chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient got break through COVID; Patient got break through COVID; This is spontaneous report from a contactable consumer. A 59-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (age at the time of vaccination was 59-year-old) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not pregnant at time of vaccination. It was unknown if the patient receives any other vaccines within 4 weeks prior to the COVID-19 vaccine. It was unknown if prior to vaccination patient was diagnosed with COVID-19. Since the vaccination the patient had tested for COVID-19. On 15Aug2021, the patient got break through covid (medically significant). It was unknown if patient received the treatment. No hospitalization was reported for AEs. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 15Aug2021. The outcome of events was not recovered.  The lot number for the vaccine, [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: Patient was fully vaccinated and got break through COVID; Patient was fully vaccinated and got break through COVID; This is a spontaneous report from a contactable consumer (patient). An adult male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as dose 2, single and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was fully vaccinated and got break through COVID (medically significant) on 12Aug2021. The patient underwent lab tests and procedures which included COVID-19 test: positive on 12Aug2021. It was unknown if patient received any treatment for the event. Outcome of the event COVID-19 was resolving.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Oropharyngeal discomfort, SARS-CoV-2 test, Thrombosis
Clinical narrative: Blood clots; Shortness of breathe; Chest and throat pressure; Chest and throat pressure; This is a spontaneous report from a contactable other HCP (patient self). A 43-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Batch/Lot Number: ew01g8), intramuscularly administered in Arm Left on 05Aug2021 at 16:00 at age of 43-year-old as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced blood clots, shortness of breathe, chest and throat pressure on 08Aug2021. Seriousness criteria of events were reported as Life threatening. The adverse event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness immediate risk of death from the event. Since the vaccination, the patient had been tested for COVID-19 (Nasal Swab) on 16Aug2021 showed negative. The patient received heparin as treatment. The outcome of events was not recovered.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of bnt162b2 administration to the events, a possible contribution of the drug to the events 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Positive for Covid-19; Positive for Covid-19; This is a spontaneous report from a contactable consumer.   A 42-year-old male patient that he received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date in Apr2021 (at the age of 42 years), as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks and did not have Covid prior vaccination. The patient was found to be positive for covid-19 on 12Aug2021. Event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The patient underwent lab tests and procedures which included covid-19: positive on 13Aug2021. The outcome of event was recovered on an unspecified date in 2021.   The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Skin exfoliation, Stevens-Johnson syndrome
Clinical narrative: Steven Johnson Syndrome; Blisters on his feet; His hands started peeling; This is a spontaneous report from a contactable consumer (patient's child). A 62-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on unknown date in Jul2021 at 12:45 (Lot number was not reported) as single dose (at age of 62-year-old) for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), emphysema. Patient had no known allergies. Concomitant medications received within two weeks of vaccination included budesonide, formoterol fumarate (SYMBICORT); paracetamol (TYLENOL). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Patient did not have COVID prior vaccination. No COVID tested post vaccination. On 30Jul2021 17:00 patient experienced steven johnson syndrome, blisters on his feet, his hands started peeling. It was reported that patient started out with blisters on his feet and then his hands started peeling. His doctor called it Steven Johnson Syndrome. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient was treated for the events, steroids were prescribed. Patient had not recovered from the events, at the time of the report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Wheezing
Clinical narrative: having a hard time breathing; Started out with the need to constantly clear my throat and then became full on wheezing and coughing; Started out with the need to constantly clear my throat and then became full on wheezing and coughing; This is a spontaneous report from a contactable consumer (patient herself). A 33-years-old non-pregnant female patient received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0186; Expiration Date: unknown) intramuscular, administered in Arm Left on 11Aug2021 09:00 (at age of as 33-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine; nor received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that, on 11Aug2021 09:30 (about 30mins after) receiving the shot patient started having a hard time breathing. Started out with the need to constantly clear throat and then became full on wheezing and coughing. The adverse event resulted in emergency room visit/department or urgent care. Therapeutic measures were taken as a result of adverse events as patient was checked multiple times within 2 hours. Was told to take inhaler before bed that night. Since the vaccination, patient has not been tested for COVID-19. The outcome of all events was recovered on an unspecified date in Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Nodule, Respiration abnormal
Clinical narrative: breathing funny; got the second shot and he has a knot on his cheek; This is a spontaneous report from a contactable consumer (patient) reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER COVID 19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER COVID 19 VACCINE) on an unspecified date as dose 1 for Covid-19 immunization and he had a small knot on his cheek. Caller states he was calling about the Pfizer shot. Caller later reclarifies the Covid 19 shot. Caller states he got the second shot, and he has a knot on his cheek. Caller reclarifies, that with the first shot, he had a small knot on his cheek, but with the second vaccine the knot was bigger. Caller also states he was breathing funny today. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: a small knot on his cheek with the first shot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a small knot on his cheek with the first shot. Patient reclarifies, that with the first shot, he had a small knot on his cheek, but with the second vaccine the knot is bigger and also stated he is breathing funny today. He inquired what should he do about the knot on his cheek. 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: F
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Angioedema; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 24Jun2021, as dose 1, single for COVID-19 immunization. Medical history included angioedema (She experienced angioedema before getting her first dose of the vaccine and was all cleared up). Concomitant medications were not reported. The patient wanted to ask if there are some reports of any types regarding angioedema. On an unknown date in 2021, the angioedema came back again so she wanted to know if she could take the second dose or wait for it to clear up. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: I began to feel faint; blood pressure remained high (145/90); rapid increase in heart rate; shortness of Breath; Dose 1 16Apr2021/ Dose 2 11Aug2021; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 11Aug2021 12:45 (Batch/Lot Number: FA7485) (at the age of 42-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included covid-19 from an unknown date, Prior to vaccination, the patient was diagnosed with COVID-19. There were no known allergies.  There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included the patient received first dose of BNT162B2 administered in Arm Left on 16Apr2021 10:00 AM (lot number: EW016) (at the age of 42-years-old) as DOSE 1, SINGLE for covid-19 immunisation.  About 8 minutes after first dose (16Apr2021), the patient began to feel faint, rapid increase in heart rate and shortness of breath.  Major symptoms subsided after a couple of minutes. On 11Aug2021 12:45 PM, Immediately after receiving 2nd dose (after consulting with primary physician), the patient began to feel faint (pharmacist rush to ensure he was okay and asked if she should call an ambulance), rapid increase in heart rate (pulse 120-130) and shortness of breath.  Major symptoms subsided after about 15 minutes, however pulse remained about 100 bpm for over an hour and blood pressure remained high (145/90) for 6-7 hours. Since the vaccination, the patient had not been tested for COVID-19. There was no treatment received for the events. The outcome of the events was resolving.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101039594 same patient, different vaccine dose and events
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Inappropriate schedule of product administration
Clinical narrative: I began to feel faint; blood pressure remained high (145/90); rapid increase in heart rate; shortness of Breath; Dose 1 16Apr2021/ Dose 2 11Aug2021; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 11Aug2021 12:45 (Batch/Lot Number: FA7485) (at the age of 42-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included covid-19 from an unknown date, Prior to vaccination, the patient was diagnosed with COVID-19. There were no known allergies.  There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included the patient received first dose of BNT162B2 administered in Arm Left on 16Apr2021 10:00 AM (lot number: EW016) (at the age of 42-years-old) as DOSE 1, SINGLE for covid-19 immunisation.  About 8 minutes after first dose (16Apr2021), the patient began to feel faint, rapid increase in heart rate and shortness of breath.  Major symptoms subsided after a couple of minutes. On 11Aug2021 12:45 PM, Immediately after receiving 2nd dose (after consulting with primary physician), the patient began to feel faint (pharmacist rush to ensure he was okay and asked if she should call an ambulance), rapid increase in heart rate (pulse 120-130) and shortness of breath.  Major symptoms subsided after about 15 minutes, however pulse remained about 100 bpm for over an hour and blood pressure remained high (145/90) for 6-7 hours. Since the vaccination, the patient had not been tested for COVID-19. There was no treatment received for the events. The outcome of the events was resolving.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101039594 same patient, different vaccine dose and events
Sex: F
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 from a contactable consumer. This consumer reported that a female patient in her late 50's received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in March as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. She tested positive for Covid last Wednesday on 11Aug2021. She is in her late 50's and a school teacher. Her son is 12 and not vaccinated. Event took place after use of product. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Pain
Clinical narrative: Severe pain in my jaw bone in my ears, my temple area like my upper neck all the way to up to my head.; Light headed/Dizzy; This is a spontaneous report received from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced severe pain in my jaw bone in my ears, my temple area like my upper neck all the way to up to my head and light headed/dizzy on an unspecified date. Consumer stated, "I had just gotten a Pfizer shot about an hour ago and I was looking up with the side effects. I am having like severe pain in my jaw bone in my ears, my temple area like my upper neck all the way to up to my head. Is that something I need to get checked out?". When clarified the name of the product as Pfizer Covid-19 Vaccine, consumer stated, "Yes, then I called here. I had just taken it about an hour ago, hour and a half." When asked to file a safety report, consumer stated, "No, I am thinking of to go to the Doctor because I am lightheaded and dizzy." Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Diplopia, Electrocardiogram, Eye pain
Clinical narrative: puffiness at bottom of eye; Blurred vision within 45 minutes of taking vaccine; Within 9 hours, right eye lid drooping; pupil dilated; pain with pressure behind & around eye; pain with pressure behind & around eye; blurred and double vision; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (Lot Number: EW0198), via an unspecified route of administration, administered in left arm on 01Aug2021 11:00 (at the age of 53 year old), as dose 1, single for COVID-19 immunisation.  Medical history included type 2 diabetes and high blood pressure. Patient had known allergies to sulfur, gold, hydrocodone. Concomitant medication included atorvastatin, estradiol, metformin, semaglutide (OZEMPIC), llisinopril all taken for an unspecified indication. Prior vaccination, the patient was not diagnosed with COVID-19, no other vaccines administered. The patient was not pregnant at the time of vaccination. On 01Aug2021,11:45,  patient experienced blurred vision within 45 minutes of taking vaccine. Within 9 hours, her right eye lid was drooping, pupil got dilated, experienced pain with pressure behind & around eye, got blurred and vision was double vision. The events required visit to Emergency room/department or urgent care. The ER/Hospital agreed the symptoms were reaction to the vaccine. The Pain and blurred vision lasted approximately for 3 days. And 15 days later, on 16Aug2021, she had pain in left eye with puffiness at bottom of eye. The patient underwent lab tests and procedures which included, on an unspecified date, CT Scan, blood work and EKG was taken and all found normal. No treatment was given in response to the events. It was unknown whether the patient tested COVID since vaccination. The outcome of the events pain and blurred vision was recovered on 04Aug2021 and of all other events was not recovered.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Eyelid ptosis, Mydriasis, Ocular discomfort, Vision blurred
Clinical narrative: puffiness at bottom of eye; Blurred vision within 45 minutes of taking vaccine; Within 9 hours, right eye lid drooping; pupil dilated; pain with pressure behind & around eye; pain with pressure behind & around eye; blurred and double vision; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (Lot Number: EW0198), via an unspecified route of administration, administered in left arm on 01Aug2021 11:00 (at the age of 53 year old), as dose 1, single for COVID-19 immunisation.  Medical history included type 2 diabetes and high blood pressure. Patient had known allergies to sulfur, gold, hydrocodone. Concomitant medication included atorvastatin, estradiol, metformin, semaglutide (OZEMPIC), llisinopril all taken for an unspecified indication. Prior vaccination, the patient was not diagnosed with COVID-19, no other vaccines administered. The patient was not pregnant at the time of vaccination. On 01Aug2021,11:45,  patient experienced blurred vision within 45 minutes of taking vaccine. Within 9 hours, her right eye lid was drooping, pupil got dilated, experienced pain with pressure behind & around eye, got blurred and vision was double vision. The events required visit to Emergency room/department or urgent care. The ER/Hospital agreed the symptoms were reaction to the vaccine. The Pain and blurred vision lasted approximately for 3 days. And 15 days later, on 16Aug2021, she had pain in left eye with puffiness at bottom of eye. The patient underwent lab tests and procedures which included, on an unspecified date, CT Scan, blood work and EKG was taken and all found normal. No treatment was given in response to the events. It was unknown whether the patient tested COVID since vaccination. The outcome of the events pain and blurred vision was recovered on 04Aug2021 and of all other events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She tested positive on PCR test. She was already vaccinated with two doses of Pfizer vaccine.; She tested positive on PCR test. She was already vaccinated with two doses of Pfizer vaccine.; This is a spontaneous report from a non-contactable consumer (Patient) via Pfizer Sales Representative. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: EL3246; Expiration Date: 30Apr2021), via an unspecified route of administration on 15Jan2021 as single dose and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: EL0140; Expiration Date: 30Mar2021) via an unspecified route of administration on 24Dec2020 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient tested positive on pcr test. she was already vaccinated with two doses of pfizer vaccine. On an unspecified date she had mild symptomatology. Event took place after use of product. Many months after application. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: They have 7 or 8 people positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine; They have 7 or 8 people positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine; This is a spontaneous report from a Contactable Nurse. This nurse reported similar events for 5 patients. This report is 2nd of 5 reports. A 62-year-old patient of an unspecified gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8734) via an unspecified route of administration as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, patient tested positive for COVID. Reporter was calling to report an outbreak of covid in the long term care setting where she works at. It was reported that they have 7 or 8 people positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the event was unknown.; Sender's Comments: Based on the known safety profile of the drug, a causal association between the reported events of drug ineffective and covid-19 and suspect drug bnt162b2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202101058200 same product and event, different patients
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: obtained a positive test for covid approx 6 months after vaccine; obtained a positive test for covid approx 6 months after vaccine; This is a spontaneous report from a contactable consumer, the patient.  A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was unknown), via an intramuscular route of administration, in the left arm, on an unspecified date in Feb2021 (at the age of 43-year-old), as DOSE 1, SINGLE, for COVID-19 immunization. The patient's medical history was none. No known allergies. The patient received other medications within 2 weeks of vaccination included bupropion, sertraline hydrochloride (ZOLOFT) and tadalafil. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Aug2021, obtained a positive test for COVID approx. 6 months after vaccine. Since the vaccination, patient has been tested for COVID-19 and covid test type post vaccination was nasal swab/ PCR Covid Test and result was positive on 16Aug2021. Prior to vaccination, patient was not diagnosed with COVID-19. The patient underwent lab tests and procedure which included SARS-CoV-2 test/ PCR test/ Nasal Swab and result was positive on 16Aug2021. No treatment for AE. Outcome of the events was recovering  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She said that they have 7 or 8 people positive for covid at this time and 6 of these people have received the vaccine; She said that they have 7 or 8 people positive for covid at this time and 6 of these people have received the vaccine; This is a spontaneous report from a contactable Nurse. This Nurse reported similar events for 5 patients. This is a 3rd of 5th reports. This Nurse reported for a patient that: A 38-years-old adult patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE formulation: solution for injection, Batch/lot number: ER8734, expiry date: unknown) via unspecified route of administration, on an unspecified date as dose number unknown, single for Covid-19 immunisation. Patients medical history and concomitant medications were not reported. Caller on the line reported an AE for the Pfizer BioNTech Covid19 vaccine. She was calling to report an outbreak of covid in the long term care setting where she worked at. She said that they have 7 or 8 people positive for covid at this time and 6 of these people have received the vaccine. She said all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine. She said that they received the vaccine at (Vaccine Facility Name) and I didnt confirm the date of first dose or second dose yet but she gave me the date of 28Mar2021. Consumer stated, so far, had these five and do not have the result back on the others. The outcome of the events was unknown.; Sender's Comments: Based on the known drug safety profile, a causal association between the events of drug ineffective, covid-19 and suspect drug bnt162b2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202101058200 Same reporter and drug, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: They have 7 or 8 people positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine; They have 7 or 8 people positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine; This is a spontaneous report from contactable Nurse. This Nurse reported similar events for 6 patients. This report is for 4th of 5 patient. This Nurse reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8734, and Expiration date: Unknown), via an unspecified route of administration on 28Mar2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The caller on the line reported an AE for the Pfizer BioNTech Covid19 vaccine. She called to report an outbreak of COVID in the long term care setting where she works at. She said that 'they have 7 or 8 people positive for covid at this time and 6 of these people have received the vaccine". She said all of them had received the vaccine and 6 people out of 7 or 8 that were infected had the Pfizer BioNTech COVID-19 vaccine. She said that she did not confirm the date of first dose or second dose but she gave the date of 28Mar2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive. The outcome of the event was unknown.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Drug ineffective, Covid 19 and the suspect drug BNT162B2. 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-202101058200 same product and event, different patients
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Caller was diagnosed with a UTI; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 19Mar2021 as dose 2, single for COVID-19 immunization (at the age of 74-year-old); tofacitinib citrate (XELJANZ XR), via an unspecified route of administration from Feb2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. Historical vaccine included first dose of BNT162B2 (Lot number: not reported) via an unspecified route of administration on 24Feb2021 for COVID-19 immunization (at the age of 74-year-old). The patient's medical history and concomitant medications were not reported. The patient experienced caller was diagnosed with a UTI (urinary tract infection) on an unspecified date in Jun2021. It was reported that, patient was diagnosed with a UTI a couple months ago around Jun2021 and was prescribed an antibiotic for it. Patient was taking XELJANZ XR 11 mg that he started taking in early Feb2021 before getting both doses of the Pfizer Covid-19 vaccine and was asking if he should stop it if he gets the booster dose of the Pfizer Covid-19 vaccine. Caller was asking if the booster of the Pfizer Covid-19 vaccine would be more effective if he holds the Xeljanz. Patient stated that, his HCP had recommended that he gets the booster dose of the Pfizer Covid-19 vaccine. Patient did not know if he needs to stop the medication Xeljanz XR 11 mg that he took while he got the booster. Patient was treated with antibiotic as a result UTI. 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: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash in her arms now it's worse; itching; This is a spontaneous report form a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 28Jul2021, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, about a week or a week and a half after the first dose of vaccine, the patient experienced itching; and rash in her arms now it was worse, which got spread to the rest of her body and legs from one to the other. Patient was scheduled for the second dose on an unknown dated however she cancelled her appointment because she was experiencing side effects. Patient enquired whether her side effects got something to do with the vaccine. Patient enquired about what must be done to stop the event. It was reported that, at the time of first dose, patient had not taken steroids and cortisones but because of the rash patient had to put on some because it was itching. The patient was concerned about the events. The clinical outcome of all the events was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Drug ineffective; Covid19; This is a spontaneous report from contactable consumer (Pfizer Colleague). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported), dose 2, via an unspecified route of administration on 23Mar2021 as DOSE 2, single and received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, single dose, both for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Aug2021 patient tested positive for COVID (Drug ineffective). Fully Vaccinated. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: tested positive on 10Aug2021. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I had Covid before I got vaccinated. After I got vaccinated with the Pfizer shots I got sick again with Covid. I currently have Covid.; I had Covid before I got vaccinated. After I got vaccinated with the Pfizer shots I got sick again with Covid. I currently have Covid.; This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query.  The patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), first dose on via an unspecified route of administration on unspecified date as Dose 1,Single for COVID-19 immunization. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date as Dose 2,Single for COVID-19 immunization. Medical history includes COVID-19 infection. No concomitant medications reported. Patient got sick again with Covid-19 after vaccination on unspecified date. The patient underwent SARS-CoV-2 test and found positive. The outcome of Events was unknown.   Information on the lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: Ache; Chills; sore arm; This is a spontaneous report received from a non-contactable consumer(patient). A 25-year-old female patient received BNT162B2 (solution for injection; lot number- ew0181, expiry date not reported) via an unspecified route of administration into right arm, on 16Aug2021 17:00  at the age of 25-year-old, dose 2, single for covid-19 immunisation in a pharmacy or drug Store. The patient did not have any medical history. Historical vaccine included BNT162B2 (solution for injection; lot number and expiry date not reported) via an unspecified route of administration, on unknown date, dose 1, single for covid-19 immunisation. The patient is not pregnant at the time of vaccination. The patient did not receive other vaccine in four weeks. The patient did not have prior COVID vaccination and was not tested post vaccination. On 17Aug2021 09:00, the patient experienced ache, chills,and sore arm. The patient did not receive treatment in response to the events. The outcome of the events was not recovered at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Influenza like illness, Malaise, Oropharyngeal pain, Portal vein thrombosis
Clinical narrative: 04Aug admitted to the hospital for Portal Vein Thrombosis; (PVT) - Blood clot in left portal vein of my liver.; On 01Aug started having abdominal pain; 22Jul started feeling sick with sore throat; 22Jul started feeling sick with sore throat; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 38-year-old Non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0181), via an unspecified route of administration, administered in Arm Right on 15Jul2021 (at age of 38 years old) as single dose for COVID-19 immunisation. Medical history included Crohn's disease, Known allergies: Shrimp. There were no concomitant medications. No other vaccine in four weeks. No Other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. 15Jul2021 date of 1st dose, 22Jul2021 started feeling sick with sore throat, flu like symptoms. On 01Aug2021 started having abdominal pain, waited until the pain was unbearable and went to ER on 04Aug. 04Aug admitted to the hospital for Portal Vein Thrombosis (PVT)-Blood clot in left portal vein of liver. AE resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). No. days hospitalization: 4. AE treatment (Xarelto - Blood thinner). The outcome of the events feeling sick with sore throat, flu like symptoms was recovered in 2021, for other events was recovered on Aug2021.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: 04Aug admitted to the hospital for Portal Vein Thrombosis; (PVT) - Blood clot in left portal vein of my liver.; On 01Aug started having abdominal pain; 22Jul started feeling sick with sore throat; 22Jul started feeling sick with sore throat; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 38-year-old Non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0181), via an unspecified route of administration, administered in Arm Right on 15Jul2021 (at age of 38 years old) as single dose for COVID-19 immunisation. Medical history included Crohn's disease, Known allergies: Shrimp. There were no concomitant medications. No other vaccine in four weeks. No Other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. 15Jul2021 date of 1st dose, 22Jul2021 started feeling sick with sore throat, flu like symptoms. On 01Aug2021 started having abdominal pain, waited until the pain was unbearable and went to ER on 04Aug. 04Aug admitted to the hospital for Portal Vein Thrombosis (PVT)-Blood clot in left portal vein of liver. AE resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). No. days hospitalization: 4. AE treatment (Xarelto - Blood thinner). The outcome of the events feeling sick with sore throat, flu like symptoms was recovered in 2021, for other events was recovered on Aug2021.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Dyspnoea, Heart rate increased, Hyperhidrosis, Skin burning sensation
Clinical narrative: shortness of breath; increased heart rate; burning sensation that went down his waist (lower part of his back), hot burning sensation that started from a small part of his body and went up to the top of his head; hot burning sensation that started from a small part of his body and went up to the top of his head; profuse sweating; This is a spontaneous report from a contactable consumer or other non hcp.   A 31-years-old male patient received bnt162b2 (BNT162B2 Solution for injection), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation (31-years at the age of vaccination). The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced shortness of breath, increased heart rate, burning sensation that went down his waist, hot burning sensation that started from a small part of his body and went up to the top of his head, hot burning sensation that started from a small part of his body and went up to the top of his head and profuse sweating on 2021 (Unspecified date). The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products, Off label use
Clinical narrative: one of his patients received 2 initial doses of Moderna COVID 19 vaccine 6 months ago and had the 3rd dose of Pfizer COVID 19 vaccine; One of his patients received 2 initial doses of Moderna COVID 19 vaccine 6 months ago and had the 3rd dose of Pfizer COVID 19 vaccine; one of his patients received 2 initial doses of Moderna COVID 19 vaccine 6 months ago and had the 3rd dose of Pfizer COVID 19 vaccine; This is a spontaneous report from a Pfizer Sponsored Program. A contactable pharmacist reported for a 73-years-old male patient that received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 3, single for covid-19 immunisation. Medical history included benign prostatic hypertrophy and malignant neoplasm of the prostate, from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received covid-19 vaccine mrna (MRNA 1273) (MODERNA COVID-19 VACCINE) as initial 2 doses for covid-19 immunisation 6 months ago. He mentioned that one of his patients received 2 initial doses of Moderna COVID 19 vaccine 6 months ago and had the 3rd dose of Pfizer COVID 19 vaccine yesterday. He stated that the patient was qualified to get the 3rd dose because of age and comorbidity - Patient also has benign prostate hypertrophy malignant neoplasm of the prostate. On 12Aug2021, the FDA updated the emergency use authorizations for the Pfizer-BioNTech COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals. People who are fully vaccinated against COVID-19 and are not immunocompromised do not need an additional dose of COVID-19 vaccine at this time. As per the updated Information: A third dose of the Pfizer-BioNTech COVID-19 vaccine (0.3 mL) administered at least 28 days following the first two doses of this vaccine is authorized for administration to individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. The outcome of event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away; This is a spontaneous report from a contactable consumer (patient's sister, caregiver). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for COVID-19 immunisation. Medical history included the patient was diabetic and had heart surgery. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 for COVID-19 immunization in Apr2021. The reporter stated she needed help and the patient (her sister) passed away in Jul2021 and she had the cards that Pfizer got proving and had gotten the shot and they need to find out and get copies of the proof that they all received the Pfizer COVID vaccine. The reporter stated this is the card that Pfizer get signed and they need another copy. The reporter stated the family had been going through her sisters drawers and they can't find it and they were in her wallet but they were not there either. The reporter stated she didn't really need her sisters since she was dead but she needed her sisters daughter withheld and her husband withheld proof that they have been vaccinated and they received the first and second dose of the Pfizer COVID vaccine. The reporter stated her sister did not die right after her first treatment which was in Apr2021 and she just passed away in Jul2021. The reporter stated she knew for a fact that it was not related to the vaccine and did not see the need to be transferred. The patient died in Jul2021.  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: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease may provide an alternative cause.; Reported Cause(s) of Death: Passed away