chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Lymphadenopathy
Clinical narrative: Swollen Lymph nodes in neck/  Lymph node swelling comes off and on for about 3weeks; Higher body temp than normal. Generally run at 97.6-98.1 and have been running at 98.7-99.1.; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the left arm on 03Mar2021 at 12:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression, ADD (attention deficit disorder), known allergies to tide detergent and COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). Concomitant medications included sertraline hydrochloride (ZOLOFT) for an unknown indication, from an unknown date and unknown if on going. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 10Feb2021 at 07:15 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Apr2021, the patient experienced swollen lymph nodes in neck and higher body temp than normal. Generally, run at 97.6-98.1 (unspecified units) and had been running at 98.7-99.1 (unspecified units). Lymph node swelling was off and on for about 3weeks. 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. No therapeutic measures were taken as a result of the events. The clinical outcome of the events swollen lymph nodes in neck and higher body temp than normal was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Vertigo
Clinical narrative: Dizzy Spells and Vertigo for about a week and a half any time I bent over or reached my arm in the sky; Dizzy Spells and Vertigo for about a week and a half any time I bent over or reached my arm in the sky; Exhaustion too but that seems to be expected.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 28Mar2021 at 16:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included coronary artery disease and microvascular Disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included unspecified cardiac medications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 28Feb2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 29Mar2021 the patient experienced dizzy spells and vertigo for about a week and a half at any time she bent over or reached her arm in the sky and exhaustion too but that seemed to be expected. The event resulted in doctor or other healthcare professional office/clinic visit. 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's dizzy spells and vertigo for about a week and a half at any time she bent over or reached her arm in the sky and exhaustion too but that seemed to be expected was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased activity, Fatigue, Pain in extremity
Clinical narrative: slightly sore arm; unable to push self nearly as much as usual, want overly tired, but unable to workout intensely for over 2 hours for a week+. And a workout of this length of usually very easy; unable to push self nearly as much as usual, want overly tired, but unable to workout intensely for over 2 hours for a week+. And a workout of this length of usually very easy/ want able to find anydata on extreme endurance.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient 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 30Mar2021 at 12:00 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 COVID vaccine. On 02Apr2021 at 08:00, the patient noticed no immediate effects besides a slightly sore arm. The patient described himself as an extreme endurance athlete. The patient took a couple days off of intense exercise, but a few days later had longer works planned (3 plus hours, intense biking). It was very noticeable that patient couldn't get his heart rate up and was unable to push nearly as much as usual. He was overly tired and was unable to workout intensely for over 2 hours for a week plus and a workout of that length was usually very easy. He thought he was fully recovered , just took second shot, but was not able to find any data on extreme endurance. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events slightly sore arm, noticeable that couldn't get heart rate up, was unable to push self nearly as much as usual, want overly tired, but was unable to workout intensely for over 2 hours for a week+ and a workout of this length of usually very easy was resolved on an unknown date in Apr2021. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021, as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: started experiencing a lot of joint pain, especially in my hands, elbows, and wrists/ shoulders/ hip/ knees; make something as simple as getting ready in the morning extremely painful; experiencing joint pain in my hands/ feet; This is a spontaneous report from a contactable Consumer or other non-health care professional (patient).  A 31-years-old female patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on an unspecified date (at the age of 31-years-old) as dose 1, single for covid-19 immunization. Medical history included High blood pressure from an unknown date and unknown if ongoing. Patient had known allergies with milk. Concomitant medications were not reported. No covid prior vaccination and not tested post vaccination. It was reported that between her first and second COVID shot on 21Mar2021 04:00 PM, she started experiencing a lot of joint pain, especially in my hands, elbows, and wrists that make something as simple as getting ready in the morning extremely painful. AE resulted in doctor or other healthcare professional office/clinic visit. Treatment received for events reported with Predisone. Outcome of events was not recovered.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Left arm pain; Fever; Chills; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0169) via an unspecified route of administration in the left arm on 24Apr2021 at 15:45 at the age of 58-year-old as a single dose for COVID-19 immunisation. Medical history included covid-19. 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. The patient did not receive any other concomitant medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the left arm on 01Apr2021 at 15:45 at the age of 58-year-old, as a single dose for COVID-19 immunisation. On 25Apr2021 at 06:00, the patient experienced left arm pain, fever, chills, and fatigue. The events did not result in doctor or other healthcare professional office or clinic visit, 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 been tested for COVID-19. On 20Apr2021, the patient underwent SARS-CoV-2 PCR test and the result was found to be negative. The clinical outcome of the events left arm pain, fever, chills, and fatigue were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance
Clinical narrative: Severe lower back pain; It hurts to walk; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient 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 22Apr2021 at 14:15 (at the age of 25-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 23Apr2021 at 08:00, the patient experienced severe lower back pain and it hurt to walk. 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 severe lower back pain and it hurt to walk was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle tightness, Nausea, Pain in jaw, Tinnitus
Clinical narrative: 2nd day after vaccine exhaustion, nausea. Those were done in a couple of days.; 2nd day after vaccine exhaustion, nausea. Those were done in a couple of days.; Same time jaw pain and tightness started along with "my" very mild tinnitus at least doubling.; Same time jaw pain and tightness started along with "my" very mild tinnitus at least doubling.; Same time jaw pain and tightness started along with "my" very mild tinnitus at least doubling.; This is a spontaneous report from a contactable consumer, the patient. A 39-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 in the left arm on 10Apr2021 at 16:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included ascorbic acid (VITAMIN C), vitamin d nos (VITAMIN D), multivitamin (unspecified), probiotics (unspecified) and zinc (MANUFACTURER UNKNOWN); all for unspecified indications from unknown dates and unknown if ongoing. On 12Apr2021 at 00:00, 2nd day after vaccine, the patient experienced exhaustion and nausea. Those were done in a couple of days.  Same time the patient also experienced jaw pain and tightness which was started along with very mild tinnitus at least doubling. These second set of symptoms were there after more than 2 weeks. The events resulted in doctor or other healthcare professional office/clinic visit. 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 exhaustion and nausea was resolved on an unknown date in Apr2021, while that of the events jaw pain and tightness which was started along with very mild tinnitus was not resolved at the time of the report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Hyperhidrosis, Night sweats
Clinical narrative: Chills; Aches; severe body shakes; Temperature of at least 101.0 Fahrenheit; Sweating; Fatigue; Restless sleep; Night sweats; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 22Apr2021 at 18:00 (at the age of 31-year-old), as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and anxiety. 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 COVID vaccine. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), ethinylestradiol, norgestimate (TRI-SPRINTEC), leflunomide (MANUFACTURER UNKNOWN), upadacitinib (RINVOQ) and cyanocobalamin (B 12); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received nitrofurantoin (MACROBID) and azithromycin (Z-PAK); both for unknown indication from an unknown date and experienced drug allergy and previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 01Apr2021 at 17:30 (at the age of 31-year-old), as a single dose for COVID-19 immunisation. On 23Apr2021 at 09:00, the patient experienced chills, aches, and severe body shakes. Temperature of body was atleast 101.0 Fahrenheit measured after the chills, aches and shakes subsided. The patient also experienced sweating, night sweats, fatigue and restless sleep. 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 reported events and included treatment with over-the-counter paracetamol (TYLENOL). On 23Apr2021, the patient underwent lab tests and procedures which included body temperature and the result was 101.0 Fahrenheit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, aches and severe body shakes, temperature of body was 101.0 Fahrenheit, sweating, night sweats, fatigue and restless sleep was resolved on unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Poor quality sleep, Pyrexia, Tremor
Clinical narrative: Chills; Aches; severe body shakes; Temperature of at least 101.0 Fahrenheit; Sweating; Fatigue; Restless sleep; Night sweats; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 22Apr2021 at 18:00 (at the age of 31-year-old), as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and anxiety. 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 COVID vaccine. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), ethinylestradiol, norgestimate (TRI-SPRINTEC), leflunomide (MANUFACTURER UNKNOWN), upadacitinib (RINVOQ) and cyanocobalamin (B 12); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received nitrofurantoin (MACROBID) and azithromycin (Z-PAK); both for unknown indication from an unknown date and experienced drug allergy and previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 01Apr2021 at 17:30 (at the age of 31-year-old), as a single dose for COVID-19 immunisation. On 23Apr2021 at 09:00, the patient experienced chills, aches, and severe body shakes. Temperature of body was atleast 101.0 Fahrenheit measured after the chills, aches and shakes subsided. The patient also experienced sweating, night sweats, fatigue and restless sleep. 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 reported events and included treatment with over-the-counter paracetamol (TYLENOL). On 23Apr2021, the patient underwent lab tests and procedures which included body temperature and the result was 101.0 Fahrenheit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, aches and severe body shakes, temperature of body was 101.0 Fahrenheit, sweating, night sweats, fatigue and restless sleep was resolved on unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hot flush
Clinical narrative: Severe headache; Severe muscle and joint aches; Severe muscle and joint aches; Could not sleep all night; Mild nausea; Chills; Hot flashes; Burning lungs; Scratchy sinuses; Sore throat; Severe fatigue; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 23Apr2021 at 16:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and portal vein thrombosis (PVT). The patient had no known allergies. 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 levothyroxine (MANUFACTURER UNKNOWN), cyanocobalamin-tannin complex (B12), one a day multi-vitamin (MANUFACTURER UNKNOWN) and cannabidiol (MANUFACTURER UNKNOWN); all for unknown indication from an 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 02Apr2021 at 11:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 11:00, the patient experienced severe headache, severe muscle and joint aches (could not sleep all night because it hurt so bad), mild nausea, chills, hot flashes, burning lungs, scratchy sinuses, sore throat and severe fatigue. 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 severe headache, severe muscle and joint aches (could not sleep all night because it hurt so bad), mild nausea, chills, hot flashes, burning lungs, scratchy sinuses, sore throat and severe fatigue was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Nausea, Oropharyngeal pain, Pleuritic pain
Clinical narrative: Severe headache; Severe muscle and joint aches; Severe muscle and joint aches; Could not sleep all night; Mild nausea; Chills; Hot flashes; Burning lungs; Scratchy sinuses; Sore throat; Severe fatigue; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 23Apr2021 at 16:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and portal vein thrombosis (PVT). The patient had no known allergies. 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 levothyroxine (MANUFACTURER UNKNOWN), cyanocobalamin-tannin complex (B12), one a day multi-vitamin (MANUFACTURER UNKNOWN) and cannabidiol (MANUFACTURER UNKNOWN); all for unknown indication from an 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 02Apr2021 at 11:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 11:00, the patient experienced severe headache, severe muscle and joint aches (could not sleep all night because it hurt so bad), mild nausea, chills, hot flashes, burning lungs, scratchy sinuses, sore throat and severe fatigue. 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 severe headache, severe muscle and joint aches (could not sleep all night because it hurt so bad), mild nausea, chills, hot flashes, burning lungs, scratchy sinuses, sore throat and severe fatigue was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus pain
Clinical narrative: Severe headache; Severe muscle and joint aches; Severe muscle and joint aches; Could not sleep all night; Mild nausea; Chills; Hot flashes; Burning lungs; Scratchy sinuses; Sore throat; Severe fatigue; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 23Apr2021 at 16:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and portal vein thrombosis (PVT). The patient had no known allergies. 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 levothyroxine (MANUFACTURER UNKNOWN), cyanocobalamin-tannin complex (B12), one a day multi-vitamin (MANUFACTURER UNKNOWN) and cannabidiol (MANUFACTURER UNKNOWN); all for unknown indication from an 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 02Apr2021 at 11:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 11:00, the patient experienced severe headache, severe muscle and joint aches (could not sleep all night because it hurt so bad), mild nausea, chills, hot flashes, burning lungs, scratchy sinuses, sore throat and severe fatigue. 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 severe headache, severe muscle and joint aches (could not sleep all night because it hurt so bad), mild nausea, chills, hot flashes, burning lungs, scratchy sinuses, sore throat and severe fatigue was recovering 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: Arthralgia, Decreased appetite, Headache, Insomnia, Joint swelling
Clinical narrative: Swelling of my face; Hand joint swelling; Sever muscles pain; Sever joint pain; Severe arm pain emanating from the injection site; Reduced appetite; Feeling unwell; Headache; Feeling pressured behind eyes; Difficulty sleeping; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 24Apr2021 at 16:30 (at the age of 52-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 received unspecified other vaccines within four weeks prior to the vaccination. Concomitant medications included estradiol (MANUFACTURER UNKNOWN), vortioxetine hydrobromide (TRINTELLIX) and nortriptyline (MANUFACTURER UNKNOWN); all were taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 13:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient previously took levofloxacin (MANUFACTURER UNKNOWN) and ciprofloxacin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 24Apr2021 at 20:00, the patient experienced swelling of her face, hand joint swelling, severe muscles pain, severe joint pain, severe arm pain emanating from the injection site, reduced appetite and feeling unwell including headache, feeling pressured behind eyes and difficulty sleeping. 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 swelling of her face, hand joint swelling, severe muscles pain, severe joint pain, severe arm pain emanating from the injection site, reduced appetite and feeling unwell including headache, feeling pressured behind eyes and difficulty sleeping were 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: Malaise, Myalgia, Ocular discomfort, Pain in extremity, Swelling face
Clinical narrative: Swelling of my face; Hand joint swelling; Sever muscles pain; Sever joint pain; Severe arm pain emanating from the injection site; Reduced appetite; Feeling unwell; Headache; Feeling pressured behind eyes; Difficulty sleeping; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 24Apr2021 at 16:30 (at the age of 52-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 received unspecified other vaccines within four weeks prior to the vaccination. Concomitant medications included estradiol (MANUFACTURER UNKNOWN), vortioxetine hydrobromide (TRINTELLIX) and nortriptyline (MANUFACTURER UNKNOWN); all were taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 13:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient previously took levofloxacin (MANUFACTURER UNKNOWN) and ciprofloxacin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 24Apr2021 at 20:00, the patient experienced swelling of her face, hand joint swelling, severe muscles pain, severe joint pain, severe arm pain emanating from the injection site, reduced appetite and feeling unwell including headache, feeling pressured behind eyes and difficulty sleeping. 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 swelling of her face, hand joint swelling, severe muscles pain, severe joint pain, severe arm pain emanating from the injection site, reduced appetite and feeling unwell including headache, feeling pressured behind eyes and difficulty sleeping were not recovered 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: Menstruation irregular, Vaginal haemorrhage
Clinical narrative: some bloody discharge like menstruation; very light menstruation outside of regular menstruation period; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24Apr2021 at 13:45 at the age of 28-year-old as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. 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. Concomitant medications included LOESTRIN for birth control from an unknown date and unknown if ongoing, VITAMIN D from unknown date for unknown indication and unknown if ongoing and ASHWAGANDHA from unknown date for unknown indication and unknown if ongoing. On 24Apr2021 at 16:00, the patient experienced very light menstruation outside of regular menstruation period. The patient had her regular menstruation a week before receiving the second vaccine dose, and then after receiving the second dose, she had some bloody discharge like menstruation. 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 very light menstruation outside of regular menstruation period and some bloody discharge like menstruation was resolving 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever; Headache; Body aches; Teeth chattering chills; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 17Apr2021 at 09:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. 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 cyanocobalamin (VITAMIN B12) and vitamin d nos (MANUFACTURER UNKNOWN); taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 25Mar2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 21:00, 12 hours after the second shot, the patient experienced fever, headache, body aches and teeth chattering chills, fully recovered 24 hours later. 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 fever, headache, body aches and teeth chattering chills was recovered on 18Apr2021 at 21:00.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: Headache (48-72 hours); Nausea; Fever; Chills; Fatigue; Joint pain; General soreness; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 15:45 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol;norgestimate (TRI-SPRINTEC) for unspecified indications, from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. 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 30Mar2021 at 15:45 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 05:30, the patient experienced headache (48-72 hours), nausea, fever, chills, fatigue, joint pain and general soreness. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events headache (48-72 hours), nausea, fever, chills, fatigue, joint pain, general soreness was resolved on an unknown date in 2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Headache (48-72 hours); Nausea; Fever; Chills; Fatigue; Joint pain; General soreness; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 15:45 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol;norgestimate (TRI-SPRINTEC) for unspecified indications, from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. 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 30Mar2021 at 15:45 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 05:30, the patient experienced headache (48-72 hours), nausea, fever, chills, fatigue, joint pain and general soreness. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events headache (48-72 hours), nausea, fever, chills, fatigue, joint pain, general soreness was resolved on an unknown date in 2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Chills; Body aches/ body aches were most intense around my hips; Extreme fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 23Apr2021 at 13:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimotos. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration on an unknown date in Mar2021 as a single dose for COVID-19 immunisation. On 24Apr2021, the patient experienced chills, body aches, extreme fatigue. Body aches were most intense around her hips. 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 chills, body aches, body aches were most intense around hips and extreme fatigue was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Red itchy rash on chest; This is a spontaneous report from a contactable nurse, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 13Apr2021 at 10:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine, cervical disc herniation and urticaria. 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 the COVID-19 vaccine. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), metoprolol (MANUFACTURER UNKNOWN), cyclobenzaprine hydrochloride (FLEXERIL) and hydroxyzine (MANUFACTURER UNKNOWN) and mul (as reported); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received sulfamethoxazole/trimethoprim (BACTRIM) and vancomycin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 13Apr2021 at 22:15, approximately 12 hours after receiving vaccine, the patient experienced red itchy rash on chest. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event and included treatment with diphenhydramine (BENADRYL) and the patient got relieved by taking it. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event red itchy rash on chest was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pain, Pyrexia, Urticaria
Clinical narrative: Low grade fever; Mild headache; Swollen lymph nodes; Welt; Pain; Itchy injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Apr2021 at 12:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. 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 COVID-19 vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02Apr2021 at 12:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021, the patient experienced low grade fever, mild headache, swollen lymph nodes, welt, pain, and itchy injection site. 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 low grade fever, mild headache, swollen lymph nodes, welt, pain, and itchy injection site was not recovered 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Low grade fever; Mild headache; Swollen lymph nodes; Welt; Pain; Itchy injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Apr2021 at 12:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. 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 COVID-19 vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02Apr2021 at 12:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021, the patient experienced low grade fever, mild headache, swollen lymph nodes, welt, pain, and itchy injection site. 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 low grade fever, mild headache, swollen lymph nodes, welt, pain, and itchy injection site was not recovered 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: painful swelling of the left supraclavicular lymph node; painful swelling of the left supraclavicular lymph node; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 19Apr2021 at 15:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included depression. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included nefazodone (MANUFACTURER UNKNOWN) and venlafaxine (MANUFACTURER UNKNOWN) both 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 20Apr2021 at 20:00, the patient experienced painful swelling of the left supraclavicular lymph node. 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 painful swelling of the left supraclavicular lymph node was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Muscle spasms
Clinical narrative: Menstrual cycle started 2 weeks early and is extremely heavy.; Menstrual cycle started 2 weeks early and is extremely heavy.; I never experience cramping and have had very intense cramping since the morning after my 2nd dose was administered.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 22Apr2021 at 14:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety and psoriasis on unknown dates. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Apr2021 at 14:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021, the patient's menstrual cycle started 2 weeks early and was extremely heavy. She never experienced cramping and had very intense cramping since 23Apr2021, the morning after her 2nd dose was administered. 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. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events menstrual cycle started 2 weeks early, heavy menstruation and cramping was not resolved 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.