chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Cough, Fatigue
Clinical narrative: Severe chills; profuse sweating; stabbing joint pain; exhaustion; fever over 100; coughing; inability to sleep; body aches/over all body aches; mild headache; arm soreness; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0164), via an unspecified route of administration in the left arm on 14Apr2021 at 14:30 (at the age of 52-years-old) as dose 2, single for COVID-19 immunization. Medical history included high blood pressure, clinical depression, anxiety from an unknown date and unknown if ongoing. Patient had known allergies- Penicillin. Concomitant medication(s) included sertraline, venlafaxine hcl, lisinopril, hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported. 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. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8733), via an unspecified route of administration in the left arm on 24Mar2021 at 14:00 (at the age of 52-years-old) as dose 1, single for COVID-19 immunization. The patient experienced body aches/overall body aches, mild headache, arm soreness on 14Apr2021 22:00 (At the rate 12 hours ) and severe chills, profuse sweating, stabbing joint pain, exhaustion, fever over 100, coughing, inability to sleep on 15Apr2021 (At the rate 24 hours). The patient underwent lab tests and procedures which included body temperature: fever over 100 on 15Apr2021. The patient did not receive any treatment for the events. The clinical outcome for the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Pain, Pain in extremity, Pyrexia
Clinical narrative: Severe chills; profuse sweating; stabbing joint pain; exhaustion; fever over 100; coughing; inability to sleep; body aches/over all body aches; mild headache; arm soreness; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0164), via an unspecified route of administration in the left arm on 14Apr2021 at 14:30 (at the age of 52-years-old) as dose 2, single for COVID-19 immunization. Medical history included high blood pressure, clinical depression, anxiety from an unknown date and unknown if ongoing. Patient had known allergies- Penicillin. Concomitant medication(s) included sertraline, venlafaxine hcl, lisinopril, hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported. 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. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8733), via an unspecified route of administration in the left arm on 24Mar2021 at 14:00 (at the age of 52-years-old) as dose 1, single for COVID-19 immunization. The patient experienced body aches/overall body aches, mild headache, arm soreness on 14Apr2021 22:00 (At the rate 12 hours ) and severe chills, profuse sweating, stabbing joint pain, exhaustion, fever over 100, coughing, inability to sleep on 15Apr2021 (At the rate 24 hours). The patient underwent lab tests and procedures which included body temperature: fever over 100 on 15Apr2021. The patient did not receive any treatment for the events. The clinical outcome for the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Severe chills; profuse sweating; stabbing joint pain; exhaustion; fever over 100; coughing; inability to sleep; body aches/over all body aches; mild headache; arm soreness; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0164), via an unspecified route of administration in the left arm on 14Apr2021 at 14:30 (at the age of 52-years-old) as dose 2, single for COVID-19 immunization. Medical history included high blood pressure, clinical depression, anxiety from an unknown date and unknown if ongoing. Patient had known allergies- Penicillin. Concomitant medication(s) included sertraline, venlafaxine hcl, lisinopril, hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported. 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. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8733), via an unspecified route of administration in the left arm on 24Mar2021 at 14:00 (at the age of 52-years-old) as dose 1, single for COVID-19 immunization. The patient experienced body aches/overall body aches, mild headache, arm soreness on 14Apr2021 22:00 (At the rate 12 hours ) and severe chills, profuse sweating, stabbing joint pain, exhaustion, fever over 100, coughing, inability to sleep on 15Apr2021 (At the rate 24 hours). The patient underwent lab tests and procedures which included body temperature: fever over 100 on 15Apr2021. The patient did not receive any treatment for the events. The clinical outcome for the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Lethargy, Vaccination site pain
Clinical narrative: Fatigue began 12 hours after injection and lasted for 48 hours; Sore deltoid 12 hours after injection and lasted for 24 hours.; Lethargy; Severe headache upon waking 2nd day after injection and lasted for 8 hours.; Fuzzy thinking for 2 days after injection; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 10Apr2021 at 14:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included leaky gut, healthy otherwise and known allergies to penicillin, garlic and sulfur meds. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021, 12 hours after the injection, the patient experienced fatigue and sore deltoid, second day after injection, experienced severe headache upon waking and also experienced lethargy and fuzzy thinking. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache was resolved on 11Apr2021, after a duration of 8 hours; pain in arm was resolved on 12Apr2021, after a duration of 24 hours; fatigue was resolved on 13Apr2021, after a duration of 48 hours; lethargy and fuzzy was resolved on 13Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Ear congestion, Fatigue, Tinnitus
Clinical narrative: woke up with significant tinnitus in my right ear; woke up with tinnitus in right ear. Over the course of next day it went away from right but it still lingered overall and was aggravated. The days following, tinnitus settled back in left but is at the same aggravated levels it was back in 2014; the left ear feels stuffed up as do my sinuses; mild fatigue; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 07Apr2021 at 09:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included benign prostatic hyperplasia, mild tinnitus since 2014 and allergy to sulpha. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included silodosin (MANUFACTURER UNKNOWN) 8mg per day, for an unknown indication from an unknown date and unknown if ongoing. The patient previously received influenza vaccine (MANUFACTURER UNKNOWN) in the left arm on an unknown date for immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that he had mild tinnitus in left ear since 2014. The onset of that had coincided with a flu shot he had taken then on the left arm. Since then, the tinnitus had subsided to a tolerable level. On 07Apr2021, the patient experienced mild fatigue. He was fine through the day. On 08Apr2021 at 03:00, that night the patient woke up with significant tinnitus in his right ear. Over the course of the next day, it went away from the right ear but it still lingered overall and was aggravated. The days following, the tinnitus settled back in the left ear but is at the same aggravated levels it was back in 2014 and also the patient experienced the left ear feels stuffed up as do his sinuses. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild fatigue, significant tinnitus in right ear. Over the course of the next day, it went away from the right ear but it still lingered overall and was aggravated. The days following, the tinnitus settled back in the left ear but is at the same aggravated levels it was back in 2014 and left ear feels stuffed up as do his sinuses was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Pain in extremity
Clinical narrative: Diarrhea; Headache; Whole right arm sore; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 14Apr2021 at 14:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), taken for an unspecified indication from an unknown date and unknown if ongoing. On 14Apr2021 at 14:15, the patient experienced diarrhea, headache, whole right arm sore and fatigue. The events did not result in doctor or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea, headache, whole right arm sore and fatigue were not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Nausea, Oral mucosal eruption, Pharyngeal enanthema
Clinical narrative: Lymph node swelling; Severe rash inside mouth and throat; Severe rash inside mouth and throat; Headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 26-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 05Apr2021 at 13:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to pollen. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included calcium carbonate (TUMS) for an unknown indication from an unknown date and unknown if ongoing. On 13Apr2021, the patient experienced lymph node swelling, severe rash inside mouth and throat that did not go away with unspecified allergy medicine, headache and nausea. The events 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 the events lymph node swelling, headache and nausea. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lymph node swelling, severe rash inside mouth and throat, headache and nausea was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Pyrexia
Clinical narrative: 48 hours after my first dose, "I" had chills; Tiredness; Vomited; Fever; Joint pain; Extreme lower back pain; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150) via an unspecified route of administration in the left arm on 08Apr2021 at 11:30 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included type II diabetes and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included insulin glargine (LANTUS INSULIN) and dulaglutide (TRULICITY) both for an unknown indication from an unknown dates and unknown if ongoing. The patient previously took tetanus vaccine (MANUFACTURER UNKNOWN) and insulin lispro (HUMALOG) for an unknown indication from an unknown dates and experienced drug allergy. On 10Apr2021 at 12:00, 48 hours after her first dose, the patient experienced chills, tiredness, vomited, fever, joint pain and extreme lower back pain. The events did not result in doctor or other healthcare professional office or clinic, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, tiredness, vomited, fever, joint pain and extreme lower back pain were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 48 hours after my first dose, "I" had chills; Tiredness; Vomited; Fever; Joint pain; Extreme lower back pain; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150) via an unspecified route of administration in the left arm on 08Apr2021 at 11:30 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included type II diabetes and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included insulin glargine (LANTUS INSULIN) and dulaglutide (TRULICITY) both for an unknown indication from an unknown dates and unknown if ongoing. The patient previously took tetanus vaccine (MANUFACTURER UNKNOWN) and insulin lispro (HUMALOG) for an unknown indication from an unknown dates and experienced drug allergy. On 10Apr2021 at 12:00, 48 hours after her first dose, the patient experienced chills, tiredness, vomited, fever, joint pain and extreme lower back pain. The events did not result in doctor or other healthcare professional office or clinic, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, tiredness, vomited, fever, joint pain and extreme lower back pain were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Heart rate
Clinical narrative: Chills; Sweating; Body aches; Poking sensation in bicep away from where the shot was given; Headache; Shaking/jittery; Extreme tiredness; Dizziness; Resting heart rate doubled from normally 40 to nearly 90bpm; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 15Apr2021 at 11:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy. It was reported that the patient was fairly healthy and the patient's family has history of heart issues. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluticasone propionate (FLONASE) for allergy from an unknown date and unknown if ongoing. The patient previously 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 26Mar2021 at 11:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 00:00 the patient experienced chills; then followed by sweating; body aches; poking sensation in bicep away from where the shot was given, not near it; headache; shaking/jittery; extreme tiredness; dizziness and resting heart rate doubled from normally 40 to nearly 90bpm (beats per minute). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. On 14Apr2021, the patient underwent nasal swab test (SARS-CoV2-test) and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events chills; then followed by sweating; body aches; poking sensation in bicep away from where the shot was given, not near it; headache; shaking/jittery; extreme tiredness; dizziness and resting heart rate doubled from normally 40 to nearly 90bpm was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Pain, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Chills; Sweating; Body aches; Poking sensation in bicep away from where the shot was given; Headache; Shaking/jittery; Extreme tiredness; Dizziness; Resting heart rate doubled from normally 40 to nearly 90bpm; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 15Apr2021 at 11:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy. It was reported that the patient was fairly healthy and the patient's family has history of heart issues. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluticasone propionate (FLONASE) for allergy from an unknown date and unknown if ongoing. The patient previously 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 26Mar2021 at 11:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 00:00 the patient experienced chills; then followed by sweating; body aches; poking sensation in bicep away from where the shot was given, not near it; headache; shaking/jittery; extreme tiredness; dizziness and resting heart rate doubled from normally 40 to nearly 90bpm (beats per minute). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. On 14Apr2021, the patient underwent nasal swab test (SARS-CoV2-test) and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events chills; then followed by sweating; body aches; poking sensation in bicep away from where the shot was given, not near it; headache; shaking/jittery; extreme tiredness; dizziness and resting heart rate doubled from normally 40 to nearly 90bpm was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Chills; Sweating; Body aches; Poking sensation in bicep away from where the shot was given; Headache; Shaking/jittery; Extreme tiredness; Dizziness; Resting heart rate doubled from normally 40 to nearly 90bpm; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 15Apr2021 at 11:45 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy. It was reported that the patient was fairly healthy and the patient's family has history of heart issues. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluticasone propionate (FLONASE) for allergy from an unknown date and unknown if ongoing. The patient previously 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 26Mar2021 at 11:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 00:00 the patient experienced chills; then followed by sweating; body aches; poking sensation in bicep away from where the shot was given, not near it; headache; shaking/jittery; extreme tiredness; dizziness and resting heart rate doubled from normally 40 to nearly 90bpm (beats per minute). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. On 14Apr2021, the patient underwent nasal swab test (SARS-CoV2-test) and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events chills; then followed by sweating; body aches; poking sensation in bicep away from where the shot was given, not near it; headache; shaking/jittery; extreme tiredness; dizziness and resting heart rate doubled from normally 40 to nearly 90bpm was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: severe fatigue; chest pressure; shortness of breath/lose my breath; dizziness; They have continued for several weeks making it difficult for me to jog as I usually do. I lose my breath and feel like my heart is struggling.; They have continued for several weeks making it difficult for me to jog as I usually do. I lose my breath and feel like my heart is struggling.; This is a spontaneous report from a contactable other health care professional, the patient. A 42-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 the right arm on 20Mar2021 at 09:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic pain, fibromyalgia and migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medication. The Patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 21Mar2021 at 17:00, approximately 30 hours after the shot, the patient experienced severe fatigue, chest pressure, shortness of breath and dizziness. It was reported that  the patient had severe fatigue, chest pressure, shortness of breath and dizziness occurred. They had continued for several weeks and on unknown date in 2021, making it difficult for the patient to jog as she usually did and she lost her breath and felt like heart was struggling. On 09Apr2021, the patient underwent COVID test (nasal swab) and the result was negative. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events severe fatigue, chest pressure, shortness of breath, dizziness, had continued for several weeks making it difficult for her to jog as she usually did, lost her breath and felt like heart was struggling was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, SARS-CoV-2 test
Clinical narrative: severe fatigue; chest pressure; shortness of breath/lose my breath; dizziness; They have continued for several weeks making it difficult for me to jog as I usually do. I lose my breath and feel like my heart is struggling.; They have continued for several weeks making it difficult for me to jog as I usually do. I lose my breath and feel like my heart is struggling.; This is a spontaneous report from a contactable other health care professional, the patient. A 42-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 the right arm on 20Mar2021 at 09:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic pain, fibromyalgia and migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medication. The Patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 21Mar2021 at 17:00, approximately 30 hours after the shot, the patient experienced severe fatigue, chest pressure, shortness of breath and dizziness. It was reported that  the patient had severe fatigue, chest pressure, shortness of breath and dizziness occurred. They had continued for several weeks and on unknown date in 2021, making it difficult for the patient to jog as she usually did and she lost her breath and felt like heart was struggling. On 09Apr2021, the patient underwent COVID test (nasal swab) and the result was negative. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events severe fatigue, chest pressure, shortness of breath, dizziness, had continued for several weeks making it difficult for her to jog as she usually did, lost her breath and felt like heart was struggling was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain in extremity
Clinical narrative: Initial soreness in right arm followed by joint aches throughout the body.; Initial soreness in right arm followed by joint aches throughout the body.; Next, persistent extreme fatigue that persists to today; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 12Apr2021 at 12:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included morbid obesity, osteoarthritis, penicillin allergy, adhesives allergy (dermatitis contact), and lupus erythematosus (lupus). The patient had received medication which was not specified within two weeks of vaccination for unknown indication and unknown if ongoing. The patient previously took cefalexin (KEFLEX), clindamycin (CLEOCIN), vancomycin (MANUFACTURER UNKNOWN), levofloxacin (LEVOQUIN), clindamycin (MANUFACTURER UNKNOWN) and colchicine (MANUFACTURER UNKNOWN) and experienced drug allergy to these. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 22Mar2021 at 12:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 13:00, the patient experienced initial soreness in right arm followed by joint aches throughout the body. Next, persistent extreme fatigue that persisted to the day of report. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events initial soreness in right arm followed by joint aches throughout the body; next, persistent extreme fatigue that persisted to the day of report was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Muscle spasms, Myalgia
Clinical narrative: Extreme muscle cramp in right calf; Extremely painful muscle; Can barely walk with it.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 04Apr2021 at 10:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to vaccination. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN) for unknown indications from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on an unknown date Mar2021 at 10:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 11:00, the patient experienced extreme muscle cramp in right calf, first it was felt like a pop then it had been extremely painful and could barely walk with it. The events 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 the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme muscle cramp in right calf and extremely painful muscle and could barely walk was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Extremely exhausted; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 16Apr2021 at 19:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to tuna (Fish allergy) and allergy to rosemary (herbal allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included valaciclovir hydrochloride (VALACYCLOVIR), dicycloverine (DICYCLOMINE) and ascorbic acid (VITAMIN C) and multi-vitamins (MANUFACTURER UNKNOWN); all for unknown indications from an unknown date and unknown if ongoing. On 16Apr2021 at 21:00, the patient was extremely exhausted and experienced nausea. The events 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 the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extremely exhausted and nausea was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Intermenstrual bleeding, Menstruation irregular
Clinical narrative: period started significantly earlier than it should have; previous period ended 4/5/21 my next one wasn't due to start until 5/6/21. I have a very regular menstrual cycle and do not experience spotting between cycles. I started bleeding again 4/15/21 5 hours after receiving the first dose of the vaccine; had worse cramps than I have ever had the entire time that I have been menstruating; This is a spontaneous report from a non-contactable consumer. A 28-year-old 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 right arm on 15Apr2021 at 11:30 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and did not have any allergies to medications, food, or other products. It was unknown if the patient was pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 15Apr2021 at 16:30, the patient's period started significantly earlier than it should have. Previous period ended on 05Apr2021 and the next one was not due to start until 06May2021. The patient reported that she had a very regular menstrual cycle and do not experience spotting between cycles. It started bleeding again on 15Apr2021, 5 hours after receiving the first dose of the vaccine and also had worse cramps that she ever had the entire time she had been menstruating. The patient reported that if this continued through the weekend, she would make a doctors appointment. The events 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 the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events period started significantly earlier than it should have, started bleeding again 5 hours after receiving the first dose of the vaccine and the worse cramps that she ever had the entire time she had been menstruating was not recovered at this time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: every joint in body hurt; felt nauseous from the pain; lower back started to ache; Second dose bled from injection and resulted in large bruise; Second dose bled from injection and resulted in large bruise; Woke up with mild headache; Had a mild fever (100.9 F); sleep was very broken with heavy sweat; sleep was very broken with heavy sweat; lethargic for the next 36 hours; This is a spontaneous report from a contactable consumer (patient herself).  A 55-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EN6205; Expiration Date: 30Mar2021), dose 2 via an unspecified route of administration, administered in Arm Left on 29Mar2021 14:45 (Age at vaccination 55-years-old) as dose 2, single for covid-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included thyroidism, allergies to medications, food, or other products: penicillin and some antibiotics, no food allergies from an unknown date and unknown if ongoing. Concomitant medications included zinc (ZINC), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EN6208; Expiration Date was reported), dose 1 via intramuscular, administered in Arm Left on 08Mar2021 14:45 (Age at vaccination 55-years-old) as dose 1, single for covid-19 immunisation. The patient had experienced second dose bled from injection and resulted in large bruise. Woke up with mild headache, took Advil (200 mg), went to tennis match, at 11:00 am lower back started to ache. When back home at 12:00 pm every joint in body hurt, felt nauseous from the pain and had a headache. Had a mild fever (100.9 F), took Advil (2 times, 200 mg). Continued to medicate with Advil and Tylenol, as per instructions on the bottles, alternating for 12 hours to 12:00 am. During the night, sleep was very broken with heavy sweat. Woke up at 8:00 am feeling better since joint pain had subsided, but still had a mild headache which continued unmedicated as a dull headache and lethargic for the next 36 hours. The patient underwent lab tests and procedures which included body temperature: 100.9 Fahrenheit on 30Mar2021. The facility most recent COVID-19 vaccine administered was other. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received thyroid, zinc, vitamin D medications within 2 weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19 was none. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received treatment for the events. Therapeutic measures were taken as a result of woke up with mild headache, had a mild fever (100.9 f). The clinical outcome of the events were recovered on 01Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Pain, Pyrexia
Clinical narrative: 101 Fever; Chills; Vomiting; Diarrhea; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 10:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. 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 25Mar2021 at 10:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 17:00, the patient experienced 101 fever, chills, vomiting, diarrhea and body aches. On the same day, the patient under went body temperature test and the result was found to be 101 (unspecified unit). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with TYLENOL. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events 101 fever, chills, vomiting, diarrhea and body aches were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 101 Fever; Chills; Vomiting; Diarrhea; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 10:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. 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 25Mar2021 at 10:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 17:00, the patient experienced 101 fever, chills, vomiting, diarrhea and body aches. On the same day, the patient under went body temperature test and the result was found to be 101 (unspecified unit). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with TYLENOL. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events 101 fever, chills, vomiting, diarrhea and body aches were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Arthropathy, Gait disturbance, SARS-CoV-2 test
Clinical narrative: Extreme weakness in right knee; It would not hold me and I was unable to walk on it. If I tried to walk, it would give out and I would almost fall; It would not hold me and I was unable to walk on it. If I tried to walk, it would give out and I would almost fall; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old patient of an unknown gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 11Apr2021 at 14:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. Prior to vaccination, the patient was not diagnosed with COVID -19. 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: ER6955) via an unspecified route of administration in the right arm on 21Mar2021 at 14:15 (at the age of 29-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. On 11Apr2021 at 23:30, the patient experienced extreme weakness in right knee and it would not hold the patient and the patient was unable to walk on it and even if the patient tried to walk, it would gave out and the patient would almost fall. It lasted about 30-40 minutes and then went away. On 12Apr2021, the patient underwent nasal swab test and the result was negative. 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 reported events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events extreme weakness in right knee, unable to walk on it and tried to walk, it would gave out and would almost fall was recovered on 12Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea
Clinical narrative: Nausea; Headache; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 29Mar2021 at 15:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included Factor V Leiden. The patient previously received fentanyl (MANUFACTURER UNKNOWN) on an unspecified date, for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included dabigatran etexilate mesilate (PRADAXA) from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 at 19:00, the patient experienced nausea, headache and diarrhea. The event 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea and headache were recovered on 31Mar2021, after the duration of 36 hours diarrhea was recovered on 02Apr2021, after the duration of 4 days.   No follow-up attempts are needed. No further information is expected.