chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Fatigue; soreness in left arm; soreness in shoulder; soreness in ribs; Body aches; headache; Trouble sleeping; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ew0187) via an unspecified route of administration in the left arm on 24May2021 at 09:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to bay shrimp. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and famotidine (MANUFACTURER UNKNOWN); all from an unknown date, for an unknown indication, unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: er8736) via an unspecified route of administration in the left arm on 03May2021 at 09:00 (at the age of 36-year-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 not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25May2021, the patient experienced fatigue, soreness in left arm, shoulders and ribs, body aches, headache and trouble sleeping. 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. The clinical outcome of the events fatigue, soreness in left arm, shoulders and ribs, body aches, headache and trouble sleeping were recovered on 25May2021.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Breast pain, Chills, Fatigue
Clinical narrative: 102 fever by Tuesday at 6pm. body chest, chills, my arm hurt feel my back into my fingers.; body chest, chills, my arm hurt feel my back into my fingers.; body chest, chills, my arm hurt feel my back into my fingers.; body chest, chills, my arm hurt feel my back into my fingers.; body chest, chills, my arm hurt feel my back into my fingers.; body chest, chills, my arm hurt feel my back into my fingers.; The joints of my fingers hurt.; My lymph node in my arm pit is swollen so much I can't lift my arm; My lymph node in my arm pit is swollen so much I can't lift my arm.; The left side of my breast feels like I've been punched.; There's a large knot and heat at the injection site.; There's a large knot and heat at the injection site.; I went to bed Tuesday at 4pm and couldn't get out of bed until Wednesday at 9am.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female 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 24May2021 at 18:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food, or other products. The patient received other medication within two weeks of vaccination which included Probiotics. Prior to the vaccination, the patient was 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. The patient experienced 102 (unspecified units) fever by Tuesday, on 25May2021 at 16:00. Body chest, chills, the patients arm hurt felt her back into her fingers. The joints of her fingers hurt. The patients lymph node in her arm pit was swollen so much that she couldn't lift her arm. The patient went to bed Tuesday 25May2021, at 16:00 and couldn't get out of bed until Wednesday, 26May2021 at 09:00. The left side of her breast felt like she had been punched. There was a large knot and heat at the injection site. The event 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 event. The clinical outcome of the events 102 (unspecified units) fever, body chest, chills, arm hurt felt her back into her fingers, the joints of fingers hurt, lymph node in arm pit was swollen so much that she couldn't lift her arm, couldn't get out of bed until Wednesday, 26May2021 at 09:00, the left side of her breast felt like she had been punched, a large knot and heat at the injection site was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypokinesia, Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: 102 fever by Tuesday at 6pm. body chest, chills, my arm hurt feel my back into my fingers.; body chest, chills, my arm hurt feel my back into my fingers.; body chest, chills, my arm hurt feel my back into my fingers.; body chest, chills, my arm hurt feel my back into my fingers.; body chest, chills, my arm hurt feel my back into my fingers.; body chest, chills, my arm hurt feel my back into my fingers.; The joints of my fingers hurt.; My lymph node in my arm pit is swollen so much I can't lift my arm; My lymph node in my arm pit is swollen so much I can't lift my arm.; The left side of my breast feels like I've been punched.; There's a large knot and heat at the injection site.; There's a large knot and heat at the injection site.; I went to bed Tuesday at 4pm and couldn't get out of bed until Wednesday at 9am.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female 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 24May2021 at 18:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food, or other products. The patient received other medication within two weeks of vaccination which included Probiotics. Prior to the vaccination, the patient was 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. The patient experienced 102 (unspecified units) fever by Tuesday, on 25May2021 at 16:00. Body chest, chills, the patients arm hurt felt her back into her fingers. The joints of her fingers hurt. The patients lymph node in her arm pit was swollen so much that she couldn't lift her arm. The patient went to bed Tuesday 25May2021, at 16:00 and couldn't get out of bed until Wednesday, 26May2021 at 09:00. The left side of her breast felt like she had been punched. There was a large knot and heat at the injection site. The event 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 event. The clinical outcome of the events 102 (unspecified units) fever, body chest, chills, arm hurt felt her back into her fingers, the joints of fingers hurt, lymph node in arm pit was swollen so much that she couldn't lift her arm, couldn't get out of bed until Wednesday, 26May2021 at 09:00, the left side of her breast felt like she had been punched, a large knot and heat at the injection site was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site warmth
Clinical narrative: 102 fever by Tuesday at 6pm. body chest, chills, my arm hurt feel my back into my fingers.; body chest, chills, my arm hurt feel my back into my fingers.; body chest, chills, my arm hurt feel my back into my fingers.; body chest, chills, my arm hurt feel my back into my fingers.; body chest, chills, my arm hurt feel my back into my fingers.; body chest, chills, my arm hurt feel my back into my fingers.; The joints of my fingers hurt.; My lymph node in my arm pit is swollen so much I can't lift my arm; My lymph node in my arm pit is swollen so much I can't lift my arm.; The left side of my breast feels like I've been punched.; There's a large knot and heat at the injection site.; There's a large knot and heat at the injection site.; I went to bed Tuesday at 4pm and couldn't get out of bed until Wednesday at 9am.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female 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 24May2021 at 18:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food, or other products. The patient received other medication within two weeks of vaccination which included Probiotics. Prior to the vaccination, the patient was 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. The patient experienced 102 (unspecified units) fever by Tuesday, on 25May2021 at 16:00. Body chest, chills, the patients arm hurt felt her back into her fingers. The joints of her fingers hurt. The patients lymph node in her arm pit was swollen so much that she couldn't lift her arm. The patient went to bed Tuesday 25May2021, at 16:00 and couldn't get out of bed until Wednesday, 26May2021 at 09:00. The left side of her breast felt like she had been punched. There was a large knot and heat at the injection site. The event 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 event. The clinical outcome of the events 102 (unspecified units) fever, body chest, chills, arm hurt felt her back into her fingers, the joints of fingers hurt, lymph node in arm pit was swollen so much that she couldn't lift her arm, couldn't get out of bed until Wednesday, 26May2021 at 09:00, the left side of her breast felt like she had been punched, a large knot and heat at the injection site was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Axillary pain, Chills, Dizziness, Fatigue
Clinical narrative: Chills; Cold; Weak; lightheaded; Nausea; Vomited; Slight dizzy spell; Feeling pain under armpit; Swelling in arm/armpit; feeling pain on arm; Feeling tired; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the arm left on 21May2021 at 13:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included uterine fibroids, breast cyst (not being treated) and indigestion (can not digest raw vegetables and banana). Concomitant medications included 310 nutrition meal replacement protein powder (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the arm left on 30Apr2021 at 13:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. It was unknown whether the patient was diagnosed with COVID-19, prior to the vaccination. 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 21May2021, after second dose patient felt ok but then in the evening, began feeling pain and swelling on arm and began feeling tired too. On 22May2021, Saturday night patient began feeling pain and swelling under armpit. On 23May2021 at 00:30, the following day on Sunday had a slight dizzy spell. On 24May2021 Monday, patient would not up dizzy with cold chills, weak and lightheaded with nausea, also vomited the water drank after patient woke up. This lasted all day and patient recovering and feeling somewhat better from everything at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of these events. The clinical outcome of the event swelling in arm/armpit, feeling tired, feeling pain on arm, feeling pain under armpit, slight dizzy spell, chills, cold, weak, lightheaded, nausea and vomited was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: Chills; Cold; Weak; lightheaded; Nausea; Vomited; Slight dizzy spell; Feeling pain under armpit; Swelling in arm/armpit; feeling pain on arm; Feeling tired; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the arm left on 21May2021 at 13:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included uterine fibroids, breast cyst (not being treated) and indigestion (can not digest raw vegetables and banana). Concomitant medications included 310 nutrition meal replacement protein powder (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the arm left on 30Apr2021 at 13:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. It was unknown whether the patient was diagnosed with COVID-19, prior to the vaccination. 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 21May2021, after second dose patient felt ok but then in the evening, began feeling pain and swelling on arm and began feeling tired too. On 22May2021, Saturday night patient began feeling pain and swelling under armpit. On 23May2021 at 00:30, the following day on Sunday had a slight dizzy spell. On 24May2021 Monday, patient would not up dizzy with cold chills, weak and lightheaded with nausea, also vomited the water drank after patient woke up. This lasted all day and patient recovering and feeling somewhat better from everything at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of these events. The clinical outcome of the event swelling in arm/armpit, feeling tired, feeling pain on arm, feeling pain under armpit, slight dizzy spell, chills, cold, weak, lightheaded, nausea and vomited was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Injection site pain; Tiredness; Headache; Joint pain; Fever; Nausea; Feeling unwell; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the left arm on 23May2021 at 14:30 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took penicillin (MANUFACTURER UNKNOWN), and amoxicillin (MANUFACTURER UNKNOWN); both from an unknown date to an unknown date for an unknown indication and experienced allergy. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 02May2021 at 02:30 (at the age of 17-year-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 not been tested for COVID-19. On 23May2021 at 02:45 the patient experienced injection site pain, tiredness, headache, joint pain, fever, nausea, feeling unwell, and vomiting. All symptoms were lasting for 3-4 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the adverse events. The clinical outcome of the events injection site pain, tiredness, headache, joint pain, fever, nausea, feeling unwell, and vomiting were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Injection site pain; Tiredness; Headache; Joint pain; Fever; Nausea; Feeling unwell; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the left arm on 23May2021 at 14:30 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took penicillin (MANUFACTURER UNKNOWN), and amoxicillin (MANUFACTURER UNKNOWN); both from an unknown date to an unknown date for an unknown indication and experienced allergy. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 02May2021 at 02:30 (at the age of 17-year-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 not been tested for COVID-19. On 23May2021 at 02:45 the patient experienced injection site pain, tiredness, headache, joint pain, fever, nausea, feeling unwell, and vomiting. All symptoms were lasting for 3-4 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the adverse events. The clinical outcome of the events injection site pain, tiredness, headache, joint pain, fever, nausea, feeling unwell, and vomiting were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, COVID-19, Chills, Myalgia, Pyrexia
Clinical narrative: fever; muscle pain; bone pain; chills; She might have infected of COVID-19; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0186), dose 1 via an unspecified route of administration on 19May2021 (at the age of 70-year-old) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She was vaccinated on 19May2021 and next day on 20May2021 she experienced fever, muscle pain, bone pain, chills and basically all the symptoms described on information she was provided with. All symptoms persist after a week of vaccination except for the fever. She might have infected of COVID-19 and not knowing since she has all symptoms. Outcome of event fever was recovered in May2021, for COVID-19 was unknown, for other events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Joint range of motion decreased, Joint swelling
Clinical narrative: severe inflammatory response, specifically in R knee; severe inflammatory response, specifically in R knee. Largely swollen, severe pain, unable to bend; Woke up after second dose with severe inflammatory response, specifically in R knee. Largely swollen, severe pain, unable to bend; Woke up after second dose with severe inflammatory response, specifically in R knee. Largely swollen, severe pain, unable to bend; This is a spontaneous report from a contactable consumer.   A non-pregnant 31 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 01Apr2021 14:00 (Batch/Lot Number: EP7534) as dose 2, single for COVID-19 immunisation.  Medical history included covid-19 from an unknown date and unknown if ongoing. There were no concomitant medications.  The patient previously took BNT162B2 dose 1 on 12Mar2021 for covid-19 immunisation, BIAXIN and experienced allergies.  The patient woke up after second dose on 02Apr2021 with severe inflammatory response, specifically in R knee. Largely swollen, severe pain, unable to bend. It's been almost 2 months since second dose and have been in physical therapy for weeks trying to repair the knee. The outcome of the events was not recovered.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dysarthria, Dyspnoea, Hyperhidrosis
Clinical narrative: burning or discomfort in lungs; discomfort in throat; discomfort in nose; eye discomfort; coughing; trouble breathing; trouble talking; sweating profusely; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 24May2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to latex. 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 COVID vaccine. Concomitant medications included diphenhydramine, paracetamol, phenylpropanolamine hydrochloride (BENADRYL) and cannabidiol (MANUFACTURER UNKNOWN); both for unspecified indication and unknown start date. On 24May2021, approximately an hour after the shot, patient was driving home and suddenly experienced horrible burning/discomfort in lungs, throat, nose, and eyes. He started coughing and had trouble breathing/talking. He also started sweating profusely. He managed to drive himself to the hospital where he let the symptoms subside over the next hour. It felt like he had inhaled tear gas. He stated he never experienced anything like it before in his life. Within a few hours of the initial experience, he felt perfectly fine. Even the next day he had zero symptoms. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome for the events chest burning/discomfort in lungs, throat discomfort, discomfort in nose, eye discomfort, coughing, trouble breathing/talking and sweating profusely were recovered on 24May2021.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal discomfort, Ocular discomfort, Oropharyngeal discomfort
Clinical narrative: burning or discomfort in lungs; discomfort in throat; discomfort in nose; eye discomfort; coughing; trouble breathing; trouble talking; sweating profusely; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 24May2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to latex. 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 COVID vaccine. Concomitant medications included diphenhydramine, paracetamol, phenylpropanolamine hydrochloride (BENADRYL) and cannabidiol (MANUFACTURER UNKNOWN); both for unspecified indication and unknown start date. On 24May2021, approximately an hour after the shot, patient was driving home and suddenly experienced horrible burning/discomfort in lungs, throat, nose, and eyes. He started coughing and had trouble breathing/talking. He also started sweating profusely. He managed to drive himself to the hospital where he let the symptoms subside over the next hour. It felt like he had inhaled tear gas. He stated he never experienced anything like it before in his life. Within a few hours of the initial experience, he felt perfectly fine. Even the next day he had zero symptoms. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome for the events chest burning/discomfort in lungs, throat discomfort, discomfort in nose, eye discomfort, coughing, trouble breathing/talking and sweating profusely were recovered on 24May2021.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Tendonitis
Clinical narrative: left foot swelled up, turned red and was painful, especially at achilles tendon; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 05May2021 at 13:30 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included enlarged prostate. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included tamsulosin hydrochloride (MANUFACTURER UNKNOWN) and multivitamin; all for unknown indication from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06May2021 at 13:00, about 24 hours after vaccination, the patient's left foot swelled up, turned red and it was painful, especially at achilles tendon. The patient could not walk with it for a few days. The swelling subsided but after 3 weeks it was still slightly swollen and red. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event achilles tendinitis and included treatment with over-the-counter advil, 18 pills over 3 days. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event achilles tendinitis was recovered with sequelae on  an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: 3 separate occasions of nose bleeds; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 12May2021 at 17:00 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have any allergies to medications, food, or other products. Concomitant medications included desogestrel, ethinylestradiol (KARIVA) from an unknown date for an unknown indication. 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 13May2021 at 14:00 the patient experienced 3 separate occasions of nose bleeds the day or two following vaccination. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event nose bleeds was recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Feeling hot, Rash
Clinical narrative: Within a few days of receiving my first vaccine (Pfizer EN6201), I got a rash on my right thigh (5" x 9 1/2") and on my right upper abdomen.; The rashes were itchy and warm to the touch; The rashes were itchy and warm to the touch; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 06Mar2021 14:30 (Lot Number: EN6198) as single dose (at the age of 71-years-old) for COVID-19 immunization. Medical history included allergies/sinus, high blood pressure, (allergies to) sulfa, and suspected granuloma annulare on 23Feb2021. The patient was not pregnant. Concomitant medications were taken but not specified ("This field will not allow me to list all meds"). The patient previously took doxycycline and tetracycline and experienced allergies. No other vaccine in four weeks. Patient reported that, "Within a few days of receiving my first vaccine (Pfizer EN6201, pending clarification), I got a rash on my right thigh (5" x 9 1/2") and on my right upper abdomen. The rashes were itchy and warm to the touch. On 23Feb2021, I began treatment for suspected granuloma annulare. That diagnosis was confirmed by a biopsy on 07May2021. I have been treated with topical ointments and injections, but the rashes have not abated. Furthermore, I continue to acquire new granuloma annulare spots (left groin, left thigh, left ankle). While I have had a localized granuloma annulare in the past, it had abated prior to the onset of this generalized granuloma annulare." The patient underwent lab tests and procedures which included biopsy: granuloma annulare on 07May2021. Therapeutic measures were taken as a result of the events which included topical ointments, injections "(I think it was ster." The events resulted in Doctor or other healthcare professional office/clinic visit. The patient had not recovered from the events.   The events were considered as serious (medically significant). Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Important Hair Loss; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 15May2021 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) taken for an unknown indication on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021, the patient underwent COVID-19 test Polymerase Chain Reaction (PCR) and the result was negative. On 17May2021, the patient experienced hair loss which was important. 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. No therapeutic measures were taken as a result of the event. The clinical outcome of the event hair loss was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headaches; Feeling the need to vomit; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old, non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  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 an unknown date, the patient experienced headaches and feeling the need to vomit. 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 events. The clinical outcome of events headaches and feeling the need to vomit were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Palpitations
Clinical narrative: Heart palpitations/racing heart rate when not active; Heart palpitations/racing heart rate when not active; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0179) via an unspecified route of administration in the left arm on 29Apr2021 at 09:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to food, medications, or other products. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0158) via an unspecified route of administration in the left arm on 15Apr2021 at 10:00 (at the age of 38-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 not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08May2021 at 20:00, the patient experienced heart palpitations/racing heart rate when not active. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events and included treatment with unknown medications and also monitoring heart activity with wearable device. The clinical outcome of the events heart palpitations/racing heart rate when not active was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain in extremity, Pruritus
Clinical narrative: Arm had extreme pain; Fatigue got really bad/ extremely worn out; Little itchy; Not feeling well; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 14May2021 at 15:30 as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. The patient was allergic to penicillin. Concomitant medication included upadacitinib (RINVOQ) and Breo (MANUFACTURER UNKNOWN) for unknown indication taken on unknown date and unknown if ongoing. 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. The patient previously taken hydroxychloroquine (MANUFACTURER UNKNOWN) and had allergy. On 19May2021, the patient experienced extreme arm pain for almost 2 days, fatigue got really bad/ extremely worn out after about a week, little itchy and not feeling well. The patient reported that she missed a day of work so far. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extreme arm pain for almost 2 days, fatigue got really bad/ extremely worn out after about a week, little itchy and not feeling well was not resolved at the time of this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Pruritus, Vision blurred
Clinical narrative: Itchy eyes and whole body and vision slightly blurred; Itchy eyes and whole body and vision slightly blurred; Itchy eyes and whole body and vision slightly blurred; This is a spontaneous report from contactable consumer (patient). A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0173; Expiration date: not provided) via an unspecified route of administration on 05May2021 at 10:00 (age at vaccination 40-year-old) as dose 1, single for covid-19 immunization Doctor Office / Urgent Centre. The patients medical history and concomitant medications were not reported. Patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient took second dose of BNT162B2, Lot number: EW0185 on 26May2021 for Covid-19 immunization. On 05May2021 at 14:00, patient experienced itchy eyes and whole body and vision slightly blurred. The patient did not receive any treatment for adverse events. The outcome of event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Headache, Pyrexia, Tremor, Uterine pain
Clinical narrative: mild low-grade fever; headache; hard to stand energy wise; pain in uterus/ovary areas within 8 hours of vaccine; shakiness until two days after; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 24May2021 at 15:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was allergic to gluten which had some small impact but she could eat it. Concomitant medications included ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE), vitamin D (MANUFACTURER UNKNOWN) and women's multivitamins (MANUFACTURER UNKNOWN), all taken for unspecified indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 03May2021 at 15:00 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 not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24May2021 at 23:15, within 8 hours of vaccine, the patient experienced pain in uterus/ovary areas, it was not related to her period cycle as that had been over two weeks prior and the pain lasted the following day, it was intensified when breathing deeply or sucking in stomach. On 24May2021, the patient experienced shakiness until two days after. On 25May2021, the day after the vaccine not until 5 hours into work, the patient experienced mild low-grade fever, headache and hard to stand energy wise, the headache was intensified when vertical through the rest of that day. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events pain in uterus/ovary areas and shakiness were resolved on 25May2021 and 26May2021 respectively, while the outcomes of mild low-grade fever, headache and hard to stand energy wise were resolved on an unknown date on May2021.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: I got red on my jaw and down my neck and it was kind of swollen under my jaw; I got red on my jaw and down my neck and it was kind of swollen under my jaw; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 72-year-old female patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: unknown, Expiry Date: Unknown), via an unspecified route of administration in right arm on 24May2021 as single dose for COVID-19 immunisation. Patient stated that it looks like EW or CW she could not read the writing 0185 and expiration date: nothing written on the back of the card. The patient's medical history included blood pressure high, thyroid, these little pin point rash things on her forehead. She had it before years ago and was told it was shingles associated with a migraine headache. She have not had it for several years. It went away after a couple of days. A few months back she had a swollen gland in that same area she thought it might be long Covid. If it was an allergy it lasted a few days and she took Benadryl. Doctor told her to take the second dose and to take 50 mg of Benadryl before getting the second dose. Concomitant medications were not reported. On 24May2021, eight to nine hours after the shot, the patient noticed that I got red on my jaw and down my neck and it was kind of swollen under my jaw. It was explained that she got the Pfizer vaccine day before yesterday and about might be 8 or 9 hours after she got red on her jaw and down her neck and it was kind of swollen under her jaw and so she was just wondering if she only get the one shot, was that considered an adverse effect that she should not get the second shot. So, if she only get the first shot how much was she protected. Upon Follow up (02Jun2021), patient received the first dose of the Pfizer Covid 19 vaccine on 24May2021. She reported that she got like for one thing she got these little pin point rash things on my forehead. She had it before years ago and was told it was shingles associated with a migraine headache. She haven't had it for several years. It went away after a couple of days. Eight to nine hours after the shot, She got redness on face and some swelling there a little bit. Does that sound like an allergy? Should she get the second shot? What protection, the percentage, if you only got the first shot? She think she had Covid back at the beginning before they were testing for it. She was wondering if she can go without that second shot. A few months back she had a swollen gland in that same area she thought it might be long Covid. If it was an allergy it lasted a few days and she took Benadryl. She called the doctor already and she told me to take the second dose and to take 50mg of Benadryl before getting the second dose. Patient received liquid Benadryl as treatment. The outcome of the events was unknown.  Limited information was available over the call. Information about the Lot/batch number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Glossodynia
Clinical narrative: Sore on left side of tongue; This is a spontaneous report from a contactable healthcare professional, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the right arm on 26Apr2021 at 16:00 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. Medical history included heart disorder, joint/pain back and neck, hypertension (htn), hyperlipidemia, angina, diabetes, and allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took (diclofenac) VOLTAREN and (topiramate) TOPAMAX; both for an unspecified indication from an unknown date and experienced drug allergy. 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 29Mar2021 at 16:00 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. On 24May2021 at 01:00, the patient experienced sore on the left side of the tongue. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with unspecified medication (Med). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore on left side of tongue was not recovered at the time of this report.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Generalized hives; itching/hives persistwith little improvement 15 days afterreceiving vaccine; This is a spontaneous report from a contactable physician. A 14-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 15May2021 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. The patient did not receive other medications in two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021, the patient experienced generalized hives within few hours of receiving vaccine, itching/hives persisted with little improvement 15 days after receiving vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with prednisone. The clinical outcome of the events generalized hives, itching/hives persisted was recovering.  Information on the lot/batch number has been requested.