chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: Headache; Mild nausea; Fatigue; Chills; This is a spontaneous report from a contactable consumer. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732), via an unspecified route of administration in the left arm on 28Mar2021 at 10:00 (at the age of 43-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive other mediations within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6206), via an unspecified route of administration in the left arm on 07Mar2021 at 10:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. On 29Mar2021 at 05:00, the patient experienced headache, mild nausea, fatigue and chills. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, mild nausea, fatigue and chills was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Heart rate increased, Hypertension, SARS-CoV-2 test
Clinical narrative: pulse over 140, no temp; Woke up at 2 am.  Uncontrollable shaking; Teeth were chattering so much thought my teeth would crack; blood pressure was high; This is a spontaneous report from a contactable consumer (patient). A 18-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration, in the right arm on 28Mar2021 at 16:00 (at the age of 18-year-old) as dose 1, single for COVID-19 immunization. Medical history included obesity from an unknown date and unknown if ongoing. No allergies to medications, food, or other products. Concomitant medications and other medications the patient received within 2 weeks of vaccination were not reported. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 29Mar2021 at 02:00, the patient woke up at 2 am. Uncontrollable shaking, pulse over 140, no temp. Teeth were chattering so much thought her teeth would crack. Patient was taken to local emergency room. Vitals where a high pulse, 143, blood pressure was high. The shaking continued in the ER until 3:30 ish. Therapeutic measures were taken as a result of events. They administered 1000 mg of Tylonol. Events were considered serious nut seriousness criteria not reported. Adverse events resulted emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure measurement was 143 mmhg on 29Mar2021, heart rate increased was 140 on 29Mar2021, negative rapid, nasal swab, sars-cov-2 test on 17Mar2021, negative PCR nasal swab sars-cov-2 test on 17Mar2021. Outcome of the events was not resolved.  Information of the Batch/lot number has been requested.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: pulse over 140, no temp; Woke up at 2 am.  Uncontrollable shaking; Teeth were chattering so much thought my teeth would crack; blood pressure was high; This is a spontaneous report from a contactable consumer (patient). A 18-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration, in the right arm on 28Mar2021 at 16:00 (at the age of 18-year-old) as dose 1, single for COVID-19 immunization. Medical history included obesity from an unknown date and unknown if ongoing. No allergies to medications, food, or other products. Concomitant medications and other medications the patient received within 2 weeks of vaccination were not reported. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 29Mar2021 at 02:00, the patient woke up at 2 am. Uncontrollable shaking, pulse over 140, no temp. Teeth were chattering so much thought her teeth would crack. Patient was taken to local emergency room. Vitals where a high pulse, 143, blood pressure was high. The shaking continued in the ER until 3:30 ish. Therapeutic measures were taken as a result of events. They administered 1000 mg of Tylonol. Events were considered serious nut seriousness criteria not reported. Adverse events resulted emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure measurement was 143 mmhg on 29Mar2021, heart rate increased was 140 on 29Mar2021, negative rapid, nasal swab, sars-cov-2 test on 17Mar2021, negative PCR nasal swab sars-cov-2 test on 17Mar2021. Outcome of the events was not resolved.  Information of the Batch/lot number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Tendonitis
Clinical narrative: Ankle pain; Feels like ankle tendinitis; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: Ep6955) via an unspecified route of administration in the left arm on 18Mar2021 at 12:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. The medical history included asthma, endometriosis, IBS (irritable bowel syndrome) and essential tremors. The concomitant medications included vitamin b12 (MANUFACTURER UNKNOWN) and vitamin d (MANUFACTURER UNKNOWN) for unknown indications. There were no known allergies of the patient. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since having the vaccine. On 18Mar2021 at 13:30, the patient experienced ankle pain which had felt like ankle tendinitis and had started hurting the day of vaccination. The patient also felt the pain when moving her foot or when walking for long periods of time. No therapeutic measures were taken as a result of ankle pain and tendinitis. The adverse events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of ankle pain and tendinitis was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Pain in extremity
Clinical narrative: Sore Right Upper Arm; Bilateral breast tenderness; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EP7534) via an unspecified route of administration in the right arm on 20Mar2021 at 12:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included idiopathic hypersomnia, obsessive compulsive disorder, bells palsy, obesity, postural orthostatic tachycardia syndrome, Ehlers Danlos syndrome, mast cell activation disorder. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and lactobacillus nos (CULTURELLE); both from unknown date for unspecified indication. The patient previously received fluticasone propionate; salmeterol (ADVAIR DISKUS), cephalexin (MANUFACTURER UNKNOWN), armodafinil (NUVIGIL) and ferric carboxymaltose (INJECTAFER IRON INFUSION); all from unknown date for unspecified indication and experienced drug allergy and IV CT Contrast from unknown date for unspecified indication and experienced contrast dye allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 14:00, the patient experienced sore right upper arm and long lasting moderate bilateral breast tenderness. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events sore arm and breast tenderness was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling like a goose egg on arm at injection site; Injection site sore to touch; Bruising at injection site; This is a spontaneous report from a contactable other healthcare professional. A 70-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: er8730), via an unspecified route of administration in the left arm on 26Mar2021 at 17:00 (at the age of 70-years-old), as a single dose for COVID-19 immunisation. Concomitant medications included monascus purpureus (RED YEAST RICE), and valsartan; hydrochlorothiazide (MANUFACTURER UNKNOWN) 160-25 (units unspecified); both for unknown indications, from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced swelling like a goose egg on the arm at injection site also sore to the touch and bruising at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of swelling like a goose on the arm at injection site also sore to the touch and bruising at injection site were recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Balance disorder, Irritability, Mood swings
Clinical narrative: Extreme irritability; Anger; Mood swings; Can't sit still; This is a spontaneous report received from a contactable consumer, the patient. A 44-years old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7533) via an unspecified route of administration in the right arm on 27Mar2021 at 16:00 (at the age of 44-years) as a single dose for COVID-19 immunisation. The medical history of the patient included bipolar disorder and fibromyalgia. The concomitant medications of the patient included lamotrigine (LAMICTAL XR), topiramate (TOPAMAX), ziprasidone hydrochloride (GEODON), benztropine (COGENTIN) and aripiprazole (ABILIFY) from unknown date and for unknown indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021, the patient experienced that her bipolar medicines were not working. She had no episodes for 9 years. On 28Mar2021, the patient experienced the events extreme irritability, patient was not able to sit still, anger and mood swings. The adverse event did not resulted in a doctor or other healthcare professional office/clinic visit. It was unknown whether the patient received any treatment for the adverse events. The clinical outcome of the events extreme irritability, not able to sit still, anger and mood swings were unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Neck pain, Throat tightness
Clinical narrative: Shortness of Breath; tightness on her throat; Neck pain; shoulder pain; This is a spontaneous report from a contactable consumer (patient) received via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: not reported,), via an unspecified route of administration on 01Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that after her first shot she experienced tightness on her throat, Shortness of Breath, Neck pain and shoulder pain. She had her first shot 01Mar2021 and scheduled to get her second dose on 29Mar2021. She took Benadryl after her first shot. The clinical outcome for the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot been obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Abdominal tenderness, Arthralgia, Back pain, Blood pressure increased
Clinical narrative: Fever 99.9; Bronchial congestion; Tenderness in lower right abdomen; Pain in lower back both right and left side; Severe pain in lower right abdomen; Severe joint  pain (pain level 9); Muscle pain (pain level 9); Wheezing; Body aches; Nausea; Spike in BP; Dizzy; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the right arm on 24Mar2021 at 11:30 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (BP), asthma, arthritis. The patient was allergic to egg whites, bananas and fish (fresh water). Concomitant medications included losartan/hydrochlorothiazide 100/12.5 (MANUFACTURER UNKNOWN) received on unspecified date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on unspecified date (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 24Mar2021 at 12:00, the patient experienced spike in BP, dizzy, nausea. On 25Mar2021 the patient experienced body aches, wheezing. On 26Mar2021 the patient experienced events of severe joint and muscle pain (level 9), bronchial congestion, severe pain and tenderness in lower right abdomen, pain in lower back both right and left side while event of wheezing persisted. On 27Mar2021, the patient experienced fever of 99.9 (unspecified units) and while events of severe joint and muscle pain (level 9), bronchial congestion, severe pain and tenderness in lower right abdomen, pain in lower back both right and left side and wheezing persisted. On 28March2021, pain and tenderness in lower right abdomen persisted. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for events. The clinical outcome of rise in BP, dizzy, general body pain, bronchial congestion, lower abdominal tenderness, low back pain, lower abdominal pain, wheezing, nausea, joint pain, muscle pain and fever was recovering at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Lower respiratory tract congestion, Myalgia, Nausea
Clinical narrative: Fever 99.9; Bronchial congestion; Tenderness in lower right abdomen; Pain in lower back both right and left side; Severe pain in lower right abdomen; Severe joint  pain (pain level 9); Muscle pain (pain level 9); Wheezing; Body aches; Nausea; Spike in BP; Dizzy; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the right arm on 24Mar2021 at 11:30 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (BP), asthma, arthritis. The patient was allergic to egg whites, bananas and fish (fresh water). Concomitant medications included losartan/hydrochlorothiazide 100/12.5 (MANUFACTURER UNKNOWN) received on unspecified date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on unspecified date (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 24Mar2021 at 12:00, the patient experienced spike in BP, dizzy, nausea. On 25Mar2021 the patient experienced body aches, wheezing. On 26Mar2021 the patient experienced events of severe joint and muscle pain (level 9), bronchial congestion, severe pain and tenderness in lower right abdomen, pain in lower back both right and left side while event of wheezing persisted. On 27Mar2021, the patient experienced fever of 99.9 (unspecified units) and while events of severe joint and muscle pain (level 9), bronchial congestion, severe pain and tenderness in lower right abdomen, pain in lower back both right and left side and wheezing persisted. On 28March2021, pain and tenderness in lower right abdomen persisted. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for events. The clinical outcome of rise in BP, dizzy, general body pain, bronchial congestion, lower abdominal tenderness, low back pain, lower abdominal pain, wheezing, nausea, joint pain, muscle pain and fever was recovering at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Wheezing
Clinical narrative: Fever 99.9; Bronchial congestion; Tenderness in lower right abdomen; Pain in lower back both right and left side; Severe pain in lower right abdomen; Severe joint  pain (pain level 9); Muscle pain (pain level 9); Wheezing; Body aches; Nausea; Spike in BP; Dizzy; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the right arm on 24Mar2021 at 11:30 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (BP), asthma, arthritis. The patient was allergic to egg whites, bananas and fish (fresh water). Concomitant medications included losartan/hydrochlorothiazide 100/12.5 (MANUFACTURER UNKNOWN) received on unspecified date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on unspecified date (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 24Mar2021 at 12:00, the patient experienced spike in BP, dizzy, nausea. On 25Mar2021 the patient experienced body aches, wheezing. On 26Mar2021 the patient experienced events of severe joint and muscle pain (level 9), bronchial congestion, severe pain and tenderness in lower right abdomen, pain in lower back both right and left side while event of wheezing persisted. On 27Mar2021, the patient experienced fever of 99.9 (unspecified units) and while events of severe joint and muscle pain (level 9), bronchial congestion, severe pain and tenderness in lower right abdomen, pain in lower back both right and left side and wheezing persisted. On 28March2021, pain and tenderness in lower right abdomen persisted. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for events. The clinical outcome of rise in BP, dizzy, general body pain, bronchial congestion, lower abdominal tenderness, low back pain, lower abdominal pain, wheezing, nausea, joint pain, muscle pain and fever was recovering at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Pain
Clinical narrative: Fever up to 104.4 times 4 days; uncontrolled chills; Weakness; body/ joint aches; body/ joint aches; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 16Mar2021 16:00 (at the age of 52-years-old) (Batch/Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included Pulmonary embolism, Heartburn. The patient had no allergies to medications, food, or other products. Concomitant medication(s) included apixaban (ELIQUIS); dexlansoprazole (DEXILANT), both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since 18Mar2021 16:00, the patient experienced fever up to 104.4 times 4 days, uncontrolled chills, Weakness, body/ joint aches. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. The reporter assessed the events as non-serious. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered with sequelae (Recovered with lasting effects).  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever up to 104.4 times 4 days; uncontrolled chills; Weakness; body/ joint aches; body/ joint aches; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 16Mar2021 16:00 (at the age of 52-years-old) (Batch/Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included Pulmonary embolism, Heartburn. The patient had no allergies to medications, food, or other products. Concomitant medication(s) included apixaban (ELIQUIS); dexlansoprazole (DEXILANT), both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since 18Mar2021 16:00, the patient experienced fever up to 104.4 times 4 days, uncontrolled chills, Weakness, body/ joint aches. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. The reporter assessed the events as non-serious. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered with sequelae (Recovered with lasting effects).  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Fatigue, Pain
Clinical narrative: This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old, non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 10Mar2021 at 14:30 (age at vaccination 55-years-old) as a single dose for COVID-19 immunisation. The patient had medical history (unspecified). The patient had history of allergy to milk, macadamia nuts and pine nuts. The patient received other medications (unspecified) within 2 weeks of vaccination for an unknown indication and from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021 at 18:00, the patient experienced soreness at injection site, fatigue, vomiting, diarrhea, fever, chills, minor achiness and loss of appetite. No therapeutic measures were taken for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events soreness at injection site, fatigue, vomiting, diarrhea, fever, chills, minor achiness and loss of appetite was resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old, non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 10Mar2021 at 14:30 (age at vaccination 55-years-old) as a single dose for COVID-19 immunisation. The patient had medical history (unspecified). The patient had history of allergy to milk, macadamia nuts and pine nuts. The patient received other medications (unspecified) within 2 weeks of vaccination for an unknown indication and from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021 at 18:00, the patient experienced soreness at injection site, fatigue, vomiting, diarrhea, fever, chills, minor achiness and loss of appetite. No therapeutic measures were taken for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events soreness at injection site, fatigue, vomiting, diarrhea, fever, chills, minor achiness and loss of appetite was resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Burning sensation, Inflammation, Lymphadenopathy, Neck pain
Clinical narrative: Burning sensation in mouth; Several canker sores; Red spots in mouth; inflammation on throat; Sore throat; Lymph glands swollen; sore on the neck; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) in the right arm on 20Mar2021 at 17:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included controlled high blood pressure. The patient had a history of allergy to penicillin and sulfa. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) and olmesartan (MANUFACTURER UNKNOWN) for high blood pressure. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 19:00, 5 days after the vaccination, the patient experienced burning sensation in mouth, several canker sores appeared on day 6, 7 and 8 (date of this report), red spots in mouth and appearance of inflammation on throat, sore throat, lymph glands swollen and sore on the neck. The patient did not receive any treatment for the reported events. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events burning sensation in mouth, canker sores, red spots in mouth, inflammation on throat, sore throat, swollen lymph glands and sore on the neck was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal erythema, Oropharyngeal pain
Clinical narrative: Burning sensation in mouth; Several canker sores; Red spots in mouth; inflammation on throat; Sore throat; Lymph glands swollen; sore on the neck; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) in the right arm on 20Mar2021 at 17:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included controlled high blood pressure. The patient had a history of allergy to penicillin and sulfa. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) and olmesartan (MANUFACTURER UNKNOWN) for high blood pressure. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 19:00, 5 days after the vaccination, the patient experienced burning sensation in mouth, several canker sores appeared on day 6, 7 and 8 (date of this report), red spots in mouth and appearance of inflammation on throat, sore throat, lymph glands swollen and sore on the neck. The patient did not receive any treatment for the reported events. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events burning sensation in mouth, canker sores, red spots in mouth, inflammation on throat, sore throat, swollen lymph glands and sore on the neck was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Swelling face, Swollen tongue
Clinical narrative: after 9 hours swollen tongue.; tingling lip; tip of tongue tingling; left side of face swollen; This is a spontaneous report from a contactable consumer, the patient. A 57-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via unspecified route of administration in the left arm on 27Mar2021 at 15:30 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. The patients medical history included high blood pressure, obese. The patient had no known allergies. Concomitant medication included, lisinopril (MANUFACTURER UNKNOWN), unspecified multi vitamins (MANUFACTURER UNKNOWN), ergocalciferol (VITAMIN D), ascorbic acid; rosa canina (VITAMIN C) for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was not tested positive for COVID-19. Since the vaccination the patient had not been tested for COVID-19. About 9 hours after shot on 28Mar2021 at 12:30, the patient woke up with swollen tongue and took Dimetapp. Awoke 7 hours later on 28Mar2021 at 07:30 and noted left side of face was swollen and lips and tip of tongue were tingly and took Dimetapp again. Adverse events did not result in Doctor or other healthcare professional office/clinic visit. Therapeutic measures taken for swollen tongue, swollen face, tingly lip and tip of tongue included Dimetapp. The clinical outcome of swollen tongue, swollen face and tingly lips, tongue tip was unknown.    No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swollen and soreness  at injection site; Swollen at injection site with soreness; Slight fatigue; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN8730), via an unspecified route of administration, in left arm on 26Mar2021 (at the age 0f 66-year-old), as single dose for COVID-19 immunisation. Medical history included Psoriasis. The patient was allergic to sulfonamide. Concomitant medications included tamsulosin (MANUFACTURER UNKNOWN), cyanocobalamin (MANUFACTURER UNKNOWN), pseudoephedrine hydrochloride (SUDAFED)), Ibuprofen (MANUFACTURER UNKNOWN), colecalciferol (MANUFACTURER UNKNOWN) and retinol (MANUFACTURER UNKNOWN); from unknown date for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198), via an unspecified route of administration in the left arm on 05Mar2021 at 10:45 (at the age of 66-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since vaccination, the patient had not tested for COVID-19. On 27Mar2021, the patient experienced swollen injection site with soreness and slight 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 event. The clinical outcome of the events swelling at injection site with soreness and slight fatigue were recovered on unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: fatigue; body aches; This is a spontaneous report from a contactable consumer, the parent. A 26-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on 27Mar2021 at 06:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history was none. The patient received medication for birth control (unspecified) within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on 06Mar2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021, the patient experienced fatigue and body aches. 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. The clinical outcome of events fatigue and body aches were resolved on an unknown date.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: I have light bleeding in my nose; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration on the left arm on 28Mar2021(at the age of 33-year-old) at 14:15, as a single dose for COVID-19 immunisation. Medical history included diabetes mellitus. Concomitant medication included insulin lispro (HUMALOG). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination the patient had not been tested for COVID-19 and since the vaccination, the patient was not tested positive for COVID-19. On 29Mar2021 at 08:30, the patient experienced light nose bleed. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of nose bleed was not unknown.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: head splitting throbbing/headache.; This is a spontaneous report received from a contactable consumer, the patient. A 47-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) as a single dose via an unspecified route of administration in the right arm on 27Mar2021 at 16:45 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the right arm on 06Mar2021 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not tested for COVID-19. On 29Mar2021, the patient experienced a head splitting throbbing headache after 35 hours of shot. The events had not resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received TYLENOL (3 x 325mg) as a treatment for the reported events. The clinical outcome of the event throbbing headache was recovered on 29Mar2021 at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: 10:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid and arthritis. The patient was allergic to pain medications (reported as pain meds). Concomitant medications were reported as levothyroxine (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN) and lysine (MANUFACTURER UNKNOWN), all for unknown indication and from an unknown date. It was unknown, if the patient was diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021, one week after injection the patient experienced sore and swollen lymph glands for 48 hours. The adverse events did not result in doctor or other healthcare professional office/clinic visit. The clinical outcome of swollen lymph nodes and lymph node pain was resolving at the time of this report.   No follow-up attempts are needed. Information about lot/ batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heavy menstrual bleeding
Clinical narrative: Heavy period; Bad headache; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: UTMC/EN6208) via unspecified route of administration in the left arm on 22Mar2021 on 10:45 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since having the vaccine. The patients concomitant medications included aspirin (MANUFACTURER UNKNOWN) and prenatal vitamin (MANUFACTURER UNKNOWN) for unknown indication. On 22Mar2021, the patient experienced bad headache every late afternoon/early evening since the patient got vaccinated. The headache was so bad that ibuprofen didn't even help. Day after the vaccine, the patient experienced abnormally heavy periods with no warning. Therapeutic measure included treatment with ibuprofen for the event headache. The patient did not receive any treatment for the event of heavy period. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache and heavy periods were not recovered 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: Dizziness, Nausea, SARS-CoV-2 test, Vaccination site bruising, Vertigo
Clinical narrative: Dizziness; Vertigo; Bruising at injection site; Some slight nausea the evening of and morning after receiving the vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732) via an unspecified route of administration in the left arm on 26Mar2021 at 09:30 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history included known allergies to sulfa drugs. The concomitant medications included escitalopram (MANUFACTURER UNKNOWN), ascorbic acid; pyridoxine hydrochloride; biotin; folic acid; cholecalciferol; cyanocobalamin; choline bitartrate; inositol; calcium pantothenate; retinol palmitate; zinc citrate; potassium iodide; Dl-alpha tocopherol acetate (SUGAR BEAR HAIR VITAMIN) for unknown indications from unknown dates. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent PCR test (nasal swab) on 27Feb2021 and the result was negative. On 26Mar2021, the patient experienced some slight nausea at the evening and morning after receiving the vaccine. On 27Mar2021 (the day following the vaccine), the patient experienced dizziness and vertigo. The patient also experienced small bruising at the injection site. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had tested for COVID-19 that included PCR test on an unknown date in Mar2021 and the result was unknown. The clinical outcome of the events nausea, dizziness, vertigo and vaccination site bruising was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Mass, Peripheral swelling
Clinical narrative: Swelling on Ulnar side of left hand.; blisters on left hand; hard lumps on left hand and wrist; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207) via unspecified route of administration in the left arm on 27Mar2021 at 11:00 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), evolocumab (REPATHA), losartan (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); all from unspecified dates for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EM9809) via unspecified route of administration in the left arm on 06Mar2021 at 11:45 (at the age of 62-years-old), as a single dose for COVID-19 immunisation and montelukast (MANUFACTURER UNKNOWN) on unknown date for unspecified indication and experienced drug allergy. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 09:00, the patient experienced swelling on ulnar side of left hand, five hard lumps on left hand and wrist and blisters on left hand. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swelling, lumps and blisters was recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in arm at injection site.; This is a spontaneous report from a contactable consumer. A 19-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 27Mar2021 at 13:30 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 28Mar2021 at 17:00 the patient experienced soreness in arm at the injection site. 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 adverse event. The clinical outcome of the event vaccination site pain was recovering at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.