chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, SARS-CoV-2 test
Clinical narrative: Soreness under left armpit (where "I" got the shot); This is a spontaneous report from a non-contactable consumer, the patient. A 43-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 left arm on 01Mar2021 at 10:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies however, the patient had penicillin reaction as a kid. 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 unspecified daily multivitamins from an unknown date and unknown if ongoing. On 03Mar2021, the patient experienced soreness under left armpit (where the patient got the shot), especially about today on 10Mar2021, about 9 days after the vaccine. 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 been tested for COVID-19. On 05Mar2021, the patient underwent nasal swab test for COVID-19 and the result was negative. The clinical outcome of the event soreness under left armpit (where "I" got the shot) was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 61-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 left arm on 14Mar2021 at 16:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 metoprolol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and dicyclomine (dicycloverine) (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication and unknown if ongoing. On 14Mar2021 at 17:00, the patient experienced sore arm at injection site. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm at injection site was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Moderate soreness on the arm that received the vaccine shot; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 08Mar2021(at the age of 36-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 did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Mar2021, the patient experienced moderate soreness on the arm that received the vaccine shot. The event did not result in doctor or other healthcare professional office/clinic, 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 moderate soreness on the arm that received the vaccine shot was resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph glands near underarm, injection side; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 25Feb2021 at 17:45 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included intermittent asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) and calcium (MANUFACTURER UNKNOWN) both taken for an unknown indication from an unknown date and unknown if ongoing. On 05Mar2021, the patient experienced swollen lymph glands near underarm, injection side. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph glands near underarm, injection side was recovering 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Nausea
Clinical narrative: extremely nauseous; lightheaded; general malaise; This is a spontaneous report from a contactable consumer, the patient. A 30-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 an unknown date in Feb2021 at 16:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid cancer and sulfonamide allergy. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), ethinylestradiol/levonorgestrel (OGESTREL) and multivitamins (MANUFACTURER UNKNOWN); all for an unspecified indication from an unknown date and were unknown if ongoing. On 28Feb2021, the next day, the patient was extremely nauseous, lightheaded and with general malaise. The events did not result in doctor or other healthcare professional office/clinic visits, 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 extremely nauseous, lightheaded and general malaise was recovered on an unknown date in 2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Glossodynia
Clinical narrative: Tongue pain (perhaps a lie bump); This is a spontaneous report from a contactable consumer, the patient. A 63-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 right arm on 11Mar2021 at 13:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, gout, reflux and psoriasis. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included nebivolol hydrochloride (BYSTOLIC), allopurinol (MANUFACTURER UNKNOWN), amlodipine besilate/benazepril hydrochloride (LOTREL) and omeprazole (PRILOSEC), all for an unknown indication from an unknown date and unknown if ongoing. On 13Mar2021 at 21:00, the patient experienced tongue pain (perhaps a lie bump). 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 reported events. The clinical outcome of the event tongue pain (perhaps a lie bump) was not recovered at the time of this report   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Vaccination site erythema, Vaccination site swelling
Clinical narrative: The red swollen arm 10 days later; The red swollen arm 10 days later; Injection site swollen and red; Injection site swollen and red; This is a spontaneous report from a contactable consumer reported for his wife. A 60-year-old female received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number not reported) via an unspecified route of administration, on 05Mar2021 (age at the time of vaccination was 60-year-old) as DOSE 1, SINGLE for COVID-19 immunization at public health. Medical history was reported as none. The patient concomitant medications were not reported. The patient got vaccine from Pfizer 10 days ago and everything seemed fine but on16Mar2021, where the vaccine site was, it was swelling and redness. The caller wants to know whether the patient can take a Benadryl. The caller wanted to know if that resolves and is it ok to receive second dose on 26Mar2021. The caller stated about the other medical conditions was the red swollen arm 10 days later. The clinical outcome of all the events was unknown.  Follow-up attempts are completed. No further The red swollen arm 10 days later information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vision blurred
Clinical narrative: Blurred vision; Dizziness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 49-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 left arm on an unknown date in Mar2021 at 10:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to any medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks of taking the COVID-19 vaccine. Concomitant medications included unspecified blood pressure medication. On 10Mar2021, the patient experienced blurred vision, dizziness and nausea. The events resulted in doctor or other healthcare professional office/clinic visit. 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 blurred vision, dizziness and nausea 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Tremor
Clinical narrative: Nausea; Chills; Shakes; Headache; Injection site pain; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 30-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 14Mar2021 at 12:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, COVID-19 and allergy to penicillin and cephalosporin. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included progesterone (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknow if ongoing. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 14Mar2021 at 20:00, the patient experienced nausea, chills, shakes, headache, injection site pain and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, chills, shakes, headache, injection site pain and fatigue was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Nausea; Chills; Shakes; Headache; Injection site pain; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 30-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 14Mar2021 at 12:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, COVID-19 and allergy to penicillin and cephalosporin. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included progesterone (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknow if ongoing. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 14Mar2021 at 20:00, the patient experienced nausea, chills, shakes, headache, injection site pain and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, chills, shakes, headache, injection site pain and fatigue was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Very sleepy; This is a spontaneous report from a contactable consumer, the patient. An 82-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 left arm on 12Mar2021 at 11:15 (at the age of 82-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient included heart condition irregular heartbeat. It was unknown if the patient had any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included amiodarone (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 12Mar2021 at 15:00, the patient experienced very sleepy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not tested for COVID-19. The clinical outcome of the event very sleepy 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Bursitis, Gait disturbance, Musculoskeletal pain, Pain in extremity
Clinical narrative: Extreme pain; Difficulty walking pain; Right after the injection, that evening I noticed my left buctock was painful,more painful than usual- note I have bursitis in that area - then on Sunday 14MAR2021 I had extreme pain, as in difficulty; Bursitis; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the arm right on 05Mar2021 at 13:15 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included bursitis, low back ache and painful feet. The patient was allergic to penicillin. 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 DEPAKOTE, GEODON, ALLEGRA, and LISINOPRIL all from unknown date for unknown indication and unknown if ongoing. On 05Mar2021, the patient experienced right after the injection, that evening, noticed that left buttock was painful, more painful than usual- note, that had bursitis in that area, and on sunday 14Mar2021 at 14:00, the patient experienced extreme pain and difficulty walking pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the extreme pain and difficulty walking pain which included treatment ADVIL which eased the pain and also using ice pack. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events right after the injection, that evening, noticed my left buttock was painful, more painful than usual- note, that had bursitis in that area, extreme pain and difficulty in walking pain was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Reading disorder, Vision blurred
Clinical narrative: Blurry vision; Difficulty reading; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 05Mar2021 at 13:00 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Medical history included 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 vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and dexlansoprazole (DEXILANT); both for unknown indications from unknown dates and unknown if ongoing. The patient previously took codeine (MANUFACTURER UNKNOWN) and pregabalin (LYRICA); both for unknown indications on unknown dates and experienced drug allergy. On 06Mar2021 at 08:00, the patient experienced blurry vision and difficulty reading, which started the day after vaccination and continued (has persisted for 9 days). 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 blurry vision and difficulty reading was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: Body aches; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6198) via an unspecified route of administration in the left arm on 13Mar2021 at 11:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies, hypertension, arthritis, hypothyroidism, hyperlipidemia and known allergies to bees, trees, grass, dust, pollen and dander. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the right arm on 20Feb2021 at 15:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 13Mar2021 at 22:00, the patient experienced body aches, nausea and fatigue. 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 events body aches, nausea and fatigue was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Feeling abnormal
Clinical narrative: mouth, lips and throat felt funny like Novocain was wearing off in my mouth/ my face felt odd too; body felt very heavy; very fatigued; This is a spontaneous report from a contactable consumer, the patient. A 59-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 11Mar2021 at 10:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis, autoimmune disorder, bee sting hypersensitivity 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-19 vaccine. Concomitant medications included ascorbic acid (VITAMIN C), vitamin d nos (VITAMIN D), vitamin b complex (VITAMIN B) and levothyroxine sodium (SYNTHROID); all for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received prochlorperazine edisylate (COMPAZINE) and erythromycin (MANUFACTURER UNKNOWN), both on an unknown date and experienced allergy. On 11Mar2021 at 10:35 (onset time also reported as 10:30), about 20 minutes after the vaccination, the patient was walking outside the office and the patient felt her mouth, lips and throat felt funny like Novocain was wearing off in the mouth. It was reported that the patient's pulse and breathing were okay but the patient felt her face odd and felt her body very heavy. The patient opined that it was clearly a reaction and not severe but the patient's fear was, would the next vaccine be more severe and whether it was needed to worry about throat closing. Even the throat closing did not happen but the patient was worried. This all subsided in a few hours. The patient kept fluids going and ate lunch. The patient was very fatigued and lied down for about an hour. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events included treatment as fluids and ibuprofen (ADVIL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mouth, lips and throat felt funny like Novocain was wearing off in my mouth/ my face felt odd too, body felt very heavy and very fatigued were recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vision blurred
Clinical narrative: Blurred vision that gets worse as I become tired; Blurred vision that gets worse as I become tired; This is a spontaneous report from a contactable consumer, the patient. A 65-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 02Mar2021 at 10:15 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and diabetic. 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 received unspecified medication in two weeks of vaccination. The patient previously took codeine (MANUFACTURER UNKNOWN), sulfur (MANUFACTURER UNKNOWN) and iodine (MANUFACTURER UNKNOWN) for an unknown indication and experienced drug allergy. On 03Mar2021 at 14:30, the patient experienced blurred vision that gets worse as become tired. 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 reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event blurred vision that gets worse as become tired was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: Headache; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 73-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 arm left on 08Mar2021(at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 11Mar2021 at 05:00, the patient experienced headache and sore throat. 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 outcomes of the events headache and sore throat were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Dizziness; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 75-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 11Mar2021 at 09:15 (at the age of 75-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 unknown concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 at 07:00, the patient experienced dizziness and weakness. 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 outcomes of the events dizziness and weakness were recovered with sequelae on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Paraesthesia
Clinical narrative: Tingling in hands and legs; Urge to swallow but feel like I won't be able to; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration on 15Mar2021 at 15:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. 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 rosuvastatin calcium (ROSUVASTATIN), ramipril (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); all for unknown indication from an unknown date and unknown if ongoing. On 15Mar2021 at 15:15, the patient experienced tingling in hands and legs and urge to swallow but felt like won't be able to. 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 tingling in hands and legs and urge to swallow but feel like won't be able to was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Movement disorder
Clinical narrative: Day 2 of the vaccine the person had a headache; Trouble moving; Lethargic; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12Mar2021 at 00:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and COVID-19. It was unknown whether the patient had any allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 14Mar2021 at 09:00, day 2 of the vaccine, the patient experienced headache, trouble moving, was very lethargic and had trouble with simple tasks. The patient had COPD and had severe Covid prior. 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, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events headache, trouble moving, very lethargic was recovering 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Glossitis, Tongue disorder
Clinical narrative: Inflammation and sores on  back of tongue and inner lip.; Inflammation and sores on back of tongue and inner lip.; Inflammation and sores on back of tongue and inner lip.; This is a spontaneous report from a contactable consumer, the patient. A 75-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 25Feb2021 at 13:45 (at the age of 75-year-old) as a single dose for COVID-19 immunisation. Medical history included polycythemia vera, shellfish allergy, allergy to legumes (raw peas) and allergy to nuts (some nuts). 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 hydroxycarbamide (HYDROXYUREA) and warfarin (MANUFACTURER UNKNOWN); both taken for unspecified indications on unknown dates and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 25Feb2021 at 15:15, the patient experienced inflammation and sores on back of tongue and inner lip. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with triamcinolone acetonide (MANUFACTURER UNKNOWN) dental paste. The clinical outcome of the events inflammation and sores on back of tongue and inner lip was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Pain at the injection site; Pain under the arm (armpit); Shooting pain when the left arm is extended over the head or straight ahead (similar to muscle pain); This is a spontaneous report from a contactable healthcare professional, the patient. A 32-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 left arm on 07Mar2021 at 13:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Mar2021 at 07:00, post-vaccination, the patient experienced pain at the injection site, in addition to that, pain under the arm (armpit) and shooting pain when the left arm was extended over the head or straight ahead (similar to muscle pain). The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 10Mar2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. The clinical outcome of the events pain at the injection site, pain under the arm (armpit), shooting pain when the left arm was extended (similar to muscle pain)  were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Peripheral swelling
Clinical narrative: Large painful swelling under left arm.; Large painful swelling under left arm.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 13Mar2021 at 13:45 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder, diabetes, hypothyroidism and COVID-19. The patient previously received hydrocortisone (MANUFACTURER UNKNOWN) and paracetamol; dextropropoxyphene napsilate (DARVOCET), and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination were reported as yes, but the medications were unspecified. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Mar2021 at 11:00, the patient experienced large painful swelling under left arm. The event 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 event. The clinical outcome of the event large painful swelling under left arm was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Slight soreness of arm.; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 04Mar2021 at 15:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and high blood pressure. The patient had no known allergies to medications, food, or other products. The patient had received other medication within two weeks of vaccination for unknown indication from unknown date, which were not specified. 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 04Mar2021 (also reported as at 00:00) the patient experienced slight soreness of arm and nothing else. Therapeutic measures were not taken as a result of the events. 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 event slight soreness of arm was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain in extremity, Vaccination site pain
Clinical narrative: Painful, swollen lymph node under left armpit; Painful, swollen lymph node under left armpit; Pain on left a and injection site; Pain on left a and injection site; This is a spontaneous report from a contactable pharmacist, the patient. A 43-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 13:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient received other vaccine within four weeks prior to the vaccination, which was influenza vaccine (MANUFACTURER UNKNOWN) (reported as Flu vaccine) on 17Feb2021 for immunisation. The patient previously received chloroquine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 10Mar2021, the patient experienced pain on left arm and injection site which persisted 5 days later. On 13Mar2021 at 03:00, the patient woke up with painful, swollen lymph node under her left armpit. It was reported that today on 15Mar2021, the pain had subsided but was still there. 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 pain on left a and injection site and painful, swollen lymph node under left armpit was recovering 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: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Localized Muscle Pain; Headache; This is a spontaneous report from a contactable healthcare professional, the patient. A 34-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 14Mar2021 at 15:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. 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 vaccines within four weeks prior to the vaccination. On 15Mar2021, the next day of vaccination, the patient experienced localized muscle pain and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events localized muscle pain and headache which included treatment with ibuprofen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events localized muscle pain and headache was resolved on 15Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This is a spontaneous report from a contactable consumer, the patient. An 81-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 18Feb2021 (at the age of 81-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. 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. The patient received other medicines (unspecified) 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: EL3302) via an unspecified route of administration in the left arm on 28Jan2021 at 14:30 as a single dose for COVID-19 immunisation. On 15Mar2021, the patient experienced vomiting. The event 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 vomiting was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, Oropharyngeal pain
Clinical narrative: Nasal congestion; Sore throat; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received 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. Medical history was not reported. Concomitant medications taken within two weeks were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date, the patient experienced nasal congestion, sore throat and fatigue. 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 nasal congestion, sore throat and fatigue was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cluster headache, Fatigue, Hypertension, Pain
Clinical narrative: Fatigue; High blood pressure; Severe cluster headache; Chills; Body aches; This is a spontaneous report from a non-contactable consumer. A 70-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 on 15Feb2021 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included cluster headaches. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Feb2021, after first vaccine, the patient experienced fatigue, high blood pressure, severe cluster headache, chills and body aches. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, high blood pressure, severe cluster headache, chills and body aches was recovered on an unknown date in 2021. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Mar2021 as a single dose for COVID-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Headaches; Nausea; General lightheadedness; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 12Mar2021 at 08:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. 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 took codeine phosphate (CODEIN) for an unknown indication on an unknown date and experienced drug allergy. On 13Mar2021, the patient experienced headaches, nausea, general light headedness. On 15Mar2021, patient woke up feeling good after taking tylenol at night but then by afternoon it all came back, headache, nausea and light headedness. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure was taken as a result of events which included treatment with paracetamol (TYNELOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headaches, nausea and general light-headedness was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.