chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Joint stiffness
Clinical narrative: Injection site became swollen; Joint pain; Chills; Fever up to 100.8; Hive covering the entire site; Tiredness; Joint stiffness; Injection site became warm; Injection site became red; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208) via an unspecified route of administration in the left arm on 01Apr2021 at 12:30 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included high BP (blood pressure high), cholesterol, osteoarthritis, asthma, allergies to cats, molds, trees, grasses, pollen and ragweed. Concomitant medications included triamterene (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN), latanoprost (MANUFACTURER UNKNOWN) and colecalciferol (VITAMIN D3), all started from an unknown dates and for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6204) via an unspecified route of administration in the left arm on 11Mar2021 at 09:30(at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient previously received simvastatin (ZOCOR) and hydroxyzine hydrochloride (VISTARIL) on an unknown date and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 01Apr2021 at 14:30 two hours post injection, the patient's injection site(vaccination site) became red and warm. On 02Apr2021 at 12:00 approximately 24 hours post injection, the patient developed joint pain and stiffness, chills, fever up to 100.8, tiredness, injection site swollen(vaccination site swelling)and had what appears to be a hive covering the entire site, approximately 6 inches diameter. The patient did not receive any treatment for the reported  events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests on 02Apr2021 which included body temperature and the result was temperature of 100.8(unspecified units). The clinical outcome of the events injection site warm, injection site red, injection site swollen and hive was not resolved at the time of this report, while that of joint stiffness, joint pain, chills, fever up to 100.8 and tiredness was recovered on 03Apr2021 at 12:30.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site became swollen; Joint pain; Chills; Fever up to 100.8; Hive covering the entire site; Tiredness; Joint stiffness; Injection site became warm; Injection site became red; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208) via an unspecified route of administration in the left arm on 01Apr2021 at 12:30 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included high BP (blood pressure high), cholesterol, osteoarthritis, asthma, allergies to cats, molds, trees, grasses, pollen and ragweed. Concomitant medications included triamterene (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN), latanoprost (MANUFACTURER UNKNOWN) and colecalciferol (VITAMIN D3), all started from an unknown dates and for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6204) via an unspecified route of administration in the left arm on 11Mar2021 at 09:30(at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient previously received simvastatin (ZOCOR) and hydroxyzine hydrochloride (VISTARIL) on an unknown date and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 01Apr2021 at 14:30 two hours post injection, the patient's injection site(vaccination site) became red and warm. On 02Apr2021 at 12:00 approximately 24 hours post injection, the patient developed joint pain and stiffness, chills, fever up to 100.8, tiredness, injection site swollen(vaccination site swelling)and had what appears to be a hive covering the entire site, approximately 6 inches diameter. The patient did not receive any treatment for the reported  events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests on 02Apr2021 which included body temperature and the result was temperature of 100.8(unspecified units). The clinical outcome of the events injection site warm, injection site red, injection site swollen and hive was not resolved at the time of this report, while that of joint stiffness, joint pain, chills, fever up to 100.8 and tiredness was recovered on 03Apr2021 at 12:30.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Bruxism, Chills, Pyrexia, Toothache
Clinical narrative: Teeth clenching; Persistent dental pain; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 62-years-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 30Mar2021, (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy, hand osteoarthritis and overweight. The patient had no known sllergies to medications, food or other products. Concomitant medications included pseudoephedrine hydrochloride (SUDAFED), guaifenesin (MUCINEX), salbutamol (ALBUTEROL), butalbital, caffeine, paracetamol (FIORICET) and hydrocodone bitartrate, paracetamol (VICODIN) all from unknown date, for unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in right arm on 09Mar2021 at 14:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 the patient experienced fever, chills as expected, but accompanied by (apparent) teeth clenching, resulting in random but persistent dental pain in both upper and lower teeth continuing till this reporting. (The patient has been seeing her Doctor of Dental Surgery (DDS) every 6 months for cleanings and preventative care. Dental health good for age. The patient has 6 crowned teeth and she was missing 2 teeth). No therapeutic measures were taken as a result of reported events. Event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events teeth clenching, fever, chills and persistent dental pain was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Lymphadenopathy, Neck pain, Rash erythematous
Clinical narrative: Extremely swollen lymph nodes; moderate pain in neck/under chin; severe ear aches in both ears; Minor red rash on face, neck and chest; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 03Apr2021 at 17:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. The patient was allergic to CIPRO/sulfa drugs. Concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 22:00 the patient experienced extremely swollen lymph nodes in neck causing moderate pain in neck/under chin. The swollen lymph nodes were causing severe ear aches in both ears. Minor red rash on face, neck and chest was also reported. 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 adverse events. The clinical outcome of the events extremely swollen lymph nodes, moderate pain in neck/under chin, aches in both ears, minor red rash on face, neck and chest were recovering 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: Urticaria
Clinical narrative: Hives on right calf & behind right knee, left knee and left arm close to injection site / More hives (right & left arms and right hip).; This is a spontaneous report from a contactable consumer, the patient. A 59-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 31Mar2021 at 11:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis spinal, spinal stenosis, spinal stenosis, neuralgia and drug allergy to sulfa drugs, penicillin and tetracyclines. Concomitant medications included pregabalin (LYRICA), celecoxib (CELEXA) and camphor, diphenhydramine hydrochloride, zinc oxide (BENADRYL), all taken for unknown indications from unknown dates. The patient previously took 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 10Mar2021 at 11:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 09:00, approximately 19 hours after the vaccination, the patient experienced hives on right calf and behind right knee, left knee and left arm close to injection site. On 02Apr2021, second day after the vaccination, the patient had more hives on the right, left arms and right hip. On 03Apr2021, third day after vaccination, the patient had more hives, the hives were red swollen and itchy, but not severe. Therapeutic measures were taken as a result of the events and the treatment (by self) included Over The Counter (OTC) benadryl, hydrocortisone cream and 91% isopropyl alcohol. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event hives on right calf and behind right knee, left knee and left arm close to injection site, more hives on the right, left arms and right hip and the hives were red swollen and itchy were resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cold sweat, Cough, Fatigue, Influenza
Clinical narrative: Skin hurt to touch chest tightness; Cough; Left lung pain; Tired; Clamy; Sleepy; Felt like flu; Skin hurt to touch; This is a spontaneous report from a contactable consumer, the patient. A 57-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 13Mar2021 at 12:00 hours (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (copd). Concomitant medications included pain meds (unspecified). The patient has no allergies to food, medication or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021 the patient experienced skin hurt to touch, chest tightness, cough, left lung pain, tired, clammy, sleepy and felt like flu. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events skin hurt to touch, chest tightness, cough, left lung pain, tired, clammy, sleepy and felt like flu were recovering. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03April2021 (at the age of 57-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Pulmonary pain, Somnolence
Clinical narrative: Skin hurt to touch chest tightness; Cough; Left lung pain; Tired; Clamy; Sleepy; Felt like flu; Skin hurt to touch; This is a spontaneous report from a contactable consumer, the patient. A 57-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 13Mar2021 at 12:00 hours (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (copd). Concomitant medications included pain meds (unspecified). The patient has no allergies to food, medication or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021 the patient experienced skin hurt to touch, chest tightness, cough, left lung pain, tired, clammy, sleepy and felt like flu. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events skin hurt to touch, chest tightness, cough, left lung pain, tired, clammy, sleepy and felt like flu were recovering. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03April2021 (at the age of 57-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: headache; light pain on my right shoulder; 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: ER8734) via an unspecified route of administration in the right arm on 04Apr2021 at 12:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 17:00, the patient experienced headache and light pain on right shoulder. It was reported that the patient still had headache and shoulder pain on 05Apr2021, the second day of vaccination. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event headache and shoulder pain was not resolved.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Two episodes of uncharacteristic nose bleeds; Two episodes of uncharacteristic nose bleeds; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male 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 01Apr2021 at 14:00 (at the age of 58-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. The patient did not receive any other medication within two weeks of vaccination. The patient did not have a history of allergies to any food products or medications or others. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 21:00 and on 04Apr2021, the patient experienced two episodes of uncharacteristic nose bleeds. The patient did not receive any treatment for the event. The clinical outcome of the event two episodes of uncharacteristic nose bleeds was unknown at the time of this report.    No follow-up attempts are needed. No further information is expected
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Extensive swelling of vaccinated limb, Vaccination site swelling
Clinical narrative: vaccination site swelling; The swelling moved down my arm to bicep, elbow and outside of my forearm.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 03Apr2021 at 13:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Patient did not receive any concomitant medication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04Apr2021 at 21:00, the patient experienced vaccination site swelling and the swelling moved down the arm to bicep, elbow and outside of the forearm. The patient did not receive any treatment for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the events vaccination site swelling and extensive swelling of vaccinated limb were not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slight soreness at injection site on left arm.; This is a spontaneous report from a contactable consumer, the patient. A 54-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 03Apr2021 at 12:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) sporadically from an unknown date and for unknown indication. The patient previously took ampicillin(MANUFACTURER UNKNOWN) and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 16:00, the patient experienced slight soreness at injection site on left arm(vaccination site pain). The patient did not receive any treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event slight soreness at injection site was recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Facial swelling; This is a spontaneous report from a contactable consumer, 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 arm left on 31Mar2021 at 14:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported.  Concomitant medications included cetirizine hydrochloride (ZYRTEC) from an unknown date for an unknown indication and unknown if ongoing. The patient previously took erythromycin and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 16:00, after 4410 minutes of the vaccination, the patient experienced facial swelling. The event 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 event. The clinical outcome of the event facial swelling was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN) all taken for unknown indication from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 at 08:00, the day after the shot, the patient noticed a rash on his lower left back. The patient went to doctor on 04Apr2021 and was informed it was shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of rash on lower left back, shingles and included treatment with valtrex from unknown date to unknown date. The clinical outcome of the event rash on lower left back, shingles was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Quarter-size knot painful to the touch; Swollen lymph node above left collar bone.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 29Mar2021 at 20:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergy to penicillin. Concomitant medications included citalopram 25mg (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 06:00, the patient experienced swollen lymph node above left collar bone and quarter-size knot which was painful to the touch. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swollen lymph node above left collar bone and quarter-size knot painful to the touch was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Cold sweat, Diarrhoea, Fatigue
Clinical narrative: Rapid and irregular heart rate; Cold sweats; Mild chest pain; Headache; Fatigue; Chills; Nausea; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 02Apr2021 at 09:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, asthma, obesity and gerd (Gastroesophageal reflux disease); all from unknown dates. The patient had known allergy to aggrandizing. The patient received unspecified medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1686) via an unspecified route of administration in the right arm on 05Mar2021 at 09:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation and erythromycin (MANUFACTURER UNKNOWN), tetracycline (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 13:00, the patient experienced rapid and irregular heart rate, cold sweats, mild chest pain, headache, fatigue, chills, nausea, vomiting and diarrhea. 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 events. The clinical outcome of the events rapid and irregular heart rate, cold sweats, mild chest pain, headache, fatigue, chills, nausea, vomiting and diarrhea was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate abnormal, Nausea, Vomiting
Clinical narrative: Rapid and irregular heart rate; Cold sweats; Mild chest pain; Headache; Fatigue; Chills; Nausea; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 02Apr2021 at 09:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, asthma, obesity and gerd (Gastroesophageal reflux disease); all from unknown dates. The patient had known allergy to aggrandizing. The patient received unspecified medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1686) via an unspecified route of administration in the right arm on 05Mar2021 at 09:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation and erythromycin (MANUFACTURER UNKNOWN), tetracycline (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 13:00, the patient experienced rapid and irregular heart rate, cold sweats, mild chest pain, headache, fatigue, chills, nausea, vomiting and diarrhea. 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 events. The clinical outcome of the events rapid and irregular heart rate, cold sweats, mild chest pain, headache, fatigue, chills, nausea, vomiting and diarrhea was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: unspecified route of administration in the arm left on 29Mar2021 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. Medical history included lupus pernio, hemolytic anemia and autoimmune disorder. Concomitant medications included azathioprine (IMURAN), belimumab (BENLYSTA) and hydroxychloroquine phosphate (PLAQUENIL) on an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENL202), via an unspecified route of administration in the arm left on 08Mar2021 (at the age of 51-year-old) at 14:00, as a single dose for COVID-19 immunisation. The past drug history included erythromycin and cellcept and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 06:00, the patient experienced entire body - intense itching after, rash left arm, vaccine was injected was swollen, red and was hot. The adverse events had resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the event entire body - intense itching after, rash left arm, vaccine was injected is swollen, red and hot was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Heavy sweating; Muscle aches; Chills; Fatigue; Rash; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration in the right arm on 30Mar2021 at 18:30 (at the age of 27-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. Concomitant medications within two weeks prior to COVID-19 vaccine was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 21:30, the patient experienced heavy sweating, chills, fatigue, muscle aches, rash and headaches. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events heavy sweating, chills, fatigue, muscle aches, rash and headaches were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Heavy sweating; Muscle aches; Chills; Fatigue; Rash; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration in the right arm on 30Mar2021 at 18:30 (at the age of 27-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. Concomitant medications within two weeks prior to COVID-19 vaccine was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 21:30, the patient experienced heavy sweating, chills, fatigue, muscle aches, rash and headaches. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events heavy sweating, chills, fatigue, muscle aches, rash and headaches were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Extremely swollen lymph node under left arm pit; This is a spontaneous report from a contactable consumer, the parent. A 21-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the left arm on 03Apr2021 at 11:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included methylmalonic acidemia. The patient had known allergies to eggs and latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control pills (MANUFACTURER UNKNOWN) taken from an unknown date. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 23:15, the patient experienced an extremely swollen lymph node under the left arm pit, approximately the size of a golf ball. The events did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/ department or urgent care. The patient did not receive any treatment for the event experienced. The clinical outcome of the event extremely swollen lymph node under left arm pit was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Eyelids are swollen/ swollen eyelids; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 02Apr2021 at 15:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADD), asthma, depression, seizure, migraine and allergies. The patient had latex allergy and seasonal allergy. The patient received unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 06:00 the patient experienced swollen eyelids. She had seasonal allergies but have never experienced this with her seasonal allergies. The patient had the COVID-19 vaccine on Friday and woke up on Saturday morning with the swollen eyelids. The only other time she had experienced swollen eyelids is when she had an allergic reaction to latex. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if patient received any treatment for the event. The clinical outcome of the event eyelids was swollen was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Headache
Clinical narrative: Bad aches around joints; Bad aches around joints and back; Sweats; Swollen face; Extreme exhaustion; Headache; Chills; This is a spontaneous report from a 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: ER8733), via an unspecified route of administration in the left arm on 31Mar2021 at 08:00 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced bad aches around joints and back, sweats, chills, headache, extreme exhaustion and swollen face. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events bad aches around joints and back, sweats, chills, headache, extreme exhaustion and swollen face were recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Swelling face
Clinical narrative: Bad aches around joints; Bad aches around joints and back; Sweats; Swollen face; Extreme exhaustion; Headache; Chills; This is a spontaneous report from a 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: ER8733), via an unspecified route of administration in the left arm on 31Mar2021 at 08:00 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced bad aches around joints and back, sweats, chills, headache, extreme exhaustion and swollen face. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events bad aches around joints and back, sweats, chills, headache, extreme exhaustion and swollen face were recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Pyrexia
Clinical narrative: Swollen, red, hot, painful injection site; Headache; Fever; Fatigue; Chills; Swollen lymph nodes under armpit; Swollen, red, hot, painful injection site; Swollen, red, hot, painful injection site; Swollen, red, hot, painful injection site; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 30Mar2021 at 10:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine and COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included topiramate (TOPAMAX), escitalopram oxalate (LEXAPRO) and cetirizine hydrochloride (ZYRTEC); all from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 02:00, the patient experienced swollen, red, hot, painful injection site 2 days post injection 6 cm, headache, fever, chills, swollen lymph nodes under armpit and fatigue. Injection site and lymph node still swollen and painful 6 days after injection. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of swollen, red, hot, painful injection site 2 days post injection 6 cm, headache, fever, chills, swollen lymph nodes under armpit and fatigue and included treatment with 50 mg diphenhydramine (BENADRYL), 800 mg ibuprofen (MANUFACTURER UNKNOWN) and ice. The clinical outcomes of swollen, red, hot, painful injection site 2 days post injection 6 cm, headache, fever, chills, swollen lymph nodes under armpit and fatigue were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swollen, red, hot, painful injection site; Headache; Fever; Fatigue; Chills; Swollen lymph nodes under armpit; Swollen, red, hot, painful injection site; Swollen, red, hot, painful injection site; Swollen, red, hot, painful injection site; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 30Mar2021 at 10:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine and COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included topiramate (TOPAMAX), escitalopram oxalate (LEXAPRO) and cetirizine hydrochloride (ZYRTEC); all from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 02:00, the patient experienced swollen, red, hot, painful injection site 2 days post injection 6 cm, headache, fever, chills, swollen lymph nodes under armpit and fatigue. Injection site and lymph node still swollen and painful 6 days after injection. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of swollen, red, hot, painful injection site 2 days post injection 6 cm, headache, fever, chills, swollen lymph nodes under armpit and fatigue and included treatment with 50 mg diphenhydramine (BENADRYL), 800 mg ibuprofen (MANUFACTURER UNKNOWN) and ice. The clinical outcomes of swollen, red, hot, painful injection site 2 days post injection 6 cm, headache, fever, chills, swollen lymph nodes under armpit and fatigue were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over body; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 01Apr2021(at the age of 61-year-old) as a single dose for COVID-19 immunisation. No relavent medical history . The patient did not have any allergies to medications, food, or other products. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), ramipril (PROVACE) and levothyroxine sodium (SYNTHROID) for unknown indication from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:  EN6205) via an unspecified route of administration in the left arm on 12Mar2021(at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 13:00 the patient experienced Hives all over body. Unknown if the patient received any treatment for the events. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The clinical outcome of the event Hives all over body was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: Burning sensation; Hives appeared on back of legs, on back or torso, on hands and feet; Itchiness and itching sensation; This is a spontaneous report from a contactable consumer, the patient. A 24-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER-8733) via an unspecified route of administration in the left arm on 03Apr2021 at 15:45 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included low blood pressure, polycystic ovarian syndrome and graves disease. The patient had known allergies to cefzil (MANUFACTURER UNKNOWN). Concomitant medications included pindolol (MANUFACTURER UNKNOWN) and thiamazole (METHIMAZOLE) from unknown dates, for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, 5 hours post vaccine i.e., at 20:45 the patient experienced first itchiness at scalp, then on 03Apr2021, at 21:30 the patient experienced hives appeared on back of legs, on back or torso and on hands, feet and were creating a mixed burning and itching sensation. Events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events and included benadryl as a treatment for the events. The clinical outcome of the events itchiness, hives and burning sensation was not recovered.  No follow-up attempts are needed. No further information is expected.