chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Vaccination site pain
Clinical narrative: The day I was vaccinated I had the usual soreness at the injection site and for the next day; Headache; Lymph nodes at the back of my neck were swollen; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ZN6205) via an unspecified route of administration in the arm left on 25Feb2021 at 15:45 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications taken within two weeks included fexofenadine hydrochloride (ALLEGRA) from an unknown date for an unknown indication. On 05Mar2021 at 03:30, on the day of vaccination, the patient experienced usual soreness at the injection site and for the next day. A week after she got the shot she got a headache so bad she had to take Tylenol for it but she also noticed her lymph nodes at the back of her neck were swollen, she called her daughter, she's working on her PHD in infectious diseases, and told her about her swollen lymph nodes and her daughter told her that she need to report it. The daughter told that means the vaccine was working and her body was doing what it's suppose to be doing. The events 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 events vaccination site pain, headache and swollen lymph nodes and included treatment with paracetmol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vaccination site pain, headache and swollen lymph nodes was resolved in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Mar2021 at 16:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and allergies to cillin based medications. 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 lansoprazole (PREVACID), pioglitazone (MANUFACTURER UNKNOWN) and unspecified birth control; all for an unknown indication from an unknown date and unknown if ongoing. On 09Mar2021 at 17:00, the patient experienced metallic taste. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event metallic taste was resolved on an unknown date in Mar2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Muscle soreness at injection site (left arm); Muscle soreness (left arm); This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 25Feb2021 at 15:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient medical history reported was not applicable. 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 COVID vaccine. Concomitant medications were not reported. On 25Feb2021 at 19:00, the patient experienced muscle soreness at injection site (left arm). The event 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 reported events. The clinical outcome of the event muscle soreness at injection site (left arm) was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Fatigue; Headache; Pain at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 03Mar2021 at 17:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to steroids. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paroxetine (MANUFACTURER UNKNOWN), zaleplon (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN), withania somnifera (ASHWAGANDHA) and ibuprofen (IBUPROF); all taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 the patient experienced fatigue, headache and pain at injection site. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, headache and pain at injection site was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Tenderness at the injection site.; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 03Mar2021 at 09:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included bupropion (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and heights (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Mar2021 at 17:00, the patient experienced tenderness at the injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tenderness at the injection site was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: Flu like systems; Headache; Body aches; Fatigue; Nausea; Painful arm; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Eng6203) via an unspecified route of administration in the right arm on 03Mar2021 at 07:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The medical history included diabetes, fibromyalgia, allergy to opioids and the patient was a breast cancer survivor. 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. The concomitant medications included metformin (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), losartan potassium (LOSARTIN) and atenolol (MANUFACTURER UNKNOWN), all from unknown dates for unknown indications and unknown if ongoing. The patient previously received tetracycline (MANUFACTURER UNKNOWN), morphine (MANUFACTURER UNKNOWN) and amoxicillin/clavulanic acid (AUGMENTIN) and experienced allergy. On 03Mar2021 at 13:00, the patient experienced flu like symptoms, headache, body aches, fatigue, nausea and painful arm. The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flu like symptoms, headache, body aches, fatigue, nausea and painful arm was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Flu like systems; Headache; Body aches; Fatigue; Nausea; Painful arm; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Eng6203) via an unspecified route of administration in the right arm on 03Mar2021 at 07:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The medical history included diabetes, fibromyalgia, allergy to opioids and the patient was a breast cancer survivor. 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. The concomitant medications included metformin (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), losartan potassium (LOSARTIN) and atenolol (MANUFACTURER UNKNOWN), all from unknown dates for unknown indications and unknown if ongoing. The patient previously received tetracycline (MANUFACTURER UNKNOWN), morphine (MANUFACTURER UNKNOWN) and amoxicillin/clavulanic acid (AUGMENTIN) and experienced allergy. On 03Mar2021 at 13:00, the patient experienced flu like symptoms, headache, body aches, fatigue, nausea and painful arm. The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flu like symptoms, headache, body aches, fatigue, nausea and painful arm was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: Swollen lymph nodes in left axils of left arm.; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El9269) via an unspecified route of administration on 06Feb2021 at 17:15 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included helicobacter pylori (HP) infection under control with meds. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received codeine (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 27Feb2021 at 17:15, the patient experienced swollen lymph nodes in the left axils of the left arm and tiredness. 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 swollen lymph nodes in the left axils of the left arm and tiredness were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test, Vomiting
Clinical narrative: severe dizziness; vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 71-year-old male patient received first dose of BNT162b2 (COMIRNATY, Lot number: EN6199) via an unspecified route of administration on the left arm on 14Feb2021 at 10:15 (at the age of 71-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration on the left arm on 07Mar2021, at 10:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergy to iodine. The patient received unspecified concomitant medications. On 30Oct2020, the patient underwent SARS-CoV-2 test and the result was negative. 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 14Feb2021 at 14:15, the patient experienced dizziness and vomiting. It was reported that the patient had severe dizziness and vomiting; at 1st dose, after about 4 hours and lasted for 6 hours. At 2nd dose, after about 24 hours and lasted for 12 hours, and still not fully recovered the next day. The dizziness was very strong that he felt the whole world was turning, and his stomach vomited whatever he had and tried to eat or drink. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event dizziness and vomiting was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Lymphadenopathy, Vomiting
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM-9809) via an unspecified route of administration in the left arm on 26Feb2021 at 12:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), polycarbophil calcium (FIBER), multivitamins (MANUFACTURER UNKNOWN); all medications from an unknown date and unknown if ongoing for unknown indications. 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: EL-9261) via an unspecified route of administration in the right arm on 05Feb2021 at 12:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 28Feb2021 at 14:30, the patient experienced swollen lymph nodes in armpit. On 28Feb2021 at 19:00, the patient experienced severe vomiting and diarrhea. The patient was surprised that these symptoms did not start until 48 plus hours after injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph nodes in armpit, severe vomiting and diarrhea were resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Vaccination site pain
Clinical narrative: Bad sore throat; swollen lymph nodes; arm pain at the injection site three hours after injection.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 01Mar2021 at 12:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, obesity and allergy to tomatoes, white potatoes, blueberries and cranberries. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included labetalol (MANUFACTURER UNKNOWN), telmisartan (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL); all for unknown indication from unknown date and unknown if ongoing. The patient previously received levofloxacin (LEVAQUIN) on unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Mar2021 at 15:45, three hours after injection, the patient experienced arm pain at the injection site. On 02Mar2021, the next day, the patient experienced swollen lymph nodes. On 03Mar2021, the third day, the patient experienced bad sore throat. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain at the injection site, swollen lymph nodes and bad sore throat was recovering at this time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling jittery
Clinical narrative: "I" was having a jittery episode, like the kind that happens when "I" take a steroid.  It lasted until about 2a/could not be still; I was exhausted; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 07:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea, anxiety, depression, overweight and allergy to sulfa drugs(sulfonamide allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) taken for an unknown indication from an unknown date and unknown if ongoing. On 03Mar2021 the patient was fine until 22:30. Then while patient was in bed, patient was having a jittery episode, like the kind that happens when patient took a steroid. It lasted until about 02:00. The patient heart was not racing, was not fast breathing. but patient could not be still and though patient was exhausted, could not rest. 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 jittery episode and exhausted, could not rest was recovered on 04Mar2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Peripheral swelling, Vaccination site discomfort
Clinical narrative: Feeling extremely weak approximately 9 hours after and the following day.; Slight discomfort at the injection site; Swelling of the upper arm area; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 10:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had known allergies to penicillin and shellfish.  Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received neomycin sulfate; polymyxin b sulfate; bacitracin (NEOSPORIN) and experienced drug allergy. On 03Mar2021 at 20:00 the patient felt extremely weak approximately 9 hours after and the following day. Slight discomfort at the injection site with noticeable swelling of the upper arm area. The events did not result in doctor or other healthcare professional office/clinic visit, and 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 reported events. The clinical outcome of the events felt extremely weak, slight discomfort at the injection site and swelling of the upper arm area was 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Hypertension, Malaise, Nausea
Clinical narrative: Headache; Malaise; Nausea; Diarrhea; High blood pressure; Medical history given as High blood pressure (HBP) and event was also high blood pressure.; This is a spontaneous report from a contactable consumer, the patient. A 46-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 08Mar2021 at 16:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included myasthenia gravis, Hashimoto's and High Blood Pressure (HBP). The patient was allergic to tricyclics, benzopene and nut products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medication within 2 weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient previously received  cyclobenzaprine hydrochloride (FLEXERIL) and experienced drug allergy. 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 15Feb2021 at 15:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 08Mar2021 at 16:00, the patient experienced headache, malaise, nausea, diarrhea and high blood pressure. The events did not result in doctor or other healthcare professional office/clinic, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, malaise, nausea, diarrhea and high blood pressure were recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Pain; swelling and redness at injectionsite; swelling and redness at injectionsite; Runny nose; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 09Mar2021 at 15:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, high blood pressure (HBP), hyperlipidemia, depression and obesity. The patient received concomitant medications within two weeks, but were not specified. The patient previously received bupropion hydrochloride (WELLBUTRIN) from an unknown date and experienced allergy to the medication. 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 09Mar2021 at 15:45, the patient experienced pain, swelling and redness at injection site and runny nose. The events did not result in doctor or other health care 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 pain, swelling and redness at injection site and runny nose was recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Gastrointestinal pain, Illness, Vomiting
Clinical narrative: vomited 44 times that day I could not keep anything in my stomach; extreme pain in my stomach area and in intestine area; extreme pain in my stomach area and in intestine area; sick; This is a spontaneous report from a contactable consumer (patient) via regulatory authority. This male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6200) via an unspecified route of administration in the left arm on 23Feb2021 at 11:00 as a single dose for COVID-19 immunisation. Medical history included heart disease from an unknown date and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19, had not received any other vaccines within 4 weeks and had no known allergies. The patient received unspecified concomitant medications within 2 weeks of vaccination. On 25Feb2021, the patient got up in the morning and went to work; he reported he was in extreme pain in the stomach area and in the intestine area and vomited 44 times that day. He reported he could not keep anything in his stomach, which lasted 4 days; further stating he could not even take his daily medications which were critical to him. He stated he was never so sick in his life and would not be getting the second dose. The events required a doctor's office visit, and no treatment was received. The clinical outcomes of the events were recovering. Since vaccination the patient had not been tested for COVID-19.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspepsia
Clinical narrative: Indigestion; Chills; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 25Feb2021 at 09:15 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies possibly sulfa. 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 testosterone enanthate (ARNOLD), losartan (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 03Feb2021 at 13:45 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. On 26Feb2021, the patient experienced indigestion and chills. 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 indigestion and chills were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness, lightheaded; This is a spontaneous report from a contactable consumer, the patient. A 32-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 03Mar2021 at 17:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient's  medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included  amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate (ADDERALL) and lamotrigine (LAMICTAL) all from an unknown date for an unknown indication and was unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 03Mar2021, the patient experienced dizziness and lightheaded. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness and lightheaded was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Significant worsening of tinnitus.; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 27Feb2021 at 07:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 28Feb2021, the patient experienced significant worsening of her tinnitus. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event significant worsening of tinnitus was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Nausea, Product administered at inappropriate site
Clinical narrative: Vaccine administered at inappropriate site; Dizzy; Anxious; Nausea; This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via intramuscular route of administration in the left leg on 01Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01Mar2021, the patient experienced dizzy, anxious and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with ondansetron. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events dizzy, anxious and nausea were recovered on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain, Peripheral swelling
Clinical narrative: Exhaustion; Very sore; Swollen arm; Foggy brain; This is a spontaneous report from a non-contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 04Mar2021 at 16:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included major depressive disorder, anxiety, high cholesterol and glaucoma. The patient previously received erythromycin (E-MYCIN), tetracycline hydrochloride (SUMYCIN), quinine sulfate (QUININE) and trazodone hydrochloride (DEPRAX) and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID -19.Concomitant medications included fluoxetine hydrochloride (PROZAC), simvastatin (MANUFACTURER UNKNOWN), calcium levomefolate (DEPLIN) and latanoprost (MANUFACTURER UNKNOWN); all for an unknown indication, from an unknown date and unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. On 05Mar2021 at 12:00, the patient experienced exhaustion, very sore, swollen arm, and foggy brain. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events exhaustion, very sore, swollen arm and foggy brain 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Left temple Migraine; Random temple pain; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 10Feb2021 at 12:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. 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 20Jan2021 at 12:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 12Feb2021 at 12:00, 2 days after the vaccination, the patient experienced left temple migraine which lasted for 4 days or so. She also experienced random temple pain on and off for days where she never had a headache like that. 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 left temple migraine and random temple pain was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain
Clinical narrative: Sore under arm pit couldn't raise it .  Although it has improved it still hurts.; Sore under arm pit couldn't raise it .; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the right arm on 27Feb2021 at 09:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as yes (unspecified). The patient had allergies to medications, food or other products (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. On 27Feb2021 at 09:00, the patient experienced sore under arm pit, couldn't raise it.  Although it had improved it still hurt. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore under arm pit, couldn't raise it was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache at crown of head.; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Mar2021 at 14:45 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO), trazodone (MANUFACTURER UNKNOWN) and alprazolam (XANAX) for unknown indication from an unknown date and unknown if ongoing. The patient previously took naproxen (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. On 09Mar2021 at 19:00, the patient experienced headache at crown of head. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache at crown of head was 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.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: Under left armpit swelling; Under left armpit pinching pain; This is a spontaneous report from a contactable consumer, the patient. An adult non-pregnant female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 08Mar2021 at 10:15 as a single dose for COVID-19 immunisation. Medical history included hemorrhoids. 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 4 weeks prior to the COVID vaccine. Concomitant medications included vitamin d nos (reported as generic: VITAMIN D) and ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, cupric oxide, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, zinc oxide (ONE A DAY WOMEN'S) for unknown indications from unknown dates and unknown if ongoing.  On 09Mar2021 at 19:00, the patient experienced under left arm pit swelling and pinching pain. 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 outcomes of the events under left arm pit swelling and pinching pain was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Glossodynia
Clinical narrative: Tongue soreness; Anxiety; This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an intramuscular route of administration in the left arm on 22Feb2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications were not reported. On 22Feb2021, the patient experienced tongue soreness and anxiety. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events tongue soreness and anxiety was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Headache; Muscle ache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the right arm on 04Feb2021 and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 01Mar2021 (both at the age of 45-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 04Feb2021, the patient experienced headache, muscle ache and fatigue. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, muscle ache and fatigue was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dizziness, Fatigue, Feeling of body temperature change
Clinical narrative: feeling lightheaded; I went to bed as I was feeling lightheaded and exhausted; After dinner last night, I started to feel nauseated; vomited a small amount of digested food; immediately developed a headache; immediately developed a chills, required extra blankets for warmth and cycled through hot/chilling cycles all night; required extra blankets for warmth and cycled through hot/chilling cycles all night; I had severe stomach pain; This is a spontaneous report from a contactable nurse.  A 73-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the right arm on 25Feb2021 at 15:45 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included transient ischemic attack (TIA), tinnitus and lactose intolerance. 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 tilactase (LACTASE), magnesium (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BABY ASPIRIN); all for an unknown indication from an unknown dates and unknown if ongoing. On 04Mar2021 at 19:00, the patient felt nauseated after dinner and vomited a small amount of digested food, immediately developed a headache and chills. The patient reported that her husband completed his second Pfizerer dose, ate the same dinner and did not have any effects. On the same day at 20:00, the patient went to bed and was feeling lightheaded and exhausted 2 hours ahead of schedule. she required extra blankets for warmth and cycled through hot and chilling cycles all night, had severe stomach pain, but no diarrhea or coughing. At 06:00, effects disappeared with the exception of light headedness and exhaustion. The patient also reported that her 77-year-old sister received the Moderna vaccine on 22Feb2021 and had a massive stroke on 23Feb2021. That left her to wonder if she should get the second dose on 18Mar2021 or not. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event nauseated, vomited, headache, hot chilling cycles, severe stomach pain, and chills were recovered on an unknown date in Mar2021, while the events feeling lightheaded and exhausted were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.