chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Mild headache over the next couple of hours; This is a spontaneous report from a contactable consumer, the patient. A 47-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 11:15 (at the age of 47-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. Concomitant medications included mepyramine maleate, pamabrom, paracetamol (PAMPRIN) and ibuprofen (ADVIL); both from unknown dates for unspecified 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 at 12:00, the patient experienced mild headache over the next couple of hours. No therapeutic measures were taken as a result of the reported event. 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 mild headache over the next couple of hours was recovered on 03Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: headache; joint pains; fever; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on an unknown date in Mar2021 at 13:45 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included allergic to penicillin and Cephalosporin. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the arm left on an unknown date in Mar2021 at 13:45 (at the age of 32-year-old) as a single dose for COVID-19 immunisation and Levofloxacin (MANUFACTURER UNKNOWN) on unknown date for unknown indication 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 27Mar2021 at 10:00 the patient experienced headache, joint pains and fever. The patient did not receive any treatment for the event. The patient events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, joint pains and fever was recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Persistent headache; 100 degree fever; This is a spontaneous report from a contactable other healthcare professional, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 05Apr2021 at 12:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medications included atorvastatin calcium (LIPITOR) 10 mg from an unknown date for an unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 16Mar2021 at 15:30 (at the age of 41-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 06Apr2021 at 10:00, the patient experienced persistent headache and 100-degree fever. The patient did not receive any treatment for the events. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The clinical outcome of the events persistent headache and fever was recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swollen tongue
Clinical narrative: rash on face; tongue started to swell; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0153), via an unspecified route of administration in the left arm on 03Apr2021 at 12:00 (at the age of 43-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not have a history of allergies to any food or medications or others products. The patient did not receive any medication within two 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 four weeks prior to the vaccination. On 03Apr2021 at 12.00, the patient immediately experienced rash on face and tongue started to swell. 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 for the events. The clinical outcome of the events rash on face and tongue started to swell was unknown at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Feel Dizziness after 1 week till today; 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: EN6207) via an unspecified route of administration in the left arm on 18Mar2021 at 16:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic. Concomitant medications included metformin 500 (MANUFACTURER UNKNOWN) for an unknown indication from unknown date. The patient previously took sulfur and experienced drug allergy. 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 29Mar2021 at 09:00 the patient experienced the feeling of dizziness after 1 week till the day of this report.  No therapeutic measures were taken as a result of this event. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event dizziness was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Swelling face
Clinical narrative: Left side of my face became swollen; Itched all over my face and my body was itchy; Incredibly nauseous; This is a spontaneous report from a contactable other healthcare professional. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 30Mar2021 at 10:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included sjogren's, fibromyalgia, crohn's, osteoarthritis (OA), degenerative disc disease (DDD), hypothyroidism. The patient had known allergies to medications, food or other products. Concomitant medications included oxycodone (MANUFACTURER UNKNOWN), hydroxychloroquine phosphate (PLAQUENIL), febuxostat (ULORIC), baclofen (MANUFACTURER UNKNOWN), potassium chloride (Kcl) (MANUFACTURER UNKNOWN), pregabalin (GABAP); all from an unknown date for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the arm left on 09Mar2021 at 10:00 (at the age of 57-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 02Apr2021, 3 days after second vaccination, the patient experienced the left side of her face became swollen, itched all over face and body was itchy and was incredibly nauseous. The first two days the patient slept. all day both days. The patient had other meds that patient took that would not fit on section. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of itchy, swollen face and nausea were unknown.    No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lymph node pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Right arm pain in lymph nodes in underarm; Pain radiating from shoulder to fingers; Fingers numb; Fingers numb and tingling; Pain on right side of body below shoulder; Right arm pain increases as the day goes on and with use.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 20Mar2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer in 2012, lymphoedema in left arm and mastectomy bilateral in 2012. The patient had no known allergies to medications, food, or other products. Concomitant medications included tapentadol hydrochloride (NUCYNTA) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN602) via an unspecified route of administration in the right arm on 27Feb2021 at 12:00 (at the age of 51-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 28Mar2021 at 14:00, the patient experienced right arm pain in lymph nodes in underarm, pain radiating from shoulder to fingers, fingers numb and tingling, pain on right side of body below shoulder and right arm pain that increased as the day went on and with use. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with prednisone, advil 800 mg, every 4 hours and tylenol 1000mg in between. The clinical outcome of the events right arm pain in lymph nodes in underarm, pain radiating from shoulder to fingers, fingers numb and tingling, pain on right side of body below shoulder and right arm pain was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: pain in elbow; Initial arm pain; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP6955) via an unspecified route of administration in the left arm on 13Mar2021 at 23:45 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure controlled with medication. The patient had no known allergies. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), hydrochlorothiazide (HTZ) and multivitamin (MANUFACTURER UNKNOWN) within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6201) via an unspecified route of administration in the left arm on 20Feb2021 at 10:30 (at the age of 68-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. Initially on unknown date in Mar2021, the patient experienced pain in arm then on 20Mar2021 at 07:00, one week later, pain in elbow causing restricted arm and wrist movement for one week. 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 pain in arm and pain in elbow was recovered and movement of arm without pain improved on unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chills, Decreased appetite, Fatigue
Clinical narrative: Headache; Fatigue; Fever; Swollen lymph nodes; Joint pain; Sore throat; Stomach pain; Loss of appetite; Chills; This is a spontaneous report from a contactable consumer. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 10:15 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar I disorder, depression, anxiety, meningioma brain tumor and migraine headache. The patient did not have any allergies to food, medications, or other products. Concomitant medications included escitalopram oxalate (LEXAPRO), lamotrigine (LAMICTAL), mefenamic acid (ADVIL), paracetamol (TYLENOL) and galcanezumab (EMGALITY) all from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 10:15 (at the age of 44-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 05Apr2021 at 20:00, the patient experienced headache, fatigue, fever, swollen lymph nodes, joint pain, sore throat, stomach pain, loss of appetite and chills. No therapeutic measures were taken as a result of the 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 headache, fatigue, fever, swollen lymph nodes, joint pain, sore throat, stomach pain, loss of appetite and chills were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Oropharyngeal pain, Pyrexia
Clinical narrative: Headache; Fatigue; Fever; Swollen lymph nodes; Joint pain; Sore throat; Stomach pain; Loss of appetite; Chills; This is a spontaneous report from a contactable consumer. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 10:15 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar I disorder, depression, anxiety, meningioma brain tumor and migraine headache. The patient did not have any allergies to food, medications, or other products. Concomitant medications included escitalopram oxalate (LEXAPRO), lamotrigine (LAMICTAL), mefenamic acid (ADVIL), paracetamol (TYLENOL) and galcanezumab (EMGALITY) all from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 10:15 (at the age of 44-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 05Apr2021 at 20:00, the patient experienced headache, fatigue, fever, swollen lymph nodes, joint pain, sore throat, stomach pain, loss of appetite and chills. No therapeutic measures were taken as a result of the 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 headache, fatigue, fever, swollen lymph nodes, joint pain, sore throat, stomach pain, loss of appetite and chills were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspepsia, Eructation, Gastrooesophageal reflux disease
Clinical narrative: Heartburn; Acid reflux; Belching; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm left on 05Apr2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included helicobacter pylori infection. Concomitant medications were not reported. The patient previously took oxycodone and experienced specific allergy (drug ). 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 06Apr2021 at 10:00, the patient experienced heartburn, acid reflux, belching 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 heartburn, acid reflux, belching and diarrhea were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Productive cough, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Sneezing; Runny nose; Sore throat; Phlegm; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received unspecified dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Mar2021 at 15:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) 50 mg from an unknown date for an unspecified indication, ethinylestradiol; norgestimate (ORTHO TRI-CYCLEN) from an unknown date for birth control. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 the patient experienced cold-like effects for 6 days now: sneezing, runny nose, sore throat, phlegm, and fatigue. Patient did not receive treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 01Apr2021, the patient underwent PCR oral swab test and the result was negative. The clinical outcome of the events sneezing, runny nose, sore throat, phlegm, fatigue was resolving.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: Sneezing; Runny nose; Sore throat; Phlegm; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received unspecified dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Mar2021 at 15:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) 50 mg from an unknown date for an unspecified indication, ethinylestradiol; norgestimate (ORTHO TRI-CYCLEN) from an unknown date for birth control. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 the patient experienced cold-like effects for 6 days now: sneezing, runny nose, sore throat, phlegm, and fatigue. Patient did not receive treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 01Apr2021, the patient underwent PCR oral swab test and the result was negative. The clinical outcome of the events sneezing, runny nose, sore throat, phlegm, fatigue was resolving.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the right arm on 23Jan2021 at 09:30 (at the age of 78-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the right arm on 13Feb2021 at 09:30 (at the age of 78-years-old); as a single dose for COVID-19 immunisation. Medical history included laryngopharyngeal reflux disease (LPRD), irritable bowel syndrome (IBS), Raynaud's disease and fibromyalgia. The patient had unspecified allergies to medications, food, or other products. The patient received unspecified medications within two 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 four weeks prior to the vaccination. On 02Feb2021 at 07:00, 10 days after first vaccine, the patient developed tinnitus, which she never had before. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. The clinical outcome of the event tinnitus was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021384484 Same reporter/ drug/ event for different patients
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe Ear Ringing; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 06Apr2021 at 10:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin and the patient reported as healthy. The patient did not receive other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the arm right on 16Mar2021 at 10:30 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 06Apr2021 at 13:30, the patient experienced severe ear ringing. 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 severe ear ringing was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Dehydration, Diarrhoea, Fatigue
Clinical narrative: Headache; Elevated temp; Chills; Fatigue; Sore Throat; Nausea; Horrible diarrhea; Racy heart; Dehydration; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 08Mar2021 at 13:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, atrial fibrillation (AFIB) and obesity. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ) for high blood pressure, rosuvastatin calcium (CRESTOR; 5mg) for high cholesterol, apixaban (ELIQUIS) and diltiazem (MANUFACTURER UNKNOWN) for atrial fibrillation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received penicillin and experienced allergy. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021 at 12:00, 4 days after getting the vaccine, the patient ended up becoming ill for a week with headache, elevated temperature, chills, fatigue, sore throat, nausea, horrible diarrhea, racy heart from dehydration. The patient spoke with the pharmacist and contacted her cardiologist. Headache was gone after a week. The patient was quarantined at home for 10 days. The patient had bouts of the feeling of nausea at the time of report. The adverse events result in a visit to the doctors or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events elevated temperature, chills, fatigue, sore throat, nausea, horrible diarrhea, racy heart, dehydration and headache was resolved on an unknown date in Mar2021 and event nausea was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Oropharyngeal pain, Palpitations
Clinical narrative: Headache; Elevated temp; Chills; Fatigue; Sore Throat; Nausea; Horrible diarrhea; Racy heart; Dehydration; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 08Mar2021 at 13:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, atrial fibrillation (AFIB) and obesity. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ) for high blood pressure, rosuvastatin calcium (CRESTOR; 5mg) for high cholesterol, apixaban (ELIQUIS) and diltiazem (MANUFACTURER UNKNOWN) for atrial fibrillation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received penicillin and experienced allergy. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021 at 12:00, 4 days after getting the vaccine, the patient ended up becoming ill for a week with headache, elevated temperature, chills, fatigue, sore throat, nausea, horrible diarrhea, racy heart from dehydration. The patient spoke with the pharmacist and contacted her cardiologist. Headache was gone after a week. The patient was quarantined at home for 10 days. The patient had bouts of the feeling of nausea at the time of report. The adverse events result in a visit to the doctors or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events elevated temperature, chills, fatigue, sore throat, nausea, horrible diarrhea, racy heart, dehydration and headache was resolved on an unknown date in Mar2021 and event nausea was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Severe leg cramps on the night of the shot; 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: ER8737) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 07:30 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included allergies, IBS (irritable bowel syndrome) and allergy to flax and NSAIDS. Concomitant medications included fluticasone furoate (ARNUITY ELLIPTA), amitriptyline (AMITRYPTILINE), omeprazole (MANUFACTURER UNKNOWN) and clarithromycin (CLARITT); all from an unknown date for unspecified indication. Prior to 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 four weeks prior to the vaccination. On an unknown date in Apr2021 at 23:00, the patient experienced severe leg cramps on the night of the shot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event severe leg cramps on the night of the shot was recovered with sequelae on unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pruritus, Rhinorrhoea
Clinical narrative: Migraine approximately 4 hours after injection along with runny nose and itchy skin on chest; Migraine approximately 4 hours after injection along with runny nose and itchy skin on chest; Migraine approximately 4 hours after injection along with runny nose and itchy skin on chest; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 13:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease and failed back surgery syndrome (reported as failed back syndrome). The patient previously experienced latex allergy. The patient previously took Aspirin and experienced drug allergy. The patient received prescription medications (unspecified) within two 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 four weeks prior to the vaccination. On 01Apr2021 at 17:30 the patient experienced migraine approximately 4 hours after injection along with runny nose and itchy skin on chest. The patient did not receive any treatment for the adverse 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 event Migraine approximately 4 hours after injection along with runny nose and itchy skin on chest was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Headache, Vaccination site pain
Clinical narrative: Chest pain approximately one week later.; Back pain approximately one week later; headaches; Pain at injection site for 2 days.; This is a spontaneous report from a contactable consumer, the patient. A 42-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 right arm on 26Mar2021 at 14:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient did not have any allergies to medications, food, or other products. Concomitant medications included esomeprazole sodium (NEXIUM) , buspirone hydrochloride (BUSPAR), buspirone (MANUFACTURER UNKNOWN) and eszopiclone (LUNESTA) 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 not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 14:30 the patient experienced pain at injection site for 2 days. chest and back pain approximately one week after the vaccination and headaches. Therapeutic measures were taken as a result of AE and included treatment with ibuprofen (MANUFACTURER UNKNOWN) and Tylenol (MANUFACTURER UNKNOWN). The patient was advised to follow up with doctor. The events resulted in emergency room/department or urgent care. The clinical outcome of the event pain at injection site for 2 days was recovered on 04Apr2021. The clinical outcome of the events chest pain, back pain  and headaches were unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperacusis, Hypoacusis, SARS-CoV-2 test, Tinnitus
Clinical narrative: Sudden hearing decreased; Tinnitus; Sensitivity to noise in left ear; This is a spontaneous report from a contactable physician. A 53-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3243) via an unspecified route of administration in the arm right on 16Jan2021 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, glaucoma, migraine, cervical radiculopathy and pre-diabetes. The patient received unspecified prescribed medication within two weeks prior to COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL1284) via intramuscular route of administration in the arm left on 26Dec2020 at 11:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had 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 21:00, the patient experienced sudden hearing decreased, tinnitus and sensitivity to noise in left ear(hyperacusis). The patient did not receive any treatment for the reported events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. On 01Apr2021, the patient underwent SARS-CoV-2 test (PCR test) through nasal swab and the result was negative. The clinical outcome of the events sudden hearing decreased, tinnitus and sensitivity to noise in left ear were not recovered 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: Ear pain, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Ear ache; Head ache; Numbness; Tingling on right side face; This is a spontaneous report from a contactable consumer, the patient. A 66-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 26Mar2021 at 12:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID), taken for an unknown indication from an unknown date. The patient previously took codeine 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 26Mar2021 at 16:00, the patient experienced ear ache, headache, numbness and tingling on right side her face. The 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 did not receive any treatment for the events. The clinical outcome of the events ear ache, headache, numbness and tingling on right side her face was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Right arm muscles have beenspasming all day; This is a spontaneous report from a contactable consumer, the patient. A 40-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 right arm on 05Apr2021 at 09:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, gluten and dairy sensitivity. Concomitant medications included salbutamol (ALBUTEROL), vitamins (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC) all from unknown date for 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 06Apr2021 at 09:00 about 24 hours after shot, the patient experienced right arm muscles spasming all day. The patient did not receive any treatment for the reported event. The event 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 event right arm muscles spasming was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Limb discomfort, SARS-CoV-2 test
Clinical narrative: Numbing and dead arm feeling; arm discomfort; 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: EN6199) via an unspecified route of administration in the arm left on an unknown date in Mar2021 at 18:00 (at the age of 27-year-old) and the patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm left on 26Mar2021 at 18:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had 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 Mar2021 the patient experienced some numbing and discomfort around just the upper left arm area after the first shot, but not nearly as significant as the second shot, and it never came back like it was now (at the time of this report). After receiving the second dose, on 26Mar2021 at 18:00, the patient experienced numbing and dead arm feeling in upper left arm, extending into the armpit area and side of upper left chest area immediately, it went away after 1-2 hours and dead arm/discomfort returned 8-11 days later. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 22Mar2021, the patient underwent COVID-19 PCR test (nasal swab) and the result was negative. No therapeutic measures were taken as a result of the events. The clinical outcome of the event numbing and dead arm feeling and arm discomfort was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Hypoaesthesia, SARS-CoV-2 test
Clinical narrative: Numbing and dead arm feeling; arm discomfort; 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: EN6199) via an unspecified route of administration in the arm left on an unknown date in Mar2021 at 18:00 (at the age of 27-year-old) and the patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm left on 26Mar2021 at 18:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had 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 Mar2021 the patient experienced some numbing and discomfort around just the upper left arm area after the first shot, but not nearly as significant as the second shot, and it never came back like it was now (at the time of this report). After receiving the second dose, on 26Mar2021 at 18:00, the patient experienced numbing and dead arm feeling in upper left arm, extending into the armpit area and side of upper left chest area immediately, it went away after 1-2 hours and dead arm/discomfort returned 8-11 days later. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 22Mar2021, the patient underwent COVID-19 PCR test (nasal swab) and the result was negative. No therapeutic measures were taken as a result of the events. The clinical outcome of the event numbing and dead arm feeling and arm discomfort was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills
Clinical narrative: chills; elevated temperature (99.5) 14 h post dose/ (100.5) again 12h later; This is a spontaneous report from a contactable consumer. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 05Apr2021 at 10:45 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history reported as none. The patient did not have any allergies to medications, food, or other products. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 14Mar2021 at 16:30 (at the age of 32-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 06Apr2021 at 12;45, the patient experienced chills. On 06Apr2021 patient experienced elevated temperature (99.5) 14 hours post dose, elevated temp (100.5) again 12h later. On 06Apr2021, the patient checked body temperature test and the result was reported as elevated temperature (99.5) 14 h post dose and elevated temperature (100.5) again 12h later. Therapeutic measures were taken as a result of the events which included treatment with ibuprofen(self administered). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of the events chills and elevated temperature (99.5) 14 h post dose/ (100.5) again 12h later were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Nausea, Vomiting
Clinical narrative: Have been sick to stomach; Headache; Nausea; Throwing up; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 05Apr2021 at 13:15 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Patient had medical history (unspecified). The patient previously received iodine and experienced allergy. The patient received medication (unspecified) within two weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration 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 05Apr2021 at 13:30, the patient experienced sick to stomach, headache, nausea and throwing up. 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 events sick to stomach, headache, nausea and throwing up was not resolved.   No follow-up attempts are needed. No further information is expected.