chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypersensitivity, Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site pain; injection site swelling; joint pain (ankle); severe allergic reactions; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the right arm on 22Mar2021 at 15:45 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included histamine intolerance. The patient did not have any allergies to food, medications, or other products. Concomitant medication included cetirizine (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 15:00, the patient experienced injection site pain, injection site swelling, joint pain (ankle) and severe allergic reactions. 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 events. The clinical outcome of the vaccination site pain, vaccination site swelling, pain ankle and allergic reactions was resolving at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: muscle ache; vaccination site pain; vaccination site swelling; Headache; joint ache; Fever; Chills; tired; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via unspecified route of administration in the right arm on 22Mar2021 at 14:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, hypertension and osteoporosis. The patient had many unknown allergies to medications, food, or other products. Concomitant medications included olmesartan (MANUFACTURER UNKNOWN), dulaglutide (TRULICITY), insulin glargine (TOUJEO) and insulin lispro (HUMALOG 200) all taken for unknown indications from unknown start dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6205) via unspecified route of administration in the right arm on 01Mar2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021, the day of vaccination, the patient was tired. On 23Mar2021 at 08:00 (reported as next day), the patient experienced headache, joint ache, fever, chills and tired. On 24Mar2021 (reported as following day), the patient also had muscle ache. On the same day (reported as third night), the patient experienced pain (vaccination site pain) and swelling at injection site (vaccination site swelling). The adverse event did not result in doctor or other healthcare professional office or clinic visit or emergency room visit. The patient did not receive any treatment for the adverse events. The clinical outcomes of the events tired, headache, joint ache, fever, chills, muscle ache, pain at and swelling at injection site were recovering. No follow-up attempts are possible.  No further information is expected. No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: muscle ache; vaccination site pain; vaccination site swelling; Headache; joint ache; Fever; Chills; tired; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via unspecified route of administration in the right arm on 22Mar2021 at 14:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, hypertension and osteoporosis. The patient had many unknown allergies to medications, food, or other products. Concomitant medications included olmesartan (MANUFACTURER UNKNOWN), dulaglutide (TRULICITY), insulin glargine (TOUJEO) and insulin lispro (HUMALOG 200) all taken for unknown indications from unknown start dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6205) via unspecified route of administration in the right arm on 01Mar2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021, the day of vaccination, the patient was tired. On 23Mar2021 at 08:00 (reported as next day), the patient experienced headache, joint ache, fever, chills and tired. On 24Mar2021 (reported as following day), the patient also had muscle ache. On the same day (reported as third night), the patient experienced pain (vaccination site pain) and swelling at injection site (vaccination site swelling). The adverse event did not result in doctor or other healthcare professional office or clinic visit or emergency room visit. The patient did not receive any treatment for the adverse events. The clinical outcomes of the events tired, headache, joint ache, fever, chills, muscle ache, pain at and swelling at injection site were recovering. No follow-up attempts are possible.  No further information is expected. No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EN6208) via an unspecified route of administration on 16Mar2021 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date, prior to vaccination and known allergies were reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021, the patient experienced severe leg cramps which was worse at night. No treatment was received for the reported events. 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 severe leg cramps was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: Menstrual spotting outside of period; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955) via an unspecified route of administration in the right arm on 23March2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, obesity, anxiety, depression, mitral valve prolapses and allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccine within four weeks prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. On 25March2021, at 07:00 the patient experienced menstrual spotting outside of periods. 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 menstrual spotting outside of periods was not recovered at the time of reporting.   No follow up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Fatigue, Headache, Lip swelling, Lymph node pain
Clinical narrative: Stinging in arm; Needle-like pains in head; Partial lip swelling; Felt like could not swallow completely; Tender lymph nodes under chin in neck; Nausea; Extreme tiredness for ten days; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6206), via an unspecified route of administration in the left arm on 11Mar2021 at 16:45 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, low thyroid, hip replacement. The patient was allergic to CT scan dye, shellfish, band aid adhesive and gluten. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), thyroid (ARMOUR THYROID), vitamins (MANUFACTURER UNKNOWN), all from unknown dates for unspecified indications. The patient previously received fluoride (MANUFACTURER UNKNOWN) on an unspecified date for unknown indication and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Mar2021 at 16:45, the patient experienced stinging in arm, needle-like pains in head, partial lip swelling, felt like could not swallow completely, tender lymph nodes under chin in neck, nausea, extreme tiredness for ten days. 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 treatment for the events. The clinical outcome of the event stinging in arm, needle-like pains in head, partial lip swelling, felt like could not swallow completely, tender lymph nodes under chin in neck, nausea, extreme tiredness was recovered on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Stinging in arm; Needle-like pains in head; Partial lip swelling; Felt like could not swallow completely; Tender lymph nodes under chin in neck; Nausea; Extreme tiredness for ten days; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6206), via an unspecified route of administration in the left arm on 11Mar2021 at 16:45 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, low thyroid, hip replacement. The patient was allergic to CT scan dye, shellfish, band aid adhesive and gluten. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), thyroid (ARMOUR THYROID), vitamins (MANUFACTURER UNKNOWN), all from unknown dates for unspecified indications. The patient previously received fluoride (MANUFACTURER UNKNOWN) on an unspecified date for unknown indication and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Mar2021 at 16:45, the patient experienced stinging in arm, needle-like pains in head, partial lip swelling, felt like could not swallow completely, tender lymph nodes under chin in neck, nausea, extreme tiredness for ten days. 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 treatment for the events. The clinical outcome of the event stinging in arm, needle-like pains in head, partial lip swelling, felt like could not swallow completely, tender lymph nodes under chin in neck, nausea, extreme tiredness was recovered on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Next morning woke up shaking chills; Feeling feverish but no fever; Arm sore immediately following shot; In evening body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration on 24Mar2021 at 11:30 (at the age of 29-year-old), as a single dose for COVID-19 immunisation. Medical history included obese and blood pressure being monitored. The patient did not have any allergies to medications, food, or other products. Concomitant medication included multi-vitamin (MANUFACTURER UNKNOWN) for unspecified indication started from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 24Mar2021 at 12:00, the patient experienced arm sore immediately following the shot and in the evening the patient experienced body aches. On 25Mar2021 (next morning), the patient woke up with shaking chills and feeling feverish but no fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events and included treatment with TYLENOL. The clinical outcome of the events pain in arm, general body pain, chills and feverish were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6208) via an unspecified route of administration in the right arm on 17Mar2021 at 14:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol and shingles two years ago. The patient had sulpha allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications received within two weeks of vaccination included losartan (MANUFACTURER UNKNOWN) 100mg 2 per day for unknown indication from an unknown date. On an unknown date in Mar2021 at 22:00, the patient experienced shingles, five days after the shot. The patient received valtrex 1gm and zorivax as a therapeutic measure for the event shingles. 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 shingles was not resolved 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: Lip swelling, Swelling face
Clinical narrative: lips began swelling; the swelling began moving to different parts of face; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9262), via an unspecified route of administration in left arm on 08Mar2021 at 15:30 hours (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient medical history included asthma. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included estrogen (MANUFACTURER UNKNOWN), progesterone (MANUFACTURER UNKNOWN), testosterone (MANUFACTURER UNKNOWN) and fluticasone propionate/ salmeterol xinafoate (ADVAIR) received within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 10Mar2021, 36 hours after the injection, the patient lips began swelling and the swelling began moving to different parts of the face. Two and half weeks later, the patient still had swelling, although it was not as pronounced. No therapeutic measures were taken 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 lip swelling and parts of face swelling was recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Pulmonary pain
Clinical narrative: Lungs hurt when deep breathing; discomfort in bronchial area; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine; Lot number: ENC 207), via an unspecified route of administration on 18Mar2021 at 11:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (HBP). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included lisinopril 25mg (MANUFACTURER UNKNOWN) and sertraline hydrochloride 75mg (ZOLOFT), for unknown indications from unknown dates. The patient previously received penicillin (MANUFACTURER UNKNOWN), cefadroxil (DURICEF), doxycycline (MANUFACTURER UNKNOWN), nalidixic acid (NEGGRAM) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Mar2021 at 16:00, the patient's lungs were hurting when deep breathing and the patient had discomfort in bronchial area. The patient did not receive any treatment for the events lungs hurt when deep breathing and discomfort in bronchial area. The clinical outcomes of the events lungs hurt when deep breathing and discomfort in bronchial area were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: This is a spontaneous report received from a contactable healthcare professional, the patient. A 23-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) on the left arm on 24Mar2021 at 16:00 as single dose (at the age of 23-year-old) for COVID-19 immunization. The patient's medical history was not reported. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 03:00, the patient experienced sore throat. No treatment was taken for the adverse 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 sore throat was recovering at the time of this report. No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Severe vertigo 6 days post vaxx, lasted about 6 hours; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN62V6), via an unspecified route of administration in the left arm on 14Mar2021 at 08:45 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included migraine. Concomitant medications included birth control (unspecified) and cetirizine hydrochloride (ZYRTEC) from unknown date for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL9267), via an unspecified route of administration in the left arm on 21Feb2021 at 05:45 (at the age of 34-years-old), as a single dose for COVID-19 immunisation and ibuprofen (MANUFACTURER UNKNOWN) on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 at 08:00, 6 days post vaccination, the patient experienced severe vertigo that lasted about 6 hours. The patient did not receive any treatment for vertigo. 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 vertigo was recovered on 20Mar2021 at 14:00.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a non-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: EL3247), via an unspecified route of administration in the left arm on 24Mar2021 at 10:30 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included birth control medications, herbal and dietary supplements; all for unknown indications from unknown date. The patient previously received tetracycline and experienced allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Prior to 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 4 weeks prior to the COVID-19 vaccine. On 24Mar2021 at 11:00, the patient experienced some headache and in night, the patient's upper arm and surrounding area was sore. On 25Mar2021, the day after the vaccination, the patient's arm was bit swollen and she had chills but doesn't show up as a fever. The patient reported that she did not seem to have headaches but felt that she was on a verge of getting a fever. The patient did not receive any treatment for the reported events. The events did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events headache, upper arm and surrounding area was sore, swollen arm and chills were resolving. No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Fatigue, Hot flush
Clinical narrative: elevated temperature; extreme nausea; hot flashes; vomiting; chills; uncontrollable shivering; Fatigued; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6199) via unspecified route of administration in the left arm on 04Mar2021 at 16:00 (at the age of 46-years-old) as a single dose for Covid-19 immunisation and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6208) via unspecified route of administration in the left arm on 25Mar2021 at 10:30 (at the age of 46-years-old) as a single dose for Covid-19 immunisation.. The patient had medical history of pneumonia several years ago. Also, the patient was somewhat overweight. The patient had an illness with an 810-week long cough from late Feb2020 - mid Apr2020. It began with one day of chills and fever. Then went straight to respiratory symptoms. Fatigue and tightness in chest lingered for a year. The patient did not know if it was COVID-19, because tests were not available in patients area when the patient was sick, and once tests became available in patients area, the patient did not have qualifying symptoms. The patient never had an antibody test. The patients concomitant medication included occasional vitamin D (UNKNOWN MANUFACTURER), vitamin C (UNKNOWN MANUFACTURER), multivitamins (UNKNOWN MANUFACTURER) and probiotics (UNKNOWN MANUFACTURER). The patients reported allergies included full body rash and hives after MRI contrast dye. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 04Mar2021, about five or six hours after receiving first dose of vaccine, the patient began experiencing extreme nausea, hot flashes, vomiting, chills and uncontrollable shivering. It was cyclical, hitting the patient in the aforementioned order, over and over for 3-5 hours. Finally, these acute symptoms abated, and the patient fell asleep. When the patient woke the next day, the patients nausea was gone, and body temp was elevated by about one degree above the normal. The patient was fatigued and run down for the next 3-4 days. The patient received no treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of nausea was recovered on 05Mar2021. The clinical outcomes of hot flashes, vomiting, chills, shivering, fatigue and temperature elevation were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: elevated temperature; extreme nausea; hot flashes; vomiting; chills; uncontrollable shivering; Fatigued; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6199) via unspecified route of administration in the left arm on 04Mar2021 at 16:00 (at the age of 46-years-old) as a single dose for Covid-19 immunisation and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6208) via unspecified route of administration in the left arm on 25Mar2021 at 10:30 (at the age of 46-years-old) as a single dose for Covid-19 immunisation.. The patient had medical history of pneumonia several years ago. Also, the patient was somewhat overweight. The patient had an illness with an 810-week long cough from late Feb2020 - mid Apr2020. It began with one day of chills and fever. Then went straight to respiratory symptoms. Fatigue and tightness in chest lingered for a year. The patient did not know if it was COVID-19, because tests were not available in patients area when the patient was sick, and once tests became available in patients area, the patient did not have qualifying symptoms. The patient never had an antibody test. The patients concomitant medication included occasional vitamin D (UNKNOWN MANUFACTURER), vitamin C (UNKNOWN MANUFACTURER), multivitamins (UNKNOWN MANUFACTURER) and probiotics (UNKNOWN MANUFACTURER). The patients reported allergies included full body rash and hives after MRI contrast dye. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 04Mar2021, about five or six hours after receiving first dose of vaccine, the patient began experiencing extreme nausea, hot flashes, vomiting, chills and uncontrollable shivering. It was cyclical, hitting the patient in the aforementioned order, over and over for 3-5 hours. Finally, these acute symptoms abated, and the patient fell asleep. When the patient woke the next day, the patients nausea was gone, and body temp was elevated by about one degree above the normal. The patient was fatigued and run down for the next 3-4 days. The patient received no treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of nausea was recovered on 05Mar2021. The clinical outcomes of hot flashes, vomiting, chills, shivering, fatigue and temperature elevation were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 23Mar2021 at 14:15 (at the age of 52-years-old) as a single dose for COVID-19 immunization. Medical history included asthma and obesity. The patient had allergy to shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and unspecified supplements, all for unknown indications from unknown dates. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021 at 01:00, the patient experienced pain at injection site radiating into shoulder blade. The adverse events did not result in a visit to the 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 pain at injection site radiating into shoulder blade and pain at injection site. The clinical outcomes of the events pain at injection site radiating into shoulder blade and pain at injection site were recovered on an unknown date in Mar2021. No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Pain in jaw
Clinical narrative: metallic taste in  mouth; ache in  jaw; Pain side of the head; This is a spontaneous report from a contactable consumer, the patient. A 58 -years-old-non-pregnant- female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8732) via an unspecified route of administration in the arm left on 24Mar2021 at 15:30 (age at the vaccination was 58-years-old) as a single dose for COVID-19 Immunisation. Medical history was reported as Overweight, HBP and GERD. The patient did not report any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not tested for COVID-19. The patient had Allergies of avelox as a reaction of anaphylaxis, Flexeril, Z Pack and aloe as a reaction of itching. On 24Mar2021 at 15:30 the patient experienced metallic taste in mouth and a bit of an ache in jaw side of the head with it and the patient reported as it was similar to having received Novocain without the numbness associated. The clinical outcome of metallic taste in mouth and ache in jaw side of the head was ongoing.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain in extremity
Clinical narrative: Sore left arm; Fatigue; Swollen lymph nodes under left arm and along left clavicle; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6199) via an unspecified route of administration on left arm on 23Mar2021 at 10:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history, however, she was allergic to milk and gluten sensitivity. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN5318) via an unspecified route of administration on the left arm on 02Mar2021 at 09:45 (at the age of 42-year-old), as 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 tested for COVID-19. On 24Mar2021 at 10:30 The patient experienced sore in the left ram, fatigue and swollen lymph nodes under left arm and along left clavicle on. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sore in the left ram, fatigue and swollen lymph nodes were resolving at the time of reporting.   No follow-up attempts are needed. No further information expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: 104 degree fever; chills; body soreness; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male 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 23Mar2021 at 13:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to penicillin. The patient did not receive concomitant medications within 2 weeks of 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. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021 at 01:45, the patient experienced 104-degree fever, chills, body soreness, and fatigue. The adverse events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive treatment for the reported events 104-degree fever, chills, body soreness, and fatigue. The clinical outcomes of the events 104-degree fever, chills, body soreness, and fatigue were recovered with sequelae (reported as recovered with lasting effects) on an unknown date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 25Mar2021 at 08:15 (at the age of 57 years old), as a single dose for COVID-19 immunisation. Medical history included heart condition, anxiety disorder. The patient was allergic to sulfur. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccination. On 25Mar2021 at 13:15, the patient experienced rash or red marks which had broken out on left arm and little on right arm. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the adverse events. The clinical outcome of the event red rash was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Nocturnal leg muscle cramps for 4 consecuitive nights; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old adult non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration on left arm 05Mar2021 at 15:45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had allergy to penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Mar2021, the patient experienced nocturnal leg muscle cramps for 4 consecutive nights. The patient did not receive any treatment for event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event nocturnal leg muscle cramps was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site mass
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in the right arm on 19Mar2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic lung disease and diabetes. The patient had a history of allergy to SEPTRA and CARDIOLITE. The concomitant medications included metformin (MANUFACTURER UNKNOWN), empagliflozin (JARDIANCE), losartan (MANUFACTURER UNKNOWN), acetylsalicylic acid (BABY ASPIRIN) and HCTC for unknown indication received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in the right arm on 23Feb2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 23Mar2021, the patient experienced hard tender lump at injection site with size of a quarter which was still there after one week. swollen, hard, painful lymph node on the right ear, quite large, about 2 1/2 inches long. No therapeutic measures were taken 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 vaccination site lump and painful lymphadenopathy was not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus started 12 hours after first injection. It got worse with the 2nd injection.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6202), via an unspecified route of administration in the left arm on 24Feb2021 at 18:00 (at the age of 60-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6204), via an unspecified route of administration in the left arm on 17Mar2021 at 18:15 (at the age of 60-year-old) as a single dose for COVID-19 Immunisation. Medical history included prostate cancer and suspected COVID-19 on 29Feb2020. Concomitant medications were reported as leuprorelin acetate (LUPRON), apalutamide (ERLEADA), Timolol (MANUFACTURER UNKNOWN), Tumeric (MANUFACTURER UNKNOWN), Vitamin D3 (MANUFACTURER UNKNOWN); all for unknown indication from unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other product. On 25Feb2021 at 06:00, the patient experienced tinnitus started 12 hours after first injection and got worse with the second injection. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of tinnitus was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Headache, Muscle spasms, SARS-CoV-2 test
Clinical narrative: cramping in legs,; coughing; headaches; Constant  pain in the left shoulder; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via unspecified route of administration in the left arm on 08Mar2021 at 11:00 (at the age of 59-years-old) as a 0.3 ml single dose for COVID-19 immunisation. The patient had unspecified medical history. The patient had received unspecified other medications within 2 weeks prior to the COVID-19 vaccine as concomitant medications. The patient had known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 08Mar2021 at 12.00, the patient experienced constant pain in the left shoulder, cramping in legs, coughing and headaches. On 11Mar2021, the patient had nasal swab test and resulted negative. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The therapeutic measure was taken as a result of events and included treatment with Tylenol. The clinical outcome of the events pain in the left shoulder, cramping in legs, coughing and headaches were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue haematoma
Clinical narrative: Hematoma on tip of tongue; 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: EP6955), via an unspecified route of administration in the right arm on 23Mar2021 at 10:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included mastectomy in 2016, ductal carcinoma in situ (DCIS) on left breast. Concomitant medications included calcium 1000mg (MANUFACTURER UNKNOWN), vit D 2000IU (MANUFACTURER UNKNOWN) and ascorbic acid (vit C) 1000mg (MANUFACTURER UNKNOWN). The patient previously received penicillin (PCN) and erythromycin and experienced an 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 23Mar2021 at 17:00, the patient experienced a hematoma on the tip of the tongue which was 10-12mm in size. The hematoma was still present on 25Mar2021. The patient did not receive any treatment for the event. The event did not result in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event tongue hematoma was not resolved.   No follow-up attempts possible. No further information expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: A marked increase in existing tinnitus in both ears; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old male patient received his second dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 23Mar2021 at 13:45 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. The medical history included bipolar disorder, erectile dysfunction, tinnitus from an unknown date and patient had known allergies to opioids. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), lamotrigine (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and sildenafil (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received his first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 02Mar2021 at 13:45 (at the age of 64-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 positive for COVID-19. On 24Mar2021 at 10:00, the patient experienced a marked increase in existing tinnitus in both ears and would estimate the intensity has doubled. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the events. The outcome of the event tinnitus aggravated was not recovered at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.