chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Haemorrhage intracranial, Imaging procedure, Infarction, Laboratory test, Platelet count decreased
Clinical narrative: [Johnson & Johnson Vaccine] use for COVID-19 under Emergency Use Authorization (EUA): The patient developed VITT (vaccine- induced thrombotic thrombocytopenia) 9 days following administration of the Johnson & Johnson vaccine. The patient demised from catastrophic intracranial hemorrhage, infarction and clot formation. The diagnosis was clear based on the clinical presentation, laboratory and radiological findings. The patient had no comorbidity and was not receiving concurrent medication.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Thrombosis, Thrombosis with thrombocytopenia syndrome
Clinical narrative: [Johnson & Johnson Vaccine] use for COVID-19 under Emergency Use Authorization (EUA): The patient developed VITT (vaccine- induced thrombotic thrombocytopenia) 9 days following administration of the Johnson & Johnson vaccine. The patient demised from catastrophic intracranial hemorrhage, infarction and clot formation. The diagnosis was clear based on the clinical presentation, laboratory and radiological findings. The patient had no comorbidity and was not receiving concurrent medication.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis
Clinical narrative: [Johnson & Johnson Vaccine] use for COVID-19 under Emergency Use Authorization (EUA): The patient developed VITT (vaccine- induced thrombotic thrombocytopenia) 9 days following administration of the Johnson & Johnson vaccine. The patient demised from catastrophic intracranial hemorrhage, infarction and clot formation. The diagnosis was clear based on the clinical presentation, laboratory and radiological findings. The patient had no comorbidity and was not receiving concurrent medication.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Condition aggravated, Dysarthria, Dysstasia, Fatigue
Clinical narrative: Patient states that her seizures were controlled.  Had not had any seizures in months.  Since the vaccine, she experienced 3 seizures on 9/8/2021 and 1 seizure on 9/9/2021.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hot flush, Pyrexia, Seizure
Clinical narrative: Patient states that her seizures were controlled.  Had not had any seizures in months.  Since the vaccine, she experienced 3 seizures on 9/8/2021 and 1 seizure on 9/9/2021.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Malaise, Pyrexia, Seizure
Clinical narrative: Patient states that her seizures were controlled.  Had not had any seizures in months.  Since the vaccine, she experienced 3 seizures on 9/8/2021 and 1 seizure on 9/9/2021.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Seizure
Clinical narrative: Patient states that her seizures were controlled.  Had not had any seizures in months.  Since the vaccine, she experienced 3 seizures on 9/8/2021 and 1 seizure on 9/9/2021.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling hot, Flushing
Clinical narrative: Blood pressure went high,  increased pulse rate.  Red flushing all over neck and chest.  Very hot.  Once I got home I Ran fever- 99.9 . Experienced slight headache and neck achiness same day that evening.   Injection arm became very sore and was also sore into the next day 9/9/21.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling hot, Flushing, Headache, Heart rate increased
Clinical narrative: Blood pressure went high,  increased pulse rate.  Red flushing all over neck and chest.  Very hot.  Once I got home I Ran fever- 99.9 . Experienced slight headache and neck achiness same day that evening.   Injection arm became very sore and was also sore into the next day 9/9/21.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Injection site pain, Neck pain, Nervousness, Pyrexia
Clinical narrative: Blood pressure went high,  increased pulse rate.  Red flushing all over neck and chest.  Very hot.  Once I got home I Ran fever- 99.9 . Experienced slight headache and neck achiness same day that evening.   Injection arm became very sore and was also sore into the next day 9/9/21.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: First thing I noticed was that the index finger on my right hand was twitching. Then I started feeling extremely dizzy and I blacked out. When I came to, the first thing I registered was that my father and the pharmacist were waking me up and trying to talk to me. Then they laid me on the floor on my side and the pharmacist started to take my blood pressure while calling emergency services. On waking up, at first I almost couldn't talk, but later I was able to talk better. The paramedics came and took me to the hospital.  My father's account: about 5 minutes after the shot, I heavily leaned to the left side in my chair, with my arms and legs stretched and trembling. My eyes were rolled up. When he and the pharmacist woke me up, I was extremely confused and could hardly talk. The pharmacist was continuously checking my blood pressure. It was about 90/70.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Dizziness, Eye movement disorder, Loss of consciousness, Muscle twitching
Clinical narrative: First thing I noticed was that the index finger on my right hand was twitching. Then I started feeling extremely dizzy and I blacked out. When I came to, the first thing I registered was that my father and the pharmacist were waking me up and trying to talk to me. Then they laid me on the floor on my side and the pharmacist started to take my blood pressure while calling emergency services. On waking up, at first I almost couldn't talk, but later I was able to talk better. The paramedics came and took me to the hospital.  My father's account: about 5 minutes after the shot, I heavily leaned to the left side in my chair, with my arms and legs stretched and trembling. My eyes were rolled up. When he and the pharmacist woke me up, I was extremely confused and could hardly talk. The pharmacist was continuously checking my blood pressure. It was about 90/70.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Speech disorder, Syncope, Tremor
Clinical narrative: First thing I noticed was that the index finger on my right hand was twitching. Then I started feeling extremely dizzy and I blacked out. When I came to, the first thing I registered was that my father and the pharmacist were waking me up and trying to talk to me. Then they laid me on the floor on my side and the pharmacist started to take my blood pressure while calling emergency services. On waking up, at first I almost couldn't talk, but later I was able to talk better. The paramedics came and took me to the hospital.  My father's account: about 5 minutes after the shot, I heavily leaned to the left side in my chair, with my arms and legs stretched and trembling. My eyes were rolled up. When he and the pharmacist woke me up, I was extremely confused and could hardly talk. The pharmacist was continuously checking my blood pressure. It was about 90/70.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: first dose, he had no symptoms other than a sore shoulder; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 29Jan2021 (at the age of 74-years-old) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation.  The patient's medical history was not reported. There were no concomitant medications. On an unspecified date, the patient experienced a sore shoulder. It was reported that the patient had no symptoms other than the sore shoulder. The outcome of the event was unknown.   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: Arthralgia, Vaccination site pain
Clinical narrative: arthralgias; Sore arm at injection site; This is a spontaneous report from a contactable other hcp (patient). A 70-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 17Feb2021 10:30 (Batch/Lot Number: EN6201) at the age of 70 years old as dose 2, single for COVID-19 immunisation. Medical history included chronic hypertension (CHTN), hyperlipidemia, bicuspid aortic valve, and known allergies to sulfa (sulfonamide allergy). Other medications in two weeks included atorvastatin calcium (ATORVASTIN); lisinopril; asa; mirtazapine; and amlodipine, all taken for an unspecified indication, start and stop date were not reported. The patient previously took ciprofloxacin and clindamycin and on both, the patient experienced allergies. Historical vaccination included BNT162b2 (Pfizer Biontech COVID-19 vaccine) received by the patient on 27Jan2021 10:30 (lot number=EN9581) administered in right arm, at the age of 70 years old as dose 1, single for COVID-19 immunisation. There are no other vaccines in four weeks. The patient experienced sore arm at injection site and arthralgias on 18Feb2021. No treatment was given for the adverse events. The patient recovered from both events on unspecified date. The patient has no history of COVID-19 and has not been tested for COVID-19 post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Pain and swelling in knees; Pain and swelling in knees; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 12Feb2021 a 12:00 PM (at the age of 65 years), as dose 1, single, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included estradiol (ESTROGEN), progesterone, esomeprazole magnesium (NEXIUM), and hyaluronate sodium (HYALURONIC) on 15Feb2021. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The most recent vaccine was administered in a doctor's office or urgent care facility. On 18Feb2021, the patient experienced pain and swelling in knees after receiving hyaluronic gel injections 3 days after vaccination. The events resulted in physician office visit. Treatment to the events included ibuprofen and cold compress. The patient has not been tested for COVID-19 post vaccination. The patient had not recovered from the events.  No follow-up attempts are required; information about lot or batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Facial rash; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in left arm on 09Feb2021 14:00 (at the age of 36-year-old) as dose 1, single for COVID-19 immunization. Medical history included Diabetes, high blood pressure, penicillin allergy and Covid. The patient's concomitant medications included unspecified medications in two weeks. No other vaccine in four weeks. The patient experienced facial rash on 10Feb2021 06:00. The patient received no treatment for the event. The outcome of the event was recovered on unspecified date in 2021.    No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on arm; This is a spontaneous report from a contactable consumer (patient). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, on 03Feb2021 11:30 (also reported as 02Mar2021 11:30, pending clarification) (Batch/lot number: EN6198), at age 17 years old, as dose 1, single, for COVID-19 immunisation, at a clinic. Relevant medical history included hypertrophic cardiomyopathy from an unknown date, not reported if ongoing or not. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included atenolol and an unspecified vitamin both taken for unknown indications, start and stop dates were not reported. The patient did not receive any other vaccines in four weeks. On 03Feb2021 (also reported as 03Feb2021 03:30 and 02Mar2021 03:30, pending clarification), the patient had rash on arm which resulted to physician's office visit. It was unknown if the patient received treatment for the event. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Wheezing
Clinical narrative: Day after 2nd dose got coughing; wheezing; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 24Feb2021 (at the age of 68-years-old) (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included no (reported other medical history was no). The patient was not pregnant at the time of the events. The patient has no known allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks. The patient did not have COVID prior to vaccination and had not been tested for COVID post-vaccination. The patient previously took the first dose of BNT162B2 administered in the left arm on 03Feb2021 at 13:30 for COVID-19 immunisation. On 25Feb2021 at 6:00, the patient experienced coughing and wheezing. No treatment was received for the events. It was reported that the patient was still having the same coughing and wheezing a week later. The outcome of the events was not recovered/not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Face went red for approximately 1 hour; This is a spontaneous report from a contactable Consumer (patient). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 02Mar2021 09:45 (Batch/Lot Number: EL3247) (at the age of 48 years) as dose 1, single for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication included olmesartan medoxomil (BENICAR) taken for an unspecified indication, start and stop date were not reported. The patient experienced face went red for approximately 1 hour on 02Mar2021 15:30 with outcome of recovered on 02Mar2021 16:30, with no treatment.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleed; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: PAA165969), via an unspecified route of administration in right arm, on 26Feb2021 at 03:15 PM (15:15) (at the age of 60 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included breast cancer from 1995 to 2014 and allergies to teagarden. The patient's concomitant medications included escitalopram oxalate (LEXAPRO) and omeprazole. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. On 02Mar2021 at 01:45 PM (13:45), the patient experienced nose bleed. The patient never has had a nose bleed before. No treatment was administered for the event. The patient has not been tested for COVID-19 post vaccination. The patient recovered from the event on 02Mar2021 (unspecified time).  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia
Clinical narrative: muscle aches; joint aches; chills; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: tn6205, expiry date not reported), via an unspecified route of administration, administered in the left arm on 25Feb2021 13:00 (at the age of 69 years old) as dose 1, single for covid-19 immunisation. Medical history included adenocarcinoma and atrial fibrillation, both from an unknown date and unknown if ongoing. The patient had no covid prior vaccination. The patient was not pregnant at the time of vaccination and of the report. Concomitantly patient had medications in two weeks (unspecified). The patient had no other vaccine in four weeks. The patient previously took wool fat (LANOLIN) and cinnamomum verum (CINNAMON), and had known allergies on both. On 26Feb2021, the patient experienced muscle aches, joint aches, chills. The patient was not tested for covid post vaccination. No treatments were received in response to the events. The patient recovered on an unspecified date in 2021 from the events reported.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site bruising
Clinical narrative: the vaccine was injected subcutaneously instead of intramuscularly; small bruise at the injection site; This is a spontaneous report from a contactable healthcare professional (patient) received via a Pfizer-sponsored program,  Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), subcutaneously, administered in arm, on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that the vaccine was injected to her subcutaneously instead of intramuscularly on an unspecified date. The patient also experienced small bruise at the injection site (upper arm), red rectangular area over the interior deltoid close to the above the muscle under the skin on an unspecified date. The patient wanted to know what antibodies test does Pfizer recommends to asses for immunity after vaccination. The outcome of event small bruise at the injection site was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Face swollen around cheeks areas; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number was not reported), via an unspecified route of administration, administered in the left arm on 02Mar2021 10:30 (at the age of 73-years-old) as dose 1, single for COVID-19 immunization. Medical history included high blood pressure, kidney disease stage 2, mild gastroesophageal reflux disease (GERD), and penicillin allergy. Concomitant medications included hydrochlorothiazide, losartan, and tamsulosin. The patient previously took ciprofloxacin (CIPRO) and experienced drug allergy. Prior to vaccination, the patient had no COVID-19. The patient did not receive any other vaccines within 4 weeks of the COVID vaccination. On 02Mar2021 18:30, the patient experienced face swollen around cheeks areas. Therapeutic measures were not taken as result of the event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue
Clinical narrative: extreme fatigue; weakness; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in left arm on 04Feb2021 14:30 (at the age of 67-year-old) single dose for COVID-19 immunisation. Medical history included A-fib, diabetes, high blood pressure, neuropathy, arthritis and sulpha drug allergies. The patient had no covid prior to vaccination. The patient reported that he had many prescriptions (not specified). On 04Feb2021, the patient extreme fatigue, weakness and shortness of breath. The event resulted in visit to the doctor and no treatment was given to the patient in response to the events. The patient was not tested for covid post vaccination. The patient had not recovered from extreme fatigue, weakness and shortness of breath at the time of the report.   No follow-up attempts are possible. Information about lot/batch number could not be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: sneezing; severe runny nose; This is a spontaneous report from a non-contactable consumer. A 68-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Feb2021 10:00 (Batch/Lot Number: EN6202) as dose 2, single (at the age of 68 years) for covid-19 immunisation. Medical history included known allergies: Sulfa from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient has not had Covid-19 prior to vaccination and was not tested for Covid post vaccination. The patient received the first dose of BNT162B2 (lot: EM9810), via unspecified route of administration in the left arm on 05Feb2021 at 08:30AM as dose 1, single (at the age of 68 years) for Covid-19 immunisation. The patient experienced sneezing and severe runny nose on 02Mar2021 08:30. The patient did not received treatment for the events. The outcome of the events was not recovered. The patient has not had vaccine in 4 weeks or other medications in two weeks.  No follow-up attempts are possible. No further information is expected. Information about the batch/lot number already obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Chills, Headache
Clinical narrative: Severe, constant chills; headache; fever of 102.8; BP 158/98; pulse 150; This is a spontaneous report from a contactable consumer.   A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Feb2021 18:15 (Age at vaccnation63 years old) (Batch/Lot Number: EN6202) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included thrombosis, covid-19 from Nov2020 to Nov2020 , drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included allopurinol (ALLOPURINOL), lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. on 28Feb2021 10:00 Severe, constant chills for approximately 22 minutes. Approximately 1 hour later, headache and fever of 102.8, BP 158/98 pulse 105. Took 3 Tylenol every 3-4 hrs. Fever broke after 12 hours. Next morning chills again (not as severe) with no fever. Headache continued for another 24-36 hrs. The patient underwent lab tests and procedures which included blood pressure measurement: 158/98   on 28Feb2021, body temperature: 102.8 on 28Feb2021, heart rate: 105 on 28Feb2021.  Therapeutic measures were taken as a result of severe, constant chills (chills), headache (headache), fever of 102.8 (pyrexia). Outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Pulse abnormal, Pyrexia
Clinical narrative: Severe, constant chills; headache; fever of 102.8; BP 158/98; pulse 150; This is a spontaneous report from a contactable consumer.   A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Feb2021 18:15 (Age at vaccnation63 years old) (Batch/Lot Number: EN6202) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included thrombosis, covid-19 from Nov2020 to Nov2020 , drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included allopurinol (ALLOPURINOL), lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. on 28Feb2021 10:00 Severe, constant chills for approximately 22 minutes. Approximately 1 hour later, headache and fever of 102.8, BP 158/98 pulse 105. Took 3 Tylenol every 3-4 hrs. Fever broke after 12 hours. Next morning chills again (not as severe) with no fever. Headache continued for another 24-36 hrs. The patient underwent lab tests and procedures which included blood pressure measurement: 158/98   on 28Feb2021, body temperature: 102.8 on 28Feb2021, heart rate: 105 on 28Feb2021.  Therapeutic measures were taken as a result of severe, constant chills (chills), headache (headache), fever of 102.8 (pyrexia). Outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash/ very fine rash/ not really raised/ on her left arm where she got the injection in the deltoid and it run down on the rest of her arm and a little bit on her forearm/ didn't itch; This is a spontaneous report from a contactable consumer (a retired nurse who is also the patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date unknown), via an unspecified route of administration, administered in the left deltoid on 23Feb2021 (at the age of 56 years old) as dose 2, single for COVID-19 immunisation. Medical history included hypertension, hypothyroidism, and gastrooesophageal reflux disease (reported as GERD). She also had stomach issues. Concomitant medications included olmesartan and hydrochlorothiazide taken for hypertension; thyroid (ARMOUR) taken for hypothyroidism, and sucralfate (CARAFATE) and rabeprazole sodium (ACIPHEX) taken for GERD. The patient previously received first dose of BNT162B2 on 29Jan2021 (Batch/Lot number and Expiry date unknown, at the age of 56 years old) for COVID-19 immunisation. The patient stated that she received her second dose on 23Feb2021 (Tuesday). At five o'clock (on 26Feb2021), she woke up in the morning and she noticed a rash. It's a very fine rash, it's not really raised, but she could see it in a different light. It was on her left arm where she got the injection in the deltoid and it run down on the rest of her arm and a little bit on her forearm. It didn't itch; she just happened to look there and there it was. She asked if it was anything she need to be concerned about and it's not anywhere else. No therapeutic measures were taken as a result of the event. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Sleep disorder
Clinical narrative: sleep pretty badly; fever; chill; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 22Feb2021 (lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got fever, chill and sleep pretty badly on Feb2021. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Swollen lymph nodes, fever and malaise.; Fever; Malaise; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 02Mar2021 10:00 (Batch/Lot Number: EN6205) (at the age of 44 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus type 2 from an unknown date and unknown if ongoing. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9264), dose 1, administered in Arm Left on 28Jan2021 11:00 (at the age of 44 years) for covid-19 immunisation. The patient's concomitant medication included metformin from unspecified date for unknown indication. The patient previously took penicillin and experienced hypersensitivity. The patient experienced swollen lymph nodes, fever and malaise on 02Mar2021 13:00 with outcome of not recovered without treatments. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative on 10Feb2021, sars-cov-2 test negative: negative   on 02Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Disease recurrence
Clinical narrative: Cough; Cough; This is a spontaneous report from a contactable nurse (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EM9809 and Expiration date: not reported) via an unspecified route of administration, administered on the right arm on 11Feb2021 13:30 (at the age of 77 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history included sinus pressure (coughs when raining; sinuses are bad), tree allergy, breast cancer, and arthritis. Concomitant medications included an unspecified injection for pain in the leg (arthritis) received two weeks before the first dose and an unspecified pill taken every night for breast cancer. The patient previously took amlodipine besilate (NORVASC) and dextropropoxyphene napsilate;paracetamol (DARVOCET) for unspecified indications and experienced drug allergy. On 12Feb2021, the patient experienced a cough. The patient had a dry cough but sometimes brings up clear sputum. The patient was not experiencing any crackles or wheezing. The outcome of the reported event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot
Clinical narrative: heat throughout entire face; redness throughout entire face; This is a spontaneous report from a contactable consumer reporting for herself. A 67-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: EJ1686), dose 1 via an unspecified route of administration, administered in left arm on 08Feb2021 16:15 (at the age of 67-year-old) as dose 1, single for COVID-19 immunization. Medical history included IV contrast allergy. Concomitant medication included ergocalciferol (VITAMIN D). No other vaccine in four weeks. On 08Feb2021 16:45, the patient experienced heat and redness throughout entire face. No Covid prior vaccination nor tested for Covid post vaccination. Therapeutic measures were taken as a result of the events which included Benadryl. The patient recovered from the events on unspecified date in 2021.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: lost most of her taste; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 60, unknown unit) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient lost most of her taste on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain and pressure; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration in left arm, on 01Mar2021 at 11:30 AM (at the age of 73 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included COVID-19 (prior vaccination), stent, and allergies to penicillin (possibly). The patient's concomitant medications included atorvastatin, ezetimibe (ZETIA), metoprolol tartrate, and ergocalciferol (VIT D). No other vaccine was administered in four weeks. On 02Mar2021 at 07:00 AM, the patient experienced chest pain and pressure. No treatment was administered for the event. The patient has not been tested for COVID-19 post vaccination. The patient recovered from the event in Mar2021.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dry eye, Eye swelling, Lacrimation increased, Swelling face
Clinical narrative: Swollen eyes; Facial swelling; she had a little ache where she got the COVID-19 Vaccine shot; Dry eyes; Eyes tearing; This is a spontaneous report from a contactable consumer (patient herself). A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200), via an unspecified route of administration, administered in left arm on 19Feb2021 (at approximately 10:50 - 11:00) (age at vaccination: 78 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included ongoing dry eyes started 2-3 years ago, saying her dry eyes are from aging, ongoing drug hypersensitivity to any form of penicillin for years. There were no concomitant medications. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1288) in her left arm, on 29Jan2021 for covid-19 immunisation, tylenol with codeine and experienced drug hypersensitivity. She was allergic to strawberries, raspberries, shell fish and tomatoes. She said she had allergies since she was a little girl, but wasn't diagnosed with the allergies until she was an adult. On an unknown date in December2020, the patient underwent blood test with unknown results. On 20Feb2021 (Saturday), she had a little ache where she got the covid-19 vaccine shot for which she put some icy hot cream, so she put some icy hot on the spot, and she had no further problem with her arm (left), dry eyes and eyes tearing. For dry eyes and facial swelling patient took Xiidra 5 percent (Lot Number: 20647, Expiration Date: June2023). She was still taking it. On 21Feb2021 (Sunday), after she woke up, the patient experienced swollen eyes, facial swelling. She said she immediately took Benadryl 25mg tablets (Lot number: AAF001, Expiration Date: September2022) . She said her allergy doctor told her to take Benadryl any time she has an allergic reaction. She said her doctor told her to put a warm compress over her eyes to help with the swelling, as well. She said she did not have any problem with the first COVID-19 Vaccine shot. The patient did not require emergency or physician's office visit. There were no prior vaccinations in four weeks. The outcome of lacrimation increased was not recovered; eye swelling, swelling face, dry eye was recovering; vaccination site pain was recovered on 20Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Swollen eyes; Facial swelling; she had a little ache where she got the COVID-19 Vaccine shot; Dry eyes; Eyes tearing; This is a spontaneous report from a contactable consumer (patient herself). A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200), via an unspecified route of administration, administered in left arm on 19Feb2021 (at approximately 10:50 - 11:00) (age at vaccination: 78 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included ongoing dry eyes started 2-3 years ago, saying her dry eyes are from aging, ongoing drug hypersensitivity to any form of penicillin for years. There were no concomitant medications. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1288) in her left arm, on 29Jan2021 for covid-19 immunisation, tylenol with codeine and experienced drug hypersensitivity. She was allergic to strawberries, raspberries, shell fish and tomatoes. She said she had allergies since she was a little girl, but wasn't diagnosed with the allergies until she was an adult. On an unknown date in December2020, the patient underwent blood test with unknown results. On 20Feb2021 (Saturday), she had a little ache where she got the covid-19 vaccine shot for which she put some icy hot cream, so she put some icy hot on the spot, and she had no further problem with her arm (left), dry eyes and eyes tearing. For dry eyes and facial swelling patient took Xiidra 5 percent (Lot Number: 20647, Expiration Date: June2023). She was still taking it. On 21Feb2021 (Sunday), after she woke up, the patient experienced swollen eyes, facial swelling. She said she immediately took Benadryl 25mg tablets (Lot number: AAF001, Expiration Date: September2022) . She said her allergy doctor told her to take Benadryl any time she has an allergic reaction. She said her doctor told her to put a warm compress over her eyes to help with the swelling, as well. She said she did not have any problem with the first COVID-19 Vaccine shot. The patient did not require emergency or physician's office visit. There were no prior vaccinations in four weeks. The outcome of lacrimation increased was not recovered; eye swelling, swelling face, dry eye was recovering; vaccination site pain was recovered on 20Feb2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cough, Palpitations
Clinical narrative: Dry cough; Heart palpitations; Worried; This is a spontaneous report from a contactable consumer (patient's child). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the second dose of the COVID-19 vaccine with Pfizer and she can't get a hold of a doctor. On an unspecified date, the patient was experiencing dry cough and a little bit of heart palpitations. The patient's child didn't know if the heart palpitation is because the patient was worried on an unspecified date. The patient's child asked if that was something to be concerned. The patient's child would rather call right now because the patient was really worried; patient's child's time is limited. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Slight chest discomfort within 30 mins after vaccine. Increasing discomfort within 6 hours and next day.; This is a spontaneous report from a contactable consumer (patient). A 29-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 01Mar2021 14:30 (at the age of 29 years old) as dose number unknown, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing; and known allergies to peas and legumes, from an unknown date and unknown if ongoing. Patient had no covid prior vaccination Concomitant medications included fluticasone propionate (FLOVENT) taken for an unspecified indication, start and stop date were not reported; and montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; both were taken within two weeks prior to vaccination.  The patient had no other vaccine in four weeks. On 01Mar2021 (at 02:45 AM, also reported as within 30 mins after vaccine), patient experienced slight chest discomfort and increasing discomfort within 6 hours and next day. The event resulted in emergency room/department or urgent care. The reported event was non-serious. Therapeutic measures were taken as a result of the event reported which included GI cocktail, and Tylenol. Patient was not tested for covid post vaccination. The outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Bursitis, Investigation, Joint swelling, Lymphadenopathy
Clinical narrative: Had to go to Emergency Room I was having severe pain from my shoulder down to my little finger on my left arm I got the shot; Had swelling in my right; The outer side of my shoulder was swollen; Lymph node under my armpit was swollen; Pain is like constant ache, like tooth ache; My arm still killing me, kind of swollen around in elbow area; Blood in urine; This is a spontaneous report from a contactable consumer. A 69-years-old female patient received second dose of bnt162b2 (Solution injection; Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 24Feb2021 as single dose for covid-19 immunisation. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot Number: not reported), via an unspecified route of administration, on an unspecified date as single dose for covid-19 immunisation. Medical history included emphysema, irritable bowel syndrome (IBS), migraine and arthritis. Concomitant medications included cyclobenzaprine hydrochloride (FLEXERIL). The patient reported that she had to go to the emergency room yesterday, a week ago on Wednesday, 24Feb2021 she had my second Covid shot she went home and she laid down for a while and when she woke up she was having severe pain from her shoulder down to her little finger on her left arm and that the arm she got the shot in and today she have been putting heat and ice and taking stuff for pain and it was just not going away so yesterday she finally went to the doctor who was sure it was from Covid shot and told her to take tylenol and keep using heat and ice. She had swelling in her right, the outer side of her shoulder was swollen and she had a lymph node under her armpit that was swollen, now today swelling was gone but the pain was still there it was like constant ache, like tooth ache. She wanted to know if she should report this. She stated that her arm was still killing her, it was still swollen in her, kind of swollen around her elbow area. She stated that she took Tylenol but it didnot do much. She was going to take Ibuprofen but she did not know how much to take. She also had hydrocodone with acetaminophen and she took one of those, that was an old and it really did not do anything either so she did not take anymore. She had blood in the urine. The patient underwent lab tests and procedures which included blood in my urine. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling, Toothache
Clinical narrative: Had to go to Emergency Room I was having severe pain from my shoulder down to my little finger on my left arm I got the shot; Had swelling in my right; The outer side of my shoulder was swollen; Lymph node under my armpit was swollen; Pain is like constant ache, like tooth ache; My arm still killing me, kind of swollen around in elbow area; Blood in urine; This is a spontaneous report from a contactable consumer. A 69-years-old female patient received second dose of bnt162b2 (Solution injection; Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 24Feb2021 as single dose for covid-19 immunisation. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot Number: not reported), via an unspecified route of administration, on an unspecified date as single dose for covid-19 immunisation. Medical history included emphysema, irritable bowel syndrome (IBS), migraine and arthritis. Concomitant medications included cyclobenzaprine hydrochloride (FLEXERIL). The patient reported that she had to go to the emergency room yesterday, a week ago on Wednesday, 24Feb2021 she had my second Covid shot she went home and she laid down for a while and when she woke up she was having severe pain from her shoulder down to her little finger on her left arm and that the arm she got the shot in and today she have been putting heat and ice and taking stuff for pain and it was just not going away so yesterday she finally went to the doctor who was sure it was from Covid shot and told her to take tylenol and keep using heat and ice. She had swelling in her right, the outer side of her shoulder was swollen and she had a lymph node under her armpit that was swollen, now today swelling was gone but the pain was still there it was like constant ache, like tooth ache. She wanted to know if she should report this. She stated that her arm was still killing her, it was still swollen in her, kind of swollen around her elbow area. She stated that she took Tylenol but it didnot do much. She was going to take Ibuprofen but she did not know how much to take. She also had hydrocodone with acetaminophen and she took one of those, that was an old and it really did not do anything either so she did not take anymore. She had blood in the urine. The patient underwent lab tests and procedures which included blood in my urine. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: This is a spontaneous report from a contactable consumer.  A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in left arm on 22Feb2021 10:15 (Batch/Lot Number: EN6203; Expiration Date: 30Jun2021) as dose 1, single (at the age of 79 years old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  On 22Feb2021, the patient had a bruise, at the site of the injection, red or brownish and greenish around the outside that has extended to about an inch to 2 inches in circumference. He said that it is about a 1.5 inches in diameter and there is no pain when touching it. It just looks like a bruise. He never had such a reaction with the flu shot and he is not on blood thinners. on 22Feb2021. The outcome of the event was unknown.   No follow-up attempts are needed. Information on lot/batch number cannot be obtained. No further information is expected.