chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, SARS-CoV-2 test, Seizure
Clinical narrative: seizures; heart pauses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 23 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 13:15 (Lot number: EW0168) at the age of 23 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0175, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 30Apr2021, when the patient was 23 years old, for COVID-19 Immunization. The following information was reported: SEIZURE (hospitalization, medically significant, life threatening) with onset 08Jan2022 12:00, outcome "not recovered", described as "seizures"; CARDIAC DISORDER (hospitalization, life threatening) with onset 08Jan2022 12:00, outcome "not recovered", described as "heart pauses". The patient was hospitalized for seizure, cardiac disorder (hospitalization duration: 14 day(s)). The events "seizures" and "heart pauses" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) negative. Therapeutic measures were taken as a result of seizure, cardiac disorder. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Clinical course: My son got his 2nd vaccine and immediately complained of side effects. He started visiting numerous doctors and had 96 Different events related to his side effects. On 08Jan2022 he started having seizures and heart pauses and he is currently at (hospital name withheld) ICU about to die from his complications. He was a healthy 23 year old male with no underlying conditions. Your vaccine is killing my son and he does not have long to live. The doctors at hospital can't Find the cause and the cure. The cause is your vaccine it will kill him, we need a miracle. AE resulted in : [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)] Treatment received for the adverse event included Plasma transfusions currently. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 positive; COVID-19 positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from regulatory authority. The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Jan2022 (Lot number: FL3209) as dose 3 (booster), single, intramuscular, administration date 13May2021 (Lot number: EW0185) as dose 2, single and intramuscular, administration date 22Apr2021 (Lot number: EW0170) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 23Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 23Jan2022, outcome "recovering" and all described as "COVID-19 positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  Clinical Course: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Hospitalization Prolonged: No, Prior to vaccination, patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between the LOE events  with the suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, C-reactive protein, Echocardiogram, Ejection fraction, Electrocardiogram
Clinical narrative: Myocarditis after COVID-19 vaccination;   A 31 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of vaccination). The following information was reported: MYOCARDITIS (medically significant), outcome "not recovered", described as "Myocarditis after COVID-19 vaccination". The patient underwent the following laboratory tests and procedures: blood test: elevated troponin of 1.7; c-reactive protein: negative; echocardiogram: revealed an ejection fraction of 55% with no wall, notes: motion abnormalities; ejection fraction: 55 %, notes: with no wall motion abnormalities; electrocardiogram: no acute ischemic changes; magnetic resonance imaging: showed an area of myocardial hyper-enhancement in, notes: the apical anterior segment suggesting the diagnosis of myocarditis; red blood cell sedimentation rate: negative; troponin: 1.7. Therapeutic measures were taken as a result of myocarditis.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between the event Myocarditis with the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Myocarditis, Red blood cell sedimentation rate, Troponin
Clinical narrative: Myocarditis after COVID-19 vaccination;   A 31 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of vaccination). The following information was reported: MYOCARDITIS (medically significant), outcome "not recovered", described as "Myocarditis after COVID-19 vaccination". The patient underwent the following laboratory tests and procedures: blood test: elevated troponin of 1.7; c-reactive protein: negative; echocardiogram: revealed an ejection fraction of 55% with no wall, notes: motion abnormalities; ejection fraction: 55 %, notes: with no wall motion abnormalities; electrocardiogram: no acute ischemic changes; magnetic resonance imaging: showed an area of myocardial hyper-enhancement in, notes: the apical anterior segment suggesting the diagnosis of myocarditis; red blood cell sedimentation rate: negative; troponin: 1.7. Therapeutic measures were taken as a result of myocarditis.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between the event Myocarditis with the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 03Jan2022 at 16:00 (Lot number: FJ1611) at the age of 44 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing), notes: Hoshimotos Thyroiditis. Concomitant medications included: NALTREXONE HCL and unspecified vitamins and supplements. Past drug history included: Naproxen, reactions: "Drug allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: ER8732, Anatomical Location: Left arm, Route of Administration: Unspecified, Time of Administration: 09:15), administration date: 05Apr2021, when the patient was 44 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0162, Anatomical Location: Left arm, Route of Administration: Unspecified, Time of Administration: 09:15), administration date: 26Apr2021, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: HERPES ZOSTER (non-serious) with onset 05Jan2022 at 13:00, outcome "recovering", described as "Shingles". The event "Shingles" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of herpes zoster. Additional Information: Patient began experiencing pain from a shingles outbreak that has lasted until & through (still experiencing) today's report. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of herpes zoster and included treatment with 2 x steroids packs and 1 antiviral and gabapentin.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Breakthrough Covid Infection; Breakthrough Covid Infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Dec2021 (Lot number: EW0196) at the age of 40 years as dose 3 (booster), single, administration date 01Mar2021 (Lot number: EL3247) at the age of 39 years as dose 2, single and (Lot number: EL3247) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Patient had no COVID prior vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jan2022, outcome "recovering" and all described as "Breakthrough Covid Infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jan2022) positive, notes: Other. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: Left arm at injection site was sore; Lymph node under left arm is swollen; lymph node under left arm is swollen and tender to touch.; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2022 at 12:45 (Lot number: 33130BA) at the age of 52 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin and "Egg allergy" (unspecified if ongoing), notes: Known allergies: eggs. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EW0153; Anatomical location: Left arm; Administration time: 11:00;Route of administration: Unspecified), administration date: 17Apr2021, when the patient was 51 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EW0172; Anatomical location: Left arm; Administration time: 09:30; Route of administration: Unspecified), administration date: 12May2021, when the patient was 51 years old, for COVID-19 immunisation.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Jan2022 at 12:00, outcome "not recovered", described as "Left arm at injection site was sore"; LYMPHADENOPATHY (non-serious) with onset 22Jan2022 at 12:00, outcome "not recovered", described as "Lymph node under left arm is swollen"; LYMPH NODE PAIN (non-serious) with onset 22Jan2022 at 12:00, outcome "not recovered", described as "lymph node under left arm is swollen and tender to touch". Therapeutic measures were not taken as a result of vaccination site pain, lymphadenopathy and lymph node pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Felt achy/ aches; Tired; Injection site hurting; He had a fever above 102F by 24 hours post injection; Chills; His lymph nodes under the arm on the injection side were very raised and swollen.; This is a spontaneous report from a contactable reporter (consumer or other non HCP).  A 12-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in right arm, administration date 19Jan2022 at 19:45 (Lot number: FJ5682) at the age of 12 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing) and "Eczema" (unspecified if ongoing), notes: ezcema. There were no concomitant medications. Past drug history included: Cephalexin, reaction: "Drug allergy", notes: Known allergies: cephalexin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: FA7484; Route of Administration: Intramuscular), administration date: 26Jul2021, when the patient was 12 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: FA7485; Route of Administration: Intramuscular), administration date: 16Aug2021, when the patient was 12 years old, for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 20Jan2022, outcome "recovered" (20Jan2022), described as "Felt achy/ aches"; FATIGUE (non-serious) with onset 20Jan2022, outcome "recovered" (20Jan2022), described as "Tired"; VACCINATION SITE PAIN (non-serious) with onset 20Jan2022, outcome "recovered" (20Jan2022), described as "Injection site hurting"; PYREXIA (non-serious) with onset 20Jan2022, outcome "recovered" (20Jan2022), described as "He had a fever above 102F by 24 hours post injection"; CHILLS (non-serious) with onset 20Jan2022, outcome "recovered" (20Jan2022), described as "Chills"; LYMPHADENOPATHY (non-serious) with onset 20Jan2022, outcome "recovered" (20Jan2022), described as "His lymph nodes under the arm on the injection side were very raised and swollen". The events "Felt achy/ aches", "Tired", "Injection site hurting", "He had a fever above 102F by 24 hours post injection", "Chills" and "His lymph nodes under the arm on the injection side were very raised and swollen." were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, fatigue, vaccination site pain, pyrexia, chills and lymphadenopathy.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. It was reported that although the reporter was aware of the adverse event, it had been waited to report until received a negative PCR Covid test, as the patient's soccer teammates had recently tested positive for Covid. The doctor stated his symptoms were consistent with Covid and she was not certain if there was an adverse event reaction.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Night sweats, Pain, Pyrexia
Clinical narrative: Fever; Chills; Nausea; Vomiting; Body aches; Injection site soreness for 6days+; Night sweats for a week+; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 27-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 18Jan2022 (Lot number: FL3209) at the age of 27 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0172; Route of administration: Intramuscular), administration date: 28Apr2021, when the patient was 26 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: ER8732; Route of administration: Intramuscular), administration date: 19May2021, when the patient was 26 years old, for COVID-19 immunisation.  The following information was reported: PYREXIA (non-serious) with onset 19Jan2022, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 19Jan2022, outcome "recovering", described as "Chills"; NAUSEA (non-serious) with onset 19Jan2022, outcome "recovering", described as "Nausea"; VOMITING (non-serious) with onset 19Jan2022, outcome "recovering", described as "Vomiting"; PAIN (non-serious) with onset 19Jan2022, outcome "recovering", described as "Body aches"; VACCINATION SITE PAIN (non-serious) with onset 19Jan2022, outcome "recovering", described as "Injection site soreness for 6days+"; NIGHT SWEATS (non-serious) with onset 19Jan2022, outcome "recovering", described as "Night sweats for a week+". Therapeutic measures were not taken as a result of pyrexia, chills, nausea, vomiting, pain, vaccination site pain and night sweats.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: Fever; Chills; Nausea; Vomiting; Body aches; Injection site soreness for 6days+; Night sweats for a week+; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 27-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 18Jan2022 (Lot number: FL3209) at the age of 27 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0172; Route of administration: Intramuscular), administration date: 28Apr2021, when the patient was 26 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: ER8732; Route of administration: Intramuscular), administration date: 19May2021, when the patient was 26 years old, for COVID-19 immunisation.  The following information was reported: PYREXIA (non-serious) with onset 19Jan2022, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 19Jan2022, outcome "recovering", described as "Chills"; NAUSEA (non-serious) with onset 19Jan2022, outcome "recovering", described as "Nausea"; VOMITING (non-serious) with onset 19Jan2022, outcome "recovering", described as "Vomiting"; PAIN (non-serious) with onset 19Jan2022, outcome "recovering", described as "Body aches"; VACCINATION SITE PAIN (non-serious) with onset 19Jan2022, outcome "recovering", described as "Injection site soreness for 6days+"; NIGHT SWEATS (non-serious) with onset 19Jan2022, outcome "recovering", described as "Night sweats for a week+". Therapeutic measures were not taken as a result of pyrexia, chills, nausea, vomiting, pain, vaccination site pain and night sweats.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes under arm for past 2 weeks; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: unknown) at the age of 47 years as dose 3 (booster), single for COVID-19 immunisation. It was unknown whether the patient had any relevant medical history. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset an unknown date Jan2022, outcome "recovering", described as "Swollen lymph nodes under arm for past 2 weeks". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Felt "crummy"; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: MALAISE (non-serious), outcome "recovered", described as "Felt "crummy"". Therapeutic measures taken as a result of malaise was unknown.   Additional information: Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pneumonia
Clinical narrative: had pneumonia; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administration date 14Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 Immunization; Pneumonia shot (when I have the Pneumonia shot before, I had my flu shot on one arm and pneumonia on the other arm.), for Immunization; Flu shot (when I have the Pneumonia shot before, I had my flu shot on one arm and pneumonia on the other arm.), for Immunization. The following information was reported: PNEUMONIA (medically significant), outcome "unknown", described as "had pneumonia"; ILLNESS (non-serious) with onset Nov2021, outcome "unknown", described as "sick". Clinical course: Consumer stated that she got the 2nd dose of the Pfizer Biontech Covid-19 Vaccine on 14Aug2021. Consumer also stated that " she had pneumonia bef.. she did not have pneumonia, when she had the Pneumonia shot before, she had her flu shot on one arm and pneumonia on the other arm. Both of those were due now. She could not go in Nov because she was sick but they were due now." Caller says that she did not think that she had contacted the right department and she doesn't know which one was the one she was supposed to do but she has had the 2 shots already and she was due for the booster shot and she was wondering if she could get that now. She had her last dose on 14Aug2021. Product clarified to be the Pfizer COVID 19 vaccine. She had already had dose one and dose two. Also she was close to the time for her regular doctor appointment, it was a month away, 21Feb2022. She usually had her pneumonia and flu shot together in the month of Nov every year she couldn't come out at that time because she was too sick, she was 85 years old, and she wanted to know when she get her booster could she gets those 2 with it. Other Products were not provided.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: tested positive for SARS CoV 2; tested positive for SARS CoV 2; Dose 1: Moderna: Dose 2: Moderna, Dose 3 Brand: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Physician) from regulatory authority. The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 28Oct2021 (Lot number: 30155BA) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), administration date 09Feb2021 (Lot number: 032L20A) as dose 2, single and administration date 12Jan2021 (Lot number: 011L20A) as dose 1, single for covid-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 23Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 24Jan2022, outcome "not recovered" and all described as "tested positive for SARS CoV 2"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 28Oct2021, outcome "unknown", described as "Dose 1: Moderna: Dose 2: Moderna, Dose 3 Brand: Pfizer". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Jan2022) positive, notes: Nasal Swab; (22Jan2022) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19. The patient not had a covid prior to the vaccination and tested for covid post vaccination.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away about 10 days ago after getting the booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 58 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Dec2021 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), for Covid-19 immunization; Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported: DEATH (death, medically significant) with onset 14Jan2022, outcome "fatal", described as "passed away about 10 days ago after getting the booster". It was unknown if therapeutic measures were taken as a result of death. The patient date of death was 14Jan2022. The reported cause of death was "passed away about 10 days ago after getting the booster". It was not reported if an autopsy was performed. The clinical course was reported as follows: I was with a friend this weekend and she mentioned that her brother in laws friend passed away about 10 days ago after getting the booster- she did not know what booster shot he received.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away about 10 days ago after getting the booster
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID19; Tested positive for COVID19; Sore throat; congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Dec2021 (Lot number: FF2587) at the age of 23 years as dose 3 (booster), single, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and administration date 27Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 16Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 16Jan2022, outcome "recovered" and all described as "Tested positive for COVID19"; OROPHARYNGEAL PAIN (non-serious) with onset 16Jan2022, outcome "recovered", described as "Sore throat"; NASAL CONGESTION (non-serious) with onset 16Jan2022, outcome "recovered", described as "congestion". The events "tested positive for covid19", "tested positive for covid19", "sore throat" and "congestion" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test (Nasal Swab): (16Jan2022) positive. Therapeutic measures were not taken as a result of covid-19, oropharyngeal pain, nasal congestion. The patient did not take other vaccine in four weeks, she did not have a covid prior vaccination and tested for covid post vaccination.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: covid test result= Positive; covid test result= Positive; headaches; vertigo; extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 (Lot number: 32030bd) at the age of 24 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Auto immune disease" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 20Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 20Dec2021, outcome "recovered with sequelae" and all described as "covid test result= Positive"; HEADACHE (non-serious) with onset 05Nov2021, outcome "recovered with sequelae", described as "headaches"; VERTIGO (non-serious) with onset 05Nov2021, outcome "recovered with sequelae", described as "vertigo"; FATIGUE (non-serious) with onset 05Nov2021, outcome "recovered with sequelae", described as "extreme fatigue". The events "covid test result= positive", "headaches", "vertigo" and "extreme fatigue" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Dec2021) positive. Therapeutic measures were not taken as a result of covid-19, headache, vertigo, fatigue. The patient not received other vaccine in four weeks. Other medications in two weeks were reported as Autoimmune disease medication. 2 weeks after vaccine the patient developed headaches, vertigo and extreme fatigue. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: covid test result= Positive; covid test result= Positive; headaches; vertigo; extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 (Lot number: 32030bd) at the age of 24 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Auto immune disease" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 20Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 20Dec2021, outcome "recovered with sequelae" and all described as "covid test result= Positive"; HEADACHE (non-serious) with onset 05Nov2021, outcome "recovered with sequelae", described as "headaches"; VERTIGO (non-serious) with onset 05Nov2021, outcome "recovered with sequelae", described as "vertigo"; FATIGUE (non-serious) with onset 05Nov2021, outcome "recovered with sequelae", described as "extreme fatigue". The events "covid test result= positive", "headaches", "vertigo" and "extreme fatigue" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Dec2021) positive. Therapeutic measures were not taken as a result of covid-19, headache, vertigo, fatigue. The patient not received other vaccine in four weeks. Other medications in two weeks were reported as Autoimmune disease medication. 2 weeks after vaccine the patient developed headaches, vertigo and extreme fatigue. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: hospitalization from allergic reactions to the Covid 19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (hospitalization), outcome "unknown", described as "hospitalization from allergic reactions to the Covid 19 vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group for a Pfizer sponsored program (159558). The reporter is the parent.  A 29 year-old male patient received bnt162b2 (BNT162B2), administration date 03Jun2021 (Lot number: EW0177) at the age of 29 years as dose 2, single and administration date 13May2021 (Lot number: EW0185) as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Patient History: No. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive. Clinical course: Reporter states she tested positive for Covid at the end of Dec2021, states she does not remember the exact date, thinks it was 26Dec2021 or 27Dec2021, states she tested with a home test. Caller states her sons have the same experience, states they got both vaccines and they all tested positive the same time she did.  Reporter states her son tested positive the same day she did and got both doses of the vaccine with her, states it is the same dates and lot numbers. Reporter has no further information to provide for this patient.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure and covid-19 and BNT162B2.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pain
Clinical narrative: Chills with shivering; Body pain all over; Nausea; Vomiting; Fever; Headache; Dizziness; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received bnt162b2 (BNT162B2), administration date 24Jan2022 at 09:15 (Lot number: 33036BD) at the age of 28 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: BUSPIRON and CITALOPRAM. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, Lot Number: 330368D, Route of administration: unspecified), for COVID-19 immunisation.  The following information was reported: CHILLS (non-serious) with onset 24Jan2022 at 10:00, outcome "not recovered", described as "Chills with shivering"; PAIN (non-serious) with onset 24Jan2022 at 10:00, outcome "not recovered", described as "Body pain all over"; NAUSEA (non-serious) with onset 24Jan2022 at 10:00, outcome "not recovered", described as "Nausea"; VOMITING (non-serious) with onset 24Jan2022 at 10:00, outcome "not recovered", described as "Vomiting"; PYREXIA (non-serious) with onset 24Jan2022 at 10:00, outcome "not recovered", described as "Fever"; HEADACHE (non-serious) with onset 24Jan2022 at 10:00, outcome "not recovered", described as "Headache"; DIZZINESS (non-serious) with onset 24Jan2022 at 10:00, outcome "not recovered", described as "Dizziness". Therapeutic measures were not taken as a result of chills, pain, nausea, vomiting, pyrexia, headache and dizziness.  Additional Information: The patient had known allergies to Bo. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Chills with shivering; Body pain all over; Nausea; Vomiting; Fever; Headache; Dizziness; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received bnt162b2 (BNT162B2), administration date 24Jan2022 at 09:15 (Lot number: 33036BD) at the age of 28 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: BUSPIRON and CITALOPRAM. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, Lot Number: 330368D, Route of administration: unspecified), for COVID-19 immunisation.  The following information was reported: CHILLS (non-serious) with onset 24Jan2022 at 10:00, outcome "not recovered", described as "Chills with shivering"; PAIN (non-serious) with onset 24Jan2022 at 10:00, outcome "not recovered", described as "Body pain all over"; NAUSEA (non-serious) with onset 24Jan2022 at 10:00, outcome "not recovered", described as "Nausea"; VOMITING (non-serious) with onset 24Jan2022 at 10:00, outcome "not recovered", described as "Vomiting"; PYREXIA (non-serious) with onset 24Jan2022 at 10:00, outcome "not recovered", described as "Fever"; HEADACHE (non-serious) with onset 24Jan2022 at 10:00, outcome "not recovered", described as "Headache"; DIZZINESS (non-serious) with onset 24Jan2022 at 10:00, outcome "not recovered", described as "Dizziness". Therapeutic measures were not taken as a result of chills, pain, nausea, vomiting, pyrexia, headache and dizziness.  Additional Information: The patient had known allergies to Bo. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Arthropathy, Product preparation issue
Clinical narrative: accidentally received an overdose of the Pfizer covid vaccine; accidentally received an overdose of the Pfizer covid vaccine; joint issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program. The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 37 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Colitis ulcerative" (unspecified if ongoing), notes: Verbatim: Ulcerative colitis; "Anxiety" (unspecified if ongoing), notes: Verbatim: Anxiety. There were no concomitant medications. The following information was reported: ACCIDENTAL OVERDOSE (non-serious), PRODUCT PREPARATION ISSUE (non-serious), outcome "unknown" and all described as "accidentally received an overdose of the Pfizer covid vaccine"; ARTHROPATHY (non-serious), outcome "unknown", described as "joint issues". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram
Clinical narrative: Patient experienced chest pains for 4 days, 1 day after receiving the COVID-19 booster.; This is a spontaneous report from a non-contactable reporter (physician).  A 14-year-old male patient received bnt162b2 (BNT162B2), administration date 10Jan2022 (Lot number: unknown) at the age of 14 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot Number: unknown; Route of administration: unspecified), administration date: an unknown date in Jun2021, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE; Lot Number: unknown; Route of administration: unspecified), administration date: an unknown date in May2021, for COVID-19 immunisation.  The following information was reported: CHEST PAIN (non-serious) with onset 11Jan2022, outcome "recovered" (15Jan2022), described as "Patient experienced chest pains for 4 days, 1 day after receiving the COVID-19 booster". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest pain.   Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. The patient's ECGs revealed no heart abnormalities. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: They had a headache; This is a spontaneous report from a contactable reporter (consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) (Lot number: unknown) as dose 1, single for COVID-19 immunisation and bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) (Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "They had a headache".   Additional information: The reporter reported this out of caution as this was something the reporter remembered on the day of report. The patient described this past summer or autumn one evening that they had a headache. The reporter realized this might have been probably after they were vaccinated (since reporter believed this past year she was likely fully vaccinated at least). This might have been not recognized as an adverse event at the time. She did not explicitly say the vaccine was the cause of headache, and did not know if date was close to vaccination date(s). The patent was in early 20s. Extremely likely had recovered. Original awareness for headache would have been in the summer/fall when first notified.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizures; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 19 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "Seizures". Patient's mother reported that she had a question about an adverse event that her daughter had seizures after vaccination. Reporter was not sure that adverse event was from the vaccine and her daughter would be going to the doctor for an evaluation.   The lot number for bnt162b2 was not provided and will be requested during follow up.