chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Head discomfort
Clinical narrative: My ears keep popping as if I am changing altitude. This happens every time I swallow; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0150), via an unspecified route of administration in right arm on 31Mar2021 at 08:45 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity. Concomitant medication included naproxen sodium (ALEVE) from an unknown date for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not tested for COVID-19 since the vaccination. On 31Mar2021, at 10:15, the patient experienced ear popping sensation, as if he was changing altitude which happened every time he swallowed. No treatment was received for the adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of ear popping sensation was not recovered at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort
Clinical narrative: My ears keep popping as if I am changing altitude. This happens every time I swallow; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0150), via an unspecified route of administration in right arm on 31Mar2021 at 08:45 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity. Concomitant medication included naproxen sodium (ALEVE) from an unknown date for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not tested for COVID-19 since the vaccination. On 31Mar2021, at 10:15, the patient experienced ear popping sensation, as if he was changing altitude which happened every time he swallowed. No treatment was received for the adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of ear popping sensation was not recovered at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 30Mar2021 at 15:00 (at the age of 48-year-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies to medications, food, or other products.  Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 09Mar2021 at 14:30 (at the age of 48-year-old) as a single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received any other vaccines within four weeks, prior to the vaccination.  On 31Mar2021 at 05:00, the patient experienced fever 100.1 (units unspecified), chills, achiness, and exhaustion starting around 12-18 hours after the second dose was administered. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events fever 100.1 (units unspecified), chills, achiness and exhaustion. The clinical outcomes of the events fever 100.1, chills, achiness, and exhaustion were resolving at the time of report. No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 30Mar2021 at 15:00 (at the age of 48-year-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient had no known allergies to medications, food, or other products.  Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 09Mar2021 at 14:30 (at the age of 48-year-old) as a single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received any other vaccines within four weeks, prior to the vaccination.  On 31Mar2021 at 05:00, the patient experienced fever 100.1 (units unspecified), chills, achiness, and exhaustion starting around 12-18 hours after the second dose was administered. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events fever 100.1 (units unspecified), chills, achiness and exhaustion. The clinical outcomes of the events fever 100.1, chills, achiness, and exhaustion were resolving at the time of report. No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased
Clinical narrative: Uncontrolled, elevated heart rate before sleep; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the left arm on 29Mar2021 at 09:45 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient's allergies were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. On 30Mar2021 at 23:30, after 1.5 days of vaccination, the patient experienced uncontrolled, elevated heart rate before sleep. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measure was taken as a result of adverse event.  The clinical outcome of the event was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: indigestion; hoarseness in her voice; tightness in her throat; throat felt swollen initially; everything felt inflamed; has a potential allergy to PEG.; lump in throat; stomach swelled up; burping; This is a spontaneous report from a Pfizer-sponsored program via contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2 solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 31Jan2021 as DOSE 1, SINGLE for covid-19 immunisation.The patient medical history and concomitant medication(s) was not reported. She received First Pfizer vaccine may not be able to get the second shot because within five min had major lump in throat-stomach swelled up and burping symptoms lasted over a month. On 31Jan2021, The patient experienced lump in throat, stomach swelled up, burping, indigestion, hoarseness in her voice, tightness in her throat on and off for a month, everything felt inflamed, Within 5 minutes she developed a lump in her throat that wouldn't go away for over a month. Her throat felt swollen initially and indigestion felt like she ate a whole bowl of chili, she had stomach swelling and everything felt inflamed. She was given Benadryl and stayed at the site for an hour and has a potential allergy to peg. Her Dr suggested that she does not receive the second vaccine.The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Dyspepsia, Dysphonia, Eructation, Hypersensitivity
Clinical narrative: indigestion; hoarseness in her voice; tightness in her throat; throat felt swollen initially; everything felt inflamed; has a potential allergy to PEG.; lump in throat; stomach swelled up; burping; This is a spontaneous report from a Pfizer-sponsored program via contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2 solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 31Jan2021 as DOSE 1, SINGLE for covid-19 immunisation.The patient medical history and concomitant medication(s) was not reported. She received First Pfizer vaccine may not be able to get the second shot because within five min had major lump in throat-stomach swelled up and burping symptoms lasted over a month. On 31Jan2021, The patient experienced lump in throat, stomach swelled up, burping, indigestion, hoarseness in her voice, tightness in her throat on and off for a month, everything felt inflamed, Within 5 minutes she developed a lump in her throat that wouldn't go away for over a month. Her throat felt swollen initially and indigestion felt like she ate a whole bowl of chili, she had stomach swelling and everything felt inflamed. She was given Benadryl and stayed at the site for an hour and has a potential allergy to peg. Her Dr suggested that she does not receive the second vaccine.The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Oropharyngeal discomfort, Pharyngeal swelling, Throat tightness
Clinical narrative: indigestion; hoarseness in her voice; tightness in her throat; throat felt swollen initially; everything felt inflamed; has a potential allergy to PEG.; lump in throat; stomach swelled up; burping; This is a spontaneous report from a Pfizer-sponsored program via contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2 solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 31Jan2021 as DOSE 1, SINGLE for covid-19 immunisation.The patient medical history and concomitant medication(s) was not reported. She received First Pfizer vaccine may not be able to get the second shot because within five min had major lump in throat-stomach swelled up and burping symptoms lasted over a month. On 31Jan2021, The patient experienced lump in throat, stomach swelled up, burping, indigestion, hoarseness in her voice, tightness in her throat on and off for a month, everything felt inflamed, Within 5 minutes she developed a lump in her throat that wouldn't go away for over a month. Her throat felt swollen initially and indigestion felt like she ate a whole bowl of chili, she had stomach swelling and everything felt inflamed. She was given Benadryl and stayed at the site for an hour and has a potential allergy to peg. Her Dr suggested that she does not receive the second vaccine.The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash all over body.; Little red dots slightly raised and itchy. Most concentrated on arms, stomach, and chest.; Little red dots slightly raised and itchy. Most concentrated on arms, stomach and chest.; Little red dots slightly raised and itchy. Most concentrated on arms, stomach and chest.; This is a spontaneous report from a contactable healthcare professional, the patient. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot Number: ER8733), via an unspecified route of administration in the arm left on 27Mar2021 at 13:15 (at the age of 21-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and proteinuria. Concomitant medications included duloxetine hydrochloride (CYMBALTA), lisinopril (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN) and sulfa antibiotic. The patient was allergic to VICODIN and experienced rash. 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 vaccine within four weeks prior to the vaccination. On 30Mar2021, the patient experienced rash all over the body. Little red dots, slightly raised and itchy. Most concentrated-on arms stomach, and chest. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of rash all over, red rash, raised rash and itchy rash which included treatment with XERTEC and PEPCID. The clinical outcomes of the events rash all over, red rash, raised rash and itchy rash were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Rash all over body.; Little red dots slightly raised and itchy. Most concentrated on arms, stomach, and chest.; Little red dots slightly raised and itchy. Most concentrated on arms, stomach and chest.; Little red dots slightly raised and itchy. Most concentrated on arms, stomach and chest.; This is a spontaneous report from a contactable healthcare professional, the patient. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot Number: ER8733), via an unspecified route of administration in the arm left on 27Mar2021 at 13:15 (at the age of 21-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and proteinuria. Concomitant medications included duloxetine hydrochloride (CYMBALTA), lisinopril (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN) and sulfa antibiotic. The patient was allergic to VICODIN and experienced rash. 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 vaccine within four weeks prior to the vaccination. On 30Mar2021, the patient experienced rash all over the body. Little red dots, slightly raised and itchy. Most concentrated-on arms stomach, and chest. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of rash all over, red rash, raised rash and itchy rash which included treatment with XERTEC and PEPCID. The clinical outcomes of the events rash all over, red rash, raised rash and itchy rash were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: Sudden onset of tinnitus; diminished hearing left ear; This is a spontaneous report from a contactable nurse, the patient. A 64-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EL1284) via an unspecified route of administration in the right arm on 06Jan2021 at 10:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer from 2006. The patient had no known allergies to medications, food or other products. Concomitant medications included exemestane (AROMASIN), vit-d (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN); all from unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EH9899) via an unspecified route of administration in the right arm on 17Dec20220 at 10:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 11Jan2021 at 20.00, the patient experienced sudden onset of tinnitus and then diminished hearing of left ear. Therapeutic measure was taken as a result of reported events and included treatment with medrol dose pack. The adverse events resulted in a visit to the doctors or other healthcare professional office/clinic visit. The clinical outcome of the events tinnitus and diminished hearing were not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Conjunctivitis, Diplopia, Dizziness, Eye discharge, Eye haemorrhage
Clinical narrative: Nausea; headache; dizziness; fatigue; severe bloodshot eyes with burst blood vessels in eyes; heavy discharge from eyes; Blurry vision; Progressively worsened until approximately 9 hrs after injection; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non pregnant female patient first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: Er8727, Expiration Date was not reported), via an unspecified route of administration, administered in right arm on 25Mar2021 11:45 (at the age of 44-years-old) as dose 1, single for covid-19 immunization. The patient medical history included asthma, seasonal allergies. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested for covid-19 since the vaccination. It was reported that on 25Mar2021 12:30 PM, the patient experienced nausea, headache, dizziness, fatigue within 30 minutes to 1 hour after shot. Several hours later severe bloodshot eyes with burst blood vessels in eyes, heavy discharge from eyes. Blurry vision. Progressively worsened until approximately 9 hrs after injection took zyrtec and symptoms began to improve. Also took benadryl several times. Eyes still very bad approximately 24hrs after shot (time of this writing). Treatment was received for AE (Adverse event). Prescription eye drops (but unable to pick up) was received as treatment. Therapeutic measures were taken as a result of nausea, headache, dizziness, fatigue, severe bloodshot eyes with burst blood vessels in eyes, heavy discharge from eyes, blurry vision, progressively worsened until approximately 9 hrs after injection. The reporter assessed the seriousness as serious. The outcome of the events nausea, headache, dizziness, fatigue, Progressively worsened until approximately 9 hrs after injection was resolving and outcome of events severe bloodshot eyes with burst blood vessels in eyes, heavy discharge from eyes, blurry vision was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Headache, Nausea, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Nausea; headache; dizziness; fatigue; severe bloodshot eyes with burst blood vessels in eyes; heavy discharge from eyes; Blurry vision; Progressively worsened until approximately 9 hrs after injection; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non pregnant female patient first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: Er8727, Expiration Date was not reported), via an unspecified route of administration, administered in right arm on 25Mar2021 11:45 (at the age of 44-years-old) as dose 1, single for covid-19 immunization. The patient medical history included asthma, seasonal allergies. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested for covid-19 since the vaccination. It was reported that on 25Mar2021 12:30 PM, the patient experienced nausea, headache, dizziness, fatigue within 30 minutes to 1 hour after shot. Several hours later severe bloodshot eyes with burst blood vessels in eyes, heavy discharge from eyes. Blurry vision. Progressively worsened until approximately 9 hrs after injection took zyrtec and symptoms began to improve. Also took benadryl several times. Eyes still very bad approximately 24hrs after shot (time of this writing). Treatment was received for AE (Adverse event). Prescription eye drops (but unable to pick up) was received as treatment. Therapeutic measures were taken as a result of nausea, headache, dizziness, fatigue, severe bloodshot eyes with burst blood vessels in eyes, heavy discharge from eyes, blurry vision, progressively worsened until approximately 9 hrs after injection. The reporter assessed the seriousness as serious. The outcome of the events nausea, headache, dizziness, fatigue, Progressively worsened until approximately 9 hrs after injection was resolving and outcome of events severe bloodshot eyes with burst blood vessels in eyes, heavy discharge from eyes, blurry vision was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Nausea; headache; dizziness; fatigue; severe bloodshot eyes with burst blood vessels in eyes; heavy discharge from eyes; Blurry vision; Progressively worsened until approximately 9 hrs after injection; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non pregnant female patient first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: Er8727, Expiration Date was not reported), via an unspecified route of administration, administered in right arm on 25Mar2021 11:45 (at the age of 44-years-old) as dose 1, single for covid-19 immunization. The patient medical history included asthma, seasonal allergies. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested for covid-19 since the vaccination. It was reported that on 25Mar2021 12:30 PM, the patient experienced nausea, headache, dizziness, fatigue within 30 minutes to 1 hour after shot. Several hours later severe bloodshot eyes with burst blood vessels in eyes, heavy discharge from eyes. Blurry vision. Progressively worsened until approximately 9 hrs after injection took zyrtec and symptoms began to improve. Also took benadryl several times. Eyes still very bad approximately 24hrs after shot (time of this writing). Treatment was received for AE (Adverse event). Prescription eye drops (but unable to pick up) was received as treatment. Therapeutic measures were taken as a result of nausea, headache, dizziness, fatigue, severe bloodshot eyes with burst blood vessels in eyes, heavy discharge from eyes, blurry vision, progressively worsened until approximately 9 hrs after injection. The reporter assessed the seriousness as serious. The outcome of the events nausea, headache, dizziness, fatigue, Progressively worsened until approximately 9 hrs after injection was resolving and outcome of events severe bloodshot eyes with burst blood vessels in eyes, heavy discharge from eyes, blurry vision was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dizziness, Eye discharge, Fatigue, Headache
Clinical narrative: Nausea; headache; dizziness; fatigue; severe bloodshot eyes with burst blood vessels in eyes; heavy discharge from eyes; Blurry vision; Progressively worsened until approximately 9 hrs after injection; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non pregnant female patient first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: Er8727, Expiration Date was not reported), via an unspecified route of administration, administered in right arm on 25Mar2021 11:45 (at the age of 44-years-old) as dose 1, single for covid-19 immunization. The patient medical history included asthma, seasonal allergies. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested for covid-19 since the vaccination. It was reported that on 25Mar2021 12:30 PM, the patient experienced nausea, headache, dizziness, fatigue within 30 minutes to 1 hour after shot. Several hours later severe bloodshot eyes with burst blood vessels in eyes, heavy discharge from eyes. Blurry vision. Progressively worsened until approximately 9 hrs after injection took zyrtec and symptoms began to improve. Also took benadryl several times. Eyes still very bad approximately 24hrs after shot (time of this writing). Treatment was received for AE (Adverse event). Prescription eye drops (but unable to pick up) was received as treatment. Therapeutic measures were taken as a result of nausea, headache, dizziness, fatigue, severe bloodshot eyes with burst blood vessels in eyes, heavy discharge from eyes, blurry vision, progressively worsened until approximately 9 hrs after injection. The reporter assessed the seriousness as serious. The outcome of the events nausea, headache, dizziness, fatigue, Progressively worsened until approximately 9 hrs after injection was resolving and outcome of events severe bloodshot eyes with burst blood vessels in eyes, heavy discharge from eyes, blurry vision was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Ocular hyperaemia, Vision blurred
Clinical narrative: Nausea; headache; dizziness; fatigue; severe bloodshot eyes with burst blood vessels in eyes; heavy discharge from eyes; Blurry vision; Progressively worsened until approximately 9 hrs after injection; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non pregnant female patient first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: Er8727, Expiration Date was not reported), via an unspecified route of administration, administered in right arm on 25Mar2021 11:45 (at the age of 44-years-old) as dose 1, single for covid-19 immunization. The patient medical history included asthma, seasonal allergies. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested for covid-19 since the vaccination. It was reported that on 25Mar2021 12:30 PM, the patient experienced nausea, headache, dizziness, fatigue within 30 minutes to 1 hour after shot. Several hours later severe bloodshot eyes with burst blood vessels in eyes, heavy discharge from eyes. Blurry vision. Progressively worsened until approximately 9 hrs after injection took zyrtec and symptoms began to improve. Also took benadryl several times. Eyes still very bad approximately 24hrs after shot (time of this writing). Treatment was received for AE (Adverse event). Prescription eye drops (but unable to pick up) was received as treatment. Therapeutic measures were taken as a result of nausea, headache, dizziness, fatigue, severe bloodshot eyes with burst blood vessels in eyes, heavy discharge from eyes, blurry vision, progressively worsened until approximately 9 hrs after injection. The reporter assessed the seriousness as serious. The outcome of the events nausea, headache, dizziness, fatigue, Progressively worsened until approximately 9 hrs after injection was resolving and outcome of events severe bloodshot eyes with burst blood vessels in eyes, heavy discharge from eyes, blurry vision was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Dizziness, Headache, Injection site pain, Pain
Clinical narrative: Pain at injection site; extreme back and body aches; headache; dizziness; low grade fever; Body aches; This is a spontaneous report from a contactable other health care professional. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733), via intramuscular route of administration in the right arm on 30Mar2021 at 15:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were included levothyroxine sodium 12mcg (MANUFACTURER UNKNOWN) taken from unknown date for unknown indication; duloxetine hydrochloride 20mg (DULOXETINE HCL), estradiol; estriol (BIEST) 4(80/20) unknown units, progesterone (Prog 80) (MANUFACTURER UNKNOWN) and prasterone (DHEA) 8mg/g (MANUFACTURER UNKNOWN) taken as hormone replacement therapy from an unknown date and multi vitamin (unspecified) taken from unknown date for unknown indication. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021, at 03:00 the patient had pain at injection site (vaccination site pain), extreme back and body aches, headache, dizziness, low grade fever. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of pain at injection site, extreme back and body aches, headache, dizziness, low grade fever was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Pain at injection site; extreme back and body aches; headache; dizziness; low grade fever; Body aches; This is a spontaneous report from a contactable other health care professional. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733), via intramuscular route of administration in the right arm on 30Mar2021 at 15:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were included levothyroxine sodium 12mcg (MANUFACTURER UNKNOWN) taken from unknown date for unknown indication; duloxetine hydrochloride 20mg (DULOXETINE HCL), estradiol; estriol (BIEST) 4(80/20) unknown units, progesterone (Prog 80) (MANUFACTURER UNKNOWN) and prasterone (DHEA) 8mg/g (MANUFACTURER UNKNOWN) taken as hormone replacement therapy from an unknown date and multi vitamin (unspecified) taken from unknown date for unknown indication. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021, at 03:00 the patient had pain at injection site (vaccination site pain), extreme back and body aches, headache, dizziness, low grade fever. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of pain at injection site, extreme back and body aches, headache, dizziness, low grade fever was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Pain at injection site; extreme back and body aches; headache; dizziness; low grade fever; Body aches; This is a spontaneous report from a contactable other health care professional. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733), via intramuscular route of administration in the right arm on 30Mar2021 at 15:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were included levothyroxine sodium 12mcg (MANUFACTURER UNKNOWN) taken from unknown date for unknown indication; duloxetine hydrochloride 20mg (DULOXETINE HCL), estradiol; estriol (BIEST) 4(80/20) unknown units, progesterone (Prog 80) (MANUFACTURER UNKNOWN) and prasterone (DHEA) 8mg/g (MANUFACTURER UNKNOWN) taken as hormone replacement therapy from an unknown date and multi vitamin (unspecified) taken from unknown date for unknown indication. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021, at 03:00 the patient had pain at injection site (vaccination site pain), extreme back and body aches, headache, dizziness, low grade fever. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of pain at injection site, extreme back and body aches, headache, dizziness, low grade fever was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; extreme back and body aches; headache; dizziness; low grade fever; Body aches; This is a spontaneous report from a contactable other health care professional. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733), via intramuscular route of administration in the right arm on 30Mar2021 at 15:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were included levothyroxine sodium 12mcg (MANUFACTURER UNKNOWN) taken from unknown date for unknown indication; duloxetine hydrochloride 20mg (DULOXETINE HCL), estradiol; estriol (BIEST) 4(80/20) unknown units, progesterone (Prog 80) (MANUFACTURER UNKNOWN) and prasterone (DHEA) 8mg/g (MANUFACTURER UNKNOWN) taken as hormone replacement therapy from an unknown date and multi vitamin (unspecified) taken from unknown date for unknown indication. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021, at 03:00 the patient had pain at injection site (vaccination site pain), extreme back and body aches, headache, dizziness, low grade fever. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of pain at injection site, extreme back and body aches, headache, dizziness, low grade fever was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Feeling hot, Rash erythematous, Urticaria
Clinical narrative: Full body rash, legs, arms, stomach and back.; shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8732) via an unspecified route of administration in the left arm on 25Mar2021 at 14:30 (at the age of vaccination 40-years-old) as a single dose for COVID-19 immunisation. The patient medical history included asthma, GERD, gastritis. The patient previously had drug allergy while taking amoxicillin (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and advil (MANUFACTURER UNKNOWN). Concomitant medications included famotidine (PEPCID), paracetamol (TYLENOL), vitamin D (MANUFACTURER UNKNOWN), prenatal vitamins (MANUFACTURER UNKNOWN) since an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 17:30, the patient experienced full body rash on legs, arms, stomach and back and shortness of breath. The patient had received BENADRYL (MANUFACTURER UNKNOWN), CLARITIN (MANUFACTURER UNKNOWN) as treatment for the events. The adverse events resulted in emergency room/department or urgent care. The clinical outcome for the events rash and shortness of breath were recovered with lasting effects at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Rash
Clinical narrative: Full body rash, legs, arms, stomach and back.; shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8732) via an unspecified route of administration in the left arm on 25Mar2021 at 14:30 (at the age of vaccination 40-years-old) as a single dose for COVID-19 immunisation. The patient medical history included asthma, GERD, gastritis. The patient previously had drug allergy while taking amoxicillin (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and advil (MANUFACTURER UNKNOWN). Concomitant medications included famotidine (PEPCID), paracetamol (TYLENOL), vitamin D (MANUFACTURER UNKNOWN), prenatal vitamins (MANUFACTURER UNKNOWN) since an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 17:30, the patient experienced full body rash on legs, arms, stomach and back and shortness of breath. The patient had received BENADRYL (MANUFACTURER UNKNOWN), CLARITIN (MANUFACTURER UNKNOWN) as treatment for the events. The adverse events resulted in emergency room/department or urgent care. The clinical outcome for the events rash and shortness of breath were recovered with lasting effects at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dehydration, Emotional disorder, Fatigue, Headache, Intermenstrual bleeding
Clinical narrative: Also had breakthrough bleeding.; Feeling like PMS but 1.5 weeks earlyfor that.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: EN6208), via an unspecified route of administration in the left arm on 11Mar2021 at 11:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic asthma. The concomitant medications included claritin (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL) received within 2 weeks of vaccination. The patient was known allergic to penicillin. 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 was not tested for COVID-19. On 18Mar2021 at 12:00, the patient experienced premenstrual syndrome (PMS) but 1.5 weeks early for that and also had breakthrough bleeding. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of feeling like premenstrual syndrome (PMS) and breakthrough bleeding were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Premenstrual syndrome, Urinary tract infection
Clinical narrative: Also had breakthrough bleeding.; Feeling like PMS but 1.5 weeks earlyfor that.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: EN6208), via an unspecified route of administration in the left arm on 11Mar2021 at 11:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic asthma. The concomitant medications included claritin (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL) received within 2 weeks of vaccination. The patient was known allergic to penicillin. 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 was not tested for COVID-19. On 18Mar2021 at 12:00, the patient experienced premenstrual syndrome (PMS) but 1.5 weeks early for that and also had breakthrough bleeding. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of feeling like premenstrual syndrome (PMS) and breakthrough bleeding were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intermenstrual bleeding, Premenstrual syndrome
Clinical narrative: Also had breakthrough bleeding.; Feeling like PMS but 1.5 weeks earlyfor that.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: EN6208), via an unspecified route of administration in the left arm on 11Mar2021 at 11:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic asthma. The concomitant medications included claritin (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL) received within 2 weeks of vaccination. The patient was known allergic to penicillin. 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 was not tested for COVID-19. On 18Mar2021 at 12:00, the patient experienced premenstrual syndrome (PMS) but 1.5 weeks early for that and also had breakthrough bleeding. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of feeling like premenstrual syndrome (PMS) and breakthrough bleeding were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hemiparesis, Hypoaesthesia, Mobility decreased, Sensory disturbance
Clinical narrative: Numbness and tingling moved up my left arm into the left side of my neck and face. The left side of my face was numb for over an hour.; Tingling moved up my left arm into the left side of my neck and face.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 29Mar2021 at 14:45 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient previously received erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested with COVID-19. On 29Mar2021 at 14:45 the patient experienced numbness and tingling which moved up her left arm into the left side of neck and face. The left side of face was numb over an hour. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of numbness and tingling was recovered on 29Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling moved up my left arm into the left side of my neck and face. The left side of my face was numb for over an hour.; Tingling moved up my left arm into the left side of my neck and face.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 29Mar2021 at 14:45 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient previously received erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested with COVID-19. On 29Mar2021 at 14:45 the patient experienced numbness and tingling which moved up her left arm into the left side of neck and face. The left side of face was numb over an hour. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of numbness and tingling was recovered on 29Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.