chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear discomfort, Fatigue, Hypoacusis, Inappropriate schedule of product administration
Clinical narrative: Stuffy ears; muffled hearing; Aches; Chills; Tiredness; Inappropriate schedule of vaccine administered; This is a spontaneous report from a non- contactable consumer, the patient. A 43-year-old adult non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 8Feb2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the left arm on 25Jan2021 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 8Feb2021 at 19:00, the patient experienced stuffy ears, muffled hearing, aches, chills, tiredness. The vaccine was administered outside the range of 19-42 days after the first dose The patient did not receive any treatment for 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 for stuffy ears, muffled hearing, aches, chills, tiredness was recovered on an unknown date at the time of this report.   No follow up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Stuffy ears; muffled hearing; Aches; Chills; Tiredness; Inappropriate schedule of vaccine administered; This is a spontaneous report from a non- contactable consumer, the patient. A 43-year-old adult non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 8Feb2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the left arm on 25Jan2021 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 8Feb2021 at 19:00, the patient experienced stuffy ears, muffled hearing, aches, chills, tiredness. The vaccine was administered outside the range of 19-42 days after the first dose The patient did not receive any treatment for 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 for stuffy ears, muffled hearing, aches, chills, tiredness was recovered on an unknown date at the time of this report.   No follow up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Musculoskeletal stiffness, Nausea
Clinical narrative: Back ache; Finger stiffness; Headache; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; lot number: Ep6955) via an unspecified route of administration in the left arm on 27Mar2021 at 09:00 as a single dose (at the age of 61-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; lot number: UNKNOWN) via an unspecified route of administration as a single dose for COVID-19 immunisation. 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 27Mar2021 at 17:30, the patient experienced back ache, finger stiffness, headache, nausea, fatigue. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit. The patient received treatment from a chiropractor for headache. The clinical outcomes of back ache, finger stiffness, headache, nausea, fatigue was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash below injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in the left arm on 05Mar2021 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergies to medications, food, or other products. The patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. On 18Mar2021 (13 days after shot), the patient experienced rash below injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event rash below injection site. The clinical outcome of rash below injection site was resolved in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: Body aches; 100.2 temp; Nausea; Fatigue; Pain on injection site; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration on her left arm on 28Mar2021 (at the age of vaccination 41-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no concomitant medication reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since having the vaccine. On 28Mar2021 at 18:30, the patient experienced fever of 100.2 temperature, body aches, nausea, fatigue and pain on injection site. The patient received treatment care at home since day 1. The adverse events did not result in hospital or doctor visit. The clinical outcome of the events fever, body aches, nausea, fatigue and pain on injection site was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Body aches; 100.2 temp; Nausea; Fatigue; Pain on injection site; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration on her left arm on 28Mar2021 (at the age of vaccination 41-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no concomitant medication reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since having the vaccine. On 28Mar2021 at 18:30, the patient experienced fever of 100.2 temperature, body aches, nausea, fatigue and pain on injection site. The patient received treatment care at home since day 1. The adverse events did not result in hospital or doctor visit. The clinical outcome of the events fever, body aches, nausea, fatigue and pain on injection site was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Lymph node pain, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: lymph node in the arm pit where got my shot got sore; lymph node in the arm pit where got my shot got swollen; pain and soreness moved to my right breast; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old adult female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208), via an unspecified route of administration in the right arm on 17Mar2021 at 12:00 (at the age of 21-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history and no allergies to medications, food, or other products. Concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 19Mar2021 at 12:00, the patient experienced sore and swollen lymph node in the arm pit where she got her shot after days receiving the vaccine. The patient also reported that the pain and soreness moved to her right breast after the lymph node pain subsided. The patient underwent lab tests and procedures post vaccination, which included COVID-19 virus test on 22Mar2021, and the result was found to be negative. The event 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. The clinical outcome of the events lymph node pain and lymphadenopathy was recovering and the clinical outcome of the event breast pain was unknown.   No follow-up attempts are needed. No further information is expected. .
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives/rash (looks similar to shingles) on right arm, and right torso (back and chest); Body was itching for a week.; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an unspecified route of administration in the left arm on 12Mar2021 at 11:30 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient did not take any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received morphine (MANUFACTURER UNKNOWN) on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On unspecified date in Mar2021, the patient's body was itching for a week after the vaccine and a week later on 19Mar2021, broke out into hives/rash (looked similar to shingles) on right arm, and right torso (back and chest). The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the events. The clinical outcome of the events hives and itching was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Vision blurred
Clinical narrative: Blurry Vision; Headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 63-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via unspecified route of administration in the right arm at 12:45 on 23Mar2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and GERD. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), lansoprazole (PREVACID), ursodeoxycholic acid (URSO), Salmeterol (SEREVENT), beclomethasone dipropionate (QVAR), Diltiazem hydrochloride (DIL). The patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), via unspecified route of administration at 14:30 in right arm on 03Mar2021 (at the age of 63-years-old) as a single dose for Covid-19 immunisation. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not be tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Mar2021 at 14:45, patient experienced headache, chills, blurry vision. The adverse events did not result in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the event headache, chills, blurry vision was recovered at the time of this report.   No follow-up attempts are needed; No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: pricking sensation from injection site radiating to finger; Left arm has tingling; numbness; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 49-year-old) as a single dose for COVID-19 immunisation and also received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 28Mar2021 at 13:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food or other products. 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 four weeks prior to the COVID-19 vaccination. The concomitant medications included vitamin D (MANUFACTURER UNKNOWN) and ascorbic acid (VITAMIN C) both taken for an unknown indication from an unknown start date and unknown if ongoing. On 08Mar2021 at 16:00, the patient experienced left arm had tingling, numbness, pricking sensation from injection site radiating to fingers. Occurred intermittently after first shot but increased duration after second shot. The patient didn't 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 the events left arm had tingling, numbness, pricking sensation from injection site radiating to fingers was not recovered  at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Headache, Malaise
Clinical narrative: I am very weak and stillhave some nausea and abdominaldiscomfort.; I am very weak and stillhave some nausea and abdominaldiscomfort.; I am very weak and stillhave some nausea and abdominaldiscomfort.; Upon waking the next morning,I had a fever of 101.8, very badheadache and body aches. My feverwas as high as 103 and continued fora total of approximately 60 hours.; I started to feel unwell; My first symptoms were headache and bodyaches along with diarrhea.; My firstsymptoms were headache and bodyaches along with diarrhea.; My first symptoms were headache and bodyaches along with diarrhea.; I did not sleep well that night and woke severaltimes.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E P 6955) via an unspecified route of administration in the right arm on 25Mar2021 at 09:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included recent emergency appendectomy on 19Feb2021 and meningioma. Concomitant medications received within 2 weeks of vaccination included escitalopram oxalate (LEXAPRO), mirtazapine (REMERON) and alprazolam (XANAX). Allergies to medications included penicillin and quinolones (quinolones caused throat tightness). The patient did not get any other vaccines within 4 weeks of COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E N 6206) via an unspecified route of administration in the right arm on 04Mar2021 at 08:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 25Mar2021, at 17:00, 8 hours after vaccination, the patient experienced feeling unwell, headache, body ache and diarrhoea. The diarrhoea was constant with 10 to 15 bouts a day, lasting for 72 hours. On the same day, she experienced sleep unwell that night and woke several times. On 26Mar2021, the patient experienced fever of 101.8 and later her fever was as high as 103 and continued for a total of approximately 60 hours. 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. Treatment received for fever included extra strength tylenol, 1000 mg, every 6 hours and for diarrhoea included pepto bismol. The clinical outcome of the events feeling unwell, headache, body ache, diarrhoea, sleep unwell, fever, weakness, nausea and abdominal discomfort was resolving.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Poor quality sleep, Pyrexia
Clinical narrative: I am very weak and stillhave some nausea and abdominaldiscomfort.; I am very weak and stillhave some nausea and abdominaldiscomfort.; I am very weak and stillhave some nausea and abdominaldiscomfort.; Upon waking the next morning,I had a fever of 101.8, very badheadache and body aches. My feverwas as high as 103 and continued fora total of approximately 60 hours.; I started to feel unwell; My first symptoms were headache and bodyaches along with diarrhea.; My firstsymptoms were headache and bodyaches along with diarrhea.; My first symptoms were headache and bodyaches along with diarrhea.; I did not sleep well that night and woke severaltimes.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E P 6955) via an unspecified route of administration in the right arm on 25Mar2021 at 09:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included recent emergency appendectomy on 19Feb2021 and meningioma. Concomitant medications received within 2 weeks of vaccination included escitalopram oxalate (LEXAPRO), mirtazapine (REMERON) and alprazolam (XANAX). Allergies to medications included penicillin and quinolones (quinolones caused throat tightness). The patient did not get any other vaccines within 4 weeks of COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E N 6206) via an unspecified route of administration in the right arm on 04Mar2021 at 08:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 25Mar2021, at 17:00, 8 hours after vaccination, the patient experienced feeling unwell, headache, body ache and diarrhoea. The diarrhoea was constant with 10 to 15 bouts a day, lasting for 72 hours. On the same day, she experienced sleep unwell that night and woke several times. On 26Mar2021, the patient experienced fever of 101.8 and later her fever was as high as 103 and continued for a total of approximately 60 hours. 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. Treatment received for fever included extra strength tylenol, 1000 mg, every 6 hours and for diarrhoea included pepto bismol. The clinical outcome of the events feeling unwell, headache, body ache, diarrhoea, sleep unwell, fever, weakness, nausea and abdominal discomfort was resolving.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Light head ache.; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) in the left arm on 26Mar2021(at the age of 53-years-old) at 19:15 as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID-19 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 26Mar2021 at 21:00, the patient experienced, light head ache and sore arm. Therapeutic measures were not taken as a result of headache and sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The The clinical outcome of the event light headache and sore arm was recovered on 27Mar2021.    No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injection site; This is a spontaneous report from a non-contactable consumer, the patient. An 18-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in left arm on 29Mar2021 at 11:30 as a single dose (at the age of 18-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Mar2021 at 16:00, the patient had sore arm at injection site (vaccination site pain). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event sore arm at injection site. The clinical outcome of vaccination site pain was unknown at the time of report.  No follow-up attempts are needed; No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the left arm on 26Mar2021 at 12:45 (at the age of 50-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient had no allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6199) via an unspecified route of administration in the left arm on 05Mar2021 at 13:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) for unknown indication since an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 01:00, the patient experienced 18-hour fever (101.00 degrees), headache and muscle aches. Lab data on 27Mar2021 included body temperature (reported as fever 101.00 degree) and result was 101.00 degree at 01:00. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatments were not taken for the adverse events. The clinical outcome of the event fever was recovered on 27Mar2021 at 19:00, while that of the events headache and muscle ache were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: Severe eye floaters; This is a spontaneous report from contactable consumer, the patient. A 63-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: er8733); via unspecified route of administration in left arm on 26Mar2021 at 09:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 and was not tested for COVID-19, since the vaccination. The patient did not receive any other vaccine within four weeks of vaccination. On 26Mar2021 at 10:45, the patient experienced severe eye floaters. The adverse event result in consultation to doctor or other healthcare professional office/clinic visit. It was unknown, if the patient received any treatment for the reported events. The clinical outcome of the event severe eye floaters was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Lymphadenopathy, Pyrexia
Clinical narrative: swollen lymph nodes underarm right side; Chills; Head ache; Low grade fever; sleepy; Light headed; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 27Mar2021 at 13:45 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included Multiple Sclerosis (MS) and high blood pressure. The patient was allergic to medications, food and other products. The patient received an unspecified concomitant medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not tested for COVID-19. On 27Mar2021, the patient experienced chills, headache, low grade fever, sleepy and light headed. On 29Mar2021, the patient experienced swollen lymph nodes under arm on the right side. The event neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events chills, headache, low grade fever, sleepy, light headed and swollen lymph nodes under arm on the right side was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: swollen lymph nodes underarm right side; Chills; Head ache; Low grade fever; sleepy; Light headed; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 27Mar2021 at 13:45 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included Multiple Sclerosis (MS) and high blood pressure. The patient was allergic to medications, food and other products. The patient received an unspecified concomitant medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not tested for COVID-19. On 27Mar2021, the patient experienced chills, headache, low grade fever, sleepy and light headed. On 29Mar2021, the patient experienced swollen lymph nodes under arm on the right side. The event neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events chills, headache, low grade fever, sleepy, light headed and swollen lymph nodes under arm on the right side was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, SARS-CoV-2 test
Clinical narrative: Right lower leg cramps; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EM9810) in the left arm on 09Feb2021 at 16:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had a known allergy to codeine. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3249) in the left arm on 19Jan2021 at 14:45 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  On 10Mar2021 at 13:00, the patient experienced right lower leg cramps. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of lower leg cramps. On 28Dec2020, the patient underwent a nasal swab COVID-19 test and the result was negative. The clinical outcome of the event right lower leg cramps was recovered with lasting effects on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain
Clinical narrative: Injection site feels like it is lumpy; strong injection sitesoreness.; This is a spontaneous report from a contactable consumer, for patient. A 37-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 31Mar2021 at 10:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux (esophageal) and arrhythmogenic right ventricular dysplasia. Allergic history was not reported. Concomitant medication included famotidine (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. 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 for COVID-19. On 31Mar2021, the patient experienced lump at the injection site with no visible inflammation and had strong injection site soreness. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events vaccination site mass and vaccination site pain were resolving at the time of report.    No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Swollen nodule located on left side of soft tissue of neck; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number ER 8727), via an unspecified route of administration in the left arm on 25Mar2021, at 10:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included obesity. The patient did not have any allergies to medications, food or other products. The patient had received unspecified medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EN 6205), via an unspecified route of administration in the left arm on 04Mar2021, at 10:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 29Mar2021 the patient underwent nasal swab test for COVID-19 virus test and the test result report was pending. On 27Mar2021 at 22:00, the patient experienced swollen nodule located on left side of soft tissue of neck. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of swollen nodule located on left side of soft tissue of neck was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain, Vaccination site pain
Clinical narrative: chills; body aches; fatigue; nausea; arm soreness at the injection site; This is a spontaneous report received from a non-contactable consumer, the patient. A 47 year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) in the left arm on 26Mar2021 at 09:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included tuberculosis as a toddler. The patient had no known allergies to food, medications, or other products. The patient did not receive any other medication within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. It was unknown if prior the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021, the patient experienced nausea the day of and the following day of the vaccine, arm soreness at the injection site and on 27Mar2021, the patient had chills, body aches and fatigue the date following the vaccine. Therapeutic measures were not taken as a result of nausea, chills, body ache, arm soreness and fatigue. 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 nausea, chills and body aches, arm soreness at the injection site and fatigue was recovered.   No follow-up attempts are possible; information about lot/ batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non pregnant female received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 30Mar2021 at 19:30 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history stated NADA (no abnormalities detected no apparent distress). Concomitant medications included cannabidiol (MANUFACTURER UNKNOWN) and gummy multi vitamins (MANUFACTURER UNKNOWN). The patient was not allergic to medications, food or other products. Prior to the 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 four weeks prior to the vaccination. On 31Mar2021 at 21:30, the patient experienced shooting pain to left kidney. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. There was no treatment received for the adverse event experienced. The clinical outcome of the event kidney pain was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Chills, Pain, Pyrexia
Clinical narrative: developed fever ranging between 99 and 100.9 degrees fahrenheit; Some stomach discomfort,; body aches; chills; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; UNKNOWN), via an unspecified route of administration in left arm on 19Feb2021 at 14:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included mixed connective tissue disease and Hashimoto's hypothyroidism. The patient had no allergies to medications, food and other products. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN) and hydroxychloroquine (MANUFACTURER UNKNOWN) for an unknown indication. 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 left arm on 29Jan2021 at 14:00 (at the age of 55-years-old) as single dose for COVID-19 immunisation. 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 had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 20Feb2021 at 12:00 (approximately after 20 hours), the patient experienced fever that ranged between 99 and 100.9-degrees Fahrenheit, stomach discomfort, body aches and chills. The adverse 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 treatment for the adverse events. The clinical outcome of the event fever was recovered on 20Feb2021 at 20.00 (Approximately lasted for 8 hours), for events stomach discomfort, body aches and chills were recovered on an unknown date in Feb2021.    No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 test, Swelling face, Swelling of eyelid
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 03Feb2021 at 13:00 (at the age of 73-years-old) as a single dose for COVID-19 immunization. Medical history included dialysis for past four and half years, colon cancer since 2008, multiple myeloma and chemotherapy. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN), colecalciferol (D 3), cyanocobalamin (B 12), nasal sprays (MANUFACTURER UNKNOWN) and unknown renal so medications, all from an unknown date, for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in the right arm on 13Jan2021 at 13:00 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. 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 been tested for COVID-19. On 27Mar2021 at 20:00, the Saturday evening, the patient experienced terribly itched head through the Sunday morning and patient stopped taking some chemo related medications, which were started on 24Mar2021. On28Mar2021, the patient experienced forehead swelling by the dinner time. On 29Mar2021, Monday, the patient experienced swollen eye lid, it was very swollen. On 30Mar2021, Tuesday, the patient experienced swelling moved to the area under the eye. The patient visited oncologist office on Monday, Tuesday and they said they never saw this type of reaction to chemotherapy.  Began medications on 29Mar2021, Tuesday and was suspecting if this could this be related to the vaccine and if she was a part of the clinical trials as she was a chemotherapy patient. The event resulted in doctor or other healthcare professional office/clinic visit on 29Mar2021. Therapeutic measures were taken as a result of adverse events included treatment with Benadryl for itching and cold compression to reduce swelling. The patient underwent lab tests and procedures, which included COVID-19 test on an unknown date and was found to be negative. The clinical outcome of head itching was recovered on Mar2021 and forehead swelling, eyelid swollen and swelling of under eye area was unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This is a spontaneous report received from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the left arm on 16Mar2021 at 11:30 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included high blood pressure. Concomitant medications were not reported. The patient was allergic to latex, sulfonamide, cipro and eggs. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. 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 21Mar2021,5 days after the vaccination, the patient had shingles . The patient applied cortizone as treatment for the adverse event. The event resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event shingles was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Vaccination site rash
Clinical narrative: circular red rash appeared around the injection site; lower back pain; This is a spontaneous report received from a non-contactable consumer, the patient. A 57-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration on 27Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patients medical history included COVID-19 prior to vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient was not tested for COVID-19. On 29Mar2021, 2 days after the vaccination, the patient experienced a circular red rash that appeared around the injection site and lower back pain. 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 treatment for the reported events. The clinical outcome of the events vaccination site rash and lower back pain were not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN620) via an unspecified route of administration in the right arm on 18Mar2021 at 17:30 (at the age 35-years-old) as a single dose for COVID-19 immunization. Medical history was reported as Ehlers Danlos Syndrome (Connective Tissue Disorder). The patient had no known allergies to medications, food, or other products. Concomitant medications were reported as probiotics (MANUFACTURER UNKNOWN), 5-HTP (MANUFACTURER UNKNOWN) and L-tryptophan (MANUFACTURER UNKNOWN). The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 25Mar2021, the patient experienced hive like itching up the right side of neck and at the injection site, it was reported that the injection site was firm to the touch and itchy. After 1 day, that was on 26Mar2021 the injection site was clearly red. and after 2 days, that was on 27Mar2021 the injection site had a red ring around it. After 3 days (10 days post injection), itchiness and redness subsided. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the reported events. The clinical outcome of the events hives like itching up the right side of neck, injection site firm to the touch and injection site had a red ring around it were resolved on an unknown date in Mar 2021 while, the clinical outcome for events itching at the injection site and injection site redness were resolved on 28Mar2021. No follow-up attempts are needed. No further information expected.