chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Extreme hyperactivity and alertness; Extreme hyperactivity and alertness; Heart rate is exacerbated; Arm is sore at the injection site; Neck muscles tight; enthusiastic/ the alertness and energy is concerning; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Mar2021 at 14:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included alpha-gal, attention deficit-hyperactivity disorder, allergy to grains (barley) and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. On 28Feb2021, the patient underwent BinaxNow SARS-CoV-2 test (Test type: Nasal swab) and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included methylphenidate hydrochloride (CONCERTA) of dose 54 mg q.d and 18 mg qd and bupro (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if ongoing. On 11Mar2021 at 09:00, 7 hours post vaccination the patient experienced extreme hyperactivity and alertness, even after having consumed 20 oz of red wine (Pinot noir) to try to sleep, the patient was amazingly alert and enthusiastic. Heart rate exacerbated. The patient reported that it felt like she overdosed on ADHD medication (she did not- took all her medication at 06:30 AM EST). The arm was sore at the injection site and neck muscles tight, but the alertness and energy was concerning 7 hours later. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events extreme hyperactivity and alertness, was amazingly alert and enthusiastic, heart rate exacerbated, arm sore at the injection site and neck muscles tight was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 05Mar2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, hypertension, obesity and penicillin allergy. Concomitant medications included metformin (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID), spironolactone (MANUFACTURER UNKNOWN) and trazodone (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously took codeine (MANUFACTURER UNKNOWN) and valaciclovir (VALACYCLOVIR) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021, the patient experienced dizziness 5 days after first dose. The event 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 event. Since the vaccination, the patient had been tested for COVID-19.The clinical outcome of the event dizziness was not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Mar2021 at 15:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetes and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. The patient did not take concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 at 21:00, the patient experienced sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain
Clinical narrative: Localized pain/soreness; Light headedness; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 06Mar2021 at 11:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic headaches and migraines. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 06Mar2021 at 18:00, the patient experienced localized pain/soreness and light headedness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Any therapeutic measures were not taken for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events localized pain/soreness and light headedness was recovered on an unknown date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 14Jan2021 (at the age of 33-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the left arm on 04Feb2021 (at the age of 33-year-old), both as a single dose for COVID-19 immunisation. Medical history included history of idiopathic pancreatitis, intestines previously severed and repaired following car accident in 1990, anxiety and depression. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included bupropion hydrochloride (WELLBUTRIN SR), lorazepam (ATIVAN) and melatonin (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received prochlorperazine edisylate (COMPAZINE) for unspecified indication from unknown date and experienced adverse reaction. On an unknown date of 2021, after first dose, the patient experienced two weeks of nausea. On 06Feb2021, after second dose, patient experienced nausea which persisted till the time of reporting. Since the vaccination, the patient had not been tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event nausea was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Headache; Fatigue; Chills; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 26Feb2021 at 15:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to vaccination. Concomitant medications included fluoxetine hydrochloride (FLUOXETINE (PROZAC)) for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Jan2021 at 14:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On 27Feb2021 at 13:00 hours, the patient experienced headache, fatigue and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, fatigue, chills was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: significant swelling and redness at injection site 6 days after receiving the second dose.; significant swelling and redness at injection site 6 days after receiving the second dose.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 05Mar2021 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received first dose (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the left arm on 12Feb2021 at 10:15 (at the age of 71-year-old), as a single dose for COVID-19 immunisation. On 11Mar2021 at 10:00, 6 days after receiving the second dose, the patient developed significant swelling and redness at injection site. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events significant swelling and redness at injection was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: "I" have ringing in "my" ears; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Mar2021 at 11:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, obesity and post COVID-19 diagnosed on 28Mar2020. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ethinylestradiol / desogestrel (ISIBLOOM), omeprazole (PRILOSEC), fluticasone propionate / salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR) and cetirizine hydrochloride (ZYRTEC); all for unknown indications from an unknown date and unknown if ongoing. On 12Mar2021 at 17:45 (also reported as 05:45), 18 hours post vaccination the patient experienced ringing in her ears. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event she had ringing in her ears was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Movement disorder, Pain in extremity
Clinical narrative: Two days after receiving the vaccine I couldnt lift my arm to touch my bicep to my ear.; My arm was sore for three days; I had mild to moderate headaches on and off throughout the day every day for five days after receiving my vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the right arm on 22Feb2021 at 12:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and known allergy to dial original soap. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included guaifenesin/pseudoephedrine hydrochloride (SUDAFED)  and ibuprofen (MANUFACTURER UNKNOWN); both for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021, the patient's arm was sore for 3 days, the patient had mild to moderate headaches on and off throughout the day every day for five days after receiving vaccine. On 24Feb2021, two days after receiving the vaccine, the patient could not lift arm to touch her bicep to her ear that went away after one day. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm was sore was recovered with sequelae on 26Feb2021; while that of the event mild to moderate headaches was recovered with sequelae on 28Feb2021. The clinical outcome of the event could not lift arm to touch her bicep to her ear was recovered with sequelae on 25Feb2021.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Heart rate, Heart rate abnormal, Hyperhidrosis
Clinical narrative: Feeling tired; Weak; Left hand fingers numb; Heart rate went to 95; Sweats; Left side neck had pain; This is a spontaneous report from a contactable consumer, the patient. A 68-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 10Mar2021 at 00:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included Atrial Fibrillation (AFib) and anxiety. The patient had allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lorazepam (MANUFACTURER UNKNOWN), dronedarone hydrochloride (MULTAQ) and diltiazem (MANUFACTURER UNKNOWN) all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received Hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN) and experienced drug allergy. On 12Mar2021 at 03:00, the patient experienced left hand fingers numb, heart rate went to 95, sweats and left side neck had pain which had lasted for 1 hour. On the same day at 08:00, the patient was still feeling tired and weak. On 12Mar2021 at 03:00, the patient underwent heart rate test and the result was 95 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left hand fingers numb, heart rate went to 95, sweats, left side neck had pain, feeling tired and weak were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neck pain
Clinical narrative: Feeling tired; Weak; Left hand fingers numb; Heart rate went to 95; Sweats; Left side neck had pain; This is a spontaneous report from a contactable consumer, the patient. A 68-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 10Mar2021 at 00:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included Atrial Fibrillation (AFib) and anxiety. The patient had allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lorazepam (MANUFACTURER UNKNOWN), dronedarone hydrochloride (MULTAQ) and diltiazem (MANUFACTURER UNKNOWN) all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received Hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN) and experienced drug allergy. On 12Mar2021 at 03:00, the patient experienced left hand fingers numb, heart rate went to 95, sweats and left side neck had pain which had lasted for 1 hour. On the same day at 08:00, the patient was still feeling tired and weak. On 12Mar2021 at 03:00, the patient underwent heart rate test and the result was 95 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left hand fingers numb, heart rate went to 95, sweats, left side neck had pain, feeling tired and weak were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 10Mar2021 at 13:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, arthritis and known allergies to bees. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included paracetamol (TYLENOL), levothyroxine sodium (SYNTHROID), famotidine (PEPCID) and cyclobenzaprine hydrochloride (FLEXERIL), all for an unknown indication from an unknown date and unknown if ongoing. On 10Mar2021 at 16:45, the patient experienced nausea, vomiting and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event nausea, vomiting and dizziness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Tinnitus
Clinical narrative: Headache 5 days later; Full ear, ear pain; Rumbling in ear; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old 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 06Mar2021 at 15:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included lyme disease, bartonella, babesiosis, allergies to sulfa, fluroquinolones and cephalosporin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 11Mar2021 the patient experienced headache 5 days later, full ear, ear pain, rumbling in ear. The events resulted in doctor or other health care professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache 5 days later, full ear, ear pain, rumbling in ear  was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain
Clinical narrative: Soreness; Fatigue; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6202) via an unspecified route of administration in the left arm on 09Mar2021 at 13:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took promethazine (PHENERGAN) and experienced drug allergy (sensitivity). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO), cetirizine hydrochloride (ZYRTEC), biotin (MANUFACTURER UNKNOWN), birth control pills and fibe, all for unknown indication from an unknown date and unknown if ongoing. On 09Mar2021 at 16:30, on the same day of vaccination, the patient experienced soreness, fatigue and dizziness. Dizziness occurs most when turning head or trying to move quickly. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events soreness, fatigue and dizziness was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: mild headache; Body aches; 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: EN6208) via an unspecified route of administration in the left arm on 09Mar2021 at 14:45 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included chemotherapy, anal cancer and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. On 10Mar2021 at 02:00, the patient experienced mild headache and body aches. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mild headache and body aches was resolved on 10Mar2021 at 14:00.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Gout
Clinical narrative: woke up with a gout flare up, which I havent had since starting my allopurinol treatment; gout flare up; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11Mar2021 at 11:00 (at the age of 38-years old) as a single dose for COVID-19 immunisation. Medical history included gout which was ongoing at the time of reporting. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN), fluoxetine (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN), all for unknown indications, from unknown dates and unknown if ongoing. On 12Mar2021 at 03:00, the day after receiving the vaccine, the patient woke up with a gout flare up, which he had not had since the allopurinol treatment. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event gout flare up was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal paraesthesia, Photophobia
Clinical narrative: Within the next 24 hours I experienced swollen lymph nodes in my neck and under my arms; Within the next 24 hours I experienced tender lymph nodes in my neck and under my arms; Within 15 minutes of receiving the vaccine my eyes felt not normal.; Throat tingled; My eyes were very sensitive to light, more so than normal even wearing sunglasses; My eyes appeared to be fully dilated; I "felt off " for the next 10 days; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 22Feb2021 at 09:30 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and known allergy to penicillin and intravenous iodine lab dye. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide, telmisartan (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN), ezetimibe (MANUFACTURER UNKNOWN) and dapagliflozin propanediol monohydrate (FARXIGA); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Feb2021 at 09:45; within 15 minutes of receiving the vaccine, the patient eyes felt not normal and throat tingled, but did not progress to anything approaching serious reaction. The patient waited for another 15 to 20 minutes and returned home. On the same day, her eyes were sensitive to light more so than normal even wearing sunglasses. Shortly after, the patient's granddaughter noticed that the patients' eyes appeared to be fully dilated. They remained fully dilated when the patient went to bed at 22:30. On 24Feb2021 at 06:30, she checked her eyes and they were no longer dilated. On 24Feb2021, the patient experienced swollen and tender lymph nodes in neck and under arms. The patient felt "off" for the next 10 days. The patient saw primary care physician on 10Mar2021 and she advised not to take the second vaccine dose which was scheduled for in 16Mar2021. The physician was most concerned that the dilation of eyes was a neurological reaction and given the other symptoms, a second dose could prove more adverse. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event eyes appeared to be fully dilated was resolved on 23Feb2021, event felt off for the next 10 days was resolved on an unknown date in Mar2021 and the events eyes felt not normal, throat tingled, eyes were very sensitive to light more so than normal even wearing sunglasses and swollen and tender lymph nodes in neck and under arms  were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Hyperhidrosis, Hypoaesthesia, Nausea
Clinical narrative: Injection site reaction; Nausea; Headache; Numbness in extremities; Tingling in extremities; Lower back pain; Sharp pains throughout body; Sweating; This is a spontaneous report from a contactable nurse. A 49-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 10Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications within two weeks prior to the COVID-19 vaccine. The patient previously received the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 17Feb2021 at 12:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 10Mar2021 at 19:00, the patient experienced injection site reaction, nausea, headache, numbness and tingling in extremities, lower back pain, sharp pains throughout body and sweating. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site reaction, nausea, headache, numbness and tingling in extremities, lower back pain, sharp pains throughout body and sweating were resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Vaccination site reaction
Clinical narrative: Injection site reaction; Nausea; Headache; Numbness in extremities; Tingling in extremities; Lower back pain; Sharp pains throughout body; Sweating; This is a spontaneous report from a contactable nurse. A 49-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 10Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications within two weeks prior to the COVID-19 vaccine. The patient previously received the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 17Feb2021 at 12:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 10Mar2021 at 19:00, the patient experienced injection site reaction, nausea, headache, numbness and tingling in extremities, lower back pain, sharp pains throughout body and sweating. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site reaction, nausea, headache, numbness and tingling in extremities, lower back pain, sharp pains throughout body and sweating were resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Large, painful Left (ipsilateral) axillary lymphadenopathy; This is a spontaneous report from a contactable physician, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 11Mar2021 at 08:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included morton's neuroma and gastritis reflux. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin d nos (MANUFACTURER UNKNOWN), paracetamol (TYLENOL), naproxen (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), famotidine (FAMOTIDIN) and cannabidiol (MANUFACTURER UNKNOWN), all were from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 17Feb2021 at 12:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 12Mar2021 at 06:00, the patient experienced large, painful left (ipsilateral) axillary lymphadenopathy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event large, painful left (ipsilateral) axillary lymphadenopathy was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: Within 5 minutes of shot the nerve endings began firing off at high levels; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Mar2021 at 14:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included pain management, amputation of 4th metacarpal left hand and repositioning of 5th metacarpal into 4th position, chronic ongoing pain from neuromas since Nov1999 when original traumatic injury occurred, the past pain has been addressed with surgery and stellate ganglion nerve blocks. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medication. The patient previously received pregabalin (LYRICA), rare occasions small doses of 7.5 mg loratadine (LORATAB) combined with meloxicam (MOBIC) for pain from unknown date and pain was currently managed with occasional doses of 600mg paracetamol (TYLENOL). The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that the patient had a modified left hand, 4th metacarpal removed and 5th metacarpal placed into 4th metacarpal position and had multiple neuromas in hand. On 11Mar2021 at 14:50, within 5 minutes of shot, the patient had nerve endings firing off at high levels, he had learned pain management over the years, but when not expecting the vaccine to be a trigger it was a bit concerning. The patient considered this as a minor event, but for others who did not have good pain management in place for neuroma pain this could be debilitating pain levels. It had been 15 hours after receiving first shot and pain levels are at a 7 - 8 still. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event within 5 minutes of the shot the nerve endings began firing off at high levels was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dysgeusia, Nausea
Clinical narrative: Nausea; DIARRHEA; METALIC TASTE; 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: EN6207) via an unspecified route of administration in the arm left on 11Mar2021 at 16:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received an unspecified booster dose within 4 weeks on 04Feb2021 prior to the COVID vaccine. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN) and potassium (MANUFACTURER UNKNOWN) both for an unknown indication from an unknown date and unknown if ongoing. On 12Mar2021 at 06:00, the patient experienced nausea, diarrhea and metallic taste. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result if the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event nausea, diarrhea and metallic taste were resolved on 12Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Nausea, Vertigo
Clinical narrative: Extreme vertigo starting 36 hours after 2nd dose.; Nausea caused by verigo; Lasting about 36 hours followed by tiredness and weakness.; Lasting about 36 hours followed by tiredness and weakness.; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration on 08Mar2021 at 15:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis, osteoporosis, irritable bowel, and penicillin allergy. The patient  had received concomitant medication within two weeks of vaccination which was not specified. The patient previously took sulfamethoxazole; trimethoprim (BACTRIM) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021 at 04:00, the patient experienced extreme vertigo starting 36 hours after second dose. The patient experienced nausea caused by vertigo lasting about 36 hours followed by tiredness and weakness on an unknown date in Mar2021. Therapeutic measures were taken as a result of adverse events and included treatment with motion sickness pills and vertigo exercises. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme vertigo starting 36 hours after second dose, nausea caused by vertigo lasting about 36 hours followed by tiredness and weakness were resolved with sequelae on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Insomnia
Clinical narrative: Feeling hot; Can't fall asleep; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GN 6199) via an unspecified route of administration in the right arm on 04Mar2021 at 12:00 as a single dose for COVID-19 immunisation. Medical history included diagnosed for HIV  on Sep2000. The patient had no known allergies (reported by patient "Not that l know of"). Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN), atazanavir (MANUFACTURER UNKNOWN), emtricitabine (MANUFACTURER UNKNOWN) and azithromycin (ASTRO); all from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 06Mar2021 at 16:00, the patient experienced feeling hot all after taking prescribed medication, symptoms started on 06Mar2021 and can't fall asleep. He needs help and symptoms worsened at night. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events feeling hot and can't fall asleep 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: Axillary pain, Lymph node pain, Lymphadenopathy
Clinical narrative: I had immense pain under my left arm that woke me up out of my sleep; My lymph nodes are swollen and very painful; My lymph nodes are swollen and very painful; This is a spontaneous report from a contactable consumer, the patient. A 37-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 09Mar2021 at 16:00 (at the age of 37-years old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Medical history included COVID-19. Concomitant medication included ethinylestradiol/etonogestrel (NUVARING) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021 at 00:00, the patient experienced "On the second evening after receiving my first dose, I had immense pain under my left arm that woke me up out of my sleep. My lymph nodes are swollen and very painful". 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events "On the second evening after receiving my first dose, I had immense pain under my left arm that woke me up out of my sleep. My lymph nodes are swollen and very painful" was not recovered at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 05Mar2021 at 15:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included Bp (blood pressure abnormal). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and Vyvase (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication and unknown if ongoing. On 12Mar2021 at 06:00 the patient experienced vertigo. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of vertigo and included treatment with meclizine. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vertigo was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.