chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lethargy, Lymphadenopathy, Malaise
Clinical narrative: Fever (103.8); headache; sore arm at injection site; lethargy; muscle aches; malaise; swollen lymph node- size of golf ball under left arm (injection arm); This is a spontaneous report from a contactable consumer or other non hcp. A 71-years-old patient of an unspecified gender received bnt162b2 (PFIZERBIONTECH, Formulation: solution for injection, Batch/Lot Number: EM9810) via intramuscular route of administration, administered in Arm Left on 08Feb2021 at 12:00 (at the age of 71-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history included influenza from 2017 to an unknown date Pertinent detail: Fever, Flu symptoms, urinary retention from 2019 to an unknown date Pertinent details: Resolved at ER. Concomitant medication(s) included omeprazole, 40 mg, oral taken for reflux gastritis from 06Mar2021 and ongoing, Tamsulosin 4 mg, oral taken for urinary retention from 06Mar2021 and ongoing. The patient previously received first dose of COMIRNATY (Lot Number: EJ1686) via an intramuscular, Anatomical site of injection was left arm on 18Jan2021 at 08:00 am for COVID-19 immunisation. On 08Feb2021 at 8PM the patient experienced Seriously high fever (103.8) with splitting headache, Sore arm at injection site, muscle aches, lethargy and Malaise. Swollen lymph node - size of golf ball-under left arm (injection arm). The patient underwent lab tests and procedures which included body temperature: 103.8 fahrenheit on Feb2021, prostatic specific antigen was negative on 2019 PSA+ Follow up- benign, urine analysis was negative on 2019 (Normal). Treatment received for the events fever and pain relief rest, Miss work. The outcome of the events was reported as recovered.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Prostatic specific antigen, Pyrexia, Urine analysis, Vaccination site joint pain
Clinical narrative: Fever (103.8); headache; sore arm at injection site; lethargy; muscle aches; malaise; swollen lymph node- size of golf ball under left arm (injection arm); This is a spontaneous report from a contactable consumer or other non hcp. A 71-years-old patient of an unspecified gender received bnt162b2 (PFIZERBIONTECH, Formulation: solution for injection, Batch/Lot Number: EM9810) via intramuscular route of administration, administered in Arm Left on 08Feb2021 at 12:00 (at the age of 71-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history included influenza from 2017 to an unknown date Pertinent detail: Fever, Flu symptoms, urinary retention from 2019 to an unknown date Pertinent details: Resolved at ER. Concomitant medication(s) included omeprazole, 40 mg, oral taken for reflux gastritis from 06Mar2021 and ongoing, Tamsulosin 4 mg, oral taken for urinary retention from 06Mar2021 and ongoing. The patient previously received first dose of COMIRNATY (Lot Number: EJ1686) via an intramuscular, Anatomical site of injection was left arm on 18Jan2021 at 08:00 am for COVID-19 immunisation. On 08Feb2021 at 8PM the patient experienced Seriously high fever (103.8) with splitting headache, Sore arm at injection site, muscle aches, lethargy and Malaise. Swollen lymph node - size of golf ball-under left arm (injection arm). The patient underwent lab tests and procedures which included body temperature: 103.8 fahrenheit on Feb2021, prostatic specific antigen was negative on 2019 PSA+ Follow up- benign, urine analysis was negative on 2019 (Normal). Treatment received for the events fever and pain relief rest, Miss work. The outcome of the events was reported as recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Colon injury
Clinical narrative: had half a colon and might die; a stent in her heart; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer said patient had half a colon and might die and had a stent in her heart after the vaccine. Outcome of event were unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: fainting; This is a spontaneous report from a contactable consumer. This consumer reported for female consumer (nurse). A female patient of an unspecified age received bnt162b2 (COMIRNATY, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fainting in the hospital. Just a few minutes after receiving the vaccine she had this encounter. Event assessed as medically significant. The clinical outcome of the event was unknown.   Follow-up attempts are completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Biopsy, Haematuria, IgA nephropathy, Protein urine
Clinical narrative: Acute kidney injury; gross hematuria; IgA nephropathy; This is a literature report. This reporter reported 2 reports; this is the 2 of 2 reports. The full publication has been requested.  We also cared for 2 patients who had prior biopsy-proven IgAN, who developed gross hematuria after their second dose of the Pfizer vaccine, without a preceding COVID-19 infection. Table 1 outlines the clinical data. Our first patient presented 5 days after his second dose, with nonspecific myalgias, chills, headache, dysuria, and gross hematuria within 24 hours of initial symptoms. Previous IgAN flares in this patient were precipitated by upper respiratory infections and were limited to gross hematuria with no AKIs and no requirement for steroids in the past. His postvaccine workup was notable for AKI, with a serum creatinine level of 3.53 mg/dl and a urine protein-creatinine ratio of 3.0. He was empirically started on steroids with recovery to baseline renal function at 1 month and recovery to baseline proteinuria within 2 months. Our second patient developed gross hematuria within 24 hours of receiving his second dose. His hematuria resolved after 3 days with supportive therapy only. To our knowledge, we are the first to report an IgAN flare that has led to an AKI that resolved with steroid therapy. We agree that it is not clear how a nonmucosal immune challenge led to an IgAN.; Sender's Comments: Based on  information in the case  a possible causal association between the reported  events IgA nephropathy , Acute kidney injury and 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.,Linked Report(s) : US-PFIZER INC-202101460758 Same article/drug/event, different patient.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Orthostatic hypotension, Syncope, Torsade de pointes
Clinical narrative: New onset Torsades de pointes with syncope; New onset Torsades de pointes with syncope; New onset recurrent orthostatic hypotension requiring medication to manage; This is a spontaneous report from a contactable physician.   A 50-years-old non-pregnant female patient received bnt162b2 (Covid vaccine, Brand Pfizer ), dose 2 intramuscular on 08Sep2021 at her 50-years-old (Lot Number: FC3180) as dose 2, single for covid-19 immunisation.  There were no concomitant medications, no medical history. No Other vaccine in four weeks, no Covid prior vaccination, no Covid tested post vaccination, no known allergies. Historical Vaccine included first dose BNT162B2 on 06Aug2021 at her 50-years-old (Lot Number: FC3180) Intramuscular as dose 1, single for covid-19 immunisation.  On 22Sep2021, The patient experienced New onset Torsades de pointes with syncope. Required two hospitalizations and implantation of AICD. New onset recurrent orthostatic hypotension requiring medication to manage. No prior history of any cardiac issues, no prior medications, no pre-existing comorbidities, no Family History. Required 2 ER visits, 2 overnight hospital stays (2 different facilities). Events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage].  The patient was hospitalized for events for 3 days.  Therapeutic measures were taken as a result of all events included Multiple diagnostic tests, AICD implantation, medication. Outcome of events was recovered with sequelae.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the event Torsade de pointes, Syncope, Orthostatic Hypotension and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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: Syncope
Clinical narrative: Fainted; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer reported for a male patient (reporter's nephew).   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was fainted. The reporter wanted to know more about the vaccine. he was very scared to get it. Read ISI and he still wanted more info. In conversation he said his nephew got the vaccine and fainted. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Death, Drug ineffective, Suspected COVID-19
Clinical narrative: got the COVID virus and passed away; got the COVID virus and passed away; got the COVID virus and passed away; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a patient (reporter's family member) that a patient of unspecified age and gender received BNT162B2 (BNT162B2), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as dose number unknown, single for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Consumer reported that a family member who had the COVID 19 vaccine, got the COVID virus and passed away. Outcome of the events was fatal. It was unknown if an autopsy was done.   The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: got the COVID virus and passed away; got the COVID virus and passed away; got the COVID virus and passed away
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, Feeling abnormal, Headache, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: appendicitis; felt horrible; had an excruciating headache; Prev dose administration date 30Aug2021. Most recent vaccine administration date 23Oct2021; This is a spontaneous report from a contactable consumer (patient).  A 22-Year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number FH8020, on 23Oct2021 10:30 at single dose in right arm (at the age of 22-Year-old) for COVID-19 immunisation. Medical history was not reported. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of BNT162B2 Batch/Lot No: EW0196 on 30Aug2021 03:30 AM in right arm.  The patient was not diagnosed with COVID-19 prior to vaccination. Less than 2 days after receiving the second dose on 24Oct2021 06:00, the patient was diagnosed with appendicitis and had to undergo emergency surgery to remove his appendix. He had never experienced issues until the shot. He also felt horrible and had an excruciating headache after receiving the vaccine. The event appendicitis was serious with life-threatening, hospitalization and disability. The events appendicitis, felt horrible and headache resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient had been tested for COVID-19 since the vaccination. Lab data on 25Oct2021 included: Nasal Swab negative. The outcome of the events appendicitis, felt horrible and headache was not resolved.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Immunisation, Nausea, Pain
Clinical narrative: Freezing; Horrible body aches; Major headache; Nausea; Administration date 28Oct2021, dose number=3; This is a spontaneous report from a contactable consumer, Pfizer colleague. A non-pregnant female patient of unspecified age received the third dose of BNT162b2 (COMIRNATY; Lot Number: Unknown) via an intramuscular route of administration in the arm on 28Oct2021 as a single dose for COVID-19 immunisation. 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. It was unknown whether the patient received any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an intramuscular route of administration on an unknown date and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an intramuscular route of administration on an unknown date as a single dose for COVID-19 immunisation. On 28Oct2021, the patient had "administration date 28Oct2021, dose number=3". On 29Oct2021, the patient woke up the following day "freezing, had "horrible body aches" and a "major headache." She also had nausea. She took ibuprofen (ADVIL) 800mg went to bed then woke up about an hour later feeling better. The events freezing, horrible body aches, major headache and nausea did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events freezing, horrible body aches, major headache and nausea which included treatment with ibuprofen (ADVIL) 800mg. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events freezing, horrible body aches, major headache and nausea was resolved on 29Oct2021. The clinical outcome of the event "administration date 28Oct2021, dose number=3" was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Choking, Feeling abnormal, Illness, Joint range of motion decreased, Malaise
Clinical narrative: feeling like she thought she was going to die; sick for 6 days, it was awful; she couldn't come to herself; producing so much phlegm she choked when speaking; body aches; running nose; did not feel well; trouble lifting her arm from so much pain; producing so much phlegm she choked when speaking; itching; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 14Oct2021 (at 79-year-old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included allergic to a lot of things and patient didn't take medications because she was allergic to it. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose1 and dose 2, both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient reported feeling like she thought she was going to die on an unspecified date and several adverse events after the dose on 14Oct2021 including: running nose, body aches, trouble lifting her arm from so much pain, producing so much phlegm she choked when speaking, and itching. She did not feel well for six days and has taken cold/flu medications to help. She was not too thrilled about it. She asked if these symptoms have been reported before. She took the Pfizer 1 and 2 shot no problem and took the booster and she thought she was going to die. 3 hours later her nose was running, her body was aching, when she tried to speak she was choking on so much phlegm. She was sick for 6 days, it was awful. She knew people that have taken it without any effects but for some reason she did. She wound up having itching since she took the shot and went to her dermatologist. She was allergic to a lot of things and they didn't ask questions or say they need to know anything about anything. She didn't know if she would take another one, it was like 6 days like that and she couldn't come to herself. She couldn't lift her arm to put on clothes she was in so much pain, it was weird. Patient thought it must be something in the shot. She said this was 6 days. She took some medication to try to ward it off and that took time and she was getting better and better. She was fine before the vaccine and was sick as a dog after. Her neighbor has been checking on her and she talked to her doctor and he told her to take cold and flu medication and that helped. Other than for itching her doctor gave her some allergy pills, she tooke allergy pills every day but he gave her something else for morning and evening. She didn't like to take medications, vitamins were ok. The outcome of the events was recovering.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Near death experience, Pain, Productive cough, Pruritus, Rhinorrhoea
Clinical narrative: feeling like she thought she was going to die; sick for 6 days, it was awful; she couldn't come to herself; producing so much phlegm she choked when speaking; body aches; running nose; did not feel well; trouble lifting her arm from so much pain; producing so much phlegm she choked when speaking; itching; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 14Oct2021 (at 79-year-old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included allergic to a lot of things and patient didn't take medications because she was allergic to it. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose1 and dose 2, both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient reported feeling like she thought she was going to die on an unspecified date and several adverse events after the dose on 14Oct2021 including: running nose, body aches, trouble lifting her arm from so much pain, producing so much phlegm she choked when speaking, and itching. She did not feel well for six days and has taken cold/flu medications to help. She was not too thrilled about it. She asked if these symptoms have been reported before. She took the Pfizer 1 and 2 shot no problem and took the booster and she thought she was going to die. 3 hours later her nose was running, her body was aching, when she tried to speak she was choking on so much phlegm. She was sick for 6 days, it was awful. She knew people that have taken it without any effects but for some reason she did. She wound up having itching since she took the shot and went to her dermatologist. She was allergic to a lot of things and they didn't ask questions or say they need to know anything about anything. She didn't know if she would take another one, it was like 6 days like that and she couldn't come to herself. She couldn't lift her arm to put on clothes she was in so much pain, it was weird. Patient thought it must be something in the shot. She said this was 6 days. She took some medication to try to ward it off and that took time and she was getting better and better. She was fine before the vaccine and was sick as a dog after. Her neighbor has been checking on her and she talked to her doctor and he told her to take cold and flu medication and that helped. Other than for itching her doctor gave her some allergy pills, she tooke allergy pills every day but he gave her something else for morning and evening. She didn't like to take medications, vitamins were ok. The outcome of the events was recovering.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Headache, Pain, Pruritus
Clinical narrative: Headache the next morning the light bothered me (it was similar to a migraine); Redness; Swelling; Pain; Rash; Itchy; The area was hot; Burning sensation in the left arm, underarm and left breast; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 08Sep2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, sinusitis, rhinitis and COVID-19. The patient had known allergies to latex. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication was not reported. On 08Sep2021, the patient had symptoms after the first shot which included redness, swelling, pain, rash, itchy, the area was hot, burning sensation in the left arm, underarm and left breast. Symptoms lasted more than three weeks. On 09Sep2021, the next morning, the patient had headache and the light bothered her (it was similar to a migraine). She still felt burning sensation sometimes (at the time of this report). The events resulted in doctor/other health care professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with an unspecified cream to control the skin reaction and paracetamol (TYLENOL) for other symptoms. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events redness, swelling, pain, rash, itchy, the area was hot, burning sensation in the left arm, underarm and left breast and headache the next morning the light bothered her (it was similar to a migraine) was resolving at the time of this report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling, Vaccination site warmth
Clinical narrative: Headache the next morning the light bothered me (it was similar to a migraine); Redness; Swelling; Pain; Rash; Itchy; The area was hot; Burning sensation in the left arm, underarm and left breast; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 08Sep2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, sinusitis, rhinitis and COVID-19. The patient had known allergies to latex. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication was not reported. On 08Sep2021, the patient had symptoms after the first shot which included redness, swelling, pain, rash, itchy, the area was hot, burning sensation in the left arm, underarm and left breast. Symptoms lasted more than three weeks. On 09Sep2021, the next morning, the patient had headache and the light bothered her (it was similar to a migraine). She still felt burning sensation sometimes (at the time of this report). The events resulted in doctor/other health care professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with an unspecified cream to control the skin reaction and paracetamol (TYLENOL) for other symptoms. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events redness, swelling, pain, rash, itchy, the area was hot, burning sensation in the left arm, underarm and left breast and headache the next morning the light bothered her (it was similar to a migraine) was resolving at the time of this report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Immunisation, Vomiting
Clinical narrative: Loose stool; Vomiting; Fatigue; Headache; Booster; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 28Oct2021 at 14:00 (at the age of 51-year-old), as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), fibromyalgia, restless leg syndrome, post laminectomy syndrome and allergy to nausea medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included naloxone hydrochloride/buprenorphine hydrochloride (SUBOXONE), pregabalin (LYRICA), pramipexole (MANUFACTURER UNKNOWN), lamotrigine (LAMICTAL) and meloxicam (MELOXICAN); all for unspecified indication from unknown date and unknown if ongoing and also included influenza vaccine (MANUFACTURER UNKNOWN) via unspecified route of administration in left arm on 15Oct2021 for immunization. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 15:00 (at the age of 50-year-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO170) via an unspecified route of administration in the left arm on 30Apr2021 at 18:00 (at the age of 50-year-old); both as a single dose for COVID-19 immunisation. On 29Oct2021 at 02:30, the patient experienced loose stool, vomiting, fatigue and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events loose stool, vomiting, fatigue and headache were resolving at the time of this report.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Glycosylated haemoglobin increased
Clinical narrative: Diabetes control was an A1c of 7% before vaccination (no medication use). Within a few weeks of vaccination, an A1c was checked and level of control was all the way up to 14.5%; This is a spontaneous report from a contactable physician. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 03Mar2021 (at the age of 63-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 24Mar2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes which was under control in which glycated hemoglobin (A1C) was 7% (unknown units) before vaccination (no medication use). Concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had injection 1 and injection 2 in Mar2021. On 19May2021, within a few weeks of vaccination, an "A1c" was checked and the level of control was all the way up to 14.5% (unknown units). The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event and included treatment with diabetes medications (unspecified). On 19May2021, the patient underwent glycated hemoglobin (HbA1C) test and the result was 14.5 % (unknown units). Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event within a few weeks of vaccination, an "A1C" was checked and the level of control was all the way up to 14.5% was resolved with sequelae on an unknown date in 2021. The patient also received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145 BA) via intramuscular route of administration on 11Oct2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation.  The lot numbers for BNT162b2 were not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Myocardial infarction
Clinical narrative: Booster; heart attack; This is a spontaneous report from a contactable consumer.  An elderly female patient (not Pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration on Oct2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  Historical vaccine included the patient received first dose of BNT162B2 on 06Jan2021 for Covid-19 Immunization; second dose of BNT162B2 on 26Jan2021 for Covid-19 Immunization. The patient had heart attack after receiving booster in Oct2021. There was no prior history of heart conditions. She was stable the next day, transferring back to long term care facility. The event resulted in hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for heart attack from Oct2021 to an unknown date.  Therapeutic measures were taken as a result of heart attack included Lasix to remove fluid from heart and nitro paste. The outcome of the events was resolving.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Myalgia, Pollakiuria
Clinical narrative: Booster dose; Diffuse myalgias to bilateral lower extremities; Urinary frequency; This is a spontaneous report from a contactable other healthcare professional. A 67-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient receive other vaccines within four weeks prior to the COVID vaccine. The patient received multiple unspecified medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, the patient experienced diffuse myalgias to bilateral lower extremities and urinary frequency. The adverse events resulted in doctor/other health care professional office/clinic visit. The patient received unspecified treatment for the reported events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events diffuse myalgias to bilateral lower extremities and urinary frequency were not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Hepatic cancer
Clinical narrative: terminal liver cancer; This is a spontaneous report from a contactable nurse (patient's friend). A female patient of an unspecified age received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was reported as healthy as a horse. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for Covid-19 immunization. The patient experienced terminal liver cancer on an unspecified date. She got the second shot of the vaccine and literally a week or 2 weeks later, was told she literally had 3 days to live with terminal liver cancer and went into hospice and was dead in 3 days. The reporter thought it was the Pfizer vaccine that did it to her. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event hepatic cancer and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.; Reported Cause(s) of Death: terminal liver cancer
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Vaccination site mass, Vaccination site pain
Clinical narrative: Painful knot on my upper right and left shoulder of each vaccination received; Painful knot on my upper right and left shoulder of each vaccination received; Swelling in my throat with both vaccinations; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (COMIRNATY; Lot Number: EW0177) via an unspecified route of administration in the left arm on 24Sep2021 at 04:00 (at the age of 51-years-old) and also received the second dose of BNT162b2 (COMIRNATY; Lot Number: FF2590) via an unspecified route of administration in the right arm on 15Oct2021 at 17:00 (at the age of 51-years-old) as a single dose of COVID-19 immunisation. The patient had no medical history and no known allergies. 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 vaccination. The patient did not receive any concomitant medication. On 26Sep2021, a few days after her first and second vaccine she received a painful knot on her upper right and left shoulder of each vaccination received. Then she got swelling in her throat with both vaccinations. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events painful knot on her upper right and left shoulder of each vaccination received and swelling in her throat with both vaccinations was resolved on an unknown date in 2021.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Hypersomnia, Pain, Pyrexia
Clinical narrative: Vomiting; Diarrhea; Body aches; Headache; Fever; Slept 17 hours after my second shot; This is a spontaneous report from a contactable healthcare professional. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 25Aug2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), loratadine (CLARITIN), citalopram hydrobromide (CELEXA), famotidine (MANUFACTURER UNKNOWN) and atenolol (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received cefalexin (KEFLEX), cyclobenzaprine hydrochloride (FLEXERIL) and thiomersal (MANUFACTURER UNKNOWN) from unknown dates for unknown indications and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration on 04Aug2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 25Aug2021 at 21:15, the patient experienced vomiting, diarrhea, body aches, headache and fever, all for 4 days and slept 17 hours after the second shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vomiting, diarrhea, body aches, headache and fever was resolved on 29Aug2021. The clinical outcome of the event slept 17 hours after the second shot was not resolved at the time of this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; Diarrhea; Body aches; Headache; Fever; Slept 17 hours after my second shot; This is a spontaneous report from a contactable healthcare professional. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 25Aug2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), loratadine (CLARITIN), citalopram hydrobromide (CELEXA), famotidine (MANUFACTURER UNKNOWN) and atenolol (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received cefalexin (KEFLEX), cyclobenzaprine hydrochloride (FLEXERIL) and thiomersal (MANUFACTURER UNKNOWN) from unknown dates for unknown indications and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration on 04Aug2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 25Aug2021 at 21:15, the patient experienced vomiting, diarrhea, body aches, headache and fever, all for 4 days and slept 17 hours after the second shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vomiting, diarrhea, body aches, headache and fever was resolved on 29Aug2021. The clinical outcome of the event slept 17 hours after the second shot was not resolved at the time of this report.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis allergic, Immunisation
Clinical narrative: Allergic type rash on full body; A third (booster) dose of BNT162b2 was administered; This is a spontaneous report from a contactable healthcare professional. A 47-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 27Oct2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. On 29Oct2021, the patient experienced allergic type rash on full body. The event resulted in doctor/other health care professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with dexamethasone (MANUFACTURER UNKNOWN) and hydroxyzine hydrochloride (VISTARIL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event allergic type rash on full body was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Crying, Depression, Dysphagia
Clinical narrative: Headache; Nausea; Running a fever / temp is 100 degrees; Severe muscle pain in whole body; Tingling in arms and legs; Neck hurts; Jaw tight; Pain behind eyes; Having trouble keeping food down; Depressed; Crying; Face pain; Shaking; Back pain; Unable to stay asleep; Throwing up; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the right arm on 28Oct2021 at 15:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included narcolepsy and depression. The patient was allergic to powder on latex gloves. 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 vaccination. Concomitant medications were not reported. The patient previously received cefalexin (CEPHALEXIN) and escitalopram oxalate (LEXAPRO) and experienced drug allergy. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0172) via an unspecified route of administration in the right arm on 30Apr2021 at 15:30 (at the age of 45-years-old) and also received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0162) via an unspecified route of administration in the right arm on 09Apr2021 at 16:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 29Oct2021 at 12:00, the patient experienced headache, nausea, running a fever, severe muscle pain in whole body, tingling in arms and legs, neck hurts, jaw tight, pain behind eyes, temperature was 100 degrees, having trouble keeping food down, depressed, crying, face pain, shaking, back pain, unable to stay asleep and throwing up. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 29Oct2021, the patient underwent body temperature test and the result was 100 degrees (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, running a fever, severe muscle pain in whole body, tingling in arms and legs, neck hurts, jaw tight, pain behind eyes, temperature was 100 degrees, having trouble keeping food down, depressed, crying, face pain, shaking, back pain, unable to stay asleep and throwing up were unknown at the time of this report.