chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Pain from injection site to the neck and through the shoulder; Pain from injection site to the neck and through the shoulder; This is a spontaneous report received from a contactable reporter (other healthcare professional). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 09Feb2022 at 15:15 (Lot number: FJ6369) at the age of 53 years as dose 3 (tris booster), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. The patient did not receive any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EJ1685; Anatomical Location: Left arm; Administration time: 06:00), administration date: 18Dec2020, when the patient was 52 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EJ1686; Anatomical Location: Right arm; Administration time: 06:00), administration date: 08Jan2021, when the patient was 52 years old, for COVID-19 immunisation.  The following information was reported: VACCINATION SITE PAIN (non-serious); PAIN (non-serious); all with onset 10Feb2022, outcome "not recovered", and all described as "Pain from injection site to the neck and through the shoulder". Therapeutic measures were not taken as a result of vaccination site pain and pain.  Additional information: It was unknown if the patient had any known allergies. 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 COVID vaccine. 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.
Sex: U
Vaccine: COVID19
Symptoms: Drug reaction with eosinophilia and systemic symptoms
Clinical narrative: Patient has an immediate hypersensitive reaction to Hemagglutinin reaction from the  Pfizer Covid-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (medically significant), outcome "unknown", described as "Patient has an immediate hypersensitive reaction to Hemagglutinin reaction from the  Pfizer Covid-19 Vaccine".  Clinical course: The reporter stated that he was just calling to ask more information or if we have literature that they can find all the this specifically, so basically they said that they are saying that the patient had an immediate hypersensitive reaction to Hemagglutinin reaction from the Pfizer Covid-19 Vaccine and again they are just finding a literature that can find on this specifically, so there Doctor said many hypersensitivity reaction include Nano (further not clarified) components of the current (Pfizer) Covid-19 Vaccine and he mentioned that he don't believe that there was hemagglutinin on the Covid-19 Vaccine, so basically he just want to getting some information or if you have literature that can prove that.  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 reported event with 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 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: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a 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: MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hyperthyroidism, Menstruation irregular, SARS-CoV-2 test
Clinical narrative: Newly diagnosed with hyperthyroidism now; Increased heart rate; Period issues irregularity now; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 24Sep2021 14:30 (Lot number: FC3184) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). No covid prior vaccination. No known allergies. There were no concomitant medications. No other vaccine in four weeks, no other medications in two weeks. Vaccination history included: Bnt162b2 (Dose 1, Pfizer, lot number= FC3184, Intramuscular in Right arm, at 01:15 PM), administration date: 30Aug2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: HYPERTHYROIDISM (medically significant) with onset 01Oct2021, outcome "recovering", described as "Newly diagnosed with hyperthyroidism now"; HEART RATE INCREASED (non-serious) with onset 01Oct2021, outcome "recovering", described as "Increased heart rate"; MENSTRUATION IRREGULAR (non-serious) with onset 01Oct2021, outcome "recovering", described as "Period issues irregularity now". The events "newly diagnosed with hyperthyroidism now", "increased heart rate" and "period issues irregularity now" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: heart rate: (01Oct2021) increased; sars-cov-2 test: (08Dec2021) negative. Therapeutic measures were taken as a result of hyperthyroidism, heart rate increased, menstruation irregular.; Sender's Comments: Based on the known drug temporal relationship and Limited information in the case report a casual association between reported event Hyperthyroidism with the suspect product 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Dizziness, Feeling abnormal
Clinical narrative: arrhythmia; lightheadedness; brain fog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 11:00 (Lot number: ER8729) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "SVT's" (unspecified if ongoing), notes: prior history of SVT's that had resolved. There were no concomitant medications. Past drug history included: Tetracycline, reaction(s): "Known allergies: tetracycline". Vaccination history included: Bnt162b2 (dose 1, lot number: ER20013, administration time: 11:00 AM, vaccine location: Left arm), administration date: 19Mar2021, when the patient was 62 years old, for COVID-19 immunization, reaction(s): "tachycardia". The following information was reported: ARRHYTHMIA (medically significant) with onset 09Apr2021, outcome "recovering", described as "arrhythmia"; DIZZINESS (non-serious) with onset 09Apr2021, outcome "recovering", described as "lightheadedness"; FEELING ABNORMAL (non-serious) with onset 09Apr2021, outcome "recovering", described as "brain fog". Therapeutic measures were taken as a result of arrhythmia, dizziness, feeling abnormal included: homeopathic and naturopathic cardiac support. Clinical course: After second dose arrhythmia, lightheadedness and brain fog, beginning within minutes of vaccine and continuing for months. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. No other medications in two weeks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200238190 Same reporter/SD/patient, Different AE/dose
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Uterine haemorrhage
Clinical narrative: Had extreme uterine bleeding; Palpitations; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received BNT162b2 (BNT162B2), intramuscular, administration date 06Jan2021 08:30 (Lot number: EK5730) at the age of 47 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: LISINOPRIL; LO LOESTRIN FE. No other vaccine in four weeks (as reported). No Known allergies. Vaccination history included: BNT162b2 (administrator route=Intra muscular, administration time=08:00 AM, dose number=1), administration date: 16Dec2020, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: uterine haemorrhage (medically significant) with onset 25Jan2021, outcome recovered, described as 'Had extreme uterine bleeding'; Palpitations (non-serious) with onset 25Jan2021, outcome recovered, described as palpitations. The events had extreme uterine bleeding and palpitations were evaluated at the physician office visit. Therapeutic measures were taken as a result of uterine haemorrhage, palpitations. Clinical course: Had extreme uterine bleeding on 25Jan2021, required a Depo Provera shot to get the bleeding to stop. At that time did not know this could be related to vaccine; also had some heart palpitations after 2nd Covid shot but did not attribute to the shot until she received the booster dose in September and began having constant heart palpitations and increased pulse rate; saw a cardiologist for work up; was indeed having Palpitations was placed on Metoprolol. Recently read an article stating these could be related to the vaccine and thought she should report. AE resulted in: Doctor or other healthcare professional office/clinic visit. No covid prior vaccination. No covid tested post vaccination. Facility type vaccine: Hospital.; Sender's Comments: Based on information available, the company cannot exclude a drug-event causal association between the reported serious event uterine hemorrhage and BNT162b2 administration. The impacts 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Peripheral swelling, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: Ultrasound to R/O DVT; Severe arm swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Oct2021 11:00 (Lot number: 301358A) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergy- cigarette smoke" (unspecified if ongoing); "Known allergy- Adhesive" (unspecified if ongoing). No covid prior vaccination. The patient's concomitant medications were not reported. Facility type vaccine: pharmacy or drug store. No other vaccine in four weeks. Past drug history included: Atropine, reaction(s): "Known allergies: Atropine". Vaccination history included: Bnt162b2 (Dose 2, lot number: EL8982, administration time: 12:00 pm), administration date: 08Feb2021, when the patient was 68 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, lot number: EL8982), administration date: 18Jan2021, when the patient was 68 years old, for COVID-19 immunization.  The following information was reported: PERIPHERAL SWELLING (medically significant) with onset 08Oct2021, outcome "not recovered", described as "Severe arm swelling"; DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "ultrasound to R/O DVT". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10May2021) negative; ultrasound scan: (unspecified date) unknown results.  Clinical course: Severe arm swelling of several months duration. Event treatment reported as ultrasound to R/O DVT.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus, Renal failure
Clinical narrative: stage 2 diabetes; stage 3 kidney failure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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 1, Lot unknown), for covid-19 immunisation; Bnt162b2 (Dose 2, Lot unknown), for covid-19 immunisation. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "stage 2 diabetes"; RENAL FAILURE (medically significant), outcome "unknown", described as "stage 3 kidney failure". The lot number for bnt162b2 was not provided and will be requested during follow up.  Amendment: This follow-up report is being submitted to update historical vaccine information and to allow appropriate reporting to health authorities.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: I'm home with covid on my 9th day so I look like a failed vaccine case; I'm home with covid on my 9th day so I look like a failed vaccine case/ sick/ cold; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown", described as "I'm home with covid on my 9th day so I look like a failed vaccine case"; SUSPECTED COVID-19 (medically significant) with onset Jan2022, outcome "unknown", described as "I'm home with covid on my 9th day so I look like a failed vaccine case/ sick/ cold". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown result, notes: Patient sent PCR swab. Clinical course: patient was in home with COVID on her 9th day (onset date Jan2022) so she looked like a failed vaccine. Patient was heavily exposed that she ended up getting sick. And to that point, COVID had been like a cold.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200239527 same reporter/SD/AE, different patient;US-PFIZER INC-202200239526 same reporter/SD/AE, different patient;US-PFIZER INC-202200239528 same reporter/SD/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Manufacturer unknown), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID". Patient thought that it was a reaction to the booster but she did a PCR test that took 4 days to come back and found out that it was covid. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2022) covid. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Vomiting
Clinical narrative: cannot even speak for herself; vomiting, throwing up; This is a spontaneous report received from a non-contactable consumer.  A 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: APHASIA (hospitalization), outcome "unknown", described as "cannot even speak for herself"; VOMITING (hospitalization), outcome "unknown", described as "vomiting, throwing up". The consumer reported that they were healthy, eating right. The patient (wife) is in the hospital. She cannot even speak for herself, vomiting, throwing up.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I believe this saved me from the hospital when I came down with covid; I believe this saved me from the hospital when I came down with covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "I believe this saved me from the hospital when I came down with covid". Therapeutic measures were taken as a result of covid-19. Patient reported that "Paxlovid did its job in curing me". It was reported that the patient received your vaccines in Feb2021 and the booster in Nov2021 and believed this saved the patient from the hospital when came down with Covid. Paxlovid did its job in curing the patient.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient experienced: vaccine for COVID is not working; Patient experienced: vaccine for COVID is not working; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4345021.  A 59 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, administration date Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (ongoing). Concomitant medication(s) included: OCREVUS. Past drug history included: Amoxicillin allergy, reaction(s): "amoxicillin allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient experienced: vaccine for COVID is not working".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Gait disturbance, Interchange of vaccine products, Investigation, Off label use
Clinical narrative: received the first dose of Moderna and the second dose of Pfizer; received the first dose of Moderna and the second dose of Pfizer; a lot of leg pain/his legs hurt a lot; walks with a lot of difficulty; a lot of abdominal pain; This is a spontaneous report received from contactable reporter(s) (Pharmacist). Other Case identifier(s): MDES22-00040 (Moderna), 132485 (Moderna). A 50 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (initial pfizer dose), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (First Dose), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (disability), INTERCHANGE OF VACCINE PRODUCTS (disability), outcome "unknown" and all described as "received the first dose of Moderna and the second dose of Pfizer"; PAIN IN EXTREMITY (disability), outcome "not recovered", described as "a lot of leg pain/his legs hurt a lot"; GAIT INABILITY (disability), outcome "not recovered", described as "walks with a lot of difficulty"; ABDOMINAL PAIN (non-serious), outcome "recovered", described as "a lot of abdominal pain". The patient underwent the following laboratory tests and procedures: investigation: possible intestinal occlusion, notes: that was then ruled out.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The contributory role of the suspect product bnt162b2 to the reported events cannot be totally excluded based on a plausible temporal association.   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: Pain in extremity
Clinical narrative: received the first dose of Moderna and the second dose of Pfizer; received the first dose of Moderna and the second dose of Pfizer; a lot of leg pain/his legs hurt a lot; walks with a lot of difficulty; a lot of abdominal pain; This is a spontaneous report received from contactable reporter(s) (Pharmacist). Other Case identifier(s): MDES22-00040 (Moderna), 132485 (Moderna). A 50 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (initial pfizer dose), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (First Dose), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (disability), INTERCHANGE OF VACCINE PRODUCTS (disability), outcome "unknown" and all described as "received the first dose of Moderna and the second dose of Pfizer"; PAIN IN EXTREMITY (disability), outcome "not recovered", described as "a lot of leg pain/his legs hurt a lot"; GAIT INABILITY (disability), outcome "not recovered", described as "walks with a lot of difficulty"; ABDOMINAL PAIN (non-serious), outcome "recovered", described as "a lot of abdominal pain". The patient underwent the following laboratory tests and procedures: investigation: possible intestinal occlusion, notes: that was then ruled out.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The contributory role of the suspect product bnt162b2 to the reported events cannot be totally excluded based on a plausible temporal association.   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: 13.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Seizure, Syncope
Clinical narrative: The morning following vaccine he walked to the bathroom, urinated, walk a few feet and had seizure like symptoms (arms flailing, jerking); fainted; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 14Jun2021 13:00 (Batch/Lot number: unknown) at the age of 13 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Vaccine Administration Time: 01:00 PM), administration date: 24May2021, when the patient was 12 years old, for COVID-19 Immunization. The following information was reported: SEIZURE (medically significant) with onset 15Jun2021 09:00, outcome "recovered", described as "The morning following vaccine he walked to the bathroom, urinated, walk a few feet and had seizure like symptoms (arms flailing, jerking)"; SYNCOPE (medically significant) with onset 15Jun2021 09:00, outcome "recovered", described as "fainted". The events "the morning following vaccine he walked to the bathroom, urinated, walk a few feet and had seizure like symptoms (arms flailing, jerking)" and "fainted" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) negative. Therapeutic measures were taken as a result of seizure, syncope.  Additional information: The patient had no other vaccine in four weeks. It was not reported that patient took Other medications in two weeks. The patient had covid prior vaccination and tested yes as covid post vaccination.Known allergies: No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Dysphemia, Imaging procedure, Investigation
Clinical narrative: diagnosed expressive aphasia; Developed new onset stuttering about 2 - 3 weeks after the second dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 03May2021 (Lot number: EW0165) at the age of 60 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 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=EW0161, prev dose lot unknown=False, prev dose administration date=12Apr2021, prev dose dose number=1), administration date: 12Apr2021, when the patient was 60 years old, for COVID-19 Immunization. The following information was reported: APHASIA (medically significant) with onset May2021, outcome "not recovered", described as "diagnosed expressive aphasia"; DYSPHEMIA (medically significant) with onset May2021, outcome "not recovered", described as "Developed new onset stuttering about 2 - 3 weeks after the second dose.". The events "diagnosed expressive aphasia" and "developed new onset stuttering about 2 - 3 weeks after the second dose." were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: imaging procedure: (2021) diagnosed expressive aphasia, notes: Evaluations, including imaging, diagnosed expressive aphasia; investigation: (2021) unknown results, notes: Evaluations, including imaging, diagnosed expressive aphasia. Therapeutic measures were taken as a result of aphasia, dysphemia. Patient was treated with speech therapy. Patient did not received any other vaccine in four weeks. Patient did not received other medications in two weeks. Patient did not experienced COVID-19 prior vaccination. Patient not tested positive post vaccination. No known allergies were present.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got infected and tested positive for COVID; got infected and tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single and (Batch/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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "got infected and tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive, notes: in the last couple weeks ago the family all tested positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Inflammation, Joint swelling, Pain in extremity, Paraesthesia
Clinical narrative: Patient states inflammatory reaction requiring hospitalization; leg pain could not lift leg or walk; leg pain could not lift leg or walk; Swelling in joints; pins and needles feeling; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 18Jan2022 09:30 (Lot number: Fj5682) at the age of 63 years as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLAMMATION (hospitalization) with onset 23Jan2022, outcome "unknown", described as "Patient states inflammatory reaction requiring hospitalization"; PAIN IN EXTREMITY (non-serious), GAIT INABILITY (non-serious) all with onset 23Jan2022, outcome "unknown" and all described as "leg pain could not lift leg or walk"; JOINT SWELLING (non-serious) with onset 23Jan2022, outcome "unknown", described as "Swelling in joints"; PARAESTHESIA (non-serious) with onset 23Jan2022, outcome "unknown", described as "pins and needles feeling". The events "patient states inflammatory reaction requiring hospitalization", "leg pain could not lift leg or walk", "leg pain could not lift leg or walk", "swelling in joints" and "pins and needles feeling" were evaluated at the physician office visit.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious event 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: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Increase in Afib; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, (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: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "Increase in Afib". The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event atrial fibrillation with 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 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: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: increase in Afib/Paroxysmal Afib that increased to AFib; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Paroxysmal Afib" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "increase in Afib/Paroxysmal Afib that increased to AFib". The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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-202200248143 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I want to thank you so much for creating the vaccines and boosters. As I write this note I had tested positive for covid and have hardly any symptoms; I want to thank you so much for creating the vaccines and boosters. As I write this note I had tested positive for covid and have hardly any symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I want to thank you so much for creating the vaccines and boosters. As I write this note I had tested positive for covid and have hardly any symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Headache, Myalgia, Pyrexia
Clinical narrative: significant side effects with the pain in the underarm on the side of the shot; fever; headache; trap muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 18Mar2021 14:15 (Lot number: ER2613) at the age of 23 years as dose 1, single and intramuscular, administered in deltoid left, administration date 13Apr2021 11:45 (Lot number: EW0151) 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: AXILLARY PAIN (disability), outcome "recovered", described as "significant side effects with the pain in the underarm on the side of the shot"; PYREXIA (non-serious), outcome "recovered", described as "fever"; HEADACHE (non-serious), outcome "recovered", described as "headache"; MYALGIA (non-serious), outcome "recovered", described as "trap muscle pain". The patient underwent the following laboratory tests and procedures: body temperature: unknown results. Therapeutic measures were taken as a result of axillary pain.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101828758 Same patient, same vaccine in different dose, partial same event
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Pain in extremity, Suspected COVID-19
Clinical narrative: Contracted COVID after being receiving the vaccine; Contracted COVID after being receiving the vaccine; Sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 40 year-old female patient received bnt162b2 (COMIRNATY) (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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Contracted COVID after being receiving the vaccine"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". Clinical course-Clinical course- Reporters whole family except 12 years has gotten the Pfizer and had no problems just a sore arm."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Myocardial infarction, Thrombosis
Clinical narrative: symptoms of a mild heart attack; blood clot; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 48 year-old male patient received bnt162b2 (COMIRNATY) (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: Comirnaty (DOSE 1), for covid-19 immunisation. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset Dec2021, outcome "unknown", described as "symptoms of a mild heart attack"; THROMBOSIS (medically significant) with onset Dec2021, outcome "unknown", described as "blood clot". Approximately two months before the report, the patient with no history of heart disease, experienced symptoms of a mild heart attack; after being cathed, there was no sign of blockage, and it was determined to be a blood clot. Patient on blood thinners post occurrence. The patient underwent the following laboratory tests and procedures: cathed: no sign of blockage. Therapeutic measures were taken as a result of myocardial infarction, thrombosis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid 19; received primary series; tested positive for Covid 19; received primary series; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  An adolescent male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid 19; received primary series". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical course: Description of Event: 12-13 year old male tested positive for Covid 19; received primary series. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: breakthrough case of Covid 19; received 2 dose primary series; experienced mild Covid symptoms; breakthrough case of Covid 19; received 2 dose primary series; experienced mild Covid symptoms; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient in his 30's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "breakthrough case of Covid 19; received 2 dose primary series; experienced mild Covid symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: I got the Pfizer shot then not 15 mins. lather I had a server allergic and ended up in the hospital. i do not know why I had the allergic reaction.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 (Batch/Lot number: unknown) at the age of 23 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "diagnosed with APL Leukemia curtly 4 years cancer free", start date: 13Dec2016 (unspecified if ongoing); "Known allergies:i have a long list to medications" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (hospitalization) with onset 06Apr2021, outcome "recovered" (2021), described as "I got the Pfizer shot then not 15 mins. lather I had a server allergic and ended up in the hospital. i do not know why I had the allergic reaction". The patient was hospitalized for hypersensitivity (start date: 06Apr2021). The event "i got the pfizer shot then not 15 mins. lather i had a server allergic and ended up in the hospital. i do not know why i had the allergic reaction." was evaluated at the physician office visit. Therapeutic measures were taken as a result of hypersensitivity. Prior to the COVID vaccine the patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Epinephrine with 2 different er visits was treatment received for the adverse event.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant) with onset 19Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 19Dec2021, outcome "recovered" and all described as "tested positive for Covid". The event "tested positive for covid" and "tested positive for covid" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Dec2021) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Amendment: This follow-up report is being submitted to amend previous information: Amended new case 202200249864 only for event.