chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Impaired driving ability, Pyrexia
Clinical narrative: have a persistent severe headache; feverish; I feel very light headed; unsteady with difficulty maintaining balance when I walk; This is a spontaneous report from a contactable healthcare professional (patient). A 61-year-old male patient received the first dose of BNT162B2 (Pfizer, lot number: EH9899), via an unspecified route of administration in left arm on 31Dec2020 12:00 at single dose for COVID-19 immunization. Medical history included known allergies: penicillin, and deep vein thrombosis (DVT). Concomitant medications in two weeks included dabigatran etexilate mesilate (PRADAXA) at 150 mg twice a day, and hydrochlorothiazide/losartan potassium (LOSARTAN + HIDROCLOROTIAZIDA) at 100-25 mg. On 04Jan2021, patient felt very light headed, unsteady with difficulty maintaining balance when I walk, had a persistent severe headache and feverish. However, he did not have a fever. Temperature was 97.5. Blood pressure (BP) was normal. Pulse was normal. No soreness at the injection site from day one. Treatment was not received. Patient was not recovered from all these events.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Blood pressure measurement, Body temperature, Dizziness, Headache
Clinical narrative: have a persistent severe headache; feverish; I feel very light headed; unsteady with difficulty maintaining balance when I walk; This is a spontaneous report from a contactable healthcare professional (patient). A 61-year-old male patient received the first dose of BNT162B2 (Pfizer, lot number: EH9899), via an unspecified route of administration in left arm on 31Dec2020 12:00 at single dose for COVID-19 immunization. Medical history included known allergies: penicillin, and deep vein thrombosis (DVT). Concomitant medications in two weeks included dabigatran etexilate mesilate (PRADAXA) at 150 mg twice a day, and hydrochlorothiazide/losartan potassium (LOSARTAN + HIDROCLOROTIAZIDA) at 100-25 mg. On 04Jan2021, patient felt very light headed, unsteady with difficulty maintaining balance when I walk, had a persistent severe headache and feverish. However, he did not have a fever. Temperature was 97.5. Blood pressure (BP) was normal. Pulse was normal. No soreness at the injection site from day one. Treatment was not received. Patient was not recovered from all these events.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Pyrexia
Clinical narrative: have a persistent severe headache; feverish; I feel very light headed; unsteady with difficulty maintaining balance when I walk; This is a spontaneous report from a contactable healthcare professional (patient). A 61-year-old male patient received the first dose of BNT162B2 (Pfizer, lot number: EH9899), via an unspecified route of administration in left arm on 31Dec2020 12:00 at single dose for COVID-19 immunization. Medical history included known allergies: penicillin, and deep vein thrombosis (DVT). Concomitant medications in two weeks included dabigatran etexilate mesilate (PRADAXA) at 150 mg twice a day, and hydrochlorothiazide/losartan potassium (LOSARTAN + HIDROCLOROTIAZIDA) at 100-25 mg. On 04Jan2021, patient felt very light headed, unsteady with difficulty maintaining balance when I walk, had a persistent severe headache and feverish. However, he did not have a fever. Temperature was 97.5. Blood pressure (BP) was normal. Pulse was normal. No soreness at the injection site from day one. Treatment was not received. Patient was not recovered from all these events.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Back pain, Dizziness, Malaise, Muscular weakness
Clinical narrative: pain on the joints, and legs (the feeling that inside the legs are stiff).; pain on the joints, and legs (the feeling that inside the legs are stiff).; woke and I was nauseus.; Pain is radiating to back and neck/I can't bend over that I feel pain from the neck to the head on the left side only.; I started to feel a little weaker, body aches.; I started to feel a little weaker, body aches.; unable to lift arm completely; Pain is radiating to back and neck; sore left arm after couple hours; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 07Jan2021 11:45 at left arm, at single dose for covid-19 immunization. Medical history was none. Known allergies was NKA/NKDA. Concomitant medication included methylcellulose (CITRUCEL), ergocalciferol (VIT D), vitamin b complex (B-COMPLEX), ubidecarenone (COQ 10) and birth control. The patient was not pregnant at the time of vaccination. The patient experienced sore left arm after couple hours on 07Jan2021 18:00. At night took Ibuprofen to help with pain. Pain woke the patient up at night. On 08Jan2021, left arm was very sore, unable to lift arm completely. Pain was radiating to back and neck. Took Ibuprofen. At night she wasn't feeling the same. She started to feel a little weaker, body aches. Her legs felt strange, as if there was some pressure, that veins were stiff. On 09Jan2021, the patient woke and was nauseas. Arm was not very sore but neck was. She couldn't bend over that she felt pain from the neck to the head on the left side only. At night her legs started to feel the pressure again. It seemed like pain on the joints. She didn't feel the same. On 10Jan2021, woke up with pain on the joints, and legs (the feeling that inside the legs were stiff). She was afraid that she was having an unusual, serious reaction and not aware of it. The outcome of the event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Neck pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: pain on the joints, and legs (the feeling that inside the legs are stiff).; pain on the joints, and legs (the feeling that inside the legs are stiff).; woke and I was nauseus.; Pain is radiating to back and neck/I can't bend over that I feel pain from the neck to the head on the left side only.; I started to feel a little weaker, body aches.; I started to feel a little weaker, body aches.; unable to lift arm completely; Pain is radiating to back and neck; sore left arm after couple hours; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 07Jan2021 11:45 at left arm, at single dose for covid-19 immunization. Medical history was none. Known allergies was NKA/NKDA. Concomitant medication included methylcellulose (CITRUCEL), ergocalciferol (VIT D), vitamin b complex (B-COMPLEX), ubidecarenone (COQ 10) and birth control. The patient was not pregnant at the time of vaccination. The patient experienced sore left arm after couple hours on 07Jan2021 18:00. At night took Ibuprofen to help with pain. Pain woke the patient up at night. On 08Jan2021, left arm was very sore, unable to lift arm completely. Pain was radiating to back and neck. Took Ibuprofen. At night she wasn't feeling the same. She started to feel a little weaker, body aches. Her legs felt strange, as if there was some pressure, that veins were stiff. On 09Jan2021, the patient woke and was nauseas. Arm was not very sore but neck was. She couldn't bend over that she felt pain from the neck to the head on the left side only. At night her legs started to feel the pressure again. It seemed like pain on the joints. She didn't feel the same. On 10Jan2021, woke up with pain on the joints, and legs (the feeling that inside the legs were stiff). She was afraid that she was having an unusual, serious reaction and not aware of it. The outcome of the event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Joint stiffness, Nausea
Clinical narrative: pain on the joints, and legs (the feeling that inside the legs are stiff).; pain on the joints, and legs (the feeling that inside the legs are stiff).; woke and I was nauseus.; Pain is radiating to back and neck/I can't bend over that I feel pain from the neck to the head on the left side only.; I started to feel a little weaker, body aches.; I started to feel a little weaker, body aches.; unable to lift arm completely; Pain is radiating to back and neck; sore left arm after couple hours; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 07Jan2021 11:45 at left arm, at single dose for covid-19 immunization. Medical history was none. Known allergies was NKA/NKDA. Concomitant medication included methylcellulose (CITRUCEL), ergocalciferol (VIT D), vitamin b complex (B-COMPLEX), ubidecarenone (COQ 10) and birth control. The patient was not pregnant at the time of vaccination. The patient experienced sore left arm after couple hours on 07Jan2021 18:00. At night took Ibuprofen to help with pain. Pain woke the patient up at night. On 08Jan2021, left arm was very sore, unable to lift arm completely. Pain was radiating to back and neck. Took Ibuprofen. At night she wasn't feeling the same. She started to feel a little weaker, body aches. Her legs felt strange, as if there was some pressure, that veins were stiff. On 09Jan2021, the patient woke and was nauseas. Arm was not very sore but neck was. She couldn't bend over that she felt pain from the neck to the head on the left side only. At night her legs started to feel the pressure again. It seemed like pain on the joints. She didn't feel the same. On 10Jan2021, woke up with pain on the joints, and legs (the feeling that inside the legs were stiff). She was afraid that she was having an unusual, serious reaction and not aware of it. The outcome of the event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Vaccination site joint movement impairment
Clinical narrative: pain on the joints, and legs (the feeling that inside the legs are stiff).; pain on the joints, and legs (the feeling that inside the legs are stiff).; woke and I was nauseus.; Pain is radiating to back and neck/I can't bend over that I feel pain from the neck to the head on the left side only.; I started to feel a little weaker, body aches.; I started to feel a little weaker, body aches.; unable to lift arm completely; Pain is radiating to back and neck; sore left arm after couple hours; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 07Jan2021 11:45 at left arm, at single dose for covid-19 immunization. Medical history was none. Known allergies was NKA/NKDA. Concomitant medication included methylcellulose (CITRUCEL), ergocalciferol (VIT D), vitamin b complex (B-COMPLEX), ubidecarenone (COQ 10) and birth control. The patient was not pregnant at the time of vaccination. The patient experienced sore left arm after couple hours on 07Jan2021 18:00. At night took Ibuprofen to help with pain. Pain woke the patient up at night. On 08Jan2021, left arm was very sore, unable to lift arm completely. Pain was radiating to back and neck. Took Ibuprofen. At night she wasn't feeling the same. She started to feel a little weaker, body aches. Her legs felt strange, as if there was some pressure, that veins were stiff. On 09Jan2021, the patient woke and was nauseas. Arm was not very sore but neck was. She couldn't bend over that she felt pain from the neck to the head on the left side only. At night her legs started to feel the pressure again. It seemed like pain on the joints. She didn't feel the same. On 10Jan2021, woke up with pain on the joints, and legs (the feeling that inside the legs were stiff). She was afraid that she was having an unusual, serious reaction and not aware of it. The outcome of the event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Dizziness, Headache, Myalgia
Clinical narrative: fever of 101.7; chills/ rigors; nausea; headache; arthralgias; myalgias; severe dizziness; This is a spontaneous report from a contactable physician.  A 29-year-old male patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration in the left arm on 08Jan2021 at 29-years-old at 12:15 at a single dose for COVID-19 immunization in a workplace clinic.  Medical history included Seasonal allergies from an unknown date and unknown if ongoing. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on an unknown date (first dose-Lot Number: EK5730; Vaccine location: Left Arm; Administration time: 12:30). Concomitant medications included fluticasone propionate (FLONASE) taken for an unspecified indication from an unspecified date to an unspecified date; within two weeks of the vaccine.  On 09Jan2021 00:30, the patient experienced: fever of 101.7, chills/ rigors, nausea, headache, arthralgias, myalgias, severe dizziness. The clinical course was reported as follows: The patient woke up after midnight with a fever of 101.7, chills/ rigors, nausea, headache, arthralgias, myalgias, and severe dizziness. The patient continued to have fevers, and his last temperature of 100.8 (taken about 36 hours post vaccination). The patient also continued to have a significant headache and dizziness. These symptoms had caused the patient to call out sick for 09Dec and tomorrow 10Dec (as reported). The patient underwent lab tests and procedures which included body temperature: 100.8 on an unknown date, body temperature: 101.7 on 09Jan2021. Therapeutic measures were taken as a result of fever of 101.7, chills/ rigors, nausea, headache, arthralgias, myalgias, severe dizziness; which included: 4g paracetamol (TYLENOL) (1g every 6 hours (Q6)) 800 mg ibuprofen, and ondansetron (ZOFRAN). The patient did not have COVID prior to vaccination; and was not tested for COVID post vaccination. The clinical outcome of the events was recovering.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: fever of 101.7; chills/ rigors; nausea; headache; arthralgias; myalgias; severe dizziness; This is a spontaneous report from a contactable physician.  A 29-year-old male patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration in the left arm on 08Jan2021 at 29-years-old at 12:15 at a single dose for COVID-19 immunization in a workplace clinic.  Medical history included Seasonal allergies from an unknown date and unknown if ongoing. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on an unknown date (first dose-Lot Number: EK5730; Vaccine location: Left Arm; Administration time: 12:30). Concomitant medications included fluticasone propionate (FLONASE) taken for an unspecified indication from an unspecified date to an unspecified date; within two weeks of the vaccine.  On 09Jan2021 00:30, the patient experienced: fever of 101.7, chills/ rigors, nausea, headache, arthralgias, myalgias, severe dizziness. The clinical course was reported as follows: The patient woke up after midnight with a fever of 101.7, chills/ rigors, nausea, headache, arthralgias, myalgias, and severe dizziness. The patient continued to have fevers, and his last temperature of 100.8 (taken about 36 hours post vaccination). The patient also continued to have a significant headache and dizziness. These symptoms had caused the patient to call out sick for 09Dec and tomorrow 10Dec (as reported). The patient underwent lab tests and procedures which included body temperature: 100.8 on an unknown date, body temperature: 101.7 on 09Jan2021. Therapeutic measures were taken as a result of fever of 101.7, chills/ rigors, nausea, headache, arthralgias, myalgias, severe dizziness; which included: 4g paracetamol (TYLENOL) (1g every 6 hours (Q6)) 800 mg ibuprofen, and ondansetron (ZOFRAN). The patient did not have COVID prior to vaccination; and was not tested for COVID post vaccination. The clinical outcome of the events was recovering.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chills, Dizziness, Headache
Clinical narrative: fever of 101.7; chills/ rigors; nausea; headache; arthralgias; myalgias; severe dizziness; This is a spontaneous report from a contactable physician.  A 29-year-old male patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration in the left arm on 08Jan2021 at 29-years-old at 12:15 at a single dose for COVID-19 immunization in a workplace clinic.  Medical history included Seasonal allergies from an unknown date and unknown if ongoing. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on an unknown date (first dose-Lot Number: EK5730; Vaccine location: Left Arm; Administration time: 12:30). Concomitant medications included fluticasone propionate (FLONASE) taken for an unspecified indication from an unspecified date to an unspecified date; within two weeks of the vaccine.  On 09Jan2021 00:30, the patient experienced: fever of 101.7, chills/ rigors, nausea, headache, arthralgias, myalgias, severe dizziness. The clinical course was reported as follows: The patient woke up after midnight with a fever of 101.7, chills/ rigors, nausea, headache, arthralgias, myalgias, and severe dizziness. The patient continued to have fevers, and his last temperature of 100.8 (taken about 36 hours post vaccination). The patient also continued to have a significant headache and dizziness. These symptoms had caused the patient to call out sick for 09Dec and tomorrow 10Dec (as reported). The patient underwent lab tests and procedures which included body temperature: 100.8 on an unknown date, body temperature: 101.7 on 09Jan2021. Therapeutic measures were taken as a result of fever of 101.7, chills/ rigors, nausea, headache, arthralgias, myalgias, severe dizziness; which included: 4g paracetamol (TYLENOL) (1g every 6 hours (Q6)) 800 mg ibuprofen, and ondansetron (ZOFRAN). The patient did not have COVID prior to vaccination; and was not tested for COVID post vaccination. The clinical outcome of the events was recovering.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: fever of 101.7; chills/ rigors; nausea; headache; arthralgias; myalgias; severe dizziness; This is a spontaneous report from a contactable physician.  A 29-year-old male patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration in the left arm on 08Jan2021 at 29-years-old at 12:15 at a single dose for COVID-19 immunization in a workplace clinic.  Medical history included Seasonal allergies from an unknown date and unknown if ongoing. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on an unknown date (first dose-Lot Number: EK5730; Vaccine location: Left Arm; Administration time: 12:30). Concomitant medications included fluticasone propionate (FLONASE) taken for an unspecified indication from an unspecified date to an unspecified date; within two weeks of the vaccine.  On 09Jan2021 00:30, the patient experienced: fever of 101.7, chills/ rigors, nausea, headache, arthralgias, myalgias, severe dizziness. The clinical course was reported as follows: The patient woke up after midnight with a fever of 101.7, chills/ rigors, nausea, headache, arthralgias, myalgias, and severe dizziness. The patient continued to have fevers, and his last temperature of 100.8 (taken about 36 hours post vaccination). The patient also continued to have a significant headache and dizziness. These symptoms had caused the patient to call out sick for 09Dec and tomorrow 10Dec (as reported). The patient underwent lab tests and procedures which included body temperature: 100.8 on an unknown date, body temperature: 101.7 on 09Jan2021. Therapeutic measures were taken as a result of fever of 101.7, chills/ rigors, nausea, headache, arthralgias, myalgias, severe dizziness; which included: 4g paracetamol (TYLENOL) (1g every 6 hours (Q6)) 800 mg ibuprofen, and ondansetron (ZOFRAN). The patient did not have COVID prior to vaccination; and was not tested for COVID post vaccination. The clinical outcome of the events was recovering.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Hypersomnia
Clinical narrative: Severe dizziness with upper and lower extremity numbness causing ER visit; Severe dizziness with upper and lower extremity numbness causing ER visit; Severe fatigue; slept for two days straight; Sore throat; Headache; Neck and shoulder pain; Neck and shoulder pain, Lower extremity joint pain; Kidney pain; This is a spontaneous report from a contactable other health professional.  A 40-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), intramuscularly in the right arm on 29Dec2020 at 10:00 at 40-years-old at a single dose for COVID-19 immunization. : The patient did not get another vaccine in four weeks around the time of the suspect vaccine. The patient's medical history was reported as none. Concomitant medications were not reported. On 07Jan2021 at 05:00, the patient experienced: severe dizziness with upper and lower extremity numbness causing ER visit, severe fatigue, slept for two days straight, sore throat, headache, neck and shoulder pain, lower extremity joint pain, and kidney pain (2 days as reported); and the patient went to the emergency room.  The patient underwent lab tests and procedures which included COVID-19 PCR-MHS: unknown (COVID test type post vaccination=Nasal Swab, COVID test name post vaccination=COVID19 PCR-MHS) on 07Jan2021, Rapid Strep with Reflex: negative (COVID test type post vaccination=other, COVID test name post vaccination=Rapid Strep with Reflex) on 07Jan2021. The clinical outcome of the events was recovered on an unspecified date in Jan2021.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Neck pain, Oropharyngeal pain, Renal pain, SARS-CoV-2 test
Clinical narrative: Severe dizziness with upper and lower extremity numbness causing ER visit; Severe dizziness with upper and lower extremity numbness causing ER visit; Severe fatigue; slept for two days straight; Sore throat; Headache; Neck and shoulder pain; Neck and shoulder pain, Lower extremity joint pain; Kidney pain; This is a spontaneous report from a contactable other health professional.  A 40-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), intramuscularly in the right arm on 29Dec2020 at 10:00 at 40-years-old at a single dose for COVID-19 immunization. : The patient did not get another vaccine in four weeks around the time of the suspect vaccine. The patient's medical history was reported as none. Concomitant medications were not reported. On 07Jan2021 at 05:00, the patient experienced: severe dizziness with upper and lower extremity numbness causing ER visit, severe fatigue, slept for two days straight, sore throat, headache, neck and shoulder pain, lower extremity joint pain, and kidney pain (2 days as reported); and the patient went to the emergency room.  The patient underwent lab tests and procedures which included COVID-19 PCR-MHS: unknown (COVID test type post vaccination=Nasal Swab, COVID test name post vaccination=COVID19 PCR-MHS) on 07Jan2021, Rapid Strep with Reflex: negative (COVID test type post vaccination=other, COVID test name post vaccination=Rapid Strep with Reflex) on 07Jan2021. The clinical outcome of the events was recovered on an unspecified date in Jan2021.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Streptococcus test
Clinical narrative: Severe dizziness with upper and lower extremity numbness causing ER visit; Severe dizziness with upper and lower extremity numbness causing ER visit; Severe fatigue; slept for two days straight; Sore throat; Headache; Neck and shoulder pain; Neck and shoulder pain, Lower extremity joint pain; Kidney pain; This is a spontaneous report from a contactable other health professional.  A 40-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), intramuscularly in the right arm on 29Dec2020 at 10:00 at 40-years-old at a single dose for COVID-19 immunization. : The patient did not get another vaccine in four weeks around the time of the suspect vaccine. The patient's medical history was reported as none. Concomitant medications were not reported. On 07Jan2021 at 05:00, the patient experienced: severe dizziness with upper and lower extremity numbness causing ER visit, severe fatigue, slept for two days straight, sore throat, headache, neck and shoulder pain, lower extremity joint pain, and kidney pain (2 days as reported); and the patient went to the emergency room.  The patient underwent lab tests and procedures which included COVID-19 PCR-MHS: unknown (COVID test type post vaccination=Nasal Swab, COVID test name post vaccination=COVID19 PCR-MHS) on 07Jan2021, Rapid Strep with Reflex: negative (COVID test type post vaccination=other, COVID test name post vaccination=Rapid Strep with Reflex) on 07Jan2021. The clinical outcome of the events was recovered on an unspecified date in Jan2021.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood magnesium normal, Chest X-ray normal, Chest pain, Chills, Computerised tomogram thorax
Clinical narrative: Covid test post vaccination: covid test result= Positive; Covid test post vaccination: covid test result= Positive; Injection pain; Tiredness; severe headache; muscle and joint pain; muscle and joint pain; severe Chills; low fever; nausea; swollen lymph nodes; Difficulty breathing; Chest tightness; Itchy; severe Dizziness; weakness; This is a spontaneous report from a contactable other health professional (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 08Jan2021 07:30 at left arm, at single dose for covid-19 immunization. Medical history included sars-cov-2 test positive from 29Sep2020. Known allergies: unknown. Concomitant medication included atorvastatin, tamsulosin HCL, oxybutynin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Injection pain, tiredness, severe headache, muscle and joint pain, severe Chills, low fever, nausea, swollen lymph nodes, Difficulty breathing, chest tightness, itchy, severe Dizziness and weakness 08Jan2021 07:00 (as reported), resulted in Emergency room. And the patient had covid test: positive on 09Jan2021. Therapeutic measures were taken as a result of Injection pain, tiredness, severe headache, muscle and joint pain, severe Chills, low fever, nausea, swollen lymph nodes, Difficulty breathing, chest tightness, itchy, severe Dizziness and weakness and included treatment with Acetaminophen, Asprin, Iohexol, Ketorolac, NaCl 0.9. the outcome of the events Injection pain, tiredness, severe headache, muscle and joint pain, severe Chills, low fever, nausea, swollen lymph nodes, Difficulty breathing, chest tightness, itchy, severe Dizziness and weakness was recovering. The outcome of the other events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive, suspected LOE and other events  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Fatigue, Full blood count, Gaze palsy, Injection site pain
Clinical narrative: Covid test post vaccination: covid test result= Positive; Covid test post vaccination: covid test result= Positive; Injection pain; Tiredness; severe headache; muscle and joint pain; muscle and joint pain; severe Chills; low fever; nausea; swollen lymph nodes; Difficulty breathing; Chest tightness; Itchy; severe Dizziness; weakness; This is a spontaneous report from a contactable other health professional (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 08Jan2021 07:30 at left arm, at single dose for covid-19 immunization. Medical history included sars-cov-2 test positive from 29Sep2020. Known allergies: unknown. Concomitant medication included atorvastatin, tamsulosin HCL, oxybutynin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Injection pain, tiredness, severe headache, muscle and joint pain, severe Chills, low fever, nausea, swollen lymph nodes, Difficulty breathing, chest tightness, itchy, severe Dizziness and weakness 08Jan2021 07:00 (as reported), resulted in Emergency room. And the patient had covid test: positive on 09Jan2021. Therapeutic measures were taken as a result of Injection pain, tiredness, severe headache, muscle and joint pain, severe Chills, low fever, nausea, swollen lymph nodes, Difficulty breathing, chest tightness, itchy, severe Dizziness and weakness and included treatment with Acetaminophen, Asprin, Iohexol, Ketorolac, NaCl 0.9. the outcome of the events Injection pain, tiredness, severe headache, muscle and joint pain, severe Chills, low fever, nausea, swollen lymph nodes, Difficulty breathing, chest tightness, itchy, severe Dizziness and weakness was recovering. The outcome of the other events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive, suspected LOE and other events  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Lipase normal, Metabolic function test, Myalgia, N-terminal prohormone brain natriuretic peptide
Clinical narrative: Covid test post vaccination: covid test result= Positive; Covid test post vaccination: covid test result= Positive; Injection pain; Tiredness; severe headache; muscle and joint pain; muscle and joint pain; severe Chills; low fever; nausea; swollen lymph nodes; Difficulty breathing; Chest tightness; Itchy; severe Dizziness; weakness; This is a spontaneous report from a contactable other health professional (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 08Jan2021 07:30 at left arm, at single dose for covid-19 immunization. Medical history included sars-cov-2 test positive from 29Sep2020. Known allergies: unknown. Concomitant medication included atorvastatin, tamsulosin HCL, oxybutynin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Injection pain, tiredness, severe headache, muscle and joint pain, severe Chills, low fever, nausea, swollen lymph nodes, Difficulty breathing, chest tightness, itchy, severe Dizziness and weakness 08Jan2021 07:00 (as reported), resulted in Emergency room. And the patient had covid test: positive on 09Jan2021. Therapeutic measures were taken as a result of Injection pain, tiredness, severe headache, muscle and joint pain, severe Chills, low fever, nausea, swollen lymph nodes, Difficulty breathing, chest tightness, itchy, severe Dizziness and weakness and included treatment with Acetaminophen, Asprin, Iohexol, Ketorolac, NaCl 0.9. the outcome of the events Injection pain, tiredness, severe headache, muscle and joint pain, severe Chills, low fever, nausea, swollen lymph nodes, Difficulty breathing, chest tightness, itchy, severe Dizziness and weakness was recovering. The outcome of the other events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive, suspected LOE and other events  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pulmonary pain, Pyrexia, SARS-CoV-2 test, Troponin normal
Clinical narrative: Covid test post vaccination: covid test result= Positive; Covid test post vaccination: covid test result= Positive; Injection pain; Tiredness; severe headache; muscle and joint pain; muscle and joint pain; severe Chills; low fever; nausea; swollen lymph nodes; Difficulty breathing; Chest tightness; Itchy; severe Dizziness; weakness; This is a spontaneous report from a contactable other health professional (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 08Jan2021 07:30 at left arm, at single dose for covid-19 immunization. Medical history included sars-cov-2 test positive from 29Sep2020. Known allergies: unknown. Concomitant medication included atorvastatin, tamsulosin HCL, oxybutynin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Injection pain, tiredness, severe headache, muscle and joint pain, severe Chills, low fever, nausea, swollen lymph nodes, Difficulty breathing, chest tightness, itchy, severe Dizziness and weakness 08Jan2021 07:00 (as reported), resulted in Emergency room. And the patient had covid test: positive on 09Jan2021. Therapeutic measures were taken as a result of Injection pain, tiredness, severe headache, muscle and joint pain, severe Chills, low fever, nausea, swollen lymph nodes, Difficulty breathing, chest tightness, itchy, severe Dizziness and weakness and included treatment with Acetaminophen, Asprin, Iohexol, Ketorolac, NaCl 0.9. the outcome of the events Injection pain, tiredness, severe headache, muscle and joint pain, severe Chills, low fever, nausea, swollen lymph nodes, Difficulty breathing, chest tightness, itchy, severe Dizziness and weakness was recovering. The outcome of the other events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive, suspected LOE and other events  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chest discomfort, Chills, Dizziness
Clinical narrative: Covid test post vaccination: covid test result= Positive; Covid test post vaccination: covid test result= Positive; Injection pain; Tiredness; severe headache; muscle and joint pain; muscle and joint pain; severe Chills; low fever; nausea; swollen lymph nodes; Difficulty breathing; Chest tightness; Itchy; severe Dizziness; weakness; This is a spontaneous report from a contactable other health professional (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 08Jan2021 07:30 at left arm, at single dose for covid-19 immunization. Medical history included sars-cov-2 test positive from 29Sep2020. Known allergies: unknown. Concomitant medication included atorvastatin, tamsulosin HCL, oxybutynin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Injection pain, tiredness, severe headache, muscle and joint pain, severe Chills, low fever, nausea, swollen lymph nodes, Difficulty breathing, chest tightness, itchy, severe Dizziness and weakness 08Jan2021 07:00 (as reported), resulted in Emergency room. And the patient had covid test: positive on 09Jan2021. Therapeutic measures were taken as a result of Injection pain, tiredness, severe headache, muscle and joint pain, severe Chills, low fever, nausea, swollen lymph nodes, Difficulty breathing, chest tightness, itchy, severe Dizziness and weakness and included treatment with Acetaminophen, Asprin, Iohexol, Ketorolac, NaCl 0.9. the outcome of the events Injection pain, tiredness, severe headache, muscle and joint pain, severe Chills, low fever, nausea, swollen lymph nodes, Difficulty breathing, chest tightness, itchy, severe Dizziness and weakness was recovering. The outcome of the other events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive, suspected LOE and other events  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Injection site pain, Lymphadenopathy
Clinical narrative: Covid test post vaccination: covid test result= Positive; Covid test post vaccination: covid test result= Positive; Injection pain; Tiredness; severe headache; muscle and joint pain; muscle and joint pain; severe Chills; low fever; nausea; swollen lymph nodes; Difficulty breathing; Chest tightness; Itchy; severe Dizziness; weakness; This is a spontaneous report from a contactable other health professional (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 08Jan2021 07:30 at left arm, at single dose for covid-19 immunization. Medical history included sars-cov-2 test positive from 29Sep2020. Known allergies: unknown. Concomitant medication included atorvastatin, tamsulosin HCL, oxybutynin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Injection pain, tiredness, severe headache, muscle and joint pain, severe Chills, low fever, nausea, swollen lymph nodes, Difficulty breathing, chest tightness, itchy, severe Dizziness and weakness 08Jan2021 07:00 (as reported), resulted in Emergency room. And the patient had covid test: positive on 09Jan2021. Therapeutic measures were taken as a result of Injection pain, tiredness, severe headache, muscle and joint pain, severe Chills, low fever, nausea, swollen lymph nodes, Difficulty breathing, chest tightness, itchy, severe Dizziness and weakness and included treatment with Acetaminophen, Asprin, Iohexol, Ketorolac, NaCl 0.9. the outcome of the events Injection pain, tiredness, severe headache, muscle and joint pain, severe Chills, low fever, nausea, swollen lymph nodes, Difficulty breathing, chest tightness, itchy, severe Dizziness and weakness was recovering. The outcome of the other events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive, suspected LOE and other events  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Pruritus, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Covid test post vaccination: covid test result= Positive; Covid test post vaccination: covid test result= Positive; Injection pain; Tiredness; severe headache; muscle and joint pain; muscle and joint pain; severe Chills; low fever; nausea; swollen lymph nodes; Difficulty breathing; Chest tightness; Itchy; severe Dizziness; weakness; This is a spontaneous report from a contactable other health professional (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 08Jan2021 07:30 at left arm, at single dose for covid-19 immunization. Medical history included sars-cov-2 test positive from 29Sep2020. Known allergies: unknown. Concomitant medication included atorvastatin, tamsulosin HCL, oxybutynin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Injection pain, tiredness, severe headache, muscle and joint pain, severe Chills, low fever, nausea, swollen lymph nodes, Difficulty breathing, chest tightness, itchy, severe Dizziness and weakness 08Jan2021 07:00 (as reported), resulted in Emergency room. And the patient had covid test: positive on 09Jan2021. Therapeutic measures were taken as a result of Injection pain, tiredness, severe headache, muscle and joint pain, severe Chills, low fever, nausea, swollen lymph nodes, Difficulty breathing, chest tightness, itchy, severe Dizziness and weakness and included treatment with Acetaminophen, Asprin, Iohexol, Ketorolac, NaCl 0.9. the outcome of the events Injection pain, tiredness, severe headache, muscle and joint pain, severe Chills, low fever, nausea, swollen lymph nodes, Difficulty breathing, chest tightness, itchy, severe Dizziness and weakness was recovering. The outcome of the other events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 virus test positive, suspected LOE and other events  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate