chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Pruritus
Clinical narrative: itchy red inflammation / lumps on elbows and knees; itchy red inflammation / lumps on elbows and knees; itchy red inflammation / lumps on elbows and knees. The inflammation spread slightly to forearms and there was a small amount on one of ankles.; This is a spontaneous report from a contactable healthcare professional, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the upper left arm on 06May2021 at 11:15 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any known allergies. Concomitant medications included METRONIDAZOLE for an unknown indication on an unknown date. 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 07May2021 at 00:00, the patient experienced itchy red inflammation/lumps on elbows and knees. The inflammation spread slightly to forearms and there was a small amount on one of ankles. 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 itchy, red inflammation, lumps on elbows, and knees, the inflammation spread slightly to forearms and there was a small amount on one of ankles was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue up to a week after Covid 2nd shot; This is a spontaneous report from a contactable healthcare professional, the patient. A 43-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 30Apr2021 at 15:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included diet-controlled diabetes mellitus (DM). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. 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: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 15:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 01May2021 at 08:00, after COVID 2nd shot, the patient experienced fatigue up to a week. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with acupuncture. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fatigue up to a week after Covid 2nd shot was resolved with sequelae on an unknown date in May2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Pain in extremity, Pruritus, Rash, Rash macular
Clinical narrative: Rash on both hands, left hand more severe/ splotchy red marks, about 4 in total/ main rash on left hand hurt and throbbed; Rash on both hands, left hand more severe/ splotchy red marks, about 4 in total/ main rash on left hand hurt and throbbed; Rash on both hands, left hand more severe/ splotchy red marks, about 4 in total/ main rash on left hand hurt and throbbed; Skin started to blister, after blistering, pain stopped and itchy started; Skin started to blister, after blistering, pain stopped and itchy started; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male 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 26Apr2021 at 10:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included sparse migraines and periodic back pain. 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 COVID-19 vaccine. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for an 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: ER8133) via an unspecified route of administration in the right arm on 05Apr2021 at 11:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 06:00, the patient experienced rash on both hands, left hand more severe and splotchy red marks, about 4 in total. It was reported that main rash on left hand hurt and throbbed and skin started to blister, after blistering, pain stopped and itchy started. 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 rash on both hands, left hand more severe/ splotchy red marks, about 4 in total/ main rash on left hand hurt and throbbed and skin started to blister, after blistering, pain stopped and itchy started was resolved with sequelae on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Heart rate, Heart rate increased, Loss of personal independence in daily activities
Clinical narrative: cardiac issues; resting heartrate has increased by 10 beats; ability to do normal activities ceased; This is a spontaneous report from a contactable consumer (patient herself). A male patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced cardiac issues. His resting heartrate has increased by 10 beats and he can no longer exercise due to extremely high heart rate. He had 3 years of data of my cardiac output prior to the shot and the day after his ability to do normal activities ceased. On an unspecified date, the patient underwent lab tests and procedures which included heart rate: my resting heartrate has increased by 10 beats. The outcome of the events was unknown.  No follow-up attempts are possible; no further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: Chest pain; Heart palpitation; This is a spontaneous report from a contactable consumer. A 16-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 10May2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication taken within two weeks of vaccination 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 previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 18Apr2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. On 10May2021, the patient experienced chest pain and heart palpitation. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chest pain and heart palpitation was resolved on an unknown date in May2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test
Clinical narrative: Extreme dizziness; This is a spontaneous report from a non-contactable nurse, the patient. A 38-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 right arm on 26Mar2021 (at the age of 38-years-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 take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 26Mar2021, the patient experienced extreme dizziness. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent Nasal swab test and the result was negative. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event extreme dizziness was recovered on an unknown date in 2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: No upward movement of shoulder after 3rd day of vaccination without severe pain; No upward movement of shoulder after 3rd day of vaccination without severe pain. After day 6 the pain is still there. I can hardly move my shoulder/ arm (left) to close my drivers door.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 02May2021 at 16:15 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and known allergies. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0161) via an unspecified route of administration in the left arm on 11Apr2021 at 16:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 04May2021 at 07:00, the patient experienced no upward movement of shoulder after third day of vaccination without severe pain. After day six, the pain was still there. He could hardly move his shoulder/arm (left) to close his driver's door. The event did not result in a visit to the doctors or other healthcare professional office/clinic, and 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 event. The clinical outcome of the event no upward movement of shoulder after third day of vaccination without severe pain and can hardly move my shoulder/ arm (left) to close drivers door was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: started feeling a small pain in 'my' right back side, similar to when you have a severe cough; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 16Apr2021 at 07:15(at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included triglycerides high. 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 rosuvastatin (MANUFACTURER UNKNOWN) started on an unknown date for unknown indication and unknown if ongoing. On 17Apr2021, the day after the second dose, the patient reported that he felt a small pain in his right back side, similar to a severe cough and the pain was tolerable but last week he had to start taking Ibuprofen (MANUFACTURER UNKNOWN) because the pain became more acute. He would schedule a visit to his doctor this week(as reported). The event 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 event which included treatment with ibuprofen(MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain in his right back side was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact
Clinical narrative: I have a poison oak like rash on legs arms back and stomach; This is a spontaneous report from a contactable consumer, the patient. A 64-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 26Apr2021 at 11:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to absolute vodka. The patient did not take any concomitant 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 26Apr2021, the patient had a poison oak like rash on legs arms back and stomach. She was not sure whether it was from the vaccination or was truly poison oak. 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 had a poison oak like rash on legs arms back and stomach was unknown 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: "I" woke up the next morning with chills; "I" woke up the next morning with chills, body aches; "I" woke up the next morning with chills, body aches, headache; "I" woke up the next morning with chills, body aches, headache, fatigue; "I" woke up the next morning with chills, bodyaches, headache, fatigue, nausea; Fever that went up to a maximum of 105.1 degrees Fahrenheit with a forehead thermometer; 10 hour after injection, "I" developed vomiting; Shoulder is very painful and stiff.; Shoulder is very painful and stiff.; This is a spontaneous report from a contactable nurse, the patient. A 37-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 06May2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The medical history included renal agenesis (congenital missing kidney), history of left calf deep vein thrombosis (DVT) in 2019 and homozygous for methylenetetrahydrofolate reductase (MTHFR) c677t mutation. 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 concomitant medications included bupropion (MANUFACTURER UNKNOWN), norethindrone (ERRIN) and women's multivitamin(unspecified), all from unknown dates for unknown indications and unknown if ongoing. 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 right upper arm on 15Apr2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation.   On 06May2021, second injection was done very high up in deltoid, almost at joint and the patient's shoulder was very painful and stiff. On 06May2021 at 22:00, the patient developed vomiting. On 07May2021, the next morning the patient woke up with chills, body aches, headache, fatigue, nausea and fever that went up to a maximum of 105.1 degrees fahrenheit with a forehead thermometer. On the same day, the patient underwent body temperature test and the result was found to be 105.1 degrees fahrenheit. Therapeutic measures were taken as a result of the reported events and included treatment with ibuprofen(MANUFACTURER UNKNOWN) 800 mg on an unknown date. The adverse 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. The clinical outcome of the events headache, shoulder was very painful and stiff, vomiting, chills, body aches, fatigue, nausea and fever that went up to a maximum of 105.1 degrees fahrenheit were resolving 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: "I" woke up the next morning with chills; "I" woke up the next morning with chills, body aches; "I" woke up the next morning with chills, body aches, headache; "I" woke up the next morning with chills, body aches, headache, fatigue; "I" woke up the next morning with chills, bodyaches, headache, fatigue, nausea; Fever that went up to a maximum of 105.1 degrees Fahrenheit with a forehead thermometer; 10 hour after injection, "I" developed vomiting; Shoulder is very painful and stiff.; Shoulder is very painful and stiff.; This is a spontaneous report from a contactable nurse, the patient. A 37-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 06May2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The medical history included renal agenesis (congenital missing kidney), history of left calf deep vein thrombosis (DVT) in 2019 and homozygous for methylenetetrahydrofolate reductase (MTHFR) c677t mutation. 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 concomitant medications included bupropion (MANUFACTURER UNKNOWN), norethindrone (ERRIN) and women's multivitamin(unspecified), all from unknown dates for unknown indications and unknown if ongoing. 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 right upper arm on 15Apr2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation.   On 06May2021, second injection was done very high up in deltoid, almost at joint and the patient's shoulder was very painful and stiff. On 06May2021 at 22:00, the patient developed vomiting. On 07May2021, the next morning the patient woke up with chills, body aches, headache, fatigue, nausea and fever that went up to a maximum of 105.1 degrees fahrenheit with a forehead thermometer. On the same day, the patient underwent body temperature test and the result was found to be 105.1 degrees fahrenheit. Therapeutic measures were taken as a result of the reported events and included treatment with ibuprofen(MANUFACTURER UNKNOWN) 800 mg on an unknown date. The adverse 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. The clinical outcome of the events headache, shoulder was very painful and stiff, vomiting, chills, body aches, fatigue, nausea and fever that went up to a maximum of 105.1 degrees fahrenheit were resolving 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Vaccination site pruritus
Clinical narrative: Delayed skin itchiness at site of injection; Arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 04May2021 at 10:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications was 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 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 13Apr2021 at 10:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 04May2021 at 14:00, the patient experienced delayed skin itchiness at site of injection and arm soreness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On an unknown date, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events delayed skin itchiness at site of injection and arm soreness was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: i have had intense itching at vaccine as well as bumps; i have had intense itching at vaccine as well as bumps; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 14Mar2021 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to shellfish. 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 included montelukast (MANUFACTURER UNKNOWN) for unspecified indication from an unknown date and unknown if ongoing. On 21Mar2021, for 8 weeks (as reported at the time of reporting), the patient experienced intense itching at vaccine as well as bumps. Nothing could stop it. The events resulted in 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 event intense itching at vaccine as well as bump was not resolved at the time of this report. The 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 unknown date in 2021 (at the age of 60-year-old), as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes on right underarm; This is a spontaneous report from a contactable health care professional, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration on the right arm on 06May2021 at 11:00 (at the age of 22-years-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 other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8B1) via an unspecified route of administration in the right arm on 14Apr2021 at 11:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 20:00, the patient experienced swollen lymph nodes on right underarm, 1 day after vaccine. The event did not result in a visit to the doctors or other healthcare professional office/clinic, and 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 swollen lymph nodes on right underarm was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Joint swelling, Myalgia, Pain, Pain in jaw
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERS235) via an unspecified route of administration on 24Apr2021 at 13:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included losartan (MANUFACTURER UNKNOWN) for an unknown indication from unknown date and unknown if ongoing. The patient did not receive 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 in the left arm on 03Apr2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 00:00, the patient experienced terrible head to toe body aches, swollen hands and joints, body aches to where patient felt like she was poisoned; jaw aches, muscles aching to where patient had to be in bed and could not walk or function without pain. The events did not result in doctor or other health care professional office/clinic visit, and 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 terrible head to toe body aches, swollen hands and joints, body aches to where patient felt like she was poisoned, jaw aches, muscles aching to where patient had to be in bed and could not walk or function without pain was resolved with sequelae on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERS235) via an unspecified route of administration on 24Apr2021 at 13:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included losartan (MANUFACTURER UNKNOWN) for an unknown indication from unknown date and unknown if ongoing. The patient did not receive 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 in the left arm on 03Apr2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 00:00, the patient experienced terrible head to toe body aches, swollen hands and joints, body aches to where patient felt like she was poisoned; jaw aches, muscles aching to where patient had to be in bed and could not walk or function without pain. The events did not result in doctor or other health care professional office/clinic visit, and 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 terrible head to toe body aches, swollen hands and joints, body aches to where patient felt like she was poisoned, jaw aches, muscles aching to where patient had to be in bed and could not walk or function without pain was resolved with sequelae on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus high frequency in background constant; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 02Apr2021 at 18:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid, low platelets and liver fibrosis. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA) and cetirizine hydrochloride (ZYRTEC); all for unknown indications from unknown dates and unknown if ongoing. 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 previously took dicloxacillin (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. On 06Apr2021 at 05:00, the patient experienced tinnitus high frequency in background which was constant. The event resulted in doctor or other healthcare professional office/clinic visit. 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 tinnitus high frequency in background which was constant was not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Rash papular, Urticaria
Clinical narrative: Hives on underside of left arm; Painful, burning and stinging; Still raised rash with same symptoms; Painful, burning and stinging; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 04May2021 at 12:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included (Facility name) chronic muscle pain, hip and knee. Pain resulting from Jan2020 school bus rear ended automobile in which she was passenger. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 13Apr2021 at 11:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient previously also received cefalexin (KEFLEX), vancomycin (MANUFACTURER UNKNOWN), clindamycin hydrochloride (CLEOCIN), desloratadine (LORETA), for unknown indication on an unknown date and experienced drug allergy. On 04May2021 at 17:00, Tuesday evening, the patient experienced hives on underside of left arm, painful, burning and stinging, still raised rash with same symptoms. 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 event hives on underside of left arm, painful, burning and stinging, still raised rash was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swelling and soreness of lymph nodes in left armpit; Swelling and soreness of lymph nodes in left armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05May2021 at 14:30 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 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 14Apr2021 at 14:30 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. On 06May2021 at 12:00, the patient experienced swelling in left armpit and soreness of lymph nodes in left armpit. 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 swelling in left armpit and soreness of lymph nodes in left armpit 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast swelling, Fluid retention, Uterine spasm
Clinical narrative: Cramping of uterus constantly; Swollen and sore breasts; Sore breasts; Water retention; This is a spontaneous report from a non-contactable consumer, the patient. A 44-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 30Apr2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient also received the first 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. On 03May2021, the patient experienced cramping of uterus constantly, swollen and sore breasts and water retention. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or 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 cramping of uterus constantly, swollen and sore breasts and water retention 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Myalgia, Palpitations
Clinical narrative: Fever; Muscle Pain; Chills; Diarrhea; Heart Palpitations; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 27-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 07May2021 at 15:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included dysautonomia, A-flutter, depression, anorexia nervosa, gastroesophageal reflux disease (GERD), hypothyroidism and known allergies to shellfish, latex and adhesive. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. 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: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 15:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 07May2021, the patient experienced fever, muscle pain, chills, diarrhea, heart palpitations and weakness. 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 fever, muscle pain, chills, diarrhea, heart palpitations and weakness was resolving 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Muscle Pain; Chills; Diarrhea; Heart Palpitations; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 27-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 07May2021 at 15:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included dysautonomia, A-flutter, depression, anorexia nervosa, gastroesophageal reflux disease (GERD), hypothyroidism and known allergies to shellfish, latex and adhesive. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. 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: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 15:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 07May2021, the patient experienced fever, muscle pain, chills, diarrhea, heart palpitations and weakness. 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 fever, muscle pain, chills, diarrhea, heart palpitations and weakness was resolving 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.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Flatulence
Clinical narrative: Diarrhea; Bloated belly and gas pains, after 5 days still have bloating; Bloated belly and gas pains, after 5 days still have bloating; This is a spontaneous report from a contactable other healthcare professional, the patient. A non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 01May2021 at 13:00 as a single dose for COVID-19 immunisation. Medical history included acid reflux. 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 medication included paracetamol (TYLENOL) for an unknown indication from an unknown date and unknown if ongoing. On 01May2021 at 14:30, the patient experienced diarrhea, bloated belly and gas pains, after 5 days still had bloating (at the time of this report). 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 diarrhea, bloated belly and gas pains, after five days still had bloating was not recovered at this time of report.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, SARS-CoV-2 test
Clinical narrative: Extreme fatigue; Ongoing chills; This is a spontaneous report from a contactable physician. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an intramuscular route of administration in the left arm on 12Apr2021 at 10:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included nicotine dependence and anxiety. Prior to vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included fluoxetine hydrochloride (PROZAC), alprazolam (XANAX) and paracetamol (TYLENOL); 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 COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an intramuscular route of administration in the left arm on 22Mar2021 at 10:00 as a single dose for COVID-19 immunisation and received sulfamethoxazole/trimethoprim (BACTRIM) and sertraline hydrochloride (ZOLOFT); both for unknown indication on unknown date and experienced drug allergy. On 13Apr2021, the patient experienced extreme fatigue and ongoing chills. On 06May2021, the patient underwent Nasal swab and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with azithromycin (Z-PAK). Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events extreme fatigue and ongoing chills was resolved with sequelae on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Migraine, Pain
Clinical narrative: Migraines everyday for a full week after; day after felt like all bones were broken, extremely painful to move; day after felt like all bones were broken, extremely painful to move; 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 on 16Apr2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS), depression and anxiety. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient received unspecified medication within two weeks of vaccination. 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: UNKNOWN) via an unspecified route of administration on 26Mar2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021, the patient experienced migraines every day for a full week after, day after felt like all bones were broken and extremely painful to move. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event migraines every day for a full week was resolved on an unknown date in Apr2021 and of the events felt like all bones were broken and extremely painful to move was resolved on an unknow date in 2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Lump the size of a Lime under the right armpit.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the right arm on 04May2021 at 09:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medicines within two weeks prior to the vaccination. On 05May2021 at 20:00, the patient noticed a lump, the size of a lime under the right armpit. 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 lump, the size of a lime under the right armpit was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.