macrodantin). Outcome of event was unknown.    No follow up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Pain
Clinical narrative: Fever up to 102; body aches; hip and back joint pain; chills; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (lot number: EH9899) on 18Dec2020 17:00 (first dose) then (lot number: EC1284) on 05Jan2021 07:45 (second dose); both intramuscular on the left arm at a single dose for COVID-19 immunization. The patient's medical history included anxiety and depression. The patient was not pregnant at the time of vaccination. Concomitant medication included citalopram and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin and experienced allergies to amoxicillin. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 05Jan2021 17:30, the patient experienced fever up to 102, body aches, hip and back joint pain, chills, and fatigue. Outcome of the events was recovering. The events were considered non-serious by the reporter.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever up to 102; body aches; hip and back joint pain; chills; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (lot number: EH9899) on 18Dec2020 17:00 (first dose) then (lot number: EC1284) on 05Jan2021 07:45 (second dose); both intramuscular on the left arm at a single dose for COVID-19 immunization. The patient's medical history included anxiety and depression. The patient was not pregnant at the time of vaccination. Concomitant medication included citalopram and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin and experienced allergies to amoxicillin. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 05Jan2021 17:30, the patient experienced fever up to 102, body aches, hip and back joint pain, chills, and fatigue. Outcome of the events was recovering. The events were considered non-serious by the reporter.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Headache, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Have a cold and headache; headache; loss smell/ taste; loss smell/ taste; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Es1685, expiry date not reported), via an unspecified route of administration on 22Dec2020 at 09:30 AM at single dose for Covid-19 immunization. There were no medical history and no concomitant medications, no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines with 4 weeks prior to COVID vaccine nor any other medications within 2 weeks of vaccination. On 01Jan2021, the patient has a cold and headache, she was sent for Covid test 1/5 loss smell/ taste 1/3. The patient did not receive treatment for the events. The patient underwent lab test on 06Jan2021 which included nasal swab: pending result.  Outcome of the events was recovered. The reporter assessed the events as non-serious.  Information on Lot/Batch has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 06Jan2021 (13:15) at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included abnormal Factor V; and kiwi allergy. Concomitant medication included ibuprofen (ADVIL). The patient previously took Ambroxol, and had drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination, and has not been tested since the vaccination. On 06Jan2021 (16:00), the patient had sore arm. The patient did not receive any treatment for the event. The outcome of the event, sore arm, was unknown.  Information on batch/lot number was requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Fatigue, Fluid intake reduced
Clinical narrative: he is also not drinking; pain at injection site; coughing/cough; chills; not wanting to eat and fatigue; not wanting to eat and fatigue; feeling of being drowsy, like he is going to get a cold; This is a spontaneous report from a contactable consumer (patient himself). A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration (arm left), on 04Jan2021 at 14:15, at a single dose, for COVID-19 immunization. Patient has no relevant medical history. Concomitant medications included metformin, empagliflozin (JARDIANCE), lisinopril, and pravastatin. Historical vaccine included shingles; and flu shot for flu vaccination both administered in Jan2020. Patient is Behavioral Health Technician. Patient received the first dose of vaccine on 04Jan2021 (Monday) at 14:15 and went through cough, chills, not eating, fatigue. Today (Wednesday) he is better; he asked if he can take ibuprofen after having the vaccine. He also asks how long do these symptoms typically last. All the symptoms he mentioned started around 8:00 p.m. the same day, it was that feeling of being drowsy, like he is going to get a cold. He also had excruciating pain on the arm that got the vaccine, it was pain at the injection site. He added that he was also not drinking, he knows he should drink fluids. His second dose is on 26Jan2021 at 8:45PM. He has no positive COVID test before the vaccine. He did not have antibody test before the vaccine. He has had no issues with vaccines in the past. Outcome of the events not wanting to eat and fatigue was not recovered, for event "he is also not drinking" was unknown, while for other events was recovering.  Information about lot/batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Somnolence, Vaccination site pain
Clinical narrative: he is also not drinking; pain at injection site; coughing/cough; chills; not wanting to eat and fatigue; not wanting to eat and fatigue; feeling of being drowsy, like he is going to get a cold; This is a spontaneous report from a contactable consumer (patient himself). A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration (arm left), on 04Jan2021 at 14:15, at a single dose, for COVID-19 immunization. Patient has no relevant medical history. Concomitant medications included metformin, empagliflozin (JARDIANCE), lisinopril, and pravastatin. Historical vaccine included shingles; and flu shot for flu vaccination both administered in Jan2020. Patient is Behavioral Health Technician. Patient received the first dose of vaccine on 04Jan2021 (Monday) at 14:15 and went through cough, chills, not eating, fatigue. Today (Wednesday) he is better; he asked if he can take ibuprofen after having the vaccine. He also asks how long do these symptoms typically last. All the symptoms he mentioned started around 8:00 p.m. the same day, it was that feeling of being drowsy, like he is going to get a cold. He also had excruciating pain on the arm that got the vaccine, it was pain at the injection site. He added that he was also not drinking, he knows he should drink fluids. His second dose is on 26Jan2021 at 8:45PM. He has no positive COVID test before the vaccine. He did not have antibody test before the vaccine. He has had no issues with vaccines in the past. Outcome of the events not wanting to eat and fatigue was not recovered, for event "he is also not drinking" was unknown, while for other events was recovering.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Lethargy, Pain in extremity, Peripheral swelling
Clinical narrative: swelling and pain on the arm that was injected; swelling and pain on the arm that was injected; Lethargic; Fever/temperature reached 100.7; fatigued/ tired; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect from a contactable Female consumer (Patient). A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142, Expiry Date: 20Mar2021), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. Medical history included torn rotator cuffs, ongoing chronic obstructive pulmonary disease (COPD), immunocompromised, shoulder pain that she was getting the cortisone shot for was prior to the COVID shot. She also reported that she took prednisone regularly. The patient's concomitant medications were not reported. The patient got the first dose of the vaccine on 04Jan2021. She was scheduled to have cortisone injections to both of her shoulders for torn rotator cuffs on 13Jan2020 and then scheduled to get the second dose of the covid vaccine on 24Jan2020. The caller confirmed that the shoulder pain that she was getting the cortisone shot for was prior to the COVID shot and she had been getting them for some time. She mentioned she had a reaction to the first shot, she had swelling and pain on the arm that was injected. Also, she had a fever and felt lethargic that night but the next day she felt fine. The next day she actually could hardly get out of bed and felt fatigued and tired. Her temperature reached 100.7. This happened on 05Jan2021. At time of the report, she felt fine and the events resolved. She really just wanted to know if the shots would interfere with each other. Events reported as non-serious. The outcome of event fatigued/ tired was unknown, of the other events was recovered on 06Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: swelling and pain on the arm that was injected; swelling and pain on the arm that was injected; Lethargic; Fever/temperature reached 100.7; fatigued/ tired; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect from a contactable Female consumer (Patient). A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142, Expiry Date: 20Mar2021), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. Medical history included torn rotator cuffs, ongoing chronic obstructive pulmonary disease (COPD), immunocompromised, shoulder pain that she was getting the cortisone shot for was prior to the COVID shot. She also reported that she took prednisone regularly. The patient's concomitant medications were not reported. The patient got the first dose of the vaccine on 04Jan2021. She was scheduled to have cortisone injections to both of her shoulders for torn rotator cuffs on 13Jan2020 and then scheduled to get the second dose of the covid vaccine on 24Jan2020. The caller confirmed that the shoulder pain that she was getting the cortisone shot for was prior to the COVID shot and she had been getting them for some time. She mentioned she had a reaction to the first shot, she had swelling and pain on the arm that was injected. Also, she had a fever and felt lethargic that night but the next day she felt fine. The next day she actually could hardly get out of bed and felt fatigued and tired. Her temperature reached 100.7. This happened on 05Jan2021. At time of the report, she felt fine and the events resolved. She really just wanted to know if the shots would interfere with each other. Events reported as non-serious. The outcome of event fatigued/ tired was unknown, of the other events was recovered on 06Jan2021.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Headache, Nasal congestion
Clinical narrative: Fever; chills; head ache; severe joint pain; nausea; congestion; severe weakness; This is a spontaneous report from a contactable nurse (patient herself).  A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on 05Jan2021 07:45AM at a single dose for COVID-19 immunization. The patient's medical history included hypothyroid and ADD (Attention Deficit Hyperactivity Disorder), both from an unknown date and unknown if ongoing. The patient had known allergies to PCN. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Concomitant medications included unspecified/ other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Jan2021 09:00 AM, the patient experienced fever, chills head ache, severe joint pain, nausea, congestion, and severe weakness. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for the events. Outcome of the events was unknown. The report was assessed as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect.  Information about lot/batch number is requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever; chills; head ache; severe joint pain; nausea; congestion; severe weakness; This is a spontaneous report from a contactable nurse (patient herself).  A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on 05Jan2021 07:45AM at a single dose for COVID-19 immunization. The patient's medical history included hypothyroid and ADD (Attention Deficit Hyperactivity Disorder), both from an unknown date and unknown if ongoing. The patient had known allergies to PCN. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Concomitant medications included unspecified/ other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Jan2021 09:00 AM, the patient experienced fever, chills head ache, severe joint pain, nausea, congestion, and severe weakness. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for the events. Outcome of the events was unknown. The report was assessed as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect.  Information about lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Myalgia, Pyrexia
Clinical narrative: Fever; Fatigue; Muscle aches; Headache; Interval between the two COVID-19 vaccine doses is 18 days; This is a spontaneous report from a contactable nurse (patient). An adult female (non-pregnant) patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm, on 05Jan2021 at 7:30, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (Lot Number: EJ1685) on 18Dec2020 for COVID-19 immunization (right arm). The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccines. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital. The interval between the two COVID-19 vaccine doses is 18 days (18Dec2020 to 05Jan2021). On 05Jan2021 at 3 PM, the patient experienced fever, fatigue, muscle aches, and headache. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events in Jan2021.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, Cough, Headache
Clinical narrative: loss of smell and taste; loss of smell and taste; low grade fever; Flu-like aching; headache; coughs; soreness of the arm; This is a spontaneous report from a contactable consumer (patient work in detention center). A 45-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1284, Expire Date: 30Apr2021), via an unspecified route of administration on 05Jan2021 07:45 in the right arm at single dose for covid-19 immunisation. Medical history included covid-19 from 26Dec2020 was recovering. The patient's concomitant medications were not reported. The patient experienced soreness of the arm on 05Jan2021 with outcome of recovering, loss of smell and taste on 06Jan2021 04:00 with outcome of not recovered, headache on 06Jan2021 with outcome of recovered, coughs on 06Jan2021 with outcome of not recovered, low grade fever on 06Jan2021 02:30 with outcome of unknown, flu-like aching on 06Jan2021 01:00 with outcome of recovering. The detail clinical course was provided as consumer calling regarding the COVID 19 vaccine. He received first dose of the Pfizer COVID 19 vaccine on 05Jan2021 07:45am in the right arm. He noticed by the afternoon his arm was sore. He worked overnight so at 01:00AM 06Jan2021 he noticed achy, like flu ache in his muscles. He took his temperature and it was 99.4 around 02:30 in the morning. Then at 04:00am he noticed he couldn't smell or taste anything. He went home and fell asleep. When he woke up he had a headache and coughing. He took Dayquil which helped with the coughing and then the headache went away. He has had the coughing all through the COVID infection. The patient underwent lab tests and procedures which included body temperature: 99.4 on 06Jan2021 02:30, COVID 19 test PCR positive 26Dec2020. The events were reported as non-serious. Mentioned he was told if you already had COVID the side effects of the vaccine may be worse. He was planning to receive the second dose 26Jan2021.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: loss of smell and taste; loss of smell and taste; low grade fever; Flu-like aching; headache; coughs; soreness of the arm; This is a spontaneous report from a contactable consumer (patient work in detention center). A 45-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1284, Expire Date: 30Apr2021), via an unspecified route of administration on 05Jan2021 07:45 in the right arm at single dose for covid-19 immunisation. Medical history included covid-19 from 26Dec2020 was recovering. The patient's concomitant medications were not reported. The patient experienced soreness of the arm on 05Jan2021 with outcome of recovering, loss of smell and taste on 06Jan2021 04:00 with outcome of not recovered, headache on 06Jan2021 with outcome of recovered, coughs on 06Jan2021 with outcome of not recovered, low grade fever on 06Jan2021 02:30 with outcome of unknown, flu-like aching on 06Jan2021 01:00 with outcome of recovering. The detail clinical course was provided as consumer calling regarding the COVID 19 vaccine. He received first dose of the Pfizer COVID 19 vaccine on 05Jan2021 07:45am in the right arm. He noticed by the afternoon his arm was sore. He worked overnight so at 01:00AM 06Jan2021 he noticed achy, like flu ache in his muscles. He took his temperature and it was 99.4 around 02:30 in the morning. Then at 04:00am he noticed he couldn't smell or taste anything. He went home and fell asleep. When he woke up he had a headache and coughing. He took Dayquil which helped with the coughing and then the headache went away. He has had the coughing all through the COVID infection. The patient underwent lab tests and procedures which included body temperature: 99.4 on 06Jan2021 02:30, COVID 19 test PCR positive 26Dec2020. The events were reported as non-serious. Mentioned he was told if you already had COVID the side effects of the vaccine may be worse. He was planning to receive the second dose 26Jan2021.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Back pain, Discomfort, Inflammation
Clinical narrative: Mild arthritis joint pain in my hands, and feet/The pain and inflammation has significantly increased; Mild arthritis joint pain in my hands, and feet/The pain and inflammation has significantly increased; pain and inflammation has significantly increased; feels very sharp especially in my hands in my back near my scapula, and my knee joints; My muscles also feel tight in these areas; The pain and discomfort are significantly greater than normal; This is a spontaneous report from a contactable other hcp. This 47-year-old female other HCP (patient) received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 30Dec2020 09:00 at single dose on right arm for COVID-19 immunisation. The patient was mostly healthy, no chronic health conditions. No known allergies. Her family had a lot of auto immune disease history. Concomitant medication included paracetamol (TYLENOL), ibuprofen. The patient had mild arthritis joint pain in her hands, and feet that were usually resolved with OTC pain medications. The pain and inflammation has significantly increased since the COVID-19 vaccine injection and felt very sharp especially in her hands, in her back near mhery scapula, and her knee joints. Her muscles also feel tight in these areas. The pain and discomfort are significantly greater than normal. Symptoms were the worst 2-5 days Post injection and have not resolved. All of the events were on 31Dec2020 09:00 and no treatment was received, all considered as non-serious. No COVID tested post vaccination. The outcome of the events was not recovered.  Information on the Lot/Batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness
Clinical narrative: Mild arthritis joint pain in my hands, and feet/The pain and inflammation has significantly increased; Mild arthritis joint pain in my hands, and feet/The pain and inflammation has significantly increased; pain and inflammation has significantly increased; feels very sharp especially in my hands in my back near my scapula, and my knee joints; My muscles also feel tight in these areas; The pain and discomfort are significantly greater than normal; This is a spontaneous report from a contactable other hcp. This 47-year-old female other HCP (patient) received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 30Dec2020 09:00 at single dose on right arm for COVID-19 immunisation. The patient was mostly healthy, no chronic health conditions. No known allergies. Her family had a lot of auto immune disease history. Concomitant medication included paracetamol (TYLENOL), ibuprofen. The patient had mild arthritis joint pain in her hands, and feet that were usually resolved with OTC pain medications. The pain and inflammation has significantly increased since the COVID-19 vaccine injection and felt very sharp especially in her hands, in her back near mhery scapula, and her knee joints. Her muscles also feel tight in these areas. The pain and discomfort are significantly greater than normal. Symptoms were the worst 2-5 days Post injection and have not resolved. All of the events were on 31Dec2020 09:00 and no treatment was received, all considered as non-serious. No COVID tested post vaccination. The outcome of the events was not recovered.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient tested positive for Covid on 22Dec2020. She wanted to know if there is any more information on receiving the second dose after testing positive. The outcome of the event was unknown.  Information on the Lot/batch number has been requested.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (in this case 2 days). However, a causal relationship between event "tested positive with Covid " (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 vaccine cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable nurse reported for herself. This female patient with unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received her first dose of vaccine on 17Dec2020, and reported hives as a result. She's asking about efficacy of just 1 dose, and if she should get the 2nd dose. Also wanting to know duration of immunity. The outcome of event was unknown.    Information on the lot/batch number has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Flushing, Heart rate, Heart rate increased
Clinical narrative: felt hot; flush; light headed; heart rate elevated; fever; This is a spontaneous report from a contactable consumer (patient). This 37-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EH9899) via an unspecified route of administration at right arm on 06Jan2020 12:15 PM at single dose for COVID-19 immunisation. Medical history included known allergies to Penicillin and Hashimoto's thyroiditis. Concomitant medications included atorvastatin and clarithromycin (CLARITIN). The patient previous took Amoxicillin and Azithromycin, both experiencing allergies; the 1st dose of flu shot on 21Dec2020 at arm left. Within 5 minutes of injection, the patient felt hot, flush, light-headed and heart rate elevated from 06Jan2021 at 12:30 PM. The patient was under observation and the nurse laid him down in a room. The patient was monitored vitals with a doctor. Symptoms subsided and stopped by 30 minutes post injection. The patient felt normal and fine after fever. The patient did not have any symptoms himself. No treatment was received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of all events was recovered.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: felt hot; flush; light headed; heart rate elevated; fever; This is a spontaneous report from a contactable consumer (patient). This 37-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EH9899) via an unspecified route of administration at right arm on 06Jan2020 12:15 PM at single dose for COVID-19 immunisation. Medical history included known allergies to Penicillin and Hashimoto's thyroiditis. Concomitant medications included atorvastatin and clarithromycin (CLARITIN). The patient previous took Amoxicillin and Azithromycin, both experiencing allergies; the 1st dose of flu shot on 21Dec2020 at arm left. Within 5 minutes of injection, the patient felt hot, flush, light-headed and heart rate elevated from 06Jan2021 at 12:30 PM. The patient was under observation and the nurse laid him down in a room. The patient was monitored vitals with a doctor. Symptoms subsided and stopped by 30 minutes post injection. The patient felt normal and fine after fever. The patient did not have any symptoms himself. No treatment was received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of all events was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: she received the Pfizer-BioNTech Covid-19 Vaccine .She said she tested positive for Covid-19 after being exposed to someone infected with the virus last Christmas; she received the Pfizer-BioNTech Covid-19 Vaccine .She said she tested positive for Covid-19 after being exposed to someone infected with the virus last Christmas; after being exposed to someone infected with the virus; This is a spontaneous report from a contactable Physician (patient). A female patient of an unspecified age receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient she received the Pfizer-BioNTech Covid-19 Vaccine on 18Dec2020. She said she tested positive for Covid-19 after being exposed to someone infected with the virus last Christmas (25Dec2020). Now, she wanted to know if she can still take the 2nd dose. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: A causal association between reported event and BNT162B2 cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Headache, Productive cough
Clinical narrative: phlegm in throat; Headache; Dry cough; It just made her uncomfortable; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL1284), intramuscular on the left arm on 04Jan2021 15:01 (she would say 15:01 because they told her to wait 20 minutes after receiving the vaccine and she left at 15:21) at SINGLE DOSE for COVID-19 immunization. The patient stated that she might be a little obese. There were no concomitant medications. When she got the vaccine on Monday (04Jan2021), she felt okay. The next day, it seemed like she had phlegm in her throat. She also had a horrible cough and headache. She don't know if it's the vaccine or what. It was mentioned that the phlegm in her throat was no longer horrible went away by the same day of 05Jan2021. The patient also stated that she took two acetaminophen (TYLENOL) for the headache and it went away last night (05Jan2021). However, she has the headache again by 06Jan2021. It was also mentioned that her dry cough that just won't go away, it's persisting. She can't cough, because people don't like that- they get uncomfortable. The patient mentioned that she didn't see any of these side effects on the paper she was given. It just made her uncomfortable, she didn't know what was going on with her body. Outcome of the events of productive cough and headache (initial occurrence) were recovered in 05Jan2021; recovering from dry cough; not recovered for headache (recurrence) while unknown for the remaining event.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Malaise, Pyrexia
Clinical narrative: Mild injection site pain initially, next day increased injection site pain; Headache; Malaise; Low grade fever; This is a spontaneous report from a contactable pharmacist. This pharmacist (Patient) reported that the 29-year-old male patient received first dose of bnt162b2 (BNT162B2, Pfizer COVID-19, Batch/lot number: EL1284), via an unspecified route of administration on 04Jan2021 02:30 PM at single dose on Left arm for covid-19 immunisation. Medical history included covid prior vaccination. No Known Allergies to medications, food, or other products. Facility type vaccine was hospital. No other vaccine in four weeks. No other medications in two weeks. The patient experienced Mild injection site pain initially, next day increased injection site pain, malaise, low grade fever, and headache from 04Jan2021 03:00 PM. No covid tested post vaccination. The event was assessed non-serious. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. No treatment was received for the adverse event. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered in Jan2021.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable consumer received from a Pfizer-sponsored program Pfizer First Connect. A 64-years-old female patient  received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899, expiry date Mar2021, NDC 59267-1000-1), intramuscular in right arm on 18Dec2020 11:45 at a single dose as prevention. The vaccine was administered in the hospital. Medical history included ongoing cardiomyopathy diagnosed about 32 years ago  and had pacemaker defibrillator Placed about 12 years ago. There were no concomitant medications. She was supposed to get the second dose of the Covid vaccine but she was positive for Covid. She found out she was positive for covid on Monday 04Jan2021 after she had a nasal swab test on 02Jan2020.  The outcome of the event was unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Pain, Pyrexia
Clinical narrative: body aches; headache; fever; body chills; wasn't able to sleep; pain throughout her arm/injection site was extremely sore; This is a spontaneous report from a contactable healthcare professional. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number ek9231/expiration date unknown), dose number 1, via an unspecified route of administration on 03Jan2021 14:15 at a single dose on the left arm for COVID-19 immunization. Medical history included migraines. Concomitant medications were not reported. The patient was fine the day she got the vaccine, but when it came to the night of 03Jan2021, she wasn't able to sleep due to the pain throughout her arm. On 04Jan2021 04:00, she woke up with a headache that was intense, fever, and body chills. The injection site was extremely sore to the point where she took some Tylenol and slept it off. On 05Jan2021, she felt a lot better, but still with mild body aches. The patient was not diagnosed with COVID-19 prior to vaccination. She was not tested for COVID-19 since the vaccination. The vaccine was received in a hospital. No other vaccines were given in four weeks. The outcome of the events was not recovered for body aches, and recovering for the other events.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: body aches; headache; fever; body chills; wasn't able to sleep; pain throughout her arm/injection site was extremely sore; This is a spontaneous report from a contactable healthcare professional. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number ek9231/expiration date unknown), dose number 1, via an unspecified route of administration on 03Jan2021 14:15 at a single dose on the left arm for COVID-19 immunization. Medical history included migraines. Concomitant medications were not reported. The patient was fine the day she got the vaccine, but when it came to the night of 03Jan2021, she wasn't able to sleep due to the pain throughout her arm. On 04Jan2021 04:00, she woke up with a headache that was intense, fever, and body chills. The injection site was extremely sore to the point where she took some Tylenol and slept it off. On 05Jan2021, she felt a lot better, but still with mild body aches. The patient was not diagnosed with COVID-19 prior to vaccination. She was not tested for COVID-19 since the vaccination. The vaccine was received in a hospital. No other vaccines were given in four weeks. The outcome of the events was not recovered for body aches, and recovering for the other events.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache
Clinical narrative: Severe diarrhea for 3-4 hours starting 2 hours after vaccine; headache; Fatigue for several day; This is a spontaneous report from a contactable other HCP. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 20Dec2020 17:30 at a single dose for covid-19 immunisation. The vaccine was administered in the hospital. Medical history included asthma. The patient was not diagnosed COVID-91 prior to vaccination. There were no concomitant medications. On 20Dec2020 21:00, the patient experienced severe diarrhea for 3-4 hours starting 2 hours after vaccine, fatigue for several days and headache. The outcome of the events was recovered on an unknown date. No treatment was required for the events. The patient was not tested for covid-19 post vaccination.  Information about lot/ batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache; fever; This is a spontaneous report from a contactable nurse. A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 14:00 in left arm at single dose for COVID-19 immunization. Medical history included Crohn's disease from an unknown date. The previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Dec2020 14:30 in right arm at single dose for COVID-19 immunization. The patient's concomitant medications were not reported. The patient experienced headache and fever on 05Jan2021 01:00. The facility where the most recent COVID-19 vaccine was administered was in the hospital. 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. The outcome of events was recovered in Jan2021. The patient was given over the counter medication as treatment for the events. The event was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Pruritus, Swelling face, Urticaria
Clinical narrative: The evening of 1/10 I spontaneously developed diffuse urticaria of my trunk and face, associated with itching, mild abdominal discomfort, and facial flushing. Symptoms somewhat improved with cetirizine. The evening of 1/11 developed recurrent spontaneous diffuse urticaria, mostly in the face. Having persistent intermittent sweats and significant fatigue.   Per Patient, He have had urticaria rarely in the past, associated with shellfish. I have never had anaphylaxis before.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Anaphylactic reaction, Fatigue, Flushing, Hyperhidrosis
Clinical narrative: The evening of 1/10 I spontaneously developed diffuse urticaria of my trunk and face, associated with itching, mild abdominal discomfort, and facial flushing. Symptoms somewhat improved with cetirizine. The evening of 1/11 developed recurrent spontaneous diffuse urticaria, mostly in the face. Having persistent intermittent sweats and significant fatigue.   Per Patient, He have had urticaria rarely in the past, associated with shellfish. I have never had anaphylaxis before.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: The evening of 1/10 I spontaneously developed diffuse urticaria of my trunk and face, associated with itching, mild abdominal discomfort, and facial flushing. Symptoms somewhat improved with cetirizine. The evening of 1/11 developed recurrent spontaneous diffuse urticaria, mostly in the face. Having persistent intermittent sweats and significant fatigue.   Per Patient, He have had urticaria rarely in the past, associated with shellfish. I have never had anaphylaxis before.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Fatigue, Flushing, Hyperhidrosis, Inappropriate schedule of product administration
Clinical narrative: The evening of 1/10 I spontaneously developed diffuse urticaria of my trunk and face, associated with itching, mild abdominal discomfort, and facial flushing. Symptoms somewhat improved with cetirizine. The evening of 1/11 developed recurrent spontaneous diffuse urticaria, mostly in the face. Having persistent intermittent sweats and significant fatigue.   Per Patient, He have had urticaria rarely in the past, associated with shellfish. I have never had anaphylaxis before.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pruritus, SARS-CoV-2 test, Urticaria
Clinical narrative: The evening of 1/10 I spontaneously developed diffuse urticaria of my trunk and face, associated with itching, mild abdominal discomfort, and facial flushing. Symptoms somewhat improved with cetirizine. The evening of 1/11 developed recurrent spontaneous diffuse urticaria, mostly in the face. Having persistent intermittent sweats and significant fatigue.   Per Patient, He have had urticaria rarely in the past, associated with shellfish. I have never had anaphylaxis before.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea, Urticaria
Clinical narrative: dizziness; Nausea; fatigue; hives; headache; This is a spontaneous report from a contactable Other HCP (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) intramuscular in left arm on 30Dec2020 08:00 at single dose for COVID-19 immunization. Medical history included Crohn's Disease, rheumatoid arthritis. The patient was known allergic to IV contrast dye, sulfa, darvacet, demoral (coded as demerol). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included citalopram and clarithromycin (CLARITIN). The patient experienced Nausea, hives, dizziness, headache, and fatigue on 01Jan2021 12:00 PM. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Received Hydroxizine as treatment for the adverse event. Events outcome was recovering.