chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Mild muscle aches; This is a spontaneous report from a non-contactable consumer reporting for herself. A 45-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot Number: EJ1685, and expiration date not reported), via an unspecified route of administration, administered in Arm Left on 01Mar2021 at 14:15 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant was not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, the patient experienced mild muscle aches on 04Mar2021 19:00. The patient did not receive any treatment for AE. The outcome of the event was resolving.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: issue with her hip; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route of administration on 23Feb2021 (batch/Lot number unknown) at single dose for Covid-19 immunization. Relevant medical history and concomitant medications were not reported. Three days later, she was seen by an orthopedic physician for an issue with her hip and she received a steroid injection. The patient was given steroids also 3 weeks before the vaccination. The patient wanted to know if it is okay to receive an injection shot before and after first dose of covid-19 vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: lightheadedness; nausea; headache; This is a spontaneous report from a non-contactable other healthcare professional. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot Number: EN6205)), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant was not reported. On an unspecified date, during his 15-minute waiting period after the injection, the patient began to experience light headedness, nausea and headache. Treatment included: water and Pepcid. Follow up response to treatment: good, symptoms resolved prior to discharge. Patient discharge: stable to go home and follow up with PCP. The clinical outcome of the light headedness, nausea, headache was recovered on unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness/tenderness in about 3 inch area below the injection site; This is a spontaneous report from a contactable consumer (Patient). This 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 04Mar2021 at 15:30 (at the age of 67-years-old) as single dose for COVID-19 immunization. The patient medical history included known allergies to Sulfa drugs, gluten and tomatoes. Concomitant medications included levothyroxine and multi vitamins. The patient did not receive any other vaccines within 4 weeks prior vaccination and not had Covid prior vaccination. 05Mar2021 at 01:30 (next day after vaccination), patient experienced soreness/tenderness in about 3-inch area below the injection site. The patient did not receive any treatment for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was not recovered.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Hypersensitivity, Oral disorder, Pain
Clinical narrative: Allergic reaction; Painful in her joints; Pain; Fatigue; Oral lesion; This is a spontaneous report from a contactable consumer (patient).  A 72-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm, on 26Feb2021 at 17:30 (Batch/Lot number was not reported) at the age of 72 years old, as 1st single dose, for COVID-19 immunisation.  Medical history included post polio syndrome with Polio having been diagnosed in 1949, food allergy, histamine and antibiotics reaction/intolerance. The patient received unspecified medications (other than vaccines) within 2 weeks prior to BNT162b2 vaccination. There were no other vaccines administered in the four weeks prior to BNT162b2 vaccination. The patient had not been diagnosed with COVID prior to BNT162b2 vaccination, and was not tested positive for COVID-19 after vaccination. The patient stated having a histamine reaction on 26Feb2021 at 23:00, that lasted 48 hours. It was painful in her joints and also caused red blotches in her mouth/tongue. In addition, the patient stated the histamine reaction triggered 2 of the more severe post polio syndrome symptoms (pain and fatigue). Due to the events, the patient took Benadryl and had to take an extra Percocet . The patient recovered from all the above described events.                        No follow-up attempts are possible; information about lot/batch number cannot be obtained.  .
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: Rash on forearm of right arm; Extremely itchy; very sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 34-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date; not reported), via an unspecified route of administration, administered in Arm Right on 26Feb2021 15:00, as a SINGLE DOSE for covid-19 immunization. The patient medical history included long term gird after having h. Pylori (gastrooesophageal reflux disease) and allergies to penicillin. The patient concomitant medications included pantoprazole and loratadine. No other vaccine in past four weeks. On 02mr2021 at 09:00 pm, the patient experienced rash on forearm of right arm, extremely itchy and very sore. Rash on forearm of right arm. It showed up four days after vaccine dose. Extremely itchy and now very sore. Area of about 8 10 inches by 5 inches at widest points. Patient did not receive any treatment as adverse event. No covid prior vaccination. No covid tested post vaccination. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: headache/migraine which is typical with vaccinations like flu vaccine; headache/migraine which is typical with vaccinations like flu vaccine; This is a spontaneous report received from a contactable consumer (patient). A 59-years-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6199, patient was not pregnant and 59-years-old at the time of vaccination), via an unspecified route of administration in Arm Left on 05Mar2021 at 15:45 as UNKNOWN, SINGLE DOSE for COVID-19 immunisation. The patient's medical history included allergies (known allergies: Yes). The patient's received unknown concomitant medication. On 05Mar2021 at 21:00, the patient experienced headache/migraine which is typical with vaccinations like flu vaccine. Facility type vaccine reported as other. Reported that patient not received other vaccine in four weeks. Reported that other medication was taken in two weeks but not reported any medicine. No treatment received for the event. Patient had not COVID prior vaccination and not tested covid post vaccination. The outcome of reported events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Pain, Pyrexia
Clinical narrative: Patient is asthmatic and experiencing difficulty breathing post the vaccination; headache; body ache; fever; chills; This is a spontaneous report from a contactable consumer (non-healthcare professional reporting for a patient). A 40-year-old male patient received second dose of BNT162B2 (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration, administered to his left arm on 05Mar2021 01:00 PM (Lot number: 032120A) as single dose for Covid-19 immunization. Age at vaccination was reported as 38-years. The patient's medical history included high blood pressure (HBP) and asthma. No COVID tested prior vaccination. It was unknown that COVID tested post vaccination. Other medications in two weeks: HBP, asthma and vitamins. The patient previously took first dose of BNT162B2 (COVID 19) on an unspecified date as single dose for Covid-19 immunization. It was reported that, on 06Mar2021 04:00 AM, patient was asthmatic and was experiencing difficulty breathing post the vaccination. He was also experiencing headache, body ache, fever, and chills. AE resulted in: Emergency room/department or urgent care. It was unknown whether the patient received treatment in response to the events. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Usual blood sugars test began to run HI by about 60 mg/dl.; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 04Mar2021 (Batch/Lot Number: EN6205) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, Heart By-Pass surgery in Jun2019. if other vaccine in four weeks: No. if covid prior vaccination: No. if covid tested post vaccination: No. No known allergies. Concomitant medication(s) (in two weeks) included insulin glargine (LANTUS) taken for an unspecified indication, start and stop date were not reported; metformin hydrochloride, sitagliptin (JANUMET [METFORMIN HYDROCHLORIDE; SITAGLIPTIN]) taken for an unspecified indication, start and stop date were not reported; repaglinide (PRANDIN) taken for an unspecified indication, start and stop date were not reported; losartan taken for an unspecified indication, start and stop date were not reported; carvedilol (COREG) taken for an unspecified indication, start and stop date were not reported; aspirin acetylsalicylic acid (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included BNT162B2 (Product: COVID 19, brand: Pfizer Biontech, lot number: EL9262, lot unknown: False) (dose number: 1) on 11Feb2021 12:30 PM in right arm for covid-19 immunisation. The patient experienced usual blood sugars test began to run hi by about 60 mg/dl (non-serious) on 04Mar2021 20:00.  Adverse event: within 6 hours my usual blood sugars test began to run HI by about 60 mg/dl. Adverse event start date 04Mar2021 08:00 PM. Treatment was received for the adverse event. AE treatment: Patient have adjusted his Medications in hope of improvem. Facility type vaccine: Other. Facility country. The patient underwent lab tests and procedures which included blood sugars: began to run hi by about 60 mg/dl on 04Mar2021. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Muscular weakness, Swollen tongue
Clinical narrative: Increased heart rate to 131 at 11:29 am; dizziness; muscle weakness; swelling of tongue; This is a spontaneous report from a contactable consumer. This 42-year-old female consumer (patient) reported that she received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 11:15 (Batch/Lot Number: EN6206; Expiration Date: Jun2021) as Ist dose, single dose for covid-19 immunisation. Medical history included chronic sinusitis, ventricular extrasystoles, covid-19 from an unknown date and unknown if ongoing If covid prior vaccination: Yes. Concomitant medications included azelastine (AZELASTINE); fluticasone (FLUTICASONE) taken for an unspecified indication, start and stop date were not reported. The patient previously took pseudoephedrine and experienced drug hypersensitivity. On 05Mar2021 11:30 the patient experienced increased heart rate to 131 at 11:29, dizziness, muscle weakness, swelling of tongue. The patient underwent lab tests and procedures which included heart rate: 131 on 05Mar2021. The action taken in response to the events for bnt162b2 was not applicable. Outcome of the events was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: lips are swollen; 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, Batch/Lot number: Unknown), via an unspecified route of administration on 04Mar2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medication were not reported. In Mar2021 the patient stated her lips are swollen. Reporter stated as, "she had her 1st dose of the Pfizer Covid Vaccine last Thursday and now her lips are swollen". The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Cough, Dizziness, Fatigue, Headache
Clinical narrative: she experienced dizziness; dry cough; Headache; Sneezing; No taste; Nausea; Extremely tired; This is a spontaneous report from a contactable consumer (patient).  A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported), age at vaccination of 76-years-old, as single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. Between the first shot (28Jan2021) and the second shot (on 18Feb2021), the patient experienced dizziness, dry cough, headache, sneezing, no taste, nausea, and was very tired/ extremely tired.  Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Sneezing
Clinical narrative: she experienced dizziness; dry cough; Headache; Sneezing; No taste; Nausea; Extremely tired; This is a spontaneous report from a contactable consumer (patient).  A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported), age at vaccination of 76-years-old, as single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. Between the first shot (28Jan2021) and the second shot (on 18Feb2021), the patient experienced dizziness, dry cough, headache, sneezing, no taste, nausea, and was very tired/ extremely tired.  Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Heat and Tender Arm; This is a spontaneous report from a contactable consumer (patient). A 74-years-old non pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6203),via an unspecified route of administration, administered in Arm Left on 26Feb2021 (at 74-years age) 09:45 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient was not tested for COVID-19. On 27Feb2021, the patient experienced heat and tender arm. No treatment was received for the event. The outcome of event was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: Extreme Fatigue; Headache; Loss of appetite; Weakness; Low Grade Fever; Nausea; Th epatient received first dose of BNT162B2 on Feb2021 and second dose on 08Feb2021; Th epatient received first dose of BNT162B2 on Feb2021 and second dose on 08Feb2021; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 89-year-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 14:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included heart & ureter Stents, mild heart attack, stroke, pacemaker, hysterectomy, temporary nephrostomy, blood pressure, pain, sulfonamide allergy and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.Concomitant medication(s) included mirtazapine (MIRTAZAPINE); blood pressure medication (unspecified), statins medication (unspecified) and pain medication (unspecified) all taken for an unspecified indication, start and stop date were not reported. The patient previously took isosorbide, heparin and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (BNT162B2) via an unspecified route of administration on Feb2021 at 02:15 PM (Batch/Lot number:Unknown) as SINGLE DOSE for covid-19 immunisation and expereinced fatigue, vomiting, diarrhea, headache, loss of appetite and low grade fever lasting over 3 weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received first dose of BNT162B2 on Feb2021 and second dose on 08Feb2021. On 09Feb2021, the patient experienced extreme fatigue, headache, loss of appetite, weakness, low grade fever and nausea. Therapeutic measures were taken as a result of extreme fatigue, headache, loss of appetite, weakness, low grade fever, nausea with otc tylenol, zofran. The outcome of the events extreme fatigue, headache, loss of appetite, weakness, low grade fever, nausea were recovering and unknown for other events.  Information about lot/batch number has been requested.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Off label use, Pyrexia
Clinical narrative: Extreme Fatigue; Headache; Loss of appetite; Weakness; Low Grade Fever; Nausea; Th epatient received first dose of BNT162B2 on Feb2021 and second dose on 08Feb2021; Th epatient received first dose of BNT162B2 on Feb2021 and second dose on 08Feb2021; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 89-year-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 14:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included heart & ureter Stents, mild heart attack, stroke, pacemaker, hysterectomy, temporary nephrostomy, blood pressure, pain, sulfonamide allergy and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.Concomitant medication(s) included mirtazapine (MIRTAZAPINE); blood pressure medication (unspecified), statins medication (unspecified) and pain medication (unspecified) all taken for an unspecified indication, start and stop date were not reported. The patient previously took isosorbide, heparin and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (BNT162B2) via an unspecified route of administration on Feb2021 at 02:15 PM (Batch/Lot number:Unknown) as SINGLE DOSE for covid-19 immunisation and expereinced fatigue, vomiting, diarrhea, headache, loss of appetite and low grade fever lasting over 3 weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received first dose of BNT162B2 on Feb2021 and second dose on 08Feb2021. On 09Feb2021, the patient experienced extreme fatigue, headache, loss of appetite, weakness, low grade fever and nausea. Therapeutic measures were taken as a result of extreme fatigue, headache, loss of appetite, weakness, low grade fever, nausea with otc tylenol, zofran. The outcome of the events extreme fatigue, headache, loss of appetite, weakness, low grade fever, nausea were recovering and unknown for other events.  Information about lot/batch number has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Night sweats
Clinical narrative: Night sweats; chills; Tired; This is a spontaneous report from a contactable consumer (Patient). A 46-year-old male patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Brand: Pfizer), dose 1 via an unspecified route of administration, administered in Left Arm on 03Mar2021 12:45 PM (Batch/Lot Number: EN6205, Lot unknown: False) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included High blood pressure, High heart beat rate. Facility type vaccine: Other, Facility type vaccine other: Vaccination Center. Known allergies: No, Other medical history: High blood pressure, high heart beat rate. There were no concomitant medications. If other vaccine in four weeks: No. The patient experienced night sweats (non-serious) on 05Mar2021 02:00 am, chills (non-serious) on 05Mar2021 02:00 am, tired (non-serious) on 05Mar2021 02:00 am. Adverse event: Night sweats and chills 36 hours after taking the vaccine. Tired up to 48 hours after taking the vaccine. Adverse event country: US. If patient recovered: Recovered. If treatment ae: No. If covid prior vaccination: No. If covid tested post vaccination: No. Explicit consent: Yes. For all events, outcome was recovered on an unspecified date in 2021.    No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Movement disorder, Myalgia
Clinical narrative: sore muscles (not to touch) left arm; could not raise above head; fever 100 degrees; chills; weakness in legs; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EN6200), dose 2 via an unspecified route of administration, administered in left arm on 05Mar2021 at 10:00 (at the age 64-years-old) as 2nd single dose for COVID-19 immunization. Patient's medical history included known allergy of sulfa. The patient's concomitant medication was not reported. Patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EL9269), dose 1 via an unspecified route of administration, administered in left arm on 12Feb2021 at 12:00 PM. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at the nursing home/senior living facility. Patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine and other medications in two weeks. The patient had not been tested for COVID19 nor before neither since the vaccination. The patient experienced after 23 hours later, sore muscles (not to touch) left arm, could not raise above head; fever 100 degrees, chills and weakness in legs on 06Mar2021 at 09:00. The patient underwent lab tests and procedures which included body temperature was 100 degrees. The outcome of events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: sore muscles (not to touch) left arm; could not raise above head; fever 100 degrees; chills; weakness in legs; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EN6200), dose 2 via an unspecified route of administration, administered in left arm on 05Mar2021 at 10:00 (at the age 64-years-old) as 2nd single dose for COVID-19 immunization. Patient's medical history included known allergy of sulfa. The patient's concomitant medication was not reported. Patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EL9269), dose 1 via an unspecified route of administration, administered in left arm on 12Feb2021 at 12:00 PM. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at the nursing home/senior living facility. Patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine and other medications in two weeks. The patient had not been tested for COVID19 nor before neither since the vaccination. The patient experienced after 23 hours later, sore muscles (not to touch) left arm, could not raise above head; fever 100 degrees, chills and weakness in legs on 06Mar2021 at 09:00. The patient underwent lab tests and procedures which included body temperature was 100 degrees. The outcome of events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymph node pain, Lymphadenitis, Malaise
Clinical narrative: Body aches; painful lymph node sweeling underarm; painful lymph node sweeling underarm; uncontrolled shivers; nausea; tired; just overall felt unwell; This is a spontaneous report received from a contactable consumer (patient). A 41-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 14:45 (at the age of 41-years-old) (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. The patient medical history was reported as none. The patient had no known allergies. Concomitant medication(s) included cetirizine hydrochloride (ALLERTEC) taken for an unspecified indication, start and stop date were not reported; famotidine (PEPCID [FAMOTIDINE]) taken for an unspecified indication, start and stop date were not reported; spironolactone (SPIRONOLACTONE) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265 and Expiration date was not reported) via an unspecified route of administration, in Arm left, on 12Feb2021 at 02:45PM, as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05MAR2021 at 03:30AM, the patient had experienced body aches, painful lymph node swelling underarm, uncontrolled shivers, nausea, tired, just overall felt unwell. The outcome of the events were recovering. The patient did not receive any treatment for the events.  No follow up attempts are possible. No further information is expected
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Body aches; painful lymph node sweeling underarm; painful lymph node sweeling underarm; uncontrolled shivers; nausea; tired; just overall felt unwell; This is a spontaneous report received from a contactable consumer (patient). A 41-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 14:45 (at the age of 41-years-old) (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. The patient medical history was reported as none. The patient had no known allergies. Concomitant medication(s) included cetirizine hydrochloride (ALLERTEC) taken for an unspecified indication, start and stop date were not reported; famotidine (PEPCID [FAMOTIDINE]) taken for an unspecified indication, start and stop date were not reported; spironolactone (SPIRONOLACTONE) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265 and Expiration date was not reported) via an unspecified route of administration, in Arm left, on 12Feb2021 at 02:45PM, as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05MAR2021 at 03:30AM, the patient had experienced body aches, painful lymph node swelling underarm, uncontrolled shivers, nausea, tired, just overall felt unwell. The outcome of the events were recovering. The patient did not receive any treatment for the events.  No follow up attempts are possible. No further information is expected
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Coordination abnormal, Muscle fatigue, Muscular weakness
Clinical narrative: Left arm is weak. My arm feels like it can't lift or type. Like the muscle in the arm is failing. The left arm has become weakened.; A type of muscle fatigue on the left side of the body; A lack of hand and muscle coordination; This is a spontaneous report from a contactable consumer (patient reported for himself). A 70-year-old male patient received first dose of BNT162B2 (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration, administered to her left arm on 04Mar2021 01:30 PM (at the age of 70-year-old) (Lot number: Unknown) as single dose for Covid-19 immunisation. The patient's medical history included heart valve replacement. Concomitant medications included atorvastatin at 40 mg day, acetylsalicylic acid (BABY ASPIRIN) and colecalciferol/magnesium oxide/vitamin B1 NOS (MAGNESIUM 400) (other medications in two weeks). On 04Mar2021 03:00 PM, the patient experienced left arm is weak. His arm felt like it could not lift or type. Like the muscle in the arm was failing. The left arm had weakened. it had lasted for two days. A type of muscle fatigue on the left side of the body. A lack of hand and muscle coordination. No COVID tested prior or post vaccination. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: extremely painful neck ache; hard to turn my neck; muscle ache; first thought it was muscle ache but think it might be lymph nodes; first thought it was muscle ache but think it might be lymph nodes; This is a spontaneous report from a contactable consumer (Patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Left Arm on 26Feb2021 11:00 AM (Batch/Lot Number: EL9269, lot unknown: False) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. if Covid prior vaccination: No, if Covid tested post vaccination: No, other medical history: none. Facility type Vaccine: Hospital. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; tocopherol (VITAMIN E [TOCOPHEROL]) taken for an unspecified indication, start and stop date were not reported; selenium taken for an unspecified indication, start and stop date were not reported. The patient previously took demerol and experienced known allergies: Demerol. Other medications in two weeks: Crestor, antibiotics, Vitamin E, Selenium. Historical Vaccine included BNT162B2 (Product: COVID 19, brand: Pfizer, lot number: EL3247, lot unknown: False) on 05Feb2021 11:00 AM, vaccine location: Left arm, dose number: 1 for covid-19 immunisation. The patient experienced extremely painful neck ache (non-serious) on 01Mar2021, hard to turn my neck (non-serious) on 01Mar2021, muscle ache (non-serious) on 01Mar2021, first thought it was muscle ache but think it might be lymph nodes ((non-serious) on 01Mar2021,.  Adverse event: On the 3rd day following the 2nd injection I developed extremely painful neck ache, making it hard to turn my neck. This has lasted 5 days and does not seem to relent, although it is less sore. I first thought it was muscle ache but think it might be lymph nodes. Adverse event start date: 01Mar2021, Adverse Event. If patient recovered: Recovering. if treatment ae: No. If other vaccine in four weeks: No. For all events, outcome was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Pyrexia
Clinical narrative: low grade fever; some headache/Some headaches; Extreme fatigue/ exhausted and tired; Very weak; This is a spontaneous report from a contactable consumer(patient herself) reported that a 88 years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6198 and expiration date: unknown), via an unspecified route of administration in left arm on 01Mar2021 at 10:45 AM as a single dose for COVID-19 immunisation. The patients medical history included asthma, sleep apnea, hypertension, bilateral hearing loss and exudative AMD, hashimotos, anaemia, aortic atherosclerosis, colonic diverticulosis, amplatzer atrial septal closure device and has got Covid-19 prior vaccination. The patient had a history of known allergies which includes severe reaction to penicillin. Concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6201 and expiration date: unknown), via an unspecified route of administration in right arm on 09Feb2021 at 10:45 AM as single dose for COVID-19 immunisation. The patient received no other vaccines in four weeks and has not been tested for Covid-19 post vaccination. The patient reported that there was no problem at all after am injection for next 13 hours. Then low-grade fever, some headache and EXTREME fatigue. Fell asleep about midnight and woke up 2pm next day (3rd). Very weak and exhausted and tired until about Friday the 5th. Some headaches and low-grade fever. Had no rest most days. No household chores possible. No treatment was received for adverse events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Vaccination site pain
Clinical narrative: arm soreness/ache after receiving the injection; arm soreness/ache after receiving the injection; arm soreness/ache after receiving the injection; This is a spontaneous report from a contactable consumer. A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 04Mar2021 as a 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer stated she and her husband (77-years-old male). They both received the first dose of the Pfizer Covid vaccine on 04Mar2021. They both reported arm soreness/ache after receiving the injection. She was calling to find out whether it was ok for her husband to take his regular daily medications (lisinopril, flonase, pravastatin, and pepcid AC) around the time of receiving the vaccine or should he wait. She stated that, he took advil 4 hours after the vaccine for reported aches and also took Benadryl, she wanted to know whether that was ok or did that affect the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021261995 Same reporter/drug/AE, different patient
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: hi, I got Pfizer covid vaccine's first shot on 6/2 at 10:20 am. At around 10:30 pm, the left side of my face and facial bones became a bit stiff. Though I recovered next morning (on 6/3) but I still have a very slight numbness in my left jaw.  So I wanted to report this adverse effect.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Flushing
Clinical narrative: Pt reported SOB on floor after receiving vaccine.   Lungs CTA x 5 lobes.  No stridor noted.   Slight flushing in face upon arrival to med obs, resolved within approx 3-5 min.  Pt drank 1 bottle water and guided through relaxation deep breathing exercises.  Pt reports SOB resolved at 1614.  Released w/ family after orthostatic VSS and pt reports SOB resolved and denies any other subjective symptoms.   VS obtained over long sleeve shirt to accommodate for pt culture, religion, and/or modesty at pt request  VS 1557 SITTING  BP 140/95, HR 89, RR 20, 97%RA 1603  SITTING  BP 136/96, HR 82, RR 18, 99%RA 1615  SITTING  BP 143/97, HR 81, RR 16, 96%RA 1617 STANDING BP 145/95, HR 86, RR 16, 97%RA
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Reconstituted incorrectly, only given the Lyophilized MenA component and reconstituted in sterile water. Patient reports no adverse reactions.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Hyperhidrosis, Hypoaesthesia, Nausea
Clinical narrative: Situation: Patient, 28 yrs old, had an appointment for 1st dose Moderna  Lot# 007C21A today. Pt felt anxious prior to vaccination. As a precaution, pt was placed on a gurney and he received the vaccine while on the gurney. RN was bedside during the process. Pt started feeling shaky and dizzy 5 mins post vaccination. . Juice and crackers provided. Pt stated that he ate and drank liquids prior to coming in. Encourage to relax and take slow deep breaths  Background: . He informed the vaccinator upon arrival that he has a hx of syncopal episode during vaccinations. Pt had a syncopal episode when he got the TB Test. Pt felt anxious prior to vaccination. Allergies: PCN and other abx, unable to state rest of allergies Hx: Asthma, MVA last April 2021, head injury, L wrist surgery Accompanied by mother  Assessment:  1020 ? Pt c/o being more dizzy, queasy to throat and chest, lightheaded and started to look pale. VS 99.0F, 65, 98% RA, 97/40 (62), 22. Clear speech noted.  1030 ? VS 105/49 (67), 72, 99% RA, 26. Paler, diaphoretic, increased dizziness, nausea, numbness to hands, anxious, shaky. Mother at bedside, comforting patient. Encourage to take slower deep breaths and continue to lie back.  1034 ? VS 114/61 (74), 72, 100% RA, 22, color is better 1038 ? VS 106/65 (77), 65, 100% RA, 18. Pt is more relaxed. Tightness to throat is better. Clear speech. Can speak complete sentences.  1043 ? VS 103/65 (79), 64, 100% RA, 18. Color has improved. More color to lips, hands are less numb. Pt stated that he is back to ?almost normal.? 1044 ? Called Dr about pt. MD was expecting that pt will be better in a few minutes. If pt is worse or if his symptoms come back while at home, pt need to go to ED or call his doctor. Relayed MD?s recommendation to patient and mother. Both verbalized understanding.  1045 ? VS 102/61 (72), 74, 18, 94% RA 1050 ? VS 116/70 (80), 74, 16, 95% RA. Moved patient and mother to room 6. Pt stated that he is ?feeling way better.? Mother at bedside. Report given to RN 1100 ? VS 103/63, 68, 98% RA semi fowlers on the gurney? conversing with mother.        VS 111/67, 72, 100% RA - sitting       VS 116/68, 85, 100% RA standing. Denies any dizziness upon position changes.  1110 ? VS 97/65, 67, 95% RA. Pt stated that he feels okay. Drank juice. 1120 ? VS 109/65, 72, 95% RA. Able to stand and walk to wheelchair.  1125 ? ambulated to bathroom. No problems. 1130 ? wheeled to car. Denies any symptoms.   Recommendations:   Dr was called about pt and expected that pt will be better in a few minutes. If pt is worse or if his symptoms come back while at home, pt needs to go to ED or call his doctor. Relayed MD?s recommendation to patient and mother. Both verbalized understanding. Pt was wheeled to the car and went home with his mother.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Nervousness, Pallor, Throat tightness
Clinical narrative: Situation: Patient, 28 yrs old, had an appointment for 1st dose Moderna  Lot# 007C21A today. Pt felt anxious prior to vaccination. As a precaution, pt was placed on a gurney and he received the vaccine while on the gurney. RN was bedside during the process. Pt started feeling shaky and dizzy 5 mins post vaccination. . Juice and crackers provided. Pt stated that he ate and drank liquids prior to coming in. Encourage to relax and take slow deep breaths  Background: . He informed the vaccinator upon arrival that he has a hx of syncopal episode during vaccinations. Pt had a syncopal episode when he got the TB Test. Pt felt anxious prior to vaccination. Allergies: PCN and other abx, unable to state rest of allergies Hx: Asthma, MVA last April 2021, head injury, L wrist surgery Accompanied by mother  Assessment:  1020 ? Pt c/o being more dizzy, queasy to throat and chest, lightheaded and started to look pale. VS 99.0F, 65, 98% RA, 97/40 (62), 22. Clear speech noted.  1030 ? VS 105/49 (67), 72, 99% RA, 26. Paler, diaphoretic, increased dizziness, nausea, numbness to hands, anxious, shaky. Mother at bedside, comforting patient. Encourage to take slower deep breaths and continue to lie back.  1034 ? VS 114/61 (74), 72, 100% RA, 22, color is better 1038 ? VS 106/65 (77), 65, 100% RA, 18. Pt is more relaxed. Tightness to throat is better. Clear speech. Can speak complete sentences.  1043 ? VS 103/65 (79), 64, 100% RA, 18. Color has improved. More color to lips, hands are less numb. Pt stated that he is back to ?almost normal.? 1044 ? Called Dr about pt. MD was expecting that pt will be better in a few minutes. If pt is worse or if his symptoms come back while at home, pt need to go to ED or call his doctor. Relayed MD?s recommendation to patient and mother. Both verbalized understanding.  1045 ? VS 102/61 (72), 74, 18, 94% RA 1050 ? VS 116/70 (80), 74, 16, 95% RA. Moved patient and mother to room 6. Pt stated that he is ?feeling way better.? Mother at bedside. Report given to RN 1100 ? VS 103/63, 68, 98% RA semi fowlers on the gurney? conversing with mother.        VS 111/67, 72, 100% RA - sitting       VS 116/68, 85, 100% RA standing. Denies any dizziness upon position changes.  1110 ? VS 97/65, 67, 95% RA. Pt stated that he feels okay. Drank juice. 1120 ? VS 109/65, 72, 95% RA. Able to stand and walk to wheelchair.  1125 ? ambulated to bathroom. No problems. 1130 ? wheeled to car. Denies any symptoms.   Recommendations:   Dr was called about pt and expected that pt will be better in a few minutes. If pt is worse or if his symptoms come back while at home, pt needs to go to ED or call his doctor. Relayed MD?s recommendation to patient and mother. Both verbalized understanding. Pt was wheeled to the car and went home with his mother.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Did not know we were pregnant, received vaccine. Got positive pregnancy test a few days later and miscarried the next month at 8 weeks with baby measuring 6 weeks. Have no history of miscarriage and two full term healthy babies prior to this. Unknown if related for sure, but this is the only change and timing seems important to report as possibly correlated.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: patient received moderna first shot and accidently received pfizer the second time. There was a language barrier and pt said they received pfizer and actually had pfizer paperwork so was given pfizer vaccine
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Borrelia test negative
Clinical narrative: Patient developed Bell's Palsy shortly after vaccination.  4/17 was vaccine. Symptoms began 5/1. Seen in ED 5/4.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast tenderness, Confusional state, Diarrhoea, Dizziness
Clinical narrative: 3 hours after injection, developed profuse sweating on neck in air conditioned room followed by hives on neck and chest, itching, pain. was advised to take benadryl. fell asleep within one hour. Hives reoccured every day for one week. I still have redness and bumps.  12 hours after injection, developed very sore arm, pain with range of motion, headache which resolved with Motrin, fatigue-slept 18 hours. 3 days after injection developed diarrhea which is still occuring 3 weeks after. developed severe PMS 2 weeks earlier than usual which has never happened. Breasts not just tender-they hurt. terrible cramps, which i never get. bleeding through super ultra tampon every 45 minutes which has never happened. Unable to exercise because of dizziness and fatigue. I typically exercise 5 days per week including jogging, hiking, resistance training. today, June 3,  I became very confused and felt like my brain wasnt sending signals to my body. I cannot remember what I needed to do 5 minutes ago. I went to fill up my sink to do dishes and poured water on the counter instead of drain, I poured coffee in my eye.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Heavy menstrual bleeding, Hyperhidrosis
Clinical narrative: 3 hours after injection, developed profuse sweating on neck in air conditioned room followed by hives on neck and chest, itching, pain. was advised to take benadryl. fell asleep within one hour. Hives reoccured every day for one week. I still have redness and bumps.  12 hours after injection, developed very sore arm, pain with range of motion, headache which resolved with Motrin, fatigue-slept 18 hours. 3 days after injection developed diarrhea which is still occuring 3 weeks after. developed severe PMS 2 weeks earlier than usual which has never happened. Breasts not just tender-they hurt. terrible cramps, which i never get. bleeding through super ultra tampon every 45 minutes which has never happened. Unable to exercise because of dizziness and fatigue. I typically exercise 5 days per week including jogging, hiking, resistance training. today, June 3,  I became very confused and felt like my brain wasnt sending signals to my body. I cannot remember what I needed to do 5 minutes ago. I went to fill up my sink to do dishes and poured water on the counter instead of drain, I poured coffee in my eye.