chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: I am so confused; There is a sore there where I got it; I got a burning sensation in my whole body, like a hot flash almost.; I got a burning sensation in my whole body, like a hot flash almost.; I am not taking the second shot; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, in Left Arm on 28May2021 (at the age of 60-years-old), as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history included Fibromyalgia syndrome; Diabetes; Conversion disorder; Arthritis; and consumer stated, "I have a Pacemaker. The patient's concomitant medications included insulin aspart (NOVOLOG) taken for diabetes mellitus; gabapentin (GABAPENTIN) taken for neuropathy peripheral; tizanidine (TIZANIDINE) taken for muscle relaxant therapy; meloxicam (MELOXICAM) taken for inflammation; and Klonopin. Consumer stated, no prior vaccinations within 4 weeks of prior vaccination. On an unspecified date, the patient reported that she was so confused, there is a sore there where she got it, she got a burning sensation in her whole body, like a hot flash almost, and she supposed to get the second shot on 07June2021but she was not taking it. She further stated that she had a bad reaction to the Pfizer shot. They had to put her in a nursing home. On an unspecified date, the patient underwent lab tests and procedures which included blood test: unknown, and sars-cov-2 test: unknown. The outcome for all the events was unknown.   Information about batch/Lot number has been requested.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Exercise tolerance decreased
Clinical narrative: cough; I have problems with breathing after only 5 or 10 minutes of exercise which I did not have before I took the first shot; This is a spontaneous report from a contactable consumer. This 54-years-old male consumer (patient) reported that: A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 14Mar2021 at 19:15 (at the age of 54 year) as single dose for covid-19 immunisation. Medical history included Allergy to penicillin from an unknown date and unknown if ongoing Maybe penicillin but I'm clear on this point. Patient other medical history reported as none and in good health. Patient not diagnosed with covid-19 prior to vaccination. The patient's concomitant medications were not reported. Patient was not received any other vaccine prior four weeks of vaccination and patient did not receive any medication prior two weeks of vaccination. Patient have problems with breathing after only 5 or 10 minutes of exercise on 14Mar2021 at 20:30 which did not have before he took the first shot, also have a small cough which started after the first shot on 14Mar2021 at 20:30 and it seems to have not gone away. Since vaccination patient not tested for covid-19. Patient visited to physician's office for the events. No therapeutic measures were taken as a result of the events. The outcome of the events was reported as not recovered.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea
Clinical narrative: cough; I have problems with breathing after only 5 or 10 minutes of exercise which I did not have before I took the first shot; This is a spontaneous report from a contactable consumer. This 54-years-old male consumer (patient) reported that: A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 14Mar2021 at 19:15 (at the age of 54 year) as single dose for covid-19 immunisation. Medical history included Allergy to penicillin from an unknown date and unknown if ongoing Maybe penicillin but I'm clear on this point. Patient other medical history reported as none and in good health. Patient not diagnosed with covid-19 prior to vaccination. The patient's concomitant medications were not reported. Patient was not received any other vaccine prior four weeks of vaccination and patient did not receive any medication prior two weeks of vaccination. Patient have problems with breathing after only 5 or 10 minutes of exercise on 14Mar2021 at 20:30 which did not have before he took the first shot, also have a small cough which started after the first shot on 14Mar2021 at 20:30 and it seems to have not gone away. Since vaccination patient not tested for covid-19. Patient visited to physician's office for the events. No therapeutic measures were taken as a result of the events. The outcome of the events was reported as not recovered.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug abuse, Seizure, Sleep deficit
Clinical narrative: Witnessed Tonic Clonic seizure lasting 30 seconds
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Witnessed Tonic Clonic seizure lasting 30 seconds
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dental discomfort, Salivary hypersecretion
Clinical narrative: RINGING IN BOTH EARS; NUMBNESS UPPER GUMS/TEETH; INCREASED SALIVATION; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and alcoholic, and other pre-existing medical conditions included patient had no known allergies and drug abuse or illicit drug use, no significant medical history, no prescription medications, no caffeine use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A) dose was not reported, administered on 22-JUN-2021 10:13 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, the subject experienced ringing in both ears. On 22-JUN-2021, the subject experienced numbness upper gums/teeth. On 22-JUN-2021, the subject experienced increased salivation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from ringing in both ears, numbness upper gums/teeth, and increased salivation. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Salivary hypersecretion, Tinnitus
Clinical narrative: RINGING IN BOTH EARS; NUMBNESS UPPER GUMS/TEETH; INCREASED SALIVATION; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and alcoholic, and other pre-existing medical conditions included patient had no known allergies and drug abuse or illicit drug use, no significant medical history, no prescription medications, no caffeine use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A) dose was not reported, administered on 22-JUN-2021 10:13 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, the subject experienced ringing in both ears. On 22-JUN-2021, the subject experienced numbness upper gums/teeth. On 22-JUN-2021, the subject experienced increased salivation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from ringing in both ears, numbness upper gums/teeth, and increased salivation. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: 4 hours after vaccination, had numbness of left side of face in the trigeminal nerve region. Later had fever an aches which resolved, but as of 7.2.21, still has numbness in face which is about 2/3 better but still present. Has no facial motor deficits.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Pain, Pyrexia
Clinical narrative: 4 hours after vaccination, had numbness of left side of face in the trigeminal nerve region. Later had fever an aches which resolved, but as of 7.2.21, still has numbness in face which is about 2/3 better but still present. Has no facial motor deficits.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Mentioned that they may have lock the vaccine in freezer for too long and might have expired and the caller was advised to take three doses; Ache in the arm and burning; Ache and burning in her arm; Ache in the arm and burning; Ache and burning in her arm; This is a spontaneous report from a non-contactable consumer (patient) received via Pfizer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported) via an unspecified route of administration, on 14Jun2021, as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced ache in the arm and burning; ache and burning in her arm on an unspecified date in Jun2021. The patient took her first dose of vaccine on 14un2021 and it was mentioned that they might have lock the vaccine in freezer for too long and might have expired and the patient was advised to take three doses (two more doses). The reporter was asking how effective the vaccine was in three doses and how safe was that for her body and heart since she experienced ache and burning in her arm after the first dose. The outcome for the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Expired product administered, Pain in extremity
Clinical narrative: Mentioned that they may have lock the vaccine in freezer for too long and might have expired and the caller was advised to take three doses; Ache in the arm and burning; Ache and burning in her arm; Ache in the arm and burning; Ache and burning in her arm; This is a spontaneous report from a non-contactable consumer (patient) received via Pfizer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported) via an unspecified route of administration, on 14Jun2021, as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced ache in the arm and burning; ache and burning in her arm on an unspecified date in Jun2021. The patient took her first dose of vaccine on 14un2021 and it was mentioned that they might have lock the vaccine in freezer for too long and might have expired and the patient was advised to take three doses (two more doses). The reporter was asking how effective the vaccine was in three doses and how safe was that for her body and heart since she experienced ache and burning in her arm after the first dose. The outcome for the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspepsia, Illness, Oropharyngeal pain, Pyrexia
Clinical narrative: LACTOSE INTOLERANCE; FEVER; SORE THROAT; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAY-2021, the subject experienced sore throat. On 12-MAY-2021, the subject experienced fever.  Laboratory data included: Body temperature (NR: not provided) 101 F. On 23-JUN-2021, the subject experienced lactose intolerance. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lactose intolerance, and the outcome of fever and sore throat was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Lactose intolerance, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: LACTOSE INTOLERANCE; FEVER; SORE THROAT; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAY-2021, the subject experienced sore throat. On 12-MAY-2021, the subject experienced fever.  Laboratory data included: Body temperature (NR: not provided) 101 F. On 23-JUN-2021, the subject experienced lactose intolerance. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lactose intolerance, and the outcome of fever and sore throat was not reported. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Lethargy, Polymerase chain reaction, Pyrexia
Clinical narrative: difficulty breathing and shortness of breath.; fever; chills; lethargy; This is a spontaneous report from a contactable consumer. A 21-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 28Mar2021 (Lot Number: ER8734) at age of 20 years old as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: EP7534) at age of 20 years old on 28Mar2021 for COVID-19 Immunisation and experienced fever, chills, lethargy. The patient experienced difficulty breathing and shortness of breath, fever, chills, lethargy on 20Apr2021 12:00. No treatment was received. Clinical course reported as: The night of the second dose, I began to have difficulty breathing and shortness of breath. This slowly became worse the next day. The breathing issues did subside over about two weeks and now I am 95% back to normal. I did experience fever, chills, and lethargy for both of the second doses. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Apr2021 Nasal Swab, sars-cov-2 test: negative on 25Apr2021 Nasal Swab, sars-cov-2 test: negative on 26May2021 Nasal Swab. Outcome of events was recovering. Since the vaccination the patient had not been tested for COVID-19. Case was reported as nonserious.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dyspnoea, Lethargy, Pyrexia, SARS-CoV-2 test
Clinical narrative: difficulty breathing and shortness of breath.; fever; chills; lethargy; This is a spontaneous report from a contactable consumer. A 21-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 28Mar2021 (Lot Number: ER8734) at age of 20 years old as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: EP7534) at age of 20 years old on 28Mar2021 for COVID-19 Immunisation and experienced fever, chills, lethargy. The patient experienced difficulty breathing and shortness of breath, fever, chills, lethargy on 20Apr2021 12:00. No treatment was received. Clinical course reported as: The night of the second dose, I began to have difficulty breathing and shortness of breath. This slowly became worse the next day. The breathing issues did subside over about two weeks and now I am 95% back to normal. I did experience fever, chills, and lethargy for both of the second doses. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Apr2021 Nasal Swab, sars-cov-2 test: negative on 25Apr2021 Nasal Swab, sars-cov-2 test: negative on 26May2021 Nasal Swab. Outcome of events was recovering. Since the vaccination the patient had not been tested for COVID-19. Case was reported as nonserious.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Gait disturbance, Mobility decreased, Pain, Pain in extremity
Clinical narrative: 3 BRUISES IN THE AREA LINED UP VERTICALLY ON RIGHT KNEE AND FEELS HARD TO TOUCH; A LITTLE SWOLLEN RIGHT KNEE; PAIN IN RIGHT LEG SPECIFICALLY BELOW THE KNEE; GENERAL BODY WEAKNESS; A LITTLE TIRED; CHILLS; GENERAL BODY DISCOMFORT; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included motor problems specifically to legs ( weakness in bilateral legs due to being born premature), non smoker, and non alcoholic, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281 and expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-JUN-2021, the subject experienced general body discomfort. On 21-JUN-2021, the subject experienced chills. On 21-JUN-2021, the subject experienced general body weakness. On 21-JUN-2021, the subject experienced a little tired. Treatment medications included: acetylsalicylic acid. On 22-JUN-2021, treatment medications included: ibuprofen. On 25-JUN-2021, the subject experienced 3 bruises in the area lined up vertically on right knee and feels hard to touch. On 25-JUN-2021, the subject experienced a little swollen right knee. On 25-JUN-2021, the subject experienced pain in right leg specifically below the knee. Laboratory data included: Pain scale (NR: not provided) 7-8 on a scale of 1-10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general body discomfort, chills, general body weakness, and a little tired on 22-JUN-2021, and had not recovered from pain in right leg specifically below the knee, a little swollen right knee, and 3 bruises in the area lined up vertically on right knee and feels hard to touch. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Skin discolouration
Clinical narrative: 3 BRUISES IN THE AREA LINED UP VERTICALLY ON RIGHT KNEE AND FEELS HARD TO TOUCH; A LITTLE SWOLLEN RIGHT KNEE; PAIN IN RIGHT LEG SPECIFICALLY BELOW THE KNEE; GENERAL BODY WEAKNESS; A LITTLE TIRED; CHILLS; GENERAL BODY DISCOMFORT; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included motor problems specifically to legs ( weakness in bilateral legs due to being born premature), non smoker, and non alcoholic, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281 and expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-JUN-2021, the subject experienced general body discomfort. On 21-JUN-2021, the subject experienced chills. On 21-JUN-2021, the subject experienced general body weakness. On 21-JUN-2021, the subject experienced a little tired. Treatment medications included: acetylsalicylic acid. On 22-JUN-2021, treatment medications included: ibuprofen. On 25-JUN-2021, the subject experienced 3 bruises in the area lined up vertically on right knee and feels hard to touch. On 25-JUN-2021, the subject experienced a little swollen right knee. On 25-JUN-2021, the subject experienced pain in right leg specifically below the knee. Laboratory data included: Pain scale (NR: not provided) 7-8 on a scale of 1-10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general body discomfort, chills, general body weakness, and a little tired on 22-JUN-2021, and had not recovered from pain in right leg specifically below the knee, a little swollen right knee, and 3 bruises in the area lined up vertically on right knee and feels hard to touch. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Contusion, Discomfort, Fatigue
Clinical narrative: 3 BRUISES IN THE AREA LINED UP VERTICALLY ON RIGHT KNEE AND FEELS HARD TO TOUCH; A LITTLE SWOLLEN RIGHT KNEE; PAIN IN RIGHT LEG SPECIFICALLY BELOW THE KNEE; GENERAL BODY WEAKNESS; A LITTLE TIRED; CHILLS; GENERAL BODY DISCOMFORT; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included motor problems specifically to legs ( weakness in bilateral legs due to being born premature), non smoker, and non alcoholic, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281 and expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-JUN-2021, the subject experienced general body discomfort. On 21-JUN-2021, the subject experienced chills. On 21-JUN-2021, the subject experienced general body weakness. On 21-JUN-2021, the subject experienced a little tired. Treatment medications included: acetylsalicylic acid. On 22-JUN-2021, treatment medications included: ibuprofen. On 25-JUN-2021, the subject experienced 3 bruises in the area lined up vertically on right knee and feels hard to touch. On 25-JUN-2021, the subject experienced a little swollen right knee. On 25-JUN-2021, the subject experienced pain in right leg specifically below the knee. Laboratory data included: Pain scale (NR: not provided) 7-8 on a scale of 1-10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general body discomfort, chills, general body weakness, and a little tired on 22-JUN-2021, and had not recovered from pain in right leg specifically below the knee, a little swollen right knee, and 3 bruises in the area lined up vertically on right knee and feels hard to touch. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint swelling, Pain assessment, Pain in extremity
Clinical narrative: 3 BRUISES IN THE AREA LINED UP VERTICALLY ON RIGHT KNEE AND FEELS HARD TO TOUCH; A LITTLE SWOLLEN RIGHT KNEE; PAIN IN RIGHT LEG SPECIFICALLY BELOW THE KNEE; GENERAL BODY WEAKNESS; A LITTLE TIRED; CHILLS; GENERAL BODY DISCOMFORT; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included motor problems specifically to legs ( weakness in bilateral legs due to being born premature), non smoker, and non alcoholic, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281 and expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-JUN-2021, the subject experienced general body discomfort. On 21-JUN-2021, the subject experienced chills. On 21-JUN-2021, the subject experienced general body weakness. On 21-JUN-2021, the subject experienced a little tired. Treatment medications included: acetylsalicylic acid. On 22-JUN-2021, treatment medications included: ibuprofen. On 25-JUN-2021, the subject experienced 3 bruises in the area lined up vertically on right knee and feels hard to touch. On 25-JUN-2021, the subject experienced a little swollen right knee. On 25-JUN-2021, the subject experienced pain in right leg specifically below the knee. Laboratory data included: Pain scale (NR: not provided) 7-8 on a scale of 1-10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general body discomfort, chills, general body weakness, and a little tired on 22-JUN-2021, and had not recovered from pain in right leg specifically below the knee, a little swollen right knee, and 3 bruises in the area lined up vertically on right knee and feels hard to touch. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Electrocardiogram abnormal, Myocarditis
Clinical narrative: myocarditis; Chest pain; This is a spontaneous report from a contactable consumer (Reporter's girlfriend). This is report 3 of 3.  A female patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech Covid-19, Solution injection; Batch/Lot Number: EW0153), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced myocarditis starting about 5 days after Covid Vaccine first dose. The patient never went back for the second dose because the chest pain was so intense. It took the patient about 4 weeks for adverse event to go away. The patient was treated and have moved on but maybe patient was a little bit healthier than the next person would be. Caller was concerned that they had gotten bad batches. Caller wanted to know how many vaccines are in each batch. Caller verified that she believes the third character in Lot number is the letter O, not the numeral zero. Caller questioned if the vaccine Lot numbers are sequentially in order, like numerically; and if there is a particular number of batches manufactured for each Lot number: like are there 10,000 or 100 of one Lot number manufactured, and then they make the next batch of the next Lot number. She called the CDC to ask those questions, but CDC did not know the answers. Caller reported she and her girlfriends experienced adverse events after Pfizer Covid Vaccine and they all kind of joked and said it must have been the Pfizer Covid Vaccine. They finally compared their cards and their vaccines Lot numbers were all within digits of each other. Caller feels it is worthwhile to look into it. They are all fine, but it might be an issue of bad batches of Lot numbers of the Pfizer Covid Vaccine. They all recovered; but if there is a bad batch Pfizer needs to know this. This patient and her girlfriends were in different locations for their Pfizer Covid Vaccine doses; they just all happened to sit down together and compare their cards. If all of the sudden it is asked why are these people who weren't in the same locations experiencing these adverse events, it might be worthwhile to consider if those Lot numbers were bad batches. She also asked if someone ends up in the emergency room or urgent care are they at the emergency room or urgent care required to report the information; or is it just for the patient to report it. What is the protocol they are supposed to do on the emergency room or urgent care's side. Caller was unwilling to complete the report. Further details for report and vaccine supplemental form not provided. The outcome of event was recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myocarditis
Clinical narrative: myocarditis; Chest pain; This is a spontaneous report from a contactable consumer (Reporter's girlfriend). This is report 3 of 3.  A female patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech Covid-19, Solution injection; Batch/Lot Number: EW0153), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced myocarditis starting about 5 days after Covid Vaccine first dose. The patient never went back for the second dose because the chest pain was so intense. It took the patient about 4 weeks for adverse event to go away. The patient was treated and have moved on but maybe patient was a little bit healthier than the next person would be. Caller was concerned that they had gotten bad batches. Caller wanted to know how many vaccines are in each batch. Caller verified that she believes the third character in Lot number is the letter O, not the numeral zero. Caller questioned if the vaccine Lot numbers are sequentially in order, like numerically; and if there is a particular number of batches manufactured for each Lot number: like are there 10,000 or 100 of one Lot number manufactured, and then they make the next batch of the next Lot number. She called the CDC to ask those questions, but CDC did not know the answers. Caller reported she and her girlfriends experienced adverse events after Pfizer Covid Vaccine and they all kind of joked and said it must have been the Pfizer Covid Vaccine. They finally compared their cards and their vaccines Lot numbers were all within digits of each other. Caller feels it is worthwhile to look into it. They are all fine, but it might be an issue of bad batches of Lot numbers of the Pfizer Covid Vaccine. They all recovered; but if there is a bad batch Pfizer needs to know this. This patient and her girlfriends were in different locations for their Pfizer Covid Vaccine doses; they just all happened to sit down together and compare their cards. If all of the sudden it is asked why are these people who weren't in the same locations experiencing these adverse events, it might be worthwhile to consider if those Lot numbers were bad batches. She also asked if someone ends up in the emergency room or urgent care are they at the emergency room or urgent care required to report the information; or is it just for the patient to report it. What is the protocol they are supposed to do on the emergency room or urgent care's side. Caller was unwilling to complete the report. Further details for report and vaccine supplemental form not provided. The outcome of event was recovered.  Follow-up attempts completed. No further information expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac imaging procedure abnormal, Myocarditis, Pericarditis, Troponin
Clinical narrative: Around 10 pm chills, fever (102°F around 1am) and migraine exacerbated to pain level 10, chest pain with every breath at around 11 am day after shot. Feeling faint. Chest pain worsened the next day after ER visit, pain with every breath, accelerated heart rate, shortness of breath with mild activity, feeling weak and faint.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chest pain, Chills, Computerised tomogram abnormal, Condition aggravated
Clinical narrative: Around 10 pm chills, fever (102°F around 1am) and migraine exacerbated to pain level 10, chest pain with every breath at around 11 am day after shot. Feeling faint. Chest pain worsened the next day after ER visit, pain with every breath, accelerated heart rate, shortness of breath with mild activity, feeling weak and faint.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram abnormal, Fibrin D dimer, Heart rate increased
Clinical narrative: Around 10 pm chills, fever (102°F around 1am) and migraine exacerbated to pain level 10, chest pain with every breath at around 11 am day after shot. Feeling faint. Chest pain worsened the next day after ER visit, pain with every breath, accelerated heart rate, shortness of breath with mild activity, feeling weak and faint.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging abnormal, Migraine, Myocarditis, Painful respiration, Pericardial effusion
Clinical narrative: Around 10 pm chills, fever (102°F around 1am) and migraine exacerbated to pain level 10, chest pain with every breath at around 11 am day after shot. Feeling faint. Chest pain worsened the next day after ER visit, pain with every breath, accelerated heart rate, shortness of breath with mild activity, feeling weak and faint.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Sinus tachycardia, Syncope, Troponin increased
Clinical narrative: Around 10 pm chills, fever (102°F around 1am) and migraine exacerbated to pain level 10, chest pain with every breath at around 11 am day after shot. Feeling faint. Chest pain worsened the next day after ER visit, pain with every breath, accelerated heart rate, shortness of breath with mild activity, feeling weak and faint.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Chest pain, Echocardiogram, Electrocardiogram T wave amplitude decreased, Electrocardiogram abnormal
Clinical narrative: Pericarditis.   Patient was admitted on Monday night 6/28/21 with chest pain for 2 days-  constant, pleuritic chest pain that was worse when supine, better when sitting up.  EKG with T-wave abnormality.  She was admitted for suspected pericarditis by EKG and history of chest pain.  Her troponin was negative x2, no evidence of myocarditis by ultrasound. No pericardial effusion.  Started on colchicine and ibuprofen.  She improved and discharged the next morning 6/29/21.   Of note, she also developed congestion, runny nose and mild cough since Sunday night 6/27/21. No fever.  Her 2 younger siblings who are in daycare were sick first with colds. Patient RV panel was +enterovirus/rhinovirus on 6/29/21. Therefore the differential diagnosis of her acute pericarditis was upper respiratory viral infection associated pericarditis Vs. COVID-19 Vaccine associated pericarditis given the timing of onset.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammatory marker increased, Influenza virus test, Pericarditis, Red blood cell sedimentation rate increased, Respiratory symptom
Clinical narrative: Pericarditis.   Patient was admitted on Monday night 6/28/21 with chest pain for 2 days-  constant, pleuritic chest pain that was worse when supine, better when sitting up.  EKG with T-wave abnormality.  She was admitted for suspected pericarditis by EKG and history of chest pain.  Her troponin was negative x2, no evidence of myocarditis by ultrasound. No pericardial effusion.  Started on colchicine and ibuprofen.  She improved and discharged the next morning 6/29/21.   Of note, she also developed congestion, runny nose and mild cough since Sunday night 6/27/21. No fever.  Her 2 younger siblings who are in daycare were sick first with colds. Patient RV panel was +enterovirus/rhinovirus on 6/29/21. Therefore the differential diagnosis of her acute pericarditis was upper respiratory viral infection associated pericarditis Vs. COVID-19 Vaccine associated pericarditis given the timing of onset.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory viral panel, Rhinorrhoea, SARS-CoV-2 antibody test, SARS-CoV-2 test negative, Troponin
Clinical narrative: Pericarditis.   Patient was admitted on Monday night 6/28/21 with chest pain for 2 days-  constant, pleuritic chest pain that was worse when supine, better when sitting up.  EKG with T-wave abnormality.  She was admitted for suspected pericarditis by EKG and history of chest pain.  Her troponin was negative x2, no evidence of myocarditis by ultrasound. No pericardial effusion.  Started on colchicine and ibuprofen.  She improved and discharged the next morning 6/29/21.   Of note, she also developed congestion, runny nose and mild cough since Sunday night 6/27/21. No fever.  Her 2 younger siblings who are in daycare were sick first with colds. Patient RV panel was +enterovirus/rhinovirus on 6/29/21. Therefore the differential diagnosis of her acute pericarditis was upper respiratory viral infection associated pericarditis Vs. COVID-19 Vaccine associated pericarditis given the timing of onset.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein normal, Chest pain, Cough, Electrocardiogram T wave abnormal, Enterovirus infection
Clinical narrative: Pericarditis.   Patient was admitted on Monday night 6/28/21 with chest pain for 2 days-  constant, pleuritic chest pain that was worse when supine, better when sitting up.  EKG with T-wave abnormality.  She was admitted for suspected pericarditis by EKG and history of chest pain.  Her troponin was negative x2, no evidence of myocarditis by ultrasound. No pericardial effusion.  Started on colchicine and ibuprofen.  She improved and discharged the next morning 6/29/21.   Of note, she also developed congestion, runny nose and mild cough since Sunday night 6/27/21. No fever.  Her 2 younger siblings who are in daycare were sick first with colds. Patient RV panel was +enterovirus/rhinovirus on 6/29/21. Therefore the differential diagnosis of her acute pericarditis was upper respiratory viral infection associated pericarditis Vs. COVID-19 Vaccine associated pericarditis given the timing of onset.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Enterovirus test positive, Human rhinovirus test positive, Pericarditis, Pleuritic pain, Red blood cell sedimentation rate increased
Clinical narrative: Pericarditis.   Patient was admitted on Monday night 6/28/21 with chest pain for 2 days-  constant, pleuritic chest pain that was worse when supine, better when sitting up.  EKG with T-wave abnormality.  She was admitted for suspected pericarditis by EKG and history of chest pain.  Her troponin was negative x2, no evidence of myocarditis by ultrasound. No pericardial effusion.  Started on colchicine and ibuprofen.  She improved and discharged the next morning 6/29/21.   Of note, she also developed congestion, runny nose and mild cough since Sunday night 6/27/21. No fever.  Her 2 younger siblings who are in daycare were sick first with colds. Patient RV panel was +enterovirus/rhinovirus on 6/29/21. Therefore the differential diagnosis of her acute pericarditis was upper respiratory viral infection associated pericarditis Vs. COVID-19 Vaccine associated pericarditis given the timing of onset.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory tract congestion, Respiratory viral panel, Rhinorrhoea, Rhinovirus infection, SARS-CoV-2 antibody test negative
Clinical narrative: Pericarditis.   Patient was admitted on Monday night 6/28/21 with chest pain for 2 days-  constant, pleuritic chest pain that was worse when supine, better when sitting up.  EKG with T-wave abnormality.  She was admitted for suspected pericarditis by EKG and history of chest pain.  Her troponin was negative x2, no evidence of myocarditis by ultrasound. No pericardial effusion.  Started on colchicine and ibuprofen.  She improved and discharged the next morning 6/29/21.   Of note, she also developed congestion, runny nose and mild cough since Sunday night 6/27/21. No fever.  Her 2 younger siblings who are in daycare were sick first with colds. Patient RV panel was +enterovirus/rhinovirus on 6/29/21. Therefore the differential diagnosis of her acute pericarditis was upper respiratory viral infection associated pericarditis Vs. COVID-19 Vaccine associated pericarditis given the timing of onset.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sick relative, Troponin, Viral upper respiratory tract infection
Clinical narrative: Pericarditis.   Patient was admitted on Monday night 6/28/21 with chest pain for 2 days-  constant, pleuritic chest pain that was worse when supine, better when sitting up.  EKG with T-wave abnormality.  She was admitted for suspected pericarditis by EKG and history of chest pain.  Her troponin was negative x2, no evidence of myocarditis by ultrasound. No pericardial effusion.  Started on colchicine and ibuprofen.  She improved and discharged the next morning 6/29/21.   Of note, she also developed congestion, runny nose and mild cough since Sunday night 6/27/21. No fever.  Her 2 younger siblings who are in daycare were sick first with colds. Patient RV panel was +enterovirus/rhinovirus on 6/29/21. Therefore the differential diagnosis of her acute pericarditis was upper respiratory viral infection associated pericarditis Vs. COVID-19 Vaccine associated pericarditis given the timing of onset.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Lip swelling, Rash, Vertigo
Clinical narrative: my normal blood pressure went from 136 / 80 to 205/112; Severe virtigo; This is a spontaneous report from a contactable consumer or other non hcp. A 70-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in arm right on 21Feb2021 15:00 as DOSE 1, SINGLE, for covid-19 immunisation. Patient medical history included thyroid disorder from an unknown date and unknown if ongoing thyroid disease, drug hypersensitivity from an unknown date and unknown if ongoing penicillin, drug hypersensitivity from an unknown date and unknown if ongoing. sulfa drugs, drug hypersensitivity from an unknown date and unknown if ongoing. Patient concomitant medications included levothyroxine sodium (LEVOTHROID) taken for an unspecified indication, start and stop date were not reported. Patient did not receive other vaccination within 4week prior to vaccination Patient didn't have covid prior to vaccination and Post vaccination patient was not tested for covid. On 12Mar2021 08:00 the patient experienced my normal blood pressure went from 136 / 80 to 205/112 and vertigo. The patient underwent lab tests and procedures which included blood pressure measurement 136 / 80 on my normal blood pressure went from 136 / 80 to 205/112, blood pressure measurement 205/112 on my normal blood pressure went from 136 / 80 to 205/112. The outcome of the events hypertension, vertigo was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Hypertension, Vertigo
Clinical narrative: my normal blood pressure went from 136 / 80 to 205/112; Severe virtigo; This is a spontaneous report from a contactable consumer or other non hcp. A 70-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in arm right on 21Feb2021 15:00 as DOSE 1, SINGLE, for covid-19 immunisation. Patient medical history included thyroid disorder from an unknown date and unknown if ongoing thyroid disease, drug hypersensitivity from an unknown date and unknown if ongoing penicillin, drug hypersensitivity from an unknown date and unknown if ongoing. sulfa drugs, drug hypersensitivity from an unknown date and unknown if ongoing. Patient concomitant medications included levothyroxine sodium (LEVOTHROID) taken for an unspecified indication, start and stop date were not reported. Patient did not receive other vaccination within 4week prior to vaccination Patient didn't have covid prior to vaccination and Post vaccination patient was not tested for covid. On 12Mar2021 08:00 the patient experienced my normal blood pressure went from 136 / 80 to 205/112 and vertigo. The patient underwent lab tests and procedures which included blood pressure measurement 136 / 80 on my normal blood pressure went from 136 / 80 to 205/112, blood pressure measurement 205/112 on my normal blood pressure went from 136 / 80 to 205/112. The outcome of the events hypertension, vertigo was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative, Unevaluable event
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 57 year old female. The patient was non alcohol user, non smoker and the concurrent conditions included diabetes, high blood pressure. The patient had drug allergy when treated with acetylsalicylic acid (As reported Aspirin).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) 01 total, dose was not reported, administered at left arm on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient had taken 2 antibody tests (spike protein test for the vaccine) on 06-MAY-2021 and 09-JUN-2021 both tests were negative and had confirmed immunological vaccine failure. The patient had reached out to CDC and reported to VAERS and concerned that she may had received saline instead of the vaccine, and wanted to know if she should get revaccinated.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210700468-Covid-19 vaccine ad26.cov2.s- Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 57 year old female. The patient was non alcohol user, non smoker and the concurrent conditions included diabetes, high blood pressure. The patient had drug allergy when treated with acetylsalicylic acid (As reported Aspirin).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) 01 total, dose was not reported, administered at left arm on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient had taken 2 antibody tests (spike protein test for the vaccine) on 06-MAY-2021 and 09-JUN-2021 both tests were negative and had confirmed immunological vaccine failure. The patient had reached out to CDC and reported to VAERS and concerned that she may had received saline instead of the vaccine, and wanted to know if she should get revaccinated.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210700468-Covid-19 vaccine ad26.cov2.s- Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS